How could adverse effects be recognized?
Differentiation of an adverse effect and a disease is difficult, sometimes impossible because there are same physiological and pathological courses of events taking part in their development. However following the below mentioned steps may help understand and conclude the dependence of an effect upon a cause concerning medicinal side effects.
1. Checking if the prescribed medicine is the same as the one taken by the patient and is taken in the prescribed dose.
2. Checking if the supposed adverse effect was the result of taking the medicine (and not in reverse order!), the patient should be questioned thoroughly about the happenings.
3. Settlement of the time between taking the medicine and developing of the adverse effect.
4. Termination of treatment or decreasing of the dose should be ordered and patient's general status should be followed with attention. Treatment should be initiated again and the probable symptoms should be controlled in case of a re-emerge.
5. All probable reasons should be taken into consideration which might produce the adverse effect (basic/concomitant disease, other taken medicines, chemicals etc.).
6. Comparing our experiences, observations with data from the Summary of Product Characteristics, with other sources; checking whether there have been similar experiences with this particular medicine. Consultation with the Department of Pharmacovigilance or with the Department of Information and Communication of National Institute of Pharmacy where important pieces of information are available concerning the side/adverse effects of the medicinal product under suspicion and on their occurence in Hungary and in foreign countries. In some cases it may be beneficial to consult with the manufacturer (or with Marketing Authorisation Holder).
7. In case of any suspicion of an adverse effect a report has to be prepared and immediately forwarded to a health professional of hospital in charge of pharmacovigilance, or directly to the Department of Pharmacovigilance of the National Institute of Pharmacy.
