Pharmacovigilance process

In terms of protecting public health, regulators are active at every stage of the pharmacovigilance process described in Chapter 4. In particular, they are concerned to ensure that signals are identified... 

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. 

Pharmacovigilance systems capture, store, process, maintain, classify, and report adverse event data. Any snch systems generating reports for regnlatory authorities (e.g., expedited reports, periodic safety updates) and the interfaces into them from a variety of sources, should be validated. Specific considerations when validating these systems are ... 

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. 

Systems audits in pharmacovigilance are useful to evaluate all processes and SOPs related to pharmacovigilance and to assess the interaction with investigator sites, CRAs and related in-house personnel involved in handling safety information. QA auditors verify if the pathways and timeframes for reporting AEs and SAEs are followed and that all required recipients of such safety information are notified as needed (e.g. http //eudravigilance. emea.eu.int). SOPs and, if required, protocol-specific... 

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. 

OMOP (observational medical outcomes partnership) Used genetically, any partnership, usually of pharmaceutical companies, applying pharmacosur-veillance (q.v.) or pharmacovigilance (q.v.) to patients. Sometimes elsewhere in the literature the P stands for pilot, process, or procedure. 

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... 

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 main types of data which are used in pharmacovigilance and their strengths and limitations. In the next chapter, I shall try to illustrate how such data fit into the overall process. 

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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