Good pharmacovigilance practice guidelines
The good pharmacovigilance 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 for
pharmacovigilance is entirely based on the safety profile of the drugs and
medicinal products that are consumed by the patients. With today’s rapidly
growing technology, medicine is also advancing. The new chronic illnesses need
a suitable cure with high bounds of safety. This is making the
pharmacovigilance process more important now than ever. Thus, for a better a
good 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 higher
authorities in the pharmaceutical world have a great deal to consider when
considering good pharmacovigilance
training. The risk versus benefit ratio parameter of any drug or
medicinal therapy is one of their list’s top contenders. Thus the scope of good
pharmacovigilance 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.
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