ABUTH Strengthens Medication Safety Through Pharmacovigilance Sensitization for Pharmacists

Zaria, Kaduna State – The Department of Pharmaceutical Services, Ahmadu Bello University Teaching Hospital (ABUTH), Shika-Zaria, has reinforced its commitment to medication safety through a pharmacovigilance sensitization programme aimed at strengthening adverse drug reaction (ADR) reporting and promoting a stronger culture of patient safety among pharmacists.

The programme was organized by the Pharmacovigilance and Drug Information Centre (PV/DIC) of ABUTH in collaboration with the Education, Research and Training (ERT) Centre. The ABUTH PV/DIC also serves as the North-West Zonal Pharmacovigilance Centre, supporting the National Agency for Food and Drug Administration and Control (NAFDAC) in pharmacovigilance activities across the North-West region.

Beyond ADR Reporting

Delivering the keynote presentation, Pharm. F. F. Garnett, Head of the North-West Zonal Pharmacovigilance Centre and Head of the Pharmacovigilance and Drug Information Centre at ABUTH, described pharmacovigilance as "the science and set of activities concerned with detecting, assessing, understanding and preventing adverse effects or any other medicine-related problem."

She explained that pharmacovigilance extends beyond adverse drug reactions to include post-marketing surveillance, medicine quality monitoring and the prevention of medicine-related harm. According to her, while medicines save lives, they can also become harmful if used inappropriately or when product quality is compromised, making continuous monitoring essential.

Pharm. Garnett emphasized that pharmacovigilance is everyone's responsibility. She noted that healthcare professionals have a professional obligation to detect, document and report suspected adverse drug reactions, while patients are equally encouraged to report medicine-related problems through available reporting channels.

She expressed concern over the country's low reporting rate, noting that although Nigeria's population exceeds 240 million, only about 4,000 Individual Case Safety Reports (ICSRs) are received annually, compared with an estimated need of about 47,000 reports based on World Health Organization pharmacovigilance performance indicators.

From a Single Report to National Action

To demonstrate the value of ADR reporting, Pharm. Garnett cited two notable cases in which reports originating from ABUTH led to major regulatory interventions by NAFDAC.

The first was the My Pikin Baby Teething Mixture tragedy, where reports from ABUTH contributed to investigations that confirmed contamination with diethylene glycol, leading to the nationwide withdrawal of the product and significant reforms in medicine safety surveillance.

She also referenced the Bioflex Intravenous Infusion case, in which ABUTH reported suspended particles observed in infusion products. Laboratory investigations later confirmed sterility failure, prompting NAFDAC to confiscate and destroy 828 cartons of the affected products, preventing further risk to patients.

"One properly documented report can save thousands of lives," she emphasized.

What Should Be Reported?

Participants were reminded that pharmacovigilance covers far more than adverse drug reactions. Reportable events include:

• •Adverse drug reactions and side effects.

• •Therapeutic failure or medicine inefficacy.

• •Poor-quality medicines.

• •Medicines without NAFDAC registration numbers.

• •Incorrect or poor labelling.

• •Faulty medical devices and consumables.

• •Vaccines, cosmetics, chemicals and herbal medicines.

• •Any other medicine-related problem affecting patient safety.

The session also reviewed the ADR reporting process—from detecting and documenting a suspected reaction to submitting reports to the Pharmacovigilance Centre for review, analysis and feedback.

Participants were introduced to the available reporting tools, including the Yellow Form (ICSR Form), the Med Safety App, VigiMobile, NAFDAC's toll-free reporting line (0800-1-623322) and the PRASCOR SMS platform (20543). A live demonstration of the VigiMobile application showed participants how to complete and submit electronic ADR reports accurately.

Calls for Stronger Clinical Practice and Research

The interactive session featured valuable contributions from senior pharmacists within the department.

The Head of the Department of Pharmaceutical Services, Pharm. Bilkisu Umar, encouraged pharmacists to strengthen multidisciplinary collaboration with other healthcare professionals, noting that pharmacists have historically played a significant role in influencing clinical decision-making. She stressed that ADR documentation is an integral part of pharmacists' professional responsibilities.

Pharm. Comfort Olurishe, Head of the Education, Research and Training Centre, announced plans to undertake research on medication errors, including prescribing, dispensing and administration errors. She explained that medication errors fall within the scope of pharmacovigilance and that the study aims to generate evidence to improve medication safety practices.

Drawing from clinical experience, Pharm. Bashir Garba, Assistant Director of Pharmaceutical Services, highlighted the importance of effective patient communication. He narrated how careful engagement with a patient revealed the use of a cheaper medicine purchased outside the hospital, which was suspected to have contributed to an adverse reaction. He noted that such interactions are essential for identifying and documenting medicine-related problems.

Also speaking, Pharm. Akinloye Bolaji Abdulfatai, Secretary of the ERT Centre, advocated greater emphasis on pharmacists' clinical competencies alongside their technical skills, describing continuous clinical development as essential for improving pharmaceutical care.

Supporting this position, Pharm. Abubakar Ibrahim, Chairman of the Association of Hospital and Administrative Pharmacists of Nigeria (AHAPN), ABUTH Chapter, proposed a departmental assessment of pharmacists' clinical competencies to identify areas requiring further capacity building and professional development.

A Renewed Commitment to Patient Safety

The sensitization concluded with a renewed commitment among participants to strengthen pharmacovigilance practice through timely reporting of medicine-related problems, continuous professional development and patient-centred pharmaceutical care.

As one of Nigeria's recognized zonal pharmacovigilance centres, ABUTH continues to play an important role in advancing medicine safety surveillance, supporting regulatory decision-making and promoting the safe and rational use of medicines in Nigeria.