There is no such thing as a medicine without a side effect.
Over 90% of medicines that are available in Ireland are manufactured by IPHA Member Companies. IPHA and its members have long understood the special responsibility that pharmaceutical companies have to the people who use their medicines and the importance of operating to the highest possible ethical standards as well as to the strict regulatory requirements.
Identifying the possible adverse effects
In an ideal world, a medicine would target only the disease or disorder it is meant to treat and never do anything else; the so called ‘magic bullet’. However, despite the best efforts of medical experts and scientists, such a medicine does not yet exist. All medicines are associated with the risk of a possible adverse effect(s). New knowledge about those risks is revealed throughout the life of a medicine.
Many common adverse effects can be identified during the clinical trials performed before a medicine is approved, but in order to detect rare adverse effects it is necessary to study the use of the medicine in much larger patient populations. To detect an adverse effect which occurs in 1 of 10,000 treated patients, one would need a clinical trial of at least 30,000 patients. Conducting clinical trials of this size is not usually feasible before license approval and it would delay access of patients to necessary new medicines.
The surveillance programme that is put in place following a medicines introduction to the market is necessary to further build a benefit risk profile for the product because it is during the post-launch phase that a medicine will be used by a vastly greater population, in a normal setting which is quite different from that of a clinical trial.
A number of methods are used to identify these risks once the medicine is on the market:
- New scientific methods and increasing pharmacovigilance anticipate and manage the possible risks associated with medicines before and after they are approved for sale, thus making medicines safer;
- Whole teams of dedicated professionals such as physicians, pharmacists, nurses and scientists are employed by pharmaceutical companies to protect patients by ensuring any new risks associated with medicines are detected as soon as possible and that appropriate action is taken quickly;
- Risk management techniques are used to ensure that the benefit-risk balance for the use of a medicine remains positive. This can help to reduce delays in approval of new treatments and help maintain access to medicines for people who need them;
- Advances in technology and data accessibility foster the application of the scientific tools of epidemiology and pharmacoepidemiology that facilitate and improve safety monitoring throughout the medicine’s life;
- Healthcare professionals report suspected adverse reactions to the Regulatory Authority and/or the pharmaceutical company;
- Every member of the pharmaceutical company staff is trained on how to quickly and accurately report a suspected adverse reaction.
After a medicine is authorised to go on the market, the pharmaceutical industry is legally obliged to collect and evaluate all available information on possible previously unknown risks as well as increased incidence of known risks to patients and to communicate any such information to the regulatory authority quickly and effectively. Health professionals and the public are also informed. A company’s responsibilities in pharmacovigilance are laid down in EU and Irish law. As part of these obligations, they must report to regulatory authorities all adverse effects that are brought to their attention, in some cases on an expedited basis, and also any other information in relation to a product that may affect its benefit-risk balance, as well as submitting regular safety reports (PSURs). These reports include the details of all adverse effects collected for that medicine, worldwide.
Only through comprehensive pharmacovigilance programmes can we continue to monitor, collect, analyse, and report all safety information associated with the use of medicines as well as communicate the adverse effects and safety profile to those concerned thus maximising patient safety.
Information on possible side effects, interactions with other medicines, use in paediatric populations, contra-indications etc. is provided on www.medicines.ie. This is a very powerful tool in helping healthcare professionals and patients alike get access to the most relevant and up-to-date information on medicines.
Pharmaceutical companies, regulatory authorities and individual healthcare professionals all have an important role to play in ensuring that close surveillance continues to ensure that the benefit-risk balance for a medicine is always known.