IMPACT ON HEALTH BUDGETS OF ANTIBIOTIC USE

3. IMPACT ON HEALTH BUDGETS OF ANTIBIOTIC USE

Infectious diseases increase demands on national health budgets that already utilise some 7–14% of GDP in developed countries, up to 5% in the better-off developing countries, but currently less than 2% in least developed states. In many developing countries where many competing needs exist, healthcare budget represent only 2–5% of their total annual budget. This cre- ates a very vulnerable public health infrastructure with small support for sus- tainability. In addition, when unexpected health crisis or natural disasters arrive in these countries, such as infectious outbreaks, emerging infectious dis- eases, earthquake, flooding, fire, etc., public health officials are faced with the difficult task of cutting existing budgets and allocating monies to solve crisis leaving scarce resources to carry on existing efforts.

Public health officials, policy makers, and clinicians must come together and develop a plan to minimise antimicrobial resistance and its economic impact. Strategies have to take into account all stakeholders affected by new policy measures such as physicians, patients, the healthcare businesses, the drug industry, and the public as a “society” (McGowan, 2001).

In outpatient settings, healthcare practitioners often feel compelled to empirically treat patients with acute infections without waiting for the results of cultures and susceptibility tests. In hospital settings, clinicians can often rely on bacteriology data and if available also on antimicrobial resistance surveillance data from routine screening of specimens. Quite often, medical, veterinarian, and dentist surgeons administer prophylactic antibiotics pre-, during, and/or post-surgery for much longer period of time required or recommended by guidelines issued by professional associations.

Differences between infectious disease and intensive care physicians prescribing attitudes have been observed (Sintchenko et al., 2001). Fear of malpractice suits also play a role in the decision-making process. When select- ing empiric therapy for infectious diseases, one must consider in vitro suscep- tibility patterns and prevalence resistance rates along with other factors, such as tissue penetration, expected efficacy, adverse effects, cost, cost-effectiveness, and selection of resistant strains.

Other factors contributing to the development and pervasiveness of antibiotic resistance include: unregulated drug approval, quality control and marketing; lack of patient resources/access to quality healthcare; patient non-compliance and self-medication; physician misuse of antibiotics; and lack of reliable infor- mation sources for physicians such as standard treatment guidelines (STGs) and laboratory facilities to confirm diagnoses.

Substandard and counterfeit drugs are also problematic, as are quality control deficiencies in pharmaceuticals and pharmaceutical companies. Many

Antibiotic Policies in Developing Countries 599 countries in Latin America, Africa, and Asia do not have agencies or regulatory

mechanisms for the approval, quality control, and marketing of medicines; and rely on the good faith of pharmaceuticals that submit data approved by other country agencies (Food and Drug Administration [FDA]).

Poverty and lack of healthcare resources exacerbate the resistance problem in the region. Patients with limited incomes generally cannot afford to see a health- care worker or receive laboratory tests to determine the aetiology of the disease (if the tests are available). These patients can sometimes only afford poor quality or substandard or counterfeit drugs, or a drug course shorter than that which would be optimally effective. Counterfeit drugs often contain the wrong ingredi- ent, contain no active ingredient, or contain only weak and inadequate amounts of the active ingredient (WHO, 2000). One study showed that patients who self- medicated were more likely to use an inadequate drug or dose, and to follow treatment for less than 5 days (Bojalil and Calva, 1994). Perhaps the single most significant problem in many countries is the widespread availability of antibi- otics without a prescription. In these countries antibiotics may be purchased from pharmacies, street vendors, convenience stores, outdoor markets, fairs, etc. One study examining the impact of unregulated antibiotic sales in Bolivia tested healthy children from urban areas and found that 97% carried Escherichia coli insensitive to ampicillin (Bartoloni et al., 1998). A survey of drugstore sales of antibiotics in Mexico revealed that only 57% of antibiotic purchases were made with a prescription, and that the person selling the drug gave instructions on its proper use in only 15% of observed transactions (Calva, 1996).

In 2001, Prof. Leonid S. Stratchounski, Director of the Institute of Antimicrobial Chemotherapy Smolensk, Russia lead a study to inventory the content of antibiotics for systemic use (ASU) in home medicine cabinets (HMCs) of the non-medical population in Russian cities and to find out for which indications people report they would use ASU on their own (Stratchounski et al., 2002). One thousand two hundred families in twelve cities participated in the study. Two thousand five hundred forty five packages of antibiotics were identified.

The number of different antimicrobials (by international nonpatent names) in HMCs was 65. The average number of antimicrobials per household was 2.6 (from 1 to 11 ASU in a single HMC). Families with two and more antibiotics represented 72.2%.

Their findings seems to indicate that (1) antimicrobials are widely preva- lent among inhabitants in Russia; (2) the most “popular” antimicrobials (co- trimoxazole, chloramphenicol, tetracycline, sulfonamides) may cause serious adverse drug reactions; (3) antibiotics are often used imprudently; and (4) the population does not have enough knowledge regarding antibiotics in general.

Physicians, who are overworked, underinformed, or feeling other pressures to overprescribe are also contributing to the spread of resistance. Other

600 Aníbal Sosa problems, such as choice of broad-spectrum antibiotics over appropriate

narrow-spectrum alternatives, or prescribing antibiotics in incorrect doses and/or treatment durations, can occur even when clinical presentations necessi- tate antibiotic prescription. In a study by Paredes et al., of 40 physicians in Lima, Peru, who were questioned on the proper use of antibiotics to treat diarrhoea (Paredes, 1996), 36 correctly reported that the majority of diarrhoeal disease is of viral origin and antibiotics are not indicated. Yet 35 of these 36 unnecessarily prescribed antibiotics for this condition. Although the physicians were clearly informed of appropriate prescribing practices, other factors including control of disease, patient demand, patient’s family’s demands, and practitioner self-confi- dence, persuaded them to misprescribe. In other cases, inappropriate prescribing has been attributed to insufficient training in infectious diseases and antibiotic treatment, insufficient use of microbiological information, and the difficulty of empiric drug choice (Nathwani and Davey, 1999).

In May of 2001, APUA conducted a survey on physician antibiotic pre- scribing practices and knowledge in seven countries in Latin America. Respondents prescribed antibiotics in the presence of acute respiratory infec- tion (ARI)/pneumonia as a first (27%) priority reason. Second (14%) priority reason was the presence of UTI. Physicians reported using penicillin most often (29%), followed by ampicillin (18%), and cephalosporins (12%). Reasons for using these particular antibiotics were that they are the drugs of choice for the most prevalent clinical cases (ARI) in the countries surveyed, and also that they are accessible, less expensive, and wide spectrum (Sosa and Travers, 2001).

A lack of proper diagnostic facilities and laboratories is another serious issue, so that many physicians must rely on empirical treatment of a disease rather than evidence-based treatment (WHO, 2000). When available, it is help- ful to use bacterial studies in order to confirm diagnosis and make the best treatment decision. Empirical treatment is the norm in most situations in the region. This survey, however, showed inconsistent and unclear knowledge on empiric treatment of the most common illnesses, pointing to a need for wider dissemination of STGs.

In many developing countries with other pressing health priorities, antimicrobial resistance is an even greater problem than in the United States, yet drug regulation and use policies are very limited or nonexistent. In the past few years, industrialised countries have at some point issued important antibi- otic policy changes. Australia, Canada, United Kingdom, and the United States have implemented measures such as guidelines for practitioners, national campaigns for primary care providers, consumer awareness cam- paigns, applied research and surveillance, guidelines for hospital and veteri- nary use of antibiotics, national medicine weeks, grassroots projects involving both practitioners and consumers, creation of national prescribing services,

Antibiotic Policies in Developing Countries 601 etc. (Hemming and Harvey, 1999). A few countries in South America, such as

Chile, Uruguay, and Venezuela have begun setting up regulatory measures towards the introduction of a national antibiotic policy (Bavestrello and Cabello, 2000).

The European Society for Clinical Microbiology and Infectious Diseases (ESCMID) have created a Study Group on Antibiotic Policies to investigate and document policy issues surrounding control measures, key infectious dis- eases, prophylactic use of antibiotics, resistance rates, antibiotic consumption, etc. (ESCMID, 2002).

Some countries in the developing world have enacted regulation to restrict the sale and dispensing of antibiotics without a prescription. Often, it does not get enforced or monitored, or there are unsanctioned dealers or illegal dis- tributors who can operate without any retribution (Becker et al., 2002) and antibiotics are still sold over-the-counter (OTC) (personal communication, Dr Celia Carlos, Philippines). Pharmacists also substitute antibiotic prescrip- tions from one class to another and not just for generic products (Unknown, 2001). These unsanctioned providers are commonly not trained to diagnose key infectious diseases or correctly prescribe appropriate doses (Hemming and Harvey, 1999).