SENIN, 02 NOVEMBER 2015 | 04:41 WIB
Ilustrasi praktek dokter online. socialmediaclub.org
TEMPO.CO, Jakarta -Ketua Komite Nasional Penyusunan Formularium Nasional Iwan Dwiparahasto mengatakan rata-rata perusahaan farmasi menghabiskan duit untuk mempromosikan obatnya sebesar 40 persen dari total biaya produksi.
Alih-alih untuk beriklan, biaya promosi merupakan uang komisi penulisan resep obat. “Itu untuk membiayai dokter jalan-jalan ke luar negeri, bertanding golf, hingga membelikan mobil,” kata Iwan, yang juga guru besar farmakologi dari Universitas Gajah Mada, kepada Tempo, akhir September lalu.
Saat menelusuri penyebab mahalnya harga obat ini, tim investigasi Majalah Tempo memperoleh puluhan kuitansi yang dikeluarkan sebuah produsen obat saat memberikan uang kepada para dokter. Ada juga puluhan file berformat Microsoft Excel yang berisi 2.125 nama dokter di Jakarta, Bekasi, Tangerang, Surabaya, Jember, dan Makassar yang diduga menerima suap dari perusahaan itu.
Baca juga:Heboh Suap Dokter: “Tak Bisa, Resepkan, Nanti Aku Kasih Mobil”
Saat ini ada 205 perusahaan farmasi yang memperebutkan Rp 69 triliun ceruk pasar obat pada tahun ini. Angka itu setiap tahun meningkat. Pada 2000, misalnya, nilai bisnis obat hanya Rp 6 triliun. Mereka bersaing dengan cara “mendekati” dokter. “Jika dokternya punya banyak pasien, berapa pun uang yang diminta dokter akan dipenuhi,” kata seorang mantan petinggi perusahaan farmasi yang kini tak lagi bekerja di dunia farmasi.
Pada salah satu kuitansi, misalnya, tercantum nama seorang dokter spesialis penyakit dalam yang berpraktek di kawasan Kelapa Gading, Jakarta Utara. Perusahaan farmasi itu menghadiahi si dokter dengan perayaan tahun baru 2014 di Jepang. Di nota agen wisata, perjalanan tersebut bernilai US$ 15.690 atau senilai Rp 170 juta dengan kurs pada masa itu.
Ada lagi kuitansi pada Januari 2014 yang menyebutkan bahwa si dokter menerima Rp 200 juta. Kuitansi itu ia stempel dan ditandatangani. Lalu, pada Januari 2015, ia tercatat menerima Rp 500 juta. Sang dokter sempat membantah menerima uang itu, mengaku setelah ditunjukkan kuitansi pada 2014 tersebut. Menurut dia, itu bukanlah uang suap agar ia meresepkan produk perusahaan farmasi. “Itu uang komisi untuk apotek saya,” katanya, Kamis tiga pekan lalu, di kliniknya.
Selengkapnya liputan investigasi itu bisa di baca di Majalah Tempo edisi terbaru.
Tim Investigasi Tempo
Sumber : Tempo
SENIN, 02 NOVEMBER 2015 | 06:56 WIB
TEMPO.CO, Jakarta–Kolusi antara dokter dan perusahaan obat terlihat dari resep yang diberikan. Dokter yang terikat “janji” dengan perusahaan obat biasa meresepkan obat yang tidak perlu buat pasien. Misalnya antibiotik dan vitamin. “Padahal kadang cukup dengan dinasihati beristirahat yang cukup dan makan teratur bisa sembuh,” kata Zaenal Abidin, Ketua Pengurus Besar Ikatan Dokter Indonesia (IDI).
Baca juga: Eksklusif: Terkuak, 40% dari Harga Obat Buat Menyuap Dokter
Ditemui di Kantor Pusat IDI, Jalan Dr Sam Ratulangi, Menteng, Jakarta Pusat, Jumat tiga pekan lalu, dia mengakui masih ada dokter yang main mata dengan perusahaan. Padahal sanksi bagi dokter yang melakukan hal itu cukup berat, sampai pencabutan izin praktek.
Banyak keluhan masih ada dokter yang suka meresepkan obat yang tak dibutuhkan pasien. Benarkah ini pengaruh kongkalikong dengan perusahaan obat?
Bisa karena orang yang datang ke dokter memang sudah sakit. Tapi saya tidak menutup kemungkinan adanya kerja sama seperti itu, karena Majelis Kehormatan Etika Kedokteran (MKEK) kadang menegur dokter yang melakukan itu, tapi tidak disebut dokter siapa.
Apakah sulit menghentikan kerja sama yang merugikan pasien itu?
Dalam etika kedokteran, dokter dibolehkan mendapat sponsorship berupa biaya transportasi, penginapan, dan makan untuk pendidikan berkelanjutan seperti seminar atau simposium.
Apakah belakangan ini ada laporan ke majelis etik mengenai dugaan persekongkolan perusahaan farmasi dan dokter dalam peresepan obat?
Banyak, tapi kalau terkait dengan obat saya belum tahu.
Kami mendapatkan banyak data dan informasi bahwa masih banyak dokter menerima gratifikasi dari perusahaan farmasi.
Iya, tapi tidak sebanyak dulu. Sebenarnya dulu belum ada aturan gratifikasi, sekarang baru ada. Semuanya sudah berhati-hati untuk menerima macam-macam. Yang tidak boleh begini: ada perusahaan obat datang dan mengatakan, “Resepkan obat saya, sekian resep selama satu tahun, saya kasih kamu mobil.” Atau, “Saya kasih kamu mobil sekarang, tapi saya kontrol resep itu.”
Selanjutnya baca temuan investigasi dalam Majalah Tempo terbaru.
Tim Investigasi Tempo
Sumber : Tempo
Ingin sedikit berbagi, siapa tahu bisa mengetuk para pembacanya untuk “eling lan waspodo”, harapannya menjadi lebih Bijak dalam menggunakan Antibiotik.
Kebetulan saya sedang membaca release dokumen terbaru (Sept 2014) dari Gedung Putih perihal Strategi Nasional Amerika dalam memerangi bencana Resistensi Antibiotik.(http://www.nabp.net/news/white-house-releases-national-strategy-for-combating-antibiotic-resistant-bacteria)
Dokumen setebal 37halaman itu cukup lengkap menginformasikan segala sesuatu tentang rencana memerangi Resistensi Antibiotik. Puluhan Juta USD digelontorkan, semua sumber daya dikerahkan dst.
Dalam hati saya berfikir, hampir semua penduduk NKRI punya televisi.
Ada sarana yang murah, mudah, sudah siap dan tidak jlimet.
Pemerintah bisa meminta ke semua stasiun TV slot edukasi/penayangan perihal ini, sebagai bagian dari CSR stasiun TV.
tanpa harus membayar seperti tahun lalu iklan dari kemenkes yg ratusan juta.
Kalau menolak tinggal dibuatkan aturannya.
Konten pemerintah yg menyiapkan, stasiun TV tinggal menayangkan berkali-kali dalam waktu yang sudah di survei efektivitasnya….itu sedikit strategi edukasi yg mungkin bisa dijalankan dalam waktu dekat.
Saya kutip fakta/data Resistensi Antibiotik di Amerika yang sungguh sangat mengerikan :
CDC’s Antibiotic-Resistant Threats in the United States, 2013
URGENT Threat Level Pathogens
• 250,000 infections per year requiring hospitalization or affecting hospitalized patients.
• 14,000 deaths per year.
• At least $1 billion in excess medical costs per year.
• Campylobacter causes ~1.3 Million infections, 13, 000 hospitalizations and 120 deaths
each year; 310,000 (25%) drug-resistant Campylobacter infections are found each year
• Campylobacter drug resistance increased from 13% in 1997 to 25% in 2011.
• Campylobacter spreads from animals to people through contaminated food, particularly
raw or undercooked chicken and unpasteurized milk.
• Antibiotic use in food animals can and does result in resistant Campylobacter that can
spread to humans.
• Out of 46,000 Candida yeast infections per year, 3,400 (30%) of patients with
bloodstream infections with DR-Candida die during their hospitalization.
• CDC estimates that each case of Candida infection results in 3-13 days of additional
hospitalization and a total of $6,000-$29,000 in direct healthcare costs per patient.
Extended Spectrum β-Lactamase (ESBL)-Producing Enterbacteriaceae
• Extended spectrum β-lactamase (ESBL) is an enzyme that makes bacteria resistant to a
wide spectrum of penicillins and cephalosporins.
• Of 140,000 Enterobacteriaceae infections per year, 26,000 are drug-resistant, causing
• 26,000 healthcare-associated Enterobacteriaceae infections are caused by ESBLEnterobacteriaceae.
• Enterobacteriaceae infections result in greater than $40,000 excess hospital charges per
• Of 66,000 Enterococcus infections per year, 20,000 are drug-resistant causing 1,300
• Enterococcus strains resistant to vancomycin have few or no treatment options.
Multidrug-Resistant Pseudomonas aeruginosa
• Of 51,000 Pseudomonas infections per year, 6,700 are multidrug-resistant causing 440
• 13% of severe healthcare-associated infections caused by Pseudomonas are multidrugresistant,
meaning nearly all or all antibiotics no longer cure these infections.
Drug-Resistant Non-Typhoidal Salmonella (Notifiable to CDC)
• Non-typhoidal Salmonella causes 1.2 million infections per year, of which 100,000 are
drug-resistant resulting in 23,000 hospitalizations and 450 deaths each year.
• Non-typhoidal Salmonella results in more hospitalizations, longer stays, and higher
Drug-Resistant Salmonella enterica serovar Typhi (Notifiable to CDC)
• Of 21.7 M Salmonella typhi infections worldwide, 5,700 illnesses in the U.S. with 3,800
(67%) of infections are drug-resistant resulting in 620 hospitalizations each year.
• Before the antibiotic era or in areas where antibiotics are unavailable, 20% of Salmonella
typhi infections result in death.
Drug-Resistant Shigella (Notifiable to CDC)
• Shigella causes ~500,000 illnesses, 5,500 hospitalizations, and 40 deaths each year in
• Since 2006, Shigella resistance to traditional first-line antibiotics has become so high
that physicians must now rely on alternative drugs (ciprofloxacin and azithromycin) to
Methicillin-Resistant Staphylococcus aureus (MRSA)
• Over 80,000 invasive MRSA infections and 11,285 related deaths per year (in 2011).
• Severe MRSA infections most commonly occur during or soon after inpatient medical
• Between 2005 and 2001, overall rates of invasive MRSA dropped 31% predominantly
due to appropriate medical procedures implemented in central-line maintenance.
Drug-Resistant Streptococcus pneumoniae (Notifiable to CDC)
• Of 4 million disease incidents and 22,000 deaths, 1.2 M are drug-resistant [to amoxicillin
and azithromycin (Z-Pak)], resulting in 19,000 excess hospitalizations and 7,900 deaths.
• In 30% of S. pneumoniae cases, the bacteria are fully resistant to one or more
antibiotics, causing complications in treatment and death.
• Pneumococcal pneumonia accounts for 72% of all direct medical costs for treatment of
pneumococcal disease and in excess of $96 million in medical costs per year.
• Pneumococcal conjugate vaccine (PCV) prevents disease, reduces antibiotic resistance
by blocking the transmission of resistant S. pneumoniae strains, and protects against 13
strains of S. pneumoniae.
Drug-Resistant Tuberculosis (Notifiable to CDC)
• Tuberculosis (TB) is among the most common infectious diseases and cause of death
• Of 9,588 TB cases in the U.S. in 2013, it is estimated that 1-2% of these cases were
resistant to antibiotics with direct costs for treatment of MDR-TB averaging $134,000 per
case (in 2010 dollars)
• CDC funds health departments in all 50 states, 10 large cities, DC, Puerto Rico, the
Virgin Islands and other territories to conduct surveillance, provide laboratory testing,
perform contact investigations, diagnose cases and provide directly-observed therapy
and medical management for TB cases and therapy for latent TB infection. Five TB
Regional Training and Medical Consultation Centers (RTMCCs) provide training and
medical consultation for these programs.
OF CONCERN Threat Level Pathogens
Vancomycin-Resistant Staphylococcus aureus (Notifiable to CDC)
• Few cases, thus far (13 cases in 4 States since 2002).
• Staph aureus strains resistant to vancomycin have very few or no treatment options.
Erythromycin-Resistant Group A Streptococcus
• Group A Strep (GAS) causes many illnesses, including strep throat (up to 2.6 M cases
per year), toxic shock syndrome, and “flesh-eating” disease (necrotizing fasciitis, 25-35%
• Erythromycin-resistant GAS causes 1,300 illnesses and 160 deaths.
• Current concern is the increase in bacteria that show resistance to clindamycin, which
has a unique role in treatment of GAS infections.
Clindamycin-Resistant Group B Streptococcus
• Of 27,000 GBS cases, 7,600 illnesses are drug-resistant, resulting in 440 deaths in the
United States each year.
Sebagai Pasien, Kita juga bisa ikut berperan: “JANGAN ‘MENEKANKAN’ DOKTER UNTUK MERESEPKAN/MEMINTA ANTIBIOTIK TANPA INDIKASI YANG JELAS, TEPAT DAN TERUKUR BAHWA FAKTOR PENYEBABNYA ADALAH BAKTERI.
Tolong jangan menyimpan Antibiotik layaknya Oralit dan Parasetamol dalAm waktu lama.
Data Riset Kesehatan Dasar th 2013 sungguh sangat memilukan
86,1% Rumah Tangga menyimpan Antibiotik TANPA RESEP DOKTER :(
Yuk Kita belajar bersama-sama….
Kita bisa mulai belajar dari situs yang terpercaya di http://bijak-antibiotik.com
Kita juga bisa belajar panduan tata laksana penyakit anak di http://milissehat.web.id
Kita juga bisa berinteraksi, berdiskusi langsung dengan media Handphone di mailinglist : email@example.com
Sebagai Dokter meluangkan waktu 3 ~ 5menit untuk mengedukasi pasien adalah perbuatan yang mulia, Tidak mudah meresepkan/memberikan Antibiotik adalah bagian dari unsur kehati-hatian.
Meluangkan waktu 10menit untuk membaca dan mengimplementasikan dalam prakteknya Permenkes No. 2406/Menkes/Per/xii/2011 akan mampu menyelamatkan jutaan jiwa.
Sebagai Apoteker, bisa menolak pembelian Antibiotik yang di jual bebas :( , tanpa resep dokter.
Yuk Kita sama-sama belajar…belajar dan belajar
Salam Sehat Indonesiaku
Doctors Net Billions From Drug Firms
Companies Paid at Least $3.5 Billion in Last Five Months of 2013By
Updated Sept. 30, 2014 7:29 p.m. ET
Drug and medical-device firms paid at least $3.5 billion to U.S. physicians and teaching hospitals during the final five months of last year. WSJ’s Peter Loftus reports on the News Hub with Sara Murray. Photo: Getty.
Drug and medical-device companies paid at least $3.5 billion to U.S. physicians and teaching hospitals during the final five months of last year, according to the most comprehensive accounting so far of the financial ties that some critics say have compromised medical care.
The figures come from a new federal government transparency initiative. The 2010 Affordable Care Act included a provision dubbed the Sunshine Act, which requires manufacturers of drugs and medical devices to disclose the payments they make to physicians and teaching hospitals each year for services such as consulting or research. The Centers for Medicare and Medicaid Services compiled the records into a database posted online Tuesday, though the agency said that about 40% of the payment information won’t identify the recipients because of data problems.
The database revealed some eye-popping totals, such as the $122.5 million paid byRoche Holding AG RO.EB -1.27% ‘s Genentech unit to City of Hope medical center in Duarte, Calif., as royalties on sales of several products including blockbuster cancer treatments Herceptin and Avastin.
Genentech licensed patents from City of Hope based on research the medical center conducted in the early 1980s. The company said that excluding the City of Hope royalties, about 85% of the physician payments it reported to CMS were focused on drug research. City of Hope said the royalties are allocated to the inventors and to support continuing research.
The Centers for Medicare and Medicaid Services posted a database online showing payments made by makers of drugs and medical devices to physicians and teaching hospitals. Bloomberg
Some doctors disputed details of the payment data. The database shows John LeDonne, a surgeon from Baltimore, as having received about $78,200 in payments for food and beverage for the five-month period from medical-device maker TeleflexInc. TFX +0.52%
Dr. LeDonne acknowledged he performs paid consulting work for health-care companies including Teleflex, but that he rarely received free meals. He said the total payment amount was in the right “ballpark,” but should not have been classified in the food-and-beverage category.
“They certainly did not give me $78,000 in lunch money,” Dr. LeDonne said in an interview. “Lunch is not a big deal in most parts of my life.” Teleflex didn’t immediately respond to requests for comment.
The push for greater transparency was driven by concerns that doctors’ prescribing decisions are tainted by the money and gifts they receive each year from companies. Supporters expect the transparency initiative to provide useful information to patients about the relationships their doctors have with industry and to curb the influence of payments on medical care.
Calls for Transparency
The government wants to have more disclosure about payments made to doctors and teaching hospitals.
U.S. physicians have faced scrutiny over gifts received from companies.
Some drug makers have reduced their payments to doctors.
Does the Open Payments database distort what doctors receive for research?
CMS is asked to drop some payments from sunshine database.
“The financial relationships between doctors and drug companies and medical-device companies are a source of conflicts of interest,” said Allan Coukell, director of the Pew Prescription Project, which has supported the Sunshine Act. “They have the potential to influence the care that patients get and so they’re a matter of interest both to individual consumers and to policy makers.”
Companies have defended their payments to physicians as necessary to conduct research and communicate how products should be used. “I welcome these disclosures,” said John C. Lechleiter, chief executive of drug maker Eli LillyLLY -0.38% & Co., which was mandated to report physician payments on its website as part of a 2009 settlement with the government over illegal-marketing allegations. “We believe the payments that are spelled out in these reports can be entirely justified and in fact are critical for us to be able to discover and develop medicines and effectively communicate their value.”
The payments and so-called transfers of value to an estimated 546,000 doctors and 1,360 teaching hospitals include such items as free meals that company sales representatives bring to physicians’ offices, fees paid to doctors to speak about a company’s drug to other doctors at restaurants, compensation for clinical trial research and consulting fees.
Some doctors have earned tens of thousands of dollars annually from drug companies by flying to various cities to give paid speeches, while some surgeons have received even larger amounts from medical-device makers, partly from royalties on products they helped develop.
Doctors have expressed concern about having their names attached to money paid by industry. Some have scaled back their interactions with industry because they know it will be reported publicly.
The information in the database is broken down by category of payment—separating out research from “general payments,” which includes money paid for a range of things including consulting, travel, grants and entertainment, for instance. But some doctors are concerned the public presentation of the data will lack context that explains the possible value of the doctor’s relationship with a company.
“Questions from confused patients are especially likely, given that the online database is not expected to offer much context for the financial interactions it reports between physicians and manufacturers of medical devices and drugs,” the American Medical Association said. The association had asked CMS to delay publication of the payment data to give doctors more time to review the accuracy of the reports.
Among individual physicians, Stephen Burkhart was one of the top recipients of non-research payments from industry. The San Antonio orthopedic surgeon received $7.4 million in non-research payments or transfers of value for the five-month period, mostly from device manufacturer Arthrex Inc. for payments identified as “royalty or license.”
Dr. Burkhart couldn’t be reached for comment. Arthrex said in a statement that it has “financial relationships with a number of orthopedic surgeons and teaching hospitals,” like many manufacturers, for their advice and expertise.
Chitranjan Ranawat, a New York orthopedic surgeon, received about $4 million in nonresearch payments or transfers of value, mostly from Johnson & Johnson’sJNJ -0.43% DePuy Synthes unit for “royalty or license,” according to the database.
Dr. Ranawat couldn’t be reached for comment. A J&J spokeswoman said the company works with surgeons and other professionals to develop products, and pays royalties to inventors holding patents.
Some drug and device companies including Lilly, Pfizer Inc. PFE -0.31% andGlaxoSmithKline GSK.LN -0.74% PLC have been disclosing individual physician-payment records on their own websites for several years because of settlements of government investigations of their marketing practices.
Such company disclosures have shown that some companies have reduced spendingon items such as speaking fees and meals in recent years. Some said they cut back on such items because they have reduced the size of their sales forces and have used other methods of communicating with doctors, such as online meetings.
The first batch of data released by CMS on Tuesday covers payments made from Aug. 1 to Dec. 31, 2013. Beginning next year, companies will report full-year data annually. Companies submitted the data to CMS earlier this year, using the so-called Open Payments portal. The agency has allowed physicians to register with the Open Payments system to get a preview of the payment records, before it went public, to allow time for them to dispute any reports they believed were inaccurate.
But it hasn’t been a smooth process. First, CMS delayed the public reporting of the data by a year to give companies more time to prepare. The Open Payments online system has experienced technical problems, including a data mix-up that resulted in some doctors being linked to payment records for other doctors with the same surname. The preview function for doctors had a cumbersome registration process, some doctors said, and was taken offline at times in recent weeks.
The first batch of data is incomplete. CMS in August said it removed about one-third of the payment records from the physician-preview database because it said some of the state medical-license numbers that companies reported for doctors didn’t match a database that the agency was using for verification, among other problems. CMS now is releasing those records but without identifying the physicians tied to them. It will update the database to include the physicians’ names for those records next year. Also, CMS isn’t immediately releasing payments related to proprietary research-and-development; those will be reported at a later date.
The agency’s handling of the problematic records also has drawn criticism from companies, which said they reported the vast majority of data properly.
About $22 million in physician-payment records reported Eli Lilly for the five-month period of last year, for example, was removed from the physician-preview database, out of a total reported of about $85 million, said Ashish Kalgaonkar, senior director of Lilly’s transparency reporting. “I’m very confident that my data is correct,” Mr. Kalgaonkar said.
Industry and medical groups also have complained that CMS didn’t offer advance information about how the data would be presented publicly.
“The rollout won’t be perfect,” Sen. Chuck Grassley (R., Iowa), a co-author of the Sunshine Act legislation, said in a written statement before Tuesday’s release. “Some information will be withheld because CMS wanted to protect doctors from a small amount of reports that might be imprecise. But as the information is refined, the database will improve. It will become more complete as doctors, drug and device companies and CMS work to update and refine the information.”
The new database may lend itself to a range of uses. A Justice Department spokeswoman said Tuesday the department may use the Open Payments data “to help assess the nature and extent of any financial relationships that exist between pharmaceutical and medical device manufacturers and prescribing physicians, and whether such relationships violate federal law.”
One former Senate staffer who was closely involved in the effort to pass the Sunshine Act hopes the database will do some good. “This website will let patients ask a very important question: ‘Is a relationship between my doctor and a drug company right for me?’ It took six years of hard work to get this site together and, hopefully, it will help clean up medicine,” said Paul Thacker, a former aide to Sen. Chuck Grassley (R-Iowa) who is now a fellow at the Safra Ethics Center at Harvard University. He said the “total amount of money is pretty eye popping.”
—Joseph Walker, Ed Silverman and Tom McGinty contributed to this article.
Write to Peter Loftus at firstname.lastname@example.org
Source : http://online.wsj.com/articles/u-s-agency-reveals-drug-makers-payments-to-doctors-1412100323
NSAID medicines include aspirin, ibuprofen and naproxen/Aleve
By Robert Preidt
Wednesday, September 24, 2014
HealthDay news image
Related MedlinePlus Pages
Deep Vein Thrombosis
WEDNESDAY, Sept. 24, 2014 (HealthDay News) — People who use painkillers called nonsteroidal anti-inflammatory drugs (NSAIDs) — which include aspirin, naproxen (Aleve) and ibuprofen (Advil, Motrin) — may be at increased risk for potentially deadly blood clots, a new study suggests.
But the study only showed an association between use of the painkillers and higher clotting risk; it did not prove cause-and-effect.
The researchers analyzed the results of six studies involving more than 21,000 cases of a type of blood clot called a venous thromboembolism (VTE).
These clots include deep vein thrombosis (a clot in the leg) and pulmonary embolism (a clot in the lungs).
Reporting online Sept. 24 in Rheumatology, the analysis found that people who used NSAIDs had an 80 percent higher risk for venous clots.
“Our results show a statistically significant increased VTE risk among NSAID users. Why NSAIDs may increase the risk of VTE is unclear,” study lead author Patompong Ungprasert, of Bassett Medical Center in Cooperstown, N.Y., said in a journal news release.
“Physicians should be aware of this association and NSAIDs should be prescribed with caution, especially in patients already at a higher risk of VTE,” the researcher added.
Ungprasert noted that all types of NSAIDs were evaluated as one group, but not all types of NSAIDs may boost the risk of VTE.
Two experts said the findings are in keeping with prior research.
“It is not entirely surprising that NSAIDs are again implicated in causing clot-related illness,” said Dr. Steven Carsons, chief of the division of rheumatology, allergy and immunology at Winthrop-University Hospital in Mineola, N.Y.
He pointed to the case of Vioxx, a powerful NSAID painkiller that was withdrawn from the market in 2004, after studies found a higher risk of heart attack and stroke in users.
The new study “makes a compelling case for further study and clinical surveillance for venous clotting events in those patients taking NSAIDs,” Carsons said. However, he stressed that the study could not pinpoint which types of NSAIDs might pose the greatest risk, or which type of patients might be most vulnerable.
According to Carsons, “aspirin, the ‘original’ NSAID, has sufficient anti-clotting properties to be effective for prevention of VTEs, and most studies show that naproxen (Aleve) — a common prescribed and over-the-counter NSAID — carries no additional clotting risk.”
Dr. Suzanne Steinbaum is a preventive cardiologist at Lenox Hill Hospital in New York City. She said that “without discerning which NSAIDS are more safe than others, this study shows the potential increase in VTE. It is important that both physicians and patients understand this risk, especially for those people who are already at risk for VTE.”
SOURCES: Steven E. Carsons, M.D., chief, division of rheumatology, allergy and immunology, Winthrop-University Hospital, Mineola, N.Y.; Suzanne Steinbaum, M.D., preventive cardiologist, Lenox Hill Hospital, New York City; Rheumatology, news release, Sept. 24, 2014
Source : nlm.nih.gov
26th Sep 2014
New Zealand Doctor all articles by this author
CHILDREN whose mothers took paracetamol while pregnant went on to have greater difficulty with emotions, concentration and behaviour than their peers, a New Zealand study has found.
The offspring had significantly worse scores for such difficulties, including ADHD, Auckland University researchers reported in PLOS ONE.
The message for women should be to see their lead maternity carer or GP if they feel ill during pregnancy, study leader Dr John Thompson said.
Dr Thompson prefers this to the default position whereby women readily obtain paracetamol at a pharmacy. He would like to see advice to women modified.
Almost half of the women in the group studied – the Auckland Birthweight Collaborative Study – had taken paracetamol when pregnant, he said in a media release.
Dr Thompson and co-authors said their findings strengthened the contention, arising from an earlier Danish study, that paracetamol exposure in pregnancy increased the risk of ADHD-like behaviours.
Paracetamol crosses the placenta, but no mechanism of action is as yet known, Dr Thompson said.
He is aiming to research this in a new study, and will present the current findings to paediatricians at their November conference.
The findings are drawn from data on 587 children from the Auckland birthweight study followed up at age seven, and 614 children followed up at 11. These children were assessed using validated Strengths and Difficulties Questionnaires.
The aim was to determine the association between drugs commonly taken during pregnancy and ADHD in children in the collaborative study.
Questions covered paracetamol, anti-inflammatories, aspirin-based painkillers, antacids and antibiotics. Only paracetamol was associated with difficulties.
At age seven, children had 20% higher total difficulty scores as gauged from parents’ reports, if their mothers used paracetamol during pregnancy. The scores at age 11, both parent-rated and child-rated, were 10% higher.
The paracetamol group did worse at each age for all difficulty scales, especially inattentive symptoms at seven years old and hyperactive impulsiveness at 11.
Particularly problematic at age seven were parent-reported emotional and conduct problems and, at age 11, child-reported conduct and hyperactivity/inattention problems.
The researchers found the differences remained after controlling for factors that might influence medication-taking in pregnant women and factors likely to predispose toward ADHD symptoms.
The researchers did not have information on dosage of acetaminophen or the trimester when used.
PLOS One 2014; online 26 Sept
Source : Medicalobserver
sebuah essai yg sangat menarik menurut saya
barangkali juga menarik untuk anda sebagai sarapan pagi menemani secangkir kopi hangat…….
quote ” uptake of the UK National Institute for Health and Care Excellence guidelines for prevention of venous thromboembolism after surgery has produced significant reductions in thromboembolic complications.12″
pesannya sangat bagus, seperti yg sering dismpaikan founding mother mega milis ini…..wow……
“Importantly, real shared decision making is not the same as taking the patient through a series of if-then decision options. Rather, it involves finding out what matters to the patient—what is at stake for them—and making judicious use of professional knowledge and status (to what extent, and in what ways, does this person want to be “empowered”?) and introducing research evidence in a way that informs a dialogue about what best to do, how, and why. This is a simple concept but by no means easy to deliver. Tools that contain quantitative estimates of risk and benefit are needed, but they must be designed to support conversations not climb probability trees”
yg sering sekali terjadi, justru sebaliknya…
dikota besar umumnya orang lebih senang langsung datang ke dokter spesialis dan bila perlu sub spesialis untuk suatu disgnosis yg sebenarnya cukup ditegakan oleh dokter umum.
pun yg terjadi kebanyakan justru ‘jumping” alias tdk melakukan pemeriksaan fisik secara mneyeluruh, tp langsung contreng lembaran pemeriksaan laboratorium…..hmmmm..
quote “In clinical diagnosis, for example, the novice clinician works methodically and slowly through a long and standardised history, exhaustive physical examination, and (often numerous) diagnostic tests.43 The expert, in contrast, makes a rapid initial differential diagnosis through intuition, then uses a more selective history, examination, and set of tests to rule in or rule out particular possibilities. To equate “quality” in clinical care with strict adherence to guidelines or protocols, however robust these rules may be, is to overlook the evidence on the more sophisticated process of advanced expertise.”
Menurut saya EBM tidak mengalami ‘krisis’ tetap dalam semangat dan nilai2 luhur yg terkandung didalamnya untuk melindungi pasien, justru dokterlah yg sedang, terus dan akan mengalami krisis, manakala nilai2 dan semangat EBM ini terabaikan.
EBM akan terus berubah untuk mencapai nilai2 luhur tersebut seiring dengan perkembangan zaman dan teknologi.
Namun maukah Dokter juga berubah mengikuti semangat dan nilai2 luhur yg terus dan akan berkembang tsb?
Evidence based medicine: a movement in crisis?
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g3725 (Published 13 June 2014) Cite this as: BMJ 2014;348:g3725
- Trisha Greenhalgh, dean for research impact1,
- Jeremy Howick, senior research fellow2,
- Neal Maskrey, professor of evidence informed decision making3
- for the Evidence Based Medicine Renaissance Group
- Correspondence to: T Greenhalgh email@example.com
Trisha Greenhalgh and colleagues argue that, although evidence based medicine has had many benefits, it has also had some negative unintended consequences. They offer a preliminary agenda for the movement’s renaissance, refocusing on providing useable evidence that can be combined with context and professional expertise so that individual patients get optimal treatment
It is more than 20 years since the evidence based medicine working group announced a “new paradigm” for teaching and practising clinical medicine.1 Tradition, anecdote, and theoretical reasoning from basic sciences would be replaced by evidence from high quality randomised controlled trials and observational studies, in combination with clinical expertise and the needs and wishes of patients.
Evidence based medicine quickly became an energetic intellectual community committed to making clinical practice more scientific and empirically grounded and thereby achieving safer, more consistent, and more cost effective care.2 Achievements included establishing the Cochrane Collaboration to collate and summarise evidence from clinical trials;3 setting methodological and publication standards for primary and secondary research;4 building national and international infrastructures for developing and updating clinical practice guidelines;5 developing resources and courses for teaching critical appraisal;6 and building the knowledge base for implementation and knowledge translation.7
From the outset, critics were concerned that the emphasis on experimental evidence could devalue basic sciences and the tacit knowledge that accumulates with clinical experience; they also questioned whether findings from average results in clinical studies could inform decisions about real patients, who seldom fit the textbook description of disease and differ from those included in research trials.8 But others argued that evidence based medicine, if practised knowledgably and compassionately, could accommodate basic scientific principles, the subtleties of clinical judgment, and the patient’s clinical and personal idiosyncrasies.1
Two decades of enthusiasm and funding have produced numerous successes for evidence based medicine. An early example was the British Thoracic Society’s 1990 asthma guidelines, developed through consensus but based on a combination of randomised trials and observational studies.9 Subsequently, the use of personal care plans and step wise prescription of inhaled steroids for asthma increased,10 and morbidity and mortality fell.11 More recently, uptake of the UK National Institute for Health and Care Excellence guidelines for prevention of venous thromboembolism after surgery has produced significant reductions in thromboembolic complications.12
Despite these and many other successes, wide variation in implementing evidence based practice remains a problem. For example, the incidence of arthroscopic washout of the knee joint, whose benefits are unproved except when there is a known loose body, varies from 3 to 48 per 100 000 in England.13 More fundamentally, many who support evidence based medicine in principle have argued that the movement is now facing a serious crisis (box 1).14 15 Below we set out the problems and suggest some solutions.
Box 1: Crisis in evidence based medicine?
The evidence based “quality mark” has been misappropriated by vested interests
The volume of evidence, especially clinical guidelines, has become unmanageable
Statistically significant benefits may be marginal in clinical practice
Inflexible rules and technology driven prompts may produce care that is management driven rather than patient centred
Evidence based guidelines often map poorly to complex multimorbidity
Distortion of the evidence based brand
The first problem is that the evidence based “quality mark” has been misappropriated and distorted by vested interests. In particular, the drug and medical devices industries increasingly set the research agenda. They define what counts as disease (for example, female sexual arousal disorder, treatable with sildenafil16 and male baldness, treatable with finasteride17) and predisease “risk states” (such as low bone density, treatable with alendronate).18 They also decide which tests and treatments will be compared in empirical studies and choose (often surrogate) outcome measures for establishing “efficacy.”19
Furthermore, by overpowering trials to ensure that small differences will be statistically significant, setting inclusion criteria to select those most likely to respond to treatment, manipulating the dose of both intervention and control drugs, using surrogate endpoints, and selectively publishing positive studies, industry may manage to publish its outputs as “unbiased” studies in leading peer reviewed journals.20 Use of these kinds of tactic in studies of psychiatric drugs sponsored by their respective manufacturers enabled them to show that drug A outperformed drug B, which outperformed drug C, which in turn outperformed drug A.21 One review of industry sponsored trials of antidepressants showed that 37 of 38 with positive findings, but only 14 of 36 with negative findings, were published.22
Evidence based medicine’s quality checklists and risk of bias tools may be unable to detect the increasingly subtle biases in industry sponsored studies.23 Some so called evidence based policies (such as dementia case finding for the over 75s and universal health checks for the over 40s in the UK) seem to be based largely on political conviction.24 25 Critics have condemned the role of the drug industry in influencing the policy makers who introduced them.26
Too much evidence
The second aspect of evidence based medicine’s crisis (and yet, ironically, also a measure of its success) is the sheer volume of evidence available. In particular, the number of clinical guidelines is now both unmanageable and unfathomable. One 2005 audit of a 24 hour medical take in an acute hospital, for example, included 18 patients with 44 diagnoses and identified 3679 pages of national guidelines (an estimated 122 hours of reading) relevant to their immediate care.27
Marginal gains and a shift from disease to risk
Evidence based medicine is, increasingly, a science of marginal gains—since the low hanging fruit (interventions that promise big improvements) for many conditions were picked long ago. After the early big gains of highly active antiretroviral therapy for HIV28 and triple therapy for Helicobacter pylori positive peptic ulcer,29 contemporary research questions focus on the marginal gains of whether these drug combinations should be given in series or in parallel and how to increase the proportion of patients who take their complex medication regimen as directed.30 31
Large trials designed to achieve marginal gains in a near saturated therapeutic field typically overestimate potential benefits (because trial samples are unrepresentative and, if the trial is overpowered, effects may be statistically but not clinically significant) and underestimate harms (because adverse events tend to be underdetected or underreported). The 74 year old who is put on a high dose statin because the clinician applies a fragment of a guideline uncritically and who, as a result, develops muscle pains that interfere with her hobbies and ability to exercise, is a good example of the evidence based tail wagging the clinical dog. In such scenarios, the focus of clinical care shifts insidiously from the patient (this 74 year old woman) to the population subgroup (women aged 70 to 75) and from ends (what is the goal of investigation or treatment in this patient?) to means (how can we ensure that everyone in a defined denominator population is taking statins?).
As the examples above show, evidence based medicine has drifted in recent years from investigating and managing established disease to detecting and intervening in non-diseases. Risk assessment using “evidence based” scores and algorithms (for heart disease, diabetes, cancer, and osteoporosis, for example) now occurs on an industrial scale, with scant attention to the opportunity costs or unintended human and financial consequences.26
Overemphasis on following algorithmic rules
Well intentioned efforts to automate use of evidence through computerised decision support systems, structured templates, and point of care prompts can crowd out the local, individualised, and patient initiated elements of the clinical consultation.8 For example, when a clinician is following a template driven diabetes check-up, serious non-diabetes related symptoms that the patient mentions in passing may not by documented or acted on.32 Inexperienced clinicians may (partly through fear of litigation) engage mechanically and defensively with decision support technologies, stifling the development of a more nuanced clinical expertise that embraces accumulated practical experience, tolerance of uncertainty, and the ability to apply practical and ethical judgment in a unique case.33
Templates and point of care prompts also contribute to the creeping managerialism and politicisation of clinical practice.8 As Harrison and Checkland observe: “As the language of EBM becomes ever more embedded in medical practice, and as bureaucratic rules become the accepted way to implement ‘the best’ evidence, its requirements for evidence are quietly attenuated in favour of an emphasis on rules.”34
For example, the Quality and Outcomes Framework (QOF) in UK general practice is incentivised by financial “quality points” and administered largely by non-clinical staff who generate these points by recalling patients for structured reviews and checks. QOF has been associated with significant improvements in blood pressure control, especially in deprived populations.35 But its downside is an audit driven, technocratic exercise in which few patients are offered personalised shared decision making with a senior clinician before having the recommended tests and treatments, and in which clinical consultations are continually interrupted by pop-up point of care prompts.32 36
Poor fit for multimorbidity
Finally, as the population ages and the prevalence of chronic degenerative diseases increases, the patient with a single condition that maps unproblematically to a single evidence based guideline is becoming a rarity. Even when primary studies were designed to include participants with multiple conditions, applying their findings to patients with particular comorbidities remains problematic. Multimorbidity (a single condition only in name) affects every person differently and seems to defy efforts to produce or apply objective scores, metrics, interventions, or guidelines.37 Increasingly, the evidence based management of one disease or risk state may cause or exacerbate another—most commonly through the perils of polypharmacy in the older patient.38
Return to real evidence based medicine
To address the above concerns, we believe it is time to launch a campaign for real evidence based medicine (box 2).
Box 2: What is real evidence based medicine and how do we achieve it?
Real evidence based medicine:
Makes the ethical care of the patient its top priority
Demands individualised evidence in a format that clinicians and patients can understand
Is characterised by expert judgment rather than mechanical rule following
Shares decisions with patients through meaningful conversations
Builds on a strong clinician-patient relationship and the human aspects of care
Applies these principles at community level for evidence based public health
Actions to deliver real evidence based medicine
Patients must demand better evidence, better presented, better explained, and applied in a more personalised way
Clinical training must go beyond searching and critical appraisal to hone expert judgment and shared decision making skills
Producers of evidence summaries, clinical guidelines, and decision support tools must take account of who will use them, for what purposes, and under what constraints
Publishers must demand that studies meet usability standards as well as methodological ones
Policy makers must resist the instrumental generation and use of “evidence” by vested interests
Independent funders must increasingly shape the production, synthesis, and dissemination of high quality clinical and public health evidence
The research agenda must become broader and more interdisciplinary, embracing the experience of illness, the psychology of evidence interpretation, the negotiation and sharing of evidence by clinicians and patients, and how to prevent harm from overdiagnosis
Individualised for the patient
Real evidence based medicine has the care of individual patients as its top priority, asking, “what is the best course of action for this patient, in these circumstances, at this point in their illness or condition?”39 It consciously and reflexively refuses to let process (doing tests, prescribing medicines) dominate outcomes (the agreed goal of management in an individual case). It engages with an ethical and existential agenda (how should we live? when should we accept death?) and with that goal in mind, carefully distinguishes between whether to investigate, treat, or screen and how to do so.40
To support such an approach, evidence must be individualised for the patient. This requires that research findings be expressed in ways that most people will understand (such as the number needed to treat, number needed to harm, and number needed to screen41) and that practitioners, together with their patients, are free to make appropriate care decisions that may not match what “best (average) evidence” seems to suggest.
Importantly, real shared decision making is not the same as taking the patient through a series of if-then decision options. Rather, it involves finding out what matters to the patient—what is at stake for them—and making judicious use of professional knowledge and status (to what extent, and in what ways, does this person want to be “empowered”?) and introducing research evidence in a way that informs a dialogue about what best to do, how, and why. This is a simple concept but by no means easy to deliver. Tools that contain quantitative estimates of risk and benefit are needed, but they must be designed to support conversations not climb probability trees.
Judgment not rules
Real evidence based medicine is not bound by rules. The Dreyfus brothers have described five levels of learning, beginning with the novice who learns the basic rules and applies them mechanically with no attention to context.42 The next two stages involve increasing depth of knowledge and sensitivity to context when applying rules. In the fourth and fifth stages, rule following gives way to expert judgments, characterised by rapid, intuitive reasoning informed by imagination, common sense, and judiciously selected research evidence and other rules.
In clinical diagnosis, for example, the novice clinician works methodically and slowly through a long and standardised history, exhaustive physical examination, and (often numerous) diagnostic tests.43 The expert, in contrast, makes a rapid initial differential diagnosis through intuition, then uses a more selective history, examination, and set of tests to rule in or rule out particular possibilities. To equate “quality” in clinical care with strict adherence to guidelines or protocols, however robust these rules may be, is to overlook the evidence on the more sophisticated process of advanced expertise.
Aligned with professional, relationship based care
Real evidence based medicine builds (ideally) on a strong interpersonal relationship between patient and clinician. It values continuity of care and empathetic listening, especially for people who are seriously and incurably sick.44 Research evidence may still be key to making the right decision—but it does not determine that decision. Clinicians may provide information, but they are also trained to make ethical and technical judgments, and they hold a socially recognised role to care, comfort, and bear witness to suffering.45 The challenges of self management in severe chronic illness, for example, are not merely about making treatment choices but about the practical and emotional work of implementing those choices.46 As serious illness is lived, evidence based guidelines may become irrelevant, absurd, or even harmful (most obviously, in terminal illness).
Public health dimension
Although we have focused on individual clinical care, there is also an important evidence base relating to population level interventions aimed at improving public health (such as pricing and labelling of consumables, fluoridation of water, and sex education). These are often complex, multifaceted programmes with important ethical and practical dimensions, but the same principles apply as in clinical care. Success of interventions depends on local feasibility, acceptability, and fit with context—and hence on informed, shared decision making with and by local communities, using summaries and visualisations of population level metrics.47
Delivering real evidence based medicine
To deliver real evidence based medicine, the movement’s stakeholders must be proactive and persistent. Patients (for whose care the movement exists) must demand better evidence, better presented, better explained, and applied in a more personalised way with sensitivity to context and individual goals.48 There are already some models of good practice here. In arthritis, for example, patient advocacy groups that emphasise the importance of experiential evidence and patient centred strategies have existed for over 30 years and have influenced the choice of outcome measures used in comparative effectiveness studies.49 Patient input has refocused several NICE guidelines (for example, on psoriasis).50
Third sector advisory and advocacy groups such as the UK’s Consumer Association (www.which.co.uk), Picker Institute (www.pickereurope.org), and Sense About Science (www.senseaboutscience.org) have a crucial role in educating citizens and contributing to public debate about the use and abuse of evidence. The James Lind Alliance (www.lindalliance.org) brings patients, carers, and clinicians together to prioritise research questions. Such groups must remain, as far as possible, independent of vested interests and aware of the distorting influence of tied funding.
Training must be reoriented from rule following
Critical appraisal skills—including basic numeracy, electronic database searching, and the ability systematically to ask questions of a research study—are prerequisites for competence in evidence based medicine.6 But clinicians need to be able to apply them to real case examples.51
Too often, teaching resources use schematic, fictionalised vignettes in which the sick patient is reduced to narrative “factoids” that can populate a decision tree or a score sheet in an objective structured clinical examination. Rather than focus on these tidy textbook cases, once they have learnt some basic rules and gained some experience, students should be encouraged to try intuitive reasoning in the clinic and at the bedside, and then use formal evidence based methods to check, explain, and communicate diagnoses and decisions.43 They must also be taught how to share both evidence and uncertainty with patients using appropriate decision aids52 and adapt their approach to individual needs, circumstances, and preferences.39
Likewise, there is a strong argument for extending the continuing medical education curriculum beyond “evidence updates.” Peer observation and review, reflective case discussion in small groups (with input from patients who want to articulate their experiences, choices, and priorities) and ongoing conversations with fellow professionals can help hone and maintain the ability to manage the challenges of applying evidence based medicine in the real world.53 The linking together of educational theory, cognitive psychology, information mastery, and implementation science into a coherent approach that supports front line decision making with patients54 is rarely taught in practice.
Evidence must be usable as well as robust
Another precondition for real evidence based medicine is that those who produce and summarise research evidence must attend more closely to the needs of those who might use it. Lengthy and expensive reviews that are “methodologically robust” but unusable in practice often fail to inform, inspire, or influence.55 A recent systematic review of diabetes risk scores revealed that the authors of most studies were primarily concerned with the intellectual concept of improving the predictive value of the score but had given little or no thought to how their score might be used, by whom, or for what—nor what the implications would be for real people who would be designated “at risk” by the score.56
Evidence users include clinicians and patients of varying statistical literacy, many of whom have limited time or inclination for the small print.41 Different approaches such as brief, plain language summaries for the non-expert (as offered by NICE), visualisations,57 infographics,52 option grids,58 and other decision aids59 should be routinely offered and widely used. Yet currently, only a fraction of the available evidence is presented in usable form, and few clinicians are aware that such usable shared decision aids exist.
Publishers must raise the bar
This raises an imperative for publishing standards. Just as journal editors shifted the expression of probability from potentially misleading P values to more meaningful confidence intervals by requiring them in publication standards,60 so they should now raise the bar for authors to improve the usability of evidence, and especially to require that research findings are presented in a way that informs individualised conversations.
Given that real evidence based medicine is as much about when to ignore or over-ride guidelines as how to follow them, those who write guidelines should flag up the need for judgment and informed, shared decision making. The American College of Cardiology recently published new cholesterol guidelines;61 JAMA followed with a pragmatic, patient focused article on how to apply this guideline and when to consider ignoring it, including an online visualisation tool to support conversations with patients.62 As the authors commented, “the target for performance measures is not the percentage of patients who . . . are prescribed statins, but the proportion of eligible patients who participate in shared decision making about statin use.”62 Their approach deserves to be emulated widely.
Research must transcend conflicts of interest
To support real evidence based medicine, and in particular to reassure policy makers, clinicians, and the public that research and the guidance derived from it can be trusted,63 the infrastructure for research and guideline development must show the highest standards of probity. Independent funding of national bodies for medical research is crucial.
Broader, more imaginative research is needed
The research agenda for real evidence based medicine is much broader than critical appraisal and draws on a wider range of underpinning disciplines. For example, it should include the study of the patient’s experience of illness and the real life clinical encounter for different conditions and in different circumstances. The field would be enriched, for example, by qualitative research to elucidate the logic of care–that is, the numerous elements of good illness management that are complementary to the application of research evidence.64
We need to gain a better understanding (perhaps beginning with a synthesis of the cognitive psychology literature) of how clinicians and patients find, interpret, and evaluate evidence from research studies, and how (and if) these processes feed into clinical communication, exploration of diagnostic options, and shared decision making.54 Deeper study is also needed into the less algorithmic components of clinical method such as intuition and heuristic reasoning, and how evidence may be incorporated into such reasoning.43
In relation to producing usable evidence, we need to identify how to balance gold standard systematic reviews with pragmatic, rapid reviews that gain in timeliness and accessibility what they lose in depth and detail.65 In the same vein, we need research on how and in what circumstances to trade detail for brevity in developing guidelines. We need to develop decision aids that support clinicians and patients to clarify the goals of care, raise and answer questions about the quality and completeness of evidence, and understand and contextualise estimates of benefit and harm. We also need to improve both the usefulness and ease of use of these and other evidence based tools (models, scores, algorithms, and so on) including the intellectual, social, and temporal demands they make on users and the resource implications for the healthcare organisation and system.
In the educational field, it is time we extended the evidence base for integrated curriculums that promote reflection and case discussion alongside the application of evidence.66 Discussions on how to interpret and apply evidence to real cases, and the sharing of collective knowledge and expertise in the form of “mindlines” among clinicians53 or within illness communities67 may provide useful data sources for such studies. It is by studying these more sophisticated forms of knowing that we are likely to determine how best to produce expert clinicians and expert patients, and to prevent the harms that arise from overdiagnosis, overtreatment, and overscreening.33
In relation to effectiveness, we need greater attention to postmarketing research in day to day hospital and primary care settings to confirm that subsequent experience replicates the results of licensing trials. This will allow gold standard tests and their cut-off points for ruling out diagnoses and treatments to be revised to minimise overdiagnosis or underdiagnosis.43
Finally, in relation to the collective effort to prevent the misappropriation of the evidence based quality mark, a key research priority remains the study of hidden biases in sponsored research—for example, by refining the statistical techniques for challenging findings that appear too good to be true.
Much progress has been made and lives have been saved through the systematic collation, synthesis, and application of high quality empirical evidence. However, evidence based medicine has not resolved the problems it set out to address (especially evidence biases and the hidden hand of vested interests), which have become subtler and harder to detect. Furthermore, contemporary healthcare’s complex economic, political, technological and commercial context has tended to steer the evidence based agenda towards populations, statistics, risk, and spurious certainty. Despite lip service to shared decision making, patients can be left confused and even tyrannised when their clinical management is inappropriately driven by algorithmic protocols, top-down directives and population targets.
Such problems have led some to argue for the rejection of evidence based medicine as a failed model. Instead we argue for a return to the movement’s founding principles—to individualise evidence and share decisions through meaningful conversations in the context of a humanistic and professional clinician-patient relationship (box 2). To deliver this agenda, evidence based medicine’s many stakeholders—patients, clinicians, educators, producers and publishers of evidence, policy makers, research funders, and researchers from a range of academic disciplines—must work together. Many of the ideas in this paper are not new, and a number of cross sector campaigns with similar goals have already begun (box 3). We hope that our call for a campaign for real evidence based medicine will open up debate and invite readers to contribute (for example, by posting rapid responses on bmj.com).
Box 3: Campaigns aligned with real evidence based medicine
Too much medicine—A rapidly growing movement, led jointly by clinicians, academics and patients, aims to reduce harm from overdiagnosis, overscreening, and overtreatment.26 33 The second of what will hopefully be an annual “preventing overdiagnosis” conference will be held in Oxford in September 2014 (www.preventingoverdiagnosis.net)
All trials (www.alltrials.net)—an international initiative to ensure that all clinical trials are registered at inception and no findings are withheld from publication
Reducing waste and increasing value in medical research (www.thelancet.com/series/research)—A recent Lancet series highlighting the waste and loss of value caused by research that addresses the wrong questions, uses inappropriate study designs; is weighed down by bureaucracy, or is so badly or inaccessibly reported that practitioners and policymakers simply cannot apply it
Improving publishing standards (www.icmje.org/urm_main.html )—A campaign by the International Committee of Medical Journal Editors to improve the quality and transparency of medical publishing by discouraging ghost-writing and raising the standards for declarations of conflicts of interest
Integrated medical education—Campaign to strengthen the integration of the different components of the curriculum by developing bedside clinical skills, understanding and applying research evidence, and reflecting and deliberating about complex cases68 69
Cite this as: BMJ 2014;348:g3725
We thank Ruth Davis and Sarah Hardy for administrative support. The workshop was funded by a National Institute for Health Research senior investigator award for TG and by the Oxford Centre for Evidence Based Medicine. We also thank Bernard Higgins for advice on sections of the manuscript and Michael Rawlins and BMJ editors for helpful comments.
Contributors and sources: Other members of the Evidence Based Medicine Renaissance Group are: Jon Brassey, Druin Burch, Martin Burton, Hasok Chang, Paul Glasziou, Iona Heath, Carl Heneghan, Michael P Kelly, Richard Lehman, Huw Llewelyn, Margaret McCartney, Ruairidh Milne, and Des Spence. This essay is partly the product of a workshop held at Kellogg College, Oxford, on 13-14 January 2014 and organised collaboratively by the Centre for Evidence Based Medicine, University of Oxford and the Centre for Primary Care and Public Health, Barts and the London School of Medicine and Dentistry. TG, in correspondence with CH, conceptualised the idea for a reappraisal and renaissance of evidence based medicine and developed the plan to hold a workshop to progress this idea. TG and JH facilitated the workshop. All authors attended the workshop and contributed to the development of key themes for the paper. TG wrote the first draft of the paper and refined it with important intellectual contribution from JH and NM. All authors provided some feedback on earlier drafts of the paper and approved the final manuscript.
Competing interests: All authors have read and understood BMJ policy on declaration of interests and declare the following interests: NM and MK have senior roles in the National Institute for Health and Care Excellence; RM is employed by, and TG and JH’s salaries are part funded by, the National Institute for Health Research; MB is director of the UK Cochrane Centre. JB is a director and shareholder in the TRIP database, which offers a rapid search service. RL is a founder member, and TG a member, of the AllTrials campaign. IH is chairing the scientific committee for the preventing overdiagnosis conference in September 2014, and PG and HL have also been active in the preventing overdiagnosis campaign. RL is currently a consultant to the Yale Open Data Access project, which receives funding from Johnson and Johnson to develop methods to promote clinical trial data sharing; the project has also received funding from Medtronic.
Provenance and peer review: Not commissioned; externally peer reviewed.
Baru kemarin ngomongin penting mana paracetamol sama oralit
selain data yg sudah sering saya posting kemilis salah sekiannya yg terbaru ini
pesannya : bijak gunakan obat dan sesuai aturan pakainya.
Paracetamol leading cause of liver failure in kids
19th Sep 2014
Sunalie Silva all articles by this author
RESEARCHERS are warning about the risk of paracetamol overdose in young children following the first study of outcomes from paediatric acute liver failure related to the painkiller in Australia and New Zealand.
An analysis of liver failure cases seen at two liver transplant units showed medication errors in relation to paracetamol were a major problem for parents of young children, the authors said.
Researchers from Starship Children’s Hospital in Auckland NZ and the Royal Children’s Hospital, Brisbane found paracetamol was the leading cause of liver failure cases seen at the two hospitals over the decade 2002–13, accounting for 14 out of 54 cases.
Twelve of the 14 children were under the age of five years.
Shockingly, seven children received doses in excess of 120mg/kg/day, the authors reported. Many of the other children were reported to have received either a double dose or too frequent administration, co-administration of other paracetamol-containing medicines, or had received regular paracetamol for more than the recommended 48 hours. One child had been given Panadol consecutively for 24 days.
Three children underwent transplant. One of these and one other child died.
Parents reported failure to read or understand labelled instructions and using incorrect measuring devices as the main reasons leading to dosing errors.
Other reasons included using an alternative concentration of paracetamol than the one prescribed, using adult regular strength tablets and not recognising that paracetamol had been contained in other cold or cough preparations that had been co-administered to their child.
According to the authors, the findings highlight the need to educate parents on the potential risk of toxicity in sick children as well as to address packaging information and dosing instructions.
The authors have also warned doctors to remain cautious about recommending paracetamol to children with viral illness.
In the study most of the children who presented with paracetamol toxicity had presented with a history of viral illness.
But, according to the authors while fever is a stated indication for paracetamol use, some animal studies have shown that fever may in fact increase the metabolism of paracetamol. What’s more, they said, was that concurrent viral infection, poor oral intake and staggered paracetamol over length of time may increase the risk of multifactorial liver injury.
They are calling on regulators to conduct a safety review into the practices surrounding the safe use of paracetamol in children.
Thursday, May 23 2013 Written by Fetika Andriyani
RRI-Jogja News/L-06, Dokter kerap memberikan resep obat racikan pada anak yang dibuat dengan cara membuat puyer dari sejumlah sediaan obat.
Racikan obat dewasa yang diberikan dengan dosis tertentu pada anak harus diwaspadai karena obat yang biasa digunakan untuk dewasa berpotensi bahaya bagi bayi dan anak.
Hasil desertasi pada ujian promosi doktor terbuka di UGM yang disampaikan Chairun Widyaningsih mengungkap kesalahan penghitungan dalam pemberian resep racikan beresiko terhadap munculnya overdosis atau under dosing.
Resiko lain yang mungkin muncul seperti penggunaan formula yang tidak sesuai untuk anak, serta seleksi senyawa yang tidak tepat.
Selain itu, peracikan obat yang diberikan pada pasien tanpa dilakukan uji klins sangat beresiko bila digunakan pada pasien anak yang lebih rentan terjadi efek samping obat.
Dari hasil penelitian terhadap 22 dokter yang tersebar di lima kabupaten kota di DIY diketahui bahwa pertimbangan dokter untuk meresepkan obat racikan disebabkan karena tidak adanya sediaan obat untuk anak, keyakinan dokter bahwa obat racikan lebih manjur serta obat racikan dilakukan atas permintaan orangtua pasien dengan alas an puyer lebih mudah diberikan pada bayi dan anak dibandingkan obat dalam bentuk tablet atau kapsul.
Sumber : rrijogja
Tribunnews.com – Selasa, 19 Februari 2013 01:53 WIB
TRIBUNNEWS.COM,PALEMBANG–Kongkalikong penjualan obat ternyata menguntungkan semua pihak yang terlibat. Dokter mendapat jatah 10-20 persen dari harga obat yang diberikan perusahaan farmasi.
Sementara sales marketing yang menjembatani transaksi juga kecipratan bonus gaji berlipat. Konspirasi berlangsung secara terbuka di Palembang.
Sales perusahaan farmasi beramai-ramai mendatangi tempat praktik dokter membawa brosur obat dan penawaran kerjasama. Dokter tugasnya hanya menuliskan resep obat mahal produksi perusahaan tersebut.
Bila penjualan berlangsung lancar, perusahaan farmasi juga dengan mudah memenuhi permintaan dokter.
“Bisa sampai puluhan juta keluarkan uang untuk kebutuhan oknum dokter. Uang itu diperoleh dari jumlah obat yang laku dijual oleh dokter. Mau mobil baru, tinggal telepon,” ujar Dayat, seorang sales distributor perusahaan farmasi, Jumat (8/2).
Bonus atau dana sponsor yang diberikan kepada oknum dokter tersebut dihitung berdasarkan keuntungan penjualan obat.
“Kami juga tidak sembarangan kasih. Kami hitung apakah dokter itu berhasil menjual obat dari kita dengan jumlah yang disepakati atau tidak. Kalau berhasil, baru kami berani kasih bantuan sponsorship,” ungkapnya.
Pengakuan seorang dokter yang enggan disebutkan namanya, kongkalikong ini tambah berjalan mulus apabila sales menjalin kerjasama dengan dokter praktik yang langsung menyediakan obat untuk pasien (tidak dibeli di apotek). Bahkan, ada satu oknum dokter yang hanya menulis resep obat hanya dari dua merek.
Dokter harus menyediakan merek tertentu karena sebelumnya telah terjalin kesepakatan dengan sales obat. Kerjasama itu bervariasi, mulai dari satu sampai lima tahun.
Sales bisa memutuskan perjanjian apabila oknum dokter tak lagi mencantumkan obatnya di resep. Dampak yang dirasakan misalnya, sales menarik dan menghentikan pembayaran kredit mobil.
Menurut dokter sumber Tribun ini, sebenarnya setiap produsen obat itu telah memiliki buget promosi. Meski tidak menjalin kesepakatan dengan sales obat, dia tetap dibantu ketika butuh pinjaman mobil untuk menghadiri seminar di luar kota.
Obat yang ditawarkan oleh sales umunya merupakan golongan obat paten dengan harga yang lebih mahal jika dibandingkan obat generik. Dokter incaran tentu saja dokter yang memiliki jumlah pasien lebih banyak.
“Kami cari dokter yang pasiennya banyak atau dokter spesialis penyakit tertentu yang belum begitu banyak di Palembang. Ini yang akan melancarkan pencualan obat,” tutur Tono.
Transaksi dan pemberian layanan ekstra bagi dokter dengan menjadi sponsornya tidak dilarang dalam bisnis penjualan obat. Ia berani memastikan transaksional seperti ini dilakukan oleh distributor obat mana pun.
Perbedaan konsep pemberian bonus dibedakan berdasarkan jenis perusahaan distributor obat. Khusus untuk perusahaan distributor berbendera luar negeri terikat oleh aturan yang melarang pemberian barang tertentu. Anak perusahaan farmasi internasional yang berbisnis di Indonesia tidak dapat melakukan transaksi sebebas distributor asal dalam negeri. Mereka terikat dengan aturan yang ditetapkan oleh perusahaan.
“Kalau untuk perusahaan internasional seperti saya ini tidak semua boleh dilakukan, kami terikat aturan, tidak sebebas perusahaan dalam negeri yang sampai berani memberikan DP mobil,” ungkapnya.
Dia mengatakan, biasanya dokter minta tiket pesawat perjalanan ke luar kota dan luar negeri, akomodasi tertentu seperti biaya sewa kendaraan operasional selama berada di luar kota, penginapan hotel dengan tarif beragam.
Berbagai keperluan ini juga termasuk kepentingan seminar atau pun workshop resmi yang diselenggarakan lembaga tertentu. “Biasanya mereka (oknum dokter, Red) telepon atau ngabari ketika kita visit (ke tempat praktik dokter). Kalau mereka butuh sponsor untuk keperluan tertentu di luar kota, tidak pakai basa basi, langsung ngomong. Saya butuh Rp 10 juta misalnya, atau saya butuh tiket nih,” tuturnya.
Pertanyaan muncul, kenapa para sales obat ini sanggup memberikan ‘bantuan’ dengan jumlah yang besar? Dari mana dana mereka peroleh? Ternyata selisih penjualan obat sangat signifikan. Perusahaan distributor tertentu memiliki angka diskon yang berbeda yang diberikan kepada dokter sebagai user mereka.
Jumlah diskon ini tidak seluruhnya dikeluarkan kepada sang dokter yang membeli obat tersebut. Marketing biasa memainkan angka keuntungan pada selisih diskon tersebut. Misalnya untuk satu merek obat mendapat diskon sebesar 50 persen dari perusahaan, jumlah itu tidak diberikan sepenuhnya kepada dokter.
Marketing hanya memberikan diskon harga 10, 15 atau 20 persen. Dengan demikian, keuntungan yang diperoleh akan menjadi lebih besar. Dari keuntungan inilah kemudian biaya ‘servis’ tadi diperoleh.
Sales bisa memperoleh untung besar dengan sistem seperti ini. Ia akan lebih cepat memenuhi target penjualan yang diberikan oleh perusahaan. Keuntungan yang diperolehnya bisa satu bulan gaji, bahkan lebih jika ia berhasil closing sesuai yang ditargetkan oleh perusahaannya.
“Dokter juga untung, mereka juga dapat sponsor dari kami. Kalau mau apa tinggal kontak,” terangnya.
Sumber : tribunnews