Close to 40,000 adverse reactions to medication reported in 2019

The Spanish Agency for Medicines and Health Products (AEMPS) has received last year a total of 37,778 notifications of possible adverse reactions to medication, an 8% decrease compared to 2018. Of those, 37% have been considered to be acute, nevertheless the issue raising most concern was that 14% of the cases reported were not indicated on the technical specifications of the medication and that constitute 8% of the acute cases.

By adverse reaction, as defined by AEMPS it is considered any negative and undesired impact of a medication, as well as any medication error that cause harm to the patient.

As stated on the  Summary of Activities 2019 of the Spanish System of Pharmacovigilance of Human Medication, the most common cases are the gastrointestinal that amount to 8.5% of the total; the dermatological (7.8%), and of the nervous system (6.9%). A significant portion of those notifications were made by the pharmaceutical industry (62%), while the remaining was reported by the Spanish System of Pharmacovigilance of Human Medication (SEFV-H). The majority of those notifications were made known by the healthcare professionals (67%) and the pharmaceutical professionals (21%).

In respect to demography of the affected patients with the worse adverse reactions, the larger amount corresponds to adult patients (with predominance of women), followed by people over 65 years of age, kids, nursing babies, teenagers, newborns and fetuses.

From the Foundation for Innovation and Development of Health Safety we work to promote the betterment of the quality and the safety of healthcare processes and to reduce the errors that occur in the process of prescription and usage of medication and in the whole medical errors environment (surgical, diagnosis, usage of medical materials and devices…). Despite the important progress observed in the healthcare industry during the last years, there is still a long path to be covered to guarantee better patient safety, reason why at FIDHS we work to collaborate in the creation of technology enhanced healthcare solutions that reduce the risk of harm to patients.

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