ARV Treatment: The Challenges of Scaling Up Procuring/Distributing/Managing ARVs 2 July 2005, ICAAP, Kobe, Japan Andy Barraclough Resident Advisor, Pharmaceutical Management RPM Plus, Vietnam: ARV Treatment: The Challenges of Scaling Up Procuring/Distributing/Managing ARVs 2 July 2005, ICAAP, Kobe, Japan Andy Barraclough Resident Advisor, Pharmaceutical Management RPM Plus, Vietnam
Scaling up is not just making bigger I: Scaling up is not just making bigger I Recently Malcolm Clark of MSH has developed the analogy of the huge insects from 1950 ‘horror movies’ as a means of illustrating the facility that scaling up just means making bigger.
Scaling Up not just making bigger - II: Scaling Up not just making bigger - II Such large insects are biologically impossible.
The breathing system, the volume/surface area ratios and the leg strength, just don’t work at larger sizes.
Yet it often appears that we are trying to use this same approach of just making bigger to scaling up ARV supply and management systems, with the same results – it does not work.
Why just making bigger won’t work – sheer size: Why just making bigger won’t work – sheer size Size of the scale up planned
Using PEPFAR Vietnam as an example, the envisaged annual ARV supply in 4 years time will be of a value greater than the currently estimated, total public sector supply cost for all medicines in Vietnam.
Added to this will be GFATM funding, Government of Vietnam and bilateral funding for ARVs
For some African countries the proposed PEPFAR supply will be greater than the entire pharmaceutical supply to the country
Why just making bigger won’t work – we are not alone: Why just making bigger won’t work – we are not alone Competition for scarce resources
PEPFAR, GFATM, Bi-laterals, host countries are all increasing funding
- Its not just ARVs that are scaling up:
Malaria, TB, Millennium Development Goals; are all receiving unprecedented funding
– all need medicines supply, logistics and pharmaceutical management
Why just making bigger won’t work – timescale: Why just making bigger won’t work – timescale Timescale of the scale up
Not only is the sheer size of the scale up huge, often requiring a more than doubling of the volumes of all supply system, the time period in which this is to be achieved is often less than 3 years.
New warehouses cannot be built so quickly, the time demands for procurement and delivery placed on the marketplace cannot be met by simplistic annual tenders, and secure distribution capacity will not develop without active long term planning.
Current Situation Difficulties - Readiness: Current Situation Difficulties - Readiness Political commitment translated into practical action
Agree procedures from importation, customs through to dispensed to patient
Detailed practicalities throughout the system
Engagement of Pharmacy Services
SOPs for Pharmacy and Laboratory
Unrealistic time expectations
Rational Pharmaceutical Use
Current Situation Difficulties - Systems: Current Situation Difficulties - Systems First recognize the harsh reality of the current situation:
Systems and Policy
Many existing public sector supply systems are already severely stressed and cannot cope with massive increases in throughput
Most of the supply systems at both macro/policy and micro levels are geared only towards management and operation of stable or slowly increasing supply situations
Current Situation Difficulties - Procurement: Current Situation Difficulties - Procurement Procurement
Most Donor procedures still require annual procurement cycles, yet without long-term, multi-year orders, securing an adequate level of ARV supply is likely to become increasingly difficult
ARVs in general are in short supply from manufacturers, and certain ARVs – especially stavudine and all pediatric formulations - are in extremely short supply.
12 month supply, single delivery shipments are becoming increasingly unlikely – in most cases it will be ‘drip feed’ from the suppliers
Current Situation Difficulties – Stock Control and Pharmaceutical Management: Current Situation Difficulties – Stock Control and Pharmaceutical Management Effects of Ramping – rapid growth in patient numbers. 6 months ‘safety stock’ can equate to millions of dollars and it is unlikely that sufficient delivery can be achieved quickly enough to maintain such safety stock levels.
Risk management functions – quantifying risks of supply disruption with reduced treatment numbers, and improved calculation of safety stock and pipelines have become necessary.
Failure to achieve maximum utilization of ARV resources means patients could be denied treatment, medicines expire, and scarce resources are wasted.
There is a need to develop policies and mechanisms to balance supply risk and utilization
Example of stock management effects – Safety Stock: Example of stock management effects – Safety Stock In normal, essential medicine supply systems, safety stock is calculated as a number of months of supply to provide a buffer against fluctuations in the supply chain
BUT often it is calculated on the average monthly PAST usage, with a small inflation factor
In highly ramped systems such as are now being funded for ARV supply, such a calculating method is inadequate to provide an adequate buffer, and the calculation must be made on predicted future monthly usage
Ramping Effects: Ramping Effects
Ramping Effects on Safety Stock: Ramping Effects on Safety Stock
Safety Stock levels: Safety Stock levels Extrapolated Cost Estimates US $ for PEPFAR Vietnam In this example the safety stock has been set at 3.6 months.
The safety stock level required at the 12 month mark equates to 87% of the first six months total ARV usage.
When considering setting safety/buffer stock levels it will be essential to consider the ramping effects, and especially the cost implications.
Response to the scale up demands: Response to the scale up demands Radical new thinking and approaches
KEY FACTOR:
Dynamic and active management of the whole of the supply chain
New Approaches
From static slow growth systems to highly ramped activities.
Identify and seek to harness all resources available
Possible new approaches: Possible new approaches NEW APPROACHES MAY INCLUDE:
At national level, a fully funded, supported and active pharmaceutical management unit to manage ARVs from all sources
Regularly updated, Pre- purchasing information and forecasting provided to the marketplace, and in the case of PEPFAR supply, active liaison with the manufacturers
Active supply pipeline information systems and management
Consideration to harnessing private sector resources
Lean stock holding, distribution systems requiring higher frequency deliveries, and a dynamic and very accurate DMIS
What is needed to make it work ?: What is needed to make it work ? Recognize the problem
It is regretted that most national authorities show few signs of having recognized the depth and range of the problems on ARV supply and management and appear intent on continuing with existing public sector supply operations.
Implement Active Pharmacy Management
There is a need for a major change to introduce active pharmacy management of the entire ARV supply and management process
Harness all the resources available