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1g. HIV/AIDS, TB: Supply Chain Issues for ARVs and TB Medicines in LMIC
Application of an International Reference Price List to National Medicines Procurement Tenders
1Management Sciences for Health, Strengthening Pharmaceutical Systems (SPS); 2Management Sciences for Health, Strengthening Pharmaceutical Systems (SPS); 3Management Sciences for Health, Strengthening Pharmaceutical Systems (SPS)
Problem statement: The success of antiretroviral (ARV) scale-up in developing countries requires access to affordable prices. Large public health programs rely on economies of scale and competitive tendering to achieve optimum prices. Previously South Africa, the largest ARV program in the world, has purchased ARVs at prices much higher than the average international ones for most ARVs. The South African Government has recently embarked on a massive HIV testing campaign with the objective of enrolling 500,000 new patients on the ARV treatment program every year. This campaign will result in a significant increase in funding requirements. If prices of ARVs remain at such high levels, the ART program might become unsustainable overtime.
Objectives: Cost reduction by improving competition among bidders through international benchmarking and publication of international reference price lists during tender process for ARVs; a study commissioned by the Minister of Health and tasked with improving medicines procurement in the country’s public sector conducted a comparison of national prices with international prices.
Design: Analysis of tender prices was performed to evaluate the potential impact of this intervention. Confounders were controlled for by analysing the impact of the number of bidders and exchange rates.
Setting: National South Africa ART program
Intervention: A reference price list was compiled based on international transactional prices and introduced as a stimulus for competition amongst local suppliers during the national ARV procurement.
Policy issues: International reference lists increase competition in national tenders through vicariously projecting competition prevalent in international markets.
Outcome measure: Reductions in ARV prices and improved access within a finite budget
Results: For key ARVs, price reductions of up to 65% were obtained. In nearly all cases, the awarded tender price was below that of the reference price list. The data suggests that international benchmarking contributed towards this price reduction and subsequent savings. Furthermore, the price reductions are larger than those projected based on volumes alone. It is estimated that these price reductions will result in ARV procurement costs saving of roughly 50%, allowing for a doubling of the number of patients accessing treatment.
Conclusion: The application of international reference lists during national tenders is a valuable tool in achieving optimal pricing. Although South Africa has traditionally sourced virtually all of its pharmaceutical requirements from local and international pharmaceutical companies represented in the country, recent experiences have demonstrated that resorting to international benchmarking and opening the market to international prices and suppliers has increased competition and allowed for reduced local prices. Through this strategy, the country has cut expenditures on ARVs by 50%.
Funding source: USAID/SPS program
Evaluating the Effectiveness of TB Medicine Supply Management Training in Western Cape, South Africa
1Management Sciences for Health, SPS, South Africa; 2Department of City Health, Western Cape
Problem Statement: South Africa (SA) has the second highest tuberculosis (TB) incidence in the world at 971 per 100,000 population. (WHO 2009) The SA National TB programme targets for 2011 are to achieve a cure rate of 85% and treatment success rate of >85%. A major key to achieve these targets is to strengthen the implementation of the DOTS strategy. To achieve this objective, it is important to have an effective medicine supply management (MSM) system to ensure an uninterrupted supply of TB medicines. In SA, TB is managed mainly at a primary health care (PHC) level. MSM at most PHC facilities presents a huge challenge. Nurses perform this function in addition to their clinical functions, often resulting in poor stock management practices. As a consequence, stock-outs of essential medicines, including those for TB, is a common occurrence.The USAID-funded Strengthening Pharmaceutical Systems project decided to provide support for MSM with a specific focus on TB.
Objectives: To determine the effectiveness of TB MSM training for PHC facilities in Western Cape, SA, using TB medicine supply monitoring indicators.
Design: Intervention with a before and after assessment and no control group
Setting: The intervention was undertaken provincially at primary health care facilities within the public sector in the Western Cape.
Intervention/Methods: A TB medicine supply facility assessment tool was developed and a two-day training workshop on TB MSM was conducted for nurses from 28 PHC facilities. A baseline assessment of TB stock management was undertaken by facilities followed by monthly facility assessments for three consecutive months after training. Effectiveness of training was monitored using key TB MSM indicators.
Outcome measures: Improvement in TB medicine management
Results: At baseline, 21% of facilities did not have stock cards for all TB medicines, stock cards were not updated in 50% of facilities, 71% of facilities did not have correct average and reorder levels, 18% facilities had expired TB medicines, and TB medicines were out of stock at 46% of facilities. Post-training assessment at 3 months showed that 100% of facilities had stock cards in place for all TB medicines (p=0.011). A 29% increase in the number of facilities with updated TB stock cards was observed (p=0.003). The number of facilities with correct average/reorder levels of TB medicines increased by 32% (0.001). There was 21% improvement in the number of facilities experiencing no stock-out of TB medicines (p=0.056). The number of facilities where expired TB medicines was found declined by 11% (p=0.086).
Conclusions: Use of TB MSM indicators was effective in measuring the outcome of training in a primary health care setting. Nurse training in TB medicine supply management resulted in improved TB stock management at PHC facilities. This method of evaluation did not follow-up on longer-term sustainability of good medicine management practices. It is recommended that future evaluations be designed as quarterly assessments over a longer period.
Funding Source: United States Agency for International Development
Calculation of Tuberculosis Patients' Drug Consumption Using Electronic Nominal Recording–Reporting System at District Level
Ministry of Health, Egypt
Problem statement: An uninterrupted supply of good quality anti-tuberculosis (TB) drugs is one of the five components of the DOTS strategy. The design and implementation of a Drug Logistics Management Information System is an important technical intervention in supply chain management. A well-implemented system reduces the likelihood of stock-outs, which is crucial to the success of any program. It also minimizes overstocking that can waste scarce resources and lead to drug expiry. Egypt has implemented an Electronic Nominal Recording–Reporting System (ENRS) for TB patients. It is the electronic version of the main four registers in the TB recording– reporting rystem, where data entry is done on nominal bases at district level using Excel. Nominal data are then processed to produce the routine reports in the NTP. Calculating indicators using Excel and Access, registers are linked to produce patient profiles. One of the ENRS packages is the electronic district (DR) file for the first- and second-line of treatment, which contain the demographic data, all investigations which may confirm the diagnosis, patient follow-up data, and the outcome of the treatment. The file is supported by built-in equations to facilitate the work and to calculate the patient's actual TB drug consumption using the average amount needed of each drug. This amount is based on the actual duration of treatment which is calculated by the total number of treatment days using another built-in equation based on the start date of treatment and the end date of treatment .
Results: During 2009, more than 7,000 district patient record were obtained from about 157 TB management units in 28 provinces. By analysis of these records, the average number of treatment days for category one treatment line is about 187 days/patient and the average consumption is 374 tablets for 4 fixed-dose combination (4FDC), 561 for isoniazid , ethambutol , and pyrazinamide .
Conclusion: By using this system, the TB drugs procurement planning now is based on the evidence of the actual consumption and actual needs of the TB patient.
Funding source: Information not provided
Causes of ATBM Shortages in GFATM and GDF-Supported Countries in the Eastern Mediterranean Region and How to Avoid Them in the Future
Problem Statement: The regional office has received many complaints. (1) country A—stock-out of rifampicin (R), isoniazid (H), Pyrazinamide (Z), ethambutol (E) due to delay in funding transfer; (2) country B—stock-out of RH due to mismanagement of the treatment regimens; (3) country C—stock-out of streptomycin due to misdistribution; and (4) country D— stock-out of RHZ 150/60/30 due to port clearance delay. The stock out may be due to (1) inadequate funding: (2) poor selection and quantification of medicines and lack of prioritization; (3) delay in procurement: (4) extensive expiration of medicines; (5) port clearance delay (in some cases, as long as 6 months); (6) countries that do not follow Good Manufacturing Practices and good laboratory practices often experience product failure; and (7) programs that do not follow push or pull system of distribution.
Methods: A regional survey was done during Global Drug Facility (GDF)/World Health Organization (WHO) field visits in 15 GDF-supported countries, 12 of which are supported by the Global Fund to Fight AIDS, Tuberculosis and Malaria. Interviews were conducted with 76 directors of the pharmacy departments at the Ministries of Health as well as NTP staff. The questionnaire endorsed GDF/WHO questionnaires about the availability of ATBM at central/district levels. It also included questions on possible causes of shortage of ATBM at all country health care levels, how countries were managing their ATBM supply system, how shortages occur despite the era of these high- quality initiatives, how WHO and countries have tried to manage the shortage, and what is the possibility for having no future shortages.
Results: Usable responses were received. Among 15 GDF-supported countries, 20% of them, the shortage was due to noticeable decrease in the political commitment towards ATBM funding; 13.3 % was due to unplanned switching to 6-month regimens in countries which were working on the 8-month regimens; 26.6 % was due to a delay of funding of ATBM; in the 33.3% of the 12 GF-supported countries. Significant increase in the GDF leadtime of ATBM orders was noticed as a result of the above reasons in 20% of the surveyed countries. The last 20.1% was due to different reasons, such as delay in port clearance and lab analysis. However, the background of why the shortages occurred raises questions. None of the countries appears to have faced a real stock-out. The shortages of TB medicines only affected the buffer stock (safety stock ) at different levels. And all countries have faced mismanagement of the drug management components.
Conclusion: To prevent future shortages of ATBM, we suggest that transparency is maintained and increased in the drug procurement and supply mechanism at national level and that health sector funding gap be addressed by partners working together to establish a revolving fund at the regional level. In addition, work should continue on the rational use of ATBM and WHO pre-qualification for more GDF/WHO pre-qualified suppliers from the region. GDF has established the system for stockpiling second-line drugs (first-line is in process).
Funding source: Information not provided
Planning for Sustainability of ARV Provision: A Study in Peru, Bolivia, and Mozambique
Sergio Arouca National School of Public Health/Oswaldo Cruz Foundation, Brazil
Problem statement: The provision of antiretroviral (ARV) medicines is central to HIV/AIDS programs, because of its impact on the course of the disease and on quality of life. Although first-line treatment costs have declined, treatment-associated expenses are steeper each year, not only due to more people living with HIV/AIDS (PLWHA) in need of treatment, but also in the face of new and costlier patented medicines incorporated into treatment guidelines. Provision sustainability is, therefore, an important variable for the success of treatment programs and should be acknowledged during planning and implementation of programs or provision schemes.
Objectives: To investigate the sustainability of ARV provision in three different settings
Design: Policy evaluation by means of a multiple-case study and in-depth analysis. The literature was reviewed for sustainability issues. A conceptual framework on the sustainability of ARV provision was developed, followed by data collection instruments. Analytical categories were identified. Qualitative data were collected through interviews with key actors and analyzed.
Setting: The pilot study was undertaken in Brazil. Three countries—Bolivia, Peru, and Mozambique—were visited. Interviews with key actors involved with HIV/AIDS programs and ARV provision in each country were carried out.
Outcome measure(s): The investigative focus centered on HIV/AIDS programs and the mechanisms undertaken to provide ARVs to PLWHA in each country. Outcome measures were (1) sustainability issues related to ARV provision and (2) routinization events of programs (or country provision schemes, in absence of specific programs).
Results: Evidence of greater sustainability potential of the program was observed in Peru, where provision is implemented and routinized by the national HIV/AIDS program, and expenditures are met by the government. In Mozambique, provision is almost totally dependent on donations and external aid. A large effort is being undertaken to incorporate ARV provision and care into routine health care activities. Bolivia, in addition to having external dependence on financing and management of drug supply, presents problems regarding implementation and routinization of ARV provision activities.
Conclusions: The conceptual framework was useful in recognizing events that may influence sustainable ARV provision in these countries. Planning ahead for sustainable provision, considering the epidemic profile and population needs, is essential, and without it, financing sources and mechanisms are not enough. Furthermore, country programs and provision schemes must consolidate themselves in the structure of health services provision as a whole, especially in limited-resource settings.
Funding source(s): UNAIDS