The patient population
The specialty of pharmaceutical medicine is concerned with the development, registration and life cycle management of medicines. Pharmaceutical physicians, working in collaborative teams, are responsible for demonstrating, through clinical studies and clinical trials, the efficacy, safety and quality of medicines in populations and cohorts of patients. These patients cover all areas of disease and medical conditions, all age groups including children and older people, and all nationalities and ethnic groups. Pharmaceutical medicine is responsible for providing medicines that improve the wellbeing of patients and acting in the interests of public health. It must therefore ensure the relative safety, tolerability and cost-benefit of medicinal products across the broad patient population.
Pharmaceutical physicians contribute to the prioritisation of medicinal products through the definition of unmet medical and public health needs by monitoring disease patterns and conduct of epidemiological surveys. In order to meet these needs, R&D has been directed towards the provision of innovative medicines for diseases for which there is no adequate treatment or preventive strategy, eg in oncology and autoimmune diseases, tropical diseases and vaccines, as well as the 7,000 or so rare or ‘orphan’ diseases which do not attract the usual research and commercial interest of the industry. The concept of unmet needs can be broadened to include many areas related to medicines research and to ensuring the practice of pharmaceutical medicine is person-centred. This encompasses a broad range of good practice including:
- the provision of patient-friendly product information
- recognising equality and diversity
- the need for a multilingual approach
- awareness of, for example, the needs of patients with sight problems.
Via appropriate channels, the concept of meeting patients’ needs extends to enhancing data sharing with researchers, public access to clinical study information, and sharing results with patients who participate in clinical trials, as well as publishing all clinical trial results. The European Patients’ Academy for Therapeutic Innovation (EUPATI), part of the Innovative Medicines Initiative, provides reliable, objective, comprehensive information to patients on medicines research and development, and also has the effect of increasing the capacity of well-informed patients to make an effective contribution to medicines development. Another central concept, which has increasing traction in the UK and around the world is ‘access to medicines’. This instils the need to overcome barriers, such as financial, geographical, political and distributional, that prevent patients obtaining licensed and available medicines for their conditions as soon as possible.
Prevention of disease
Conducting clinical trials in cohorts and populations of patients contrasts with the responsibilities of prescribing clinicians to provide medicines for the benefit and safety of individual patients. When a licensed medicine is made available for prescription, it is the responsibility of pharmaceutical physicians in collaboration with healthcare professionals and prescribers to ensure that the right medicine for the right disease reaches the right patient at the right time through the right route and in the right dose. Data and evidence for this are not only from clinical trials in populations but through consideration of the individual attributes of patients, and are sought in many different ways throughout the life cycle of the medicine so that prescribers are informed about the profile of the medicine and its suitability for individuals.
Pharmaceutical physicians provide assistance for healthcare professionals and the prescribing decision and care of the patient. This is based on multiple considerations that include the effects of the medicine on patients with:
- renal and hepatic impairment
- concomitant diseases and co-prescribed medications
- cognitive dysfunction
- other physical, mental and behavioural characteristics.
This work, through reporting of pharmacokinetics, side effects and adverse reactions, drug interactions and toxic effects of overdose, and including considerations of age and specific use in young people, adds to the product information, which assists prescribers in focusing their treatment on individual patients.
Effective and efficient use of medicinal products is increasingly seen as dependent on patient understanding of information, patient participation in discussion about their care and their treatments, including decisions on choice and the agreement of patients to the course of prescribed treatment. This is fostered through patient support programmes, interactions with patient advocacy groups, and individual patients themselves. Patients are the continuing focus for data gathering of the appropriate use and application of medicines, after licensing and prescribing.
Planning effective services
Pharmaceutical medicine will continue to develop collaborative medicines research and development methodologies and programmes, mindful of the needs and the contributions of the many stakeholders in the provision of proven and appropriate technologies for the treatment and prevention of disease. For example, through advancements in technology (eg genomics and biotechnology), pharmaceutical research and medicines development will be more individualised, resulting in a personalised medicine approach for patients. Effective collaboration between researcher, healthcare professional and patient will necessarily become much more transparent, collective, resourceful and productive.