Whereas the US FDA controls the drugs and their labeling and distribution, the state legislatures control who may prescribe drugs through their licensing boards, eg, the Board of Medical Examiners. Prescribers must pass examinations, pay fees, and—in the case of some states and some professions—meet other requirements for
TABLE 65–2 Prescribing authority of certain allied health professionals in selected states.
1Under protocol; see Box: Who May Prescribe? 2In collaboration with or under the supervision of a physician.
TABLE 65–3 Classification of controlled substances. (See Inside Front Cover for examples.) relicensure such as continuing education. If these requirements are met, the prescriber is licensed to order dispensing of drugs.
The FDA Amendments Act of 2007 gave the FDA authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. The goal of this strategy is to inform physicians of the emphasized risks and benefits. Furthermore, some drugs have “boxed warnings” to elucidate their risks as part of FDA-mandated labeling.
The federal government and the states further impose special restrictions on drugs according to their perceived potential for abuse (Table 65–3). Such drugs include opioids, hallucinogens, stimulants, depressants, and anabolic steroids. Special requirements must be met when these drugs are to be prescribed. The Controlled Drug Act requires prescribers and dispensers to register with the Drug Enforcement Agency (DEA), pay a fee, receive a personal registration number, and keep records of all controlled drugs prescribed or dispensed. Every time a controlled drug is prescribed, a valid DEA number must appear on the prescription. In the USA, there is an opioid epidemic with an increase in overdoses. To combat this public health trend, prescriber education, tracking of prescribing patterns, limitations on amounts prescribed, and target education are being instituted.
Prescriptions for substances with a high potential for abuse (Schedule II drugs) cannot be refilled without a new prescription. However, multiple prescriptions for the same drug may be written with instructions not to dispense before a certain date and up to a total of 90 days. Prescriptions for Schedules III, IV, and V can be refilled if ordered, but there is a five-refill maximum, and in no case may the prescription be refilled after 6 months from the date of writing. Schedule II drug orders may not be transmitted over the telephone, and some states require a tamper-resistant security prescription blank to reduce the chances for drug diversion.
These restrictive prescribing laws are intended to limit the amount of drugs of abuse that are made available to the public.
Unfortunately, the inconvenience occasioned by these laws— and an unwarranted fear by medical professionals themselves regarding the risk of patient tolerance and addiction—continues to hamper adequate treatment of patients with terminal conditions. This has been shown to be particularly true in children and elderly patients with cancer. There is no excuse for inadequate treatment of pain in a terminal patient; not only is addiction irrelevant in such a patient, it is actually uncommon in patients who are being treated for pain (see Chapter 31). Unfortunately, the initiative begun several years ago to manage pain more actively has led to the overuse of opioids in patients with chronic pain, a condition that does not respond well to these drugs. Chronic use of oxycodone, hydrocodone, and methadone has resulted in a marked increase in habituation, overdoses, and deaths. As a result, most professional authorities now advise limiting the use of any opioid to acute pain only and the use of NSAIDs and other nonaddicting therapies in chronic conditions.