Medical Information
Medical Information is an integrated part of medical product life cycle and the provision of medical information is the responsibility of the marketing authorization holders (MAH). According to the Directive 2001/83/EC Art. 98 (1), the marketing authorization holder shall establish, within his undertaking, a Scientific Service in charge of information about the medicinal products, which he places on the market. Another name used for this service is Medical Information or Medical Communications. It is the set of activities connected, on one hand, with maintaining the information about the medicinal products up-to-date and in line with current scientific knowledge. On the other hand, communicating this knowledge to healthcare professionals (HCPs) and patients. In short, medical information involves reactively answering unsolicited questions about a product from external requestors.
Know your drug
Education is the key to drug safety. In the constantly changing environment of scientific research, new information emerges regularly for new therapeutic molecules, as do the pharmacovigilance data. But new findings may appear also for old, well-known medications. As a consequence, the marketing authorization holders must ensure that Product information of their drugs is up to date.
Who can request medical information?
Consumers/patients, healthcare professionals, representatives of Competent Authorities and others contact the MAH asking questions and seeking additional information on the product that concerns them. Many questions come from physicians and pharmacists, who seek advice on how to use the product. At times, these are also questions on behalf of patients. But patients themselves often do not hesitate to contact the MAH directly to obtain the information they need. From our experience, most questions arise when a new product/new active substance is launched on a particular market and when important data is published.
Of particular interest is the appearance of reports that may affect the safety of the medicine. Patients most often seek information on the administration of a drug when they are taking it for the first time. When the disease is rare, when they have comorbidities or when they are taking multiple drugs (interactions).
Knowledge and expertise
SciencePharma has several years of experience in handling medical information/scientific service for medicinal products from various therapeutic areas available on many markets. We provide medical and safety information in accordance with product labelling, registration dossier, regulatory requirements and guidelines, industry standards, and above all – scientific data.
We answer questions on e.g.:
- use of the product;
- composition and manufacturing process;
- development studies carried out for the product;
- other needs as required.
We correctly identify the enquirer’s question(s) and formulate and communicate an accurate answer tailored to the enquirer, i.e. answers for patients are based on the product information, while answers for HCPs are based (if necessary) on multiple sources of information, as they often require scientific interpretation.
For personnel with medical/life scientific background, it is usually not a challenge to communicate with healthcare professionals of regulatory bodies. What requires a particular skill is the communication with patients, who often come to us with their problems not only related to the drug they use, but with the condition, they are suffering from. It is important to distinguish between the information which can be given, and which is outside the scope of our expertise. For we are not physicians, who treat the patients, who know their medical history, concomitant treatments, laboratory results. Thus, the scope of the information, which can be given, is limited to that included in Product information. The key information is already presented in the Package Leaflet, but it is sometimes better for patients to talk and be able to ask questions. Our experts are aware of this and have the necessary expertise. They feel the difference between the medical information and health consultancy.
We are flexible when it comes to the means of communication. Nowadays, e-mail or the forms on the client’s or product’s website are preferable. But we are also aware that patients may prefer more direct contact e.g., on the phone. For Polish and English speakers, we can provide this as well.
We are vigilant
Medical questions can sometimes be tricky. They may contain hidden content related to the occurrence of an adverse reaction or quality complaint. Our experts are attentive and can quickly identify and capture this information and process it within the required timeframes in accordance with regulations (learn more about our Pharmacovigilance service).
We are also vigilant to legal requirements on what type of information can be given to HCPs and patients. Our experienced team knows how not to cross the thin line between informing about the product and advertising its benefits. With our services, the MAHs can feel safe and sure that we will act within the legal requirements.
Why SciencePharma?
We are a trusted company with 18 years of experience in the medical industry. Perhaps we are the oldest one in Poland offering contractual medical information services for your product(s) as well as more complex services. We have extensive experience in medical communications both as the MAH and as the provider to other MAHs. Our experts have the medical know-how to communicate complex product knowledge in a friendly way and directly address the needs of our clients and their customers. Our experience covers the global market (e.g. EU, Middle-East, Canada). We are trusted by many clients for whom we provide comprehensive pharmaceutical services including medical information.
If you are interested in cooperation, please contact us. Our experts will be happy to answer all your questions.