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How patient support programs have changed over the past two decades, considering adding safety data collection to the mix, and what regulations are driving pharma to adopt pharmacovigilance.
In an interview with Pharm Exec, CEO and co-founder of MyMeds&Me (developer of Reportum), Dr. Andrew Rut, talks about the evolution of patient support programs, and adding safety data collection into the mix to adhere to regulatory concerns and pharmacovigilance standards.
Patient Support Programs (PSPs) have changed dramatically over the past two decades. PSPs originally operated primarily out of call centers and were designed to enable reimbursement to prescribers and to record patient coverage. Once a patient received their prescription no additional services were provided.
Nowadays PSPs are much more sophisticated with a greater emphasis placed on providing services to the patient throughout the course of their treatment plan, helping pharma to stay close to their customers. PSPs have evolved to help patients take their medication correctly, improve adherence, better manage their disease, reduce complications, and provide financial assistance. They have also become a vital tool for pharmacovigilance due to the large amount of patient safety data that can be gathered relating to the real-world use of medical products, including adverse events.
The volume of PSPs has also increased dramatically over the past few years as pharmaceutical companies will implement sets of PSPs for recently launched products resulting in hundreds running concurrently across the world. The expansion and transformation of PSPs has coincided with the growing number of management and compliance challenges of running increasingly complex programs across new markets and in different languages. Understandably, pharma is seeking smart solutions to these challenges.
As PSPs have transformed and grown, they have become an increasingly valuable resource for pharmacovigilance as an extensive amount of patient safety data is generated during the PSP process, which can be used to gain insight into adverse events.
Pharmaceutical companies not only want to have access to vital feedback on the medicines they market, but they are also obliged by regulators to adhere to strict pharmacovigilance standards. The onus is very much on pharma to ensure that patient safety is paramount, and they risk huge fines and reputational damage for non-compliance. A key challenge faced by pharma is that they currently have no standardized mechanism for recording, reconciling, and managing the huge volumes of data PSPs generate, affecting their ability not only to use the data effectively but also to adhere to pharmacovigilance standards. Consequently, pharma views improving data capture and compliance as a key priority for PSPs.
Regulatory authority inspectors such as the US Food and Drug Administration (FDA), The European Medicines Agency (EMA), and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) are responsible for ensuring that PSP sponsors are meeting their pharmacovigilance obligations. These bodies have the power to investigate compliance and can request evidence that pharma and any contracted third parties have well documented processes in place and evidence of pharmacovigilance training.
PSP sponsors who are found to come up short face significant penalties with action from regulatory authorities such as the EMA. The European Commission can require the EMA to conduct infringement procedures under the framework of Commission Regulation (EC), No 658/2007, the Penalties Regulation, into companies suspected of failing to comply with pharmacovigilance obligations. The EMA investigation of a major pharma spanned almost five years resulting in the threat of huge financial penalties and significant remedial actions including re-analyses of the complete data sets.
Pharmaceutical companies currently face a number of barriers when implementing PSPs worldwide, including diversity in languages, increased regulations, and the growing complexity in the medicines being prescribed. Due to the large number of PSPs, pharma will often also outsource the PSP process and the management of adverse event collection to third parties located across the globe. These factors contribute to a lack of data consistency and poor data quality as the methods by which PSP operators collect their data will vary depending on the PSP and country they are located in. The lack of standardized mechanisms for recording and managing the data also creates burdens for operational teams and destroys the value of downstream signal management.
Reportum, by MyMeds&Me, provides a multi lingual, multiâplatform intake solution for adverse event and product complaints. Reportum can be configured so that data intake from PSPs is the most relevant to the product, providing medical coding and downstream export as an E2B file to safety databases. Given the global requirement for staff training in PV process with evidence of PV training, Reportum integrates with Learning Management Systems (LMS) to ensure training compliance as well as minimizing effort and cost.
All medicines have the potential to cause adverse drug reactions, they can range from minor discomfort to serious harm, some of which can be fatal. Not only can adverse events have important consequences for patients but they can have a big impact on public health. A Frost & Sullivan analysis showed that adverse events cost the U.S. and European healthcare systems $317.93 billion in 2016 and contributed to approximately 1.95 million deaths. The same report showed that 30–70% of these deaths were potentially avoidable had the preceding adverse events been reported and managed proactively. It is, therefore, vital that data is gathered continuously from patients throughout their treatment plan as patients tested during clinical trials are not fully representative of those receiving prescription medicines. Clinical trials are not powered to detect rare adverse reactions that become apparent only during spontaneous reporting. It is important that adverse events are reported in a standardized, streamlined manner so that pharmaceutical companies can have a rich data source to understand the safety and efficacy profile of their medicines across all segments of a population. Adaptations to product labelling and patient information-based robust data analysis can ensure that benefit and risk are managed to the benefit of all patients.