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ENSURING SECURE and RELIABLE SUPPLY and DISTRIBUTION SYSTEMS in DEVELOPING COUNTRIES, in the CONTEXT OF HIV/AIDS and PMTCT Forecasting, estimating requirements for Procurement of HIV related supplies. Helene Möller , (M.Pharm, PhD) UNICEF Supply Division, Copenhagen December 2004. - PowerPoint PPT Presentation
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Supply DivisionJuly 2005
ENSURING SECURE and RELIABLE
SUPPLY and DISTRIBUTION SYSTEMS in DEVELOPING
COUNTRIES, in the CONTEXT OF HIV/AIDS and PMTCT
Forecasting,
estimating requirements for
Procurement of HIV related supplies
Helene Möller , (M.Pharm, PhD)UNICEF Supply Division, CopenhagenDecember 2004
Supply DivisionJuly 2005
OVERVIEW OF PRESENTATIONChallenges in Forecasting supply needs in HIV Introduction: defining the context in
which the estimate is made
Managing supply and demand in scale up
Key issues in forecasting paediatric needs
Conclusion
Determine Quantities
needed
Reconcile needsand funds
Choose Procurementmethod
Locate and selectsuppliers
Specify contract termsMonitor
order status
Receive and Check Supplies
Make Payments
Distribute Supplies
Collect Consumption Information
Review Product Selection
THE PROCUREMENT CYCLEManaging Drug Supply; Second Edition
Supply DivisionJuly 2005
QUANTIFICATION Estimating requirements …
Screening tests
Confirmatory tests
Tie breakers
Consumables and waste management
VCT
Knowing one’s HIV status is
a key step in HIV
prevention and care Quality assurance
Supply DivisionJuly 2005
QUANTIFICATIONEstimating requirements …..
Cotrimoxazole
Isoniazid
Diagnosis, treatment of PCP
Diagnosis, treatment of TB
OI’s CPT/IPT
In high prevalence populations PCP is common, and
TB a leading cause of death
Diagnosis, treatment of OI’s
Supply DivisionJuly 2005
QUANTIFICATIONEstimating requirements …
Diagnostic tests
Pharmaceuticals forSyndromic management
Medical consumables(syringes, needles, waste)Condoms
STI
Regular STIscreening, prompt
treatment andcondom
distributionshould be part of
care of PLWHAInformation leaflets ?
Supply DivisionJuly 2005
QUANTIFICATIONEstimating requirements …
Palliative Care (relief of pain and distressing symptoms) Nutritional Support (nutritional assessment, dietary guidance, supplementary and therapeutic feeding) Universal precautions (clinical and home setting ) (Infection control, PEP)
OTHER …
More specialised … HAART, diagnosis and treatment of OI’s and HIV related cancers
Supply DivisionJuly 2005
ENSURING SECURE and RELIABLE SUPPLY and DISTRIBUTION SYSTEMS in DEVELOPING COUNTRIES, in the CONTEXT OF HIV/AIDS and PMTCT
ESTIMATING REQUIREMENTS challenges and hints
ANTI - RETROVIRALS
Supply DivisionJuly 2005
DEMAND : When to start ; What to start with ….
WHO Guidelines exist(http://www.who.int/hiv/pub/mtct/guidelines/en/)
• For Prevention of Mother to Child Transmission:– Guideline for mothers who qualify for initiation of treatment, who may become pregnant,
– Mothers on ART who become pregnant, and infants
– HIV infected pregnant women with or without indications for ART, and infants, etc
Zidovudine tablets, oral liq.
Nevirapine tablets, suspension
Lamivudine tablets, oral liq.
Zidovudine / lamivudine combination tablets
Supply DivisionJuly 2005
DEMAND : When to start ; What to start with ….
WHO Guidelines exist(http://www.who.int/3by5/publications/documents/arv_guidelines/en/)
• For Treatment and Care: First Line– Adults (zdv or d4T) + 3TC + ( NVP or EFV )– Preferred option for children (zdv or d4T) + 3TC + NVP– Guideline for children on TB treatment regiments containing rifampicin,
substitute NVP for EFV
• For Treatment and Care: Second Line– Guidelines for adults, toxicity, treatment failure
– Guidelines for children with toxicity, treatment failure
Supply DivisionJuly 2005
QUANTIFICATIONWhere to start ???
STEP 1: Postulate a patient profile at site(s) of service delivery
number of adults, pregnant women, children infants
what are their bodyweight ranges ? number of patients with TB co-infection potential to develop ADRs and/or treatment
failureFIRST LINE OPTIONS
d4T(30mg) + 3TC + NVP d4T(30mg) + 3TC + NVP
d4T(40mg) + 3TC + NVP d4T(40mg) + 3TC + NVP
d4T – ADRs ? NVP - TB or ADR ?
ZDV (100-200mg) + 3TC =NVP d4T(30mg) + 3TC + EFV
ZDV (300mg) + 3TC + NVP d4T(40mg) + 3TC + EFV
Supply DivisionJuly 2005
EXAMPLE OF MYANMARAssumptions for defining a patient profile
90% of all patients will weigh less than 60kg when enrolled
Stavudine will be the NRTI of choice
10% of cases may develop intolerance to d4T, switch to ZDV
Nevirapine is the NNRTI of choice.
Initial treatment with 200mg daily, for 2 weeks, is needed to reduce incidence of serious side-effects.
Regardless of this precaution, 20% of patients will develop intolerance to nevirapine. Switch to Efavirenz 600mg daily dose.
Not many patients on TB treatment to initiated on ARVs, allow for 5% of patients on rifampicin plus ART
Supply DivisionJuly 2005
QUANTIFICATIONWhere to start ???
STEP 2: Estimate the growth in numbers of patients on treatment
how many need treatment today ? what are the enrolment criteria ?, no. of trained health workers in the field to provide
care ? new enrolments, ability to screen and diagnose ?
HONESTLY, HOW MUCH MONEY WILL BE AVAILABLE THIS YEAR ?
Supply DivisionJuly 2005
0
50
100
150
200
250
Jan Feb March April May June
TOTAL on Rx
Nr enroled
Doctor on holiday
New doctor
arrives ( nurse trained to
Rx ?
Supply DivisionJuly 2005
QUANTIFICATIONWhere to start ???
STEP 3: Estimate the number of packs/kits needed to start, also to prevent stock outs
lead time for arrival of stocks decide on an ordering interval that will
minimise stock holding calculate a safety stock level, and a re-order
trigger calculate the number of packs needed per
recommended treatment regimen multiply the cumulative number of patients
with the numbers of treatment packs needed per regimen
MONITOR stock situation and re-order/redistribute until you have data on stock movement
Supply DivisionJuly 2005
MANAGING LEAD TIMES
0
100
200
300
400
500
600
TOTAL onRx
Nr enroled
Place order Place order
Supplies arrive Supplies arrive
Supply DivisionJuly 2005
? A PUBLIC HEALTH APPROACH
0
100
200
300
400
500
600
TOTAL onRx
Nr enroled
Place order Place order
Supplies arrive Supplies arrive
Re-order trigger
Month 3 x 2
1 2 3 4 5 6
Supplies arrive
Supply DivisionJuly 2005
WHAT ABOUT THE NEXT ORDER? When to place, how much ???
NEXT STEPS: Monitoring supply and demand continuously monitor lead time for arrival of
stocks continuously revise safety stocks and re-
order triggers continuously monitor expiry dates redistribute as needed to avert disaster
UNICEF Supply DivisionDec 2004
Supply DivisionJuly 2005
ENSURING SECURE and RELIABLE SUPPLY and DISTRIBUTION SYSTEMS in DEVELOPING COUNTRIES, in the CONTEXT OF HIV/AIDS and PMTCT
ESTIMATING REQUIREMENTS challenges and hints
ANTI – RETROVIRALSfor children, especially young infants
Supply DivisionJuly 2005
FORMULATIONS FOR PMTCT Key challenges in quantification ….
• Nevirapine suspension (10mg/ml):– Commercially available as 240ml– Donation programmes supply 20ml or 25ml– Large bottles adapted with fitted caps to facilitate dispensing– For PMTCT, need 0,6ml per day ?
– Dispensing syringe : BAXA Donation
• Zidovudine oral liquid (10mg/ml)– Commercially available as 100ml, 200ml, 240ml bottle– For PMTCT, need approximately 35ml for one week ?
• Lamivudine oral liquid (10mg/ml)– Commercially available as 100ml, 240ml– For PMTCT, need approximately 25ml for one week ?
Supply DivisionJuly 2005
CHILDREN ARE NOT LITTLE ADULTS Likelihood of developing AIDS within 12 Monthsfrom HPPMCS, Lancet 2003
49.0%
29.0%
20.0%16.0%
38.0%
20.0%
13.0%10.1%
27.0%
12.0%7.5% 5.7%14.0%
5.3% 3.1% 2.4%7.9%
2.5% 1.5% 1.2%
0%
20%
40%
60%
80%
100%
10 20 30 40
10 Yrs
5 Yrs
2 Yrs
1 Yr
6 Mos
CD4 Percent
Supply DivisionJuly 2005
CHILDREN ARE NOT LITTLE ADULTS• 510,000 children died of HIV in 2004 ; 1,400 per day
• Aggressive and bimodal presentation – 30% mortality at yr 1, – 50% at yr 2 and – 60% at yr 5
• Diagnosis for children below 18 months limited -PCR expensive; require sophisticated labs ad expertise
• Clinical staging difficult in infants
• Laboratory monitoring in children under 6 years difficult –CD4% required for children below 6 years
• Capacities and expertise on care and treatment limited, formulations limited
Supply DivisionJuly 2005
NUMBER OF INFECTED CHILDREN ALIVE AT SELECTED AGES (effect of COTRIMOXAZOLE [TMP-SMX] prophylaxis and/or ART for symptomatic)
300000
236,274210,881
196,736171,106
194,045
144,413119,596
74,6320
100000
200000
300000
BIRTH Age 1 Age 2 Age 5 Age 10
no TMP, no ARV
with ARV, no TMP
with TMP. No ARV
Marie-Louise Newell, Kirsty Little, Madeleine Bunders (Ghent-IAS Group on HIV infection in women and children)
Supply DivisionJuly 2005
NUMBER OF INFECTED CHILDREN ALIVE AND ELIGIBLE FOR ART AT SELECTED AGES
(effect of COTRIMOXAZOLE [TMP-SMX] prophylaxis and/or ART for symptomatic)
0
10,000
20,000
30,000
40,000
50,000
60,000
Age 1 Age 2 Age 5 Age 10
no TMP, no ARV
with ARV, no TMP
with TMP. No ARV
Marie-Louise Newell, Kirsty Little, Madeleine Bunders (Ghent-IAS Group on HIV infection in women and children)
Supply DivisionJuly 2005
NUMBER OF INFECTED CHILDREN ALIVE AND ELIGIBLE FOR ART AT SELECTED AGES
effect of COTRIMOXAZOLE [TMP-SMX] prophylaxis and/or ART for symptomatic)
171106
56,265
050,000
100,000150,000200,000250,000300,000
Age 1 Age 2 Age 5 Age10
no TMP, no ARV
with ARV, no TMP
with TMP. No ARV
ALIVE 100% CTX
Marie-Louise Newell, Kirsty Little, Madeleine Bunders (Ghent-IAS Group on HIV infection in women and children)
Supply DivisionJuly 2005
ESTIMATING THE NUMBER OF TREATMENTS NEEDED
STEP 1: Estimated number of births, existing death-rates, HIV prevalence in ANC settings
STEP 2: Estimated PMTCT coverage and transmission rates= estimated HIV positive infants born
STEP 3: What is the chance of survival ? Morbidity ? Mortality ?Coverage with cotrimoxazole prophylaxis
STEP 4: Estimated number of children at different ages eligible for treatment (assumptions around disease progression)
STEP 5: Reality check – who will enrol them into treatment, etc …
Supply DivisionJuly 2005
MSF PAPER: prices, availability of specific children formulations …• Cost of treatment drops when switching to adult
formulations:
Peak around 14kg bodyweight
• Using tablets for a child (20 kg) reduces the cost per treatment per year nearly 8 times:– (d4T / 3TC / NVP )
Best generic price/y $ 566 $224
Best innovator price/y $1,706 $631
• Managing the switch – increases complexities in resource poor settings
Supply DivisionJuly 2005
ARV REGIMENS COSTS …..(Ex manufacturer = excluding procurement and delivery costs)
Regimen Paediatric Cost / month Cost /month Total Generic Costs
original generic 1 yr 5 yrsZDV+3TC+NVP*
(<3yrs/10kg) 58.29 44.18 524.29 2,621
ZDV+3TC+NVP* (>3yrs/20kg) 90.46 68.93 817.97 4,090
d4T*+3TC+NVP* (<3yrs/10kg) 68.16 65.87 781.64 3,908
d4T*+3TC+NVP* (>3yrs/20kg) 134.89 130.67 1550.60 7,753
ZDV+3TC+EFV* (10kg - liq) 68.22 44.72 530.64 2,653
ZDV+3TC+EFV* (10kg - tab) 56.67 33.17 393.58 1,968
ZDV+3TC+EFV* (20kg - liq) 92.41 63.28 750.98 3,755
ZDV+3TC+EFV* (20kg - tab) 79.32 50.19 595.65 2,978
* No generic available
Supply DivisionJuly 2005
CONCLUSIONMaking demand forecasting simple …..Do an estimate as best as you can based on treatment targets
Consider the need for buffer stocks during scale up
Calculate the needs to fill up the pipeline
Look at lead times from industry and establish order intervals
Place order
ENSURE SECURE INVENTORY CONTROL MECHANISMS
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