“Safety monitoring of medicines in common use should be an integral part of clinical practice. The degree, to which clinicians are informed about the principles of pharmacovigilance, and practice according to them, has a large impact on healthcare quality. Education and training of health professionals in drug safety, exchange of information between national centres, the coordination of such exchange, and linking clinical experience of drug safety with research and health policy, all serve to enhance effective patient care. National programmes for pharmacovigilance are perfectly placed for identifying research necessary for better understanding and treatment of drug-induced diseases.”1 An important clinical responsibility of the pharmacist is in the early detection of ADRs and other drug-related problems as well as monitoring the effectiveness of medicines. The pharmacist, as a part of the healthcare team, is a source of both information and critical evaluation of drug information. The pharmacist’s expertise is vital to the application of the safety profile of a medicine to the needs of a particular patient. An effective approach in pharmacovigilance requires the use of modern informatics. FIP recognises that pharmacists are a key part of the post-approval environment. Also, pharmacists can provide early detection of new ADRs and other drug related problems and identify certain patient subgroups with exceptional sensitivities. Against this background, FIP asserts that pharmacists in all practice settings are the key health professional for effective pharmacovigilance programmes, and recommends that:
Pharmacist Educators • should ensure that the curriculum include the pharmacist’s importance in pharmacovigilance. The contribution of the pharmacist and the pharmacy profession should also include the various pharmaceutical disciplines that enhance the understanding of the nature of safety of medicines. Pharmacist practitioners • should understand their pivotal role in the surveillance of the safe use of medicines. The pharmacy profession should acknowledge and promote this role of the pharmacist in the detection and reporting of suspected ADRs and other drug-related problems. Pharmacists need to be actively involved in the surveillance of drug safety issues within the context of their practices. Greater participation by pharmacist practitioner in all practice settings would be an important tool to increasing the reporting of ADRs and other drug-related problems. The pharmacist’s role in pharmacovigilance varies from country to country, but the professional responsibility is the same regardless of jurisdiction.
Pharmacists Associations • should negotiate with governments to expand the pharmacist authority and primary responsibility for pharmacovigilance. This should include the following: o promotion to consumers and prescribers of the role of the pharmacist o acceptance of the pharmacovigilance activities for continuing education and continuing professional development requirements o provision of compensation and tools to support this expanded responsibility. Governments and medicines control agencies authorised by governments • should recognise the pivotal role of pharmacists in pharmacovigilance and ensure that the necessary resources and incentives are appropriately directed to achieve maximum benefit from their involvement; • provide a method for reporting that is concise, electronic and compatible with pharmacy practice; • promote a greater awareness about ADRs and other drug-related problems with emphasis on their significance, recognition, management and prevention as an important instruction to promote rational and safe prescription practices; • assign the primary responsibility for the collection of pharmacovigilance to the pharmacist along with the necessary tools and compensation.
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