The process of pharmacovigilance

The process of pharmacovigilence requires the contribution of many healthcare professionals in industry, government, and clinical practice. With improved harmonization, more sophisticated analysis tools, and clearer communication, more patients will be able to realize the benefits of drug therapy while minimizing the attendant risks. 

In the past, the process of pharmacovigilance has often been considered to start when a drug is authorised for use in ordinary practice. Nowadays, it is more commonly considered to include all safety-related activity beyond the point at which humans are first exposed to a new medicinal drug. 

This chapter has considered the process of pharmacovigilance from signal of possible hazard through to remedial action. The outlined principles apply to both pharmaceutical companies and regulatory authorities. Both parties should be involved in all stages of the process, have access to all the relevant data and communicate developments promptly to each other. Chapter 5 will consider how companies and regulators should interact to ensure that the process is appropriately applied. 

AU the parties mentioned above are stakeholders in the process of pharmacovigilance, but with the exception of industry and regulators they are mostly involved when a problem has already occurred. Generally, only industry personnel, regulator and individual users (i.e. patients/health professionals) between them have the potential to prevent some specific problems occurring - the ultimate purpose of the process. Other stakeholders may influence... 

As discussed in Chapter 4, the final step in the whole process of pharmacovigilance is to assess the extent to which risk minimisation... 

In terms of the overall process of pharmacovigilance, several years ago a scientific model to support excellence in the discipline was proposed by Evans and myself (Figure 8.1). 

Therefore, postmarketing surveillance is conducted to examine safety and effectiveness. The terms pharmacovigilance and pharmacosurveillance studies are also used in this context. Pharmacosurveillance monitors all reports of adverse reactions and thus compiles extended safety data. Pharmacosurveillance is therefore a critical component of the overall process of ensuring all members of a target disease population receive the greatest protection from adverse reactions. 

The production process of porcine factor VIII does not incorporate virus-eliminating steps. However, each batch is extensively screened to confirm the absence of viruses. In a pharmacovigilance study of 81 hemophiliacs treated with porcine factor VIII, there were no cases of transmission of porcine viruses (porcine parvovirus, encephalo-myocarditis virus, porcine respiratory, and reproductive syndrome virus) (49). 

The Network of Regional Pharmacovigilance Centres ensures the collection and processing of secondciry effects with medicines within the framework of healthcare. This network also ensures a liaison between the Agency and the National Pharmacovigilance Commission. 

Post-market approval medical affairs—this involves the promotion of each product bymarketing and sales functions and the oversight of this process by pharmaceutical physicians. Two other critical postmarketing components are first, continued learning about the safety and efficacy of the product in normal medical practice, as opposed to clinical trials and second, the development of new or improved uses of the product as more is learned about it and as medical science moves on. The former of these two functions is termed pharmacovigilance and the latter product evergreening . 

Pharmacovigilance has been defined by the WHO as The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. There are other definitions but this very broad one seems to be the most appropriate since there is a clear implication that the process is one of risk management. This is a concept which is applicable to many... 

As indicated in Chapter 1, pharmacovigilance is essentially a risk management process for medicines. The process starts with identification of a possible hazard, this is then evaluated and investigated and, if necessary, some action is then taken with a view to minimising risk. Implementation requires tools for communicating with users and the final step should be that an assessment of effectiveness is made. The process is iterative because new evidence may emerge or the measures taken may mm out to be insufficient. Rarely can a dmg safety issue be considered completely and permanently resolved. 

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