Pharmacovigilance purposes

The creation of purposeful, coordinated, worldwide support amongst politicians, officials, scientists, clinicians, patients and the general public, based on the demonstrable benefits of pharmacovigilance to public health and patient safety. 

The reform of pharmacovigilance as a whole, and the reassessment of the activities, attitudes and goals associated with it, are urgent and important matters for debate and action by all players. This science should be placed centre-stage and made truly fit-for-purpose in the 21st century. 

Pharmacovigilance. A branch of pharmacoepidemiology concerned with monitoring drug use in patients (whether in clinical trials or more generally) with the purpose of detecting possible harms and eventually establishing the risks (if any) attendant on... 

In the beginning, there was thalidomide. It can be argued that the history of pharmacovigilance goes back further but, for practical purposes, the story of modern pharmacovigilance begins there. 

The ultimate purpose of pharmacovigilance is to minimise, in practice, the potential for harm that is associated with all active medicines. Although data about all types of ADRs are collected, the main focus is on identifying and preventing those which are defined to be serious. This means an ADR which meets at least one of the following criteria ... 

The ultimate purpose of pharmacovigilance is prevention and therefore the actions which are taken will generally be intended to help prevent the occurrence of ADRs. There are many factors which may impact on the potential for prevention of ADRs. Broadly these may be classified into characteristics of the user or the drug. For example ... 

The purpose of the safety specification is to explicitly consider the level of safety that has been demonstrated so far. It should identify what is and is not yet known about safety and the latter (i.e. what is not known) should be a major driver of the pharmacovigilance plan. The purpose of that plan is essentially to attempt to find out what is not yet known, largely because of the limitations of clinical trials. Risk minimisation plans are not invariably required - essentially they are needed when there are known or potential risks which cannot simply be managed through routine measures contained in the product information. 

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... 

The major euthanasia agents used in veterinary medicines are the barbiturates and these have already been discussed in Chapter 5. When formulated for euthanasia, these products, and indeed other products used for this purpose, are not normally sterile unlike other parentally, and especially intravenously, administered formulations as this is considered unnecessary as the patients concerned will not recover from the effects of the drug and so the secondary effects of bacteria and other extraneous agents are irrelevant. The products are often frequently formulated with a dye to distinguish them from other similar but sterile formulations. Euthanasia agents differ from all other veterinary medicinal products in pharmacovigilance terms in that lack of efficacy, that is failure to cause death of the patient, is a reportable adverse event (lack of expected efficacy). 

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