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Pharmacovigilance Program Increases Patient Safety

July 10, 2019

The establishment of a pharmacovigilance program led to an increase in the detection of adverse drug reactions in patients, according to a recent study.  

“The pharmacy department leads the pharmacovigilance program and performs prospective, retrospective, intensive, and spontaneous reporting of inpatients and outpatients (emergencies, day hospital, external consultations, and nursing homes),” researchers explained. “Each adverse drug reaction is incorporated in the electronic health record of the patient along with an alert.”

Researchers described the adverse events detected through the pharmacovigilance program in the Spanish journal Farmacia hospitalaria: órgano oficial de expresión científica de la Sociedad Española de Farmacia Hospitalaria. 

Between 2008 and 2016, the program identified 2631 adverse drug reactions in 2436 patients, the study found. Pharmacists reported 93.8% of the events, and physicians, nurses, and technicians reported the remainder. Nearly two-thirds occurred in inpatients.

Adverse drug reactions were described as mild 38.7% of the time, and 30.8% were severe. Most affected the skin and appendages (19.7%) and gastrointestinal tract (19.1%).

Researchers found 21.3% of the drug reactions involved antineoplastic agents, 12.3% involved antibacterials, 7.7% involved antithrombotics, and 6.7% involved analgesics. Corticosteroids and psycholeptics were each involved in 5.2% of the adverse events, and diuretics and antivirals were each involved in 4.9%. Anti-inflammatories and antirheumatics were involved in 4.2% of the events, and immunosuppressants in 3.3%. 

The most common response to an adverse drug reaction was treatment interruption (65%), according to the study, although 56% of the time patients received additional specific treatment.

“The incorporation of the pharmacovigilance program within the daily routine of the hospital pharmacist provides added value to the safety and pharmacotherapy of the patient,” researchers concluded.

Jolynn Tumolo



Pérez-Ricart A, Gea-Rodríguez E, Roca-Montañana A, Gil-Máñez E, Pérez-Feliu A. Integrating pharmacovigilance into the routine of pharmacy department: experience of nine years. Farmacia hospitalaria: órgano oficial de expresión científica de la Sociedad Española de Farmacia Hospitalaria. 2019;43(4):128-133.

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