5-Year Trend of Reporting Adverse Drug Reaction: an Italian General Practice Experience

Background: Adverse Drug Reactions (ADRs) underreporting is a serious drawback of the pharmacovigilance system. Spontaneous reporting of ADRs is a valid instrument to enhance pharmacovigilance. Objectives: To avoid prescribing again to patients the drug that caused them the ADRs, to evaluate spontaneous reporting of ADRs by patients to their General Practitioner (GP); to investigate the most involved Anatomical Therapeutic Chemical (ATC) classes in ADR signaling; to focus on sex-related differences in reporting ADRs; to propose suggestions to increase awareness about the issue. Methods: All ADRs reports collected by an Italian GP, during a period of five years, had been recorded by himself into his own array of records and then evaluated. The database of case histories in which data were filed allows data mining through queries formulated in SQL (Structured Query Language). We analyzed the numbers of prescriptions for each class of every ATC group in order to demonstrate the most involved ATC classes in ADR signaling. Results: We observed a total of 1278 ADRs for 11596 medical acts (11.02 ADRs per 100 consultations); four ATC groups (N, J, C, M) were responsible for the majority of ADR reports. Women had a higher reporting aptitude than men; 58% of women versus 38.9% of men has done at least one ADR report. Conclusion: The autonomous attention of the GP has led to more knowledge about the issue, the importance of reporting ADRs has been stressed in his local community, and, therefore, he has definitely changed the quality of life of his patients. Our study demonstrates that a close collaboration between GPs, patients and Pharmacovigilance Authorities may lead to a better pharmacovigilance practice, and may provide useful data about reporting trend and about unknown drug adverse reactions. We suggest to offer GPs some training courses to raise awareness to the problem of underreporting.