Planning of pharmacovigilance on the basis of the norms

The approval of any drug or product is based on the drug having homeostasis between risks and benefits within the specified conditions in the product labeling. The basis of approval of the drug is solely dependent on the information available during the time of approval. The information gathered about the safety characteristics and number of patients exposed to the drug. Especially during the early post-marketing period, the drug shall be used in various settings that are very different from clinical trials. Much larger sample size will be exposed to the drug in a relatively shorter time-frame.

As soon as the drug is marketed, new knowledge with respect to the drug shall be uncovered, which may or may not have an impact on the balance between the risks and the benefits of the drug. The analysis and evaluation of this newly acquired knowledge should be a continuous process with the regulatory authorities. This evaluation is extremely detailed and is conducted by pharmacovigilance processes to ensure the safe use of the drug. Learn Pharmacovigilance Course.

Planning of pharmacovigilance on the basis of the norms       

The entire pharmacovigilance plan revolves around the safety specifications of the drug. The plan is developed only after a discussion with the regulators during product development. The plan can be a stand-alone document. However, it should have the essence of the whole project.

Drugs with no complications generally undergo a routine pharmacovigilance plan which must be sufficient for post-approval safety monitoring without any form of additional actions. Additional actions are designed to address concerns like potential risks or missing information for products with identified risks. The length of this document depends on the development and planning program of the drug. This pharmacovigilance plan plays a vital role in the development of the drug and should be updated on a regular basis. This plan is updated as important information on the safety of the drug is discovered, and milestones are achieved. Structure of the Pharmacovigilance Plan based on the Norms

The structure of a pharmacovigilance plan is the most basic outline. This plan is customized and modified based on the safety specifications and the issues identified with a particular drug.

Routine pharmacovigilance procedures are conducted on all types of drugs. These are done irrespective of the additional procedures which are a part of the pharmacovigilance plan. This routine generally includes methods and systems that guarantee that information about all the suspected negative effects reported are initially collected and later collated in an efficient manner. Routine procedures also include the formation of reports for the regulatory authorities. Periodic safety update reports (PSUR) and expedited adverse drug reaction reports (ADR) are drawn up.  Another vital part of this routine pharmacovigilant procedure involves the continuous monitoring of the safety profile of the drug. This includes signal detection, issue evaluation, updating of the labels, and liaison with the authorities. The local regulations determine the rest.

A plan of action for the safety issues is presented and justified based on the objective of the proposed action of the drug. These include actions proposed by the drug itself, the rationale of these proposed actions caused by the drug, safety profile of the drug, monitoring of the drug based on the safety profile, the achieved milestones for evaluation and reporting of the drug. Take Clinical Research Training.

An overall plan for the drug bringing together the actions for all individual safety issues must be presented. It is practicable that milestones for the completion of the studies and other forms of analysis and the submission of safety results must be included in the Pharmacovigilance Training. On the path to achieving these milestones, the key points to be kept in mind include:

• Results of the ongoing or proposed safety studies are to be available.
• The exposure to the drug would have reached a certain level of characterization based on the adverse effects of concern or resolving a particular issue.

The regulatory milestones are generally aligned with these milestones. These are specifically used to revise or update the Pharmacovigilance plan.