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We are all now well aware of the emerging side effects of the new vaccines, which are generating some concern. There is a clear need, therefore, for a better understanding of the side effects to medicines in general so that such reactions can be put into perspective.
Firstly, all medicines can potentially cause side effects as indicated in the often overlooked little statement on the package leaflets of all medicines marketed in European Member States and other countries:
“4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.”
What is important, therefore, is to be able to detect and identify such effects so that decisions can be made regarding the safety of our medicines. In technical terms, this process is referred to as pharmacovigilance. The fact that the side effects of the new vaccines are already being identified proves that systems are in place to identify these and ensure that they are duly evaluated and the necessary action taken as required to ensure the safety of our medicines and vaccines.
Secondly, it is important to be familiar with these pharmacovigilance systems so we can all report any adverse effect we may experience, and in doing so provide more information on the overall safety of medicines. This may also help increase confidence in these mechanisms knowing that most events are detected, reported and analysed, individually and in the context of all the other possible reports.
Translators working in the pharmaceutical and regulatory affairs sectors are often very familiar with the intricacies of pharmacovigilance, and the challenges of translating, for example, the individual case safety reports (ICSR). These may contain sensitive material, the reporter may not always be overly concerned about his or her linguistic expression, and the use of medical abbreviations is extremely high (see link at end for very use publication for Spanish abbreviations). Although ICSR may be short, they require careful reading and interpretation to ensure that the translation is accurate. Deadlines are another issue, as reports must be made as swiftly as possible. For further information on the timelines for submission of case reports, check out this EMA Guideline on good pharmacovigilance practices.
To shed a little light on the various pharmacovigilance schemes for the reporting of side effects, I will briefly describe three: the European and World Health Organisation schemes and the yellow card scheme in the United Kingdom.
Firstly, in Europe and in accordance with the provisions of European Union (EU) legislation relating to medicinal products, the European Medicines Agency (EMA) is the body responsible for coordinating existing scientific resources for the evaluation, supervision and pharmacovigilance of medicines. The EMA coordinates this pharmacovigilance in the EU using its EudraVigilance data processing system which enables:
One of the fundamental principles of adverse event reporting is the determination of what actually constitutes a case report or ICSR. The person submitting the report is generally a healthcare provider or patient. Once submitted, the report is subject to a triage phase to determine if the four elements of a valid ICSR are present: an identifiable patient, an identifiable reporter, a suspect drug and an adverse event. There is a set of criteria to establish if the event is serious or non-serious. An adverse event is considered serious if it:
Adverse events are then coded to convert the information on the event into terminology that can be readily identified and analysed. For instance, a patient may report experiencing “a bad headache that felt like he or she was being hit by a hammer” when taking medicine X, or another patient may report a “throbbing headache that occurred only at night” while taking medicine Y. Neither will exactly match a code in the MedDRA coding dictionary, for example, but both describe different manifestations of a headache. As a result, in this example both would be coded as PT Headache (PT = Preferred Term in MedDRA).
It is important to note that a submitting a report does not necessarily mean the medicine actually caused that reaction or event. The report is a record of a suspected event, even if the reporter is unsure if it was caused by the medicine in question. Many suspected reactions reported may be unrelated to the medicine as it is often coincidental that they both occurred around the same time. Reports are continually reviewed to detect possible new side effects that may require further action.
Similarly, the World Health Organization (WHO) has developed the single largest drug safety data repository in the world. This global ICSR database is known as the VigiBase. It was developed on behalf of the WHO by the Uppsala Monitoring Centre (UMC; established in Uppsala, Sweden) and has been maintained since 1978. Vigibase is used to compile information about the safety profile of medicines. These data are used by pharmaceutical industries, academic institutions and regulatory authorities for statistical signal detection, updating periodic reports, ICSR comparisons with company databases and studying the reporting patterns.
And finally at a national level, many countries have their own pharmacovigilance systems. In the United Kingdom, for example, people are encouraged to report a suspected problem with a medicine or medical device as soon as possible using what is known as the Yellow Card Scheme (https://yellowcard.mhra.gov.uk/). This recommendation is shown in the package leaflet of all medicines.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine.
To sum up therefore, there are various well-established systems for the reporting and monitoring of the side effects of all medicines. We all have a role to play to ensure that the medicines available on the market are safe. And we as translators have an important role to play to ensure careful transfer of these data to other languages and thus help improve the health of all.
P.S. My old time favourite resource for Spanish medical abbreviations, I like that I still use a printed version! So rare these days!