Drug safety surveillance: Modern Trends and Industrial Action

    Published on:31st Dec, 2014
    Journal of Young Pharmacists, 2015; 7(2):69-75
    Review Article | doi:10.5530/jyp.2015.2.3

    Abdullahi Rabiu Abubakar1, Nordin Bin Simbak2, Mainul Haque3

    1Masters Student, Unit of Pharmacology, Faculty of Medicine and Health Sciences (FPSK), Universiti Sultan Zainal Abidin (UniSZA), 20400 Kuala Terengganu, Terengganu, Malaysia.

    2Dean, FPSK, UniSZA, 20400, Kuala Terengganu, Malaysia.

    3Professor and Head of the Unit of Pharmacology, FPSK, UniSZA, 20400 Kuala Terengganu, Terengganu, Malaysia.


    The primary aim of patient care is to provide the best medication that can produce the best treatment with minimal or no harm. This is only possible when the entire health care workers play their card well through correct prescription, dispensing, drug administration and adequate patient monitoring. However, the outcome is not always favorable because of the limited time undergone by the drug during premarketing studies as well as the bias by the pharmaceutical-industries to get approval from regulatory-agencies. As a result of this many safety data and information are lacking. Therefore, in order to preserve patient confidence and integrity of pharmaceutical products, post-marketing surveillance has become necessary. The methods commonly in used in post-marketing surveillance include spontaneous reporting, data mining and active reporting which have meaningfully contributed to patient safety. Despite the improvement made, spontaneous reporting have some disadvantages such as underreporting, poor quality of reports, and cannot be used to determine risk rate. Pharmaceutical companies as owners of the drug have noteworthy role to play in adverse drug reactions monitoring and can adopt similar techniques used by the regulatory-agencies and academic research. Unfortunately, this has led to reporting bias. This has suggested the need for more awareness and educational intervention for health care professionals at all levels. The curriculum of training medical and health related students should be incorporated with PV programme. This appraisal has described how to identify adverse drug reactions and methods used in reporting, current developments in pharmacovigilance and role of pharmaceutical-industries in drug safety studies.

    Key Words: Pharmacovigilance, Spontaneous-Reporting, Patient-safety, Pharmaceutical-industries.

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