Background
Monitoring and understanding patterns of abuse, misuse, and diversion (AMD) of prescription medications is an important aspect of post-marketing for pharmaceutical companies. This is especially the case when the medication is used in a high-risk population of patients undergoing medication assisted therapy (MAT) for substance use disorder. In addition to traditional pharmacovigilance activities such as adverse event reporting and post-market surveillance, ongoing research and development can include analysis of unique datasets and assessments of published literature to follow trends, perceptions and behaviors surrounding the use, and potential AMD of a company’s drug.
Situation
A pharmaceutical company with over $1 billion in annual revenue was seeking to evaluate AMD of its marketed compound for MAT, using drug utilization data that included the numbers of patients, prescribers, and prescriptions, plus additional details that included geographic identifiers, payment type, and product quantity, dosage, and formulation. The company sought to use these data to complete an evaluation of prescribing in general and with respect to indicators of AMD, with a particular focus on identifying geographic patterns.
In addition, the company wanted to better understand motives behind AMD of its compound and the relationship between motives behind AMD and evolving health policy. This information was thought to be best gathered through a review of the published literature.
Solution
After receiving and organizing the company’s proprietary data files, Venebio’s analytics team first analyzed the prescribing data, paying particular attention to location, specialty, patient load of active prescribers, volume of medication prescribed, and potential indicators of AMD. Next, Venebio’s team performed several geospatial analyses at the county level to identify clusters of prescribers exhibiting potential AMD-related behaviors.
In parallel with the quantitative analyses, Venebio’s literature review team conducted a comprehensive review of the medical and public health literature to assess motives for AMD of the company’s compound in the United States. The process involved designing and executing a literature search, reviewing titles and abstracts of search results, and completing a thorough extraction, review, and qualitative analysis of data from relevant studies.
Outcomes
The results of the quantitative analyses were compiled in a report, complete with several plots, paired maps, and choropleths. The findings from the literature review on motives for AMD of the product were turned into a manuscript with an emphasis on the ways in which health policy can minimize the potential for future AMD. That manuscript is currently under peer review for a well-regarded substance abuse journal. Finally, the results from both approaches to this situation were incorporated into a whitepaper for use as an internal resource, providing an integrated collection of prescribing data (including rates, quantities, locations, and potential AMD-related behaviors), motives for patients and the public to abuse, misuse, or divert the product, and associated policy and regulatory trends.
How Venebio addressed the challenge
Complex research questions often require a multifaceted approach. Quantitative data can be convoluted, and a client’s ability to assemble an effective, efficient analytic team in-house is sometimes limited. In this case, the project team must possess a variety of skills not limited to epidemiologic methods, analytics, scientific writing, and be well-versed in current health and regulatory policy. Outsourcing to a lean but experienced group of well-rounded researchers is often the fastest, most cost-effective option.
By partnering with Venebio on this multi-pronged project, the company benefited by turning its complicated data into useful, digestible results and received a detailed document summarizing the current state of AMD for education and use by internal personnel. The anticipated publication of the literature review manuscript increases the company’s visibility to prescribers, regulators, and policymakers and further contributes to the global literature surrounding addiction research and access to care.
Epidemiology, Biostatistics, Advanced Analytics, and Real-World Evidence
Systematic Review and Scientific Writing