Posted on August 31, 2016
Pharmaceutical companies play a key role in supporting the quality use of medicines through patient focused programs. These programs are designed to aid compliance and lifestyle choices. They provide significant value to patients through the accessibility of information and support.
Each program run by a pharmaceutical company is managed under strict ethical guidelines and for a specific medicine. Participation is only available to patients who have already been prescribed a medicine and supported by their healthcare professional.
Programs can provide information to patients about their condition, how to better manage their health, or encourage adherence to the medicines they have been prescribed. They are aimed to complement the important roles their doctors and pharmacists play in the management of their condition.
Companies must ensure that all aspects of a program including written materials or verbal interactions are patient focused and are not in any way promotional nor have the intention of promoting a prescription medicine to members of the general public.
A rationale must be developed for each program which describes the clinical significance of the program, the anticipated number of patients to be enrolled, the type of educational/informational material to be provided to a patient, the number of interactions (if any) that may be had with a patient and the duration of the program. Any communication with a patient considering enrolling in a patient support program should clearly identify the company, what materials or calls the patient may receive and their rights under the program. Companies have a duty of care to ensure that patients are fully aware how their privacy and confidentially is maintained and that they can elect to opt out of a program at any time. Patients should also be advised how and who will be holding their data and assurances given that data will not be used for purposes other than for the designed program. At specified intervals companies should evaluate whether a program is delivering on its initial objectives including improvements in compliance and patient wellbeing.
The importance of reporting adverse events identified through interactions with patients enrolled in patient support programs cannot be over emphasised. Careful monitoring of programs ensures accurate and timely reporting of de-identified product safety related information. It also aids our understanding of medicines in the post market environment.
Medicines Australia Code of Conduct has detailed provisions on how such programs should be administered and recognises that they offer important support to patients and have a key role to play in delivering positive health outcomes.
This article was written by Terence Khoo, from our Medical Services team.