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A prescription for better prescriptions

A prescription for better prescriptions

by Raymond L. Woosley

Physicians cannot remain dependent on the drug companies as the primary source of information about pharmaceuticals.

Among the factors regularly blamed for skyrocketing health care costs are the price of prescription drugs and the large profits of the leading pharmaceutical companies. As health care reformers consider universal access to care and prescription-drug benefits, measures to limit drug prices and pharmaceutical profits are receiving increased attention. Although the reality is that drug costs comprise only a small fraction of the nation's total health care budget and many of the drugs have reduced the economic impact of disease, it is still important to ask why the free-market system is not operating as it normally would to allow competition to restrain drug prices and profit margins. In theory, consumers respond to high prices by seeking less costly alternatives, spurting competition and bringing prices and profits down. However, in the case of pharmaceutical products, it is the physician, not the consumer, who chooses the therapy. The cost of this decision is then borne by the patient or the health care insurer. As a result, the feedback loop between price information and consumer behavior is severed.

Moreover, the predominant source of detailed information about the quality and performance of drags is the industry itself. Pharmaceutical companies rightfully pursue and publish the research that will enhance sales. They have no responsibility to perform research designed specifically to provide physicians with unbiased information on which to base their choice of therapy. Access to this kind of information could increase competition among drags, thereby reducing prices.

Because of the high cost of medications and the high profits of many companies, the pharmaceutical industry has come under vigorous attack by academics, politicians, and consumer groups, who have called for coercive measures that restrict physicians' choices or corporate practices. Heavy-handed command-and-control policies are likely to alienate physicians and drug companies, making cooperation and success unlikely. Current trends to change the practice of medicine toward managed competition will increase the impact of restrictive formularies and price controls on pharmaceutical profits. However, these restrictions will also adversely affect future drug development and the quality of medical care. A more constructive approach would make better information available to physicians so that they could prescribe the most cost-effective drugs. This would enlist the support of physicians, who would be enhancing their effectiveness, and would appeal to the industry by preserving the incentive to develop and produce a wide range of effective medications.

The high cost of marketing

Prescription drugs sold in the United States are among the most expensive medications in the world. The high price of these drugs imposes a tremendous burden on many of our citizens. The poor and the elderly, in particular, often pay a major fraction of their incomes for life-sustaining medications. The American Association of Retired Persons recently reported that more than half of all Americans over age 65 have difficulty paying for their prescription drugs. Ten percent have to sacrifice on food or fuel to purchase their prescriptions.

The pharmaceutical industry attributes the high cost of drugs to the cost of research and development. But an equally important reason is the high cost of marketing. The U.S. Congress's Office of Technology Assessment (OTA) estimates that the industry spends roughly $11 billion a year on promotion and marketing of drugs to physicians, compared with the $10 billion that it reports spending on the development of new drugs.

One might ask why, if these new drugs are such major advances, must so much money be expended to promote them to physicians? One reason is that the performance of most new products differs only subtly from that of other drugs in the same class. These subtle differences may be of critical importance to individual patients who do not respond well to existing treatments, but marketing campaigns typically try to convince physicians to substitute the new for the old in all situations, not just a few special cases.

Of the $11 billion spent on drug promotion, $3 billion is spent on advertising and more than $5 billion is spent for sales representatives, of whom fewer than 5 percent have any formal training in pharmacy or pharmacology. There are more than 45,000 sales representatives, each costing the companies an estimated $125,000 or more, calling on the approximately 550,000 U.S. physicians. OTA estimates that the industry's marketing efforts add an average of 22 percent to the cost of every prescription.

Drug companies apparently find this strategy profitable because the number of sales representatives employed in the industry has increased by 40 percent in the past 10 years. Some managers in the pharmaceutical industry have predicted that health care providers' efforts to cut costs--for instance, by putting price restrictions on prescriptions--will reduce the industry's reliance on sales representatives. However, this change is not yet apparent. Moreover, even if marketing strategies change, it is not likely that marketing budgets will be reduced, because firms perceive this investment as vital to maintaining sales. Marketing expenses will therefore continue to drive up the price of prescription drugs, and with them the cost of health care.

Bias in the scientific literature

The scientific literature--much of it reporting the results of research funded by the pharmaceutical industry--does not provide an effective balance to the marketing information provided by the companies themselves. Pharmaceutical companies primarily fund research that has the potential to establish or improve a drug's place in the market. This leads to a preponderance of reporting that is favorable to particular new drugs. Meanwhile, many valuable scientific studies are never conducted. For instance, careful analyses of comparative safety or studies exploring the mechanisms underlying adverse side effects are not performed unless specifically required by the Food and Drug Administration (FDA).

But the FDA has little power to require pharmaceutical companies to provide additional research. The agency can demand only that drug companies demonstrate that a new drug is effective and relatively safe. If problems appear prior to marketing, the FDA can request further studies to quantify the risk of adverse effects. However, during development, only a few thousand patients are likely to receive significant exposure to a new drug. Many serious problems appear only after the drug is approved and marketed more widely. At that point, the FDA cannot require that any further research be performed. It can require only that the manufacturer warn physicians, usually by adding the information to a package insert. But the insert is rarely read by physicians, and most potentially serious consequences are buried in a long list of trivial side effects.

The FDA can ban a drag only if it poses an imminent health risk that outweighs all potential benefits. As a result, few drugs are ever removed from the market. The FDA plays no active educational role and is even forbidden to comment on the relative merit of drugs or to otherwise direct the practice of medicine.

A second source of bias in the medical literature is the research investigator's lack of enthusiasm for publishing a trial that has a negative result. Physicians are not eager to publish negative trials because the results imply that they formulated an incorrect hypothesis. They are more eager to publish papers that will show that they helped to find new and effective treatments. In addition, the drug companies encourage the publication of trials that have favorable outcomes and aggressively promote their results. This further biases the literature read by physicians.

Most physicians believe that they obtain their information about drugs from the medical literature and scientific conferences, but numerous studies find that they obtain their information primarily from industry sales representatives and the Physicians' Desk Reference, a commercial compilation of information reviewed by the FDA but selected by pharmaceutical manufacturers. A study by Jerry Avorn of Harvard Medical School and his colleagues found that in instances when the medical literature and drug-promotion materials were at odds, between 33 percent and 49 percent of practicing physicians agreed with the drug companies' marketing message.

Misleading claims

A recent study published in the Annals of Internal Medicine set out to assess the quality of the information being provided by pharmaceutical companies. After analyzing more than 100 advertisements in medical journals, the authors concluded that 32 percent of the claims were misleading, 57 percent had little or no educational value, and 44 percent would have led to improper prescribing practices. A similar study published in the New England Journal of Medicine concluded that as many as 41 percent of the reports from industry-sponsored educational symposia published in the medical literature included misleading claims.

In 1991, the FDA stepped up its review of drug advertising and the promotion of drugs through the medical literature in order to ensure the accuracy of the industry's claims. However, it has no effective means to monitor or counter the flow of information provided by sales representatives.

A variety of evidence suggests that pharmaceutical-industry promotion encourages undesirable prescribing practices. Physicians often believe that they are providing the very best for their patients if they prescribe the newest and most costly drugs available--even though these drugs are less tested. For instance, the calcium channel blocker was extensively prescribed before there were sufficient data to justify its broad use; indeed, it remains overused.

Additional problems occur in the way that physicians prescribe drugs. Avorn and several of his colleagues have found that physicians place inadequate emphasis on history-taking and resort to the use of drugs even when nonpharmacologic approaches might be more effective. Other researchers have found that physicians regularly fail to individualize the dosage of drugs. Elderly patients frequently receive dosages that are excessive because they are not scaled down for their lower body weight. The pharmaceutical industry goes to great lengths to promote a simple and easily remembered dosing regimen for its products, since physicians are more likely to remember how to use a one-dosage-fits-all drug.

The misuse of prescription drugs resulting from physicians' reliance on inadequate or misleading information can create medical problems that endanger patients. Estimates of the magnitude of health care problems resulting from incorrect prescriptions vary according to the class of drug prescribed and the type of problem encountered. A dramatic example was the rise in mortality among heart-attack survivors resulting from the use of sodium channel blockers to treat asymptomatic arrhythmias.

Failed efforts

Aware that a problem exists, regula-tory agencies and state governments have taken steps to improve the prescribing practices of physicians. The FDA has established warning campaigns and educational programs, and state governments have tried to restrict reimbursements or pass legislation to limit physicians' choices. The results are not encouraging.

Data on the effectiveness of FDA warnings is scarce because underreporting prevents quantification of specific adverse drug reactions. In extreme cases, such as the incidence of Reye's syndrome following aspirin use by children, widely promoted warnings appear to have been effective. But FDA warnings about other potentially life-threatening interactions between drugs, such as those involving nonsedating antihistamines such as Seldane, have failed to stem the occurrence of preventable adverse events. Some drugs, such as pro-cainamide, carry explicit warnings reminding physicians of the need to monitor patients carefully. Yet potentially fatal complications continue to arise in patients using this and other potentially toxic drugs. These examples confirm findings by Stephen Soumerai of Harvard Medical School and other researchers that regulatory warnings and even limitations on prescriptions (such as a no-refill role) have insufficient impact on prescribing practices.

Soumerai has collaborated with Avorn on a number of studies identifying the factors that influence physicians' prescribing practices. He and his colleagues have also investigated the effectiveness of state efforts to mandate changes in these practices. When a state Medicaid program limited the number of prescriptions that could be provided to each patient in an attempt to reduce costs, for instance, the number of prescriptions written fell by 30 percent. The prescriptions most commonly dropped were those for drugs deemed ineffective. However, there were also large declines in the number of prescriptions issued for essential drugs, such as insulin and medications for hypertension and heart failure. This unintended outcome surely outweighed any monetary savings. Indeed, the researchers found that during the time when restrictions were in effect, the rate at which elderly patients were admitted to nursing homes increased, thus increasing overall Medicaid costs.

In another state, legislative efforts to reduce costs by refusing to pay for a group of drags of questionable value led to increases in the number of prescriptions for other drugs, canceling out any savings. Undesirable as well as desirable drugs were substituted for the nonreimbursable medications. Similarly, the General Accounting Office (GAO) conducted a study of Canada's Patented Medicine Prices Review Board, which has the power to apply sanctions in cases where the price of a prescribed drug is excessive. The GAO concluded that the board did not slow the increase in drag spending. Other factors, such as the number of prescriptions written and the mix of new, costly products with older, cheaper drugs, offset any savings.

A recent example of how the pharmaceutical industry can circumvent efforts to restrict the rising cost of prescription drugs is Merck-Dupont's decision to stop producing certain medications in single-dose packages. Although it is more expensive to produce individually packaged meditations, these were being sold at a lower price than those packaged in large volumes because they were usually sold to major clients, such as hospitals, that can negotiate significant discounts. The company made its decision in order to circumvent the 1991 Medicaid Drug Rebate Law, which requires pharmaceutical companies to give Medicaid the best discounted price available to any client. By canceling the production of drags packaged in single doses and sold at a very low price to hospitals, the company effectively increased costs to consumers and boosted profits without technically having raised its prices.

In contrast to the failure of the top-down approaches is the promise found in several small-scale, experimental efforts to educate physicians in the hope of influencing their prescribing practices. As long as these efforts have been sustained, they have generally proven effective.

In some cases, trained personnel worked with physicians on a one-to-one basis. Using computerized databases, researchers identified physicians with poor prescribing practices and offered them information about ways to improve their performance. In each case, physician practices improved, but only for as long as personal contact was continued. Especially in light of the onslaught of new marketing information from the pharmaceutical companies, efforts are needed to maintain and update physicians' prescriptive skills.

Clinical pharmacologists at the Royal Melbourne Hospital in Australia took another tack. They demonstrated that an advertising campaign aimed at physicians and modeled on commercially successful techniques was able to correct inappropriate prescribing habits and reduce the cost of medical therapy. The hospital invested about $10,000 in direct mail, pads, pencils, posters, and other items. Within months, the hospital had recouped the full amount through savings on unnecessary or ineffective prescriptions.

Having reviewed the alternatives, Soumerai and Avorn conclude that physician education and peer pressure are the most effective means to provide a sustained improvement in physicians' prescribing practices. Other studies support this conclusion and suggest that the intervention must appeal to the physician's desire to provide the best care for patients--rather than solely to cut costs--in order to be effective. In addition, it is essential that the information given to physicians come from a qualified and unbiased source. Finally, it must emphasize and reinforce the basic principles of therapeutics. To limit the impact of high drag prices and poor prescribing practices on the cost--and quality--of health care, we must create a scientifically based research and education program that incorporates these essential components.

A potential solution

It is unrealistic to expect that pharmaceutical companies, which must remain profitable to survive, will ever be motivated to generate and distribute all of the information necessary to give physicians a balanced perspective on the drugs they manufacture. What our society needs is research that will allow those who prescribe drugs to make an informed and cost-effective choice of therapies. In addition, physicians and other health care providers must relearn the basic principles of therapeutics. This education must be provided by physician-educators in a structured and sustained program that can effectively modify prescribing practices.

The most logical source of research and education is the existing infrastructure of medical centers that employ physicians trained in clinical pharmacology. There are currently 11 university-based clinical pharmacology training programs sponsored by the National Institute of General Medical Sciences (NIGMS), a branch of the National Institutes of Health. Under Congressional mandate, four new training programs are being created with financial support and direction from the FDA. Although they are funded to train only clinical pharmacologists, all of these programs also conduct research and train local physicians in the principles of rational therapeutics. In addition, there are 20 clinical pharmacology training programs that do not now receive federal support. These 35 centers have the expertise to provide unbiased research and education for the nation's practicing physicians, but their research funding--most of which comes from the pharmaceutical industry for narrowly focused studies--is limited, and they lack the capital to create the massive educational program needed to reach all the practicing physicians in the United States.

Congress should authorize the establishment of federally funded regional centers for education and research in therapeutics (CERTs). To guarantee their objectivity and maximize their effectiveness, the centers should be given adequate financial support to conduct their mission without reliance on support from the pharmaceutical industry. The sites for these centers should be chosen on the basis of peer review, and we can expect the 35 existing training programs in clinical pharmacology to be among the strongest candidates.

Each CERT would require a budget of roughly $2.5 million to $5 million annually. To fund 15 sites will cost no more than $75 million annually--a small investment to balance the $11 billion spent annually to market drugs to physicians. The best approach would be direct appropriation of funds for distribution by the FDA, which is familiar with the problem and has the expertise to oversee research and the education of clinical pharmacologists. Other options are to use FDA funds or include funding for CERTs in the federal appropriation for health care reform or in the appropriation for the Agency for Health Care Policy and Research. Surcharges on user fees paid by the pharmaceutical industry, physicians' licensing fees, or pharmaceutical advertisements could also be a source of funds. But this type of funding would have to be structured carefully to ensure that the CERTs are unencumbered by any perception of commercial influence.

Regardless of how they are funded, the CERTs should be administered by the FDA. This would prevent duplication of effort and ensure that the centers address areas of need as they evolve. FDA staff can serve as lecturers in CERT teaching programs; physician-scientists at the FDA can collaborate with the CERTs' research faculty. In addition to performing their primary mission of research and education, the CERTs will provide an important resource for monitoring drug safety and physician prescribing practices.

Research. Some of the neglected areas in which the CERTs could sponsor clinical and basic research include:

* Research on comparative forms of therapy. Specifically, is a new drug better or safer than the available alternatives? Under what circumstances should it be prescribed?

* Studies of the mechanisms by which a given drug produces side effects and of the patient characteristics that might help to predict adverse drag reactions. This information will help physicians tailor medication to a patient's needs, avoid adverse reactions, and perhaps eventually develop medications with fewer side effects.

* Development of new methods to test generic drugs. Existing tests use blood levels of the drags to establish equivalency of different formulations. However, this standard does not accurately reflect the effectiveness of all drugs. Moreover, it is difficult to prove the efficacy of generic equivalents for complex medications, such as the estrogen supplement Premarin, which involve more than one potentially active ingredient. More effective and accurate tests will permit the development and evaluation of a wider range of generic drugs.

* Evaluation of new clinical applications for generic drugs. Pharmaceutical companies have little interest in exploring new applications for drugs whose patents have expired, since the profit margin is likely to be low. Similarly, CERTs could conduct research on new applications for orphan drugs--those with a limited market--which could help to reduce the cost of these medications.

* Dosage determination and safety evaluation for women, children, the elderly, and patients with special conditions, such as liver or kidney impairments. Pharmaceutical research often focuses only on narrowly defined patient populations, without exploring whether the results can be extrapolated to others. Additional information is needed to provide optimal treatment for women, children, and the elderly and to prevent overmedication and adverse effects in these populations.

* Pharmaco-economic studies to assess the cost-effectiveness of various drugs within given populations. This information will help the pharmaceutical industry and health care insurers to develop guidelines for pricing and reimbursement.

Based on their research, the CERTs could formulate and test consensus guidelines for specific forms of therapy, such as anticonvulsant therapy. Hospitals, professional groups, or government agencies often develop consensus guidelines for standard medical problems. However, these guidelines are usually based on a review of an inadequate scientific literature. The lack of data comparing different forms of treatment makes it difficult to determine the best standard practice: We know what works, but we don't know what works best. The CERTs can either test the guidelines themselves or participate in the design of multicenter clinical trials to assess and refine guidelines for standard practice.

Education and training. The CERTs can play an important role in training physicians in clinical pharmacology and in improving the therapeutic skills of practicing clinicians. Right now, there is a severe shortage of physicians trained in clinical pharmacology. The 35 existing programs are not enough. Each of the 200 or so major teaching hospitals in the country should have from three to five clinical pharmacologists. Yet each year, only 25 to 30 doctors are trained in clinical pharmacology, and most of these go to work in the drug industry or the FDA. The CERTs could begin to close this gap by graduating 100 to 150 clinical pharmacologists a year.

Each CERT will conduct regional symposia and seminars for physicians, physician assistants, pharmacists, and nurses. Special courses will be conducted for members of local or state formulary committees, which are responsible for selecting the treatment options among which physicians may choose. These courses will provide education in the principles of therapeutics. In addition, each center shall staff and maintain a phone-in, e-mail, and/or fax service for consulting with local physicians and health care workers. It will also maintain a resource database of expert consultants for rare or uncommon therapeutic problems and will publish research results in the medical literature as well as issue periodic newsletters on topics of interest to practitioners.

Safety surveillance. The CERTs will assist the FDA in monitoring the safety issues arising from drug performance and physicians' practices. It can encourage physicians to participate in voluntary programs, such as the FDA's Medwatch, for reporting adverse drug reactions. CERTs' staffs can also lend their expertise in analyzing these reports to ensure that each incident indeed represents a drug reaction and not some other problem, and credits the proper drug. (The Medwatch program currently has no independent mechanism for assessing the accuracy of these reports.) The CERTs can also conduct pharmaco-epidemiologic research to identify rare but serious adverse reactions to new drugs.

Using databases such as that generated by Medicare's Drug Utilization Review program, CERTs' staffs could identify and educate physicians whose prescribing practices fall outside established norms. Although the Drug Utilization Review program should eventually allow Medicare officials to review the appropriateness of every prescription issued, it contains no educational component to improve physicians' therapeutic performance. To enhance these efforts, the CERTs can also establish and test indicators that suggest the presence of specific problems in prescription practices.

Better products, better prices

Although the CERTs can lower health care costs by helping providers choose the most appropriate treatments, it is unclear whether they will directly reduce the price of drugs. It is simply impossible to predict how the market will respond to changes in demand patterns based on physicians' access to more accurate information. Competition among manufacturers may increase in some cases and decrease in others. But in the best of all possible worlds, CERTs will discourage pharmaceutical companies from spending money on marketing appeals that are not supported by independent scientific research.

The CERTs will be of tremendous value to the pharmaceutical industry. They will provide a respected, unbiased source of post-marketing data, including cost-benefit analyses. They will point the way for the development of potentially profitable new drugs and will allow some drug manufacturers to build market share based on the real strengths of their products. Last, the CERTs will provide a much-needed increase in the number of clinical pharmacologists trained and available to join the industry as employees.

Most important, the creation of the CERTs will forestall efforts to legislate restrictive changes on the part of either physicians or the pharmaceutical industry. In recent years, a number of bills have been proposed to create restrictive national and state formularies, as well as to limit drag advertising and promotion. Unlike these proposals, the CERTs' educational and research programs would maintain (and strengthen) the incentive for the pharmaceutical industry to develop new forms of therapy. Companies would be less likely to invest in marginal improvements and more likely to concentrate on drugs that have obvious advantages. In short, the CERTs would complement the market mechanisms that have laid the foundation for the pharmaceutical industry's financial and medical success.

Research and education are essential to improving the quality and cost-effectiveness of drug therapy. With access to full and balanced information, generated by the CERTs, physicians will be able to provide optimal drug therapy at a reasonable cost. In a free-market society, government has the responsibility to provide the checks and balances to ensure that physicians have all the information that they need to provide optimal cost-effective care.

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