Post Authorization Safety Studies – An Important Tool in PV

Post authorisation safety studies (PASS) are defined in Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised to obtain further information on a medicine’s safety, or to measure the effectiveness of risk-management measures.  In this article, our Medical Manager, Dr. Danica Cvetkovic, looks at the PASS and the link with Risk Minimisation Plans (RMP’s)

Post Authorisation Safety Studies - Acorn Regulatory

There is growing evidence that the increased frequency and severity of adverse drug events has contributed to the negative impact on patient’s health status. Also, it should be noted that observational studies can further characterise the effectiveness and  safety of medicines in real world clinical settings.

Post authorisation safety studies (PASS), also referred to as ‘post marketing surveillance studies’ or ‘phase IV trials’, are an example of this type of research. In contrast to the controlled settings of pre marketing trials, these studies are not rigorously controlled, and can provide valuable information on the use of drugs in the general population as well as in special patient populations (elderly patients, pregnant or breast-feeding women, children, patients with multiple comorbidities, etc.). PASS may be proposed as a part of a marketing authorization or specific obligation. In addition, PASS may be planned as a requirement in the Risk Management Plan (RMP) as an additional pharmacovigilance activity to evaluate the effectiveness of risk management measures.

The development of PASS protocols is guided by the European Medicines Agency’s Guideline on Good Pharmacovigilance Practices, Module VIII—Post-Authorization Safety Studies (Guideline on Good Pharmacovigilance Practices (GVP) Module VIII – Post -authorisation safety studies (Rev 2). Post authorisation safety studies are often multi-country studies, designed according to strong scientific principles, and should provide long‐term follow‐up data and the quantification of specific risks. Statistical methods, including sample size considerations (e.g., risk level that can be detected) are of the greatest importance.

It is important to understand the link between PMS studies and RMPs, since the primary purpose of the RMP is safety surveillance. Given the specific definition of PASS in the context of RMP, the adequacy of pharmacoepidemiological methodology needs to to be assessed on a case‐by‐case basis.

PASS provide critical information for regulators, public health agencies and manufacturers. Collaborative approaches and synergistic efforts between manufacturers and key stakeholders, are needed to facilitate access to data, and to drive optimal study design and implementation.

If you require assistance in undertaking a post authorisation safety study, we can assist you.  Our Medical & Clinical team, led by Dr. Danica Cvetkovic, has extensive experience in the sector.  Contact us on 00353 52 61 76 706 or complete the webform below and we will get back to you.

 

References:

  • European Medicines Agency . Guideline on good pharmacovigilance practices (GVP) – Module VIII: Post‐authorisation safety studies (Rev 2). Doc. Ref. EMA/813938/2011 Rev 2;
  • Hoekman J, Klamer TT, Mantel‐Teeuwisse AK, Leufkens HG, De Bruin ML. Characteristics and follow‐up of post‐marketing studies of conditionally authorized medicines in the EU. Br J Clin Pharmacol 2016; 82: 213–26.
  • Public Policy Committee International Society of Pharmacoepidemiology. Guidelines for good pharmacoepidemiology practice (GPP) Pharmacoepidemiol Drug Saf 2016; 25 (1):2-10.
  • Carroll R, et al. : Dataset 1 in: An Analysis of Characteristics of Post-Authorisation Studies Registered on the ENCePP EU PAS Register. F1000Research. 2017;6:1447.
About the Author:
Dr. Danica Cvetkovic
Dr. Cvetkovic heads up our Clinical & Medical team at Acorn Regulatory. She has significant experience in the clinical and medical sector. Prior to joining our company she headed the medical department of a major pharmaceutical company in her native Serbia. You can read more articles by Dr. Cvetkovic by clicking the link below.
Other articles by Dr. Danica Cvetkovic