This study has shown inadequate knowledge of doctors about ADRs and reporting similar to the previous reports among resident doctors in Nigeria and doctors in many countries across Europe,[18,22–24] America[25,26] and Asia.[27,28] Perhaps, the undergraduate training in pharmacovigilance and medicine risk perceptions may be either insufficient or improperly delivered to prepare the doctors for the task of ADR monitoring and reporting in their future career.
Spontaneous ADR reporting by other health professionals and individuals is practiced in many countries[29–31] and it is recommended by the NPC but not recognised by the respondents. This is reflected in their low percentages that considered individuals and physiotherapists qualified to report ADRs. A significant number of the respondents were not aware of the existence of a national pharmacovigilance centre in Nigeria and amongst those who were aware, only 39.2% were able to correctly identify Abuja as the office. Lack of knowledge of where ADRs should be reported would automatically affect reporting, therefore, awareness programmes; through publicity, would appear necessary to improve ADR reporting in Nigeria.
The general lack of awareness of ADR reporting system in Nigeria was reflected by the 63.4% of the respondents who did not know about the existence of a Yellow Card reporting scheme coupled with the fact that only two respondents had ever reported ADRs with a Yellow Card. This proportion is rather very low when compared to a similar reporting scheme among doctors in the United Kingdom, America, Netherland, Spain, China and India. The differences in the reporting rates may be attributed to the priority, attention and commitment given to pharmacovigilance by the government of these countries. Such attitudes need to be emulated by the Nigerian government.
When we compared the factors that may influence reporting by the respondents with those reported by Lopez-Gonzalez et al, the results were similar. Our study has shown that, like most countries around the world, ignorance (not feeling the need to report well recognised reaction), diffidence (concern that the ADR report may be wrong) and indifference (lack of time to fill in a report and a single unreported case may not affect ADR database) (Table 2) would significantly influence ADR-reporting among the doctors working in a Nigerian teaching hospital. However, complacency, fear, financial incentives and bureaucracy involved in filling in the Yellow Card would have a little influence on the respondents to report ADRs. Therefore ADR under-reporting in Nigeria appears to be associated more with knowledge gaps and attitudes of the doctors rather than with personal and professional characteristics reported in other studies.[18,19,36,37] Previous studies have shown that distribution and availability of Yellow Cards to the doctors increase ADRs reporting[22,38] but unfortunately, a very high proportion of the respondents did not consider this as an important means of improving reporting.
Most of the respondents were willing to report reactions to newly marketed drugs and serious reactions to established products because they perceived post-marketing surveillance as an important part of pharmacovigilance. Globally, vaccines and antibiotics are among the leading causes of ADRs, especially in children.[39–42] In addition to antibiotics, herbal medicines and antimalarial drugs have contributed significantly to ADRs in Nigeria; this may therefore explain the higher number of respondents who would report serious ADRs to these drugs when compared with OTC drugs and topical agents. Post marketing drug surveillance encouraged ADR reporting if reaction was serious and unusual in nature. These encouraging factors were recognised by over 70% of the respondents. The NPC is known not to receive reports of proven reactions. The respondents may probably not be aware of this as 46.5% of them would report a well recognised reaction to a particular drug.
Anxiety of respondents not to appear incompetent or become subject of ridicule may cause them to want to report only ADRs that they consider certainly were caused by a drug. Such fear may probably explain the 45.5% respondents with this response which is a consistent finding in other studies.[18,21] The need to allay this fear, through sensitisation and pharmacovigilance education by NAFDAC, cannot be over-emphasized.
The five hypothetical examples of ADRs reportable to NPC were recognised by 30% to 50% of the respondents. These values are rather low. Palpitation with the use of coartem, skin rashes to roxithromycin, and jaundice to frusemide were more recognised than thrombocytopenia to heparin and gastrointestinal bleeding to diclofenac as unusual reactions. The NAFDAC may need to formulate a guideline for health professionals to improve recognition of unusual ADRs.
Educational intervention has been shown to improve ADR reporting in Portugal and Rhode Island in the USA. Education and training on spontaneous ADR reporting and how to use the Yellow Card is very necessary among the doctors since only one respondent had ever received such training. Almost all the respondents showed interest in education and training. Continuous Medical Education, training and refresher courses were the most cited means of improving ADR reporting. This certainly shows that the doctors are willing to improve their knowledge of ADR reporting and increase their participation in the Yellow Card reporting scheme if education and awareness on the reporting scheme is instituted in the hospital. The other methods recommended by the respondents such as instituting and encouraging feedback between patients, prescribers and dispensers of drugs, receiving reminders and increased awareness from ADR Monitoring Committee, and increasing the awareness of other healthcare professionals on reporting ADRs are very important and can certainly be considered as examples of a good practice that should be instituted in the hospital. Most of the factors considered unimportant to improve ADR reporting (Table 4) had been implemented in the developed countries and have yielded good results.[14,18,19,44] Efforts should be made at implementing these methods in the teaching hospital.
The objective of this study was to evaluate the attitudes and knowledge of doctors in a teaching hospital in Lagos, Nigeria to spontaneous ADR reporting. However, this study was limited by not comparing the attitudes and knowledge of the doctors with their years of practice and position/level. This is likely to be addressed in our future studies. It would be logical to extend this study to other teaching hospitals in Nigeria to enable us generalise our findings.
BMC Clin Pharmacol. 2009;9:15 © 2009
Cite this: Perceptions of Doctors to Adverse Drug Reaction Reporting in a Teaching Hospital in Lagos, Nigeria - Medscape - Aug 11, 2009.