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

Essay : BMJ : Evidence based medicine: a movement in crisis?

semangat pagi…
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?

Salam sehat


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 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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-1″ rel=”#ref-1~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-2″ rel=”#ref-2~.ref-cit”>2 Achievements included establishing the Cochrane Collaboration to collate and summarise evidence from clinical trials;http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-3″ rel=”#ref-3~.ref-cit”>3 setting methodological and publication standards for primary and secondary research;http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-4″ rel=”#ref-4~.ref-cit”>4 building national and international infrastructures for developing and updating clinical practice guidelines;http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-5″ rel=”#ref-5~.ref-cit”>5 developing resources and courses for teaching critical appraisal;http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-6″ rel=”#ref-6~.ref-cit”>6 and building the knowledge base for implementation and knowledge translation.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-7″ rel=”#ref-7~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-8″ rel=”#ref-8~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-1″ rel=”#ref-1~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-9″ rel=”#ref-9~.ref-cit”>9 Subsequently, the use of personal care plans and step wise prescription of inhaled steroids for asthma increased,http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-10″ rel=”#ref-10~.ref-cit”>10 and morbidity and mortality fell.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-11″ rel=”#ref-11~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-12″ rel=”#ref-12~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-13″ rel=”#ref-13~.ref-cit”>13 More fundamentally, many who support evidence based medicine in principle have argued that the movement is now facing a serious crisis (box 1).http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-14″ rel=”#ref-14~.ref-cit”>14 http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-15″ rel=”#ref-15~.ref-cit”>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 sildenafilhttp://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-16″ rel=”#ref-16~.ref-cit”>16 and male baldness, treatable with finasteridehttp://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-17″ rel=”#ref-17~.ref-cit”>17) and predisease “risk states” (such as low bone density, treatable with alendronate).http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-18″ rel=”#ref-18~.ref-cit”>18 They also decide which tests and treatments will be compared in empirical studies and choose (often surrogate) outcome measures for establishing “efficacy.”http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-19″ rel=”#ref-19~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-20″ rel=”#ref-20~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-21″ rel=”#ref-21~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-22″ rel=”#ref-22~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-23″ rel=”#ref-23~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-24″ rel=”#ref-24~.ref-cit”>24 http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-25″ rel=”#ref-25~.ref-cit”>25 Critics have condemned the role of the drug industry in influencing the policy makers who introduced them.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-26″ rel=”#ref-26~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-27″ rel=”#ref-27~.ref-cit”>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 HIVhttp://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-28″ rel=”#ref-28~.ref-cit”>28 and triple therapy for Helicobacter pylori positive peptic ulcer,http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-29″ rel=”#ref-29~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-30″ rel=”#ref-30~.ref-cit”>30 http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-31″ rel=”#ref-31~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-26″ rel=”#ref-26~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-8″ rel=”#ref-8~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-32″ rel=”#ref-32~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-33″ rel=”#ref-33~.ref-cit”>33

Templates and point of care prompts also contribute to the creeping managerialism and politicisation of clinical practice.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-8″ rel=”#ref-8~.ref-cit”>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.”http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-34″ rel=”#ref-34~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-35″ rel=”#ref-35~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-32″ rel=”#ref-32~.ref-cit”>32 http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-36″ rel=”#ref-36~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-37″ rel=”#ref-37~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-38″ rel=”#ref-38~.ref-cit”>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?”http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-39″ rel=”#ref-39~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-40″ rel=”#ref-40~.ref-cit”>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 screenhttp://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-41″ rel=”#ref-41~.ref-cit”>41) 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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-42″ rel=”#ref-42~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-43″ rel=”#ref-43~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-44″ rel=”#ref-44~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-45″ rel=”#ref-45~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-46″ rel=”#ref-46~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-47″ rel=”#ref-47~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-48″ rel=”#ref-48~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-49″ rel=”#ref-49~.ref-cit”>49 Patient input has refocused several NICE guidelines (for example, on psoriasis).http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-50″ rel=”#ref-50~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-6″ rel=”#ref-6~.ref-cit”>6 But clinicians need to be able to apply them to real case examples.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-51″ rel=”#ref-51~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-43″ rel=”#ref-43~.ref-cit”>43 They must also be taught how to share both evidence and uncertainty with patients using appropriate decision aidshttp://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-52″ rel=”#ref-52~.ref-cit”>52 and adapt their approach to individual needs, circumstances, and preferences.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-39″ rel=”#ref-39~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-53″ rel=”#ref-53~.ref-cit”>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 patientshttp://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-54″ rel=”#ref-54~.ref-cit”>54 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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-55″ rel=”#ref-55~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-56″ rel=”#ref-56~.ref-cit”>56

Evidence users include clinicians and patients of varying statistical literacy, many of whom have limited time or inclination for the small print.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-41″ rel=”#ref-41~.ref-cit”>41 Different approaches such as brief, plain language summaries for the non-expert (as offered by NICE), visualisations,http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-57″ rel=”#ref-57~.ref-cit”>57 infographics,http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-52″ rel=”#ref-52~.ref-cit”>52 option grids,http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-58″ rel=”#ref-58~.ref-cit”>58 and other decision aidshttp://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-59″ rel=”#ref-59~.ref-cit”>59 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,http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-60″ rel=”#ref-60~.ref-cit”>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;http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-61″ rel=”#ref-61~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-62″ rel=”#ref-62~.ref-cit”>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.”http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-62″ rel=”#ref-62~.ref-cit”>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,http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-63″ rel=”#ref-63~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-64″ rel=”#ref-64~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-54″ rel=”#ref-54~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-43″ rel=”#ref-43~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-65″ rel=”#ref-65~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-66″ rel=”#ref-66~.ref-cit”>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 clinicianshttp://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-53″ rel=”#ref-53~.ref-cit”>53 or within illness communitieshttp://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-67″ rel=”#ref-67~.ref-cit”>67 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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-33″ rel=”#ref-33~.ref-cit”>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.http://www.bmj.com/content/348/bmj.g3725?utm_medium=email&utm_campaign=15943&utm_content=Read%20our%20top%205%20specially%20selected%20articles&utm_term=Evidence%20based%20medicine&utm_source=Adestra_BMJ#ref-43″ rel=”#ref-43~.ref-cit”>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


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.


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September 22, 2014 Posted by | Uncategorized | Leave a comment

Parasetamol Penyebab Utama Kegegalan Hati pada Anak-anak

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.


September 19, 2014 Posted by | Uncategorized | Leave a comment

Dokter Perlu Perhatikan Obat Racikan Pada Anak

Thursday, May 23 2013 Written by Fetika Andriyani

Racikan Puyer Bayi

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

May 27, 2013 Posted by | Artikel | Leave a comment

Jual Obat Mahal, Dokter Dapat Bonus Mobil dari Perusahaan Farmasi

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

February 19, 2013 Posted by | Artikel | Leave a comment

Pengetahuan Orangtua Mengenai Obat Puyer di Poliklinik Umum Departemen Ilmu Kesehatan Anak FKUI-RSCM

Soepardi Soedibyo, Effie Koesnandar

Latar belakang. Obat puyer telah lazim diterima oleh masyarakat, hal ini tidak terlepas dari kebiasaan dokter yang sering meresepkannya. Peresepan obat puyer mulai banyak dikritisi, bahkan menjadi topik menarik saat diseminarkan. Dalam era evidence based medicine (EBM) saat ini, peresepan obat puyer perlu dikaji kembali sehingga sesuai dengan kaidah praktik peresepan dan pembuatan obat yang baik.
Tujuan. Mengetahui bagaimana pengetahuan, sikap dan perilaku orangtua yang datang ke Poliklinik Umum Departemen Ilmu Kesehatan Anak FKUI-RSCM mengenai peresepan obat puyer.
Metode. Desain studi deskriptif cross sectional, pengambilan sampel secara konsekutif dilakukan selama bulan Juni 2008, dengan menggunakan kuesioner sederhana yang berisi 10 pertanyaan. Subjek penelitian adalah orangtua pasien yang datang pada periode penelitian dan bersedia mengisi kuesioner penelitian.
Hasil. Dari 119 responden, 111 responden (93,3%) diantaranya pernah mendapatkan obat puyer. Sebaran umur, pendidikan, dan pekerjaan responden, berturut-turut didapatkan responden berusia >30-40 tahun (57,1%), pendidikan kategori sedang (59,7%), dan mempunyai status bekerja (65,5%). Sebaran responden lebih banyak pada umur anak antara 1-5 tahun (47,1%), jumlah anak 1-3 orang (85,0%), jumlah obat dalam satu puyer lebih dari satu macam (64,9%), dan obat diperoleh di apotik (59,5%). Responden yang tidak menyukai obat puyer (58,6%), terutama responden, berturut-turut (57,7%), (56,8%), dan (62,2%) menyatakan harga obat, kemanjuran, dan ketepatan dosis obat puyer sama saja dengan obat sirup.
Kesimpulan. Hampir semua responden pernah mendapatkan obat puyer. Responden lebih banyak yang menyatakan tidak menyukai obat puyer, serta menilai harga, kemanjuran dan ketepatan dosis obat puyer sama saja dengan obat sirup. (Sari Pediatri 2009;10(6):397-403).
Kata kunci: pengetahuan, orangtua, obat puyer

Unduh Fulltext (dibutuhkan Adobe Acrobat)

Sumber : IDAI

April 16, 2012 Posted by | Artikel | Leave a comment

Polypharmacy and its risks on the rise

NEW research showing a high prevalence of polypharmacy in older Australians has highlighted the need to help patients better manage their ever more complex medical regimens.


The study, published in the MJA, was based on a postal survey sent to a random sample of 4500 Australians aged 50 years and older. Just over a third responded. It found that 43% of participants had taken five or more medicines (conventional and/or complementary) in the previous 24 hours and 87% had taken at least one medicine over the same time frame. (1)


The authors found that polypharmacy (defined as five or more medications taken in 24 hours) was significantly associated with increasing age — 66% of participants aged 75 years and older were taking five or more medications.


The research found that polypharmacy had increased since the National Health Survey in 1995, as had the proportion of people taking lipid-lowering agents and antidepressants. (2)


The authors stressed the need to support safe and effective use of medicines and called for “further research into appropriateness of medicines use”.


“Although medicines can play a pivotal role in the quality of life of older people, polypharmacy can contribute to non-adherence and increase the risk of adverse drug reactions”, the authors wrote.


Another recent study of polypharmacy in older Canadians backed this view. Researchers found that 12% of people aged 65 years and older who were taking five or more medications experienced a side effect that required medical attention compared with just 5% of seniors taking only one or two medications. (3)


“Even when controlling for age and number of chronic conditions, the number of prescription medications was associated with the rate of emergency department use”, the Canadian authors wrote.


Professor Leon Flicker, professor of geriatric medicine at the University of WA, said the issue grew more pressing as people aged because older people were less able to clear drugs from their systems and were more sensitive to drug side effects.


He said managing patients on multiple medications was complicated, especially those with more than one condition, because the guidelines for different medicines were usually built around single diseases.


“GPs are obviously the linchpin as they are in a position to coordinate care across multiple specialists — but it is demanding work, especially when you’re talking about multiple medications, and it does require time.”


The Australian researchers also found that complementary medicines, particularly fish oil and glucosamine, were used by 46% of participants.


Rohan Elliot, a senior aged care pharmacist at Austin Health and a senior lecturer in pharmacy at Monash University, said regular medication reviews should ideally incorporate a home visit to obtain an accurate medication list, including over-the-counter and complementary medicines.


Dr Janette Randall, chair of the board at NPS, said GPs could make more use of home medicine reviews. She said the rules for reviews had recently changed and GPs could now refer patients directly to an accredited pharmacist of their choice.


“GPs have not used home medicine reviews much because they never knew who would be doing the review and the quality of those reviews was variable — but that barrier has gone”, Dr Randall said.


One of the study’s authors, Dr Marie Pirotta, a senior lecturer in the department of general practice at the University of Melbourne, said the home medicines review scheme was a “great initiative”.


She said part of the reason why patients were on so many medications was that it was easier to start someone on a medication than it was to stop one. “As GPs, we need to be much better at reviewing medicines and their role in a person’s treatment plan over time.”


- Amanda Bryan


1. MJA 2012; 196: 50-53
2. Australian Bureau of Statistics: National Health Survey: Use of Medications, Australia, 1995
3. Fam Pract 2012; 5 January


Posted 16 January 2012

Source : Mjainsight.com

January 16, 2012 Posted by | Artikel | Leave a comment

Diperkirakan 6000 Obat Yang Beredar di Indonesia Tidak Rasional

Penggunaan Obat yang Rasional
Lusia Kus Anna | Selasa, 31 Mei 2011 | 10:59 WIB

Oleh: Irwan Julianto

Masyarakat Indonesia dikepung ribuan merek obat. Anda boleh percaya atau tidak, lebih dari 40 persen obat jadi yang beredar di Indonesia tidak rasional. Selain justru bisa membahayakan kesehatan, juga merupakan pemborosan.

Tak kurang dari Ketua Umum Pengurus Besar Ikatan Farmakologi Indonesia dan Guru Besar Farmakologi Fakultas Kedokteran Universitas Gadjah Mada Prof dr Iwan Dwiprahasto, MMedSc, PhD menyatakan keprihatinan ini dalam wawancara di Jakarta 11 Mei lalu.

Pada dekade 1980-an, Direktur Jenderal Pengawasan Obat dan Makanan Departemen Kesehatan (POM Depkes) RI waktu itu, Prof Midian Sirait, menarik 285 merek obat dan obat kombinasi dari peredaran karena dinilai tidak rasional dan ada bukti dari sejumlah negara mengenai aspek keamanan dan khasiatnya.

Menurut Iwan, sekarang ada lebih dari 14.800 merek obat jadi di Indonesia dan sekitar 6.000 di antaranya diperkirakan tidak rasional. Obat-obat itu masuk dan diterima Direktorat Jenderal POM Depkes ketika belum ada sistem evaluasi obat yang baik. Contohnya obat tetes mata, obat mag dan tukak lambung, obat flu, serta obat batuk campuran.

Obat batuk campuran, misalnya, mencampurkan antitusif untuk menekan batuk yang terus-menerus dan ekspektoran diindikasikan untuk batuk berlendir. Hal ini tidak logis. Obat tetes mata juga tidak rasional karena mencampurkan obat steroid dan antibiotik.

Yang lebih tidak masuk akal lagi adalah obat mag yang mencampurkan berbagai jenis obat yang sebagian bertentangan indikasinya, seperti aluminium hidroksida, magnesium hidroksida, skopolamin, semitikon dan dimetikon (untuk menetralkan asam lambung), kafein yang menyegarkan, hingga penenang seperti codein.

Tentang obat-obat penghilang nyeri campuran dengan steroid yang banyak menimbulkan efek samping, seperti gagal ginjal dan moonface, Iwan menegaskan bahwa obat-obat analgetik seharusnya tidak boleh dikombinasikan dengan steroid. Nyatanya, di apotek-apotek daerah tersedia obat kombinasi NSAID, misalnya fenilbutason dengan steroid seperti prednison, dan vitamin. Ini sama sekali tidak rasional dan dapat membahayakan pasien.

Mitos “obat paten”

Sejak tahun 1980-an Organisasi Kesehatan Dunia (WHO) telah mengampanyekan perlunya setiap negara memiliki Daftar Obat Esensial Nasional (DOEN) agar tak perlu jumlah merek obat begitu banyak yang sebagian tidak rasional. Prof Iwan, yang juga anggota Komite Nasional DOEN menyatakan bahwa hampir 70 persen produk industri farmasi di seluruh dunia termasuk dalam kategori non-esensial dan duplikatif. Di Indonesia tak terkecuali.

Tentang mahalnya harga obat “jiplakan” yang tidak rasional, berlipat kali daripada harga obat generik padahal sebenarnya masa paten obat originator-nya sudah lewat, Iwan menjelaskan bahwa tingginya harga obat, khususnya untuk obat merek dagang, bukan merupakan isu yang begitu saja muncul di permukaan.

Obat telah menjadi komoditas ekonomi yang penetapan harganya diserahkan pada mekanisme pasar. “Pada situasi ini, obat telah kehilangan rohnya sebagai bagian dari hak individu untuk dapat sembuh dari penyakit atau memperpanjang usia karena kemampuan ekonomi seseorang menjadi kendala untuk mencapai tujuan tersebut,” katanya.

Ditambahkan, berbedanya harga obat antarnegara dan antarpelayanan kesehatan di satu negara menunjukkan bahwa harga obat tidak sepenuhnya didasarkan pada harga pabrik semata, tetapi juga kompetisi tidak sehat yang terjadi di pasar.

Obat yang oleh suatu industri farmasi semula ditetapkan dengan harga yang jauh lebih murah dari kompetitornya akhirnya harus menyesuaikan (menaikkan harga) dengan hargar yang ditetapkan oleh industri farmasi yang telah terlebih dahulu memiliki brand image.

Sebagai contoh di Indonesia, harga siprofloksasin merek dagang (branded generic) yang patennya sudah habis tahun 2003 bervariasi mulai Rp 1.200 hingga lebih dari Rp 29.000, padahal siprofloksasin generik hanya Rp 345.

Bayangkan, harga obat generik bermerek ada yang hampir seratus kali lebih mahal dibandingkan obat generik biasa, padahal isi dan khasiatnya sama. Dan sebenarnya obat generik bermerek hanyalah ‘ jiplakan” obat originator yang dibuat dengan riset mahal.

Celakanya, masyarakat awam dan sebagian dokter justru sudah telanjur salah kaprah menganggap obat generik bermerek sebagai “obat paten”. Padahal, mahalnya harga obat generik bermerek sama sekah tidak rasional. Absurd.

Di tengah belantara ribuan merek obat, mulai dari yang generik dan esensial hingga obat-obat merek dagang baik yang originator maupun obat generik bermerek, konsumen harus cerdas.

“Konsumen yang cerdas kalau perlu tak meminum obat walaupun diresepkan oleh dokter. Kalau diberi antibiotik, harus tanya ke dokter untuk apa. Tidak semua ke1uhan sakit seperti flu atau radang tenggorokan (faringitis) membutuhkan antibiotik. Kalau memang ada infeksi bakteri, bukan infeksi virus, dan harus diberi antibiotik, harus diminum sampai habis,” ujar Prof Iwan.

Khusus untuk puyer yang biasanya diresepkan untuk bayi dan anak-anak, ia menyarankan sebaiknya orangtua menanyakan apa saja komponen obat di dalamnya. Jika ada antibiotik, mintalah untuk dikeluarkan dari racikan. Tentang polifarmasi, peresepan berbagai jenis obat sekaligus disarankan untuk diwaspadai dan tak bisa dianggap sepele.

“Tidak mustahil ada interaksi antarjenis obat yang justru akan merugikan pasien. Sebagai contoh, ada orang yang kemampuan untuk memetabolisme obat amat cepat, tapi ada juga orang yang kemampuan metabolismenya amat lambat. Kedua kelompok tersebut tidak begitu saja bisa diberikan obat dengan dosis yang sama. Pada kelompok metabolisme lambat, dosis beberapa jenis obat harus diturunkan karena dapat menimbulkan efek toksik. Di era personalized medicine, pemberian obat harus sangat mempertimbangkan faktor-faktor biologis individu agar obat yang diberikan tidak mencelakakan pasien” kata Prof Iwan.


May 31, 2011 Posted by | Artikel | Leave a comment

50% Antibiotik Salah Guna

Penggunaan antibiotik yang tidak tepat menimbulkan penyakit-penyakit yang sulit disembuhkan. Jika ini berlanjut, akan banyak penyakit infeksi tidak bisa disembuhkan.”

Sri Indrawaty Dirjen Bina Kefarmasian dan Alat Kesehatan Kemenkes

SEKITAR 50% antibiotik di Indonesia diguna kan secara tidak tepat.

Kondisi itu meningkatkan ancaman bakteri kebal antibiotik.

Demikian diungkapkan Direktur Jenderal Bina Kefarmasian dan Alat Kesehatan Kementerian Kesehatan (Kemenkes) Sri Indrawaty di Bekasi, kemarin.

Menurut Sri, contoh ketidaktepatan penggunaan itu antara lain 40% anak penderita diare akut diberi oralit dan antibiotik. Padahal semestinya tidak perlu. Selain itu, hanya 50%70% penderita pneumonia yang mendapat terapi antibiotik secara tepat.

“Penggunaan antibiotik se cara tidak tepat tidak hanya terjadi di Indonesia. Akibatnya, semakin banyak ditemukan kuman di dunia yang kebal terhadap antibiotik,” ujarnya.

Beberapa kuman yang diketahui kebal terhadap antibiotik antara lain methicillin-resistent stapphylococcus (MRSA), vancomycin-resistent enterococci (VRE), dan clebsiella pneumoniae. Infeksi ketiganya menimbulkan penyakit yang sulit disembuhkan.

Selain itu, sambung Sri, hasil penelitian Antimicrobial Resistent in Indonesia (AMRINstudy) yang melibatkan 2.494 masyarakat responden, diketahui 43%-nya terinfeksi bakteri penyebab gangguan pencernaan Escherichia coli (E-coli) yang kebal terhadap berbagai jenis antibiotik. Seperti, ampisilin (34%), ko-trimoksazol (29%), dan kloramfenikol (25%).

“Jika ini berlanjut, antibiotik yang biasa digunakan tidak lagi mampu bekerja optimal dan akan banyak penyakit infeksi tidak bisa disembuhkan karena membutuhkan antibiotik jenis baru,” cetusnya.
Dengan resep Untuk mencegah hal itu, sesuai anjuran Badan Kesehatan Dunia (WHO), Sri mengingat kan masyarakat untuk menggunakan antibiotik secara bijak.
Antara lain, dengan tidak sembarang mengonsumsi antibiotik tanpa resep dokter. Antibiotik juga tidak perlu digunakan untuk penyakit-penyakit yang disebabkan virus.

“Pilek, batuk, dan diare pada umumnya tidak memerlukan antibiotik, karena penyakit itu disebabkan virus, bukan bakteri,” imbuh Sri.

Kebiasaan cuci tangan menggunakan sabun atau antiseptik juga penting diterapkan untuk mengendalikan penyebaran bakteri kebal.

Sementara itu, sebagai bagian dari program penggunaan antibiotik secara bijak, Kemenkes telah mengeluarkan Daftar Obat Esensial Nasional (DOEN) pada tahun 2008. DOEN adalah daftar obat terpilih yang paling dibutuhkan dan yang diupayakan tersedia di unit pelayanan kesehatan, dan direvisi secara berkala tiap tahun.

Selain itu, untuk meningkatkan ketepatan penggunaan antibiotik di fasilitas layanan kesehatan, Kemenkes akan meluncurkan Pedoman Umum Penggunaan Antibiotik. Pedoman itu bakal menjadi acuan nasional dalam menyusun kebijakan antibiotik dan pedoman penggunaannya bagi rumah sakit dan fasilitas kesehatan lainnya.

“Pedoman itu akan diluncurkan pada 7 April mendatang, bertepatan dengan Hari Kesehatan Sedunia,” pungkas Sri.


April 1, 2011 Posted by | Artikel | Leave a comment

Adakah Kebijakan Obat Nasional

Oleh Kartono Mohamad

Pada awal tahun 1970-an Indonesia membuka kesempatan bagi industri farmasi internasional menanam modal di Indonesia. Mulailah PMA bidang farmasi berbondong-bondong masuk ke Indonesia.

Pemerintah Indonesia waktu itu menetapkan, setelah lima tahun beroperasi, industri farmasi asing harus sudah memproduksi bahan baku di Indonesia. Kemudian, dibuka pula kesempatan bagi modal dalam negeri untuk membuka pabrik farmasi.

Dalam waktu singkat jumlah merek dan jenis obat jadi di Indonesia meningkat cepat. Salah satu alasan dibiarkannya begitu banyak jenis dan merek obat adalah persaingan mereka di pasar sehingga harga makin murah. Sulit dimengerti bahwa pakar farmasi di Departemen Kesehatan menyamakan perdagangan obat dengan baju, yang semakin banyak merek semakin murah harganya.

Persaingan obat dan baju sangat berbeda. Dalam produk konsumsi, seperti baju, konsumen dapat memilih dan memutuskan mana yang paling sesuai dengan kebutuhan. Dalam hal obat, terutama obat etikal, konsumen sama sekali tidak tahu mana yang harus ia beli, mana yang paling cocok dengan penyakitnya, dan mana yang mutunya lebih baik. Yang menentukan adalah dokter. Konsumen terpaksa membeli, berapa pun harganya. Maka, persaingan terjadi dengan cara membujuk dokter agar meresepkan produk tertentu.

Obat esensial

Kebijakan pertama seharusnya menetapkan jenis obat apa saja yang secara esensial diperlukan rakyat Indonesia. Di luar jenis itu, seharusnya izin memproduksi dan mengedarkannya dipersulit. Di situlah perlunya pemerintah menyusun daftar obat esensial (DOE) tanpa menentukan merek dagang yang akan beredar asal mutunya memenuhi syarat. DOE selanjutnya menjadi pedoman bagi rumah sakit pemerintah, baik pusat maupun daerah, untuk pengadaan obat. Dengan demikian, ada efisiensi penggunaan dan pemantauan rezim terapi.

Banyaknya jenis obat yang beredar saat ini membuat persaingan tidak sehat dan berdampak pada kekacauan dalam menentukan terapi yang efektif dan efisien. Jenis yang sangat banyak dan merek dagang yang juga sangat banyak ini akibat mudahnya pemerintah memberi izin (terutama lokal) untuk membuka pabrik obat. Banyak yang sebenarnya tidak profesional dan bahkan tidak berlatar belakang membuat obat.

Sebagian besar dari mereka hanya menjadi perakit obat dengan hanya bermodal membeli mesin dan bahan pembuat obat. Bandingkan, misalnya, dengan Bayer atau Hoechst (dulu) yang bermula dari pabrik kimia dan kemudian melalui penelitian dapat menemukan bahan berkhasiat obat.

Akibat perizinan yang begitu lunak—tanpa melihat jangka panjang—industri farmasi lokal berkembang sangat cepat. Padahal, pangsa pasar sangat kecil. Mereka kemudian hanya memproduksi obat-obat ”latah” (meniru). Ini pula yang membuat merek dagang untuk jenis yang sama menjadi sangat besar.

Untuk memenangi pasar, mereka berusaha mendapat izin edar lebih dulu dari pesaing— yang membuka peluang korupsi—dan berikutnya membujuk dokter.

Kebijakan harga

Para pejabat di Depkes dulu berprinsip biar pasar yang mengatur harga obat. Depkes hanya mengatur kapan pabrik obat boleh menaikkan harga produk. Akan tetapi, seperti telah disebut, pasar obat berbeda jauh dengan pasar produk lain.

Ketentuan ini lagi-lagi menjadi peluang untuk korupsi. Karena tidak ada kebijakan yang terarah, industri farmasi lokal yang hanya menjadi perakit obat bebas menentukan harga produk. Pada umumnya mereka menetapkan harga mendekati harga yang ditentukan industri penemu untuk mengesankan bahwa mutu mereka tidak berbeda dengan produk orisinal tersebut. Padahal, industri lokal tidak pernah melakukan riset awal.

Tidak selayaknya mereka dibebaskan menentukan harga produk mendekati harga produk orisinal. Pemerintah seharusnya menetapkan bahwa harga obat tiruan maksimal 60-70 persen dari harga obat orisinal karena tidak ada beban biaya riset. Bahkan bahan bakunya pun dibeli dari pasar di luar penemu awal, misalnya dari India, Hongaria, dan China, dengan harga jauh lebih murah daripada harga di negara penemu awal.

Bahan baku tersebut secara bebas dapat diproduksi oleh negara lain setelah masa perlindungan patennya habis. Jadi, sebenarnya yang dibuat industri lokal bukanlah obat paten, melainkan obat generik yang diberi merek dagang tersendiri.

Seandainya pemerintah tegas dalam menentukan batas harga obat tiruan atau generik bermerek tersebut, harga obat tidak seenaknya ditetapkan oleh industri nasional dengan keuntungan sangat besar.

Bahan pembuat obat

Setelah lima tahun pertama, tidak satu pun industri farmasi memproduksi bahan baku di sini dan pemerintah tidak bisa berbuat apa-apa. Alasannya sederhana saja, selain fasilitas dan kemampuan riset obat di Indonesia sangat lemah, pangsa pasar bahan baku obat di Indonesia sangat kecil sehingga tidak ekonomis untuk berproduksi di sini.

Pemerintah waktu itu mungkin berpikir bahwa membuat obat seperti membuat kerupuk. Bahan bakunya cukup tepung dan garam. Jadi, ketika kita mensyaratkan agar industri farmasi membuat bahan baku obat di Indonesia, tidak terpikirkan bahwa bahan baku obat memerlukan dukungan industri hulu yang sesuai serta riset yang lama dan mahal.

Bahkan banyak industri farmasi dunia bergabung karena biaya riset semakin mahal dan persyaratan riset obat semakin ketat. Kalau hanya membuat bahan baku yang mudah diperoleh di pasar internasional, mengapa pula harus repot membuat sendiri di Indonesia yang pangsa pasarnya masih sangat kecil. Jumlah penduduk Indonesia memang besar, tetapi konsumsi obat per tahun dan per kapita masih sangat kecil.

Sampai sekarang tidak ada kebijakan pemerintah untuk mengembangkan industri hulu bagi produk obat. Jangankan bahan baku obat, untuk bahan pembantu saja pengembangannya tidak dipikirkan. Obat tidak hanya terdiri dari bahan baku zat aktif, tetapi diperlukan juga pencampur yang memenuhi syarat. Bahan bantu itu, antara lain, tepung khusus, gula khusus, perekat, dan kapsul, yang sampai sekarang tidak terpikirkan oleh pemerintah.

Produksi bahan bantu tidaklah sesulit membuat bahan baku aktif dan mempunyai peluang diekspor ke negara lain. Selama ini hampir 90 persen bahan pembuat obat (bahan aktif dan bahan bantu) diimpor. Industri dalam negeri hanya merakitnya menjadi obat jadi.

Selama kita tidak memikirkan masalah ini, Indonesia akan terus sebatas menjadi negara perakit obat yang tidak akan pernah mandiri. Harga obat pun akan terus menjadi beban bagi rakyat dan negara.

Kartono Mohamad Mantan Ketua Umum PB IDI


April 1, 2011 Posted by | Artikel | Leave a comment

Kementerian Kesehatan: Pemberian Antibiotik Diperketat



Kementerian Kesehatan:
Pemberian Antibiotik Diperketat

Bekasi, 1 April 2011 06:18
Pemberian antibiotik akan diatur dengan lebih ketat oleh Kementerian Kesehatan karena banyak terjadi resistensi terhadap antibiotik yang disebabkan karena tidak tepatnya dosis yang diberikan.

“Pedoman penggunaan antibiotik ini dikeluarkan karena banyak indikasi penyimpangan-penyimpangan penggunaan antibiotik. Sebenarnya ada prosedur dalam pemberian antibiotik ini tapi karena sarana dan fasilitas yang terbatas di rumah sakit, maka dokter langsung memberikan antibiotik kepada pasien dengan mengira-ngira,” papar Direktur Jenderal Bina Farmasi dan Alat Kesehatan Kementerian Kesehatan Sri Indrawati, di Cibitung, Bekasi, Kamis (31/3).

Pedoman untuk penggunaan antibiotik di rumah sakit itu akan mengatur mengenai pemberian antibiotik yang memang harus menggunakan resep dokter agar tidak merugikan pasien maupun dunia kesehatan pada umumnya.

Sri mencontohkan, banyak kasus dimana pasien hanya menderita flu ringan namun dokter langsung memberikan antibiotik, padahal seharusnya tidak memerlukan antibiotik.

Begitu juga ada kasus pemberian antibiotik diperbanyak karena adanya promosi dari industri obat. “Maka dari itu, sekarang kita benahi dengan membuat pedoman penggunaan antibiotik yang tepat,” katanya.

Badan Kesehatan Dunia (WHO) juga telah mengeluarkan peringatan mengenai adanya resistansi terhadap antibiotik itu sehingga menjadi tema Hari Kesehatan Internasional 2011 yang diperingati tiap tanggal 7 April.

Sri menyebut kasus infeksi akibat bakteri atau kuman merupakan salah satu masalah kesehatan yang cukup besar di negara berkembang sehingga resistensi terhadap antibiotik itu tidak bisa dianggap masalah ringan.

Sri mencontohkan sudah ada keluhan dari dokter-dokter di rumah sakit mengenai antibiotik yang tidak lagi mempan untuk mengobati beberapa penyakit tertentu sehingga menghambat layanan kesehatan. “Ini tidak hanya jadi masalah di Indonesia tapi di seluruh dunia sehingga menjadi concern WHO,” katanya.

Dari berbagai studi ditemukan bahwa saat ini sebesar 40-60% antibiotik tidak digunakan secara tepat dalam artian tidak tepat dosis maupun peruntukannya.

Sri juga mengungkapkan, hingga 40% anak-anak yang menderita diare akut diberi antibiotik padahal mereka tidak memerlukannya. “Sebanyak 50% penderita pneumonia juga tidak tepat pemberian antibiotiknya,” kata Sri.

Untuk menghindari terjadinya kerugian dalam hal kesehatan yang disebabkan oleh penggunaan antibiotik yang tidak tepat, Sri mengingatkan agar masyarakat tidak sembarang mengkonsumsi antibiotik dan harus menggunakan resep dokter. “Jika mendapat resep dari dokter, tanyakan mana obat yang mengandung antibiotik,” tambahnya.

Masyarakat juga diingatkan untuk tidak membeli antibiotik dengan menggunakan resep yang didapat sebelumnya karena harus melalui resep dokter yang baru. [EL, Ant]


April 1, 2011 Posted by | Artikel | Leave a comment


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