Life Sciences: Potential Compliance Implications

Manufacturers may need to plan to respond to such demands through existing Patient Assistance Programs (PAPs). Increased demand for PAPs may entail creating new co-paid, subsidized or free prescription services to serve additional patients.

FREMONT, CA: The effect of COVID-19 on the life sciences field is both acute and sustaining. And an uncertain timetable for disruption makes companies prepare corporate operations for the near term, with actions taken regularly and sometimes daily. Potential threats of compliance for organizations with unestablished processes and controls can occur during times of rapid change. To help enforcement practitioners proactively mitigate changing market threats, discuss below the particular effect of COVID-19 on three main areas: specialty pharmacies and patient support, patient assistance services, and product sample distribution.

What Are Some Potential Compliance Implications?

Specialty Pharmacies and Patient Support

Restrictions on travel have affected people's day-to-day lives, creating spikes in demand for medications and supply chain problems for conventional discount pharmacies. Businesses can aim to extend their network of specialty pharmacies to ensure that product supplies are available. Although life sciences businesses seek to step up to support patient needs, it is crucial to improve regulatory protections and reassess controls regarding previous authorizations and profit inquiries.

In comparison, patient medication adherence and education systems that deliver care by clinical or nurse instructors could see a peak in use around this period, when physicians are not as readily available to view patients. 

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Appropriate guidelines on these forms of experiences should be given and repeated to ensure that attitudes do not have an inappropriate effect on patients.

Patient Assistance Programs

Due to unprecedented economic instability and record unemployment, U.S. patients may lose their health care benefits and need help to continue their life-saving prescription medications. Manufacturers may need to plan to respond to such demands through existing Patient Assistance Programs (PAPs). Increased demand for PAPs may entail creating new co-paid, subsidized or free prescription services to serve additional patients. To ensure compliance, organizations must provide clear criteria on these entities' independence and completely disclose the eligibility of patients for these programs.

Product Sample Distribution

Since in-person face-to-face experiences have been canceled, sales agents are no longer hand-delivering product demos on their visit to the practitioner's office. Instead, they submit product sample requests for Direct to Practitioners (DTP) or direct product samples shipping. Around the same time, suppliers have seen an increase in product sampling requests from HCPs requesting help for their patient needs. While such methods may be compatible with the present market's requirements, adherence to regulatory criteria should be included in the process, like ensuring product samples are distributed directly to suitable and approved HCPs with robust paperwork to ensure the distribution of drug products.