The involvement of nurses in reporting suspected adverse drug reactions: experience with the meningococcal vaccination scheme

• Published in: British journal of clinical pharmacology 2003-12, Vol.56 (6), p.658-663
• Main Authors: Ranganathan, S. Sri, Houghton, J. E., Davies, D. P., Routledge, P. A.
• Format: Article
• Language: English
• Subjects: Adolescent; adverse drug reaction; Adverse Drug Reaction Reporting Systems - organization & administration; Adverse Drug Reaction Reporting Systems - statistics & numerical data; Bacterial diseases; Bacterial diseases of the nervous system. Bacterial myositis; Biological and medical sciences; Child; Child, Preschool; Family Practice - statistics & numerical data; Human bacterial diseases; Humans; Infant; Infant, Newborn; Infectious diseases; Injections; Medical sciences; meningococcal group C conjugate vaccine; Meningococcal Vaccines - administration & dosage; Meningococcal Vaccines - adverse effects; Neisseria meningitidis; Nurse Practitioners - statistics & numerical data; nurses; Pharmacovigilance; Professional Practice; Skin Diseases - chemically induced; Wales; yellow card
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1046/j.1365-2125.2003.01903.x

Aims  In order to aid the monitoring of the new Meningococcal serogroup C Conjugate (Men C) vaccine, the Yellow Card Scheme was extended to allow nurses for the first time to report any suspected adverse reactions associated with these vaccines. We have analysed the Yellow Cards received by the Committee on Safety of Medicines (CSM) Wales from nurses reporting a suspected reaction in association with these vaccines during the first 16 months of the programme. Methods  CSM Wales receives Yellow Cards from healthcare professionals in Wales. Details of Yellow Cards reporting a suspected adverse reaction associated with Men C vaccines during the study period were extracted from the CSM Wales database and analysed according to health professional category [nurses, General Practitioners (GP), hospital doctors or pharmacists]. Results  During the study period 534 117 doses of Men C vaccines were administered in Wales; in the same period CSM Wales received 1095 Yellow Cards containing 1952 suspected reactions. Nurses completed 529 [48.3%, 95% confidence interval (CI) 43.6, 53.1] Yellow Cards compared with 294 (26.8%, 95% CI 22.7, 30.8) from GPs, 262 (23.9%, 95% CI 20.1, 27.6) from hospital doctors and 10 (0.91%, 95% CI 0.43, 1.73) from others, which include hospital pharmacists, community pharmacists and health visitors. The proportion of Yellow Cards sent by nurses was significantly higher than those sent by GPs and hospital doctors. Ninety‐five percent CIs for differences in proportions (CI diff prop) were (0.175, 0.254) and (0.204, 0.282), respectively. The majority (90.9%, 95% CI 88.7, 93.5) of the Yellow Cards from nurses reported suspected reactions children in over the age of 5 (95% CI diff prop 0.861, 0.917). The spectrum of suspected adverse drug reactions (ADRs) involved the skin and subcutaneous tissue, central nervous system, general reactions, and the gastrointestinal tract. Of the suspected reactions reported by nurses, GPs and hospital doctors, 13.4% (95% CI 10.5, 15.8), 12.9% (95% CI 9.6, 16.8) and 9.1% (95% CI 6.5, 11.8), respectively, were of serious reactions. Nurses reported 52.5% (95% CI 45.4, 60.6) of all the suspected serious reactions, which was statistically more significant than hospital doctors [χ2 = 5.864, degree of freedom (DF) = 1, P  0.05). Conclusions  Nurses were the health professionals who provided the largest proportion of reports of suspected ADRs and almost half of all reports during