Pharmacovigilance in Neurosurgery: Analysis of Adverse Drug Reactions at Mohammed V Military Teaching Hospital

Amezouar A, Bouhlala N, Belhouari M, Sabri S, Elouadghiri B and Enneffah W

Department of Pharmacy, Mohammed V Military Teaching Hospital, Rabat, Morrocco Faculty of Medicine and Pharmacy, Rabat, Morrocco

^*Correspondance to: Amezouar A 

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Abstract:

Introduction: Pharmacovigilance is an essential pillar of medication safety, aiming to detect, assess, understand, and prevent adverse events related to the use of medicines. In the hospital setting, particularly in a specialized department such as neurosurgery, patients are often exposed to complex therapeutic regimens, thereby increasing the risk of adverse drug reactions (ADRs). This study was conducted in the neurosurgery department of Mohammed V Military Teaching Hospital, using the official adverse event reporting form developed by the Moroccan Pharmacovigilance Center. The objective of the present work is to analyze the ADRs that occurred, characterize the drugs involved, and assess their severity, clinical outcome, and the corrective measures implemented. Materials and Methods: This retrospective descriptive study was conducted in the neurosurgery department of Mohammed V Military Teaching Hospital. It was based on the analysis of adverse drug reaction (ADR) reports collected using the official pharmacovigilance form of the Moroccan Pharmacovigilance Center. Each form provided information on the patient’s clinical data, the suspected drugs, the nature of the adverse reactions, their outcome, and the corrective measures implemented. The data were entered into an Excel spreadsheet for descriptive analysis. The objective was to characterize the observed ADRs and assess their clinical impact. Results and Discussion: The analysis identified 19 cases of adverse drug events (ADEs) reported in the neurosurgery department. Patients were distributed as follows: 52.6% were women and 47.4% were men. The most frequent ADEs were dizziness (15.8%), followed by nausea, vomiting, hypokalemia, and confusion, each accounting for 10.5%. The suspected drugs included sodium valproate (10.5%), empagliflozin (10.5%), carbamazepine, nefopam combined with pregabalin (5.3%), as well as anticoagulants and antibiotics. Among the 19 events identified, 73.7% were described in the Summary of Product Characteristics (SmPC) of the drugs concerned, whereas 26.3% were not listed. The five reports concerning adverse events not mentioned in the SmPC were forwarded to the local pharmacovigilance officer for further assessment and appropriate follow-up measures. This therapeutic diversity reflects the complexity of neurosurgical care and the risks associated with polypharmacy. The clinical outcome was generally favorable, particularly after discontinuation or substitution of the suspected treatment. These findings highlight the importance of pharmacotherapeutic monitoring and rigorous reporting of ADEs. In this context, the clinical pharmacist plays a key role by identifying ADEs, documenting them, and collaborating with the medical team to ensure safer prescribing. This role is fully integrated into a quality improvement and medication risk prevention approach. Conclusion: This study highlights the risk associated with adverse drug events and the importance of their reporting. It also emphasizes the role of the clinical pharmacist in their identification, analysis, and management. Hospital pharmacovigilance therefore appears to be an essential tool for securing prescriptions. It contributes to improving the quality and safety of care in the hospital setting.

Keywords:

Pharmacovigilance; Adverse drug events; Neurosurgery; Clinical pharmacist

Cite the Article:

Amezouar A, Bouhlala N, Belhouari M, Sabri S, Elouadghiri B, Enneffah W. Pharmacovigilance in Neurosurgery: Analysis of Adverse Drug Reactions at Mohammed V Military Teaching Hospital. World J Surg Surgical Res. 2026; 9: 1621..