Physical access to care generally involves the geographical distribution of people and providers, including distribution of primary care providers and specialists, health care facilities, and transportation facilities.
Physical access to prescription medications, however, requires an unbroken chain of decisions and actions that are often more important than geographic location. In order for a patient to have physical access to drug therapy for a particular indication, a drug product would have to exist for that indication. This is not quite as obvious or as simple as it may first appear. Drug products (whether natural or synthetic) have to be discovered and developed. An approved manufacturer must have produced and tested a drug product. Before a drug product can be marketed within legitimate channels in the United States, its sponsor (manufacturer) must have received Food and Drug Administration (FDA) approval. Approval is for specific indications, and the manufacturer cannot promote the product for other (off-label) uses. According to the pharmaceutical industry, developing a new drug product requires an average of 15 years and costs an average of $880 million.
No drug therapy has been approved for thousands of rare or "orphan" diseases, even if a potentially safe and effective therapy may exist. (See Appendix 1.) Many approved drugs have unapproved indications, however. A possibly safe and effective therapy would not have been approved for a rare disease or even a common indication without formal sponsorship and testing. Without approval, the drug cannot be promoted for the indication. A physician can prescribe for an unapproved drug or indication if he knows about it and is willing to disregard the apparatus of FDA approval. A pharmacist can dispense it if he can obtain a supply of reliable purity and potency. Some drug products that are not available here are available in other countries. The Internet, especially, has made it easy for a patient to go abroad to get a drug. But that deprives the patient of the protection of U.S. drug standards.
The problem has resulted in a gray market in foreign drugs, including many drugs approved for treating AIDS and its complications. The FDA has allowed some exceptions to its usual drug approval procedures for AIDS drugs, putting them on a fast track. Another example is RU-486, mifepristone, used in combination with misoprostol to produce abortions. The combination was shown to be as effective in ending pregnancy in U.S. women as in women tested previously in France. In July 1996, an FDA advisory committee recommended that mifepristone be approved for pregnancy termination when used in combination with misoprostol. An "approvable" letter was issued September 18, 1996. The drug was not finally approved by the U.S. Food and Drug Administration until September 2000, and U.S. shipments to health care providers began on November 20, 2000. The delay was in part because of political opposition to abortion.* (Federal drug law is briefly outlined below.)
Another necessity for physical access is that the patient be able to actually get and use the therapy, meaning in most instances a prescription from a doctor, a local pharmacy or mail-order service, and a means to pay. The prescription requirement obviously means that a physician or other licensed prescriber must agree that the patient needs the therapy. The pharmacy must stock the medicine or be willing to get it. Some prescribers will not prescribe, and some pharmacies will not dispense, a necessary medicine or amount of medicine. Chronic severe pain and the opiate drugs used for it are common examples of this problem, especially for terminally ill patients who may require unusually high dosages. Another example is ethically or politically controversial treatments, e.g., morning-after contraceptives that are already on the market but which some health professionals will not recommend, prescribe, or dispense because of their personal beliefs or values. Finally, the patient must learn how to use the drug correctly. For example, the patient has to be able to correctly use a metered-dose inhaler, an injectable drug such as insulin, a suppository, or a vaginal tablet. This illustrates the need for access to information about drugs as a part of access to the drug products themselves. Of course, physical access also depends on financial access. The patient has to be able to afford the therapy and the associated medical care.
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