Addressing the under-reporting of adverse drug reactions in public health programs controlling HIV/AIDS, tuberculosis and malaria: A prospective cohort study

Background Adverse Drug Reactions (ADRs) are a major clinical and public health problem world-wide. The prompt reporting of suspected ADRs to regulatory authorities to activate drug safety surveillance and regulation appears to be the most pragmatic measure for addressing the problem. This paper evaluated a pharmacovigilance (PV) training model that was designed to improve the reporting of ADRs in public health programs treating the Human Immunodeficiency Virus (HIV), Tuberculosis (TB) and Malaria. Methods A Structured Pharmacovigilance and Training Initiative (SPHAR-TI) model based on the World Health Organization accredited Structured Operational Research and Training Initiative (SOR-IT) model was designed and implemented over a period of 12 months. A prospective cohort design was deployed to evaluate the outcomes of the model. The primary outcomes were knowledge gained and Individual Case Safety Reports (ICSR) (completed adverse drug reactions monitoring forms) submitted, while the secondary outcomes were facility based Pharmacovigilance Committees activated and health facility healthcare workers trained by the participants. Results Fifty-five (98%) participants were trained and followed up for 12 months. More than three quarter of the participants have never received training on pharmacovigilance prior to the course. Yet, a significant gain in knowledge was observed after the participants completed a comprehensive training for six days. In only seven months, 3000 ICSRs (with 100% completeness) were submitted, 2,937 facility based healthcare workers trained and 46 Pharmacovigilance Committees activated by the participants. Overall, a 273% increase in ICSRs submission to the National Agency for Food and Drug Administration and Control (NAFDAC) was observed. Conclusion Participants gained knowledge, which tended to increase the reporting of ADRs. The SPHAR-TI model could be an option for strengthening the continuous reporting of ADRs in public health programs in resource limited settings

An evaluation of the knowledge and utilization of the essential medicines list among health professionals in a tertiary institution in South-South, Nigeria.

Background: The concept of essential drugs is based on the premise that a limited number of effective, safe, high quality, reasonably priced drugs are capable of satisfying the priority health care needs of the majority of the population. The Essential Medicines list is intended for use across the three levels of the health care system to promote higher quality care, better management of medicines and a more cost-effective use of available health resources. This study assessed the current status, understanding and level of penetration of the concept amongst the health care providers in a tertiary healthcare facility in South-South, Nigeria, after four decades of its introduction.Methods: It is a cross-sectional, descriptive study conducted between January and July 2017..Results: A response rate of 92.7% (278/300) was obtained for questionnaires distributed More than half of the respondents were doctors (176; 63.3%). Nurses and pharmacists were 77(27.7%) and 24(8.6%) respectively. The mean age of the respondents was 34.8 ± 7.3. Males and females were almost equal in this study (males 47.1%, females 49.6%). There was significant awareness of the EML among all the health professionals (p=0.001). Pharmacist had better understanding of the concept of the EML document (p=0.001) and also exhibited a positive attitude in making use of the document in their daily practice (p<0.001) when compared with the doctors and nurses.Conclusion: This study found a high level of awareness of the EML among the health professionals, however it did not translate to their knowledge and utilization of the document. Key words: Essential medicines list, Health professionals, Nigeri

Medication use practices and inspection of returned pills during follow-up attendance at a tertiary care hypertension clinic in Nigeria

Background: Medication use practices in the treatment of hypertension (HTN) have been shown to determine outcomes. This study characterizes the profile of medication practices by hypertensive patients attending a tertiary health-care facility in Nigeria. Materials and Methods: This was a cross-sectional study in the outpatient HTN clinic of a tertiary hospital in southern Nigeria. Hypertensive patients seen during routine clinic visits were given the usual clinic instructions and requested to come with all medicines including herbal medications in their possession at their subsequent visits. A semi-structured observer-administered questionnaire was used to document all information sought and on medicines inspected. Data collected were analyzed and presented descriptively. Results: A total of 509 patients were recruited into the study (M:F ratio 1:2.2) aged 22–97 years. The mean(SD) number of all medicines used by the patients was 5.5 ± 2.While the mean(SD) number of antihypertensive medicines was 2.9 ± 1.3 with 75 patients (14.8%), 135 (26.6%), 144 (28.3%) and 154 (30.3%) on 1, 2, 3, and 4 or more antihypertensive medicines respectively. Calcium channel blocker was the most used antihypertensive medicine, 350 (68.8%). Of interest, was the use in 68 (13.4%) patients of unprescribed herbal medicines. A number of patients, i.e., 205 (40.2%) had discrepancy between their prescribed medicines and that presented to the clinic. This included the use of nonprescribed medicines, including analgesics (35%), vitamins (28.1%), nonsteroidal anti-inflammatory drugs (17.1%), and food supplements (6.8%). Conclusion: This study highlights the profile of antihypertensive medication use, revealing the significant use of nonprescribed medicines and factors likely to influence outcomes of therapy. It further underscores the importance of careful inspection during clinic attendance of all medication being taken by the patient

A Comparison of Two Instruments for the Assessment of Legibility of Prescriptions in a Developing Country

Purpose: To compare the utility of a rating and visual analogue scale for the assessment of legibility in prescriptions Methods: A sample of fifty randomly selected prescriptions from a tertiary hospital in Benin City, Nigeria was assessed by five independent assessors - three doctors and two pharmacists using a rating scale and a 100 mm visual analogue scale. Rating scores were allocated as: 0 - completely illegible; 1 - barely legible; 2 - moderately legible; 3 - clearly legible, and 4 - print. Visual analogue scores were measured in millimetres. Results: Rating and visual analogue scores were skewed. The median rating score by doctors and pharmacists were 2.0 and 3.0, respectively. Median visual analogue scores were 59.5, 67.0, 55.0, 51.5 and 46.0 mm, respectively. Inter-quartile ranges (rating scores) were 2.0 – 3.0 for both doctors and pharmacists except for one pharmacist whose inter-quartile range was 1.0 – 2.3; inter-quartile ranges (visual analogue scores) were 49.3 – 63.0, 59.8 – 71.0, 31.0 – 65.5, 40.8 – 62.0, 43.0 – 55.5 mm, for the five independent assessors. The pharmacists’ scores using either scale were significantly positively correlated (rs = 0.900; 2-tailed p = 0.05); one doctor’s scores were negatively correlated (rs = -0.308). Conclusion: The findings support the utility of both instruments in the assessment of handwriting but suggest that there may be important differences between doctors and pharmacists using either method

Sources of information on the use of medicines utilized by resident doctors in a tertiary health care facility in Nigeria

Background: The use of quality information is an essential element in ensuring rational pharmacotherapy and limiting the harmful effects of medicines. This study evaluates the available sources of information utilized by doctors undergoing training in a tertiary health care facility.Methods: The study was carried out at the University of Benin Teaching Hospital, Benin City, Nigeria – a 730 bed tertiary health care facility. Questionnaires were distributed to 120 junior and senior resident doctors during a general meeting of residents. Information sought included their demographic characteristics, the sources of information, category and frequency of request, frequency of utilization of the hospital drug information services among othersResults: The response rate was 99.2 % (119/120) – 91 junior and 28 senior residents with a practice time of 0.17 to 17 years (median(IQR) 1.5(1-6) The most frequent sources of information utilized were Monthly Index of Medical Specialties MIMS 73(61.3%), British National Formulary BNF 59(49.6%) and senior colleagues 53(44.5%). The reasons for seeking information included clarification of dosage requirements 112(94.1%), adverse drug reactions 97(81.5%), precautions 95(79.8%) and indications for use 86(72.3%). Of interest, is the finding that 100(84.0%) of doctors had not visited the hospital's drug information centre. Twenty five percent (25.2%) of doctors admitted to significant influence of pharmaceutical detailers' gifts on their prescribing habits.Conclusion: The study suggested a less than optimal utilization of objective information sources by doctors practicing in this low resource setting.Keywords : Drug information services, Physicians, Nigeri

Drug-related events in an emergency department of a tertiary health care facility in South- South Nigeria

Background: Drug-related adverse events refer to any injury from a medical intervention relating to a drug. This study identified suspected drug-related events presenting to the accident and emergency (A&E) unit of a teaching hospital. Methods: The adult admission registers of the A&E unit of the University of Benin Teaching Hospital, Benin-City, Nigeria were retrospectively reviewed over a four-year period (January 2015 –December 2018). Patients with diagnosis that may indicate a drug-related event were included in the study. Results: A total of 24510 new patients were seen over the 4- year period, with 648(2.6%) presenting with a drug-related event (DRE). There were 353 (54.5%) males, and the mean age (SD) was 48.9(20.4) years. Main DRE identified were adverse drug reactions (n=465, 71.8%) and of these, Non-steroidal antiinflammatory drugs (NSAIDs)-induced upper gastrointestinal bleeding (n=145, 31.2%), drug-induced hypoglycaemia (n=79, 21.5%), herbal medicines related events(n=27, 4.2%), were the commonest. Other DREs were substance abuse/misuse (n=105, 16.2 %), causing substance (notably cannabis) - induced mental and behavioural disorders (n=60, 9.3%), andlastly poisoning (n=78, 12%) which were mostly intentional poisoning (notably organophosphates) (n=43, 6.6%). Conclusions: Drug-related events constitute a significant burden on the emergency system. Upper gastrointestinal bleeding following use of NSAIDs, drug induced hypoglycaemia, organophosphate poisoning were found to be notable life threatening causes of emergency admissions. require multifaceted public health interventional strategies to mitigate the burden. Keywords: drug-related medical emergencies; adverse drug reactions; poisoning; anti-inflammatory agents non-steroidal; Nigeri

Economic burden, impact, and consequence of adverse drug reactions among medical inpatients in clinical practice

Background: An adverse drug reaction (ADR) is defined in this study as a response to a drug which is noxious and unintended that occurs at doses normally used for therapeutic purposes. Despite the extensive study and attention given to ADRs, they still represent a clinically significant problem and burden with high prevalence. Aim: The main aim of this study was to adequately evaluate the economic burden, impact, and consequence of ADRs among adult medical inpatients in clinical practice, to highlight the pattern of medications most frequently involved in ADRs, and to estimate the economic cost implication of treating ADRs in such clinical practice setting. Methods: The patients admitted into the adult medical wards of a Nigerian university teaching hospital over a 9-month period from December 2013 to August 2014 were prospectively recruited for the study and followed up till discharge. Results: Five hundred and seven patients were evaluated during the study, out of which 269 (53.1%) of them were male and 238 (46.9%) were female. The mean age of the study population was 48.9 ± 17.8 years (median: 46 years). Most ADRs were mild and moderate in 21 (41.2%) cases and 24 (47.1%) cases, respectively. Severe ADRs occurred in 2 (3.9%) cases, while four (7.8%) cases were fatal ADRs. The economic cost implication of treating ADRs was ₦ 161,668.00 ($1243.60), equivalent to about 1.9$24.38 ± $48.84), while the mean ADR treatment cost per admitted medical inpatient was ₦ 318.87 ($2.45). The most frequently affected body systems by ADRs were the central nervous system and the gastrointestinal system corresponding to the antidiabetic drug – insulin use causing neuroglycopenic symptoms and nonsteroidal anti-inflammatory drugs (NSAIDs) use causing NSAID-induced gastroenteritis/GIT bleeding, respectively. Conclusions: The economic burden, impact, and consequence of ADRs were significantly high among these adult medical inpatients. In this study, ADRs increase patients' morbidity, mortality, cost of health care, and length (duration) of hospitalization. Insulin and NSAIDs caused the highest number of ADRs which indicate that adequate caution, proper care, and continuous monitoring must be implemented during the course of treating patients with these drugs to optimize their clinical efficacy and prevent the occurrence of ADRs in them

Pattern of medications causing adverse drug reactions and the predisposing risk factors among medical in-patients in clinical practice: A prospective study

Background: Pharmacological interventions sometimes carry inherent significant risks which include adverse drug reactions (ADRs), drug interactions (DIs) and other consequences of inappropriate medication use. An adverse drug reaction (ADR) is defined in this study as a response to a drug which is noxious and unintended that occurs at doses normally used in man for therapeutic purposes. Despite the extensive study and attention given to ADRs, they still represent a clinically significant problem and burden with high incidence and prevalence. Aim: The main aim of this study was to evaluate and highlight the pattern of medications most frequently involved in ADRs and the predisposing risk factors among adult medical in-patients in clinical practice setting with the goal of preventing them and improving their treatment outcome. Methods: The patients admitted into the adult medical wards of a Nigerian University Teaching Hospital over a 9-month period from December 2013 to August 2014 were prospectively recruited for the study and followed up till discharge. Results: Five hundred and seven (507) patients were evaluated during the study, out of which 269 (53.1%) of them were males and 238 (46.9%) were females. The mean age of the study population was 48.9 ± 17.8 years (median of 46 years). The drugs most frequently involved in ADRs were insulin in 14 (27.5%) patients, Non-steroidal Anti-inflammatory drugs in 10 (19.6%) patients, antihypertensives in 8 (15.7%) patients, antimalarials in 5 (9.8%) patients, herbal medications in 4 (7.8%) patients and antibacterials in 3 (5.9%) patients. Furthermore, four (4) fatal ADRs were observed during the study; in which herbal medications caused two (2) deaths, sulfadoxine/pyrimethamine combination (maloxine®) caused one (1) death, and Iron dextran caused one (1) death. The most frequently affected body systems by ADRs were the central nervous system and the gastrointestinal system corresponding to the Antidiabetic drug-insulin use causing neuroglycopenic symptoms and Non-steroidal Anti-inflammatory drugs (NSAIDs) use causing NSAID-induced gastroenteritis/GIT bleeding, respectively. The elderly age group (≥ 65 years), presence of polypharmacy (taking more than 5 different pharmacologically active medications by a particular patient at the same time) and the presence of multiple comorbidities in a particular patient are clinically proven and significant risk factors found to be associated with and predisposed adult medical in-patients to ADRs in this study. Conclusion: The negative health burden and consequences of ADRs with the predisposing risk factors were significantly high among these adult medical in-patients. In this study, ADRs increase patients morbidity, mortality and length (duration) of hospitalization. Insulin and NSAIDs caused the highest number of ADRs which indicate that adequate caution, proper care and continuous monitoring must be implemented during the course of treating patients with these drugs in order to optimize their clinical efficacy and prevent the occurrence of ADRs in them

Funding and financial sustainability of pharmacovigilance: suggested models for funding pharmacovigilance in resource-limited African countries

Background: An important factor hindering the growth of pharmacovigilance (PV) in resource-limited settings is the lack of adequate funds to establish a functional National Pharmacovigilance System. Consequently, the crucial function of monitoring and ensuring the availability of safe medicines in these settings cannot be guaranteed considering the peculiarities of diseases and medicines used. Objectives: The objective of this paper is to provide an overview as to the availability of potential sources of funds, which could be explored to ensure Medicine Safety and to proffer a potential framework likely to ensure sustainable funding of PV in Africa. Methods/processes: The process of developing this framework entailed a review of PV financing in some developed economies, a landscape study of funding of PV in some African countries, an in-depth understanding of the PV system and the organisational structure and nexus between the regulatory agencies and National Pharmacovigilance Centre. Critical points for consideration included the sources of funds, revenue pool, the disbursement of funds, budgeting and expenditure profile and the legal framework. Consultative meetings, webinars and interviews with experts were carried out. Results: The findings showed that most of the PV systems were mainly integrated into the regulatory agencies regarding operational and fiscal governance with few facilities being independent of the regulatory agencies. The main source of funding was from the government with significant donor funding which is ad hoc and non-sustainable. Several potential sources were identified but yet to be exploited. There were no legal provisions for PV financing. A framework likely to ensure sustainable PV financing is suggested to capture all available sources of funding, mine the potential sources providing a sizeable pool of revenue to address its activities and enabling legal framework which will engender autonomy. Furthermore, it will address the nexus between the regulatory agencies and the PV outfits, thus enabling appropriate share of resources and blockage of diversions. Conclusion: In all, addressing the various elements identified in this study and providing the legal provisions which guarantees some degree of autonomy will provide a sustainable mechanism for PV funding in the resource-limited setting of Africa