Post-marketing safety surveillance

IV Post-marketing safety surveillance undertaken for some drugs that are administered over particularly long periods of time (number of patients varies) Several... 

Morse ML, LeRoy AA, Strom BL. COMPASS a population-based post-marketing drug surveillance system. In Inman WHW, ed. Monitoring for Drug Safety. Philadelphia JB Lippincott, 1986. 

Adverse Incident Reporting is an essential part of POC management and important to post-market regulation surveillance. Adverse incidents include any event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users including patients or other persons [Medicines and Healthcare Products Regulatory Agency (MHRA)] and reports should be made to the relevant local bodies [48]. 

Monitoring, violation and sanction spheres For post-marketing surveillance of product safety, ADR monitoring systems exist in all the countries, with the exception of Uganda. But it is difficult to evaluate the effectiveness of these systems in monitoring product safety. Only the Adverse Dmg Reactions Advisory Committee in Australia... 

Phase III Extended large-scale trials to obtain additional evidence of efficacy and safety, and definition of adverse effects. Humans exposed several hundred to several thousand Phase IV Post-marketing surveillance occurs after the chnical trials programme is complete. It is used to collect adverse event data from a large patient population. Humans exposed 10 000+... 

The need for monitoring long-term followup in post-marketing surveillance (PMS) and safety assessment of marketed medicines studies to determine effects of the drug on physical functions and development, such as bone maturation, growth and sexual development. 

The pharmaceutical industry presents many new challenges to such a person which include the interface with pharmacy and pharmacology, toxicological research, human volunteer studies, clinical trials and post-marketing surveillance to name just a few. Product safety is a factor which impacts on all of those endeavours and the pharmaceutical physician will be expected to work and provide advice within that framework. It will be clear to anyone that evidence of lack of safety in a medical product is not good news for the company concerned and that some level of protective action will often be required which in extreme circumstances may involve product withdrawal. It is, therefore, essential that the pharmaceutical physician should be absolutely clear what constitutes lack of safety in relation to the intended use of the product. 

There has never been any incentive for the pharmaceutical industry to pursue research along these lines even though, as in the case of Vioxx, the end results of neglecting adverse effects may be very costly. The aim of the industry has usually been to extend the market size irrespective of potential risk and attempts to implement effective post-marketing surveillance has received little enthusiasm. It is to be hoped that company medical departments and pharmaceutical physicians will continue to support the need for a broad range of safety evaluation studies to be conducted on new medicinal products. 

Shapiro S. The role of automated record linkage in the post-marketing surveillance of drug safety a critique. Clin Pharmacol Ther 1989 46 371-86. 

Jones JK, Faich GA and Anello C. Post-Marketing Surveillance in the General Population - the U.S.A. In William H Inman, ed. Monitoring for Drug Safety, 2nd edn. Lancaster, U.K. MTP Press Limited, 1985 153-63. 

These guidelines apply to the conduct of all company-sponsored studies which evaluate the safety of marketed products. They take the place of previous guidelines on post-marketing surveillance which were published in 1988 (BMJ, 296 399-400). Studies performed under those guidelines were found to have some notable limitations (BMJ, 1992, 304 1470-1472) and these new guidelines have been prepared in response to the problems identified. The major changes maybe summarised as follows ... 

Coulter DM, Edwards IR, McQueen EG. Post marketing surveillance in the general population - New Zealand. In Inman WHW, editor. Monitoring for drug safety. 2nd ed. Lancaster (UK) MTP Press/Kluwer Academic Publishers Group 1986. p. 119-34. 

Protection of patient safety remains a responsibility at service delivery. Post-marketing surveillance systems aim to monitor, collect, and evaluate ADEs to identify long-term or unknown safety issues. Most developing countries lack the resources to make pharmaco-vigilance a priority therefore, international data can help inform national DRA decisions (WHO 2001). 

Pioglitazone also causes fluid retention, possibly because of increased production of vascular endothelial growth factor (92). The safety profile of monotherapy and combined therapy with pioglitazone has been evaluated in 3500 patients over 2500 patient-years, and some data from post-marketing surveillance were included peripheral edema and hemodilution were common (93). 

Lombardi C Safety of sublingual immunotherapy with monomeric allergoid in adults Multicenter post-marketing surveillance study. Allergy 2001 56 989-992. 

Di Rienzo V Post-marketing surveillance study on the safety of sublingual immunotherapy in children. Allergy 1999 54 1110-1113. 

Medwar, C., Herxheimer, A., Bell, A., Jofre, S. (2002). Paroxetine, Panorama and user reporting of ADRs Consumer intelligence matters in clinical practice and post-marketing surveillance. International Journal of Risk and Safety in Medicine, 15, 161-169. 

Hajak G, Bandelow B. Safety and tolerance of zolpidem in the treatment of disturbed sleep a post-marketing surveillance of 16 944 cases. Int Clin Psychopharmacol 1998 13(4) 157-67. 

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