training course on introducing pharmacovigilance into hiv/aids programmes

Training course on Training course on Introducing Introducing

pharmacovigilance into pharmacovigilance into HIV/AIDS programmesHIV/AIDS programmes

Pretoria, South Africa,Pretoria, South Africa,September 1-10,2004September 1-10,2004

Training course on Introducing pharmacovigilance into HIV/AIDS programmesTraining course on Introducing pharmacovigilance into HIV/AIDS programmes

ANTIRETROVIRALS USED IN KENYAANTIRETROVIRALS USED IN KENYA

Presentation by Presentation by

Dorine Kagai and Wilfred Oguta Dorine Kagai and Wilfred Oguta

STRUCTURE FOR PROVISION OF ARV DRUGSSTRUCTURE FOR PROVISION OF ARV DRUGS

NATIONAL AIDS CONTROL COUNCIL(NACC) NATIONAL AIDS CONTROL COUNCIL(NACC)

MINISTRY OF HEALTHMINISTRY OF HEALTH OTHER MINISTRIESOTHER MINISTRIES OTHERSOTHERS

Ministerial Aids CommitteesMinisterial Aids Committees

Pharmacy &Poisons BoardPharmacy &Poisons BoardDrug regulationDrug regulationMarket surveillanceMarket surveillance

Kenya Medical Supply Agency(KEMSA0Kenya Medical Supply Agency(KEMSA0

National Aids and STI Control ProgrammeNational Aids and STI Control Programme Procurement and distribution Procurement and distribution (NASCOP)(NASCOP) of medicinesof medicines

Training Healthcare WorkersTraining Healthcare WorkersProcurement and provisionProcurement and provisionGuidelines and policy on …Guidelines and policy on …Implementation of ART in hospitalsImplementation of ART in hospitalsAssessment and supervisionAssessment and supervision


Role of NACC Role of NACC • Oversees and coordinates all the HIV/AIDS CommitteesOversees and coordinates all the HIV/AIDS Committees• Communication to the public. (VCT .Prevention. Advertisement)Communication to the public. (VCT .Prevention. Advertisement)• Resource mobilizationResource mobilization

NASCOP is involved in:NASCOP is involved in:• Training HEALTHCARE workersTraining HEALTHCARE workers• Procurement and provisionProcurement and provision

– What to procure? Specifications.What to procure? Specifications.– What quantities?What quantities?– This is done in collaboration with Ministerial Tender Committee (MTC) and Kenya This is done in collaboration with Ministerial Tender Committee (MTC) and Kenya

Medical Supplies Agency (KEMSA) .Directorate of Public Procurements (DPP) is also Medical Supplies Agency (KEMSA) .Directorate of Public Procurements (DPP) is also involved.involved.

• Guidelines and PolicyGuidelines and Policy• Implementation of antiretroviral therapy programmes in hospitalsImplementation of antiretroviral therapy programmes in hospitals• Supervision and assessmentSupervision and assessment


• Storage and Distribution of Storage and Distribution of antiretroviral is done by KEMSA.antiretroviral is done by KEMSA.

• NASCOP assists with coordination of NASCOP assists with coordination of distribution i.e.distribution i.e.

•Whom to give and how muchWhom to give and how much

•Draws the list of allocationsDraws the list of allocations


• Initial installation of the drugs is done by Initial installation of the drugs is done by NASCOP i.e.NASCOP i.e.

• Training of healthcare workers on tracking of patients, Training of healthcare workers on tracking of patients, dosage regimen and any changes as may be necessary. dosage regimen and any changes as may be necessary. Guidelines followed.Guidelines followed.

• Drugs are given as patient packs for purposes of Drugs are given as patient packs for purposes of promoting patient compliance and should not be brokenpromoting patient compliance and should not be broken

• Logistics data collection and reporting. Patients, Logistics data collection and reporting. Patients, numbers, gender, age, regimen used, opportunistic numbers, gender, age, regimen used, opportunistic infections etc. Monthly summary and request forms very infections etc. Monthly summary and request forms very useful.useful.

Supervision and assessmentSupervision and assessment

• Quarterly logistics monitoring, evaluation Quarterly logistics monitoring, evaluation and supervision conducted by NASCOP / and supervision conducted by NASCOP / KEMSA to check stock status conditions KEMSA to check stock status conditions including;including;

Adequacy of stocksAdequacy of stocks Out of stock situationsOut of stock situations Damages/LossesDamages/Losses Expiry datesExpiry dates storage conditionsstorage conditions

-security-security-temperatures-temperatures-accessibility-accessibility

Accuracy of logistics data submitted.Accuracy of logistics data submitted.


DRUGS USEDDRUGS USEDAlready available in public sectorAlready available in public sector• Stavudine (d4T)Stavudine (d4T)• Lamivudine (3TC)Lamivudine (3TC)• Nevirapine (NVP)Nevirapine (NVP)• Efavirenz (EFV)Efavirenz (EFV)

To be available in the next few monthsTo be available in the next few months• Zidovudine (AZT)Zidovudine (AZT)• Didanosine (ddI)Didanosine (ddI)• Lopinavir/ritonavir (Kaletra) Lpv/rLopinavir/ritonavir (Kaletra) Lpv/r• Nelfinavir (NFV)Nelfinavir (NFV)

Training course on Introducing pharmacovigilance into HIV/AIDS programmes Training course on Introducing pharmacovigilance into HIV/AIDS programmes

Drugs used…Drugs used…

According to the National Antiretroviral Therapy According to the National Antiretroviral Therapy guidelines guidelines first line first line and second line and second line regimen are given as follows:regimen are given as follows:

11stst Line Line

d4T+ 3TC + NVP d4T+ 3TC + NVP oror

D4t +3TC +EFV for patients on Rifampicin, those who D4t +3TC +EFV for patients on Rifampicin, those who react to NVP, or those previously on EFVreact to NVP, or those previously on EFV

22ndnd Line LineddI + AZT + Lpv/rddI + AZT + Lpv/r

ororddI + AZT + NLF for those who react to Lpv/r or are ddI + AZT + NLF for those who react to Lpv/r or are

intolerant.intolerant.


Prevention of Mother to Child Transmission (PMTCT)Prevention of Mother to Child Transmission (PMTCT)

Nevirapine 200mg to the mother at onset of labour and 2mg/kg body wt to Nevirapine 200mg to the mother at onset of labour and 2mg/kg body wt to the baby 72 hrs from birththe baby 72 hrs from birth

OROR

AZT 300mg OD from 36 weeks gestation, then 300 q3hrs at onset of labourAZT 300mg OD from 36 weeks gestation, then 300 q3hrs at onset of labour

OROR

AZT 100mg 5 times daily from 14 weeks gestation, and to the baby 2 mg /kg AZT 100mg 5 times daily from 14 weeks gestation, and to the baby 2 mg /kg body weight qid for six weeksbody weight qid for six weeks

OROR Mother started on HAART if <20 weeks gestation and the baby given either 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 NVP 2mg/kg body wight within 72 hours of delivery or AZT 2mg/kg body weight for 6 weeks.weight for 6 weeks.


For Post Exposure Prophylaxis (PEP.)For Post Exposure Prophylaxis (PEP.)

3TC 150mg bd + AZT 300mg bd.3TC 150mg bd + AZT 300mg bd.

Pediatric RegimePediatric Regime

11stst line. line.AZT + 3TC + NVPAZT + 3TC + NVP ORORd4T + 3TC + NVP.d4T + 3TC + NVP.

22ndnd line. line.AZT + ddI + LPV/r (If patient was on AZT as 1AZT + ddI + LPV/r (If patient was on AZT as 1stst line.) line.)ORORd4T + ddI + LPV/r (If patient was on d4T as 1d4T + ddI + LPV/r (If patient was on d4T as 1stst line.) line.)


MONITORING OF DRUGSMONITORING OF DRUGS• The drug regulatory authority (Pharmacy and The drug regulatory authority (Pharmacy and

Poisons Board-PPB) is in charge of Post-Marketing Poisons Board-PPB) is in charge of Post-Marketing Surveillance and monitoring of drugs.Surveillance and monitoring of drugs.

• The National Quality Control Laboratory (NQCL) is The National Quality Control Laboratory (NQCL) is mandated to do quality analysis of all drugs.mandated to do quality analysis of all drugs.

• However, adverse drug reactions/events However, adverse drug reactions/events monitoring and reporting has not been developed.monitoring and reporting has not been developed.

MONITORING OF DRUGS….MONITORING OF DRUGS….

• Some specific programmes e.g. Malaria Control Some specific programmes e.g. Malaria Control Programme perform random sampling and quality Programme perform random sampling and quality analysis of relevant drugs in the marketanalysis of relevant drugs in the market

• Every batch of antiretroviral received at KEMSA is Every batch of antiretroviral received at KEMSA is subjected to quality checks (specifically assay, subjected to quality checks (specifically assay, dissolution and lately friability tests)dissolution and lately friability tests)

• Discussions with NQCL and PPB to develop a post-Discussions with NQCL and PPB to develop a post-marketing surveillance programme for ARVs are marketing surveillance programme for ARVs are ongoing.ongoing.

training course on introducing pharmacovigilance into hiv/aids programmes

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