Transcript Training course on Introducing pharmacovigilance into HIV/AIDS

Training course on Introducing
pharmacovigilance into
HIV/AIDS programmes
Pretoria, South Africa,
September 1-10,2004
Training course on Introducing pharmacovigilance into HIV/AIDS programmes
ANTIRETROVIRALS USED IN KENYA
Presentation by
Dorine Kagai and Wilfred Oguta
STRUCTURE FOR PROVISION OF ARV DRUGS
NATIONAL AIDS CONTROL COUNCIL(NACC)
MINISTRY OF HEALTH
OTHER MINISTRIES
Ministerial Aids Committees
Pharmacy &Poisons Board
Drug regulation
Market surveillance
Kenya Medical Supply Agency(KEMSA0
National Aids and STI Control Programme
(NASCOP)
Training Healthcare Workers
Procurement and provision
Guidelines and policy on …
Implementation of ART in hospitals
Assessment and supervision
Procurement and distribution
of medicines
OTHERS
Training course on Introducing pharmacovigilance into HIV/AIDS programmes
Role of NACC
• Oversees and coordinates all the HIV/AIDS Committees
• Communication to the public. (VCT .Prevention. Advertisement)
• Resource mobilization
NASCOP is involved in:
• Training HEALTHCARE workers
• Procurement and provision
– What to procure? Specifications.
– What quantities?
– This is done in collaboration with Ministerial Tender Committee (MTC) and Kenya Medical
Supplies Agency (KEMSA) .Directorate of Public Procurements (DPP) is also involved.
• Guidelines and Policy
• Implementation of antiretroviral therapy programmes in hospitals
• Supervision and assessment
Training course on Introducing pharmacovigilance into HIV/AIDS programmes
• Storage and Distribution of antiretroviral is
done by KEMSA.
• NASCOP assists with coordination of
distribution i.e.
• Whom to give and how much
• Draws the list of allocations
Training course on Introducing pharmacovigilance into HIV/AIDS programmes
• Initial installation of the drugs is done by
NASCOP i.e.
• Training of healthcare workers on tracking of patients,
dosage regimen and any changes as may be necessary.
Guidelines followed.
• Drugs are given as patient packs for purposes of promoting
patient compliance and should not be broken
• Logistics data collection and reporting. Patients, numbers,
gender, age, regimen used, opportunistic infections etc.
Monthly summary and request forms very useful.
Supervision and assessment
• Quarterly logistics monitoring, evaluation and
supervision conducted by NASCOP / KEMSA to
check stock status conditions including;
Adequacy of stocks
 Out of stock situations
 Damages/Losses
 Expiry dates
 storage conditions
-security
-temperatures
-accessibility
 Accuracy of logistics data submitted.

Training course on Introducing pharmacovigilance into HIV/AIDS programmes
DRUGS USED
Already available in public sector
• Stavudine (d4T)
• Lamivudine (3TC)
• Nevirapine (NVP)
• Efavirenz (EFV)
To be available in the next few months
• Zidovudine (AZT)
• Didanosine (ddI)
• Lopinavir/ritonavir (Kaletra) Lpv/r
• Nelfinavir (NFV)
Training course on Introducing pharmacovigilance into HIV/AIDS programmes
Drugs used…
According to the National Antiretroviral Therapy guidelines
first line
and second line regimen are given as follows:
1st Line
d4T+ 3TC + NVP
or
D4t +3TC +EFV for patients on Rifampicin, those who
react to NVP, or those previously on EFV
2nd Line
ddI + AZT + Lpv/r
or
ddI + AZT + NLF for those who react to Lpv/r or are intolerant.
Training course on Introducing pharmacovigilance into HIV/AIDS programmes
Prevention of Mother to Child Transmission (PMTCT)
Nevirapine 200mg to the mother at onset of labour and 2mg/kg body wt to
the baby 72 hrs from birth
OR
AZT 300mg OD from 36 weeks gestation, then 300 q3hrs at onset of labour
OR
AZT 100mg 5 times daily from 14 weeks gestation, and to the baby 2 mg
/kg body weight qid for six weeks
OR
Mother started on HAART if <20 weeks gestation and the baby given either
NVP 2mg/kg body wight within 72 hours of delivery or AZT 2mg/kg body
weight for 6 weeks.
Training course on Introducing pharmacovigilance into HIV/AIDS programmes
For Post Exposure Prophylaxis (PEP.)
3TC 150mg bd + AZT 300mg bd.
Pediatric Regime
1st line.
AZT + 3TC + NVP
OR
d4T + 3TC + NVP.
2nd line.
AZT + ddI + LPV/r (If patient was on AZT as 1st line.)
OR
d4T + ddI + LPV/r (If patient was on d4T as 1st line.)
Training course on Introducing pharmacovigilance into HIV/AIDS programmes
MONITORING OF DRUGS
• The drug regulatory authority (Pharmacy and Poisons
Board-PPB) is in charge of Post-Marketing Surveillance
and monitoring of drugs.
• The National Quality Control Laboratory (NQCL) is
mandated to do quality analysis of all drugs.
• However, adverse drug reactions/events monitoring and
reporting has not been developed.
MONITORING OF DRUGS….
• Some specific programmes e.g. Malaria Control
Programme perform random sampling and quality
analysis of relevant drugs in the market
• Every batch of antiretroviral received at KEMSA is
subjected to quality checks (specifically assay,
dissolution and lately friability tests)
• Discussions with NQCL and PPB to develop a post-
marketing surveillance programme for ARVs are ongoing.