Medicines are essential for the treatment of acute, communicable, and non-communicable diseases. The World Health Organization developed a toolkit for drug (medicine) utilization studies to assist in reviewing and evaluating the prescribing, dispensing, and use of medicines. There is a growing need for rigorous studies of medicine use in low- and middle-income countries (LMIC) using standard approaches, especially in the context of universal health coverage. This commentary provides a succinct summary of how to use the WHO anatomical therapeutic chemical (ATC)/defined daily dose (DDD) methodology in pharmacoepidemiological studies, with a focus on LMIC contexts. We drew on information from WHO resources and published literature, citing examples and case studies. We encourage readers to publish their drug utilization studies, although we caution about predatory journals. We recommend the use of the RECORD-PE initiative which focuses on methods for doing pharmacoepidemiological research and evaluating the quality of published papers.
Suitable dosage forms are not always available for specific patient populations and must be extemporaneously compounded. Extemporaneous preparation is the manipulation of drugs and excipients for a particular patient using traditional compounding techniques; these are referred to as ‘off-label’ and ‘unlicensed’ medicines. Off-label use can include altered doses, dosage forms or indications for use. Registered medicines are produced to internationally recognized standards of Good Manufacturing Practices. Within the pharmaceutical manufacturing industry, quality, safety and efficacy are enforced by regulatory legislations. In contrast, the responsibility for acceptable standards for the compounding of ‘off-label’ medicines falls on the prescriber, pharmacist or hospital nurse. Studies have been conducted by researchers from Australia and throughout Europe, highlighting the frequency of off-label use for paediatrics, with one study reporting that most extemporaneous preparations (29.6%) were for drugs required to treat metabolic diseases. Risks include compounding errors, adverse reactions to ingredients and excipients, and non-validated stability of the product. Sterile compounded products, including products for ophthalmic and palliative care, carry additional risks in these vulnerable patients. This paper provides an overview of off-label medicines highlighting biopharmaceutical, quality, safety and efficacy issues important to medical and allied health professionals.
1 December 2013 in International Journal of Clinical Pharmacy
In recent times the basic understanding, perceptions and CAM use among undergraduate health sciences students have become a topic of interest. This study was aimed to investigate the understanding, perceptions and self-use of CAM among pharmacy students in Malaysia.