Puyer’s Go Blog

Say No To Puyer,Stop Polypharmacy And Back To Guidline(EBM)

Dampak Penggunaan Antibiotik yang Irasional

Kamis, 17 September 2009 | 11:22 WIB

KOMPAS.com — Penggunaan atau pemberian antibiotik sebenarnya tidak membuat kondisi tubuh semakin baik, justru merusak sistem kekebalan tubuh karena imunitas anak bisa menurun akibat pemakaiannya. Alhasil, beberapa waktu kemudian anak mudah jatuh sakit kembali.

Jika pemberian antibiotik dilakukan berulang-ulang, ujung-ujungnya anak jadi mudah sakit dan harus bolak-balik ke dokter gara-gara penggunaan antibiotik yang tak rasional.

“Kenyataannya, kita ‘boros’ dalam menggunakan antibiotik sehingga bisa menimbulkan dampak buruk antara lain sakit berkepanjangan, biaya yang lebih tinggi, penggunaan obat yang lebih toksik, dan waktu sakit yang lebih lama,” sesal dr Purnamawati S Pujiarto, SpA (K), MMPed, yang akrab disapa Wati ini.

Selain itu, ada beragam efek yang mengancam bila anak mengonsumsi antibiotik secara irasional, di antaranya kerusakan gigi, demam, diare, muntah, mual, mulas, ruam kulit, gangguan saluran cerna, pembengkakan bibir maupun kelopak mata, hingga gangguan napas. Bahkan, berbagai penelitian menunjukkan, pemberian antibiotik pada usia dini berisiko menimbulkan alergi di kemudian hari.

Dampak lain akibat pemberian antibiotik irasional adalah gangguan darah di mana salah satu antibiotik seperti kloramfenikol dapat menekan sumsum tulang sehingga produksi sel-sel darah menurun. Risiko kelainan hati muncul pada pemakaian antibiotik eritromisin, flucloxacillin, nitrofurantoin, trimetoprim, dan sulfonamid.

Golongan amoxycillin dan kelompok makrolod dapat menimbulkan allergic hepatitis (peradangan hati). Sementara antibiotik golongan aminoglycoside, imipenem/meropenem, ciprofloxacin juga dapat menyebabkan gangguan ginjal.

Selain itu, pemberian antibiotik spektrum luas tanpa indikasi yang tepat dapat mengganggu perkembangan flora normal usus karena dapat mematikan bakteri gram positif, bakteri gram negatif, kuman anaerob, serta jamur yang digunakan pada proses pencernaan dan penyerapan makanan dalam tubuh. Bakteri yang ada di dalam tubuh umumnya menguntungkan, seperti bakteri pada usus yang membantu proses pencernaan serta pembentukan vitamin B dan K.

Nah, anak yang kelebihan antibiotik bisa mengalami kekurangan vitamin K yang berguna mencegah perdarahan. Selain itu, juga akan menyebabkan anak menderita penyakit diare karena sistem pencernaan terganggu dan mengalami iritasi di bagian usus akibat zat-zat kimia dari antibiotik.

Diare disebabkan terbunuhnya kuman yang diperlukan untuk pencernaan dan menjaga ketahanan usus sehingga bakteri “jahat” menguasai tempat tersebut dan merusak proses pencernaan.

Akibat lain dari pemberian antibiotik yang tidak tepat adalah timbulnya kuman yang resisten. Setiap makhluk memiliki kemampuan untuk bertahan, begitu pun bakteri atau kuman. Jika jasad renik ini diserang terus-menerus, akan tercipta suatu sistem untuk bertahan dengan cara bermutasi atau berubah bentuk sehingga sulit dibunuh oleh antibiotik. “Jadi, semakin sering mengonsumsi antibiotik, makin resisten pula bakteri, parasit, atau jamur tersebut!” tandas Wati.

Bibit penyakit yang resisten itu dikenal dengan nama superbugs. Superbugs ini dapat menjadi masalah serius bagi kesehatan, baik bagi si penderita maupun masyarakat luas. Bila ada anggota masyarakat di suatu lingkungan mengonsumsi antibiotik secara berlebihan (tidak rasional), lingkungan tersebut potensial terinfeksi oleh kuman yang sudah resisten antibiotik.

Infeksi akibat superbugs ini memerlukan antibiotik yang jauh lebih kuat. Pasien harus dirawat di rumah sakit karena antibiotiknya harus diberikan melalui cairan infus. Antibiotik ini berisiko menimbulkan efek samping kesehatan yang lebih berat. Selain itu, dalam waktu cepat, bakterinya akan kebal kembali terhadap antibiotik yang superkuat tadi.

Itulah sederet akibat buruk dari penggunaan antibiotik secara berlebihan (irasional). “Yang akan dirugikan tentu bukan hanya pasien, tapi juga lingkungan sekitarnya,” kata Wati. Lantaran itu, pasien diharapkan tidak selalu meminta dokter memberikan antibiotik terutama untuk penyakit infeksi virus seperti flu, pilek, atau batuk.

Memang, antibiotik mampu memerangi infeksi akibat bakteri atau kuman sehingga tak lepas perannya dalam proses penyembuhan. Akan tetapi, penggunaan yang irasional menyebabkan antibiotik lebih banyak merugikannya ketimbang menguntungkan. (Nakita/Hilman Hilmansyah)

Sumber : Kompas

September 17, 2009 Posted by | Artikel | Leave a comment

Mekanisme Resistensi Bakteri pada Antibiotik

Sabtu, 12 September 2009 | 09:17 WIB

KOMPAS.com - Berbagai jenis bakteri saat ini semakin cerdik menghancurkan kerja antibiotik. Selain itu, bakteri juga mampu menghancurkan mekanisme pertahanan yang seharusnya dipakai antibiotik untuk melawan infeksi. Akibatnya makin banyak bakteri yang meningkat kekebalannya.

Para peneliti dari Universitas New York mengatakan beberapa bakteri patogen bisa menghasilkan semacam nitric oxide yang memproduksi enzim yang membuatnya jadi resisten terhadap antibiotik. Selanjutnya, bakteri yang kebal itu dengan cepat berkembang biak dan menghasilkan koloni baru dan makin sulit dilumpuhkan.

Karena itu para ahli berusaha membuat obat-obatan yang mampu menghambat produksi enzim tersebut agar antibiotik dapat semakin kuat, bahkan bakteri super seperti methicillin-resistant Straphylococcus aureus atau MRSA pun bisa dihancurkan.

“Membuat obat baru untuk melawan bakteri yang resisten seperti MRSA adalah sebuah tantangan, yang dikaitkan dengan biaya besar dan isu keamanan kesehatan,” kata Evgeny Nudler dari Langone Medical Center, AS.

Bakteri yang resisten pada antibiotik, seperti MRSA telah menjadi masalah utama kesehatan dunia, dan telah membunuh sedikitnya 19.000 orang di Amerika Serikat setiap tahunnya.

Dalam riset yang dilakukan oleh Nudler diketahui bahwa kebanyakan antibiotik membunuh bakteri dengan memproduksi partikel berbahaya yang dikenal sebagai spesies reaktif oksigen atau oxidatif stres.

“Antibiotik membuat bakteri memproduksi lebih banyak jenis reaktif oksigen. Hal itu akan merusak DNA dan membuat bakteri tak bisa bertahan, bahkan mati. Nitric oxide dikeluarkan bakteri untuk melindunginya dari oxidatif stres,” kata Nudler yang hasil risetnya dipublikasikan dalam jurnal Science.

Karena itu, menurut Nudler komponen sintetis nitric oxide inhibitor yang biasanya ada pada obat anti peradangan bisa dipakai untuk mengurangi produksi nitric oxide yang dihasilkan bakteri, dengan demikian kekuatan bakteri untuk melawan antibiotik pun berkurang. Ini artinya, para ilmuwan tak perlu mencari antibiotik baru.

Sumber : Kompas

September 13, 2009 Posted by | Artikel | Leave a comment

Indonesian doctor sends her message about “poeioor/puyer”

The practice of parcelling ground-up drug mixtures to treat paediatric conditions, still common in Indonesia, results in irrational drug use that threatens the health of children. An Indonesian paediatrician is using radio and television to call for the practice to stop. Cininta Analen reports.

When Sasha Jusuf’s six-month-old baby developed a fever she took her to the emergency department. “Zea had a temperature of 40°C, and was coughing,” Sasha remembers. A doctor at the hospital in Jakarta diagnosed a common cold and prescribed paracetamol and a cough syrup. But, seeing little improvement in Zea’s condition, 27-year-old Sasha went to a paediatrician the following day. He took a quick look at the baby, “diagnosed” throat inflammation – needless to say, not a disease but a symptom – and prescribed amoxycillin.

After two days on the antibiotic, Zea became extremely lethargic. Alarmed, Sasha returned to the emergency department in the middle of the night where the doctor she had seen on the first visit now discovered hives behind Zea’s ears. This time he diagnosed measles and scribbled out a list of powerful medications that included an antibiotic, an antihistamine, an anti-asthma drug and, to top it all off, an anticonvulsant. These were to be ground up into a powder by a pharmacist and given to the baby in fifteen “paediatric” packets.

WHO/Martin Weber
Piles of puyers, cocktails of medicines ground up into powder.

Such concoctions, known as puyers – derived from “powder” in Dutch – are a typical response to commonplace paediatric ailments in Indonesia. According to studies carried out in the Indonesian provinces of Bali in 2000 and West Sumatra in 2006, puyers contain on average around four active ingredients, while a national study carried out by the Indonesian Ministry of Health in 1997 reported an average number of medications per prescription of 3.49.

But the reality may be even more alarming according to a preliminary study of prescribing patterns for common paediatric ailments carried out in 2006–2007 by paediatrician Purnamawati S Pujiarto, founder of a nongovernmental organization (NGO) Yayasan Orang Tua Peduli, in collaboration with her colleague Dr Arifianto. This limited study, based on e-mail testimony from mothers aged between 26 and 30 years, found that in every case the women’s children had been prescribed mixtures of up to 11 medications for ailments that were both mild and self limiting. The most commonly prescribed drugs were antibiotics.

According to Purnamawati, more than 50% of the medicines consumed in Indonesia are prescribed, dispensed, or sold irrationally, often as a result of the grinding and compounding that is a key aspect of puyer production. “Medicines are prescribed for children when they are not needed, when they are inappropriate, when they are ineffective and when they are unsafe,” she says. The practice also leads to overuse of antibiotics and steroids, which can lead to drug resistance. Meanwhile, effective and affordable medicines that are available, including many generic medicines, are underused or not used correctly.

For Dr Sri Suryawati, a leading proponent of rational drug use in Indonesia, where she runs the International Network for Rational Use of Drugs (INRUD), polypharmacy – the prescription of many drugs at one time – is one of the biggest risks associated with the use of puyers, notably where there are adverse drug-to-drug interactions. Meanwhile, where side-effects occur, the fact that the drugs have been taken together makes it difficult to pinpoint which medicine is causing the problem. Other concerns include the likelihood of human error in mixing, contamination and lack of information for the consumer. “Puyer packets have no information on them,” says Suryawati, pointing out that this means that puyers are not in compliance with a 1992 law on complete and accurate labelling.

WHO/Cininta Analen
Dr Purnamawati S Pujiarto

Children are put at particular risk when the doctor grinds adult solid dosages to a powder, which is then divided into assumed paediatric doses. This was one of many problems underlined by a meeting in March in Geneva of the World Health Organization’s Expert Committee on the Selection and Use of Essential Medicines. In a draft report of that meeting published on the Internet, the committee concluded that puyers should not be used because “some medicines in the mixture are not indicated for the condition being treated. These medicines add to the risk of adverse events without any possibility of adding additional benefit.”

In Indonesia, there are signs that things may be changing. Suryawati takes heart from a recent government decision to include paediatric preparations in the latest revision of the Indonesian National Essential Medicine List of 2008. “This revision is extremely important as there will be no place for compounding anymore when paediatric preparations are available,” Suryawati says.

Given the powerful scientific argument against the use of puyers, why is it still commonplace in Indonesia? According to Purnamawati, one reason is convenience. “It’s easier and faster for the doctors to write the same template prescription over and over again, rather than prescribing individually and having to explain the sickness, its cause and what must be done by the patient,” she says, noting that her study revealed that doctors seldom informed parents about the cause of a given ailment. “They just repeat the symptoms as the ‘diagnosis’ – the most common being ‘a sore throat’,” she says. This practice puts the focus on medicating the symptom rather than the cause.

Inertia also plays a role: “Prescribing puyers has become a part of the health-care culture,” Purnamawati says. It is simply the way things have been done for a long time. Finally, there is the perennial issue of financial interest. “The prescribing pattern in one of our studies showed a low rate of generic prescriptions,” says Purnamawati, noting that doctors preferred to prescribe brand-name drugs likely to generate money for the providers.

WHO/Cininta Analen
Zea with her father, Jusuf. Zea is now 18 months old.

In an effort to push back against these entrenched practices, Purnamawati’s NGO has made a concerted effort to address the public directly through mass media rather than try to persuade doctors to change their ways. Since 2005, Purnamawati, has promoted the cause of rational drug use through a Be Smarter, Be Healthier campaign, which she publicizes in interviews on radio, television and the Internet. “We encourage people to get health information to reduce their dependency on curative services from doctors,” Purnamawati says, adding that a more informed public will encourage doctors to adopt rational use practices.

Needless to say the approach has upset members of Indonesia’s medical establishment. Back in February, Purnamawati spoke about puyers on a programme entitled Polemik Puyer, aired on a private television station, RCTI. The show provoked a good deal of controversy and Purnamawati was surprised by the number of doctors who spoke out against her, saying that her statements were misleading. At the same time she was encouraged by the public response. “This show encouraged a critical attitude in the general public and as a result many parents consulted me directly,” she says.

Of course not every mother has the courage to adopt this critical attitude when faced by a doctor. Sasha Jusuf certainly did not. But she did have misgivings. “When I got home, I did some research in magazines and on the Internet and I found out that at six months my baby would start teething and that the fever was a common symptom,” she says. She didn’t give Zea the puyer and after a couple of days the baby made a complete recovery. Without knowing it, she was following Purnamawati’s recommendations for people who doubt their doctor’s puyer recipe. “If there are more than two lines in the prescription don’t buy it,” Purnamawati says. ■

Source : www.who.int

August 5, 2009 Posted by | Artikel | Leave a comment

Menimbang Obat Keras dengan Waras

Pasien memburu dokter yang memberi obat cuma sekali dan langsung sembuh.

Sewaktu menderita tifus, Alvin (bukan nama asli), diresepkan dokter minum obat antibiotik bernama kloramfenikol. Obat itu harus diminum empat kali sehari selama dua pekan hingga dia bebas demam. Ternyata baru sepekan minum obat, pria berusia 21 tahun ini sudah pulih. Dia tak lagi menyentuh antibiotik, tapi dalam setahun penyakitnya kambuh lagi. Namun, ia malas memeriksakan diri ke dokter. Ia merasa cukup dengan menebus kopi resep lama di apotek dekat rumah.

Pola pengobatan sendiri atau swamedikasi ini mudah ditemukan di masyarakat. Serupa juga dengan penanganan gangguan pada mata, seperti mata merah. Meski mata si A dan B tampak sama merah, yang satu bisa diakibatkan oleh debu dan yang satu bisa diakibatkan oleh virus. Maka obatnya pun berlainan. Menurut praktisi kesehatan, dokter Handrawan Nadesul, kerugian bisa muncul karena swamedikasi.

Handrawan menjelaskan, meski obatnya sama, dosis sama, dan untuk penyakit yang sama, tapi belum tentu respons tubuh sama. “Fisiologis tubuh itu berubah-ubah,”ujarnya dalam kelas jurnalis bertajuk “Pemakaian Obat Keras di Masyarakat” di Hotel Sahid Jaya pekan silam.

Seperti diketahui, obat antibiotik dan tetes mata digolongkan sebagai obat keras. Definisi obat keras adalah obat yang berkhasiat kuat dan penggunaannya mesti dengan resep dokter. Obat ini memakai tanda lingkaran merah bergaris tepi hitam dengan tulisan huruf K di dalamnya. Yang termasuk dalam golongan ini adalah antibiotik, seperti kloramfenikol, tetrasiklin, dan penisilin, serta obat-obatan untuk diabetes melitus, obat penenang, atau obat yang mengandung hormon.

Saat ini banyak sekali penyalahgunaan obat keras. Hal ini didukung juga oleh pihak apotek yang dengan mudah melayani pembelian obat keras tanpa resep dokter atau kopian resep dokter. Handrawan menyebutkan, dokter memilih jalan pintas agar pasien cepat sembuh. Yang penting, minum obat sekali, dan semua keluhan langsung hilang. “Dengan begitu, pasien menjadi puas,” tutur dokter yang doyan menulis puisi ini.

Pasien memang berburu dokter yang memberi obat cuma sekali dan langsung sembuh, sehingga dokter berlomba memberi obat yang paling kuat agar pasien lekas sembuh. Apalagi sang dokter–khususnya di Indonesia–menangani terlalu banyak pasien. Waktu untuk melakukan anamnesis–komunikasi pasien dengan dokter–yang intens pun sangat minim. “Pasien belum duduk, resep obat sudah jadi,” ujar Handrawan.

Di sisi lain, industri medis mendorong dokter berpikir bisnis. Sebaliknya, pasien dalam posisi yang menerima. Karena itu, berapa pun harga obat yang diberi dokter, kalau pasien mampu, mereka akan membelinya. Masyarakat harus pintar. Handrawan berpesan, yang harus dicari masyarakat adalah resep dengan sedikit obat, sedikit dosis, dan murah harganya.

“Obat yang terlalu tinggi harganya, selain membebani kantong, menyebabkan tubuh memikul efek samping yang sebetulnya tidak perlu,” tutur Handrawan. Ia menyebutkan, pemakaian obat keras secara sembarangan bisa meracuni tubuh, memperparah penyakit, bahkan menyebabkan kematian.

Sebagai contoh pasien penyakit mag. Pengobatan sakit mag itu bikin pusing, mual, dan lemas. Semua keluhan itu, menurut dokter berusia 60 tahun ini, tidak perlu diberikan obat. Bayangkan, berapa banyak obat yang diberikan kalau setiap keluhan diobati. “Itu yang disebut polifarmasi atau resep berlebihan.” Sebenarnya cukup obat mag saja, karena apinya ada di lambung. Untuk memadamkan api, cukup diberi obat mag yang tepat.

Handrawan menyatakan perhitungan manfaat dan risiko harus menjadi dasar pertimbangan dokter dalam menulis resep yang rasional. Sikap polifarmasi–memberi obat secara berlebihan–dalam menulis resep adalah bagian dari industri medis. Menurut dokter ramah ini, kasus iatrogenic (gangguan kesehatan akibat kekeliruan layanan medis) berpotensi muncul dari kelalaian menulis resep yang tidak rasional. Termasuk munculnya kasus adiksi terhadap obat.

Menurut Handrawan, pasien mempunyai hak bertanya ke dokter. Dokter pun seharusnya mengkomunikasikan obat dan efek sampingnya kepada si pasien. Hanya, hal itu jarang terjadi di negeri ini. Malah dokter dan pasien cenderung tidak kenal. Pasien juga kerap berpindah-pindah dokter. Banyak pasien tak punya catatan kesehatan, apakah memiliki riwayat diabetes atau epilepsi. Padahal hal ini menjadi pertimbangan dalam pemberian obat.

Jangankan obat etikal yang harus ditebus dengan resep dokter, obat warung saja perlu perhatian. Apalagi sampai diperlakukan bak kacang goreng. Rata-rata masyarakat mudah sekali mengkonsumsi obat padahal tidak perlu. Handrawan mengungkapkan, tubuh memiliki otoregulasi otomatis untuk memulihkan kondisinya bila mengalami ketidakseimbangan. Jadi biarkan tubuh melaksanakan tugas mekanisme pemulihan diri. Ia menyatakan intervensi obat yang cepat, selain merugikan secara ekonomis, membuat dampak fisiologis yang tidak perlu menjadi beban dalam tubuh pasien. “Kalau bisa tanpa obat, mengapa harus memilih dengan obat?” HERU TRIYONO

MENYIKAPI OBAT

  1. Tidak memperlakukan obat bak kacang goreng.
  2. Berhenti minum obat kalau tidak kunjung sembuh atau penyakit malah makin parah.
  3. Antibiotik harus dihabiskan dan tidak membelinya separuh resep.
  4. Seringan-ringannya obat, tentu ada efek samping, apalagi obat keras.
  5. Menjadi racun bila tidak tepat dan salah penggunaannya.

SEDERET PANDANGAN KELIRU

  1. Makin tokcer obat, makin tergolong hebat.
  2. Obat generik adalah obat kelas dua.
  3. Harga obat menentukan kualitas.
  4. Keluhan dan gejala yang sama bisa ditangani oleh obat yang sama.
  5. Melanjutkan sendiri pemakaian obat untuk penyakit menahun.
  6. Semua kasus hipertensi atau diabetes sama obatnya.

JENIS OBAT

  1. Obat daftar G = Etikal = obat keras (huruf K lingkaran merah)
  2. Obat warung (OTC-over the counter)
  3. Obat bebas (lingkaran hijau)
  4. Obat bebas Terbatas (lingkaran biru)
  5. Ada tanda huruf P (Perhatian) untuk baca aturan-untuk pemakaian luar-untuk tidak ditelan-untuk dibakar-untuk wasir
  6. Obat yang sangat diawasi (daftar O)

SUMBER: DR HANDRAWAN NADESUL

Sumber : TEMPOl


August 5, 2009 Posted by | Artikel | Leave a comment

WHO : Powdered/Compounding/”Puyer” Drug Concerns Unwarranted

The Committee also considered extemporaneous preparations involving polypharmacy.
The Committee noted that in 1985, the WHO defined rational use of medicines as requiring “patients receive medications appropriate to their needs, …”.
The custom in some places is to treat sick children with a mixture of several medicines (“puyer”), not necessarily all  appropriate to their needs.
Commonly, adult solid dosages forms are mixed together, ground to a powder, and the powder divided into assumed pediatric doses and then dispensed for administration to the child.
Often, some medicines in the mixture are not indicated for the condition being treated. These medicines add to the risk of adverse events without any possibility of adding additional benefit.
The Committee recommended that as this practice is irrational it should not be used.

Source : http://www.who.int/selection_medicines/committees/expert/17/en/index.html

May 16, 2009 Posted by | Artikel | Leave a comment

Bau Tak ‘Sedap’ Dari Puyer

Fakta  yg sudah terjadi  di negari ini :

Berbagai studi menemukan bahwa penggunaan obat untuk ISPA cenderung
berlebih. Penyebab pertama, keterbatasan pengetahuan petugas kesehatan
mengenai bukti-bukti ilmiah terkini, sehingga tak jarang tetap meresepkan
obat yang tak diperlukan (misal antibiotika dan steroid untuk common cold). Kedua,
keyakinan dan perilaku pasien. Contoh, kebiasaan memberikan injeksi pada
pasien dengan gejala pada otot-sendi. 43 puskesmas ikut dalam penelitian. Jumlah ratarata
obat yang diresepkan untuk ISPA anak dan dewasa, yaitu 3.62 dan 3,69. Pasien myalgia
mendapat rata-rata 3.24 jenis obat. Di sebagian besar kabupaten penggunaan
antibiotika untuk ISPA mencapai lebih dari 90%. Hanya beberapa puskesmas yang meresepkan
antibiotika kurang dari 70%.

Tujuan penelitian (1) menilai pola peresepan ISPA dan myalgia di puskesmas
di 8 kab/kota, SumBar (data peresepan retrospektif), dan (2) meningkatkan
mutu penggunaan obat untuk ISPA dan myalgia (dilakukan intervensi pelatihan
penggunaan obat rasional, melibatkan dokter dan perawat di 15 puskes).
Enam bulan pasca intervensi, penggunaan obat termasuk antibiotika dan
injeksi menurun bermakna. Rata-rata jumlah obat untuk ISPA pada anak turun
dari 3.74 + 0.58 menjadi 2.47 + 0.67 (p<0.05) (dokter) dan dari 3.67 + 0.49
menjadi 2.39 + 0.73 (p<0.05) (perawat). Penurunan penggunaan antibiotika pada anak
dengan ISPA secara bermakna hanya ditemukan pada perawat, dari 81.37%
menjadi 42.40%.
Proporsi pasien dewasa dengan ISPA yang mendapat antibiotika Turun bermakna
dari 89.18% menjadi 44.15% (p<0.05) (dokter) dan dari 91.22% menjadi 38.71%
(p<0.05) (perawat). Penggunaan injeksi juga turun bermakna pada pasien
myalgia, yaitu dari 69.11% menjadi 31.89% (p<0.05) (dokter) dan dari 79.56%
menjadi 62.91% (p<0.05) (perawat).

————————————————————————————–

Yayasan Orang Tua Peduli (YOP) melakukan 2 penelitian cross sectional dengan mengumpulkan resep yang di email ke mailing list kami, penelitian kedua, mengumpulkan resep dan kwitansi yang dikirim ke markas YOP.

Resep yang ditelaah adalah resep untuk anak dengan 4 kondisi : batuk pilek demam (ISPA), demam, diare akut (dengan atau tanpa muntah), dan batuk tanpa demam lebih dari 1 minggu.

Berikut ini ringkasan penelitian pertama dengan responden 160 anggota mailing list.

Jumlah obat.
Median jumlah obat yang diresepkan adalah 5 (dengan rentang 2 – 11 obat).

Batuk merupakan kondisi yang jumlah obat dalam peresepannya paling tinggi yaitu 11 obat.

Dengan tingkat peresepan puyer sebesar  :

- 55,4% pada diare akut

-  72,6% pada demam

-  77,4% pada ISPA

-  87% pada batuk

Antibiotik:

- 87% pada anak demam

- 75% pada diaare

- 54.5% pada ISPA

- 47% pada anak batuk tanpa demam.

Generik:

- 0% pada kasus demam

- 5% pada diare akut

-  7% pada ISPA

- 10,5% pada batuk tanpa demam
Steroid:

- 60,9% pada batuk

- 50,9% pada ISPA

-  53,5% pada demam

- Bahkan 18,5% anak diare diberi steroid (umumnya triamnisolon).

Tingginya tingkat pemberian steroid juga sangat memprihatinkan yang
sebetulnya tidak akan terjadi apabila bekerja sesuai guideline”.
Tambahan:

Peresepan suplemen (multivitamin, ensim, perangsang nafsu makan”,
atau imunomodulator”, cukup tinggi :

- 21,9% pada ISPA

- 34,9% pada demam

-2,4% pada batuk

- Paling tinggi pada diare yaitu 61,9%.
Biaya:

- Pada ISPA, Rp 15,000 – Rp 747,000;-  median 117.500

- Pada demam Rp 20.800 – Rp 137.000, maksimum Rp 326,000

- Pada diare akut Rp 56.000 – 161.000, maksimum Rp 349.000.

Analisis biaya pada peresepan pediatri di Jakarta menunjukkan tingginya biaya ketika dokter tidak bekerja sesuai
guideline. Padahal, biaya bukan sekedar rupiah.

Harm” atau potential harm” juga biaya.

selengkapnya :
http://purnamawati.wordpress.com/2008/06/02/rational-use-of-medicine-rum/
Fakta lainnya :

http://video.okezone.com/play/2009/02/12/235/7343/dokter-cawang-dibanjiri-pasien

http://bdwiagus.blogspot.com/2009/02/puyer.html

Ida Z. Hafiz, Dra, Apt, Msi

Data yang diperoleh dari  beberapa tempat pelayanan kesehatan, mengenai
peresepan puyer untuk anak di Jakarta :

a)  Setiap hari rata-rata apotik Rumah Sakit  X di  Jakarta membuat  130
resep puyer untuk memenuhi permintaan resep dokter.

b)  Data dari  Apotik  R di Tangerang , dari sekitar 30 lembar resep obat
untuk anak-anak yang masuk setiap hari , 2/3 dari obat yang diresepkan
adalah dalam bentuk puyer.

c)   Demikian juga data dari Apotek Klinik Spesialis  Anak, K   di Jakarta Selatan,

1. R/  Metilprednison     4 mg

mf pulv dtd                     No. XX

Aturan pakai:

14/4 – 16/4/08:  3×21/2 bungkus

20/4 – 23/4/08:  3×1 bungkus

24/4 – 27/4/08:  3×1/2 bungkus

28/4 – 30/4/08:  2×1/2 bungkus

========================&

Pro:  An. Sariska ( 9 bulan)

WD /Syndroma nefrotik.)

Resep dituliskan oleh mahasiswa xxxx  tk.5 yang sedang berada di Dep.Farmasi
Kedokteran xxxx

Analisis:

1.      Penulisan nama obat seharusnya metil prednisolon, harus di
konfirmasi kebenaran nama tersebut

2.      Jumlah total puyer yang diminta adalah  39 bungkus, tertulis 20
bungkus. Perlu konfirmasi mengenai jumlah yang diresepkan.

Komentar: Penulisan resep ini memang dapat membuat penyiapan obat yang lama
dan dapat menurunkan mutu pelayanan di  apotik . Mengingat ketersediaan
tablet metil prednisolon adalah 4 mg, 8 mg dan 16 mg sebaiknya peresepan
langsung bentuk tablet dan pasien diberikan edukasi mengenai cara
pemberiannya. Bila di Rumah Sakit maka dapat di siapkan per single unit dose

2. Resep yang berasal dari Klinik Spesialis dan Umum di Jakarta Selatan.

Ketersediaan produk:

a) R/ Hexer      1/3         Hexer : Ranitidine tab.150 mg,caplet 300
mg

Dometic      1/3         Dometic: Domperidon tab. 10 mg, sirup
(5mg/5ml ) 60 ml

Largactil     1/3         Largactil : Chlorpromazine tab. 25, 100
mg

m.f.p.dtd. No.X

S.t.d.d. I .a.c

————————

b) R/Neurosanbe plus175 mg                Neurosanbe plus (Sugar
coated tablet) Isi :

Alegi                        ½                      Vit B1
50 mg, Vit B6  100 mg,

Luminal                    7,5                    Vit B12
100 mcg, metamizol Na 500 mg

Efedrin                       4 mg              Alegi  tab
Isi :

Codein                       3 mg
Dexametason 0,5 mg

Lapimuc                    1/3
Deksklorfeniramine maleat 2 mg

DMP            5 mg                             Lapimuc :
Ambroksol HCl tab 30 mg

m.f.p.dtd. No.XII

S.t.d.d. I .a.c

————————

Pro: Lintang (5 tahun)

Analisis:

Resep 2a.: Hexer  1/3,Dometic 1/3  dan Lapimuc 1/3 ; karena tidak dijelaskan
satuannya , perlu konfirmasi apakah tablet atau gram.

Hexer apakah tablet( 150 mg ) atau kaplet (300mg) yang diambil karena
dosisnya berbeda. Perlu konfirmasi.

Resep 2b. :

Neurosanbe plus  175 mg, tidak dapat diketahui jumlah tablet yang diambil.
Asumsi yang diperlukan adalah metamisolnya, maka jumlah metamisol yang
dibutuhkan  175mg x 12 =2100 mg . Jumlah tablet yang diambil 4 1/10 tab.

Luminal 7,5. Bila dalam resep tidak dicantumkan satuan maka kesepakatan
diambil gram, yang berarti 7,5 gram luminal per bungkus perlu konfirmasi.

Komentar:  Resep puyer ini sarat & kental dengan masalah safety dan kualitas
seperti yang telah disebutkan oleh praktisi yang tidak menyetujui peresepan
puyer.  Farmasis harus mulai mempersoalan peresepan yang seperti ini.

Berat badan pasien sebaiknya dicantumkan sehingga dapat diketahui dosis yang
diberikan.

Belum yang terungkap…..?????

March 21, 2009 Posted by | Artikel | 5 Comments

RATIONAL USE OF MEDICINE (RUM)

Oleh : Purnamawati S Pujiarto Dr SpAK, MMPed


Yayasan Orang Tua Peduli

Drugs are much too serious a thing
to be left to the medical profession and the pharmaceutical industry G.
Cannon

Semua orang dalam hidupnya suatu saat pasti membutuhkan obat, termasuk tenaga
medis. Semua orang, termasuk pemberi jasa layanan kesehatan (provider) adalah
konsumen. Semua orang butuh dan berhak memperoleh layanan kesehatan yang TERBAIK.
Di lain sisi, apakah semua gangguan kesehatan harus senantiasa dijawab dengan
obat? Apakah ketika anak sakit, solusinya harus peresepan sederet obat dalam
bentuk puyer?
Memang, tidak sedikit konsumen yang beranggapan bahwa konsultasi medis adalah
kunjungan berobat” alias upaya meminta obat. Uniknya, meminta obat ini
sudah seolah terpatri, harus” cespleng dan harus” puyer. Ironisnya
lagi, anak merupakan populasi yang paling terpapar pada pola pengobatan yang
tidak rasional antara lain pemberian antibiotika dan steroid yang berlebihan,
serta polifarmasi. Padahal, gangguan kesehatan harian pada anak umumnya merupakan
penyakit ringan yang sifatnya self limiting”. Demam, diare akut, batuk
pilek, dan radang tenggorokan, merupakan kondisi yang umumnya ditangani dengan
antibiotika. Keempat kondisi tersebut juga peresepannya polifarmasi. Padahal,
ketika orang dewasa mengalami gangguan yang sama, peresepan obatnya lebih ramping”
ketimbang buat anak. Padahal, di dalam kamus bahasa Indonesia, konsultasi medis
adalah perundingan antara pemberi dan penerima layanan kesehatan untuk mencari
penyebab terjadinya penyakit & untuk menentukan cara-cara pengobatannya.
Singkatnya, konsultasi medis adalah upaya advocacy, upaya berbagi informasi,
upaya meminta penjelasan dan kejelasan. Namun demikian, siapa yang paling berperan
terhadap terpaterinya pola pikir sakit = obat, obat = puyer (kalau mau murah,
praktis dan cespleng”)? Barangkali, sudah waktunya kita merenungkan kembali
praktek keseharian kita di lapangan. Membuka hati, karena kita ingin senantiasa
memberika yang TERBAIK buat bangsa ini. Waktunya pun terasa cocok karena sudah
semakin banyak konsumen yang memahami bahwa konsultasi medis tidak selalu berarti
obat, keputusan klinis tergantung penyebab gangguan kesehatan yang tengah dialami
si konsumen.
Tulisan ini merupakan bagian dari upaya perenungan dan upaya berbagi terkait
konsep pola pengobatan yang rasional, yag sudah lebih dari 20 tahun di canangkan.
Diawali dengan beberapa cuplikan termasuk dari beberapa guru yang saya hormati
dan kagumi semangat dedikatifnya bagi pasien-pasien kita tercinta.

PENINGKATAN MUTU PENGGUNAAN OBAT DI PUSKESMAS MELALUI PELATIHAN BERJENJANG
PADA DOKTER DAN PERAWAT

Iwan Dwiprahasto; Bag Farmakologi & Toksikologi FK, UGM Yogyakarta

Berbagai studi menemukan bahwa penggunaan obat untuk ISPA cenderung berlebih.
Penyebab pertama, keterbatasan pengetahuan petugas kesehatan mengenai bukti-bukti
ilmiah terkini, sehingga tak jarang tetap meresepkan obat yang tak diperlukan
(misal antibiotika dan steroid untuk common cold). Kedua, keyakinan dan perilaku
pasien. Contoh, kebiasaan memberikan injeksi pada pasien dengan gejala pada
otot-sendi.
43 puskesmas ikut dalam penelitian. Jumlah ratarata obat yang diresepkan untuk
ISPA anak dan dewasa, yaitu 3.62 dan 3,69. Pasien myalgia mendapat rata-rata
3.24 jenis obat. Di sebagian besar kabupaten penggunaan antibiotika untuk ISPA
mencapai lebih dari 90%. Hanya beberapa puskesmas yang meresepkan antibiotika
kurang dari 70%.

Tujuan penelitian (1) menilai pola peresepan ISPA dan myalgia di puskesmas
di 8 kab/kota, SumBar (data peresepan retrospektif), dan (2) meningkatkan mutu
penggunaan obat untuk ISPA dan myalgia (dilakukan intervensi pelatihan penggunaan
obat rasional, melibatkan dokter dan perawat di 15 puskes).
Enam bulan pasca intervensi, penggunaan obat termasuk antibiotika dan injeksi
menurun bermakna. Rata-rata jumlah obat untuk ISPA pada anak turun dari 3.74
+ 0.58 menjadi 2.47 + 0.67 (p<0.05) (dokter) dan dari 3.67 + 0.49 menjadi
2.39 + 0.73 (p<0.05) (perawat). Penurunan penggunaan antibiotika pada anak
dengan ISPA secara bermakna hanya ditemukan pada perawat, dari 81.37% menjadi
42.40%.
Proporsi pasien dewasa dengan ISPA yang mendapat antibiotika Turun bermakna
dari 89.18% menjadi 44.15% (p<0.05) (dokter) dan dari 91.22% menjadi 38.71%
(p<0.05) (perawat). Penggunaan injeksi juga turun bermakna pada pasien myalgia,
yaitu dari 69.11% menjadi 31.89% (p<0.05) (dokter) dan dari 79.56% menjadi
62.91% (p<0.05) (perawat).

Rabu, 22 November 2000: Obat, Komoditas atau Produk Karitas?

OBAT itu unik. Ia adalah komoditas ekonomi komersial tetapi sekaligus produk
yang lekat dengan fungsi sosial, penyelamat nyawa manusia. Obat memag telah
lama menjadi bahan perdebatan tak berkesudahan. Otoritas meresepkan obat yang
diberikan kepada profesi kedokteran terbukti kerap disalahgunakan, menimbulkan
pengobatan yang irrasional yang merugikan konsumen, namun memperkaya para dokter
dan industri farmasi.
Ivan Illich (Medical Nemesis: Expropriation to Health, 1975) mengkritik institusi
dan industri medis yang membuat manusia tak lagi memiliki otonomi atas kesehatannya
sendiri. Dunia medis justru menciptakan “kesehatan” menjadi “kesakitan”.
“Industri kesehatan telah menjadi ancaman besar terhadap kesehatan.”
Buku-buku lain yang menggugat kemapanan “kolusi” industri dan para
dokter ditulis Dianna Melrose (Bitter Pills-Medicines and the Third World Poor,
1982), Milton Silverman (Prescription for Death-The Drugging of the Third World,
1982), Charles Medawar (The Wrong Kind of Medicines?, 1984), John Braithwaite
(Corporate Crime in the Pharmaceutical Industry, 1984), hingga pengarang novel
Arthur Hailey (Strong Medicine, 1984). ………
Khusus tentang obat-obat generik bermerek, di Indonesia jumlahnya paling banyak.
Obat-obat ini berhasil membangun citra seolah-olah seperti obat paten. Ada nilai
tambah dengan kemasan yang baik, merek yang keren, serta biaya promosi yang
tidak kecil.
Obat, kecil skala ekonominya. Namun, keuntungan yang diraih luar biasa besar.
Di Amerika Serikat, menurut survei majalah Fortune, 12 perusahaan farmasi termasuk
dalam kelompok 50 perusahaan yang menghasilkan keuntungan paling besar. Padahal
tidak satu pun yang omsetnya besar. Di Indonesia, ada perusahaan farmasi PMA
mematok harga obat lebih tinggi daripada di Kanada dan banyak negara kaya. Ini
karena praktik transfer pricing ke perusahaan induk. Sementara perusahaan farmasi
swasta nasional juga pesta pora obat generik bermerek yang sebenarnya obat latah
(me-too drugs) yang margin keuntungannya jauh lebih besar ketimbang obat paten
PMA sehingga mereka leluasa mengontrak dokter.
Apakah masih layak menyebut obat dan dokter itu penyelamat? (ij)

Obat Rasional, Kuncinya Dokter

PROFESI kedokteran ditantang untuk mau dan mampu melakukan audit profesi dan
audit kerasionalan preskripsi. Sampurno berharap masalah ketidakrasionalan penggunaan
obat dapat diatasi, sehingga dampak negatifnya dapat dihindari, antara lain
meningkatnya inefisiensi biaya pengobatan dan terjadinya efek obat yang tidak
diharapkan. Ia mengusulkan 3 agenda aksi untuk meningkatkan penggunaan obat
yang rasional. Pertama, pendekatan edukasi: Konsep obat esensial dan aplikasinya
serta pendidikan preskripsi yang rasional RS pendidikan punya tanggung jawab
etis terhadap masyarakat untuk mempromosikan preskripsi yang rasional melalui
contoh konkret dari para staf pengajarnya. “Sayangnya, justru di Indonesia
rumah sakit pendidikan adalah tempatnya mengajarkan preskripsi yang tidak rasional”.
Agenda aksi kedua adalah skim manajerial: melalui siklus pengadaan obat. DOEN
yang diimplementasikan secara konsisten dan diikuti dengan baik oleh setiap
tingkat pelayanan kesehatan. Estimasi pengadaan obat harus didasarkan pada morbiditas
(angka kesakitan), bukan atas dasar penggunaan sebelumnya. Agenda aksi ketiga,
intervensi regulasi. ………
Jumlah dan merek obat yang terus bertambah (sekitar 10.000 merek atau bentuk
sediaan), bukan soal mudah bagi seorang dokter untuk menjatuhkan pilihan. Menurut
Prof Iwan, dalam proses pemilihan ini dokter mudah dipengaruhi produsen. Sering
pilihan dokter jatuh pada preparat yang kurang efektif atau yang malahan merupakan
plasebo (obat bohong) dan substandar yang seringkali jauh lebih mahal dibanding
obat-obat lama yang telah terbukti keampuhannya. Di tengah rimba belantara ribuan
merek obat, dokter harus mempelajari sifat obat yang lama dan yang baru secara
terus-menerus seumur hidup.

From: http://www.ugm.ac.id/index.php?page=rilis&artikel=1116
Pengukuhan Prof Iwan Dwiprahasto: “Tradisi Menulis Resep Obat Perlu
Dikoreksi” (”Farmakoterapi Berbasis Bukti: Antara Teori dan Kenyataan”).

Kurangnya informasi terhadap bukti ilmiah baru tentang obat dan farmakoterapi
tampaknya tetap menghantui kalangan professional kesehatan di negara-negara
berkembang, seperti Indonesia. Meskipun hampir semua jurnal biomedik dan buku-buku
teks kedokteran telah tersedia dalam bentuk elektronik…. tenaga kesehatan
dikhawatirkan semakin jauh dari konsep-konsep farmakoterapi berbasis bukti yang
mutakhir.
Ironisnya, kelemahan inilah yang dimanfaatkan duta-duta farmasi sebagai peluang
dan secara gencar membanjiri para dokter dengan informasi-informasi tentang
obat mereka. Sayang, informasi ini umumnya unbalanced, cenderung misleading
atau dilebih-lebihkan, dan berpihak pada kepentingan komersial.
“Penggunaan informasi seperti ini sangat beresiko dalam proses terapi,”
ungkap Prof dr Iwan Dwiprahasto MMedSc PhD, Senin (7/1) …Wakil Dekan Bidang
Akademik & Kemahasiswaan FK UGM saat dikukuhkan sebagai Guru Besar FK UGM.
Ketua Komite Pendidikan, Penelitian dan Pengembangan RSUP Dr Sardjito. Keterbatasan
informasi ini menjadikan off-label use of drug sangat marak dalam praktek sehari-hari.
Off-label use adalah penggunaan obat di luar indikasi yang direkomendasikan.
Obat yang sering digunakan secara off label antara lain antihistamin, antikonvulsan,
antibiotika, serta obat flu dan batuk. Berbagai obat kardiovaskuler pun sangat
sering digunakan secara off label, antara lain antiangina, antiaritmia, dan
antikoagulan.” Berbagai penggunaan obat di luar dosis yang direkomendasikan,
termasuk pula dalam katagori ini. Banyak praktek-praktek kefarmasian di apotek
tergolong off label use.
“Menggeruskan tablet untuk dijadikan puyer, kapsul, bahkan sirup untuk
sediaan anak, atau menggeruskan tablet atau kaplet untuk dijadikan saleb dan
krim adalah bentuk off label use yang jamak ditemukan. Hal itu terjadi secara
turun menurun, berlangsung puluhan tahun tanpa ada yang sanggup menghentikannya.”

LANJUTAN

Melestarikan penyimpangan, menikmati kekeliruan, dan mengulang-ulang kesalahan
tampaknya sudah menjadi hedonisme peresepan. Yang satu mengajarkan dan yang
lain mengamini sambil menirukan. Itulah cara termudah untuk mendiseminasikan
informasi yang tidak berbasis bukti.”
Menulis resep, seolah telah menjadi tradisi ritual yang tidak bisa dikoreksi.
Tulisan yang sulit dibaca seolah menjadi bagian dari sakralisasi peresepan.
“Padahal bahaya mengintai dimana-mana. Kebiasaan keliru menuliskan aturan
resep 3 kali sehari (signa 3 dd 1) seharusnya mulai ditinggalkan dan diganti
menjadi diminum tiap 8 jam. Pun dengan obat yang diberikan 2 kali sehari, seharusnya
bisa ditulis tiap 12 jam dan seterusnya.
“Menulis resep dalam bentuk campuran (beberapa jenis obat digerus dijadikan
satu sediaan puyer atau sirup) perlu untuk segera dikoreksi, karena termasuk
off label use. Jika praktek-praktek primitive semacam itu tetap dipertahankan,
maka keselamatan pasien (patient safety) tentu akan jadi taruhannya,” tandasnya.

Prof Iwan mengajak para professional kesehatan untuk senantiasa mengacu pada
bukti-bukti ilmiah terkini. “Keeping up to date” bukanlah sekedar
slogan tapi merupakan prasyarat fundamental dalam implementasi Evidence Based
Medicine (EBM).

ERA INFORMASI DAN TRANSPARANSI

Era informasi ini telah menggulirkan pergeseran di berbagai aspek kehidupan
termasuk aspek kesehatan khususnya di sisi pengetahuan dan kesadaran kesehatan.
Khalayak umum dengan mudah memperoleh akses ke pengetahuan kesehatan; kemudahan
ini seperti mengisi kehausan ilmu kaum muda Indonesia yang sudah semakin menyadari
haknya dan sudah mulai memposisikan dirinya sebagai konsumen. Tercermin dari
semakin meningkatnya upaya masyarakat dalam membekali diri dengan pengetahuan
kesehatan meski mereka tidak memiliki komputer sekalipun. Era informasi ini
merupakan anugerah karena dengan biaya murah kita bisa memilih situs yang reliable”.
Mereka juga mencermati iklim layanan kesehatan baik di luar Indonesia dimana
konsumen terbukti berhasil membantu mewujudkan iklim layanan kesehatan yang
lebih baik dan rasional. Mereka juga gencar mencari dan berbagi informasi perihal
siapa-siapa saja dokter yang RUD. Dan ketika mereka datang membawa print out
artikel dan guideline, ketika pasien sudah memahami tatalaksana harus sesuai
EBM dan guideline nya, lalu bagaimana dokter menyikapi fenomena dan kondisi
seperti ini? Aplikasi guidelines dalam praktek sehari-hari cepat atau lambat
akan membantu mengangkat citra profesionalisme kita sebagai tenaga medis.
Di lain pihak, tenaga kesehatan asing sudah berdatangan masuk ke Indonesia.
Mmapukah kita bersaing menghadapi serbuan” ini? Apakah para pemberi jasa
layanan kesehatan memahami perubahan pasar” lalu mampu tetap tegak dan
profesional di tengah persaingan global?


EBM, EBP, DAN GUIDELINES

EBM adalah landasan penyusunan guidelines dalam rangka membuahkan praktek
pengobatan yang rasional atau EB practices. Secara filosofis, tujuan EBM adalah
peningkatan mutu layanan kesehatan bagi pasien karena EBM berawal dari pasien
dan berakhir dengan pasien. Banyak sekali alasan mengapa kita butuh EBM. Pertama,
agar ilmu pengetahuan kita senantiasa up to date. Dengan bertambahnya jam terbang,
terbukti bahwa pengetahuan kita mengalami kemerosotan meski mungkin kemampuan
(skill) meningkat. Ilmu kedokteran terus berkembang dengan pesat dan terus berubah
dan kita sering tak bisa mengetahui informasi terkini secara tepat waktu alias
… selalu kedodoran! Perkembangan obat yang pesat bisa membuat kita tanpa sadar
belum memberikan yang terbaik untuk pasien-pasien kita. Oleh karena itu, EBM
merupakan upaya untuk melakukan the right thing in the right way; melakukan
the best for our patients.

Teknis praktisnya (EBP)? Ketika kita dihadapkan pada seorang pasien, langkah
pertama adalah menerjemahkan semua gejala pemeriksaan fisik dan keluhan menjadi
suatu pertanyaan klinis dalam 2 bentuk yaitu
(1) pertanyaan mendasar (4W dan 1H) serta
(2) pertanyaan yang lebih spesifik (terdiri dari 4 komponen yaitu PICO atau

a. Patient,
b. Intervention,
c. Comparison,
d. Outcome
Langkah kedua, Menerjemahkan pertanyaan di atas menjadi suatu upaya pencarian
bukti yang terkuat/terbaik. Ini membutuhkan pengetahuan IT medis serta metodologi
penelitian dan statistik sehingga tahu harus mencari kemana (mengetahui bagaimana
mencari evidence based resources, Medline, dll) untuk diagnosis, terapi, prognosis,
serta harm/casualty nya.
Langkah ketiga, menelaah evidence di atas secara kritis (critical appraisal)
terkait kualitas dan manfaatnya melalui telaah validitas, reliabilitas, relevansi
serta clinical importance nya.
Kuasai kekuatan evidence (level 1 s/d 5, dan kita pun akan senantiasa diingatkan
bahwa ecpert opinion memiliki kekuatan yang sangat lemah apalagi testimoni).

Guidelines.Clinical practice guidelines are systematically developed statements
that aim to help physicians and patients reach the best health care decisions.
Good guidelines have many attributes, including validity, reliability,
reproducibility, clinical applicability and flexibility, clarity, development
through a multidisciplinary process, scheduled reviews, and documentation.
More than 2000 guidelines are currently represented in the National Guideline
Clearinghouse (www.guideline.gov).
Guidelines disusun berdasarkan evidence dan experience. Guideline merupakan
suatu rekomendasi tatalaksana suatu kondisi klinis. Guideline berhasil
menstandarisasi layanan kesehatan, mengurangi variasi lokal, dan memperbaiki
health outcomes (termasuk prognosis). Contoh guideline yang baik misalnya
dari USA adalah panduan imunisasi ACIP, STD dari CDC; dari UK, guideline
buatan NICE; dan tentunya guideline dari WHO. Untuk anak, AAP, BMJ dengan
clinical evidence nya, dan RCH.

Data WHO tahun 2004 yang dipresentasikan di ICIUM Thailand menunjukkan bahwa
tingkat kepatuhan terhadap standard guideline (STG) penanganan diare akut sangat
rendah di belahan Asia Tenggara. Di sektor publik hanya 39% sedangkan di sektor
swasta jauh lebih rendah lagi yaitu 17%. Studi pendahuluan pola peresepan pada
4 kondisi harian pediatri (n = 160) menunjukkan tidak ada satupun yang ditangani
sesuai guideline”.

POLA PENGOBATAN RASIONAL, KONSULTASI MEDIK.

Mari kita ambil contoh, bayi diare. Penyebab utamanya adalah infeksi virus
dan obatnya adalah cairan rehidrasi oral (oralit) untuk mencegah dehidrasi.
Dokter memberi informasi perihal penyebab, tatalaksana, dan risiko komplikasi.
Dokter menyatakan bahwa diare akan sembuh sendiri, tidak ada obat yang diperlukan
selain cairan rehidrasi oral. Dengan demikian, konsultasi medis tidak senantiasa
harus diakhiri dengan penulisan secarik kertas resep. Nasehat dokter yang profesional
juga suatu bentuk obat”. Pada dasarnya, tidak banyak gangguan kesehatan
yang tatalaksananya harus berupa pemberian obat (di makalah terdahulu sudah
dikemukakan bahwa ada 5 bentuk terapi; pemberian obat hanyalah salah satunya).
Ketika butuh obat, banyak sekali faktor yang berperan dalam peresepan obat.

Selain effectiveness, faktor keamanan merupakan salah satu faktor utama yang
melandasi konsep pola pengobatan rasional (rational use of drugs/RUD). Di lain
pihak, faktor utama yang menentukan pelaksanaan RUD ini adalah kebijakan peresepan
obat yang dipengaruhi oleh banyak faktor. Antara lain regulasi obat, pendidikan
kedokteran, informasi dan pengetahuan pola peresepan yang baik, industri farmasi,
serta kondisi sosio-kultural setempat. Semua saling terkait.

RUD adalah pola pemberian obat yang tepat yaitu pemilihan obat yang sesuai dengan
diagnosis penyakitnya, tepat konsumsinya, tepat dosisnya, tepat jangka waktu
pemberiannya, dan aman, dengan harga semurah mungkin serta dengan pemberian
informasi yang obyektif. Singkatnya, pola pemakaian obat yang aman dan efektif
(cost-effective), efisien dengan good outcome. Pendekatannya sesuai alur di
bawah:

1. Pasien dan permasalahannya. Dokter harus mengumpulkan data perihal perjalanan
penyakit dan pengobatan yang pernah diperoleh pasien.
2. Diagnosis: diagnosis tepat atau akurasi tinggi. Bila tidak memungkinkan,
setidaknya ada diagnosis perkiraan untuk selanjutnya dikonfirmasi dengan pemeriksaan
penunjang (laboratorium, pemeriksaan radiologis, dan sebagainya).
3. Tujuan terapi: dipengaruhi jenis penyakit dan keparahannya. Secara garis
besar tujuan adalah kesembuhan atau berkurangnya/hilangnya gejala/keluhan.
4. Pemilihan obat. Dilakukan dalam dua tahapan berikut:
– Menetapkan obat yang akan dipilih dengan catatan, hanya sebagian gangguan
kesehatan yang memang membutuhkan obat. Nasehat yang profesional juga obat.
Tidak jarang, ketika pasien tidak membutuhkan obat, dokter tetap memberikan
resep misalnya suplemen atau imunomodulator.
– Dari berbagai obat yang tersedia di tahap pertama di atas, dilakukan kajian
dari berbagai aspek yaitu efektivitas, keamanan, suitability, biaya, kemudahan
pemberiannya, serta persyaratan penyimpanannya. Pada anak misalnya, sirup tentunya
lebih suitable ketimbang puyer (belum lagi bicara soal stabilitas obat di udara
tropis). Dari sisi efektivitas versus biaya, obat generik tentunya menjadi pilihan
ketimbang obat bermerek. Ketika membutuhkan antibiotik, tentunya dipilih yang
sesuai target yang dibidik.
5. Terapi dimulai: Dokter meresepkan obat; memberi penjelasan manfaat dan efek
samping obat serta tindakan seandainya terjadi reaksi efek samping obat.
– Hasil terapi: Dokter melakukan penilaian terhadap terapi yang sudah dilakukan
agar dapat menyimpulkan hasilnya.
– Kesimpulan terapi: Dokter menilai tercapai tidaknya tujuan terapi. Bila tujuan
tidak/belum tercapai, dokter meninjau kembali akurasi diagnosis serta mengevaluasi
kepatuhan pasien dalam menjalankan terapi.

Menentukan permasalahan. Berdasarkan rangkaian langkah yang harus dilakukan
sebelum sampai pada langkah penatalaksanaan adalah menentukan permasalahan dan
penyebabnya. Keduanya ini merupakan fondasi pelaksanaan pola pengobatan yang
rasional. Contoh sederhana adalah ketika seorang anak batuk; kita tahu bahwa
batuk adalah gejala dan langkah pertama adalah mencari penyebabnya sehingga
dokter dapat menentukan diagnosisnya dan atas dasar diagnosis tersebut baru
ditetapkan tatalaksananya.

Institute of Medicine: According to the
committees vision (see box), the FDA must embrace a culture of safety
in which the risks and benefits of medications are examined during their
entire market life. This so called life-cycle approach would entail evaluating
risks in the context of benefits, sustaining attention to both efficacy
and safety after approval, and advancing and protecting the health of
the public. Risk benefit analyses would highlight key areas of uncertainty.
The careful design and conduct of post-marketing studies would help to
resolve uncertainties as drug use expanded.

POLA PENGOBATAN TIDAK RASIONAL (IRUD)

Pola pengobatan yang tidak rasional adalah pola pengobatan yang tidak mengikuti
kaidah pengobatan rasional. Dari berbagai studi, bentuk utama IRUD adalah:
– polifarmasi (pemberian beberapa obat sekaligus pada saat yang bersamaan pada
kondisi yang tidak memerlukan beberapa obat sekaligus)
– pemberian antibiotika yang berlebihan
– pemberian steroid yang berlebihan
– tingginya tingkat pemakaian obat non generik
– tingginya tingkat pemakaian obat injeksi
– tingginya tingkat pemakaian obat” yang sebenarnya tidak dibutuhkan (off
label use). Termasuk di dalam kategori off label use adalah pemberian antibiotik
untuk infeksi virus seperti diare akut dan ISPA, pemberian steroid untuk batuk
pilek ISPA. Contoh lain misalnya, pemberian suplemen, vitamin, antihistamin
untuk common colds/flu, bronkodilator untuk batuk pada ISPA, dsb nya.

Penelitian pola peresepan pediatri di India menunjukkan bahwa 83,9% peresepan
yang tidak rasional dilakukan oleh sektor swasta. Sebesar 52,7% peresepan terdiri
dari 3 obat atau lebih. Empat puluh persen meresepkan suplemen dan tonikum.
Lebih dari 90% meresepkan obat bermerek (branded generic). Kesimpulan mereka,
Private practitioners prescribed significantly greater number of medicines and
were more likely to prescribe vitamins and antibiotics, and branded medicines.

Yayasan Orang Tua Peduli (YOP) melakukan 2 penelitian
cross sectional dengan mengumpulkan resep yang di email ke mailing list
kami, penelitian kedua, mengumpulkan resep dan kwitansi yang dikirim ke
markas YOP. Resep yang ditelaah adalah resep untuk anak dengan 4 kondisi
yaitu batuk pilek demam (ISPA), demam, diare akut (dengan atau tanpa muntah),
dan batuk tanpa demam lebih dari 1 minggu. Berikut ini ringkasan penelitian
pertama dengan responden 160 anggota mailing list.
Jumlah obat. Median jumlah obat yang diresepkan adalah 5 (dengan rentang
2 – 11 obat). Batuk merupakan kondisi yang jumlah obat dalam peresepannya
paling tinggi yaitu 11 obat. Dengan tingkat peresepan puyer sebesar 55,4%
pada diare akut, 72,6% pada demam, 77,4% pada ISPA, dan 87% pada batuk.Antibiotik. Tingkat pemberiannya paling tinggi pada anak demam yaitu 87%
disusul dengan diare 75%, ISPA 54,5%, dan pada anak batuk tanpa demam sebesar
47%.
Generik. Tingkat peresepannya sangat rendah yaitu 0% pada kasus demam, 5%
pada diare akut, 7% pada ISPA dan 10,5% pada batuk tanpa demam.
Steroid. Pada batuk sebesar 60,9%, pada ISPA sebesar 50,9%; sebesar 53,5%
pada demam dan bahkan 18,5% anak diare diberi steroid (umumnya triamnisolon).
Tingginya tingkat pemberian steroid juga sangat memprihatinkan yang sebetulnya
tidak akan terjadi apabila bekerja sesuai guideline”.
Tambahan. Peresepan suplemen (multivitamin, ensim, perangsang nafsu makan”,
atau imunomodulator”, cukup tinggi yaitu 21,9% pada ISPA, pada demam
34,9%, pada batuk 2,4% dan paling tinggi pada diare yait6u 61,9%.
Biaya. Pada ISPA, Rp 15,000 – Rp 747,000; median 117.500; Pada demam
Rp 20.800 – Rp 137.000, maksimum Rp 326,000; Pada diare akut Rp 56.000
– 161.000, maksimum Rp 349.000. Analisis biaya pada peresepan pediatri
di Jakarta menunjukkan tingginya biaya ketika dokter tidak bekerja sesuai
guideline. Padahal, biaya bukan sekedar rupiah. Harm” atau potential
harm” juga biaya.

ONGKOS. Di Indonesia, pengeluaran terbesar untuk antibiotics (63% dari pengeluaran/ongkos
ISPA), disusul dengan obat batuk-pilek, analgesik. Di sektor publik, biayanya
kurang lebih Rp 512 Rupiahs per kasus (padahal biaya sesungguhnya hanya Rp 153
per kasus apabila ditangani sesuai guideline). Biaya obat untuk diare dan ISPA
adalah 68% dari total biaya layanan kesehatan untuk balita dan 38% pada anak
di atas 5 tahun alias 36% total belanja kesehatan untuk obat.

SEPUTAR OBAT SIMTOMATIK FLU DAN COLDS:

• Chlorpheniramine or doxylaminine reduced runny nose and sneezing
after 2 days compared with placebo, but the clinical benefit was small.
Another review, found no significant difference in overall cold symptoms
at 1–10 days between antihistamines and placebo• Some non-sedating antihistamines are associated with arrhythmias
and adverse interactions with other drugs.

• Compared with placebo, decongestants (norephedrine, oxymetazoline,
pseudo-ephedrine) reduced nasal congestion over 3–10 hours after
a single dose, but found insufficient evidence to assess the effects of
longer use of decongestants.

• Decongestants provide short-term relief of nasal obstruction
for adults, but may not work in children. Oral or nasal decongestants
are often used, but evidence that they work is scanty. Well-conducted
trials show that single doses are moderately effective. There is insufficient
evidence to show whether repeated doses are effective, or whether single
or repeated doses WORK IN CHILDREN UNDER THE AGE OF 12. Link: http://www.cochrane.org/reviews/english/ab001953.html

• No convincing evidence that anti-histamines, when used alone,
can relieve the cold. In combination with decongestives, antihistamines
might lead to some relief from a blocked and/or runny nose although there
is not enough evidence to be certain. Link: http://www.cochrane.org/reviews/english/ab001267.html

Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal
of Oral Infant Medicines www.chpa-info.org
The branded cough and cold medicines that are being voluntarily withdrawn
are:• Dimetapp® Decongestant Plus Cough Infant Drops
• Dimetapp® Decongestant Infant Drops
• Little Colds® Decongestant Plus Cough; Little Colds® Multi-Symptom
Cold Formula
• PEDIACARE® Infant Drops Decongestant (containing pseudoephedrine)

• PEDIACARE® Infant Drops Decongestant & Cough (containing
pseudoephedrine)
• PEDIACARE® Infant Dropper Decongestant (containing phenylephrine)

• PEDIACARE® Infant Dropper Long-Acting Cough
• PEDIACARE® Infant Dropper Decongestant & Cough (containing
phenylephrine)
• Robitussin® Infant Cough DM Drops
• Triaminic® Infant & Toddler Thin Strips® Decongestant

• Triaminic® Infant & Toddler Thin Strips® Decongestant
Plus Cough
• TYLENOL® Concentrated Infants’ Drops Plus Cold
• TYLENOL® Concentrated Infants’ Drops Plus Cold & Cough

Apabila kita tilik isinya, obat jadi tersebut mengandung bahan aktif dekongestan.
Dengan demikian, pelajaran yang kita tarik dari kondisi di atas antara lain
adalah bahwasanya anak batuk pilek TIDAK usah dan tidak boleh diberi dekongestan.
Apakah itu dalam sediaan puyer ataupun dalam sediaan jadi (bermerek).

http://pediatrics.aappublications.org/cgi/content/full/121/4/783?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=cold+

medicine&andorexactfulltext=and&searchid=1&FIRSTINDEX=10&sortspec=relevance&resourcetype=HWCIT
BACKGROUND. Adverse drug events in children from cough and cold medications
have been identified as a public health issue with clinical and policy
implications.

Nationally representative morbidity data could be useful
for targeting age-appropriate safety interventions.

OBJECTIVE. To describe emergency department visits for
adverse drug events from cough and cold medications in children.
METHODS. Emergency department visits for adverse drug events attributed
to cough and cold medications among children aged <12 years were identified
from

a nationally representative stratified probability sample
of 63 US emergency departments from January 1, 2004, through December
31, 2005.

RESULTS. Annually, an estimated 7091 patients aged <12
years were treated in emergency departments for adverse drug events from
cough and cold

medications, accounting for 5.7% of emergency department
visits for all medications in this age group. Most visits were for children
aged 2 to 5 years (64%).

Unsupervised ingestions accounted for 66% of estimated
emergency department visits, which was significantly higher than unsupervised
ingestions of other

medications (47%), and most of these ingestions involved
children aged 2 to 5 years (77%). Most children did not require admission
or extended observation (93%).

http://www.mayoclinic.com/health/cold-medicines/CC00083
Avoid cough suppressants and other cold medicines. Coughing helps clear
the mucus from your baby’s airway. For otherwise healthy babies, there’s
usually no reason to suppress it. In fact, the Centers for Disease Control
and Prevention warns against giving cough and cold medicines to children,
especially those younger than age 2 years. Cough and cold medicines haven’t
been proved effective for children — and for young children, an
accidental overdose could be fatal.
Remember, over-the-counter pain relievers and cough and cold medicines
don’t kill the viruses that cause upper respiratory infections. And low-grade
fevers — which do help kill viruses — don’t need treatment.
If you give your baby an over-the-counter pain reliever, follow the directions
printed on the label.
What’s the concern about cough and cold medicines for kids?Over-the-counter cough and cold medicines won’t cure a common cold or
make it go away any sooner. In fact, cough and cold medicines haven’t
been proved effective for children. And there are serious risks to consider.
For example, the sedating effects of antihistamines can be dangerous for
kids already having trouble breathing. For young children, an accidental
overdose of cough or cold medicine could be fatal.
The Food and Drug Administration (FDA) encourages parents to avoid cough
and cold medicines for children younger than age 2.

What if cough and cold medicines seemed to work for my child
in the past?

Chances are, your child’s signs and symptoms simply improved on their
own — or the sedating effects of the medication made you think that
your child was feeling better. Low-grade fevers don’t need treatment,
and research shows that cough and cold medicines for kids are no more
effective than a placebo.

Are cough and cold medicines a problem for children older than
age 2?

Older children aren’t as likely as younger children to experience side
effects from cough and cold medicines, but side effects are still possible.
Some cough and cold medicines may make kids sleepy, while others may have
the opposite effect. Even then, remember that cough and cold medicines
can’t make a cold go away any sooner.
Experts from the FDA are studying the safety and effectiveness of cough
and cold medicines for children older than age 2. In the meantime, if
you choose to give cough or cold medicines to an older child, carefully
follow the label directions.

CLINICAL EVIDENCE
• The evidence for effectiveness
of over-the-counter (OTC) cough medicines is weak.
• Acute cough
is a common and troublesome symptom in people who suffer from acute upper
respiratory tract infection (URTI). Many people self-prescribe OTC cough
preparations and health practitioners often recommend their use for the
initial treatment of cough
• The results of this review: no good
evidence for or against the effectiveness of OTC medications in acute cough.• link: http://www.cochrane.org/reviews/english/ab001831.html

Source : http://www.cdc.gov/drugresistance/community/campaign_materials/Color/FactSheet-RunnyNose(color).pdf

Source : http://www.cdc.gov/drugresistance/community/campaign_materials/Black-White/VirusBacteriaChart(BW).pdf

BATUK

TRADE OFF BENEFITS & HARMS - Antibiotics
UNKNOWN EFFECTIVENESS - B2 agonist
– Antihistamines
– Antitussive, Expectorants

Buat anak, WHO menegaskan, pemberian obat penekan refleks batuk, TIDAK dianjurkan.

Radang tenggorokan – Clinical evidence: BMJ

Treating symptoms Likely to be beneficial NSAIDs, Parasetamol
Unlikely to be beneficial Antibiotik, steroid
Unknown effectiveness Probiotik
Preventing complications Trade off – benefits and risks Antibiotik

TONSILITIS

CLINICAL EVIDENCE:
• No clinically relevant
differences in the health related quality of life. The number of episodes
was lower in the surgical group in the first 6 months after operation but
from 6–24 months there was no difference between the groups. Adenotonsillectomy
seemed more beneficial in children with 3–6 throat infections a year
before entry into the trial than those with fewer episodes (difference:
–1.07, 95% CI –1.59 to –0.56 v +0.34, 95% CI –0.08
to +0.77. The authors concluded that adenotonsillectomy for mild symptoms
has little clinical benefit over watchful waiting and no discernable benefit
after 6 months.
• The risks of tonsillectomy include those associated
with general anaesthesia and those specific to the procedure (bleeding,
pain, otalgia, and, rarely, nasopharyngeal stenosis). The subsequent RCT
found that 16/203 [8%] children who had surgery suffered complications.• In the smaller RCT (91 children), erythematous rashes occurred in
4% of children in the non-surgical group while taking penicillin.[4] Other
adverse effects of antibiotics include allergic reactions and the promotion
of resistant bacteria. One RCT found that, for people with milder episodes
of sore throat, the prescribing of antibiotics compared with no initial
prescription significantly increased the proportion of people who returned
to see their physician in the short term because of sore throat (716 people
with sore throat and an abnormal physical sign; return rate: 38% with initial
antibiotics v 27% without initial antibiotics; adjusted HR for return 1.39,
95% CI 1.03 to 1.89).

DIARE

Kaolin: Obat ini tidak perna masuk guideline tatalaksana diare akut. Bahkan
dari produsen nya sendiri menyatakan bahwa obat ini justru tidak boleh diberikan
pada infeksi E coli, salmonella, shigella, dan tidak boleh juga diberikan pada
diare yang ada darahnya serta bila ada kecurigaan obstruksi usus dan berbagai
kasus bedah lainnya. Kaolin juga dapat menimbulkan efek samping yang disebut
Toxic megacolon yaitu terkumpulnya dan terperangkapnya tinja di usus besar sehingga
racun-racun yang seharusnya dikeluarkan oleh tubuh kita akan meracuni tubuh
kita. Selain itu, baru-baru saja ada warning agar tidak memberikan Kaopectate
karena kandungan aspirin di dalamnya.

Pepto Bismol Warning
====================
Parents generally know that they shouldn’t give aspirin to their kids. There
are other medicines that contain salicylates, which are related to aspirin,
that you should also avoid. Their link to Reye’s syndrome is just theoretical
though. These include: Kaopectate & Pepto-Bismol
Also remember that the AAP, in the practice parameter: The management of
acute gastroenteritis in young children, makes the recommendation that ‘as
a general rule, pharmacologic agents should not be used to treat acute diarrhea’
and that ‘the routine use of bismuth subsalicylate is not recommended in
the treatment of children with acute diarrhea’.

BERBAGAI BENTUK IRUD

Polifarmasi. Salah satu contoh polifarmasi adalah pemberian puyer (racikan)
yang berisikan beberapa obat sekaligus untuk anak-anak dengan gangguan kesehatan
ringan harian seperti demam, batuk-pilek atau diare.
Pada suatu lokakarya RUD dikemukakan bahwa rerata jumlah obat di Pakistan adalah
3,6 obat/resep. Di Nigeria, 3,8 obat per pasien. Di Sudan, lebih dari 50% memperoleh
4 atau lebih obat per resep. Rerata obat balita (apapun diagnosisnya) adalah
3,58. Di Indonesia, suatu survey di Denpasar, menunjukkan 84,4% resep pediatri
mengandung lebih dari 4 kandungan aktif. Di Sumatera Barat, rerata obat yang
diberikan untuk anak ISPA adalah 3.69 obat. Sedangkan penelitian Depkes menunjukkan
bahwa rata-rata jumlah obat yang diberikan adalah 3,49.

Peresepan obat yang tidak perlu. Pada Technical briefing seminar WHO awal tahun
2004 perihal Kebijakan Obat Esensial dikemukakan bahwa di negara sedang berkembang,
jumlah obat yang diresepkan padahal sebenarnya tidak perlu diberikan sebesar
39 – 59%. Hal ini mencerminkan tingginya uang yang dibelanjakan untuk
obat sebenarnya tidak perlu dikeluarkan; sungguh suatu pemborosan.
Obat injeksi. Di negara sedang berkembang, persentase pemberian obat secara
injeksi (yang sebenarnya bisa diberikan secara oral) juga tinggi (20 –
76%). Sebenarnya, tidak banyak pasien yang membutuhkan pemberian obat melalui
suntikan. Selain itu, dipandang dari berbagai aspek, selama obat masih dapat
diberikan secara oral, pemberian melalui suntikan banyak dampak negatifnya termasuk
tingginya biaya karena pasien umumnya harus rawat inap di rumah sakit dan meningkatnya
risiko efek samping obat, kemungkinan masuknya bakteria ke tubuh kita saat penyuntikan
dilakukan, serta terusiknya rasa nyaman. WHO melaporkan bahwa sedikitnya 15
milyun penyuntikan per tahun di seluruh belahan dunia. Separuhnya mempergunakan
jarum suntik yang tidak steril. Setiap tahun, tercatat 2,3 – 4,7 juta
infeksi hepatitis B/C dan 160.000 infeksi HIV akibat pemberian obat melalui
suntikan. Diskusikan dengan dokter bila dinyatakan perlu memperoleh obat suntikan.

Antibiotika. Di beberapa negara sedang berkembang, persentase peresepan antibiotika
yang sebenarnya tidak perlu diberikan sebesar 52% – 62%. Data yang terekam dari
Indonesia mencatat sedikitnya 43% antibiotika yang diberikan sebenarnya tidak
diperlukan. Mengingat luasnya Indonesia, tidak kecil kemungkinan adanya data
yang lolos dan tidak terekam. Penelitian di beberapa tempat di Sumbar menunjukkan
bahwa tingkat pemakaian antibiotika sebesar 90%. Sedikit sekali puskesmas yang
memberikan antibiotika kurang dari 70%. Tingkat penggunaan antibiotika untuk
balita mencapai 83% dan 60% pada mereka di atas 5 tahun.
Penelitian membuktikan bahwa setiap harinya, telah diresepkan jutaan antibiotika
bagi pasien dengan penyakit infeksi virus. K. Holloway di Technical Briefing
Seminar 2004 WHO Geneva, menyatakan bahwa 30 – 60% pasien memperoleh antibiotika;
padahal, sebenarnya hanya 10 – 25% saja yang memerlukannya. Indonesia
menempati urutan tertinggi dibandingkan Nepal dan Bangladesh.


PENYEBAB IRUD.

Menurut Dr Weerasurya salah satu pakar RUD dari WHO SEARO, antara lain karena:
1. Membanjirnya obat dalam jumlah yang sangat besar. Di pasaran, suatu produk
obat tertentu tersedia dalam ratusan bahkan ribuan macam. Dokter sulit memilih
suatu obat secara rasional dan independen dari ribuan pilihan tersebut.
2. Proses pengambilan keputusan oleh para dokter & farmasis. Secara garis
besar, hal ini dipengaruhi oleh pengetahuan, kompetensi serta profesionalisme
dokter dalam menghadapi pasien yang demanding” (misalnya selalu meminta
antibiotika atau meminta obat yang manjur”) dan dalam menangkal promosi
obat yang agresif.
3. Dispensing doctors.
4. Perilaku interventionist, dll

Suatu penelitian skala besar di beberapa negara maju menunjukkan sedikitnya
3 alasan mengapa para dokter cenderung agak “abusive” dalam pola
peresepannya:
– LACK OF CONFIDENCE. Dokter sering “kurang percaya diri” untuk
menyata-kan bahwa penyakitnya disebabkan infeksi virus dan tidak memerlukan
antibiotika. Dokter juga bisa “cemas” pasien akan pindah ke dokter
lain yang justru akan memberikan antibiotika; saat pasien sembuh ia akan menganggap
antibiotikanya lah yang menyembuhkannya. Padahal, setiap penyakit memiliki pola
perjalanan penyakit; saat berobat ke dokter kedua, penyakitnya diambang kesembuhan,
samasekali tidak ada hubungan dengan antibiotika yang diberikan.
– PATIENT PRESSURE. Tidak sedikit pasien yang meminta antibiotika atau menuntut
obat cespleng”.
– COMPANY PRESSURE. Tidak akan dibahas di bagian ini.


HARUS PUYER?

Ketika pertama kali melontarkan pertanyaan mengapa harus puyer”? Aneh,
mengapa harus dipertanyakan? Selama ini semua orang take it for granted”
bahwa resep (khususnya buat anak) adalah puyer. Puyer adalah bagian dari kultur”,
tradisi, tak terpisahkan dari dunia kedokteran di Indonesia. Puyer dianggap
yang terbaik dan paling tepat untuk Indonesia karena murah” (tetapi tidak
ada negara miskin lainnya yang memberikan peresepan puyer). Puyer paling tepat
buat Indonesia karena dosisnya bisa tepat (padahal dosis bisa kurat dengan apabila
kita mempergunakan syringe” untuk mengukurnya. Puyer juga dianggap terbaik
buat Indonesia karena sedikit sekali sediaan buat anak. Puyer juga paling tepat
karena mudah” yaitu ketika anak butuh banyak obat (gagguan kesehatan harian
tidak butuh banyak obat ketika kita kerjakan sesuai guidelinenya). Benarkah?
Di lain pihak, pasien Indonesia pun sudah menganggap (otomatis) bahwa anaknya
jauh lebih baik mengkonsumsi obat puyer.

Puyer harus ditinjau sedikitnya dari 2 aspek yaitu aspek
1. Good Manufaturing Practice (GMP/CPOB)
2. Good Prescribing Practice (GPP) dan EBMnya (lihat 6 langkah peresepan yang
benar di halaman 7)

Sebelumnya, kita tilik beberapa contoh komentar providers dan consumers terkait
puyer.

Ilustrasi di lapangan – PROVIDERS (ketika terjadi diskusi seputar
puyer)

Puyer dibuat dengan dasar pemikiran bahwa obat paten yg ada di pasaran
tidak sesuai dengan kemauan dokter sehingga dokter memiih untuk meracik
sendiri. Selain itu ada juga pemikiran bahwa pasien akan mendapat obat dengan
harga lebih murah + manjur…. Tapi sekarang bukannya sudah banyak obat
paten, selain itu banyak obat berarti lebih banyak efek samping, dan lagi…..masih
ada puyer yg ternyata harganya selangit….sooooooooo ???
Merubah perilaku pemberian resep puyer juga tidak mudah, mulai dari pengajaran
saat kuliah di FK, bagian farmasi harus dilibatkan….. saat saya sekolah
di FK pelajaran membuat puyer merupakan salah satu mata kuliah farmasi,
gak tahu sekarang gimana??? Kemudian para guru dan guru besar yg mengajar
di FK maupun Program Pendidikan Dokter Spesialis (PPDS) mesti juga memberi
contoh, agar generasi penerus lebih baik.
Membuat teori jadi kenyataan di lapangan bukan hal yg mudah apalagi kalo
pasiennya awam sekali…..membuat. Belum lagi pasien askeskin atau jamkesmas
yg dapet jatah obat sangat terbatas” dan kurang memberikan perhatian
pada obat anak sehingga hanya ada tablet untuk dewasa yg akhirnya dipuyerkan
agar sesuai untuk anak. Paket obat anti tuberkulosa (TBC) untuk anak juga
tidak memberi jatah yg cukup untuk masyarakat, OAT yg bentuk sirup atau
tablet untuk anak harganya mahal, tak ada di askeskin.
Dr X: silahkan… mungkin punya solusi jitu ttg masalah puyer … barangkali
pabrik obat disuruh bikin obat kecil2 kaya permen berdasarkan berat badan
si bayi misalnya??
ttg tulisan di”prof” yang bilang dalam bentuk sirup apakah bisa
juga menjamin dosis yang diminum bisa lebih “tepat” dibanding
puyer mengingat satu sendok misalnya bisa tertumpah, tidak pas takarannya
ataupun mengendap karena tidak dikocok sebelumnya.
dear all… menggerus obat… duuh rasanya di Indonesia aja nih yang masih
pakai… ya agak susah sih memberantasnya… tunggu menkes turun tangan
kali ya… tapi yang jelas… logikanya begini…..
Mortar itu permukaannya berbentuk pori pori kecil … dimana setiap habis
menggerus serbuk obat tersimpan didalamnya dan sulit dibersihkan… kebayangkan
kalau berkali kali digunakan mortarnya… berapa obat yang tertinggal di
dalamnya… belum lagi obat itu kan proses pembuatannya steril begitu masuk
mortar sudah tidak steril lagi…
Nah itu baru dari pembuatannya… belum lagi dari segi polifarmasi (poli
= banyak) (farmasi = obat), satu obat saja efek sampingnya sudah macam macam
apalagi kalau banyak…. dan belum lagi terjadi interaksi obat yaitu obat
satu meningkatkan atau melemahkan kerja obat yang lain, meningkatkan risiko
menjadi racun, meningkatnya risiko efek samping yang tidak diinginkan….
jadi … jangan mau ya kalau dikasih puyer…

Ilustrasi di lapangan – CONSUMERS

Seperti biasa anak – anak common cold, semua menganggap saya kebangeten
nggak bawa ke dokter. Kadang saya berfikir saya bawa anak ke dokter karena
tidak tahan pandangan orang atau tidak tahan anak batuk pilek, atau kurang
sabar? Ketemu dokter langsung dituduh tidak memberikan ASI, duh senang juga
ni dokter pro ASI, setelah itu sedih deh diresepin puyer, ditambah antibiotik
ditambah vitamin. Saya langsung nanya kok puyer dok kan berbahaya. Puyer
kan cuma ada di Indonesia. Dia bilang itu karena puyer paling sesuai
dengan Indonesia (????)
Jadi puyer termasuk kekayaan budaya kita
ya??? Bulan depan aku mau ke dr. lagi, siapa tahu bulan depan beliau sudah
tidak mau meresepkan puyer. Semoga ya…! Li…
Dear SP & doctors,
Saya punya dokter langganan yg cukup unik (menurut ukuran saya). Beliau
ini kalo ngasih obat ke pasien, selalu dari obat2-an yg dia punya dgn
jenis obat, jumlah maupun ukuran yg ber-variasi. Misalnya, 1 (satu) plastik
berisi tablet A, kapsul B, setengah tablet C, dst., dan 1 plastik ini
untuk (misalnya) dikonsumsi 3 kali sehari Uniknya (sekali lagi, ini menurut
ukuran saya), si pasien-lah yg harus menggerus obat2an itu sendiri.
Sebenarnya boleh nggak sih hal seperti ini dalam kode etik kedokteran?
Salam, Sa….J1: Ikut urun rembug yah….. Yang saya tahu Pak…..dokter itu kalau
ngasih obat ati2….. ndak lebih dari 2 baris atau 2 jenis obat….pun
tidak di tumbuk…
Nah Pak…..kenapa ndak boleh di gerus…diuleg jadi satu…..alias puyer….
bahasa kerennya polifarmasi. Kenapa ndak boleh…lebih banyak mudhorotnya
Pak.
Pemberian obat secara polifarmasi lebih banyak ruginya daripada untungnya
bagi pasien…… harga lebih mahal…belum tentu perlu semua obat2annya….mubazir.
Yang tidak kalah syeremnya….kemungkinan timbulnya interaksi obat semakin
besar…sehingga kemungkinan timbulnya efek toksik dan efek samping serta
penyakit karena obat semakin meningkat/nggilani. mohon maaf kl kurang
membantu, salam, ba….
saya coba urun rembug versi buruh pabrik dan pengalaman saya ngasuh
anak.
Pak…kalau anak-anak sakit kira2 butuh obatnya apa saja? Paling bater
Paracetamol…. ada sirupnya kok. Apalagi…diare….ada oralit; Butuh
antibotik…ada tuh syrup amoksisilin
gimana yg ndak ada syrupnya? Misalnya … antihistamin..buat alergi. alergi
kan umumnya cukup cegah pemicunya..jarang butuh antihistamin.
apalagi…steroid…..jaraanggg sekali ini pak. kl di indon iya batpil
hajar pakai ginian… alhamdulillah anak saya cukup minum air putih hangat
dan cukup makan.Bagaimana dgn keadaan di puskesmas yg juga masih menggerus puyer ???
masih banyak juga pasien batpil di puskesmas dikasih racikan puyer (termasuk
jaman dulu saat si sulung kena batpil dan saya masih oon dgn RUD). Moga
kedepannya bisa lebih baik lagi
Thks/ Mamanya F…

masukan please… Habis ke DSA…dapet resep kayak antrian bus-way abis
jam kantor (
– Zitromax (ga ketemu di medicastore?)–> AB, kata DSA karna infeksi
– Puyer : Spiropen, homoclomin, kenacort, ambril, HCL codein –> katanya
untuk batuk pilek, tp indikasi obatnya kok untuk penyakit yg cukup gawat
ya??
– Dumin–> obat panas
Kecewa berat ama DSA nya… terburu2 (banyak pasien). Jadi masuk ruang
periksa, periksa pake stetoskop, tulis resep.. selesai d acaranya… (ngukur
panas juga kaga tuh…) Kemudian, ke kasir bayar, di apotik, pas saya
nanya famasisnya (kebetulan lagi keluar dari tempat persembunyian..hehehe..)
eh, malah nanya: “Ibu mau beli obat nya di sini apa tempat laen?”….

Oh ya, Ruam yg keluar di bag dada, perut, ketiak, punggung, n sedikit
di selangkang itu Roseola ya? Kata DSA, karna minyak.. Sori ya, rada curhat.
Salam, Ri…

GOOD MANUFACTURING PRACTICES
Industri farmasi harus memenuhi stau standar untuk memperoleh ijin produksi
dan mereka yang telah memperoleh ijin untuk memproduksi obat, harus mematuhi
standar Quakity Assurance.

The quality of pharmaceuticals has been a concern of the World Health Organization
(WHO) since its inception. The setting of global standards is requested in Article
2 of the WHO Constitution, which cites as one of the Organizations functions
that it should develop, establish and promote international standards with respect
to food, biological, pharmaceutical and similar products.”
Every government allocates a substantial proportion of its total health budget
to medicines. This proportion tends to be greatest in developing countries,
where it may exceed 40%. Without assurance that these medicines are relevant
to priority health needs and that they meet acceptable standards of quality,
safety and efficacy, any health service is evidently compromised. In developing
countries considerable administrative and technical effort is directed to ensuring
that patients receive effective medicines of good quality. It is crucial to
the objective of health for all that a reliable system of medicines control
be brought within the reach of every country.
Both for manufacturers and at national level, GMP are an important part of a
comprehensive system of quality assurance. They also represent the technical
standard upon which is based the WHO Certification Scheme on the Quality of
Pharmaceutical Products Moving in International Commerce.
Good manufacturing practice is that part of quality assurance which ensures
that products are consistently produced and controlled to the quality standards
appropriate to their intended use and as required by the marketing authorization.
GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical
production. Such risks are essentially of two types: cross contamination (in
particular of unexpected contaminants) and mix-ups (confusion) caused by, for
example, false labels being put on containers. Under GMP:

a. all manufacturing processes are clearly defined, systematically reviewed
in the light of experience, and shown to be capable of consistently manufacturing
pharmaceutical products of the required quality that comply with their specifications
b. qualification and validation are performed;
c. all necessary resources are provided, including:

(i) appropriately qualified and trained personnel;
(ii) adequate premises and space;
(iii) suitable equipment and services;
(iv) appropriate materials, containers and labels;
(v) approved procedures and instructions;
(vi) suitable storage and transport;
(vii) adequate personnel, laboratories and equipment for in-process controls;

d. instructions and procedures are written in clear and unambiguous language,
specifically applicable to the facilities provided;
e. operators are trained to carry out procedures correctly;
f. records are made (manually and/or by recording instruments) during manufacture
to show that all the steps required by the defined procedures and instructions
have in fact been taken and that the quantity and quality of the product are
as expected; any significant deviations are fully recorded and investigated;

g. records covering manufacture and distribution, which enable the complete
history of a batch to be traced, are retained in a comprehensible and accessible
form;
h. the proper storage and distribution of the products minimizes any risk to
their quality;
i. a system is available to recall any batch of product from sale or supply;
j. complaints about marketed products are examined, the causes of quality defects
investigated, and appropriate measures taken in respect of the defective products
to prevent recurrence.
Singkatnya, urusan membuat obat merupakan rantai panjang nan rumit. Banyak persyaratan
yang HARUS dipenuhi. Misalnya, untuk premise, ada 36 persyaratan. Salah satunya
saya kutip di bawah. Apakah penggerusan obat kembali” menjadi bubuk tidak
melanggar konsep GMP? Bagaimana dengan kualitas (dan stabilitas) obat yang digerus
apalagi ketika penggerusanya bersama-sama dengan berbagai obat lainnya? Apalagi
Indonesia sebagai negara tropis yang lembab, kita patut mempertanyakan stabilitas
obat apalagi yang dicampur dan digerus bersama menjadi puyer.

12.3 Where dust is generated (e.g. during sampling, weighing,
mixing and processing operations, packaging of powder), measures should
be taken to avoid cross-contamination and facilitate cleaning.


PENUTUP

Apakah kita bisa dan mau membuka hati meninjau kembali praktek peresepan kita
termasuk peresepan puyer yang nampaknya suda menjadi suatu comfort zone”
buat kita semua? Apakah kita bisa jujur menilai diri kita sendiri, seberapa
jauh kita sudah menjalankan tugas sesuai evidence dan panduannya? Mari kita
bergandengan tangan …..PRIMUM NON NO CERE” … Above all do not harm.
Semoga kita bisa bersama-sama men translate” EBM ke kehidupan & praktek
sehari-hari dan tidak berkubang dalam atmosfer lost in translation”.

Daftar Pustaka:

1. World Health Organization. The Role of Education in the Rational Use of
Obat-obatan. South-East Asia Regional Office Publication Series, No. 45, 2006:
ix.
2. Arustiyono. Promoting Rational Use Of Drugs at the Community Health Centers
in Indonesia. Department of International Health School of Public Health Boston
University September 1999.
3. Bjerrum L. Pharmacoepidemiological Studies of Polypharmacy: Methodological
issues, population estimates, and influence of practice patterns. PhD Thesis,
Research Unit of General Practice and Department of Clinical Pharmacology The
Faculty of Health Sciences Odense University Denmark 1998.
4. Aman GM. Masalah Pemberian Polifarmasi.
5. Dwiprahasto I. Improving the Quality of Prescribing at Primary Health Centres
through a Training Intervention for Doctors and Paramedics. Jurnal Manajemen
Pelayanan Kesehatan, 2006: 94-101.
6. Widyastuti S, Dwiprahasto I, Andajaningsih, Bakri Z. The impact of problem-based
rational drug use training on prescribing practices, cost reallocations and
savings in primary care facilities. International
Conferences on Improving Use of Obat-obatan (ICIUM)
. World Health Organization
Essential Obat-obatan and Policy Department (EDM).
7. Quick J D, Foreman P, Ross-Degnan D. Where Does the Tetracycline Go? Health
Center Prescribing and Child Survival in East Java and West Kalimantan, Indonesia,
Jakarta: Management Sciences for Health, 1988.
8. MOH Republic of Indonesia. Integrated Analysis of Focused Problem Assessments
on Drug Management and Use and Design Interventions, Washington, DC: International
Science and Technology Institute Inc, 1990.
9. MOH Republic of Indonesia. Final Report on Pre-Post Controlled Trial of Drug
Use, Jakarta, 1994
10. Ross-Degnan D, Laing RO, Quick JD, Santoso B, Bimo, Chowdlury AK, Ofori-Adjei
D, et al. Field tests for rational drug use in twelve developing countries,
The Lancet 1993; 342:1408-1410
11. Department of Child and Adolescent Health and Development. The Treatment
of Diarrhoea. A Manual for Physicians and Lain-lain Senior Health Workers. World
Health Organization. 2005.
12. Makalah workshop Promoting Rational Use of Drugs in the Community (PRUDC),
WHO SEARO, Jaipur, India, January 2005.
13. WHO. Quality assurance of pharmaceuticals. A compendium of guidelines and
related materials Volume 2, 2nd updated edition. Good manufacturing practices
and inspection, 2007. www.who.int/topics/pharmaceutical_products/en

THE GREAT PHYSICIAN. We physicians all have heroes during
our training. We all remember the great physicians. I contend that the great
physicians differ from the good physicians because they understand the entire
story. Only when we understand the complete story do we make consistent
diagnoses.

Each patient represents a story. That story includes their diseases, their
new problem, their social situation, and their beliefs.
How do we understand the story? We must develop excellent communication
skills and gather the history in appropriate depth. We must perform a targeted
physical examination based on the historical clues. We must order the correct
diagnostic tests, and interpret them in the context of the history and physical
exam. Once we collect the appropriate data, we then should construct that
patient’s story.
The story includes making the correct diagnosis or diagnoses. The story
must describe the patient’s context. Who is this patient? What are the patient’s
goals? How might the patient’s personal situation impact our treatment options?
Sir William Osler said, “The good physician treats the disease; the
great physician treats the patient who has the disease.” The great
physician understands the patient and the context of that patient’s illness.
Be a great physician. Understand the full story. Make correct diagnoses.
Consult the patient in designing the treatment plans that best fit that
patient.
Follow the results with consistency and compassion. By so doing, you will
not only be providing the highest quality medical care; you will also be
living up to the ideals of William Osler and those of Tinsley Randolph Harrison
– the greatest of physician role models. That’s my opinion. I’m Dr. Robert
Centor, Professor of Medicine at the University of Alabama, Birmingham.

March 20, 2009 Posted by | Artikel | Leave a comment

DRUG POLICY IN INDIA: COMPOUNDING HARM?

THE BECKLEY FOUNDATION DRUG POLICY PROGRAMME

Molly Charles, Dave Bewley-Taylor and Amanda Neidpath

The Beckley Foundation Drug Policy Programme (BFDPP) is a new initiative dedicated to providing a rigorous
independent review of the effectiveness of national and international drug policies. The aim of this programme of
research and analysis is to assemble and disseminate material that supports the rational consideration of complex drug
policy issues, and leads to more effective management of the widespread use of psychoactive substances in the future

INTRODUCTION
Contemporary international drug policy seeks to control
both the demand and supply of drugs through the
criminalisation of production, trafficking and use.
Furthermore, adherence to the United Nations drug
control conventions ensures that most nation states adopt a
similar prohibition-oriented approach when formulating
national drug control legislation. Recent research suggests
that this can be problematic in some Asian countries where
longstanding cultural sanctions already existed for drug use;
particularly those involving psychoactive plant products
such as cannabis and opium.
With its focus on India, this briefing paper examines the
impact of the punitive approach towards drugs in those
societies and communities that have traditionally exerted
socio-cultural controls over the use of mind-altering
substances. The discussion highlights the unintentional but
often harmful consequences of such drug control policies.
In framing the discussion of this topic, it is important to
note that the socio-cultural context of traditional drug use
within many Asian countries means that experiencing an
altered state of consciousness is only a part of the drug
taking experience and not the ultimate goal of users

Indeed, norms controlling excessive and regular drug use
have customarily governed socially and culturally accepted
consumption of native mind-altering substances.
While such traditional use management strategies vary
across Asian countries, it is possible to identify similarities
that exist between these approaches to drug use and
contemporary interventions that collectively fall within the
so-called harm reduction paradigm. The defining feature of
harm reduction programmes is their focus on the
prevention of harm rather than the prevention of drug use
itself.
It can be argued, therefore, that as signatories to the 1961
UN Single Convention on Narcotic Drugs, many Asian
countries have been required to move away from
longstanding approaches to control customary drug use. In
many respects, there has been a subsequent shift from
traditional drug use management to an emphasis on
eradicating all drug use and trade. The implementation of
law-enforcement-dominated policies has generated a tense
relationship between contemporary legislation and
culturally ingrained drug use patterns and associated
management strategies

This situation is compounded by changing patterns of drug
use within India. This is the result of a number of inter-
related factors; the rising popularity of new non-traditional
forms of drug use introduced via tourism; urbanization; and
leakage from illicit drug production in the region. Indeed,
evidence suggests that changes in policy may have
contributed to increases in the use of harder forms of drugs
and more harmful modes of consumption, notably drug
injecting. Such a change in user behaviour is particularly
significant given the role played by injecting drug use in the
transmission of HIV/AIDS and other blood borne
infections. The management of this issue has become a
cause for concern within the field of drug demand
reduction and has serious implications for the development
realities of many Asian countries.
History
The use of the cannabis plant for a variety of purposes has
long existed in India (Charles et al, 1999; Charles, 2001), a
fact also noted for many other countries of Asia (Li Hui
Lin, 1975; Martin 1975, Fisher, 1975; Khan et al 1975 and
Charles, 2004).
Its use for medicinal reasons, as well as its mind altering
capacity, is significant. Cannabis has been used along with
other ingredients to treat rheumatism, migraine, malaria
and cholera; to relieve fluxes; facilitate surgical operations;
to relax nerves; restore appetite; for general well-being; and
it is also considered beneficial for the functioning of the
heart and liver. Additionally, the cannabis plant provides
food grain, oil seed and fibre for manufacture of fibrous
products in select parts of India.
The practice of using cannabis to alter consciousness and as
part of religious and shamanistic rituals has also existed in
India for centuries. For example, the drug has a strong
religious association as a gift from Lord Shiva to his
followers.
Opium has also been used for socio-cultural reasons in
different parts of the country (Chopra et al, 1990), with
medicinal use being more prevalent than cultural use, like
that seen among the Rajputs in Rajasthan and Gujarat
(Masihi et al 1996).
Prior to the introduction of contemporary drug control
legislation, a system for procuring opium and cannabis
through legal outlets existed. However, drug control
initiatives put in place procedures that made it difficult
to obtain these substances. Legislation in 1985 and 2001
include provisions for medical use, but there has been a
trend not only to reduce the quantity released by the
government, but also to tighten up procedural
regulations for obtaining the drugs by traditional

medicinal practitioners. The resulting inability to source
sufficient licit opium and cannabis for traditional use has
forced such practitioners to make purchases from the
expanding illegal market.
Socio-Cultural Controls
Until the 1980s cannabis consumption does not appear to
have been regarded as an issue of major social concern in
India, with little or no official mention of excessive use.
Prevalent socio-cultural regulations with regard to the form
of use, mode of consumption, context of use and profile of
users, ensured a system of use management that limited
drug use within the country.
For instance, norms restricted the use of cannabis and
opium to the adult male population. In the case of cannabis,
this is a pattern documented in a number of countries
including Cambodia, Vietnam, Thailand, Laos, China,
Nepal and Pakistan. Even among the male adult
population, there were restrictions on the context for
consumption, with sanctioned use often linked or limited to
specific religious and social occasions.
In India and Nepal, the use of cannabis appears to be linked
to religious festivals like Shivaratri, Krishna Ashtami (birth
of Lord Krishna) and participation in bhajan sessions.
Indeed, occasions like Holi, ‘the festival of colours,’ are not
complete without the sharing of bhang – a drink made with
cannabis. At such select occasions, women and youngsters
were permitted to use bhang and other items made from
cannabis, including snacks, sweets and curry. Opium is also
offered at the harvest festival in a ceremony called akha
teej, intended to strengthen family marital clan bonds and
put aside old feuds.
It is this specification regarding the profile of users and a
desire for cultural confirmation that ensured the existence
of mechanisms to control drug use. The provision made for
women and children to consume cannabis products in select
cultural contexts and in specified forms indicates a strong
cultural acceptance for cannabis within India. Norms
reaffirmed the cultural dimension of cannabis use and
probably prevented excessive non-cultural use of cannabis.
As noted earlier, the adherence to cultural norms on
sanctioned use emerged from a strong association of
cannabis with Lord Shiva. For example, Sadhus (hermits) of
various sects who primarily worship Lord Shiva make use
of the drug for strengthening their concentration and
spiritual search.
Prior to smoking cannabis, the sadhus praise their Lord and
take it in his name, a pattern of consumption seen also
among lay followers. During Shivaratri, the distribution of

Page 1
THE BECKLEY FOUNDATION
DRUG POLICY PROGRAMME
BRIEFING PAPER TEN
OCTOBER 2005
DRUG POLICY IN INDIA:
COMPOUNDING HARM?
Molly Charles, Dave Bewley-Taylor and Amanda Neidpath
INTRODUCTION
Contemporary international drug policy seeks to control
both the demand and supply of drugs through the
criminalisation of production, trafficking and use.
Furthermore, adherence to the United Nations drug
control conventions ensures that most nation states adopt a
similar prohibition-oriented approach when formulating
national drug control legislation. Recent research suggests
that this can be problematic in some Asian countries where
longstanding cultural sanctions already existed for drug use;
particularly those involving psychoactive plant products
such as cannabis and opium.
With its focus on India, this briefing paper examines the
impact of the punitive approach towards drugs in those
societies and communities that have traditionally exerted
socio-cultural controls over the use of mind-altering
substances. The discussion highlights the unintentional but
often harmful consequences of such drug control policies.
In framing the discussion of this topic, it is important to
note that the socio-cultural context of traditional drug use
within many Asian countries means that experiencing an
altered state of consciousness is only a part of the drug
taking experience and not the ultimate goal of users.
Indeed, norms controlling excessive and regular drug use
have customarily governed socially and culturally accepted
consumption of native mind-altering substances.
While such traditional use management strategies vary
across Asian countries, it is possible to identify similarities
that exist between these approaches to drug use and
contemporary interventions that collectively fall within the
so-called harm reduction paradigm. The defining feature of
harm reduction programmes is their focus on the
prevention of harm rather than the prevention of drug use
itself.
It can be argued, therefore, that as signatories to the 1961
UN Single Convention on Narcotic Drugs, many Asian
countries have been required to move away from
longstanding approaches to control customary drug use. In
many respects, there has been a subsequent shift from
traditional drug use management to an emphasis on
eradicating all drug use and trade. The implementation of
law-enforcement-dominated policies has generated a tense
relationship between contemporary legislation and
culturally ingrained drug use patterns and associated
management strategies.
The Beckley Foundation Drug Policy Programme (BFDPP) is a new initiative dedicated to providing a rigorous
independent review of the effectiveness of national and international drug policies. The aim of this programme of
research and analysis is to assemble and disseminate material that supports the rational consideration of complex drug
policy issues, and leads to more effective management of the widespread use of psychoactive substances in the future.
Page 2
2
This situation is compounded by changing patterns of drug
use within India. This is the result of a number of inter-
related factors; the rising popularity of new non-traditional
forms of drug use introduced via tourism; urbanization; and
leakage from illicit drug production in the region. Indeed,
evidence suggests that changes in policy may have
contributed to increases in the use of harder forms of drugs
and more harmful modes of consumption, notably drug
injecting. Such a change in user behaviour is particularly
significant given the role played by injecting drug use in the
transmission of HIV/AIDS and other blood borne
infections. The management of this issue has become a
cause for concern within the field of drug demand
reduction and has serious implications for the development
realities of many Asian countries.
History
The use of the cannabis plant for a variety of purposes has
long existed in India (Charles et al, 1999; Charles, 2001), a
fact also noted for many other countries of Asia (Li Hui
Lin, 1975; Martin 1975, Fisher, 1975; Khan et al 1975 and
Charles, 2004).
Its use for medicinal reasons, as well as its mind altering
capacity, is significant. Cannabis has been used along with
other ingredients to treat rheumatism, migraine, malaria
and cholera; to relieve fluxes; facilitate surgical operations;
to relax nerves; restore appetite; for general well-being; and
it is also considered beneficial for the functioning of the
heart and liver. Additionally, the cannabis plant provides
food grain, oil seed and fibre for manufacture of fibrous
products in select parts of India.
The practice of using cannabis to alter consciousness and as
part of religious and shamanistic rituals has also existed in
India for centuries. For example, the drug has a strong
religious association as a gift from Lord Shiva to his
followers.
Opium has also been used for socio-cultural reasons in
different parts of the country (Chopra et al, 1990), with
medicinal use being more prevalent than cultural use, like
that seen among the Rajputs in Rajasthan and Gujarat
(Masihi et al 1996).
Prior to the introduction of contemporary drug control
legislation, a system for procuring opium and cannabis
through legal outlets existed. However, drug control
initiatives put in place procedures that made it difficult
to obtain these substances. Legislation in 1985 and 2001
include provisions for medical use, but there has been a
trend not only to reduce the quantity released by the
government, but also to tighten up procedural
regulations for obtaining the drugs by traditional
medicinal practitioners. The resulting inability to source
sufficient licit opium and cannabis for traditional use has
forced such practitioners to make purchases from the
expanding illegal market.
Socio-Cultural Controls
Until the 1980s cannabis consumption does not appear to
have been regarded as an issue of major social concern in
India, with little or no official mention of excessive use.
Prevalent socio-cultural regulations with regard to the form
of use, mode of consumption, context of use and profile of
users, ensured a system of use management that limited
drug use within the country.
For instance, norms restricted the use of cannabis and
opium to the adult male population. In the case of cannabis,
this is a pattern documented in a number of countries
including Cambodia, Vietnam, Thailand, Laos, China,
Nepal and Pakistan. Even among the male adult
population, there were restrictions on the context for
consumption, with sanctioned use often linked or limited to
specific religious and social occasions.
In India and Nepal, the use of cannabis appears to be linked
to religious festivals like Shivaratri, Krishna Ashtami (birth
of Lord Krishna) and participation in bhajan sessions.
Indeed, occasions like Holi, ‘the festival of colours,’ are not
complete without the sharing of bhang – a drink made with
cannabis. At such select occasions, women and youngsters
were permitted to use bhang and other items made from
cannabis, including snacks, sweets and curry. Opium is also
offered at the harvest festival in a ceremony called akha
teej, intended to strengthen family marital clan bonds and
put aside old feuds.
It is this specification regarding the profile of users and a
desire for cultural confirmation that ensured the existence
of mechanisms to control drug use. The provision made for
women and children to consume cannabis products in select
cultural contexts and in specified forms indicates a strong
cultural acceptance for cannabis within India. Norms
reaffirmed the cultural dimension of cannabis use and
probably prevented excessive non-cultural use of cannabis.
As noted earlier, the adherence to cultural norms on
sanctioned use emerged from a strong association of
cannabis with Lord Shiva. For example, Sadhus (hermits) of
various sects who primarily worship Lord Shiva make use
of the drug for strengthening their concentration and
spiritual search.
Prior to smoking cannabis, the sadhus praise their Lord and
take it in his name, a pattern of consumption seen also
among lay followers. During Shivaratri, the distribution of
Page 3
3
cannabis drink and other products is perceived as a way to
strengthen the association with the Lord. It is likely that
such a relationship played a major role in restricting its use
within India and Nepal, despite easy availability and local
cultivation. The drug’s connection to Shivaratri almost
certainly limited its use beyond the ceremonial context.
Unlike cannabis, opium does not appear to have any
significant religious associations, but even here the link
between cultural identity and the consumption of opium
acted as a strong mechanism to restrict consumption of the
drug in excess. Studies conducted into opium use in
Rajasthan and Gujarat indicate strong links between
cultural and caste membership, and use of the drug.
An opium drink can be used to greet guests to social
functions that include marriage celebrations, sealing a
business deal or mourning the demise of a relative. In this
case, culture permits opium consumption in the male adult
population but, unlike with cannabis, there is no specific
cultural sanction for women and youngsters to use the
substance except for medicinal purposes.
Such sanctioned cultural use, and its occasion or context,
produces a situation within which a drug’s mind-altering
properties are not the sole focus of the practice. For
example, in consumption during a celebration or get
together, songs and social interaction form the binding
force for consuming the substance. Consumption of bhang
during Holi calls for community participation from the
decision to prepare the drink, through to making it, and
finally its consumption in a group setting.
The pattern of consumption for smoking cannabis and
opium also restricts drug use, because as a group activity
the users only inhale a few times from the pipe. Moreover,
smoking the pipe is but a part of social interaction and not
the sole activity of the group. Sharing the drug is also not
the result of any economic consideration as is sometimes
seen in the case of heroin (Charles et al, 1999).
Narcotics Drugs and Psychotropic
Substances Act (NDPS) 1985.
Prior to the present drug control legislation, the focus of
Indian drug policies was control of the drug trade and the
collection of revenues through licensed sales (Hasan, 1975).
The change in policy direction had much to do with India’s
international commitments. As a signatory to the UN 1961
Single Convention, India, like many other nations, was
obliged to eradicate culturally ingrained patterns of drug
use, including those involving cannabis and opium

Indian delegations at the UN had long objected to a
proposed policy of international cannabis prohibition, but
had “made little headway against the massive,”
predominantly Western and US-led, “anticannabis bloc.”
(Bruun, Pan and Rexed, 1975). Yet, in order to gain
widespread acceptance, the final draft of the Single
Convention included transitional reservations allowing so-
called grace periods for phasing out traditional drug use.
This meant that the “quasi-medical use” of opium had to be
abolished within 15 years of the Convention coming into
force. Similarly, the non-medical or non-scientific use of
cannabis was to be discontinued as soon as possible, “but in
any case within 25 years” from the date the convention
came into force (United Nations 1972). Referring to
cannabis, one expert has commented that it was a rather
optimistic timetable when “matched against three thousand
years of use by untold millions” (see Bewley-Taylor, 2001).
In political terms, any moves to phase out cultural drug use
within India were problematic, since it was difficult for any
party in power to tamper with popular religious and
cultural feelings concerning the use of opium and cannabis.
Consequently, mindful of international obligations
regarding the UN grace period and the political sensitivity
of the issue within the country, the NDPS Act was quietly
put on to the statute books with little national debate
(Charles et al, 1999). The only provision for non-medical
cultural use within the 1985 Act was that drinks made from
cannabis leaves were to be sanctioned (Britto, 1989).
As such, the legislation made many traditional forms of
drug use a criminal act that could be punishable by
imprisonment. Some of the significant measures taken
under the NDPS Act (1985) include:
• For the consumption of substances such as narcotic
drugs or psychotropic substances or any other substance
specified by the Central Government, the punishment is
imprisonment for a term, which may be extended to one
year, or a fine, which may extend to twenty thousand
rupees, or both.
• In the case of consumption of cannabis products other
than bhang, imprisonment may be for a term of six
months, or a fine which may extend to ten thousand
rupees, or both.
• The quantity specified for various substances that
could lead to arrest for trading in drugs was not very
large. For example, 250 milligrams of heroin, five grams
of opium, five grams of charas or hashish, 500 grams of
ganja (marijuana) and 25 milligrams of cocaine (NDPS
Act, 1985)

Evidence suggests that, in largely ignoring the socio-
cultural context of traditional drug use, the NDPS Act led
to a significant increase in the arrests of low-level drug
users. Arrests under the Act in 2001 totalled 16,315, of
which around 76 per cent (12,400) were prosecuted and 28
per cent (4,568) convicted. A study undertaken in the same
year in Tihar jail provides an insight into the make-up of
such figures. Interviews with 1,910 individuals arrested
under the NDPS Act (1985) indicated that around 325 (17
per cent) were arrested under Section 27 (Seethi, 2001).
This refers to the possession of small quantities of drugs
meant for personal consumption. While the law has
provision for such arrestees to seek treatment instead of
serving a sentence, the provision is rarely utilised
(Annuradha, 1999).
Research also shows that many of those arrested on drug
charges spent years in jail before their cases came up for
hearing (Annuradha, 2001; Charles et al, 1999). This was a
result of the notoriously slow pace of the Indian judicial
system. In some instances, it has meant that those caught
with small quantities of drugs were eventually acquitted
after spending years behind bars. Beyond concerns about
the obvious injustice of such cases, prolonged prison time
for low level drug offenders also raises the issue of
recruitment by criminal groups. A recent study on
organised crime in Mumbai suggests that prisons in India,
as in many other parts of the world, are ideal places for
orienting vulnerable individuals into the world of crime
(Charles et al, 2002).
Changes in patterns of drug use
The convergence of a number of important structural
changes, at both national and international levels, around
the time of the NDPS Act (1985), impacted on long-
standing patterns of drug use within India.
Research suggests that tourism has contributed to a
diversification of drug use patterns. In the mid and late
1970s, exposure to other cultures in both Nepal (Fisher,
1975) and India produced new forms of drug taking
behaviour. Since the early 1980s, most major Indian cities
have been introduced to new “foreign” drugs such as
heroin. The interaction of young Indians with tourists has
also facilitated an alteration in the relationships they later
form with those drugs traditionally consumed (Charles et
al, 1999, Charles, 2001). This is seen in all parts of the
country, although the process is more gradual in rural areas.
Such a rural-urban split can be explained by the impact of
urbanization upon traditional patterns of drug use and
management. Put simply, urban communities do not tend
to adhere to traditions to the same degree as those in rural
areas. Furthermore, the relatively easy availability of a

“foreign” drug like heroin, in comparison to opium, within
the urban setting contributed to a shift in the drug of
choice. As such, data from 16,942 drug users as part of the
Drug Abuse Monitoring System reveal that, other than
alcohol, there is significant variation in drug use patterns
between urban and rural areas. With regard to heroin, for
example, 14.9 per cent of users were from urban areas with
nearly half that figure (7.9 per cent) being from rural areas
(Siddiqui, 2002). The shift to heroin is also more likely to
take place in urban settings that fall along the illicit heroin
trafficking routes from South West and South East Asia.
Indeed, the illicit drug trade has a significant, although
complex, impact on drug use patterns within many parts of
India. Shifts from opium to heroin use can be seen to
depend on a number of inter-related factors. These include
proximity to areas of illegal cultivation and processing,
traditional regional drug use patterns and geographic
accessibility. For example, there is illicit poppy cultivation
in the North Eastern state of Arunachal Pradesh.
Nonetheless, in a state with a history of cultural opium use
and, due to the densely forested nature of the terrain,
limited connectivity with the surrounding areas, drug use is
limited to opium (Narcotics Control Bureau Report, 2001).
In other parts of North East India (especially Manipur,
Nagaland and Mizoram), circumstances are different,
however. The combination of the easy availability of
heroin from Myanmar and absence of cultural use of opium
in these regions resulted in the emergence of heroin use. In
the states of Madhya Pradesh, Rajasthan and Uttar Pradesh
there is a history of cultural opium use with the demand
long supplied by diversion from licit cultivation. A study
in Rajasthan in 1989 indicated that drug use was largely
limited to opium and cannabis. Nonetheless, recent
research shows that in the mid-1990s there was a shift from
traditional drugs to heroin. It is significant that this change
took place at a time when there was an increase in the illicit
heroin traffic to India from Afghanistan via Pakistan
(Charles, 2004).
Evidence suggests that the new legislation exacerbated the
problems arising from such structural changes. For
example, far from reaching its goal of eradicating drug use,
enforcement of the NDPS Act (1985) appears to have
inadvertently facilitated a shift to harder forms of drugs and
riskier modes of consumption.
The impact of the legislative changes was initially felt in
urban areas in the 1990s, especially the major cities (Charles
M, Nair K.S., et. al, 1999). As a result of the factors
discussed above, hard drugs seem to have found a niche in
many cities. An official study showed that of those drug
users seeking treatment, significant numbers were using
heroin, opium and the narcotic analgesic, propoxyphene
(Siddiqui, 2002)

Another study among opiate users in fourteen sites across
India indicated the primary substance of abuse was heroin
followed by buprenorphine, a synthetic opiate. From the
total sample of 4,648 drug users, around 43 per cent had
injected drugs at some time. In many cases, the drug of
choice was buprenorphine followed by heroin and
propoxyphene. Among the injectors around 51 per cent in
Amritsar (in the State of Punjab) were found to have shared
needles at some time, with 15 per cent from Hyderabad,
New Delhi, Dimapur, Trivandrum and Chennai reporting
the same practice. The conditions for widespread
transmission of HIV and other infections through drug use
are therefore increasingly present in India.
It is possible to see that the shift in patterns of use is not
only from traditional drugs to derivative drugs but also to
synthetic products as well (Kumar, 2002). A 2004 study on
the illicit Indian drug trade indicated that increasing
controls over poppy straw used in the preparation of opium
drinks is creating a shift towards synthetic opiates (Charles,
2004). This is a dangerous trend considering that the
morphine content in poppy straw is very low.
Given the cultural acceptance of cannabis and opium,
monitoring of the drug of initiation among users can be a
useful process in identifying changing patterns of drug use
across the country. For example, the 2002 Ministry of
Social Justice and Empowerment Rapid Assessment Study
revealed that within the majority of fourteen study sites
respondents cited cannabis (40 per cent) followed by
alcohol (33 per cent) to be dominant drugs of initiation.
However, in Dimapur, a city from North Eastern region,
for around 34 per cent of the sample the first drug of abuse
was propoxyphene, followed by heroin for 30 per cent
(Kumar, 2002).
The profile of drugs users is another area that has
undergone significant changes. As mentioned above,
traditional users were predominantly from the male adult
population (Masihi et al, 1996; Charles et al, 1999). Data
collected from fourteen study sites in the Rapid Assessment
Study indicate that after legislative measures were put in
place to criminalise drug use, the age of initiation to drug
use fell. The Study showed the mean age to be nineteen
and below, with around 52 per cent of the users in the
sample starting to use drugs between the ages of 16 and 20
years (Kumar, 2002).
Socio-cultural mechanisms also traditionally ensured that
drug use by women within India was limited. There now
appears to be a shift in this pattern. Drug use among
women is often hidden with available data being based on
random sampling of identified drug users. Nonetheless,
data collected from 75 drug users in Mumbai, Delhi and
Aizwal indicated the main substances of abuse to be heroin,
propoxyphene, alcohol, minor tranquilisers and cough

syrup. Around 40 per cent were injecting drug users with
49.3 per cent of the sample aged between 21 and 30 years
old. In Aizwal, a larger proportion of the drug users were
between 15 and 20 years old (Murthy, 2002).
The consequences of an erosion of the traditional gender
based restrictions on drug use also include negative
secondary impacts. Of the seventy-five women within
Pratima Murthy’s 2002 study, 45.3 per cent derived their
main source of income from sex work and drug dealing. In
combination with the high incidence of injecting drug use,
this reality clearly has serious implications for the
management of HIV/AIDS and other blood borne
infections.
The 2001 Amendments of NDPS Act
(1985) and unaddressed concerns
The criminalisation of drug use and the increasing rates of
arrest for possessing small quantities of drugs led to
officials, social scientists, members of the judiciary and
others to question the suitability of such harsh legislation.
According to one observer, the Act failed because of delay
in trials, a weak bail law that left the poor languishing in
prisons, the failure of investigating agencies to follow the
procedural requirements of NDPS Act and a poor
understanding of the addiction problem (Anuradha, 2001).
As a consequence of such criticisms, including those from
the National Addiction Research Centre, a reassessment of
the Act in 2001 resulted in amendments relating to the
length of imprisonment and the quantity and type of drug
seized. This ensured that, where traditional drugs are
concerned, only individuals with large quantities of
cannabis can be arrested for drug trafficking and face
imprisonment.
Further changes in the law in 2002 created two categories
that are based on quantity seized. These are defined as
small quantities and commercial quantities. For trafficking
in commercial quantities, the sentence is imprisonment for
more than twenty years and a fine varying between 100,000
and 200,000 Rupees. The categorisation of quantity varies
according to the substance seized; for hashish, a small
quantity is classified as below 100 grams and commercial
quantity as 1 Kilogram and above; for heroin, a small
quantity is below 5 grams and commercial quantity above
250 grams.
This is arguably a more realistic figure than the former law
that classified those possessing more than a quarter gram as
drug traffickers. Nonetheless, despite the efforts made to
revise the Act, one contradiction persists. This is that any
form of use remains a criminal offence, which can result in

imprisonment for a period of six months. Such an offence
appears to be unrealistic in a country where the use of
cannabis and opium retains widespread cultural acceptance
in many states across the country.
The National Drug Policy follows the lines drawn by
legislation and the focus has been on demand reduction
through prevention and treatment, and supply reduction
through enforcement activities. However, there has been a
clear emphasis of political support and resource allocation to
supply reduction. One example of this relates to one of the
2001 amendments to the act, which created a National Fund
for Control of Drug Abuse. This was designed to support
the expansion of demand reduction programmes, but has yet
to become active (NDPS Act, 2003; Anuradha, 2001).
At present, efforts on the demand side focus on prevention,
treatment, rehabilitation and after care services undertaken
within institutional and community settings. There are
currently 450 centres funded across the country for de-
addiction and counselling services. National level Drug
Abuse Monitoring Systems have also been established in an
effort to understand trends in drug use and its implications
for drug abuse management. Most efforts in the area of
demand reduction are funded by Ministry of Social Justice
and Empowerment and United Nations Office on Drugs
and Crime.
Ongoing issues of concern in the area of
drug demand control in India.
As described here, the authorities have clearly made efforts
to alter provisions of the NDPS to take more account of
the indigenous drug use culture within the country. That
said, evidence suggests that Indian drug policy could be
made far more effective and appropriate to national
realities. This is crucial at a time when overall, “the drug
situation is still in a benign stage in India, though moving in
dangerous directions” (Charles and Britto, 2002). While
cultural norms in rural areas effectively restrict drug use to
traditional forms and drug-related HIV is still relatively
low within the national context of drug use, current trends
suggest increasing levels of problematic non-traditional use
and addiction. We suggest that in any assessment of
contemporary Indian drug control policies, there are a
number of key issues of concern:
• Most prevention efforts within India are, within the
international framework laid down by the United
Nations, currently based on experiences in
predominantly Western countries. As such, they start
from a position that considers all forms of drug use
criminal and deviant. Thus, this leaves no scope for
strengthening cultural mechanisms of use management
or integrating them into contemporary legislation. For

example, where institutional care appears unsustainable,
practitioners could consider traditional forms of control
such as the use of doda pani (a drink made from poppy
pod) to wean users away from excessive opium or heroin
consumption. Research suggests that cultural norms in
India are far more efficient means of drug control, and
have fewer negative side-effects than legislation inspired
by global norms (Charles & Britto 2002).
• Limited government funding means that the treatment
of drug abuse is not widely available.
– Centres tend to provide services on a fee paying basis
and the marginalised street level drug user
consequently has limited options. In the city of
Mumbai, for example, there are no treatment centres
that cater to street level users with complications.
Furthermore, the government hospital catering to the
general population dislikes dealing with drug users
because they are considered to be ‘difficult’ patients.
Treatment for drug addiction is consequently not
widely available and this sometimes results in users
dying without receiving any care (Charles, et al,
1999).
– There is a systematic reduction of government grants
to drug treatment centres and the remuneration for
the services of professionals is so minimal there are
few takers. Under such conditions, there appears to
be limited scope for an appropriate approach to care.
• Attempts at cost management by users, in
combination with the deteriorating quality of street
drugs, have produced more risky forms of use; that is to
say, injecting behaviour. This has serious consequences
for public health in some parts of India. A recent study
found that the purity of heroin sold on the street varies
from 3 per cent to 12 per cent. The Narcotics Drugs
Control Board of India places the purity of street level
heroin at 5 per cent (Charles, 2004). In the north-
eastern part of the country it seems that a shift to
injecting drug use is also a result of time management
issues. The behaviour of a drug user in these areas of
political instability is more dangerous than in other parts
of the country.
• The approach of the Indian government is law
enforcement led, with limited resources provided for
treatment. This is unfortunate, since studies in other
cultural settings show that efforts dominated by the law
enforcement are not particularly effective. A high rate of
drug incarceration as a strategy to control drug use has at
best a marginal impact and does not lead to a significant
undermining of the drug market (Bewley-Taylor et al.
2005). Indeed, experience from around the world reveals
the cost effectiveness of appropriate treatment and harm
reduction programmes and interventions

Mindful of these issues, and within the context of current
research, we therefore urge Indian authorities to:
– Strengthen efforts to understand patterns and trends
of drug use within the country, especially in rural
areas falling along the drug trading routes and those
close to cultivating areas.
– Develop methods for supporting socio-cultural
controls on drug use.
– Urgently assess the demand for drug treatment,
particularly amongst the urban poor engaging in the
most dangerous forms of drug use, and increase the
coverage of a range of treatment interventions.
By concentrating predominantly on the punitive aspects of
UN legislation, the Indian authorities are currently failing
to address adequately the issue of drug use within their
own borders. Without an urgent change in approach,
involving not only the refocusing of resources but also the
recognition of traditional attitudes to the use and
management of mind-altering substances, the nation may in
the future face similar drug-related problems to those
recently experienced in other countries in the region.
Within the Islamic Republic of Iran, there is currently a
high incidence of drug-related deaths and HIV/AIDS
infection among injecting drug users (Nissaramanesh et al,
2005), while increasing problems surrounding the use of
“amphetamine type stimulants” are to be found in Thailand
(Roberts et al., 2004). Specific national circumstances mean
that no two countries experience identical patterns of
problematic drug use. Yet the timely implementation of
pragmatic and culturally appropriate policies within India
would surely do much to prevent a repeat of such crises.
REFERENCES
1.
Annuradha K V I N. (2001), A flawed Act, Semiar
504: 50-54.
2.
Annuradha KVIN , (1999), The Narcotics Drugs and
Psychotropic Substances Act, 1985, in ) Drug Culture
in India- A Street Ethnographic Study of Heroin
Addiction in Bombay, Charles et al, Jaipur: Rawat
Publishers p. 302-308.
3.
Bewley-Taylor, D.R. (2001), The United States and
International Drug Control: 1909-1997,
Continuum, p. 176.
4.
Bewley-Taylor, et al, (2005) Incarceration of drug
offenders: costs and impacts, Beckley Foundation
Drug Policy Programme, Briefing Paper 7.
5.
Britto Gabriel, (1989), Policy Perspective in the
Management of Drug Use, Bombay: National
Addiction Research Centre

Bruun, K, Pan, L and Rexed, I, (1975) The
Gentlemen’s Club: International Control of Drugs
and Alcohol, The University of Chicago Press.
7.
Charles M. (2004) Drug Trade Dynamics in India.
Available from http://www.drugstat@free.fr
8.
Charles M, Nair K.S, Das A and Britto Gabriel,
(2002) Bombay Underworld: A Descriptive Account
and its Role in Drug Trade in Christian Geffary,
Guilhem Fabre, Michel Schiray, Scientific
Coordinators, Globalisation, Drugs and
Criminalisation, Paris: UNESCO MOST and
UNDP, 2 :12-72
9.
Charles, M and Britto, G (2002) Culture and the
Drug Scene in India, in in Christian Geffary, Guilhem
Fabre, Michel Schiray, Scientific Coordinators,
Globalisation, Drugs and Criminalisation, Paris:
UNESCO MOST and UNDP, 1 : 4-30
10. Charles M Nair, K.S and Britto Gabriel. (1999) Drug
Culture in India- A Street Ethnographic Study of
Heroin Addiction in Bombay; Jaipur: Rawat
Publishers.
11. Charles M. (2001) Drug Trade in Himachal Pradesh
the Role of Socio-economic changes, Economic and
Political Weekly, Vol XXX VI, June 30:2433-2439.
12. Chopra R.N and Chopra I.C, (1990), Drug Addiction
with special reference to India; New Delhi: Council
of Scientific and Industrial Research.
13. Fisher James. (1975) Nepal: An Overview in Cannabis
and Culture (Ed) Vera Rubin; The Hague: Mouton
Publishers: 247-256.
14. Hasan A Khwaya, (1975) Social Aspects of the Use of
Cannabis in India, in Cannabis and Culture( Ed) Vera
Rubin; The Hague: Mouton Publishers: 235-246.
15. Nissaramanesh, B et al (2005) The Rise of Harm
Reduction in the Islamic Republic of Iran,
Beckley Foundation Drug Policy Programme,
Briefing Paper 8.
16. Roberts, M. et al (2004) Thailand’s ‘War on Drugs,’
Beckley Foundation Drug Policy Programme,
Briefing Paper 5.
17. United Nations (1972) The Single Convention on
Narcotic Drugs, New York, 1961 as amended by the
1972 Protocol amending the Single Convention on
Narcotic Drugs,1961, Geneva

Source : http://internationaldrugpolicy.net

March 11, 2009 Posted by | Artikel | Leave a comment

Drug Pricing Strategies in India

March 11, 2009 Posted by | Artikel | Leave a comment

FDA Compliance Policy Guide Sec. 460.200 Pharmacy Compounding

Issued 3/16/1992, Reissued 5/29/2002

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

This guidance has been prepared by the Office of Regulatory Policy and the Office of Compliance in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration.


INTRODUCTION

This document provides guidance to drug compounders and the staff of the Food and Drug Administration (FDA) on how the Agency intends to address pharmacy compounding of human drugs in the immediate future as a result of the decision of the Supreme Court in Thompson v. Western States Medical Center, No. 01-344, April 29, 2002. FDA is considering the implications of that decision and determining how it intends to regulate pharmacy compounding in the long term. However, FDA recognizes the need for immediate guidance on what types of compounding might be subject to enforcement action under current law. This guidance describes FDA’s current thinking on this issue.

BACKGROUND

On March 16, 1992, FDA issued a compliance policy guide (CPG), section 7132.16 (later renumbered as 460.200) to delineate FDA’s enforcement policy on pharmacy compounding. That CPG remained in effect until 1997 when Congress enacted the Food and Drug Administration Modernization Act of 1997.

On November 21, 1997, the President signed the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) (the Modernization Act). Section 127 of the Modernization Act added section 503A to the Federal Food, Drug, and Cosmetic Act (the Act), to clarify the status of pharmacy compounding under Federal law. Under section 503A, drug products that were compounded by a pharmacist or physician on a customized basis for an individual patient were entitled to exemptions from three key provisions of the Act: (1) the adulteration provision of section 501(a)(2)(B) (concerning the good manufacturing practice requirements); (2) the misbranding provision of section 502(f)(1) (concerning the labeling of drugs with adequate directions for use); and (3) the new drug provision of section 505 (concerning the approval of drugs under new drug or abbreviated new drug applications). To qualify for these statutory exemptions, a compounded drug product was required to satisfy several requirements, some of which were to be the subject of FDA rulemaking or other actions.

Section 503A of the Act took effect on November 21, 1998, one year after the date of the enactment of the Modernization Act. In November, 1998, the solicitation and advertising provisions of section 503A were challenged by seven compounding pharmacies as an impermissible regulation of commercial speech. The U.S. District Court for the District of Nevada ruled in the plaintiffs’ favor. FDA appealed to the U.S. Court of Appeals for the Ninth Circuit. On February 6, 2001, the Court of Appeals declared section 503A invalid in its entirety (Western States Medical Center v. Shalala, 238 F.3rd 1090 (9th Cir. 2001)). The government petitioned for a writ of certiorari to the U.S. Supreme Court for review of the circuit court opinion. The Supreme Court granted the writ and issued its decision in the case on April 29, 2002.

The Supreme Court affirmed the 9th Circuit Court of Appeals decision that found section 503A of the Act invalid in its entirety because it contained unconstitutional restrictions on commercial speech (i.e., prohibitions on soliciting prescriptions for and advertising specific compounded drugs). The Court did not rule on, and therefore left in place, the 9th Circuit’s holding that the unconstitutional restrictions on commercial speech could not be severed from the rest of section 503A. Accordingly, all of section 503A is now invalid.

FDA has therefore determined that it needs to issue guidance to the compounding industry on what factors the Agency will consider in exercising its enforcement discretion regarding pharmacy compounding.

DISCUSSION

FDA recognizes that pharmacists traditionally have extemporaneously compounded and manipulated reasonable quantities of human drugs upon receipt of a valid prescription for an individually identified patient from a licensed practitioner. This traditional activity is not the subject of this guidance. [Footnote: With respect to such activities, 21 U.S.C. 360(g)(1) exempts retail pharmacies from the registration requirements of the Act. The exemption applies to “Pharmacies” that operate in accordance with state law and dispense drugs “upon prescriptions of practitioners licensed to administer such drugs to patients under the care of such practitioners in the course of their professional practice, and which do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail” (emphasis added). See also 21 U.S.C. §§ 374(a)(2) (exempting pharmacies that meet the foregoing criteria from certain inspection provisions) and 353(b)(2) (exempting drugs dispensed by filling a valid prescription from certain misbranding provisions).]

FDA believes that an increasing number of establishments with retail pharmacy licenses are engaged in manufacturing and distributing unapproved new drugs for human use in a manner that is clearly outside the bounds of traditional pharmacy practice and that violates the Act. Such establishments and their activities are the focus of this guidance. Some “pharmacies” that have sought to find shelter under and expand the scope of the exemptions applicable to traditional retail pharmacies have claimed that their manufacturing and distribution practices are only the regular course of the practice of pharmacy. Yet, the practices of many of these entities seem far more consistent with those of drug manufacturers and wholesalers than with those of retail pharmacies. For example, some firms receive and use large quantities of bulk drug substances to manufacture large quantities of unapproved drug products in advance of receiving a valid prescription for them. Moreover, some firms sell to physicians and patients with whom they have only a remote professional relationship. Pharmacies engaged in activities analogous to manufacturing and distributing drugs for human use may be held to the same provisions of the Act as manufacturers.

POLICY:

Generally, FDA will continue to defer to state authorities regarding less significant violations of the Act related to pharmacy compounding of human drugs. FDA anticipates that, in such cases, cooperative efforts between the states and the Agency will result in coordinated investigations, referrals, and follow-up actions by the states.

However, when the scope and nature of a pharmacy’s activities raise the kinds of concerns normally associated with a drug manufacturer and result in significant violations of the new drug, adulteration, or misbranding provisions of the Act, FDA has determined that it should seriously consider enforcement action. In determining whether to initiate such an action, the Agency will consider whether the pharmacy engages in any of the following acts:

  1. Compounding of drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving valid prescriptions.
  2. Compounding drugs that were withdrawn or removed from the market for safety reasons. Appendix A provides a list of such drugs that will be updated in the future, as appropriate.
  3. Compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs without an FDA sanctioned investigational new drug application (IND) in accordance with 21 U.S.C. § 355(i) and 21 CFR 312.
  4. Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substance has been made in an FDA-registered facility.
  5. Receiving, storing, or using drug components not guaranteed or otherwise determined to meet official compendia requirements.
  6. Using commercial scale manufacturing or testing equipment for compounding drug products.
  7. Compounding drugs for third parties who resell to individual patients or offering compounded drug products at wholesale to other state licensed persons or commercial entities for resale.
  8. Compounding drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drug products. In certain circumstances, it may be appropriate for a pharmacist to compound a small quantity of a drug that is only slightly different than an FDA-approved drug that is commercially available. In these circumstances, FDA will consider whether there is documentation of the medical need for the particular variation of the compound for the particular patient.
  9. Failing to operate in conformance with applicable state law regulating the practice of pharmacy.

The foregoing list of factors is not intended to be exhaustive. Other factors may be appropriate for consideration in a particular case.

Other FDA guidance interprets or clarifies Agency positions concerning nuclear pharmacy, hospital pharmacy, shared service operations, mail order pharmacy, and the manipulation of approved drug products.

REGULATORY ACTION GUIDANCE:

District offices are encouraged to consult with state regulatory authorities to assure coherent application of this guidance to establishments that are operating outside of the traditional practice of pharmacy.

FDA-initiated regulatory action may include issuing a warning letter, seizure, injunction, and/or prosecution. Charges may include, but need not be limited to, violations of 21 U.S.C. §§ 351(a)(2)(B), 352(a), 352(f)(1), 352(o), and 355(a) of the Act.

APPENDIX A
LIST OF COMPOUNDING DRUGS THAT WERE WITHDRAWN OR
REMOVED FROM THE MARKET FOR SAFETY REASONS

  • Adenosine phosphate: All drug products containing adenosine phosphate.
  • Adrenal cortex: All drug products containing adrenal cortex.
  • Aminopyrine: All drug products containing aminopyrine.
  • Astemizole: All drug products containing astemizole.
  • Azaribine: All drug products containing azaribine.
  • Benoxaprofen: All drug products containing benoxaprofen.
  • Bithionol: All drug products containing bithionol.
  • Bromfenac sodium: All drug products containing bromfenac sodium.
  • Butamben: All parenteral drug products containing butamben.
  • Camphorated oil: All drug products containing camphorated oil.
  • Carbetapentane citrate: All oral gel drug products containing carbetapentane citrate.
  • Casein, iodinated: All drug products containing iodinated casein.
  • Chlorhexidine gluconate: All tinctures of chlorhexidine gluconate formulated for use as a patient preoperative skin preparation.
  • Chlormadinone acetate: All drug products containing chlormadinone acetate.
  • Chloroform: All drug products containing chloroform.
  • Cisapride: All drug products containing cisapride.
  • Cobalt: All drug products containing cobalt salts (except radioactive forms cobalt and its salts and cobalamin and its derivatives).
  • Dexfenfluramine hydrochloride: All drug products containing dexfenfluramine hydrochloride.
  • Diamthazole dihydrochloride: All drug products containing diamthazole dihydrochloride.
  • Dibromsalan: All drug products containing dibromsalan.
  • Diethylstilbestrol: All oral and parenteral drug products containing 25 milligrams or more of diethylstilbestrol per unit dose.
  • Dihydrostreptomycin sulfate: All drug products containing dihydrostreptomycin sulfate.
  • Dipyrone: All drug products containing dipyrone.
  • Encainide hydrochloride: All drug products containing encainide hydrochloride.
  • Fenfluramine hydrochloride: All drug products containing fenfluramine hydrochloride.
  • Flosequinan: All drug products containing flosequinan.
  • Gelatin: All intravenous drug products containing gelatin.
  • Glycerol, iodinated: All drug products containing iodinated glycerol.
  • Gonadotropin, chorionic: All drug products containing chorionic gonadotropins of animal origin.
  • Grepafloxacin: All drug products containing grepafloxacin.
  • Mepazine: All drug products containing mepazine hydrochloride or mepazine acetate.
  • Metabromsalan: All drug products containing metabromsalan.
  • Methamphetamine hydrochloride: All parenteral drug products containing methamphetamine hydrochloride.
  • Methapyrilene: All drug products containing methapyrilene.
  • Methopholine: All drug products containing methopholine.
  • Mibefradil dihydrochloride: All drug products containing mibefradil dihydrochloride.
  • Nitrofurazone: All drug products containing nitrofurazone (except topical drug products formulated for dermatalogic application).
  • Nomifensine maleate: All drug products containing nomifensine maleate.
  • Oxyphenisatin: All drug products containing oxyphenisatin.
  • Oxyphenisatin acetate: All drug products containing oxyphenisatin acetate.
  • Phenacetin: All drug products containing phenacetin.
  • Phenformin hydrochloride: All drug products containing phenformin hydrochloride.
  • Pipamazine: All drug products containing pipamazine.
  • Potassium arsenite: All drug products containing potassium arsenite.
  • Potassium chloride: All solid oral dosage form drug products containing potassium chloride that supply 100 milligrams or more of potassium per dosage unit (except for controlled-release dosage forms and those products formulated for preparation of solution prior to ingestion).
  • Povidone: All intravenous drug products containing povidone.
  • Reserpine: All oral dosage form drug products containing more than 1 milligram of reserpine.
  • Sparteine sulfate: All drug products containing sparteine sulfate.
  • Sulfadimethoxine: All drug products containing sulfadimethoxine.
  • Sulfathiazole: All drug products containing sulfathiazole (except those formulated for vaginal use).
  • Suprofen: All drug products containing suprofen (except ophthalmic solutions).
  • Sweet spirits of nitre: All drug products containing sweet spirits of nitre.
  • Temafloxacin hydrochloride: All drug products containing temafloxacin.
  • Terfenadine: All drug products containing terfenadine.
  • 3,3′,4′,5-tetrachlorosalicylanilide: All drug products containing 3,3′,4′,5-tetrachlorosalicylanilide.
  • Tetracycline: All liquid oral drug products formulated for pediatric use containing tetracycline in a concentration greater than 25 milligrams/milliliter.
  • Ticrynafen: All drug products containing ticrynafen.
  • Tribromsalan: All drug products containing tribromsalan.
  • Trichloroethane: All aerosol drug products intended for inhalation containing trichloroethane.
  • Troglitazone: All drug products containing troglitazone.
  • Urethane: All drug products containing urethane.
  • Vinyl chloride: All aerosol drug products containing vinyl chloride.
  • Zirconium: All aerosol drug products containing zirconium.
  • Zomepirac sodium: All drug products containing zomepirac sodium.
This page was posted on November 26, 2005.
Source : http://www.pharmwatch.org/

March 10, 2009 Posted by | Artikel | Leave a comment

Follow

Get every new post delivered to your Inbox.

Join 1,157 other followers

%d bloggers like this: