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[e-drug] WHO 3x5 strategy on supplies management


  • From: e-drug@healthnet.org
  • Date: Sat, 29 Nov 2003 07:47:55 -0500 (EST)

E-DRUG: WHO 3x5 strategy on supplies management
-----------------------------------------------
[Below the commodity chapter of the 3x5 strategy that will be announced by
WHO on 1 December.
It was based on an expert consultation held in Lusaka 18-21 November.
The full report incl better layout will become available at
http://www.who.int/hiv/en/ on 1 December.
WB]

SECTION 4

COMMODITIES AND SUPPLIES MANAGEMENT

Commodities for ART must be fully available and accessible for ART. A wide
range of commodities is required, including ARVs, HIV tests, supplies for
care of opportunistic infections and other HIV-related illnesses, palliative
care (including morphine), laboratory reagents and condoms.

To achieve full access to commodities by all those eligible for ART, it will
be necessary to have:

- clearly defined and well performing logistics management information
systems
- secure transportation to get the commodities close to where the patients
live
- integration of ART supplies into the existing medical supply system
(provided it is secure and reliable ? if not, a separate system might be
necessary in the early stages of scale-up)

The following assumptions are made:

· National policies, quality of services and products, product registration
and patent issues have been addressed to support access to treatment.
· Financing for supply management is secured, including human resources,
commodities, training and information, transport, storage and dispensing
facilities
· Selection and procurement of commodities for ART will be done at central
level
· Importation taxes and fees for ART supplies have been eliminated
· Patent laws have been updated in line with the Doha Declaration
· New products, such as fixed-dose combinations (FDCs) will be used as soon
as formulations of proven quality and bioequivalence are pre-qualified, and
provide programmatic advantages
· Fast track registration for new medicines or tests and for customs
clearance are in place
· Organizational accountability in place for supply chain management. The
supply chain will be monitored at the central level
· Operational research will be built in to track supply system impact on
outcomes.


RECOMMENDATION 1 - Simplify supply systems to support access to ART
Priority Actions
Phase I

· Limit the number of different formulation/items moving in the supply chain
through standardization of treatment regimens and diagnostics used
· Supply drugs in either fixed dose combinations or in blister packs
whenever possible; also consider use of pill organisers (pill boxes) for
dispensing to help patients with adherence
· Keep inventory systems & documentation as simple as possible and integrate
as far as possible with existing systems
· Multidisciplinary management teams must work to exchange vital information
between supply managers and clinicians through all levels of the system.


RECOMMENDATION 2 - In Phase I, use a ?push? system to introduce ART in
health centres and district hospitals.

In a push system, the central supply unit provides supplies as standard
kits, supplied at fixed intervals. This ?push? system would use starter
packs (called Standardised ART? StART - kits) to jump start activities in
health centre and district level facilities. These kits should be designed
to treat a set number of patients (e.g. 10-25 patients) for a set period of
time (e.g. 6 months). In addition to the ARV drugs needed, a StART kit
would contain all necessary manuals and flow-charts, education materials,
HIV tests for 100-200 people, a fixed amount of ARVs for PMTCT, a PEP kit,
and a selected supply of drugs for OI. During training of the health care
workers and/or the accreditation of an ART treatment site, the StART kit
would be demonstrated and then left at the treatment site.

Health Centre Level

· Stocks would be subsequently replenished from the supply centre at set
times according to numbers of patients enrolled
· In this system, a monthly limit would be set on the number of new patients
that can be enrolled in the ART program to allow systems to develop and
health workers to get used to treatment regimens

District Level

· Use expanded starter packs which contain alternative first line drugs to
cover treatment of patients with TB, pregnant women & children
· Help first level facilities to ensure readiness for supply management
· Act (where required) as distribution centre for kit supplies to first
level care
· Ensure accurate estimates of patient numbers, based on eligibility
criteria, availability of HIV testing, size of existing patient population
already in follow-up and HIV prevalence estimates, to define total demand
for commodities.
· Forecast short-term demand and planned build-up of patient numbers

Central Level

· Develop and provide starter packs for all levels and services according to
treatment guidelines and protocols
· For first line regimens, select only products not needing refrigeration,
unless a cold chain can be guaranteed
· Provide guidelines for districts and first line facilities for supply
management
· Specify the maximum number of patients to be recruited at each level per
month
· Ensure continuous training and supervision of staff
· Ensure the availability of second line ARVs


RECOMMENDATION 3 - In Phase II, move to a ?pull? supply system.

In a pull system, supplies must be ordered by health care or dispensing
facilities from one or more central level supplier.

Health Centre Level

· Expand supply to paediatric & second line treatment
· Communicate changing needs to central supply level

District Level

· Provide training, supervision, distribution and treatment for more
centres, including children, TB, pregnant women
· Communicate changing needs to central supply level,

Central Level

§ Ensure continuing, uninterrupted supplies of packs of medicines.


RECOMMENDATION 4 - Enrolment of new patients during scale-up must not
outpace resource mobilization for sustainable drug, test and other necessary
commodity supplies. Patients on treatment have priority for new supplies of
drugs over patients waiting to start.

Priority Actions

For Dispensing Unit at All Levels

Phase I

Reserved and marked stocks should be set aside for continued treatment of
existing patients (e.g. by name). Buffer stocks should be maintained at a
level of 3-6 months minimum supply

Community Level

· Support patients to access new supplies before supply in their possession
runs out

Health Centre Level

· Use standardised inventory control systems - patient register, ledgers,
stock cards, prescriptions, and dispensing register ? and use them to
trigger timely re-supply.

District Level

· Provide drugs for patients treated at district, and ensure transportation
of supplies to health centre level
· Assume responsibility for training of health centre level providers on
supply management
· Forecast commodity needs for treatment of children, pregnant women and TB
patients for whole district

Central Level

Overall quantification, procurement, quality control of received drugs,
coordination of financing, including:

· Standardise supply procedures for ARV and laboratory supplies
· Operational research, monitoring and supervision of distribution and
service delivery at all levels
· Monitor use of drugs and enrolment of patients and set monthly limits to
enrolment.
· Define re-order levels, reserve stocks and lead times (must be responsive
and flexible in Phase 1 to deal with uncertainties or unexpected changes in
treatment uptake).

Phase II

Community Level

· Assess if members of the community are not having access to ARVs and
reasons why, and take corrective action.

Health Centre Level

· Expansion of product range with paediatric formulation and alternative
first line drugs, and introduce second line drugs for maintenance of second
line treatment initiated at the district level.

District Level

· Conduct operational research.
· Collaboration/networking of districts for experience exchange.

Central Level

· Use morbidity and consumption figures from districts to forecast and
quantify future supply needs


RECOMMENDATION 5 - Ensure security of commodities to minimise wastage and
costs

Priority Actions

Phase I

Community Level
· Identify problems with usage and abuse of supplies in the community

Health Centre Level

· Use inventory control system to identify losses of supplies
· Identify sources of wastage
· Monitor expiry dates and request redistribution of excess stock

District Level

· In addition to the storage for district treatment, ensure secure storage
for redistribution of first level supplies.
· Supervise commodity supply at health centre level (extra staff & training
may be needed)
· Ensure adequate storage conditions (secure storage space, inventory
management, accountability, monitoring and supervision system) before the
release of starter packs into health centres

Central Level

· Monitor and analyse data from all levels to ensure patient numbers and
commodity usage match each other.
· Investigate discrepancies and take disciplinary action in cases of misuse
or diversion
· Ensure adequate storage conditions (secure storage space, inventory
management, accountability, monitoring and supervision system) before the
release of starter packs to the district level

Phase II

At all levels

· Review security and storage within whole distribution system, identify
gaps & problems; revise systems if necessary.
· Expand secure storage space to keep pace with program expansion
· Expand cold chain capacity to keep pace with program expansion

Central Level

· Develop systems of patient identification to prevent enrolment in two or
more centres
· Develop and use guidelines to ensure the safety of community members or
groups holding supplies of ARVs, and the supplies they hold


RECOMMENDATION 6 - Establish good dispensing practices to ensure rational
use of drugs.

Priority Actions

Phase 1

Health Centre Level

· Train patients on ARV use and ensure their commitment to adherence before
ART is initiated.

· Provide patients with initial supply for short period e.g. 2 weeks, then
continue with monthly or longer supplies when ability to adhere to treatment
regimen is demonstrated.

· As part of the dispensing process, drug information should be given to all
patients orally and in writing (in language the patient understands)

District Level

· Make a specific person responsible for ARV dispensing.
· Start planning the creation of a drug information centre to disseminate
information e.g. within AIDS information centres, to health care workers,
patients and communities

Central Level

§ Start developing pharmaco-vigilance systems for monitoring drug effects on
the populace.
§ Start designing and providing patient information leaflets for all levels
of health care, in appropriate language and content for the user of the
information

Central Level

· Build continuous staff training into the supply management system, to keep
staff up to date and cater for changeover of staff
· Continue and complete phase 1 priority activities


RECOMMENDATION 7 - Collaborate with the private sector to ensure quality of
commodities and care.

Priority Actions

Phases I and II

District and Central Levels

· Assess the ability and the willingness of private sector actors, including
for-profit, not for profit and corporate organisations, to develop
collaborations in HIV commodity and supply management
· Outsource specific supply chain functions where improved performance
effectiveness is achievable. Monitor success of public-private collaboration
via performance indicators built into outsource contracts, and enforce
sanctions for failure to reach targets
· Share lessons learned in different countries on public-private
interactions for improving supply

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