The goodpharmacovigilance practice guidelines include:
- All criteria based on patients, healthcare professionals, and public health on the sole aspect of safety have to be met.
- All the organization members should be involved in support of the vigilance system based on the task of ownership and responsibility for the most optimal level of quality in accordance with their individual responsibilities.
- The higher management levels should have good leadership qualities and must be capable of driving the team toward achieving the above-formulated objectives.
- All members of the team must strive toward improving the quality cycle of the drug.
- The resources and tasks should be structured such that the processes are proactive, continuous, integrated, risk-proportionate, and co-operative conduct of pharmacovigilance training
- An overall highly efficient and co-operative rapport should be maintained by all departments related to the pharmacovigilance department. Especially with the marketing department, co-operation should be at the peak.
- Good relations and co-operation should also be fostered with the respective authorities and public health organizations in accordance with applicable legal provisions.
The need forpharmacovigilance is entirely based on the safety profile of the drugs andmedicinal products that are consumed by the patients. With today’s rapidlygrowing technology, medicine is also advancing. The new chronic illnesses needa suitable cure with high bounds of safety. This is making thepharmacovigilance process more important now than ever. Thus, for a better agood pharmacovigilance department, the above guidelines have to be adhered to.The main reasons to adhere to these guidelines include:
- Emerging safety issues related to the balance of risks and benefits of the drugs and medicinal product.
- New and unknown information that arrives from the specific marketing authorization holders.
- Procedures relevant to pharmacovigilance may give rise to new information resulting in the updating of the process by itself.
- On-going or new clinical trials may give rise to new symptoms or adverse effects of the drugs, causing the process to need updating frequently.
The leaders and higherauthorities in the pharmaceutical world have a great deal to consider whenconsidering good pharmacovigilance training. The risk versus benefit ratio parameter of any drug ormedicinal therapy is one of their list’s top contenders. Thus the scope of goodpharmacovigilance practices includes interaction with the medication or drug,abuse and misuse of the drug or medication, medical errors, lack of efficacy,adverse reactions, and good co-operation.
