The Patient Support Programs (PSPs) developed by the pharmaceutical industries are often controversial as to the real benefit they provide, how much they contribute to patient loyalty and the risks they bring to the companies implementing them.
When they were initially conceived, PSPs started from the premise of using call centers, contacting patients only through telephone lines.
PSPs aim to improve the patient's quality of life, with the proper medication usage, improving treatment adherence and clinical results. To this end, PSPs typically have some or all of the components listed below:
1. Help the patient in correctly taking their medication, especially since the administration of too many drugs can harm one's health when the instructions in the package insert are not followed. Unfortunately, on the one hand, not all patients are careful, completely reading the package insert, and, on the other hand, there are some complexities that are difficult for the patient to deal with alone.
2. Provide services that can bring a better quality of life to the patient, such as tips on nutrition, healthy habits, lifestyle changes, exercise recommendations, and the like.
3. Enabling the patient's access to the medication through donations, special discounts, partial or full refunds, until they can acquire the medication through their healthcare plan or the Brazilian Public Healthcare System (SUS).
4. An appendix of a PSP still used by some companies is offering medical diagnoses, so as to identify if the patient has a certain disease. However, there is an important differential: the PSP can and should be communicated to physicians, but it is addressed to the patient; whilst the diagnoses, which can even receive the title of a diagnostics program, is addressed to the physician and determines which patient will benefit from the free medical examination.
Unfortunately, in Brazil, the Brazilian FDA (Anvisa) has not yet made specific regulations for PSPs, although it has issued Rule RDC #11, of January 26, 2006, which provides for the Technical Regulations for the Operation of Home Care Services. However, PSPs do not always include home care and, even when they do, there is no guidance of clinical nature, as PSPs never interfere in the relationship between physician and patient.
Meanwhile, pharmaceutical industry associations such as INTERFARMA have an entire Code of Conduct section regarding support programs, including PSPs.
One of the biggest success factors of a PSP is the healthcare professional. Firstly, the physician prescribing the medication, upon knowing the PSP and accepting that it will add value to their patient's treatment, becomes a great motivator for the patient to at least get to know the PSP, as the program is free of charge. There are also nurses and pharmacists who can be part of the team operating PSPs at the company's request, with skill and expertise in interacting with patients and can make the difference between the success and failure of a PSP. On the other hand, it is also up to the company to provide medical, compliance and pharmacovigilance training.
The interaction with physicians also raises some concerns related to potential conflicts of interest, and pharmaceutical companies wishing to implement PSPs must meet the following restrictions:
1. Never remunerate or provide any other type of benefit to the physician for the admission of patients to their PSP, even if there was a recommendation by said physician.
2. Never relate the physician's diagnoses (medical examinations) to the prescription of their own medications, as the prescription of the most appropriate treatment must be left to the physician.
3. It should always be made clear to physicians that PSPs will never be used to promote medications to patients.
4. It should be equally clear to physicians that PSPs themselves will never provide clinical guidance or criticize the treatment established for their patient.
Another important caution should be given to the interaction with patient, either due to the risk of a direct promotion of medication being perceived, or due to the inappropriate processing of the patient's private data, especially when sensitive, notably those related to health. Therefore, the collection of personal data from patients should be avoided, except when individualization is necessary, such as in cases where there are reports of side effects to be addressed by pharmacovigilance.
As such, there should be guidelines to patient approach, which the team operating the PSP must be properly trained with. Seemingly simple and innocuous questions may end up getting unnecessary attention from the company, as it cannot ignore the patient's response due to the pharmacovigilance commitment of its product.
For example, should the PSP operator ask “How were you overnight?” and the patient responds with “I went to bed with a lot of pain in my back, my head throbbing, and I had insomnia all night due to frequent bathroom trips.” This simple response demonstrated four potential adverse events, which could be medication-related or otherwise: (i) backache, (ii) headache, (iii) sleeplessness, and (iv) frequent urination. Depending on the patient's illness, they may indeed take several medications, and it is often quite difficult to link a symptom as an side effect of the respective medication.
It is imperative to point out that marketing and commercial areas, as a rule, should not interact with PSPs, with the exception of receiving statistical data or in aggregated databases, to help in mapping the disease, etc.
Every PSP must have written rules determining its basic guidelines, especially if patient access to medication is among its components – after all, initiatives to facilitate patient access generally imply a reasonable financial burden for the pharmaceutical industries and clear limits must be thus established, even before the patient enters the PSP. By excluding this component of PSPs, the patient should spontaneously decide when to enter and to leave the PSP.
PSP automation is also an important added value for its optimal management. Here, it is also necessary to discuss in advance whether the fields to be filled should be of free text type (where the operator is free to write) or drop down type (where the operator chooses among options provided by the software).
PSPs can be operated by both company employees and companies outsourced to this end. When outsourcing, it is important that companies follow all guidelines provided by the pharmaceutical industry and that there is constant monitoring of their evolution. Aside from the economic issue – considering the comparison between the fees paid to an outsourced company and the cost of keeping employees, considering their payments, benefits, and taxation – the use of an outsourced company brings an important advantage: it can be isolated so as not to directly access patient private data included in the PSP.
Currently, PSPs are especially focused on medications prescribed to patients with diabetes mellitus and multiple sclerosis. Nevertheless, cancer medication, especially considering their specialization and complexity, have been gaining visibility in PSPs and are becoming the main pieces in the promotion of PSPs by pharmaceutical industries.
Finally, the trend for the evolution of PSPs lies in the use of technology to bring the patient closer and to facilitate the communication of guidelines. Thus, there are now specific apps for patients to install on their cell phones, when adhering to a particular PSP, greatly facilitating communication between program operators and the patients.