USAID awarded Management Sciences for Health (MSH) its five year Strengthening Pharmaceutical Systems (SPS) program in 2007 as follow-on to its Rational Pharmaceutical Management plus program. The mandate of the SPS program is to build capacity within developing countries to effectively manage pharmaceutical systems, and ultimately impact on saving lives by improving access to and use of medicines of assured quality.

The SPS program focuses on achieving four key results:

1. Improving governance in the pharmaceutical sector;

2. Strengthening pharmaceutical and laboratory management systems to support public health services/interventions;

3. Containing the emergence and spread of antibiotic resistance; and

4. Expanding access to essential medicines.

SPS programs assisted in improving medicines policies, regulation, quality assurance and pharmacovigilance in Africa and south East Asia. The program applied the pharmaceutical care concept in resource-limited settings of sub-Saharan African countries. In addition to providing global technical leadership through their consortium partners such as the WHO collaborating center in Pharmaceutical Policy at the Harvard University, the program also draws specialized resources from the London School of Hygiene and Tropical Medicine and the African Medical Research Foundation.

India has a robust $2.5 billion National HIV/AIDS program (The National AIDS Control Plan/NACP-III) with a primary focus on prevention of new infections in high risk groups. There is a commitment under NACP-III to strengthen the infrastructure, systems and human resources in prevention, care and treatment at the district, state and national levels. While the public health care delivery system is fairly well defined, the private health sector offers an alternate rapid health care delivery system. There is widespread agreement that though the government has the necessary resources (financial, human and equipment); the health outcomes remain relatively poor. The key challenges include inefficient use of resources, poor quality of health delivery services and federal-state dynamics, as health is a state subject. Overall, there is inadequate information on key variables in the health service planning process such as forecasting demand, cost analysis, existing resources in the health market, quality of services, and utilization of services. Additionally, there is insufficient effort to make this information available at sub-national levels or provide technical assistance in the use of such data.

Currently, the National AIDS Control Organization (NACO) provides financial assistance for supplies, drugs and medicines for opportunistic infections, STI and PMTCT services to various district hospitals through the state level State AIDS Control Societies (SACS). The scaling of CT services across nearly 5,000 centers in India translates into a base requirement for about 22 million tests a year in the public sector. The main HIV Rapid Testing kits are procured at the federal level while the confirmatory test kits are procured at the state level. Additional procurement requirements include the supply of first line ARV drugs that are supported through the Global Fund for at least 150,000 who are currently on ART. NACO intends to cover 300,000 adults and 40,000 children on ART by 2011.

States which have a high burden of HIV such as Karnataka, a USG priority state, have a need for stronger pharmaceutical management including a systemic regulation for selection, procurement, distribution and use. For instance, the state has 33 fully functional ART centers with close to 30,000 patients on ART. As in other USG priority states, each of these centers performs a spectrum of functions ranging from dispensing of ART and adherence counseling to basic laboratory investigations and networking with other services. There is a need for accreditation of ART centers for improved delivery of high quality services and human capacity building at all levels from drug distributors and stockists, to pharmacists and health care providers, including those from the private sector.

Under the public-private partnership initiative of NACP-3, comprehensive antiretroviral therapy (ART) centers with amenities for HIV care services are being initiated in the private sector including private medical hospitals to expand the base of service delivery for HIV care and treatment. However, assessments in high HIV burden states indicate that almost 30% of general practitioners in the private sector who see HIV patients prescribe ART, with the medical/pharmaceutical representative as the only source of information. Similarly, there is no system to calculate the volume of ART being dispensed in the private sector or system for a decentralized procurement of opportunistic infection (OI) drugs and essential laboratory supplies at the district level.

The need of the hour is to provide a model for applying systems strengthening interventions that are most appropriate for India's specific health, economic and political situation that would also address gaps at the state level systems.

SUMMARY SPS with its mandate to provide technical assistance (TA) for building country capacity will serve as a mechanism to fulfill the gaps existing in the pharmaceutical management functions and services in USG priority states where the burden of HIV is high. While antiretrovirals (ARV) are centrally procured, the states perform key procurement functions for certain HIV test kits and drugs for OIs and sexually transmitted infections (STIs) as part of the decentralization process. Some of the USG priority states which have high HIV burden of care and treatment lack the infrastructure, management systems, information technology as well as experienced and competent staff to plan and implement an efficient procurement system. Additionally, the capacity building of the private sector for rationale use of ARV is a gap that is not yet addressed.

USG intends to work in close collaboration with MSH, the implementing agency for SPS to design and implement potential contributions in improving the state level responses for efficient HIV care, support and treatment services. The project intends to address the state specific gaps in the USG priority states including gaps in quality of services, barriers for treatment adherence and initiating pharmacovigilance systems. Drug safety is also a priority issue for research and post-market adverse drug reaction (ADR) monitoring is emerging as a key for determining a structured analysis of clinical patterns and morbidity associated with antiretroviral therapy (ART).

The project envisages working in close collaboration with the State AIDS Control Societies (SACS) and the local drug and logistics society and will leverage the government program where ART is dispensed in the public sector ART centers and where the treatment services are provided at the government ART and/or community care centers (CCC).

As part of the private sector engagement, NACO has initiated comprehensive ART centers with amenities for HIV care services in private medical hospitals with teaching institutions. This has expanded the base of service delivery for HIV care and treatment. The project will work to build capacity of such private sector institutions such as the Kempegowda Institute of Medical Sciences (KIMS) in Karnataka in improving quality of service of laboratories and delivery of ART services. Standard operating protocols (SOPs) to standardize the testing processes and laboratory functions in accordance with national and international standards will be a primary focus. The work with the private medical sector will be in collaboration with local associations such as the Indian Medical Association or the state chapters of the Nursing Home and Hospitals Association with joint agreements from the local SACS.

Activity 1: Provision of TA at state and district levels for improving quality of service of laboratories and pharmacies in delivery of ART services

Laboratory and pharmacy components are essential elements of an ART center. Efficient quality service comprising a full-spectrum of services is the cornerstone of effective ART. The rapid scale-up of ART under NACP-III, however has not balanced the commensurate quality of services. Current gaps include lack of data on current pharmacies and laboratory management systems in terms of their current manpower and knowledge, physical infrastructure, stock and dispensing procedures and protocols that are followed for inventory management, distribution, dispensing and forecasting. The key sub-activities that will be undertaken for improving the quality of pharmacies and lab services will include accreditation of ART centers. TA will be provided at selected state-headquartered ART centers and 30 district level ART centers across 5 USG priority states for the following: a) Development of SOPs for laboratories and pharmacy services - This will bring in a standardization of testing procedures across the USG priority states and allow high quality and uniform interpretation of results. This TA will also be adapted to the regulation of testing for laboratories which have CD4 machines. Capacity building of the laboratory technicians in these laboratories for regular calibration, maintenance of the machines, trouble shooting, improving sensitivity of the CD4 machines, standardization of protocols, quality assurance procedures will contribute to the improved services of the ART center. b) Designing and evaluation of tools of pharmaceutical medication for medication counseling and treatment adherence- Addition support will be provided to overcome the barriers in treatment adherence such as state specific pharmaceutical communication in an appropriate and technically sound manner commensurate with the patient's literacy skills and cultural context. Patient treatment charts will be designed and field tested to evaluate the patient's understanding of the pictograms on the adherence to medication.

Activity 2: Establish pharmacovigilance systems

In FY 2010, TA will be provided in the high HIV burden state of Karnataka for establishing a pilot pharmacovigilance study at two sites to monitor adverse drug reactions. Treatment of TB in HIV infection presents several challenges including pharmacological interaction between antiretroviral s (ARV) and anti tuberculosis (ATT) drugs, overlapping toxicity profiles and clinical manifestations of non-adherence of complicated HIV-TB treatment regimens. In collaboration with the NACO-approved ART center at the private medical teaching hospital of KIMS, patients on ARV as well as those on ARV and concomitant treatment of TB will be monitored over a 12 month period in compliance with ethical and management protocols by national and international standards.

Activity 3: Capacity building of private sector including private providers and hospitals in the private sector

In FY 2010, a total of 500 medical practitioners from priority USG states will be trained in the rational prescription of ART. The project will partner with KIMS, a private medical institution that has a Memorandum of Understanding (MoU) with NACO for a private-sector partnership to expand HIV related services. USG will provide support to develop KIMS as a learning site for capacity building of the private sector in implementing HIV/AIDS programming. The training will increase capacity of various partner institutions under the NACO-private sector partnership program to provide pharmaceutical management. The program will address effective referrals to the free ART program supported through the government to reduce the likelihood of resistance to first-line ART. Additionally, a customized training package will be planned for capacity building of 500 pharmacies and chemists located around the private medical institutions that have a MoU for private-sector collaboration with NACO in the USG-priority states to support the country's first assessment of private sector ART. The package will include training to establish a system for collection, collation and calculation of volume of ARVs being dispensed from the private sector; and support training of pharmacists and chemists in their role for a concerted response to ART management. The project will work in close collaboration with the pharmaceutical companies that manufacture ARVs to identify champions among the medical/pharmaceutical representatives who will be trained as peer leaders.

Activity 4: Improve procurement efficiency at the district level

The project will support the capacity building of the district procurement program at the level of the ART centers in select high-burden districts of USG priority states. District surgeons and medical superintendents who are currently authorized by the government for the decentralized procurement will be trained in forecasting, procurement protocols in adherence with national guidelines and logistic management of drugs and supplies. The training will facilitate the continuous availability of critical drugs at the time and in the quantity required including supplies for basic microscopy including availability of critical stains needed for TB diagnosis such as Acid-Fast Bacilli (AFB) and basic serology at the ART or community care centers located at the district level.