PMTCT MOTHER - BABY PACK Considerations on contents and design

UNICEF Pharmaceutical Supplier Meeting, Copenhagen 2008

Bianca Kamps, Contracts Manager HIV/AIDS and MalariaAtieno Ojoo, Technical Officer HIV/AIDS and Malaria

PRESENTATION OUTLINE

1. Graphic of WHO PMTCT and Cotrimoxazole guidelines

2. Objectives of proposed Mother-Baby Pack3. Propose MBP contents4. Proposed MBP design5. Innovative drug delivery mechanisms6. Challenges, discussion questions

Prevention of Mother To Child Transmission of HIVZidovudine, Nevirapine and Lamivudine: first line HIV drugs used for PMTCT Cotrimoxazole: drug to prevent opportunistic infections

or

Counseling to Mum on infant

feeding

Continued infant feeding counseling &

support to Mum

CD4-testing: to determine stage of HIV-disease and needfor treatmentPCR-testing: to determine HIV status in childrenART: Antiretroviral Treatment (only when indicated by CD4- testing or clinical assessment)

If Mum HIV- positive, CD4- testing and/or

clinical assessment

(staging) takes place and

Cotrimoxazole provided for 12

months

If no need for ART,

Mum given Zidovudine

(from 28 weeks)

Mum at labor: single

dose Nevirapine

and Zidovudine + Lamivudine

START: Recommend HIV testing at first ANC

visit

Mum: Zidovudine + Lamivudine (7

days) and referral for HIV

care

Baby: single dose

Nevirapine + Zidovudine for

7 days

At 6 weeks:

Baby: PCR testing to

determine HIV status. If HIV

infected, refer to ART

Provide Cotrimoxazole

for up to 2 years or until HIV risk

can be excluded

ART provided to Mum if needed on

basis of CD4 result or clinical

assessment

Mum: Zidovudine + Lamivudine (7 days) and referral for HIV care

Baby: single dose Nevirapine plus Zidovudine for 4 weeks

If Mum received no or less than 4 weeks of Zidovudine

If Mum received 4 or more weeks of Zidovudine

WHY?

The main reasons for slow uptake of PMTCT services are: • Poor supply management of PMTCT drugs and HIV test

kits; • High rate of deliveries outside mainstream health

institutions; • Weak health care infrastructure;• Insufficient numbers of health workers; • Lack of integration of PMTCT programs into regular

Maternal, Newborn and Child health care services; • Poor involvement of male partners in HIV testing;• Stigma and issues of disclosure by HIV positive women.

OBJECTIVES OF THE MOTHER- BABY PACK• Improve/increase PMTCT uptake• Reduce interruptions in access to ARVs and Cotrimoxazole

during pregnancy, delivery, and post partum.• High incidence of first ANC visit, but sharp decrease in follow-up• Low rate (50%) of delivery in health facilities• Complexity of PMTCT regimen

• Facilitate adherence• Provide HIV Care and Treatment to both Mother and Baby• Improve procurement, distribution and supply chain

management• Forecasting difficulties when managing products separately• Supply chain difficulties when managing products separately

THE IDEAL PACK

Has all the medicines required Is user friendly, manageable One pack per mother/baby Is usable outside of clinical setting Holds incentives to encourage ANC/HIV clinic

attendance Includes medicines that are stable, easy to use and

not bulky

PACK CONTENTS - MEDICINESDuring pregnancyAZT 300mg: at least 200 tablets CTX 960mg at least 100 tablets (or 200 tablets of 480mg)

During deliverysd NVP 200mg one tabletsd NVP 10mg/ml + dosing syringe AZT 300mg two tablets

After DeliveryAZT/3TC 300+150mg 20 tablets AZT 10mg/ml + dosing syringe (100 ml bottle) (1 or 4 weeks

depending on when mum started AZT)CTX 960mg (mother) at least 70 tablets (up to first post natal visit at 6

weeks)CTX 100+20mg (baby) at least 70 tablets (to be started after 6 weeks of

age)

AntepartumDuring pregnancy

PostpartumAfter delivery

IntrapartumDuring delivery

Zidovudine tablets

Cotrimoxazole tablets

Zidovudine + Lamivudine tablets & Cotrimoxazole tablets (mother)

Zidovudine syrup & Cotrimoxazole (baby)

Nevirapine Single Dose tablet &Zidovudine tablets (mother)

Nevirapine Single Dose syrup (baby)

PACK CONTENTS

Will also include various (visual) guides/road maps, instructions and other relevant information

Durable, attractiveWater-resistant container/box/pouch Sub-packs Clear sectioning off of the pack Clear directions on how to use Reusable packaging?

UNICEF has submitted the Mother-Baby Pack to the Danish ‘Aspen Design Challenge’

DESIRED ATTRIBUTES FOR PACKAGING

INTERESTING DRUG DELIVERY MECHANISMS •AZT and NVP “sprinkles” (effervescent granules) in development (Strides)•Lop/Rit sprinkles for pediatric use (Cipla)•Vitamin A “Applicaps” (Strides) or “Medicaps” (Thailand) for oral dosing of baby•Nystatin suspension in a pacifier (Bioglan)•Codeine drops in squeeze tube (Abbott)•Fentanyl lollipop (Actiq by Cephalon)•Triaminic muco-adhesive strip•Tylenol fastmelts strips•Polio drops•Others??

TYPICAL PRODUCT DEVELOPMENT PROCESS

Innovation-new idea, new solutionResearchModelingDesign/simulationDevelopment/Verification/ValidationFull scale production

TIMELINES

CONCEPT RESEARCH OngoingPROJECT PLANNING Oct 2008 - Jan 2009PRELIMINARY DESIGN (PROTO TYPE) Feb - April 2009TENDER March - May 2009DETAILED DESIGN June -July 2009PILOT PRODUCTION July - Nov 2009DEVELOP TOOLS FOR PILOT TESTING July - Sept 2009DEVELOP IMPLEMENTATION PLAN June - Oct 2009PILOT TESTING Dec 2009 - 2010FULL SCALE PRODUCTION From July 2010

DEMAND (1)

DEMAND (2)UNICEF is the implementing partner for two UNITAID

PMTCT projects2009 2010

# HIV+ Pregnant Women TargetedPMTCT I - 8 countries 117,000PMTCT II - 9 countries 115,000 169,000

Total UNITAID PMTCT Supply Budget$23 million $25 million

At this point in time it is not clear whether the PMTCT I project will be extended beyond 2009

How can we make a pack that will not propagate stigma?

- How to ensure that there is constant linkage between mother/baby and the health system to deliver quality health care and for monitoring?

- How best to handle the different expiry dates and storage requirements of pack contents?

- How best to deal with patent and registration issues?

- Are the timelines realistic?

- What are your experiences with this type of product development?

DISCUSSION QUESTIONS

THANK YOU

HIV/AIDS and Malaria UnitHIV/AIDS and Health CenterUNICEF Supply Division

www.unicef.org/supplybkamps@unicef.orgaojoo@unicef.org