Market Research Report
Pharmacovigilance: Balance Signal Detection and Case Management Responsibilities with Emerging Drug Safety Regulations
|Published by||Cutting Edge Information||Product code||279389|
|Published||Content info||348 Pages
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|Pharmacovigilance: Balance Signal Detection and Case Management Responsibilities with Emerging Drug Safety Regulations|
|Published: September 22, 2016||Content info: 348 Pages||
Life science companies enact a number of pre- and post-marketing activities in the interests of drug safety, including:
The extent and depth of dialogue between teams that handle pharmacovigilance prior to and post product launch depends heavily upon the strength of companies' existing communication channels. Ideally, life science teams will establish a network that enables two-way conversations between teams supporting investigational and marketed products. Using this structure, post-marketing teams can relay safety findings to teams on the investigational side. This information will help these investigational product teams further research any newly identified pharmacovigilance concerns.
When it comes to pharmacovigilance, life science teams benefit heavily from understanding the associated regulatory climate. Since 2010, regulatory guidance has resolved some pervading issues related to drug safety processes. For example, interviewed executives emphasized that life science teams have largely grown more familiar with the requirements of a European risk management plan (RMP). Despite this progress, other challenges remain. In some cases, document requirements associated with RMP documents may lead to high - and potentially redundant - document volume. Additionally, teams may also be uncertain as to expected protocols and timelines surrounding company-provided RMP updates.
In the US, risk evaluation and mitigation strategies (REMS) guidance has resolved some of the previous confusion surrounding the Food and Drug Administration's (FDA) requirements. Since 2010, the FDA has also shifted its focus to products that require either a formal mitigation process or an escalated communication strategy. Consequently, the FDA may release some products from their respective REMS programs. However, products that require elements to assure safe use (ETASUs) or a communication plan will continue to require a REMS. For reference, communication plans may exist between either pharma and product consumers or pharma and healthcare practitioners.
Despite progress in the pharmacovigilance space, both achieving label approval and resolving regional differences in label interpretations continue to pose challenges for life science teams. For one Top 50 pharmaceutical executive, the decentralization of Asian markets renders these markets among the more difficult in which to secure labeling approval.
By comparison, mutual recognition makes label approval processes easier for companies operating within multiple European markets. Additionally, the close alignment between the European Medicines Agency (EMA) and the FDA regulations also makes the US fairly user-friendly for life science teams operating in both regions. More convenient still for companies seeking label approval, Latin American and Canadian regulatory bodies tend to require similar materials as the FDA. If companies' materials are accepted by the FDA, they are also likely to be accepted by Latin American and Canadian regulators.
Even so, other markets - from Eastern Europe, to central Africa - remain fairly undefined. Consequently, preparing for label approval in these regions can be more complicated.
Ensuring that approved labels remain consistent across each region in which products are approved may be equally - if not more - challenging for industry teams. Regulatory authorities may not dramatically diverge in their risk interpretations. However, the differences are sufficient to complicate life science companies' labeling processes. One CRO has worked with multiple companies for which consistent labeling is difficult. Essentially, having slightly different risk portfolios from region to region is not a favorable situation. Asymmetrical labels can make characterizing global product risk more difficult. In a worst-case scenario, differing risk interpretations can vastly complicate pharmacovigilance activities - particularly for life science teams with RMPs, REMS or a combination of both in place.
To ensure label harmonization across each of their drug safety teams, life science companies undertake multiple approaches. Top 50 Company A leverages a globally developed risk management plan template. This template includes a mixture of core company safety information and key data from aggregate safety documents such as periodic benefit-risk evaluation reports (PBRERs). Company A uses this template to highlight the most important elements of each of its product's risk-benefit profiles. During negotiations with local regulators, concepts discussed in Company A's template take precedence over any elements that country-, regional- or global-level teams may identify. Consequently, Company A's template helps to ensure that its most important safety materials receive label inclusion from country to country.
Other teams circumvent potential labelling challenges by communicating with regulatory bodies and researching associated legislation early. Companies seeking dual submission may describe what approved labels in one market look like to regulators in others. For example, ready access to a company's FDA-approved label may make it easier for the EMA to approve a complementary label in Europe.
One CRO recommends researching market-specific regulations as soon as possible. For example, life science companies with primary operations in the US may be unfamiliar with European requirements pertaining to qualified persons for pharmacovigilance (QPPVs) and their scope of responsibilities. Familiarizing themselves with applicable QPPV requirements will help companies comfortably establish this vital staffing representation in Europe. Researching associated regulations will also help life science teams identify the EU member states that will accept a QPPV - provided he or she resides in Europe - versus member states that require QPPVs to reside locally.
Unsurprisingly, new regulatory guidance will continue to shape the levels of harmonization expressed between various drug safety markets. Over the years, the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) has continued its efforts to improve drug identification and safety reporting practices within the life science industry. Most recently, the ICH has adjusted its existing identification of medicinal products (IDMP) guidelines and provided a separate update to its existing case reporting standards.
Preparing for upcoming regulatory changes may require some life science teams to rethink their pharmacovigilance practices. Specifically, teams might refine their drug safety standard operating procedures (SOPs) to focus on how to achieve consistent, standardized pharmacovigilance activities. As part of their SOP modifications, teams may also leverage technologies to develop organization-wide drug safety education. One drug safety vendor likens successful training programs to the flight simulators that pilots-in-training use. Essentially, any drug safety training that companies provide will need to equip FTEs with real-world, strategic applications - not just theoretical expertise.
The majority of surveyed teams (59%) leverage online channels, including social media, in drug safety monitoring. However, the frequency of teams' monitoring varies (Figure E.3). Among surveyed teams that do monitor online channels for adverse events, the majority perform daily monitoring (60%); this percentage includes all surveyed country-level drug safety groups. Global groups comprise the remaining 40% - which are evenly divided between monitoring weekly and maintaining no formal monitoring schedule.
Frequency of Online Channel Monitoring Activities, by Team Type