The Pharmacovigilance practice has been evolving over time. The need for pharmacovigilance practices can be traced back to the very first individual case reports of adverse drug reactions such as the Thalidomide cases. In recent years, pharmacovigilance reporting has evolved. The ever-growing need for pharmacovigilance has seen more stakeholders get on board.
They now include:
- Pharmacovigilance consulting companies that are contracted by pharmaceutical companies to offer pharmacovigilance services and consultation.
- Government reporting systems which are accessible to all members of the public.
The scope of business in pharmaceutics and life sciences in general has grown immensely. Equally, the need for safer and more effective pharma products has increased.1
This article provides insights into the existing need to build a good pharmacovigilance system in any life science company. It sheds light on the pharmacovigilance scope within which these companies should operate in order to ensure they are meeting market demand for safe and effective products.
Over time, Jeyflex Consultants has bridged the gap in good pharmacovigilance practices. Making sure that pharmaceutical products are safe and satisfy regulatory standards.
Some of the components of good pharmacovigilance practices are:
COMMUNICATION
The focus of a pharmaceutical company regarding the risk management approach for a specific product is communication. Pharmaceutical businesses mainly use labelling tools, currently regulated based on templates such as those of the European Medicines Agency, to communicate product safety and risk.
These tools may also include the: Summary of Product Characteristics (SmPC), package insert, patient information leaflet (PIL), and secondary packaging.
It could be challenging to determine whether a company’s communication with patients, healthcare providers, or the general public is redundant or inefficient when using these communication tools. Pharmaceutical companies should establish a pharmacovigilance base. Its main responsibility should be organising the company’s communications strategy by predetermined goals with stakeholders, not merely regulatory bodies.
For each specific product that the corporation sells, this same group can evaluate the efficacy of the communications, track audience responses, and modify the marketing plan as necessary. An example would be the addition of an electronic support system for reporting adverse effects by a company apart from the one provided by the state.
AUDITS AND INSPECTIONS
By law, pharmaceutical organisations and businesses are subject to audits and inspections by the appropriate national and international regulatory agencies such as the European Medicines Agency and Health Canada.
The WHO (World Health Organization) auditing the PPB, the Kenyan pharmaceutical regulatory agency, is an excellent example of an international body auditing a local regulatory body. Pharmaceutical companies must carry out pharmacovigilance audits and inspection programs. These aid in both the execution of audits predicated on process risk assessment and the modification and enhancement of pharmacovigilance procedures.
Pharmacovigilance systems that can be enhanced by proper inspection programs include:
- Signal detection, management and recording
- Proper use of data mining tools and data source management
As a sound pharmacovigilance practice, audits also assist in maintaining the company’s compliance with medication safety standards and regulations. Conducting audits on pharmaceutical companies helps to assess compliance and guarantee patient safety.
The responsible Marketing Authorization Holders (MAH) of health products must keep records of post-authorization safety studies.
CONCLUSION
Considering the two tools mentioned above for good pharmacovigilance practices, our team at Jeyflex is committed to assisting pharmaceutical companies in implementing these practices through the development of data source management. We also have a team capable of carrying out the required self-audit in connection with good pharmacovigilance practices.
References
- Deloitte, 2023. Life Sciences: Deloitte. [Online]
Available at: https://www2.deloitte.com/cn/en/pages/life-sciences-and-healthcare/articles/global-life-sciences-sector-outlook-2023.html
[Accessed 11 03 2024]. - Agency, E. M., 2012. Guideline on good pharmacovigilance practices (GVP). [Online]
Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-iv-pharmacovigilance-audits-superseded_en.pdf
[Accessed 13 03 2024].
Article by Purity Wanjiku
