TWN Info Service on Health Issues No. 9
Data on irrational drug use show an increasing trend worldwide, leading to adverse health consequences.
WHO reports that countries have done little to promote rational use of medicines and this has now become a very serious global public health problem, with serious health and economic implications.
The report below highlights some of the issues on the subject raised at the World Health Assembly in May 2005. It was published in the South-North Development Monitor (SUNS) of 27 May 2005.
With best wishes
By Martin Khor
Though the WHA debated these inter-related issues, measures to control irrational drug use were downplayed because some major developed countries did not want the spotlight to be placed on the marketing tactics of drug companies.
Provisions aimed at controlling the sales of drugs as growth promoters in animals were dropped in a draft resolution at the insistence of these countries.
However, the topic of the irrational use of drugs in general (and not just as a part of the issue of anti-microbial resistance) is expected to be placed as an agenda item of its own at next year's WHA, at the suggestion of some countries.
Worldwide, more than 50% of all medicines are prescribed, dispensed or sold inappropriately, and 50% of patients fail to take them correctly. These startling facts were presented by WHO officials at a briefing for WHA participants on "Irrational use of medicines damages health and wastes resources."
"Only two thirds of the world's population have regular access to medicines, and of the people who do receive medicines, more than half of those people are prescribed medicines incorrectly," said Dr. Kathleen Holloway, Medical Officer at the WHO Department of Medicines Policy and Standards. "And of the people that are prescribed medicines, more than half of those people fail to take them correctly."
Arithmetically, that would mean that less than a quarter of medicines prescribed are used appropriately.
Data on trends in medicines use showed that the average number of drugs used increased from 1990 to 2003 from 2.2 to 2.7 per patient. Only 40-50% of patients were treated in compliance with standard treatment guidelines.
Holloway gave some data on the adverse consequences of irrational drug use:
* 2.3 to 4.7 million new cases of hepatitis B and C and 160,000 new cases of HIV per year, resulting from 15 billion injections per year, half of which are non-sterile.
* 4% to 10% of hospital in-patients suffer an adverse drug reaction in developed countries. This is the fourth to sixth leading cause of death in the US and costs $130 billion in the US and 466 million pounds sterling in the UK yearly.
* There is increasing anti-microbial resistance, with resistance of up to 70-90% to original first-line antibiotics for dysentery (shigella), pneumonia (pneumococcal), gonorrhoea, and hospital infections (staph. Aureus).
According to Dr Hans Hogerzeil, director of the WHO Department of Medicines Policy, although there have been previous WHA resolutions, and a WHO programme on rational drug use, not much has been done in countries, and there is a "big and unnecessary problem."
Holloway said very little is being spent to promote rational use of medicines. The global sales of prescription drugs in 2000 were $282.5 billion and drug promotion costs in the US were $15.7 billion the same year. In 2002-03, global WHO expenditure was $2.3 billion, of which the WHO expenditure on promoting rational drug use was only 0.2%.
The WHO is tackling the issue through advocacy, the essential medicines list, training programmes and a WHO global strategy on anti-microbial resistance.
There was inadequate implementation of rational medicines use in countries, with only 26% of countries having a national strategy and only 50% of countries having public education in the past two years, she said.
Holloway recommended that countries implement national programmes to improve medicines use, scale up successful interventions and implement measures to address community medicines use.
"Irrational drug use is a very serious global public health problem and much more policy implementation is needed at national level," she concluded. "Rational use could be greatly improved if a fraction of the resources spent on medicines were spent on improving use."
Examples of successful national programmes for rational drug use were presented by Dr Surya Suryawati of the Centre for Clinical Pharmacology in Gadjah Mada University, Indonesia, and by Prof. Otto Cars, Director of the Swedish Strategic Programme for Rational Use of Anti-microbial Agents, Sweden.
During question time, a member of an Asian consumer organization remarked that a major cause of irrational medicines use in developing countries was the unethical promotion of drugs by drug companies, which practised double standards in marketing and labeling (in developed and developing countries) and gave incentives to doctors to induce them to use more medicines.
He added that a large portion of antibiotics produced were sold as inputs in animal feed to fatten the animals, and as there was little control of this in developing countries, this had contributed to resistance in the bacteria and viruses in the animals which were then passed on to resistance in microbes that affect humans.
He expressed concern that part of a draft WHA resolution on anti-microbial resistance, that dealt with the need to regulate drugs in animal feed had been removed.
There were other interventions from the floor, stating that sales promotion methods by drug companies was a very important problem, and that ways should be found to lower prices of medicines as they were very expensive, and asking whether the WHO was still having alliances with the drug industry as in the period of the former WHO Director General.
Hogerzeil of the WHO replied that the WHO was working with Consumers International on responsible promotion of drugs. He observed that sales promotion by companies is effective in influencing the decisions of doctors on their use of drugs. On what can be done towards more responsible sales promotion, he said regulation seems to be the measure that works as it was shown to prevent the worst aspects of promotion.
On the use of drugs in animals, Hogerzeil said that the drafting group for the WHA resolution had decided that the resolution should only deal with the medical problem as there are other international agencies that deal with drug use in animals.
He added that the previous Director General had held roundtables with drug companies, generic companies and NGOs. At present, discussions are still going on, but at the technical level, based on technical issues.
In his response, Prof. Otto Cars from Sweden agreed that the ethical standards of drug companies is a very important issue, and that there needs to be regulation on sales promotion. On drugs in animal feedstuff, he agreed it was a major issue, and that the European Union was going to prohibit the use of drugs as growth promoters in animals in 2006. Although this issue had been taken away in the present resolution, it had been dealt with in a previous resolution, and thus measures can be taken to implement that.
Holloway said that the WHA resolution this year was focused on anti-microbial resistance. However, at the next WHA there would be a special resolution on the rational use of drugs, which could address more issues linked to this topic.
As the discussion at the briefing indicated, there have been serious differences behind the scenes on how the issue of irrational drug use (which the WHO has clearly indicated is a major problem) should be brought up at the WHA.
According to NGOs which have been following the issue, the original agenda item was to have been irrational drug use, but this had been narrowed down to anti-microbial resistance at the insistence of some developed countries. They were apparently concerned that the marketing strategies and tactics of drug companies should not become the focus of attention and proposed measures for action.
As a result, the WHO paper for WHA and the resolution was on containment of anti-microbial resistance, and there was no agenda item or paper on rational drug use.
During the discussions on anti-microbial resistance, an amendment was made to the original draft resolution to include action on the use of antibiotics in animals.
The two amendments on this topic were that the 58th WHA: "urges member states to monitor and control the non human use of antibiotics, specifically the quantity and therapeutic group of those antibiotics used to promote growth in animals intended for human consumption;" and "requests the Director General to promote the appropriate use of antimicrobial agents in spheres other than human, specifically in the practice, considered hazardous since the 1970s, of using antibiotics as growth promotion agents in animals intended for human consumption."
These two paragraphs were struck off at the working group level, at the insistence of a major developed country, according to sources close to the negotiations.
During the discussion on the agenda item on anti-microbial resistance last week, many countries stressed the link between this issue and the rational use of medicines in general and asked WHO to expand its work on the latter.
The United Kingdom suggested that the general topic of the rational use of medicines be put on the agenda of the next WHA and to work towards a resolution on this. The WHO secretariat responded that it welcomed this proposal.
In a note on its technical briefing on irrational drug use, the WHO had stated that: "Inappropriate use wastes scarce resources and results in poor patient outcome, adverse drug reactions and increased anti-microbial resistance - a major public health threat.
"Evidence presented in 2004 made it clear that misuse of medicines continues to be widespread and has serious health and economic implications. There is an urgent need to move away from small-scale research projects towards implementing programmes that achieve large-scale and sustained improvements within health systems."
The final WHA resolution on improving the containment of anti-microbial resistance, adopted on Wednesday, asked the Director General to strengthen the leadership role of WHO in containing anti-microbial resistance, and to work with others to promote the appropriate use of anti-microbial agents in the context of the rational use of medicines.
The WHO was also asked to provide support for generating up-to-date information on anti-microbial resistance, and evidence on cost-effective interventions to prevent and control anti-microbial resistance.
The resolution also urged Member states to develop a coherent, comprehensive and integrated national approach to implement the strategy for containment of anti-microbial resistance; to enhance the rational use of anti-microbial agents including through using national standard-practice guidelines for common infections; and to strengthen legislation; and to mobilize resources to minimize the spread of resistance by promoting rational use of medicines by providers and consumers.
An April 2005 WHO policy paper on "Containing anti-microbial resistance" says that anti-microbial resistance is one of the world's most serious public health problems. Many of the microbes that cause infectious disease no longer respond to common anti-microbial drugs such as antibiotics, antiviral and antiprotozoal drugs.
"The problem is so serious that unless concerted action is taken worldwide, we run the risk of returning to the pre-antibiotic era when many more children than now died of infectious diseases and major surgery was impossible due to the risk of infection."
According to the paper, WHO country data 2002-03 show the following anti-microbial resistance global prevalence rates: malaria (chloroquine resistance in
81 out of 92 countries); tuberculosis (0-17% primary multi-drug resistance); HIV/AIDS (0-25% primary resistance to at least one antiretroviral drug); gonorrhoea (5-98% penicillin resistance); pneumonia and bacterial meningitis (0-70% penicillin resistance in streptococcus pneumonia); diarrhoea: shigellosis (10-90% ampicillin resistance, 5-95% cotrimoxazole resistance); hospital infections (0-70% resistance of staphylococcus aureus to all penicillins and cephalosporins).
Emergence of resistance is a natural phenomenon that follows use of anti-microbials but it is being accelerated by inappropriate anti-microbial use, and higher consumption is associated with higher resistance, says the paper.
Another WHO paper for the WHA says that irrational medicines use includes use of more medicines than are clinically necessary, inappropriate use of anti-microbial agents for non-bacterial infections; inappropriate selection or dosing of antibiotics for bacterial infections; over-use of injections when oral formulations are more appropriate; failure to prescribe in accordance with clinical guidelines; and inappropriate self medication often of prescriptions-only medicines.
"The extensive misuse of anti-microbial agents leads to bacterial pathogens becoming resistant, thereby rendering treatment ineffective," says the paper. "The rapid and alarming spread of anti-microbial resistance around the world has not been matched by a concerted and powerful public health response." Despite two previous WHA resolutions and a WHO strategy paper, action has been limited. "Moreover, few new antibiotics are being developed to replace those rendered ineffective through resistance."
Referring to the HIV/AIDS, TB and malaria epidemics, the paper says "concerns are growing about accelerating rates of anti-microbial resistance and rising prices for alternative anti-microbial agents to treat infections due to resistant pathogens."
The WHO paper lists measures that governments can take. One of the interventions suggested relate to drug sales promotion. "Pharmaceutical promotion often has negative effects on prescribing and consumer choice, but regulation of promotional activities has been proven to be one of the few effective interventions," says the paper.
"Countries should therefore consider regulating and monitoring the quality of drug advertising and of the pharmaceutical industry's promotional practices, and enforcing sanctions for violations."