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Using focused pharmacovigilance for ensuring patient safety against antileishmanial drugs in Bangladesh's National Kala-azar Elimination Programme.
Infect Dis Poverty. 2018 Aug 13; 7(1):80.ID

Abstract

BACKGROUND

Adverse effects of antileishmanial drugs can affect patients' quality of life and adherence to therapy for visceral leishmaniasis (VL) and post-kala-azar dermal leishmaniasis (PKDL). In Bangladesh, there are 26 treatment centers that manage leishmaniasis cases coming from 100 endemic upazilas (subdistricts) of 26 districts (these include VL, PKDL, treatment failure, and relapse VL and cutaneous leishmaniasis cases). This study aimed to investigate the feasibility of using focused pharmacovigilance for VL (VLPV) in Bangladesh's National Kala-azar Elimination Programme for the early detection and prevention of expected and unexpected adverse drug reactions (ADRs).

METHODS

This activity has been going on since December 2014. Activity area includes secondary public hospital or Upazila health complex (UHC) in hundred sub districts and Surya Kanta Kala-azar Research Center (SKKRC) in Mymensingh District, a specialized center for management of complicated VL and PKDL cases. Communicable Disease Control (CDC) of the Directorate General of Health Services (DGHS) assigned twenty five of hundred UHCs and SKKRC (total 26) as treatment centers depending on their suitable geographical location. This was implemented for better management of VL cases with Liposomal Amphotericin B (AmBisome®) to ensure patient convenience and proper utilization of this expensive donated drug. A VLPV expert committee and a UHC VLPV team were established, an operational manual and pharmacovigilance report forms were developed, training and refresher training of health personnel took place at UHCs and at the central level, collected information such as patient data including demographics, treatment history and response, adverse events were analyzed. This report includes information for the period from December 2014 to December 2016.

RESULTS

From December 2014 to December 2016, 1327 leishmaniasis patients were treated and 1066 (80%) were available for VLPV. Out of these, 57, 33, 9, and 1% were new VL, PKDL, VL relapse, and other cases, respectively. Liposomal amphotericin B was mostly used (82%) for case management, followed by miltefosine (20%) and paromomycin (3%). Out of the 1066 patients, 26% experienced ADRs. The most frequent ADR was fever (17%, 176/1066), followed by vomiting (5%, 51/1066). Thirteen serious adverse events (SAEs) (eight deaths and five unexpected SAEs) were observed. The expert committee assessed that three of the deaths and all unexpected SAEs were possibly related to treatment. Out of the five unexpected SAEs, four were miltefosine-induced ophthalmic complications and the other was an AmBisome®-induced avascular necrosis of the nasal alae. The Directorate General of the Drug Administration entered the ADRs into the World Health Organization Uppsala Monitoring Centre (WHO-UMC) VigiFlow database.

CONCLUSIONS

This study found that VLPV through NKEP is feasible and should be continued as a routine activity into the public health system of Bangladesh to ensure patient safety against anti-leishmanial drugs.

Authors+Show Affiliations

68 Shaheed Taj Uddin Ahmed Sarani, Parasitology Laboratory, International Centre for Diarrhoeal Disease Research (icddr,b), Mohakhali, Dhaka, 1212, Bangladesh.Program for Appropriate Technology in Health (PATH), 15th Floor, Dr. Gopal Das Bhawan 28 Barakhamba Road, New Delhi, 110001, India.Communicable Disease Control Unit, Directorate General of Health Services, Government of Bangladesh, Mohakhali, Dhaka, 1212, Bangladesh.Adverse Drug Reaction Monitoring Cell, Directorate General of Drug Administration (DGDA), Government of Bangladesh, Mohakhali, Dhaka, 1212, Bangladesh.Program for Appropriate Technology in Health (PATH), 15th Floor, Dr. Gopal Das Bhawan 28 Barakhamba Road, New Delhi, 110001, India.Adverse Drug Reaction Monitoring Cell, Directorate General of Drug Administration (DGDA), Government of Bangladesh, Mohakhali, Dhaka, 1212, Bangladesh.Program for Appropriate Technology in Health (PATH), 15th Floor, Dr. Gopal Das Bhawan 28 Barakhamba Road, New Delhi, 110001, India.68 Shaheed Taj Uddin Ahmed Sarani, Parasitology Laboratory, International Centre for Diarrhoeal Disease Research (icddr,b), Mohakhali, Dhaka, 1212, Bangladesh.Communicable Disease Control Unit, Directorate General of Health Services, Government of Bangladesh, Mohakhali, Dhaka, 1212, Bangladesh.68 Shaheed Taj Uddin Ahmed Sarani, Parasitology Laboratory, International Centre for Diarrhoeal Disease Research (icddr,b), Mohakhali, Dhaka, 1212, Bangladesh.68 Shaheed Taj Uddin Ahmed Sarani, Parasitology Laboratory, International Centre for Diarrhoeal Disease Research (icddr,b), Mohakhali, Dhaka, 1212, Bangladesh. Infectious Disease Research Institute (IDRI), Seattle, USA.Program for Appropriate Technology in Health (PATH), 15th Floor, Dr. Gopal Das Bhawan 28 Barakhamba Road, New Delhi, 110001, India.68 Shaheed Taj Uddin Ahmed Sarani, Parasitology Laboratory, International Centre for Diarrhoeal Disease Research (icddr,b), Mohakhali, Dhaka, 1212, Bangladesh. din63d@icddrb.org. Nutrition Infection Interaction Research Group, Nutrition and Clinical Services Division (icddr,b), Dhaka, 1212, Bangladesh. din63d@icddrb.org.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30099967

Citation

Hossain, Md Sakhawat, et al. "Using Focused Pharmacovigilance for Ensuring Patient Safety Against Antileishmanial Drugs in Bangladesh's National Kala-azar Elimination Programme." Infectious Diseases of Poverty, vol. 7, no. 1, 2018, p. 80.
Hossain MS, Kumar A, Hossain AFMA, et al. Using focused pharmacovigilance for ensuring patient safety against antileishmanial drugs in Bangladesh's National Kala-azar Elimination Programme. Infect Dis Poverty. 2018;7(1):80.
Hossain, M. S., Kumar, A., Hossain, A. F. M. A., Mahshin, M., Sharma, A., Hossain, M. A., Sharma, V., Haque, R., Shamsuzzaman, A. K. M., Maruf, S., Ghosh, P., Ahuja, V., & Mondal, D. (2018). Using focused pharmacovigilance for ensuring patient safety against antileishmanial drugs in Bangladesh's National Kala-azar Elimination Programme. Infectious Diseases of Poverty, 7(1), 80. https://doi.org/10.1186/s40249-018-0461-0
Hossain MS, et al. Using Focused Pharmacovigilance for Ensuring Patient Safety Against Antileishmanial Drugs in Bangladesh's National Kala-azar Elimination Programme. Infect Dis Poverty. 2018 Aug 13;7(1):80. PubMed PMID: 30099967.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Using focused pharmacovigilance for ensuring patient safety against antileishmanial drugs in Bangladesh's National Kala-azar Elimination Programme. AU - Hossain,Md Sakhawat, AU - Kumar,Amresh, AU - Hossain,A F M Akhtar, AU - Mahshin,Md, AU - Sharma,Abhijit, AU - Hossain,Md Akter, AU - Sharma,Varun, AU - Haque,Rashidul, AU - Shamsuzzaman,A K M, AU - Maruf,Shomik, AU - Ghosh,Prakash, AU - Ahuja,Vivek, AU - Mondal,Dinesh, Y1 - 2018/08/13/ PY - 2017/11/09/received PY - 2018/07/11/accepted PY - 2018/8/14/entrez PY - 2018/8/14/pubmed PY - 2018/12/12/medline KW - Antileishmanial drugs KW - Bangladesh KW - Health system KW - Pharmacovigilance KW - Visceral leishmaniasis SP - 80 EP - 80 JF - Infectious diseases of poverty JO - Infect Dis Poverty VL - 7 IS - 1 N2 - BACKGROUND: Adverse effects of antileishmanial drugs can affect patients' quality of life and adherence to therapy for visceral leishmaniasis (VL) and post-kala-azar dermal leishmaniasis (PKDL). In Bangladesh, there are 26 treatment centers that manage leishmaniasis cases coming from 100 endemic upazilas (subdistricts) of 26 districts (these include VL, PKDL, treatment failure, and relapse VL and cutaneous leishmaniasis cases). This study aimed to investigate the feasibility of using focused pharmacovigilance for VL (VLPV) in Bangladesh's National Kala-azar Elimination Programme for the early detection and prevention of expected and unexpected adverse drug reactions (ADRs). METHODS: This activity has been going on since December 2014. Activity area includes secondary public hospital or Upazila health complex (UHC) in hundred sub districts and Surya Kanta Kala-azar Research Center (SKKRC) in Mymensingh District, a specialized center for management of complicated VL and PKDL cases. Communicable Disease Control (CDC) of the Directorate General of Health Services (DGHS) assigned twenty five of hundred UHCs and SKKRC (total 26) as treatment centers depending on their suitable geographical location. This was implemented for better management of VL cases with Liposomal Amphotericin B (AmBisome®) to ensure patient convenience and proper utilization of this expensive donated drug. A VLPV expert committee and a UHC VLPV team were established, an operational manual and pharmacovigilance report forms were developed, training and refresher training of health personnel took place at UHCs and at the central level, collected information such as patient data including demographics, treatment history and response, adverse events were analyzed. This report includes information for the period from December 2014 to December 2016. RESULTS: From December 2014 to December 2016, 1327 leishmaniasis patients were treated and 1066 (80%) were available for VLPV. Out of these, 57, 33, 9, and 1% were new VL, PKDL, VL relapse, and other cases, respectively. Liposomal amphotericin B was mostly used (82%) for case management, followed by miltefosine (20%) and paromomycin (3%). Out of the 1066 patients, 26% experienced ADRs. The most frequent ADR was fever (17%, 176/1066), followed by vomiting (5%, 51/1066). Thirteen serious adverse events (SAEs) (eight deaths and five unexpected SAEs) were observed. The expert committee assessed that three of the deaths and all unexpected SAEs were possibly related to treatment. Out of the five unexpected SAEs, four were miltefosine-induced ophthalmic complications and the other was an AmBisome®-induced avascular necrosis of the nasal alae. The Directorate General of the Drug Administration entered the ADRs into the World Health Organization Uppsala Monitoring Centre (WHO-UMC) VigiFlow database. CONCLUSIONS: This study found that VLPV through NKEP is feasible and should be continued as a routine activity into the public health system of Bangladesh to ensure patient safety against anti-leishmanial drugs. SN - 2049-9957 UR - https://www.unboundmedicine.com/medline/citation/30099967/Using_focused_pharmacovigilance_for_ensuring_patient_safety_against_antileishmanial_drugs_in_Bangladesh's_National_Kala_azar_Elimination_Programme_ L2 - https://idpjournal.biomedcentral.com/articles/10.1186/s40249-018-0461-0 DB - PRIME DP - Unbound Medicine ER -