What are Patient Support Programs (PSPs) and Market Research Programs?
A patient support program is an organized system where a marketing authorization holder receives and collects information relating to the use of its medicinal products. Post-authorization patient support and disease management programs, surveys of patients and healthcare providers, information gathering on patient compliance and compensation/re-imbursement schemes are some PSP applications.
A market research program refers to the systematic collection, recording and analysis by a marketing authorization holder of data and findings about its medicinal products, relevant for marketing and business development.
Patient Support Program: Categories
The focus of Patient Support Programs is to address problems patients experience, following a diagnosis or prescription made by a doctor, so patient outcomes can be optimized. In the last ten years, we have observed increasing adoption of some form of PSP. The PSP implements:
1. Compliance and Adherence:
The support focuses on addressing patient medication persistence beside helping them continuing the treatment for the prescribed duration.
By way of alternative, several factors contribute to non-adherence including, forgetfulness, confusion due to a complex treatment regimen, struggle with self-administration, cost, side effects and absence of perceived benefit.
To minimize the unintentional non-adherence acts, patients should be educated, assisted in medication administration (homecare programs) and regularly reminded by SMS text messaging or iPhone apps.
2. Disease Education:
Patient education increases disease awareness and improves disease management. It is typically conducted through groups sessions using educational material and aims to improve individual quality of life through education.
The disease education is not product specific; patients can be on different medications. Accordingly, it helps them understand their condition and provide advice on managing their disease.
3. Financial Assistance:
The financial assistance aims to provide patients with financial aid by improving the affordability of pharmaceutical products through compensation of a part of their price, supporting the patient financially in carrying out or providing free diagnostic, laboratory and instrumental examinations, physician consultations, and medicinal manipulations.
The financial assistance programs are the Co-payment programs, the Free of Charge medicine schemes known as FOC programs and the re-imbursement support programs.
Pharmacovigilance and Safety Reporting
Pharmacovigilance (PV) of patient support programs is a discipline that detects, assesses, understands and prevents drugs adverse effects or any related problems.
The Adverse Event (AE) is any untoward/unwanted medical occurrence in a patient or clinical trial subject administered a medical product and which does not necessarily have to have a causal relationship with the treatment.
The basic essence of the pharmacovigilance and suspected adverse event reports is to detect the risk profile of the drug at the earliest and identify the population at risk. The safety reporting should assess Adverse events (Serious and non-serious), lack of Efficacy, pregnancy and lactation, overdose and missed dose, medication errors, transmission of infectious agent, device failure, technical complaints, off label and counterfeit/stolen.
The three main report criteria are: Patient, Product and Event.
The Patient is identified by his initials, age, gender, weight and height. The product is identified by its name, route of administration, batch number, expiry date and administration dose. The AE Identification is via detailed explanation of the signs & symptoms of the event. It reported to the PV Department/Safety unit immediately within 1 business day or 3 calendar days.