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Indian Journal of Pharmacology, Vol. 43, No. 2, March-April, 2011, pp. 225-226 The Journal Club The Journal Club RK Dikshit Chief Editor, Indian Journal of Pharmacology, Correspondence Address: R K Dikshit, Chief Editor, Indian Journal of Pharmacology, chiefeditorijp@gmail.com Code Number: ph11065 Not a bad news for fixed dose combination (FDC) enthusiasts! In a retrospective, longitudinal, cohort design study in the UK, it has been concluded that the safety risk outcomes do not differ between the concomitant use of ibuprofen and paracetamol as compared to the use of these drugs alone (De Vries F., Setakis E. and Van Staa T.-P. Concomitant use of ibuprofen and paracetamol and the risk of major clinical safety outcomes. Br J Clin Pharmacol 2010;70:429-38). The study was conducted on the medical records of 1.2 million patients (aged 18 years or over) stored at the General Practice Research Database (GPRD). Dose, duration and exposure patterns were taken into account. Using a number of statistical analyses, it was elucidated that the relative risks of upper gastrointestinal events, myocardial infarction, stroke, renal failure, congestive heart failure, intentional or accidental overdose, suicidal behavior and mortality were no different with the use of combination as compared to that of each drug alone. This combination, used in abundance in India, has generally been considered to be innocuous. However, omission of the hepatotoxicity from the list of outcomes immediately comes to the mind. More importantly, the superiority of the combination over either of the ingredients used alone remains to be established. **** Providing safe medicines is a complex task, particularly in case of children. The condition of children in terms of their access to safe medicines (or lack thereof) has been increasingly acknowledged. Several organizations (including WHO and UNICEF) have, therefore, launched a major campaign entitled "Make Medicines Child Size" with a view to improve the availability and access to safe, child specific medicines throughout the world. Against this background, the authors of a review article (Oshikoya KA, Senbanjo IO. Providing safe medicines for children in Nigeria: The impediments and remedies. Ann Afr Med 2010;9:203-12) have systematically analyzed the situation in Nigeria. Medicine related morbidity and mortality has been quite high in Nigeria where deaths due to counterfeit, fake medicines and unethical clinical trials have been brought to light. Authors have described the existing problems and their possible solutions in details. Lack of evidence-based practice, up-to-date information among prescribers and training and research in pediatric clinical pharmacology, inadequate training in undergraduate and postgraduate clinical pharmacology, irrational use of medicines, lack of pediatric focus in essential medicine list, lack of access to pediatric essential medicines (due to the non-availability of suitable formulations and lack of storage facilities, particularly in rural areas), lack of awareness of pediatric pharmacovigilance/pharmacoepidemiology and weak national drug policies are described to be some of the broad impediments. Suggested remedies include enhancing information to doctors, undertaking research and training in pediatric clinical pharmacology, review (and a possible correction) of undergraduate/postgraduate teaching of clinical pharmacology, encouraging the application of evidence-based medicine, strengthening national drug policies and education of parents. The problems that are listed may not be unique to Nigeria as they are prevalent in most of the developing world. Similarly, the solutions provided are also not unknown. The review, however, compiles a good number of problems and the remedial possibilities from which one can choose a possible area of action. **** A common experience gets the scientific approval! It has been detected that ingestion of caffeine causes several urinary effects (Lohsiriwat S, Hirunsai M, Chaiyaprasithi B. Effect of caffeine on bladder function in patients with overactive bladder symptoms. Urol Ann 2011;3:14-8). Authors carried out the investigation in 12 adult patients (9 females and 3 males) suffering from the symptoms of overactive bladder (OAB). Each subject was given 8 ml/kg of water with and without caffeine (4.5 mg/kg) at two separate sessions. A large number of urodynamic parameters were assessed through uroflowmetry (voided volume and time, time to maximum flow rate, peak/mean flow rate, etc.) and cystometry (first/normal or strong desire to void, various pressure parameters, etc.). It was observed that caffeine (1) causes diuresis, (2) increases the bladder sensitivity (the desire to void comes earlier), and (3) increases the flow rates (detrusor contractions become stronger at urgency and urine volume increases). These effects can promote early urgency and frequency of urination as well as nocturia. Therefore, symptoms in those with lower urinary tract disorders (such as OAB) may be aggravated and such individuals should avoid caffeine or caffeinated foodstuffs. A simple investigation with straightforward observations! Hopefully, the methodology employed can serve as a possible research tool in clinical pharmacology! **** Thanks to the massive instrumentation, many of us may wonder if the medicine as a profession has now transformed into a "medical technology". Airing parallel views, author of an editorial (Kapoor MC. Evidence based medicine: Can everything be evident? Ann Card Anaesth 2011;14:3-5), feels that the "fashion" of evidence-based medicine (EBM) is likely to turn the medical practice into a "protocol-based recipe" that is least concerned about clinical techniques and individual innovations in patient care. Referring to about two dozen publications on this subject, the author traces the history of EBM to 1991 when the American College of Physicians (ACP) began a journal, "The ACP Journal Club", and the year 1995 when the ACP and the BMJ Publishing Group collaborated to initiate the publication of another journal called "Evidence Based Medicine". Cochrane Collaboration probably catalyzed the process further. Large randomized controlled clinical trials (RCT) and the meta-analyses became the backbone of EBM which further lead to the framing of appropriate guidelines. It is said that approximately 1000 guidelines are created annually, it is difficult to follow them and that the guidelines for framing the guidelines must also exist. Some of the failed (or flawed) guidelines ("Surviving Sepsis Guidelines-2004", "Tight Glucose Control regime", "Efficacy and anti-inflammatory effects of aprotinin") are mentioned to bring home the point that a large amount of published research (that forms the very basis of EBM) may be untrustworthy. Several common errors in framing of RCTs and in selecting them for inclusion in meta-analyses have also been described (selection of only few clinical variables, less reliance on clinically observed data, differences in inclusion/exclusion criteria in the chosen RCTs, non-feasibility of RCTs in some clinical areas, differences in the quality of RCTs, their sample sizes and levels of significance, etc.). Publication biases, quality of reviewers and conflicts of interests (in developing the evidence-based guidelines) are described to be some other factors that may influence the studies. EBM may have come to stay and get stronger, but the observations described provide some food for thought for everyone sitting on either side of fence! **** Several functions have been ascribed to the clinical pharmacologists and now they are being called to act as health economists too! In a recently published informative review (Edlin R, Round J, Hulme C, McCabe C. Cost-effectiveness analysis and efficient use of the pharmaceutical budget; the key role of clinical pharmacologists. Br J Clin Pharmacol 2010;70:350-55), the authors opine that the clinical pharmacologists can play a significant role in delivering an efficient healthcare system by ensuring the meaningful allocation of budget using cost-effective analyses. This is particularly important in view of the shrinking healthcare budgets in developed countries and inadequate resources in developing economies. On the other hand, costs are always escalating, especially in case of newer therapies including the prescription drugs. Authors say that an efficient use of the available resources should be made, and for that matter, their most appropriate application would be to maximize the population health (rather than a single patient′s interests). Thus, the least efficient health technologies should be removed and newer methods should be included in the healthcare system only if they are proved to be more efficient than the existing ones (Making the right disinvestment decision is as important as making the right investment decision). Readers are introduced to a number of pharmacoeconomic terms and their meaning (e.g. "Cost Effective Analysis", "Quality Adjusted Life Year", "Incremental Cost Effectiveness Ratios" and "Cost Effectiveness Threshold", etc.) and adequate references have been given for the methods to calculate them. Those of us with an aptitude for economics may really want to go for it! Copyright 2011 - Indian Journal of Pharmacology |
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