Perceptions of Doctors to Adverse Drug Reaction Reporting in a Teaching Hospital in Lagos, Nigeria

Kazeem A Oshikoya; Jacob O Awobusuyi

Disclosures

BMC Clin Pharmacol. 2009;9:15 

In This Article

Results

Demographics

Of the 120 questionnaires distributed, 99 were duly filled and returned thus giving a response rate of 82.5%. The characteristic features of the respondents are shown in Table 1.

Doctors' Knowledge of ADR Reporting Scheme and Pharmacovigilance

The vast majority of the respondents (89, 89.9%) knew that, as doctors, they could report ADRs. Dentists (61, 61.6%), nurses (63, 63.6%) and pharmacists (63, 63.6%) were also considered capable of reporting ADRs. Individual persons (42, 42.5%) and physiotherapists (14, 14.1%) were considered the least important people to report ADRs. About half of the respondents (51, 51.5%) were aware of the existence of NPC in Nigeria among whom 20 (39.2%) correctly identified Abuja as the office. Less than a half (32, 32.3%) of the respondents was aware of the Yellow Card reporting scheme in Nigeria among whom only two had ever reported ADRs with a Yellow Card submitted to the NPC. The reporting was done only once by each of the respondents. The purposes of Yellow Card reporting scheme were incorrectly identified by the respondents as to identify safe drugs (35, 35.4%) and to calculate incidence of ADRs (25, 25.3%). Contrarily, the purposes of Yellow Card scheme were correctly identified by the respondents as to identify previously unrecognised reactions (44, 44.4%), to serve as a source of information about the characteristics of reactions (34, 34.3%) and to compare the adverse effects of drugs within the same therapeutic class (30, 30.3%). Most of the respondents knew that all ADRs should be reported to newly marketed drugs (92, 92.9%), and serious reactions should be reported for established products (88, 88.9%). When compared with the position/level of the respondents, there was no significant difference in reporting ADRs to newly marketed drugs (χ2 = 3.7, P = 0.49) and serious reactions to established products (χ2 = 5.1, P = 0.28). When compared with the responses for serious reactions to established products, a significantly higher number of the respondents knew that all reactions should be reported for over the counter (OTC) drugs (65/99; χ2 = 4.6, P = 0.03) and topical agents (63/99; χ2 = 2.25, P = 0.04), but the difference was not significant for vaccines (84/99; χ2 = 1.4, P = 0.27), herbal medicines (68/99; χ2 = 0.14, P = 0.72), antibiotics (89/99; χ2 = 0.01, P = 0.93), antimalarials (66/99; χ2 = 0.1, P = 0.75) reporting.

Attitudes to Reporting ADRs

Sixty-four respondents (64.6%) felt that ADR reporting was a professional obligation, 63 (63.6%) felt that all serious ADRs could be identified after a drug had been marketed and that one report made no difference to the Yellow Card reporting scheme. About half (52, 52.5%) of the respondents opined that ADR reporting should be compulsory, 36 (36.4%) stated that ADR reporting should be voluntary and 11 (11.1%) were either unsure or not responding. There was a significant difference between the proportion of respondents that felt ADR reporting should be either compulsory or voluntary (χ2 = 38.9, P < 0.001). A very few respondents felt ADR reporters should be remunerated (22, 22.2%), have their identity hidden (18, 18.2%) and also the identity of the prescribers hidden (4). The two respondents that had alerted NPC of ADR with a Yellow Card were clear of what should be reported, however they both found the form too complex to fill.

Factors Influencing ADR Reporting

The respondents were encouraged to report ADRs if the reaction was serious (77, 77.8%) and unusual (70, 70.7%) in nature. Other factors that would influence ADR reporting include if the reaction was to a new product (58, 58.6%), certainly that the reaction was truly an ADR (45, 45.5%), and if the reaction was well recognised for a particular drug (46, 46.5%). Contrarily, those factors that would discourage the respondents from reporting ADRs are listed in Table 2. The fear of the report being wrong (47, 47.5%) was the most discouraging factor.

From the list of hypothetical cases of ADRs illustrated to the respondents, only five examples listed in Table 3 were considered reportable to the NPC. Palpitation to coartem® (58/98, 59.2%), skin rashes to roxithromycin (54/98, 55.1%) and jaundice to frusemide (53/98, 54.1%) would be reported more frequently. A significantly higher proportion of the respondents would report fixed drug eruption to co-trimoxazole and sulphadoxine/pyrimethamine than hiccup to enalapril (χ2 = 12.5, P = 0.02). There was no significant difference in the proportion of respondents that would report fixed drug eruption to co-trimoxazole and sulphadoxine/pyrimethamine and headache to isordil dinitrate (χ2 = 2.2, P = 0.68).

Education and Training on ADRs

Only one respondent had received training on how to report ADR with a Yellow Card. However, the respondent did not mention where the training was received. The majority of the respondents (98, 98.9%) are willing to undergo training on how to recognise ADRs and how to report them with a Yellow Card.

Improving ADRs Reporting

The various methods suggested by the respondents to improve ADR reporting are presented in Table 4. Continuous medical education, training and refresher courses (94, 95.9%) were the methods mostly recommended. Leaving the Yellow Card on the ward for easy accessibility (6) was considered the least important method.

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