Pharmacovigilance of suspected or confirmed therapeutic ineffectiveness of artemisinin-based combination therapy: extent, associated factors, challenges and solutions to reporting

Background Therapeutic ineffectiveness of artemisinin-based combination therapy (ACT) increases the risk of malaria-related morbidity and mortality, and raises healthcare costs. Yet, little has been done to promote the pharmacovigilance (PV) of ACT ineffectiveness in sub-Saharan Africa, particularly in Uganda. This study aimed to determine the extent and associated factors of the past 6 months reporting of suspected or confirmed ACT therapeutic ineffectiveness by healthcare professionals (HCPs), and difficulties and potential solutions to the PV of ACT therapeutic ineffectiveness. Methods Survey of 685 HCPs conducted using a self-administered questionnaire from June to July 2018 in a nationally representative sample of public and private health facilities in Uganda. HCPs disclosed if they had spontaneously reported ACT therapeutic ineffectiveness to appropriate authorities in the previous 6 months. Multivariable logistic regression models were used to identify determinants of past 6-months, HCP-reported ACT therapeutic ineffectiveness. Results One in five (20%, 137/685; 95% CI 17–23%) HCPs reported ACT therapeutic ineffectiveness to an appropriate authority in the previous 6 months. HCPs commonly reported ACT therapeutic ineffectiveness to immediate supervisors (72%, 106/147), mostly verbally only (80%, 109/137); none had ever submitted a written report of ACT therapeutic ineffectiveness to Uganda’s National Pharmacovigilance Centre. Common difficulties of reporting ACT therapeutic ineffectiveness were: unavailability of reporting procedures (31%, 129/421), poor follow-up of treated patients (22%, 93/421) and absence of reporting tools (16%, 68/421). Factors associated with reporting ACT therapeutic ineffectiveness in the past 6 months were: hospital-status (vs other; OR = 2.4, 95% CI 1.41–4.21), HCPs aged under 25 years (OR = 2.2, 95% CI 1.29–3.76), suspicion of ACT therapeutic ineffectiveness in the past 4 weeks (OR = 2.3, 95% CI 1.29–3.92), receipt of patient-complaint(s) of ACT therapeutic ineffectiveness in the past 4 weeks (OR = 2.9, 95% CI 1.62–5.12) and HCPs from northern (vs central; OR = 0.5, 95% CI 0.28–0.93) and western (vs central; OR = 0.4, 95% CI 0.17–0.77) parts of Uganda. Conclusion One in five HCPs reported ACT therapeutic ineffectiveness, mostly verbally to supervisors. The existing adverse drug reaction (ADR)-reporting infrastructure could be leveraged to promote the PV of ACT therapeutic ineffectiveness.

Pharmacovigilance of suspected or confirmed therapeutic ineffectiveness of artemisinin-based combination therapy: extent, associated factors, challenges and solutions to reporting

Background Therapeutic ineffectiveness of artemisinin-based combination therapy (ACT) increases the risk of malaria-related morbidity and mortality, and raises healthcare costs. Yet, little has been done to promote the pharmacovigilance (PV) of ACT ineffectiveness in sub-Saharan Africa, particularly in Uganda. This study aimed to determine the extent and associated factors of the past 6 months reporting of suspected or confirmed ACT therapeutic ineffectiveness by healthcare professionals (HCPs), and difficulties and potential solutions to the PV of ACT therapeutic ineffectiveness.Methods Survey of 685 HCPs conducted using a self-administered questionnaire from June to July 2018 in a nationally representative sample of public and private health facilities in Uganda. HCPs disclosed if they had spontaneously reported ACT therapeutic ineffectiveness to appropriate authorities in the previous 6 months. Multivariable logistic regression models were used to identify determinants of past 6-months, HCP-reported ACT therapeutic ineffectiveness.Results One in five (20%, 137/685; 95% CI: 17-23%) HCPs reported ACT therapeutic ineffectiveness to an appropriate authority in the previous 6 months. HCPs commonly reported ACT therapeutic ineffectiveness to immediate supervisors (72%, 106/147), mostly verbally only (80%, 109/137); none had ever submitted a written report of ACT therapeutic ineffectiveness to Uganda’s National Pharmacovigilance Centre. Common difficulties of reporting ACT therapeutic ineffectiveness were: unavailability of reporting procedures (31%, 129/421), poor follow-up of treated patients (22%, 93/421) and absence of reporting tools (16%, 68/421). Factors associated with reporting ACT therapeutic ineffectiveness in the past 6 months were: hospital-status (vs other; OR = 2.4, 95% CI, 1.41-4.21), HCPs aged under 25 years (OR = 2.2, 95% CI, 1.29-3.76), suspicion of ACT therapeutic ineffectiveness in the past 4 weeks (OR = 2.3, 95% CI, 1.29-3.92), receipt of patient-complaint(s) of ACT therapeutic ineffectiveness in the past 4 weeks (OR = 2.9, 95% CI, 1.62-5.12) and HCPs from northern (vs central; OR = 0.5, 95% CI, 0.28-0.93) and western (vs central; OR = 0.4, 95% CI, 0.17-0.77) parts of Uganda.Conclusion One in five HCPs reported ACT therapeutic ineffectiveness, mostly verbally to supervisors. The existing adverse drug reaction (ADR)-reporting infrastructure could be leveraged to promote the PV of ACT therapeutic ineffectiveness.

Pharmacovigilance of suspected or confirmed therapeutic ineffectiveness of artemisinin-based combination therapies: extent, associated factors, challenges and solutions to reporting

Background: This study aimed to determine the extent and associated factors of past 6-month reporting of artemisinin-based combination therapy (ACT)-failure by healthcare professionals (HCPs); and difficulties and solutions to the pharmacovigilance (PV) of ACT therapeutic ineffectiveness.Methods: Survey of 685 HCPs from June to July 2018 in purposively selected public and private health facilities in Uganda.Results: One in five [20%, 137/685; 95% confidence intervals (CI) 17% to 23%] HCPs reported ACT-failure to any authority in the previous 6-months. HCPs commonly reported ACT-failure to immediate supervisors (72%, 106/147), mostly verbally only (80%, 109/137); none had ever reported a written ACT-failure to Uganda’s National Pharmacovigilance Centre. Common difficulties to reporting ACT-failure were; unavailability of reporting procedures (31%, 129/421), poor follow-up of treated patients (22%, 93/421) and absence of reporting tools (16%, 68/421). Factors associated with reporting ACT-failure in past 6-months were: hospital-status (vs other; OR = 2.4, 95% CI, 1.41 to 4.21), HCPs aged under 25 years (OR = 2.2, 95% CI, 1.29 to 3.76), suspicion of ACT-failure in past 4-weeks (OR = 2.3, 95% CI, 1.29 to 3.92), receipt of patient-complaint(s) of ACT-failure in past 4-weeks (OR = 2.9, 95% CI, 1.62 to 5.12) and HCPs from northern (vs central; OR = 0.5, 95% CI, 0.28 to 0.93) and western (vs central; OR = 0.4, 95% CI, 0.17 to 0.77) parts of Uganda.Conclusion: One in five HCPs reported ACT-failure, mostly verbally to supervisors. The existing ADR-reporting infrastructure should be leveraged to promote the PV of ACT therapeutic ineffectiveness.

A SNAP-SHOT OF FIRST-LINE ART TREATMENT FAILURE CASES FROM MPUMALANGA PROVINCE ON THE DECENTRALISED PHARMACOVIGILANCE PROGRAMME DATABASE

The increase in ART use comes with the inevitable increase in cases of ART treatment failure, especially that patients are living longer on ART. The main objective of this short study was to conduct an interim review of the Pharmacovigilance database at the National Pharmacovigilance Centre of South Africa in order to profile cases of treatment failure with first-line antiretroviral therapy among HIV-infected patients in Mpumalanga Province. From 2851 ADR reports, 853 were reported for male patients, 1699 females and 299 had no gender reported. A total of 271 patients were diagnosed with treatment failure. 170 of these were female, 78 male and for 23 of the reports, gender was unreported. The mean age of the patients who were reported to have treatment failure was 36 years. The highest number of treatment failure was reported from the age group 31 - 40 years with the majority being females. A strong correlation was observed between female sex and treatment failure. The South African National Pharmacovigilance Centre decentralized Pharmacovigilance database is a useful tool that can be used to consistently monitor and document ART treatment failures.

Adverse drug reaction to antiparkinson agents in Idiopathic Parkinson Disease: a prospective observational study in a Movement Disorder outpatient clinic

Background: Parkinson disease (PD) generally requires therapy for prolonged periods often with multiple drugs; drug-related adverse effects often add to the existing morbidity. Although, such ADRs are common, comprehensive information about their incidence, severity, and ultimate health effects are not available. The objective of the study was to analyze the pattern of occurrence of Adverse Drug Reactions (ADRs) in patients receiving anti-parkinson agents (APA) in a tertiary care hospital. We also aimed to assess the causality, severity and preventability of these ADRs.Methods: This prospective, observational study with 6 month follow up was conducted among consecutive PD patients receiving anti parkinson agents attending the Movement disorder clinic of Neurology department between April 1st 2011 and September 30th 2012. Tools used were ADR Reporting form of National Pharmacovigilance centre, WHO causality scale, Hartwig and Siegel scale to assess severity and Schumock and Thornton scale to assess preventability of ADRs. Descriptive statistics was used and the values were expressed in numbers and percentages.Results: ADRs were experienced in 87 patients (82.1%) out of 106 patients and most of these patients were on combination therapy (66%). No gender difference in distribution of ADRs was observed. The most common reactions were sedation, dizziness, dry mouth and fatigue. The drug usage was in the order of pramipexole (58.4%), levodopa+carbidopa (55.7%), trihexyphenidyl (28.3%), entacapone (5.7%) and amantadine (7.5%). Majority of the ADRs were mild level 1 (71.1%). ADR was maximum with entacapone. Majority of ADRs belonged to the causality possible ADR category. All the ADRs came under the definitely or probably preventable category.Conclusions: ADRs with antiparkinsonian drugs is common but mild and preventable.

Strengthening adverse drug reaction reporting in Nepal

Pharmacovigilance in Nepal is still in infancy. Till date only healthcare professionals are involved and the problem of underreporting is seen. The national pharmacovigilance centre is located in the national regulatory authority of Nepal, i.e. Department of Drug Administration (DDA). Lack of adequate human resources for managing the pharmacovigilance program in Nepal has been a limitation for the growth of pharmacovigilance activities. Currently, there is neither any involvement of community pharmacists in Adverse Drug Reaction (ADR) reporting process nor any involvement of consumers for the same. This paper reviews the current status of pharmacovigilance and mentions possible benefits of involving consumers or patients in the existing pharmacovigilance program. A systematic review were conducted by searching different databases like PubMed, Google scholar, EMBASE, NepJOL, and Scopus. This study also describes the role of healthcare professionals in ADR reporting, possible reasons for underreporting of ADRs, regulatory perspectives and benefits of involving consumers in pharmacovigilance. DOI: http://dx.doi.org/10.3126/ajms.v6i4.11659Asian Journal of Medical Sciences Vol.6(4) 2015 9-13

Strengthening the Pharmacovigilance Programme in Nepal

The aims of pharmacovigilance are early recognition of previously unknown adverse drug reactions (ADRs), recognition of changes in frequency of known ADRs, identification of risk factors and mechanism of ADRs, quantitative analysis of benefit/risk ratio and dissemination of safety information for rational drug prescribing and regulation. The pharmacovigilance programme in Nepal is a recent development. The Department of Drug Administration (DDA) took the initiative to set up a pharmacovigilance program in 2002; however, it was initiated systematically only after two years. DDA acts as the National Pharmacovigilance Centre (NPC). It collects ADR case reports from the Regional Pharmacovigilance Centre (RPC). Currently there are six RPCs operating in the country. The current reporting trends suggest high under-reporting of suspected ADRs. This paper is a review of those studies which are focused on pharmacovigilance and healthcare professionals’ perspectives on ADR reporting in Nepal. It also recommends the possible ways to improve the ADR reporting based on the context of Nepal.DOI: http://dx.doi.org/10.3126/nje.v3i1.8286 Nepal Journal of Epidemiology 2013;3 (1): 230-235