Pharmacovigilance

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.¹

Patient safety is always a priority for pharmaceutical companies. Making medicines to improve lives requires monitoring all aspects of safety and assessing the data associated with the patient experience for the life of the product. The tasks associated with the collection, input, and assessment of the adverse event information are performed by skilled health care professionals. Across the industry, these professionals are technically proficient. They recognize the importance of staying current, given the dynamic regulatory environment around the world.

The collection and processing of adverse event information requires many steps by individuals with special training in pharmacovigilance. The manner in which these steps are executed are dictated by regulations. Each country or geographical area are governed by regulatory authorities. Each of these regulatory authorities, where a product is marketed, determine how and when qualifying adverse event information gets reported. Pharmaceutical companies often rely on external vendors to perform daily or periodic regulatory reporting tasks on their behalf.

Med Communications has a global pharmacovigilance team ready to serve your company’s needs. Physicians, pharmacists, nurses, and other health care professionals are fully trained in all aspects of pharmacovigilance and provide outstanding support.

References:

¹ World Health Organization. The importance of pharmacovigilance: safety Monitoring of medicinal products. [Internet]. 2002. [cited 14 Oct 2020].

Risk management activities within pharmacovigilance have evolved in the last several years. The development of new products outside of the traditional small and large molecules require broader views of how to obtain adverse event information and use current technologies to assess this data. The industry must keep an eye to the future and be prepared to anticipate how best to capture and evaluate this data.

According to the Drug Information Association (DIA), “Today’s safety and pharmacovigilance professionals assess and manage risk of a broad and changing scope of therapeutic products. Their ability to apply best practices in current daily operations while anticipating coming changes associated with new therapies and technologies is key to putting safe products on the market and optimizing benefits to patients.”¹

Health care professionals working in pharmacovigilance understand this changing landscape and are trained to navigate through the data points to guide companies in determining safety profiles for their product. This information helps populate the reference safety information / product label and helps guide the architecture of future trials to further learn about safety and the patient experience.

The pharmacovigilance team at Med Communications are highly skilled in the assessment and evaluation of safety information. The benefit-risk profile of a product is reviewed per regulatory guidelines. Our global pharmacovigilance team works cohesively with our clients to provide robust assessment and documentation. We remain inspection-ready as we perform our work and support our clients during inspection, taking responsibility for our outsourced work.

We welcome the opportunity to discuss your company’s pharmacovigilance needs. Risk Management will continue to evolve and our Med Communications team is committed to keeping current with industry and regulatory trends and guidelines to keep patient safety a priority!

References:

¹ Drug Information Association. Pharmacovigilance and risk management in 2020: A global perspective. 2020 [Internet]. 2015 [cited 14 May 2020].

Standard operating procedures, or SOPs, are quality documents critical to any pharmacovigilance (PV) quality system. Experienced PV professionals need to dedicate time and diligence to ensure these documents are clear, concise, and easy to follow. SOPs need routine content review to ensure they are in compliance with current regulations.

Although it is well known that a list of SOPs is one of the first items to be requested during an FDA inspection, lack of or inadequately written SOPs, or failure by the companies to follow their own SOPs, is still one of the most common inspection findings.

Knowing the challenges that our clients face, Med Communications offers our clients a comprehensive PV SOP package that is:

• Fully auditable
• Regularly reviewed
• Maintained by Med Communications through our own Quality Management System

Companion documents, such as Work Instructions and Handling Guides, are also created to provide the client-specific and product-specific details necessary to effectively manage your safety information. With Med Communications’ team of experts, we can ensure your SOPs and companion documents are inspection ready.

Dealing with safety data overload is nothing new for biotech companies, it has been an ongoing discussion in the industry for many years now. As companies are “drowning” in post-approval safety information from a growing variety of sources, the quality of it is sometimes less than relevant, turning the safety surveillance activities increasingly difficult.

The ICH E2D (R1) group is dealing with an ambitious task updating the ICH E2D guideline on the management of post-approval safety data, in place since 2003.

The challenges come from the lack of harmonized regulatory requirements across ICH member regions, the need for consistency with other pertinent documents and from the sometimes poor understanding among different regulatory authorities on the various projects companies put in place to receive feedback (including patients’ safety-related) on their approved products: patient support programs, drug delivery/continuity programs, or the so-called “social media listening” and “sentiment analysis” programs.

A draft version of the revised guideline is hoped to be issued for consultation by Q4, 2022.

Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

The FDA has issued the final guidance. The document is one in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s CDER and CBER.

This guidance is intended for any party with postmarketing safety reporting responsibilities for human drug products and licensed biological products, except for vaccines and its revised draft version was issued in June 2014.

The agency made minimal changes in the final guidance, clarifying and updating topics included in the draft guidance on how to submit postmarketing safety reports that FDA can process, review, and archive. The final guidance also provides recommendations on postmarketing safety reports submissions to FDA for other categories of products, including compounded and combination products.

EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorization applications for new medicines as well as post-authorization applications and to explore the practical aspects of the submission and analysis of such data.

This pilot stems from one of the ten priority recommendations issued by the joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) in 2020.

There are several potential benefits the analysis of raw data might bring, including faster evaluation through fewer questions being put to applicants and a better definition of the target treatment population, enabling faster and better access to new medicines for patients.