During the last years, there has been a skyrocketing demand for pharmacovigilance as medicinal products consumption is growing and disorders and diseases are becoming more prevalent. To top this, an increasing number of adverse drug reactions (ADRs) is becoming a significant concern leading to the climb of the pharmacovigilance demand for new and effective solutions. Current industry changes are already impacting future developments, and it is becoming more and more challenging to keep up with recent advancements. Here you will find the latest pharmacovigilance industry news, trends, and insights. Stay tuned and keep up with the new updates as the most recent information will be continuously published.
- Patient and public involvement strategy
- Risk management: avoiding deficiencies
- Pharmacovigilance after Brexit
The strategy of patient and public involvement
As the healthcare landscape changes rapidly and the pharma Industry is transforming according to patients needs and new technologies, all stakeholders should be aligned with the latest trends. Under this perspective, the Medicines and Healthcare Products Regulatory Agency (MHRA) recognizes the value of patients in the decision making and is adopting a more systematic approach to listen and involve them at every opportunity. MHRA has established a Strategy of Patient and Public Involvement to be in effect until 2025. This strategy includes the following main objectives:
1. Patient and public involvement.
MHRA will develop detailed procedures and create opportunities to ensure patient and public engagement. This objective aims to identify the gaps and provide means and possibilities for stakeholders who are not active members of patient groups, as well as under-represented groups and diverse communities to increase involvement and accurate measure the promising outcomes.
To ensure that the delivered MHRA services meet the patient needs, MHRA will develop a new system and protocol based on the “patient and public voice”. The new processes will help maintain frequent reviews of high-risk issues, highlight the upcoming needs for specific patient group involvement and create one single point of contact to ease communication challenges for the public and patients.
3. Internal culture.
New systems, procedures and additional training will be introduced until mid-2022. These new tools will allow the current and future MHRA staff decisions to be more aligned to patients after evaluating the public’s perspective.
4. Measuring outcomes.
MHRA will establish a detailed patient outcome evaluation structure to measure the outcomes of the involvement results. It will give a more in-depth look into the effectiveness of the determined strategy, the progress of the MHRA culture change and highlight the missing activities and unrealized opportunities.
A partnership initiative will take place up until the first quarter of 2022.
New partnerships within the health sector aim to improve patient engagement effectiveness and sharing of patient and public’s feedback. Various workshops, forums, and consultancy options will provide the MHRA with patients’ insights and partnerships will assist in creating wider network of similar patient insight sources to utilize this information in the best way.
Patient health is affected by numerous significant factors, such as possible personalized treatments, long-term disease control with minimal side effects and quality of life. Patient and public’s contributions and voice recognition can lead MHRA to develop more innovative solutions for the future of the health sector.
Pharmacovigilance risk management: how to avoid deficiencies?
Significant changes in pharmacovigilance, such as Brexit, can lead to increased risks of operational gaps. To effectively manage them, the Medicines and Healthcare products Regulatory Agency’s (MHRA) Good Pharmacovigilance Practice (GPvP) inspectorate conducted 22 inspections of MAs within the period 01 April 2019 to 31 March 2020. The purpose was to examine compliance with existing EU and national pharmacovigilance regulations and guidelines.
The inspectorate identified 76 major findings, and 30% were related to the pharmaceutical product’s risk management. 26% of major findings were concerning Quality Management Systems. Risk management has remained the topic with the highest number of findings overall, which was the same for the previous two reporting periods. Thus, the question arises: what can be done to avoid these deficiencies in the pharmaceutical product’s risk management process?
- A risk-based approach shall be engaged whilst planning internal audits. The Risk Management Process should be considered as the top priority.
- A procedure for the control and implementation of educational materials should be in place.
- The MAH should establish regulatory processes with clearly defined steps, responsibilities, and timelines for proper maintenance of Summaries of Product Characteristics (SmPCs) and Product Information Leaflets (PILs).
- A separate procedure should be developed for the conduct of PASS studies with QPPV responsibilities defined and a Safety Management Plan implemented.
Close and consistent monitoring of the whole pharmacovigilance procedure is crucial to stay compliant and avoid risks and discrepancies.
Pharmacovigilance after Brexit: what changed?
It has been almost six months since the United Kingdom completed its separation from the European Union. When the UK initially announced Brexit, it raised many questions related to Pharmacovigilance procedures for both EU and UK. During the whole transition period, the Medicines and Healthcare Products Regulatory Agency (MHRA) determined the future requirements for placing medicines on the UK market and provided guidance on updated pharmacovigilance requirements.
Since 1 January 2021, the MHRA is the standalone medicines and medical devices regulator and retains responsibility for pharmacovigilance across the UK (Great Britain and Northern Ireland). UK legislation has incorporated existing EU legislation as far as possible. In general, the Good Vigilance Practices (GVP) modules remain in force, but MHRA has published a guidance note on the exceptions and modifications.
Key changes and updates in daily pharmacovigilance practice:
1. Role of Qualified Person for Pharmacovigilance (QPPV)
MHRA requires a Qualified Person for Pharmacovigilance (QPPV) to reside in the UK or the EU/EEA. Where the QPPV is not in the UK, there will be a need for a national contact person for pharmacovigilance. However, there is a temporary exemption until the end of 2021, which allows an EU QPPV to assume responsibility for UK Mas without a national contact person for pharmacovigilance. At the end of this period, should the MAH decides to have a QPPV residing in EU/EEA, MAH will have to appoint a national contact person for pharmacovigilance that resides and operates in the UK and reports to the EU QPPV. A national contact person for pharmacovigilance who lives and works in the UK and reports to the QPPV must be nominated, if MAH chooses to appoint a QPPV who resides and operates in the EU/EEA.
2. Pharmacovigilance system master files (PSMF)
MHRA requires Pharmacovigilance system master files (PSMFs) for all UK national MAs, including those that cover the whole of the UK or are specific to Northern Ireland or Great Britain. The “UK PSMF” must be accessible electronically and should be available upon request of the MHRA. The essential point is that the UK PSMF must describe the global pharmacovigilance system and reflect the global availability of safety information for UK authorized products.
3. Medicines and Healthcare products Regulatory Agency (MHRA) submissions
After Brexit, MHRA established its UK-based database for various submissions. The two main components are:
- The Submissions Portal. Sponsors, MAHs and the pharma industry use it for the submission of clinical trial applications, marketing authorizations, renewals, variations, Pediatric Investigations Plans (PIPs), Period Safety Update Reports (PSURs), and Development Safety Update Reports (DSURs).
- The Gateway and ICSR Submissions Portal. It is used to submit and receive expedited reports (ICSRs, SUSARs, and ASPRs). If the MAs are registered with MHRA Gateway, then ICSR / SUSAR exchange (receipt and submission) with the MHRA will be performed only through it.
As the UK has been a significant contributor to medicines regulation and pharmacovigilance in Europe and any change to its involvement in the system may result in operational and intellectual gaps, it is crucial to monitor the whole procedure and stay vigilant!