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Pharma Business The document is also expected to provide insight into audit findings, including open corrective actions and preventive actions related to the GVP processes of the product. GVP Module II states that, "A description of the approach used to plan audits of the pharmacovigilance system and the reporting mechanism and timelines should be provided, with a current list of the scheduled and completed audits concerning the pharmacovigilance system maintained in the annex." For example, when an MAH contracts pharmacovigilance services to a third party, a mechanism of oversight is required, which could include an audit. Any planned audits of the service provider and any significant audit findings should be recorded in the PSMF in accordance with European Union legislation and GVP Module II. GVP Module II also states that, "The master file shall also document deviations from pharmacovigilance procedures." The impact of either planned or unplanned deviations should be assessed when deciding whether to record them in the PSMF — for example, if the MAH identified (outside a quality system audit) that a large number of cases had not been transferred from an affiliate office to pharmacovigilance. That type of deviation, along with the proposed corrective actions and preventive actions, should be recorded in the quality system and a note placed in the PSMF until resolution. The document is intended to be meticulous in its level of detail. The PSMF is to be used for assessing whether an MAH complies with current GVP guidelines. It also reveals how soon the MAH was able to disseminate important patient safety information to the relevant audience — for example, Direct Healthcare Professional Communication letters or Summary of Product Characteristics (SmPC) variation submissions that inform the competent authorities and the EMA. MANAGING METRICS Central to the PSMF is the inclusion of metrics or key performance indicators in the annex, alongside the results of those measurements. The GVP guidance lists the minimum metrics for inclusion, but it also states that companies should develop their own company-specific metrics for their unique situations and systems. Inclusion of metrics is a useful tool not just for regulators but also for the company and its qualified person responsible for pharmacovigilance (QPPV) to ensure compliance and identify deficiencies in the pre-existing pharmacovigilance system. The MAH should determine the most useful and correct metrics for providing an effective overview of the functioning of the company's pharmacovigilance system. Targets for the pharmacovigilance system's performance should be described and explained in either the PSMF section on pharmacovigilance system performance or in the annex. 48 LifeScienceLeader.com February 2014 MANAGING THE INTERFACES As is the case in most departments in pharma today, many companies are choosing to outsource either their entire pharmacovigilance function — or aspects of it — to reduce fixed overhead costs, avoid high up-front investments, secure additional capacity, increase resource flexibility, or augment the performance of an activity not considered a core area of the business. Companies, however, retain overall responsibility for the safety of their products and must ensure that a third party or parties can provide the necessary support, understand the ever-evolving guidelines, and demonstrate necessary compliance with the regulations. Preparation and maintenance of the PSMF relies on a cross-functional team of subject-matter experts to develop all annexes covering information for all products. The PSMF has enormous importance in both the preapproval and postmarketing phases of a product's life cycle. More transparency and more communication from companies to third-party vendors are required with regard to process updates, such as standard operating procedures, validation updates to the company database, and compliance information. All updates must be documented in the PSMF, which will be the first thing auditors scrutinize. SEIZE THE DAY A number of companies have started writing the PSMF; few are in a hurry to implement it. But postponing implementation of the PSMF could increase costs and lead to greater complexities later because the PSMF is a document that can take a great deal of time and a great deal of thought to prepare and construct. In addition to laying the groundwork for the PSMF, the QPPV and other pharmacovigilance and regulatory staff will need to interact with other parts of the company as well as third parties, including service providers, distributors, and affiliates. The PSMF also helps provide a better framework for the GVP guidelines, because rather than being included in a detailed explanation of the way pharmacovigilance was handled for the product being submitted, such explanatory information is contained in the PSMF in a structured way. With so much to consider and with so many benefits to be realized in oversight and harmonization, companies would do well to consider early adoption or at least to begin preparing the way for the PSMF. About the Author Amanda Sibley is head of safety services, managing all of ProductLife Group's postmarketing pharmacovigilance services. Drawing on more than 18 years of pharmacovigilance experience, she serves as the senior contact for all postmarketing PV activities.