Generic drugs - safe, effective, and affordable

Abstract

This article discusses the history and evolution of the process for generic drug evaluation and approval in the United States, with emphasis on locally acting dermatologic products. The requirements for in vivo bioequivalence (BE) testing and the statistical criteria for BE are discussed, and an example of a topical antifungal dermatologic product is used to demonstrate the BE determination for locally acting drugs. Other factors in the dispensing of prescription medications that are not within the Food and Drug Administration regulatory authority are also mentioned.

Exploring community pharmacists’ views on generic medicines: a nationwide study from Malaysia

“…Approximately one in five pharmacists surveyed did not think that certain generic medicines can cause serious therapeutic failure. In fact, in countries with generic medicines policy, generic substitution is not allowed for non-bioequivalent products and narrow therapeutic index medicines to avoid the possibility of therapeutic failures [16,17,27]. For instance, there were reports of untoward effects resulting from substitution of narrow therapeutic index medicines such as anticonvulsants [28][29][30].…”

“…The Malaysian DCA has developed lists of medicines which are required to fulfill the bioequivalence standard and the number of listed medicines has increased annually [13,14]. Bioequivalence requirements have been used in many developed countries such as Australia and United States of America (US) as the method of substantiating therapeutic equivalence and clinical interchangeable between medicinal products [15][16][17]. The Malaysian DCA has adopted the basic principle outlined by the European Agency for the Evaluation of Medicinal Product (EMEA) [12].…”

Students and Doctors are Unaware of the Cost of Drugs they Frequently Prescribe

“…We think that the upcoming revisions of the WHO six-step guideline, the guide to good prescribing and the teacher's guide to good prescribing, all should address the role of cost in the relevant six steps, by including topics such as selecting a P-drug from (sponsored) guidelines, the difficulties in estimating drug costs, universal mechanisms that influence drug costs, pharmacy dispensing costs and how to address drug costs in daily teaching practice. For example, drug prices change over time, with drugs becoming cheaper after their patent has expired [27,28]. The cost difference between generic and proprietary drugs is substantial, and generic drugs are relatively inexpensive.…”

Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world

“…Generic excipients have to be previously used for approved drugs for which there is evidence that they have not affected their safety or efficacy. 53 Excipients, which include preservatives, stabilisers, coloring agents, sweeteners, and aromatics can lead to different absorption properties or adverse reactions. 54 Pharmaceutical excipients used for oral dosage forms have been traditionally considered inert.…”