MANUEL ENRIQUE LEZANA*
* Ing. Manuel Enrique Lezana is Chief of the Drug Coordination Office, Ministry of Health, Guatemala.
OVER the past 15 years, Guatemala has followed through its commitment to the concept of essential drugs by developing a range of strategies and actions designed to improve the supply of drugs and ensure wider access to them1. More recently, the Guatemalan Ministry of Health has drawn up a blueprint for overall health policies to the year 2000. The proposals include: the modernisation of state health services through decentralisation of finance and administration; strengthening the capacity of governing bodies; improving sectorial and intersectorial coordination; and making better use of existing resources for health. The Ministry of Health is also committed to improving the quality of health services and ensuring wider access as well as improving the management of health services.
1 Working together, learning together. Essential Drugs Monitor [editorial] 1992; 13.
Within the Health Ministry’s budget, the largest items of expenditure are medicines (10%), surgical materials (5%) and medical equipment, including maintenance and replacement equipment purchases (6% - 7%). However, over time, the administration of this budget has lacked transparency in the selection, purchase and distribution of these products. The quality of the product purchased was neither defined in advance nor checked on receipt. Meanwhile, suppliers had no guarantee of payment - resulting in price speculation of up to 400% of the original price.
One of the first steps taken was to form a group of national consultants to work with the WHO Regional Office for the Americas and the Pan American Health Organization. The group was to draw up a strategy to resolve existing problems and capitalise on the then current employment of an international company with expertise in drug purchasing systems.
SWEEPING POLICY CHANGES
A Multisectorial Commission for Policies on Medicines was formed within the Public Health Ministry with representation from both the private and public sector as well as international health organizations. The Commission’s remit was to advise the Ministry on new policies for the quality control and supply of drugs. Because of the seriousness of the problems encountered, it was decided to implement new policies across the board. These included:
strengthening the drug regulatory authorities and the official quality control laboratory;
setting up working groups to develop quality standards and new procedures for administration, purchasing and distribution;
revision of the legal framework;
new guidelines for the purchase of drugs;
an improved system of logistics for the provision of supplies;
establishment of a drug vigilance programme.
Reform of the drug regulatory authorities and the official quality control laboratory was achieved through strengthening the management structure, decentralisation of finance, staff training programmes and a review of salaries. Other measures included: the establishment of new administrative procedures for the register of authorised drug sales; better quality control of medicines; the creation of a standardised system for drug registration; better inspection of Good Manufacturing Practices; the purchase of laboratory equipment; and the development of a computerized data system for drugs.
Elsewhere, the Quality Standards Working Group studied the list of 1,400 drugs purchased by the Government - which contained many duplicate products - and recommended the use of the 13th edition of the US Pharmacopeia and the US Pharmacopiea Dispensing Information, to define the specifications of products purchased by the Government. Other products on the list had to be ratified from alternative sources, such as the British, French and Japanese Pharmacopoeias.
The Working Group also estimated supply needs on the basis of figures provided by different health units. The aim was to establish quantities that would be attractive to suppliers and ensure savings through bulk purchase orders. Medical surgical materials and medical equipment were handled in a similar way, using international standards such as those of the US Food and Drug Administration, as well as alternative standards. At every stage, both consumers and suppliers were involved in defining the quality of the product. A second working group was established to review the legal aspects of Government purchases of medicines and medical surgical materials2.
2 Governmental Agreement 472 - 96, dated 4 November 1996, related to the quality of medicines and medical surgical materials in which the purchasing standards are established.
Dispensing drugs to a patient at Panajachel Health Centre, Guatemala
Photo: A. Rutgers
As part of the modernisation process, the law was updated and a new Health Code issued3. The regulation4 that this law implements facilitates Guatemala’s participation in the globalisation process, and establishes responsibilities for all personnel involved in the supply of medicines. Meanwhile, overall control remains within the Ministry of Health.
3 Legislative Agreement 90 - 97 in force from February 1998.
4 This regulation is awaiting final Presidential approval.
The legal framework provides for the development of a Programme of Ease of Access to Medicines5 through already established state and municipal pharmacies6, and the establishment of a Sales of Medicines for Community Benefit scheme7 run by civilian groups to ensure they are self-financing and sustainable. The proposal for the Purchase of Medicine system, which came into operation in early 1997, adopted the open contract system already in force for Government purchases. This is an administrative tool with centralised negotiation and decentralised execution - designed to guarantee the quality of the product, purchased at prices previously determined at central level.
5 Governmental Agreement 714 - 97 dated 8 July 1997.
6 Ministerial Agreement 161 - 98 dated 26 May 1998.
7 Ministerial Agreement 162 - 98 dated 26 May 1998.
ENSURING TRANSPARENCY IN SUPPLY
The new drug purchasing system was modified to include an open tendering system, with control over those who make the offers, and clear rules to ensure transparency and bring an end to corruption. A computerized system has been developed for this.
Resources must be used rationally to allow for extended coverage. Meanwhile, quality must be in conformity with the US Pharmacopeia, and all medicines referred to by their International Nonproprietary Name. Norms have been established for the qualification and awarding of suppliers and products, together with a procedure and payment guarantee to ensure successful relationships. This agreement provides for payment within a maximum of 30 days after receiving the product, compensation in the event of fluctuations in the exchange rate and payment of interest on delayed invoices. Sanctions can now be imposed for the supply of poor quality products and for failure to deliver within the agreed timeframe (with a maximum penalty of five years’ suspension as a Government supplier).
The central drug warehouse in Solola District. The Guatemalan Government is implementing measures to improve drug supply
Photo: A. Rutgers
The new system allows for a maximum of 3% deviation in the minimum price offered by a maximum of eight suppliers. Meanwhile, an inter-institutional commission has been established to oversee the operation of the open contract system and apply sanctions for non-fulfilment. The private sector participates as an observer in this commission. The Process of Public Awarding provides for the participation of personnel from the administrative units and executing officers from the public health sector as well as observers from private sector organizations and professional colleagues (doctors and pharmacists).
FOCUS ON QUALITY
The establishment of administrative and technical norms was also necessary to guarantee that the item gets to the user in perfect condition, in the correct quantity and on time. These included a definition of the role of the professional pharmacist to ensure that drugs are used and administered correctly. Norms were also established for selection, purchase, reception, storage and distribution in order to ensure the punctual delivery of the correct medicines. A system was put into place to deal with complaints about the efficacy or safety of products, and take appropriate action wherever needed.
In late 1997 doubts about the quality of medicines purchased through prescription prompted the launch of clinical studies of some products. The finding that some products were lacking in efficacy led to the establishment of the Drug Vigilance Programme - designed to assess complaints about therapeutic failure and/or adverse reactions to medicines purchased through the open contract system.
The new policies have met with opposition from some groups - including prescribers and suppliers who failed to win contracts - each preferring to maintain the status quo on drug supplies. Other problems have included inadequate supply forecasting - leading to drug shortages - and budgetary restrictions on efforts to ensure vigilance and control. However, failure by some suppliers to provide the correct amount and quality of drugs has led to the imposition of sanctions, including five-year exclusion from the Government supply system.
Among the major achievements of the new system are the savings on drug budgets and the extended coverage with low cost, high quality medicines. The Ministry of Health has saved 65% of its budget and the Guatemalan Institute of Social Security - the country’s other public health service provider - saved 23% of its drugs budget. Meanwhile, through the Access to Medicine Programme - which benefits from decentralised price negotiations - medicines are now being made available to underserved communities.
Elsewhere, quality standards have been established for the purchase of medicines and sanctions put in place to deter the supply of poor quality medicines or late deliveries.
Multidisciplinary teams now participate in negotiations for the purchase of drugs and other medical items, and the decentralisation of health budgets facilitates the prompt payment of suppliers.