The Pharmaceutical Journal
Vol 275 (Supplement) F5-F6
October 2005

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FIP Congress 2005

The world's poor are still poor when it comes to access to medicines

Speaking at a session on access to medicines on 5 September, Hans Hogerzeil, director of the department of medicines policy and standards, World Health Organization, said that national medicines policies are being introduced in many countries and the number of people with access to essential medicines has doubled in the past 20 years. However, population expansion means that the number of people with no access to essential medicines has remained the same. In other words, the poor have remained poor. As well as that, financing, delivery and other constraints still limit access, he said.

Substandard drugs are common in developing countries. Over half of these comprise antibiotics, antimalarials and other anti-infective agents. A survey has shown that, of 325 cases of substandard drugs discovered, 16 per cent had the incorrect ingredient and 17 per cent had the incorrect amount of the correct ingredient, but a staggering 60 per cent had no active ingredient at all. These are gross quality failures, he said, which may be due to intentional counterfeiting.

The challenge is that some two billion people still lack regular access to essential medicines, including six million people in low-income countries who lack access to antiretroviral drugs. Dr Hogerzeil said that medicines are the largest health expense for poorer households — up to 70 per cent of household income and the second largest public health expenditure. But prices are high and vary greatly, owing to margins such as taxes, duties and retail and distribution costs, which could account for 20 to 80 per cent of the final price. Also, unreliable procurement and supply result in medicines shortages and up to a third of poor households in some countries receive none of their prescribed medicines due to low income and high prices. And poor quality of medicines is common and life-threatening: 50 to 90 per cent of antimalarial combinations fail quality tests, less than half of assessed antiretroviral medicines meet international standards and counterfeit medicines are a growing problem.

Dr Hogerzeil mentioned the WHO access to essential medicines framework, which has four essential components: rational selection, affordable prices, sustainable financing and reliable systems.

To aid rational selection, there is a WHO model list of essential drugs. Based upon it, 156 countries now have a national list of such drugs. Major agencies such as UNICEF, base their catalogue on the WHO list. There are also subsets of the model list. For example, the United Nations list of essential drugs for emergencies contains 85 of these medicines. Some formularies also follow the list.

However, there are discrepancies. Dr Hogerzeil took as an example drugs for reproductive health. The WHO model list contains 194 of these drugs. But only 75 of these are on the United Nations Family Planning Agency list and 150 on the inter-agency reproductive health medical commodities list. Only 63 drugs were on all three lists. Dr Hogerzeil said that he believed each list should be a subset of another.

Turning to medicines prices, Dr Hogerzeil said that there are many ways to reduce prices. The price of all medicines could be reduced if taxes, tariffs and margins were reduced. For multi-source products, generic competition and generic substitution should be allowed in order to help to reduce prices. However, this might require adapted legislation in some countries. It would also require that quality of generics could be assured so that the public and professionals would accept them. For single source products, prices could be reduced through the use of clinical guidelines and therapeutic substitution, ie, where a cheaper drug in the same therapeutic class might be promoted over the more expensive one, leading to differential pricing.

Dr Hogerzeil said the overall goal is to lower prices and improve access to medicines by providing information on outlet prices and price structures. Specifically there is a need to promote analysis of medicines affordability, of price differences within countries and of how retail prices are built up. These data should then be freely available on a web site for international price comparisons and changes in prices over time.

The WHO has done a lot of work on this, he said. It had sampled medicines outlets in at least four districts with a minimum of 10 pharmacies per area, including public, NGO and private facilities. The prices of 30 selected commonly used medicines were assessed. The survey had thrown up some interesting data. For example, Lasix (furosemide 40mg) in Sri Lanka cost four times the mean international not-for-profit generic wholesale price of the drug. In Armenia it was six times the mean and in Kenya 108 times the mean.

There were also differences when brand versus generic prices were studied. Again, in Sri Lanka, the story was not too bad, For ciprofloxacin 500mg, the price in a private pharmacy for a branded medicine was six times the mean and for the generic medicine two times the mean. However, in Peru, the figures were 92 times the mean and 62 times the mean, respectively. This suggests, said Dr Hogerzeil, that there was only one generic ciprofloxacin available in Peru.

The survey also looked at the number of days’ wages a lowest-paid government worker would need to buy 30 days’ ulcer treatment with omeprazole. In Cameroon, no generic product is available and a worker would have to work for over 56 days to buy a course of treatment. In Sri Lanka, the generic treatment would cost around one day’s wages.

Dr Hogerzeil concluded his presentation by discussing access to medicines as a human rights issue. Promoting this is part of the WHO strategy, he said, but a human rights-based approach means that all beneficiaries must be consulted about what is best for them; this does not always happen. For instance, do all groups, eg, women, children, girls, have equal access? How can this be assured? What about prisoners? Do ethnic and linguistic minorities have equal access to health information? This could definitely be improved. It is clear that states are working towards universal access to medicines. But if that target is not reached, is there anyone to blame? Is there any method of redress? All these are human rights issues, so marrying human rights with promotion of equal access to medicines is a difficult process, he said.

Telepharmacy increases access in the rural US

Phil Schneider, of the College of Pharmacy, Ohio State University, US, described the development of telepharmacy in the US. He was presenting a paper during a session on access to medicines in 5 September on behalf of Carmen Catizone, executive director of the US National Association of Pharmacy Boards, who was unable to be present.

Dr Schneider told the congress that telepharmacy had been defined by the NABP as “the provision of pharmaceutical care through the use of telecommunications and information technologies to patients at a distance”.

Factors that had contributed to its development included health care professional shortages, a decrease in health care premises — including hospital and community pharmacies — in rural communities, an ageing population and increase demands for medicines. The NABP had looked for ways to make telepharmacy more efficient through use of the telephone, integrated data networks, videoconferencing, image transfer, fax, the internet and automated dispensing devices. Image transfer could be used to transfer prescriptions remotely, but the most significant development is the internet.

The potential advantages of telepharmacy included restoring access of rural communities to pharmaceutical care and improved quality of care. However, there are challenges, too. The cost of implementing it is high and there is always some resistance to new technology among patients and providers. A lack of training among pharmacists and technicians and increased workload on pharmacy staff are also barriers. There are problems about reimbursement issues, since often it is difficult to secure remuneration for “just talking to someone”. Finally, there is a lack of rules and regulations surrounding this emerging technology.

Dr Scheider outlined how telepharmacy works in community and hospital practice. In the community, there is always a central, urban provider site, which contains the drug stock and which is staffed by a pharmacist and pharmacy technicians. There are remote dispensing sites in rural areas containing the drug stock and staffed only by pharmacy technicians. There are also remote consultation sites. These have no drug inventory; medicines are delivered there. They are staffed by technicians or other specialised personnel.

In the hospital sector, a small rural hospital with no pharmacy can be connected to a pharmacist-staffed urban centre, where no drug stocks are held. The rural hospital has drugs available in an automated dispensing machine and is staffed by nurses. Prescription orders are transferred electronically to the urban centre, where the pharmacist processes the order electronically and authorises dispensing from the remote machine.

The emergence of telepharmacy has stimulated some states to write regulations, Dr Schneider said. In Texas, for example, telepharmacy sites are limited to medically underserved areas as defined by state and federal parameters. Telepharmacy sites are prohibited in areas where a community pharmacy is already available. Only prepackaged medicines can be dispensed. Pharmacist counselling is required on all new and refill prescriptions via a live video and audio link. Records must be kept of prescriptions filled at the remote site. All prescriptions filled at the remote site must be verified by the pharmacist at the central site. Finally, the central site may operate up to a maximum of three remote sites.

Alleviating the shortage of human resources in developing countries

A large factor contributing to the lack of access to medicines in developing countries is a lack of health care personnel, said Wefak Mohamed Abd-Elmoneim, quality assurance and technical training consultant pharmacist, Egypt. Dr Abd-Elmoneim was speaking at a session on access to medicines on 5 September on behalf of Eva Ombaka, of the Ecumenical Pharmacist Network, Kenya, who was unable to be present.

Dr Abd-Elmoneim pointed out that in Africa there were 0.8 health workers per 1,000 population as opposed to the world median of five per 1,000. This absolute shortage in numbers was in some way due to a lack of training opportunities. For instance, in the Netherlands there is a population of 16 million, and it has three schools for training pharmacists and six for training technicians. She invited the congress to contrast that with the situation in Tanzania, where the population numbered 35 million yet there was only one pharmacy school and one technician training establishment.

There is also the phenomenon of brain drain, both external and internal. For instance, in Ghana, 60 per cent of the doctors trained in the 1980s had left the country and, between 1993 and 2002, 410 pharmacists had been lost. Internally, there is an urban versus rural bias. Eighty per cent of Ghana’s registered pharmacists work and live in Accra. There is also a public versus private bias: in Kenya, only 30 of the country’s 1,800 pharmacists work in the public sector.

The consequence is the sale of medicines of uncertain quality in the streets of developing countries. But ensuring that there are enough pharmacists to get medicines off the streets and into pharmacies might be achieved through three types of strategy, said Dr Abd-Elmonein. These were coverage strategies, motivation strategies and competence-advancing strategies.

Coverage strategies include defining job specifications and providing training for specific tasks to be addressed. This means increasing the training of different types of pharmacy personnel, including community health workers, pharmacy assistants and technicians. The role of the pharmacist needs to be rethought; pharmacists should provide clinical care, leadership and supervision, not just dispensing services. Workforce data need to be collected for planning, policy and programming purposes. Older workers need to be kept on to gain the benefit of their experience and for mentoring. Health care staff could be trained in the south through building and strengthening facilities and twinning with establishments in the developed north; for example, Nottingham university has a Malaysian campus.

Motivation strategies include twinning of staff positions in such a way that skills and knowledge can be transferred, sharing available pharmacists by equal time service in two institutions or countries, and possibly instituting bonding agreements, such as a mandatory home country service period.

Competence-advancing strategies include the provision of further training and a clear career path in order to increase staff retention. Pharmacists should also look beyond medicines to social sciences, public health issues, epidemiology and financial management, for instance. There is also a need for mandatory continuing education as a condition for registration and pharmacist empowerment to use information and communications technology, for example, videoconferencing, e-mail, and online and compact disc libraries.

But for all this to work and to tempt pharmacists to remain in their countries, there needs to be international co-operation said Dr Abd-Elmonein. Also required are a commitment by developing countries with regards to political will and resource allocation, and involvement of all stakeholders from the private sector, the public sector, academia and professional pharmacy associations.