Products market surveillance

Post-marketing surveillance of product quality is carried out by means of a QC system. The quality of products available on the market is therefore an important indication of the effectiveness (or otherwise) of the dmg regulatory system. 

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... 

Human studies (including estimations of occupational and environmental exposure, epidemiological investigations, post-marketing surveillance for medicines, cosmetics and household and agricultural products, and the ethical and properly controlled use of human volunteers) [6]. 

Post-marketing surveillance for medicines, cosmetics and household or agricultural products... 

Monitoring, surveillance, and exploratory subprograms as defined above are carried out on foreign production marketed in the USA. 

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. 

More effective market surveillance of medicinal products on the markets by ... 

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 ... 

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). 

The Ministry of the Interior otherwise focusses its chemical-relevant activities on market surveillance and the recall of dangerous products, which generally falls outside the scope of Directive 76/769. 

The registration of the product Wcis conditional upon conducting post marketing surveillance. 

The National Pharmaceutical Administration is staffed by pharmacists who evaluate all applications for product licence, conduct GMP audits in the case of a local manufacturer, conduct post-marketing surveillance and also actively monitor adverse drug reaction reports. 

Drug registration, coupled with efficient and effective post-marketing surveillance, provide the Ministry of Heeilth with a means to control the quality, safety and efficacy with the introduction of medicinal products into Singapore. Drug registration also provides for a more effective system of product recall in cases of detection of defective or drugs harmful to public health. 

Promotion should not be disguised. Clinical assessments, post-marketing surveillance and experience programmes, and post-authorisation studies must not be disguised promotion. Such assessments, programmes and studies must be conducted with a primarily scientific or educational purpose. Material relating to pharmaceutical products and their uses, whether or not promotional in nature, that is sponsored by a company should clearly indicate by whom it has been sponsored. 

Only patients being treated for approved indications of the product are to be included in the post-marketing surveillance study. 

They must concern regulatory approved products used in approved indications and can include, but not only, non-interventional trials, observational trials, post-marketing surveillance and post-authorisation safety studies. 

It is typical before conducting a post-marketing surveillance study to obtain the view of the regulatory authorities on its design. The study may have been a condition of product approval, and it is both reasonable and wise to ensure that the study design can be expected to provide the information that is needed both by the sponsor and the regulators. Unblinded designs that imitate the ordinary clinical situation are the norm. 

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