How PSPs and MRPs can be useful from a pharmacovigilance point of view? It was discussed at the European Pharmacovigilance Congress held the 26th and 27th November and of which we were sponsors.

Phillip Eichorn, Senior Director of Pfizer Pharmaceuticals as a speaker explained what PSPs and MRPs are and how they are useful.

Patient Support Programmes

What are PSP

Here is how PSPs are defined by GVPs:
“A patient support program is an organized system where the marketing authorization holder receives and collects information related to the use of his medicines. Examples are post-authorization patient support, management programs, patient and healthcare provider surveys, patient compliance information gathering or compensation / reimbursement. ”

Variety of PSP

Patient Support programs can affect many areas, among these there are:

  • Adherence and Compliance Programs: these are programs developed to help patients and manage their medications
  • Information and educational programs: these include, for example, call centers and awareness programs, which are information on general health problems, specific diseases, or certain drugs
  • Reimbursement assistance programs: in this case, information is given to patients, or healthcare professionals, about health insurance, etc.
  • Support programs for drug delivery and other types of direct financial support.

Market Research Programmes

MRPs find different definitions.

GVP: “A market research program refers to the systematic collection, recording and analysis by a marketing authorization holder of data and discoveries on its medicines, relevant to marketing and business development.”

BHBIA : “Market research attempts to generate understanding and knowledge of a market and its consumer’s behavior. It does this by obtaining information (data) from specific samples of consumers and extrapolating results to the population as a whole. MR u scientifically conducted, and respondent’s identity and all other personal data is confidential and not disclosed or used for non-research purposes.

  • It is not a commercial communication or a sales opportunity
  • It has no interest in the individual identity of the respondents
  • It does not result in direct actions relating to persons or organizations mentioned in it. “

EphMRA (European Pharmaceutical Market Research Association): “Market research… is defined by the following key characteristics:

  • the systematic gathering and interpretation of information about individuals, organizations and marketplaces using the collection of information gathering and analytical methods and techniques of the applied social, behavioral and applied data sciences.
  • Its purpose is to gain insight or support decision making
  • The identity of the MR subjects will not be revealed to the user of the information without explicit consent (and can never be disclosed in Germany), market research has no interest in the individual identity of MR subjects
  • No direct action, e.g. a sales approach, will be taken in relation to individual organizations as a result of market research (except for the follow-up of adverse events when permitted). Market research is not a commercial communication or a sales opportunity”.

The importance of training for PSP and MRP purposes

This kind of program can be also exploited to capture some information useful for pharmacovigilance such as lack of efficacy, incorrect use, or off-label use. What is important is that there is a correct training of the operators, as incorrect interpretations could distort the risk/benefit profile. Here is an example reported by Dr. Eichorn:
A survey is published for patients known to have taken Product X, a drug with a relatively benign safety profile but generally prescribed to older patients. A significant portion of the surveys are returned by family members indicating that the patient has died.
Is the drug more “dangerous” than we thought?”
This is why it is important to give precise information to operators. The two organizations EphMRA and BHBIS / ABPI have both published a guide on Market Research Programs: https://www.ephmra.org/media/2012/ephmra adverse events reporting-guidelines-January 2017 3117.pdf and https://www.bhbia.org.uk / guidelines-and-legislation useful for staff training.

In conclusion, it can be said that PSPs and MRPs can add value to the business and pharmacovigilance activity, but care must be taken not to “dirty” the safety database with incorrect data.