MONITORING THE SAFETY OF ANTIRETROVIRALS IN SOUTH AFRICA

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1 MONITORING THE SAFETY OF ANTIRETROVIRALS IN SOUTH AFRICA Simangele Hlongwana Manager: Pharmaceutical System Development

2 IMPLEMENTING AN ACTIVE SURVEILLANCE SYSTEM IN KWAZULU-NATAL, SOUTH AFRICA

3 BACKGROUND KZN is one of the nine provinces in South Africa with 11 Health Districts Health care delivered through District Health System Health facilities broken down as follows: 74 Hospitals (District, Regional, Tertiary and Central) 17 Community Health Centres 553 Primary Health Care (PHC) facilities patients accessing ART as at December sites initiating ARVs Province in transition state of implementing nurse initiated management of ART (NIMART) at PHC

4 INTENSITY OF SURVEILLANCE 3 LEVELS OF ACTIVE SURVEILLANCE FOR ARVS SUPPORTED CEM Sentinel sites Solicited AME reporting ACADEMIK cohort study- 5 facilities Collection of selected indicators - 14 facilities ARV AE reporting by all accredited facilities

5 ENSURING THE SAFETY OF ARVS THROUGH PARTNERSHIP SPS/ SIAPS HAST Unit KZN Pharmaceutical Services VPPS programme rs prescribers and dispensers

6 SUPPORT FROM SPS/SIAPS Provided support since 2006 in the following areas: Trainings to health care workers on HIV/AIDS and Pharmacovigilance Implementation of active surveillance tools and guidelines Human Resources for focused surveillance Technical support Implementation of electronic system for data capture

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8 Total no. of AEs Cumulative no. of AE reports BENEFIT OF ACTIVE SURVEILLANCE No. of AEs reported before and after active surveillance implementation AE reporting for the period 2007 to June 2004 to May 2007 (3 yrs before) June 2007 to May 2010 (3 yrs after)

9 No. of AE reports per month CENTRALISATION VS DECENTRALISATION Centralisation-approval for changes to ARV regimens done by Head Office Decentralisation- approval process devolved to facility level capacity building Average AE reporting per month Reporting period % of accredited sites reporting (n=91) Centralisation (May Sep2009) 88% Decentralisation (Oct Nov 2011) 86% Centralisation (May Sep2009) 647 Decentralisation (Oct Nov 2011)

10 OLD VERSUS NEW ARV TREATMENT GUIDELINES % distribution of AEs before and after change in ARV treatment guidelines Transaminitis/Hepatitis Anaemia Serious Skin reactions Other Gynaecomastia Lactic Acidosis Symptomatic Hyperlactactaemia Lipodystrophy Peripheral Neuropathy AEs before April 2010 (n=10065)-d4t based regimen AEs after April 2010 (n=15048)-tdf based regimen

11 ACADEMIK STUDY PROGRESS Commenced in December 2010 and ends in June study sites currently enrolled Approximately 1800 patients enrolled in the project vs. target of Currently in the data analysis phase CHALLENGES Lack of cooperation of site investigators-no dedicated HR at study sites and high staff turnover Challenges with protocol implementation- poor recruitment and recording of patient management information at sites Project based on assumptions SUCCESSES Improved systems and patient flow at study sites Improved quality of care of patients

12 GENERAL CHALLENGES OF ACTIVE SURVEILLANCE Poor budget allocation No dedicated pharmacovigilance unit Poor planning by DoH to sustain activities after support from partners Lack of cooperation from the clinical practitioners Quality of reports not optimal No provincial pharmacovigilance committee Reports not submitted to regulatory authority

13 SUCCESSES Support from SPS/SIAPS Trainings conducted on Pharmacovigilance and awareness of ARV medicine safety Development of a platform for continued solicited and sentinel site surveillance Electronic system available to capture reports Ongoing solicited reporting by facilities despite challenges Fair number of reports received from facilities Fair number of facilities initiating ARVs submitting reports

14 STRATEGIES AND NEXT STEPS Establish pharmacovigilance unit with financial and human resources Revive PhV committees at all levels (district and provincial)- link these to PTCs at all levels Produce regular reports and present them at provincial and district level Strengthen reporting by sentinel sites - flagship sites for monitoring specific AEs of interest Strengthen the electronic system to link the submission to regulatory authorities Strengthen the reporting of AEs at PHC level to support NIMART

15 STRATEGIES AND NEXT STEPS Expansion of surveillance to incorporate TB adverse events High burden of drug resistant TB Increased toxicity with TB/HIV co-medication especially MDR/XDR TB Move toward treatment of MDR TB in the communityhence mechanism needed to ensure AE reporting for both TB/HIV medicines Implementation of an adapted reporting tool for TB/HIV AEs is needed

16 ADVERSE EVENT REPORTING FORM FOR TB AND HIV Facility: Fax No: Date of event: PATIENT DETAILS Gender: M Patients Name and Surname: Age: ID No: F Race: Weight: Height: Pregnant : Y N MEDICATION HISTORY- INDICATE ALL THE MEDICATION THAT THE PATIENT IS CURRENTLY TAKING (TB/HIV plus all acute/chronic and traditional) & CIRCLE THE SUSPECTED MEDICINE Diagnosis/Disease Name & strength of medicine Dose and dosing interval (e.g. 300mg bd) Date Commenced Date Stopped (if applicable) Tick the suspected medicine Adverse Drug Event Type (Tick event) Ototoxicity Deafness Ringing in ears Hepatic Description of event/severity ADVERSE EVENT Date of onset Date resolved (if applicable) Laboratory Values on Diagnosis of the Event/Clinical Investigations (if applic.) Hepatitis ALT: AST: Pancreatitis Amylase Level: Renal Nephrotoxicity Baseline CrCl: Current CrCl: Renal Failure Baseline CrCl: Current CrCl:

17 ASANTE! NGIYABONGA! THANK YOU!