72. Ensuring Supplies of Appropriate Drugs and Vaccines

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Issues for the Future

As the world's population ages, health systems that formerly focused primarily on infectious disease are being asked to deliver new types of care, mostly for chronic illnesses and increasingly for mental illness. By 2020, the major causes of the burden of disease will shift from pneumonia, diarrhea, and perinatal conditions to heart disease, mental illness (particularly depression), and road traffic accidents. Tobacco will kill more people than any other cause of disease, including HIV. Unlike the United States and the countries of Western Europe, China and India will face the challenges of an aging population before they become high-income countries. Most health systems in the developing world are now prepared to deliver acute care, particularly for infectious disease, rather than chronic care. They are ill suited to long-term chronic care and follow-up; in general they lack recordkeeping, demonstrate little development of personal relationships with caregivers, and have little provision for enhancing patient adherence with medication. In many situations, the irregular and intermittent supply of medications for chronic disease means that the chronically ill suffer many interruptions of their treatment. The changing nature of health care will require changes in drug supply, which are only beginning to become visible. The (perceived) difference between "good" and "bad" care is often the availability of drugs and supplies. Programs and funding agencies that are planning improvements in health care—for example, increasing coverage or case detection rates—often overlook the fact that such improvements will increase drug needs and costs.

 

Drug Resistance


Although the burden of chronic and noninfectious disease is increasing rapidly in the developing world, infectious diseases still account for nearly half of deaths in low-income countries. Most of these deaths are caused by six diseases: acute respiratory infections (mainly pneumonia), diarrheal disease, HIV and AIDS, tuberculosis, malaria, and measles. Drug resistance complicates the effective treatment for nearly all of these acute infections. Furthermore, this trend is expected to accelerate in the coming decades. In the treatment of HIV and AIDS, the increase of retroviral drug resistance is becoming a serious problem, especially in view of the limited number of treatment regimens available to date.

Drug-resistant malaria is now widespread. Chloroquine—once a cheap and reliable first-line treatment for malaria—is no longer effective in most countries. Newer drugs are significantly more expensive. Most recently, the trend has been toward multidrug combinations of products, and the addition of more than one drug is often to "protect" the component drugs from developing resistance as well as to improve the therapeutic effect (WHO 2002a).

Drug resistance in tuberculosis control—in particular, multidrug resistance—is a growing problem. Multidrug-resistant TB has now appeared around the world, and in many places more than 20 percent of resistant new tuberculosis cases are resistant to several drugs. Furthermore, the emergence of multidrug-resistant bacilli means that medication that once cost US$20 must now be replaced with drugs that are significantly more expensive and more difficult to use (WHO 2002a). Another major concern is the use of antimicrobials in farming, because about half of the antimicrobials produced each year are used in farm animals. Some of the new resistant bacteria are transmitted from food of animal origin or through direct contact with farm animals. Some reports indicate that as much as 50 percent of human antimicrobial resistance is caused by growth promoters in livestock, which are added to feed in sub-therapeutic antibiotic doses (WHO 2002a).

 

HIV and AIDS


The HIV epidemic has had a tremendous impact on the pharmaceutical supply situation. First, it has highlighted weaknesses of drug supply and access around the world; the arrival of highly active antiretroviral therapy for the treatment of HIV/AIDS (HAART) means that HIV is to a large extent now a treatable condition, yet treatment is not available to the majority of those who suffer from HIV. Second, it has drawn the world's attention to the growing gap between rich and poor in terms of pharmaceutical provision. Unlike many other highly prevalent illnesses in the developing world, HIV and AIDS are also of major concern in the wealthier countries, and thus significant research has been undertaken and has yielded effective new medications (HAART, in particular).

A recent WHO report highlights the issue of the affordability of medications, pointing out that of the 23 countries that are estimated to make up 80 percent of the 2003 global need for HIV and AIDS treatment—estimated at about US$300 per annum per patient—only 8 have pharmaceutical expenditure levels above US$5 per capita, far short of the level of expenditure needed (WHO 2004c). Prices have fallen dramatically; WHO has continued to monitor the quality of AIDS drugs available on the world market for sale in developing countries and has removed substandard drugs from its list when necessary (WHO 2004e). Many high-profile initiatives to solve this problem have been started, most notably the WHO's "3 x 5" program; the Global Fund to Fight AIDS, Tuberculosis, and Malaria; the Clinton Foundation's efforts to lower prices for HAART; and President George W. Bush's Emergency Plan for AIDS Relief. A number of issues are raised by the delivery of a complex, lifelong, costly treatment to poorer communities, especially in rural areas, one of which will be how to ensure adequate adherence to treatment in different clinical settings, ranging from district hospitals to health centers or even home settings, for HAART delivery.

 

Aging and Chronic Diseases


One of the important results of the exercise to estimate the global burden of disease was to highlight the growing importance of chronic disease, particularly in the developing world. A large percentage of chronic illnesses are related to smoking and lifestyle, and thus attempts to reduce smoking—or the lethality of smoking—would have an important effect on the need for medication for chronic disease.

Although many cancers are not yet curable, many are treatable with the goal either of slowing the spread or of palliating the symptoms of the disease. As the burden of cancer increases, palliative care, which involves the treatment of the symptoms and especially the pain that accompanies most cancers, needs to be given much higher priority. At present, the vast majority of the millions of cancer patients in the developing world receive totally inadequate pain control and suffer needless agony, in part because of antiquated laws governing the use of opioid analgesics (particularly morphine) and attitudes of medical and nursing personnel toward pain control (as well as attitudes of family members in some settings). The myths about morphine need to be dispelled. When used appropriately, especially in oral form, morphine does not lead to addiction, tolerance, respiratory depression, cognitive impairment, or premature death. In fact, people live longer when their pain is controlled, and they can eat, sleep, and live normal lives (Merriman and others 2002).

In countries where palliative care is fairly well developed and available, the consumption of morphine per capita averages over 20 milligrams, but in most developing countries it is negligible, and most of the needs for pain relief are unmet (Joranson, Rajagopal, and Gilson 2002). The World Bank recognized the importance of alleviating pain, which it included in its package of "essential clinical services" (World Bank 1993). As the population ages, the ability of the health care system to provide palliative care must grow along with it.

The trend toward more sedentary lifestyles and toward consumption of diets with higher fat and sugar content is leading to a steep increase in the burden of diabetes, with 150 percent increases in prevalence predicted for many countries by 2030; the absolute numbers will grow from 171 million in 2000 to about 366 million in 2030. The greatest increases in diabetes prevalence are predicted for the Middle East, Sub-Saharan Africa, and India (Wild and others 2004). Most of these new cases will be type 2 and, thus, most will not be insulin dependent, but they will require oral diabetic medications. For those who do require insulin, given the current state of technology, the main barrier (other than cost) is the need for storage of the insulin in a cold or cool location and for sterile injection equipment. In either case, to meet the predicted rise in cases and to treat them with current drugs, a major expansion of drug supply for diabetes must be anticipated. Many diabetics currently do not receive adequate treatment. The pressure to provide adequate treatment will increase as the population ages and begins to demand treatment of its chronic afflictions—and in that case the increase in demand for diabetes medications would potentially be much more than 150 percent.

Another important finding of the global burden-of-disease exercise was the high number of DALYs lost to mental illness, depression in particular. In 2020, unipolar depression is projected to be the leading cause of morbidity and disability among females worldwide and in developing countries. Whereas in the industrial countries a pharmacological solution is often used, this approach may not be feasible in the developing world, at least not at present price levels. Recent research in the developing world has shown good results with weekly group interpersonal therapy, without the use of antidepressants. Trained laypersons ran the therapy sessions, not psychiatrists or medical personnel (Bolton and others 2003).