Drug Safety
-
Pharmaceutical advances over the past 50 years have benefited many people in terms of disease prevention and management. However, probably without exception, most pharmaceutical products can cause adverse consequences of varying severity and frequency. In the last 10 years, many medicines that were originally prescription only have now become available over the counter (OTC), either from pharmacies or other general retail outlets. ⋯ Many doctors are unaware of the range of OTC preparations available, and therefore do not consider them as a possible cause of presenting symptoms. Neither do they take them into account when making a new prescribing decision. The public need to be aware that OTC medicines should be treated with the same care as prescribed medicines, and that advice on recommended dose, contraindications and interactions should be adhered to.
-
Misoprostol, a prostaglandin E(1) analogue, is widely used in the US and other countries for cervical ripening and labour induction. Its use for these indications is not approved by the US Food and Drug Administration (FDA). The manufacturer of misoprostol issued a letter to American healthcare providers in August 2000, cautioning against the use of misoprostol in pregnant women and citing a lack of safety data for its use in obstetrical practice. ⋯ Low-dose misoprostol (25 microg) is an effective agent for cervical ripening and labour induction when used in a judicious and cautious fashion. There are insufficient data to support the widespread use of oral misoprostol for cervical ripening and labor induction. Some trials suggest that this approach may be effective; however, the ideal dose and administration regimen have yet to be defined.
-
The 3-hydroxy-3-methyl coenzyme A (HMG-CoA) reductase inhibitors or statins, specifically inhibit the enzyme HMG-CoA in the liver, thereby inhibiting the rate limiting step in cholesterol biosynthesis and so reducing plasma cholesterol levels. Numerous studies have consistently demonstrated that cholesterol lowering with statin therapy reduces morbidity and mortality from coronary heart disease, whilst recent evidence has demonstrated that benefits of statin therapy may also extend into stroke prevention. Since hypercholesterolaemia is a chronic condition, the long-term safety and tolerability of these agents is an important issue. ⋯ Reduced activity of this enzyme due to either reduced expression or inhibition by other drugs prescribed concomitantly such as cyclosporin or itraconazole may increase drug bioavailability and the risk of myotoxicity. Such factors may partly account for the interindividual variability in susceptibility to statin-induced myotoxicity, although other as of yet unclarified, genetic factors may also be involved. The risk of rhabdomyolysis is increased with combination fibrate-statin therapy, with initial evidence suggesting that gemfibrozil-statin combination may particularly increase the risk of myotoxicity, with pharmacodynamic as well as pharmacokinetic mechanisms being involved.
-
Hypovolaemia is extremely common among surgical and intensive care patients. The best strategy for volume replacement therapy has been the focus of debate for several years. The lack of acceptance of hydroxyethylstarch (HES) for volume replacement therapy is most likely due to reports of abnormal coagulation and to recently published studies indicating negative effects of HES on renal function. ⋯ Theoretical and documented hazards are associated with each kind of volume replacement therapy. There appears to be no reason to banish modern HES preparations with a low or medium Mw (e.g. 70, 130 or 200 kD) and a low DS (0.4 or 0.5) in patients without pre-existing kidney dysfunction. In patients with known renal dysfunction (e.g. plasma creatinine level >3 mg/dl), all HES preparations should be used cautiously and other volume replacement regimens (e.g. gelatins) should be considered since no convincing data are yet available for the latest generation of HES (Mw 130; DS 0.4).
-
To assess the preventability of adverse drug reactions (ADRs) leading to hospital admissions and to investigate the feasibility of the use of a standardised preventability scale in clinical practice. ⋯ These results emphasise that ADRs leading to hospitalisation are frequent, with one-third of them likely to be preventable. Moreover, the risk of ADRs mainly involved a small number of drugs. Our experience suggests that there is a need for further studies to validate the French standardised scale of preventability assessment.