U.S. Pharmacy Policy: A Public Health Perspective on Safety and Cost

A public health perspective based on social justice and a population health point of view emphasizes pharmacy policy innovations regarding safety and costs. Such policies that effectively reduce costs include controlling profits, establishing profit targets, extending prescription providers, revising prescription classification schemes, emphasizing generic medications, and establishing formularies. Public education and universal programs may reduce costs, but co-pays and "cost-sharing" do not. Switching medications to over-the-counter (OTC) status, pill splitting, and importing medication from abroad are poor substitutes for authentic public health pharmacy policy. Where policy changes yield savings, public health insists that these savings should be used to increase access and improve population health. In the future, pharmacy policies may emphasize public health accountability more than individual liberty because of potential cost savings to society. Fear of litigation, as an informal mechanism of focusing manufacturer's attention on safety, is inefficient; public health pharmacy policy regarding safety looks toward a more active regulatory role on the part of government. A case study of direct-to-consumer advertising illustrates the complexity of public health pharmacy policy. KEYWORDS: Medicationpharmacypolicydirect-to-consumer advertisingpublic healthcostssafety Notes 1. Pharmaceutical industry ads contribute a great deal to the financial viability of even the most prestigious peer-reviewed journals. Importantly, industry-sponsored clinical trials end up in published articles in these same prestigious journals, which in turn enhances industry financial success (CitationSmith, 2005). The vast majority of sponsored trials reported in these journals indicate that the sponsor's product is superior to competitors or placebos. This result is 4 times more likely than research sponsored by other sources (CitationLexchin, Bero, Djulbegovic, & Clark, 2003; CitationRochon et al., 1994). Specific techniques are employed to obtain these highly favorable results, which include statistical manipulation. If all else fails, industry simply ignores negative results or consciously suppresses the publications of results that are not favorable to their product (CitationSmith, 2005). Merck's dishonesty with regard to results on Vioxx® is a case study on this topic (CitationBombardier et al., 2000). 2. The Supreme Court upheld the constitutional right of the terminally ill to use medication even if it has not been proven effective. This decision is said to call into question standard FDA approval processes and to make it more difficult to test the efficacy of new medications because they will be distributed straight away outside the clinical trial environment (CitationOkie, 2006). 3. On occasion, long-term studies funded by the National Institutes of Health have forced drugs off the market (CitationHenney, 1999). 4. The American Public Health Association supported limiting price increases to an average basket index of other industrialized countries (CitationAmerican Public Health Association, 2000). 5. Volume discounts may mean that medication is available at lower prices. This could improve manufacturers' profits if lower prices mean that a greater number of people purchase the drug. 6. While this pharmacy policy may be welcomed at the moment by private pharmaceutical companies, how long they will remain content in the future is hard to say; the federal government, as the payer behind the scenes, could at any time move to reduce profit levels and this could bring government and the pharmaceutical industry onto a collision course. PricewaterhouseCoopers sees the United States as inevitably moving in the direction of countries with a national health service system (CitationBowe, 2006). 7. The Wall Street Journal concludes that the Medicare drug plan will benefit pharmaceutical companies that "make drugs that have less competition and higher markups.…" The early winners include as well "the nation's largest health plans, which are peddling the drug coverage" (CitationLueck & Fuhrmans, 2006, p. B1) This is a case in which insurance for pharmaceuticals "enhances the ability of pharmaceutical companies to set their prices well above the cost of production and distribution, all else being equal" (CitationScherer, 2004, p. 928). 8. Pharmaceutical manufacturers are thought to always gain from switching a medication, but this is not clear-cut. Sometimes switching is part of their advance planning and their marketing strategy early on in the development of a drug. In these cases, there is no doubt that the manufacturers will profit from it. Manufacturers also benefit because they receive extended patent protection to compensate for the additional costs of the research they must undertake concerning how a medication will be used by the public after it is switched. In a few cases, the FDA has recommended for switching a medication although the manufacturer was against this action (CitationCohen et al., 2005, p. 40). Such was the case with Claritin®. Sometimes manufacturers and insurance companies are on opposite sides of the switch movement. Insurance companies have publicly lobbied for increasing switches and filed "interested third party" requests for specific cases with the FDA. Their incentive is that insurance companies do not have to cover drugs once they are OTC (CitationReynolds, 2002). 9. Some Americans travel to Mexico or Canada to purchase medication, but this involves additional indirect costs (CitationCalvillo & Lal, 2003). 10. There is clearly little problem with the safety of medication ordered from Canada (CitationChoudry & Detsky, 2005), although the FDA regularly warns consumers about bogus Canadian drugs. Concerns about safety that emerge for the growing global market in pharmaceuticals are unlikely to be without legislative remedy in the long term. An open global market in pharmaceuticals appears inevitable; almost all medication is manufactured outside the country in which it is consumed today in any case (CitationChoudry & Detsky, 2005). Problems with fake drugs are not only a cross-border problem. They have been found internal to the U.S. market as well though in a far lower proportion than in Asia, Africa, or South America (CitationRudolf & Bernsteing, 2004). In a global marketplace, fake drugs find their way into all countries in the end (CitationZamiska & Tesoriero, 2006). 11. The American Public Health Association has not, however, taken a position on this topic (CitationAmerican Public Health Association, 2000). 12. In the case of New Zealand, the Christchurch School of Medicine and Health Sciences has posted on its Web site a report to the minister of health supporting a ban on DTC ads in the strongest terms possible (CitationToop et al., 2003). 13. There is a role for public health advocacy on this issue because other groups are actively pursuing it as well (CitationAmerican Medical Association, 2005).