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Medical products, vaccines, infrastructures and equipment

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A well-functioning health system ensures equitable access to essential medical products, vaccines and technologies of assured quality, safety, efficacy and cost effectiveness, and their scientifically sound and cost-effective use.[1]

Major components of the medicines market[2]

To achieve these objectives, the following are required:

  • national policies, standards, guidelines and regulations that support policy;
  • information on prices, international trade agreements and capacity to set and negotiate prices;
  • reliable manufacturing practices and quality assessment of priority products;
  • procurement, supply, storage and distribution systems that minimize leakage and other waste;
  • support for rational use of essential medicines, commodities and equipment, through guidelines, strategies to assure adherence, reduce resistance, maximize patient safety and training.

Major components of the medicines market are shown in the figure.


This section on Medical products, vaccines, infrastructures and equipment is structured as follows:

Contents

Analytical summary

Support services are probably remaining one of the weak chain of the Zambian health sector. Efforts have been consented these last years on restructuring and streamlining the organization of pharmaceuticals, but some problems remain. Some areas, particularly rural and peri-urban areas in poor provinces, suffer from insufficient equipment and infrastructure, and poor maintenance.


Medical products

Organization and management of pharmaceuticals

The pharmaceutical sector is now under the full authority of the Pharmaceutical Regulatory Authority (PRA), which is a semi-autonomous public board created under the National Drug Policy (attach doc) in 2006. Previously the function was shared between Pharmacy and Poison Board and a number of specialized boards, each of them with a specific but limited mandate.

The Pharmaceutical Regulatory Authority is in charge of registration and regulation, procurement and distribution of drugs, financial management, as well as issues concerning quality control of drugs and rational use of medicines

The warehousing and distribution of medicines at the central level is undertaken by three types of central medical stores: (1) Medical Store Limited, acting as a parastatal agency for the public system; (2) Churches Health Association of Zambia Medical Store, which mainly deliver to other facilities and might facilitate procurement for other NGOs or CPs; (3) a number of private pharmacy wholesalers[3], which provide the private market with drugs and medical products. Before 2006, all used to apply different rules. The creation of the PRA has allowed harmonizing the regulation and standards among these three type of providers.

The public network of medical stores throughout the country has been developed following the National Health Policies and Strategies 1992. It offers a very comprehensive mapping of the country with a network of Provincial Medical Store, District Medical Store, Hospital Medical Store and Health Facility Medical Store. The CHAZ medical store distributes medicines directly from central level to CHAZ health facilities. The Private sector Pharmacy Wholesalers sell to a network of various outlets that include licensed pharmacies, local (provincial or district) licensed wholesalers and unlicensed drug vendors.

Most producers of medicines circulating on the Zambian drug markets are foreign producers. To receive the market authorization, they must all comply with anyone of the following set of regulation: the WHO certification, the certification standards of the country of origin of the drugs and/or re-testing by the Zambia Food and Drug Laboratory. Medicines produced by local manufacturers must be certified by the Zambia Food and Drugs Laboratory before being introduced on the market.

Regulation, quality and safety of the pharmaceutical sector

The National Drug Policy, passed in 1998, provides the regulatory framework that guide the registration and regulation, procurement and distribution of drugs, financial management, issues concerning quality control of drugs and rational use of medicines, whether manufactured locally or imported. Its enactment has been the starting point for a set of policies and initiatives contributing to regulate the market of drugs and medical products in Zambia.

The National Essential Medicines List (NEML) defines ‘essential medicines’ that are associated with the implementation of a basic health care package (BHCP). The NEML is supposed to be updated every 2 years to keep pace with trends, but this is not so in practice. The list was last updated 4 years ago, thereby making it out-of-date for some clinical conditions (see Rational use of medicines)

The Zambia Standard Treatment Guidelines (ZSTG) is produced by the National Formulary Committee every 2 years to reduce irrational prescribing behaviour (e.g. excessive use of injection to please the demand, excessive prescription ending up in budget shortages). However, a recent study[4] has noted that some facilities did not prescribe medicines consistently and according to ZSTG

There is no specific or special policy promoting utilization of generic drugs. Yet, they are allowed on the Zambian market, as long as they meet the Zambian quality standards.

The Pharmaceutical Regulatory Authority (PRA) has the responsibility to deliver market authorization to providers. A specific committee is set up for that purpose, to review all information as per provider along criteria defined by the PRA (quality, safety, storage conditions, observation of clearance with other (international) certification boards).

All new drugs entering the country should ideally be sample-tested by the Food and Drugs Laboratory. However, this is not so in practice, due to funding shortages.

The quality conditions of warehousing and distribution of medicines to the public health sector are under the responsibility of the Medical Store Limited for the public sector, and other medical stores for the faith-based and private sector (see the previous section).

Cost of drugs in public health facilities is included in a lump sum per episode of illness. This lump sum must (in theory) result from an annual negotiation process between each public health facilities and the surrounding population, with later justification to the ministry of Health. As a reminder, nowadays, most drugs under the Basic Health Care Package & all drugs dispensed at urban & peri-urban health centres and district hospitals are free. The picture is obviously not the same in the private sector, which is fully liberalized since 1991, with prices varying and payment mechanisms among providers. Still some NGOs subsidize and facilitate access to some priority drugs.

Drug procurement system

The organizational structure and procurement policies of essential medicines are based both on the principles of decentralization and the autonomy of each facility within the drug management and distribution system (i.e. Medical Store Limited (MSL) → Hospital and MSL → District → health centres). Each facility is granted an annual drug budget by the MOH and is kept responsible for its own procurement decisions.

Public health facilities are given clear guidelines and tools for quantifying drugs. Ideally at health centre level, a committee must be set up with health staff and community representatives for determining the volume of drugs needed according to consumption and remaining stock. In practice, the calculation often rest in the hands of one staff member, often with insufficient capacities. Governance arrangements are quite poor at lower levels, and suffer from the absence of external control and weak accountability.

Orders from health centres will be sent (normally every quarter) to the District Medical Store (DMS), placed under the responsibility of the District Health Management Team. (DHMT). As long as drugs are available, they are usually delivered on short notice, but what you order is rarely what you get, as DMS budget ceilings create numerous restrictions. District hospital proceed the same way, while provincial hospital usually directly manage the Provincial Medical Store.

In general, MOH procurement rules state that a hospital or DMS must look to MSL first, to source for its pharmaceutical supply needs. If MSL is unable to meet these needs, and the requested item is out of stock, then the district or hospital can buy from the open market. However, budget allocation for this purpose caters only for emergence drugs and not necessarily for all essential medicines, and because of frequent stock-outs, funds for emergency items are often times used to purchase other essential pharmaceuticals. For lower level facilities, a similar approach is followed by going to the district health office first, then only when the district is unable to supply can the health centre turn to the private sector, through the district. Government allocates up to 10% of the grant to cover for this foreseen eventuality.

In terms of the flow of pharmaceutical supplies, the DMS makes order to the PMS on a quarterly basis. The PMS on a quarterly basis makes order to the national medical store. Here also there is a ceiling on how much each institution is allowed to order to guide with equitable distribution and consumption.

Some alternative systems are operated in parallel particularly for vertical programmes (e.g. PEPFAR buys in the US and conveys the drugs up to the targeted health facilities. Most other vertical programmes or NGOs would buy the drugs themselves but distribute it through an existing network (public, CHAZ)

Procurement of vaccines is separate: come from GAVI & UNICEF under the authority of the UCI unit which buy, store, and distribute vaccines with their own logistics during the immunization weeks apart from the existing network.

A recent study[5] reported serious problems of acces to medicines, with stock-outs up to 14% of the stock. Stock outs occurred in both private and public health facilities, of maximum 86.5 days and 112 days respectively, (more than 3 months), The reasons for stock outs were given as (i) the lack of staff, (ii) lack of transport, (iii) patient load and (iv) logistical system to capture data for better planning at lower levels of the system. On average, 2.9% of public health facilities and 0.34% private drug outlets were found with expired drugs on the shelves; reaching a maximum of 31% and 7% at public and private facilities, respectively.

It is common knowledge that Zambia has a serious problem with importation of fake drugs, largely from the middle and Far East. Such drugs are illegally imported by private drug sellers and distributed through the network of (unlicensed) private retail outlets.

Finally there is no specific problem of geographical inequity regarding drug procurement. The centralization of drug funding and procurement under the MOH authority seems to have provided poor and better-off areas with similar conditions. However, the distribution of medicines to the periphery (especially to the health centre level) can be a problem, and recourse to alternative procurement from the 10% grant allocation is limited; thereby contributing to cases of drug shortages.


Vaccines

Organization and management of vaccines

The authority in charge of regulating vaccines is the Directorate of Public Health and Research, which is a directorate within the Ministry of Health (MOH)

Main actors are the MOH (regulation and coordination), GAVI & UNICEF (funders) and the Universal Child Immunization (UCI) unit at MoH, which undertakes all logistical aspects and serves as a coordination secretariat.

All the vaccine consignments are procured and managed according to the UNICEF technical specifications, thereby ensuring quality. In addition, bulk buying by UNICEF helps to ensure procurement at lower costs.

Objective of vaccinations are set every year by the MOH in the annual planning cycles and are aimed at attaining the MDGs. The annual projection of needs per district are estimated by a national technical working group, coordinated by the UCI unit, with input from district health offices countrywide.

Vaccines procurement system

Based on the annual projections done by the national technical working group, quantifications of need orders are made in line with action plans drawn up. UNICEF & GAVI play a big role in procurement (see the previous section).

Upon arrival in the country, vaccines are stored at Universal Child Immunization (UCI) cold chain equipment and relayed through the cold chain system in place in the country, down to the HC level, for storage prior to use (see the section on drug procurement system for further details about the existing procurement network).

For routine vaccination usage, vaccines are procured on demand from the UCI unit national cold chain stores to provincial stores, which distribute to district stores, who in turn distribute to facility stores (hospitals and health centres). Routine vaccination sessions are undertaken at facilities (static sessions) or during outreach services, using vaccine carrier bags.

In addition, mass vaccination campaigns are undertaken twice in a year over a 7-day period, to help ensure reaching the 80% target coverage set by the Ministry of Health. Calculation of the number of doses needed obviously does not depend on the decentralized level, but is coordinated by UCI, in line with the annual planning. Vaccine supplies are dispatches to points of use along the channels as described.

Cold chain and other quality issues

There are some quality and equity issues in getting effective vaccination coverage. At the national level, the quality of vaccines is assured through the technical specifications and contracting by UNICEF. However, problems may arise in-country, which are related to long distances and difficult road conditions to some distribution points, associated with poor maintenance of cold chain conditions.


Infrastructures and equipment

Organization and management of infrastructures and equipments

Investment in medical equipment and accessories falls under the authority of the Technical Support Services directorate of the Ministry of Health; while real estate investment falls under the authority and supervision of the Policy and Planning Directorate.

National decisions on how much to allocate to these investments are also strongly influenced by the availability of resources and financial ceilings set by the Ministry of Finance and National Planning.

Local decisions on actual investment result from the health planning process as described in the section on health activity planning. Health staff and population at local level have some say regarding their investment but end up being constrained by the total budgetary envelope. There is some additional discretionary space to use collections on infrastructure improvements in places where user fees are still applied. Yet, extension of removal of user fees has reduced this budget allocation space in many health facilities, although part of the Government grant is still supposed to remain to the discretion of local decision makers (e.g. health centre staff & health centre committees).

Equity issues regarding investment and infrastructures are treated at central level according to national priorities. Some clear inequities subsist, as e.g. 19 districts subsisting without a district hospital. Work is in progress (and at various stages of implementation) to ensure every district has a district hospital.

There has been a significant increase in physical investment over the last 3 to 4 years; comprised of (i) completion and extension of existing health infrastructures to reach geographical coverage, (ii) expansion, renewal and expansion of all training institutions, (iii) significant procurement of motor vehicles and motorcycles to all districts, and (iv) investment in critical missing medical equipment (medical imaging, laboratory equipment, etc).

Projections are also quite encouraging. In the 2010 national health budget and over the Medium-Term Expenditure Review period 2010 – 2012, the government plans to spend 2% - 3% of the budget procuring medical equipment and accessories; and a further 14% - 16% on investments in infrastructure[6].

Different documents and tools contribute to regulate and provide necessary information for the development of infrastructure and equipment.

  • Health facility censuses have been undertaken in 2005 - 2006. They gathered critical data on the availability of equipment, infrastructure, human resources and other inputs and investments made for use in making subsequent national health strategic plans.
  • All health facilities were mapped using the Geographical Information System (GIS) in 2005 - 2006 This was undertaken to get a better view of the distribution of health facilities countrywide and within a district. The primary purpose of this activity and the health facility census was to take an inventory of key health care delivery thrusts, map them and ensure improved support to targeted sector development.
  • The Policy and Planning Directorate has also coordinated the development of an infrastructure development plan in 2006, to ensure creation of a conductive work environment. It did not only focus on improvement and extension of health facilities, but also to the upgrading and creation of training institutions, in line with MOH’s current efforts regarding teaching and education.
  • A transport management system was set up in 2004 to ensure the setting up of a transport maintenance unit and capacity within the Ministry of Health; thereby increasing the lifespan of procured transport fleet.

Health infrastructures

The mapping of public health infrastructures is planned as follows

  • On average, a district comprises 19 health centres, 1 to 2 hospitals and is placed under the management of one district health office
  • A province is made of an average of 8 districts and lead by the province health office.
  • At national level, there are 5 central hospitals, for national referrals to access specialized care.

There is a clear geographic imbalance within the country, which reflect the different levels of socioeconomic development. Rural areas and some rural provinces categorised as D suffer from undeniably poorer infrastructure and equipment (see the Government's categorization into 4 categories, namely A (Most urban), B, C, and D (most rural) as discussed in Specific stock and distribution information). The issue is clearly identified by the government and corrective actions are being taken along parallel policies aimed at rebalancing health workforces in these underserved areas (see Performance appraisal and non-financial incentive schemes)

Conditions of health facilities are improving. Previous water and sanitation concerns are almost solved now. PROVIDE ADDITIONAL APPRECIATION ABOUT IMPROVEMENTS & UNSOLVED ISSUES IN HEALTH INFRASTRUCTURES

Medical equipment, devices and aids

Medical equipment and instruments are better maintained than non-medical equipment. Health facilities had surprisingly low rates of nonfunctional medical equipment. Only 2-4 percent of health facilities reported non-functioning medical equipment in their possession (such as x-ray, sonogram, refrigeration equipment, anesthetic equipment, laboratory equipment, blood bank, and oxygen supply). Rural health centres were least provided with these equipment and expressed the highest demand for items such as height measuring devices, microscopes, audioscopes, surgical insruments for Obstetrics & Gynaecology, gowns and protective clothing, malaria blood smears, and urine test strips[7].

Information technology

Since the mid 1990s, the health system is computerized up to the district hospital level. Nowadays, some health centres are equipped with IT facility, but mainly in urban and provinces classified as A (among the richest)

Actually, Zambia can be presented as a pioneer country within low-and-middle-income-countries regarding its utilization of computerized information in health. The very first computerized HMIS was developed in 1995 and already standardized countrywide. It has been significantly improved and extended in 2008 (see Organization and management of HIS). Other management systems are computerized as the recently introduced Human Resource management database (see Overview of the organization and management of HRH). A patient file database is also under development.

Internet is slowly getting expanded thanks to mobile phones connections, but there is currently no reliable network throughout the country. Zones A & B are quite well covered, while the poorest C & D tend to have a lower network. Most government agencies are currently working with the Zambian public provider Zamnet. Yet it appears that the system is poorly reliable and does hardly hold the comparison with existing private providers and the upcoming optical fibre.

There are plans to further develop the IT systems as a condition for the efficient utilization of the related information systems. The first step would obviously to ensure an appropriate IT coverage throughout the country, and find efficient ways to transfer and backup information coming from health centre level. Ambitious additional projects are sometimes evoked, as a telemedicine programme which would require videoconferencing facilities. But there are probably some intermediary steps.

Maintenance policy and other quality issues

The Ministry of Health recognizes that maintenance issues were not highlighted in previous initiatives, thereby resulting in under-investment and major waste on equipment. Since 2005, the MoH has initiated a special programme to help with maintenance of medical equipment at the Northern Technical College (Nortec) in Ndola. The college will train technicians to maintain medical equipment countrywide.

EXPLAIN A BIT MORE: who sets the standards for maintenance? how is it organized? Are there some specific maintenance agents at each level of the system? How has the budget for maintenance evolved these last years? ... and related questions...


Clinical biology

Blood

Priorities and ways forward

Others

Endnotes: References, sources, methods, abbreviations, etc.

  1. Everybody’s business. Strengthening health systems to improve health outcomes. WHO’s framework for action (pdf 843.33kb). Geneva, World Health Organization, 2007
  2. The world medicines situation (pdf 1.03Mb). Geneva, World Health Organization, 2004
  3. Wholesalers and pharmacies which are properly licensed have the option to bypass the national medical stores and to import directly from the foreign producer.
  4. MoH / WHO; Pharmaceutical Sector Baseline Survey report (2006), Lusaka, Zambia].
  5. MoH/WHO; Pharmaceutical Sector Baseline Survey Report issued in 2006
  6. Source: 2010 – 2012 MTEF ceilings and frameworks and 2010 budget, Ministry of Finance, August 2009)
  7. Ministry of Health/World Bank; The Zambia Public Expenditure Tracking and Quality of Service Delivery Survey (PET/QSDS) in the Health Sector - Findings and Implications. Lusaka (2006)