Confessions of a Dreamer
In the United States, the manufacture, importation, and distribution of pharmaceutical drugs is subject to Federal regulation. The Food and Drug Administration (FDA), a part of the U.S. Department of Health and Human Services (DHHS), is responsible for certifying the safety and efficacy of new medications and monitoring the safety of pharmaceuticals already on the market.
Pharmaceuticals controlled by the FDA are designated either as over-the-counter drugs or prescription drugs depending on their level of safety and potential for causing adverse effects. Over-the-counter drugs are available without a physician’s prescription but are subject to usage guidelines stated on the label, which must be approved by the FDA. Prescription drugs are given that name because they are available only with a prescription from a physician, who is responsible for ensuring that the recipient has a legitimate need for the medication, that the dosage and other specified aspects of usage are appropriate for the patient and his or her condition, that the patient understands the directions for use, that any possible problems with usage are recognized and dealt with, and that usage is monitored in a manner consistent with the level of safety and potential adverse effects of the medication.
The FDA evaluates safety and efficacy prior to approving a drug for distribution and medical use and monitors the occurrence of serious adverse events related to use of the drug once it is on the market. Health care providers (e.g., physicians, pharmacists, nurses) are required to report to a designated Federal adverse event monitoring system any severe adverse effect that is potentially associated with a drug. Any death that is deemed to be potentially related to a drug also is required to be reported. All drugs are subject to revocation of FDA approval or legal action to withdraw the drug from the market.
One of the issues that FDA regulators must address is the potential of medications to produce patterns of dependence or nondependent abuse, a characteristic referred to as “abuse potential.” Drugs with abuse potential, which fall mainly into the category of psychoactive or psychotherapeutic substances, are subject to further regulation by the Drug Enforcement Administration (DEA, a part of the U.S. Department of Justice) under the Controlled Substances Act (CSA), which is Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. These regulated drugs include both illegal substances (referred to as “street drugs”) and the pharmaceuticals subject to FDA regulation. The CSA separates drugs into five categories, known as schedules, depending on their abuse potential, utility in medical treatment, and safety when used under medical supervision:
The majority of the pharmaceuticals that the FDA has approved for marketing in the United States are not on the CSA schedules, including most prescription drugs and all over-the-counter drugs. The NSDUH questionnaire includes some prescription psychotherapeutic drugs that are not on the CSA schedule, such as tramadol (Ultram®) and cyclobenzaprine (Flexeril®).
The usual distribution network for prescription pharmaceuticals involves manufacture under FDA approval, delivery to wholesalers, and dissemination to local pharmacies and hospitals to be dispensed to patients who have prescriptions from physicians. Distribution is subject to a number of administrative controls, and tightness of these controls increases the lower they are on the CSA schedule. CSA forbids distribution of Schedule I drugs and imposes a number of limits on the distribution of drugs in Schedules II and III, including monitoring of physician prescribing practices.
In the context of this report, pharmaceuticals that are misused may have been manufactured by the usual companies but stolen in shipping or at other points in distribution. They are said to have been diverted and ultimately wind up in illicit trafficking. The drugs also may be obtained inappropriately from legitimate end users. In many cases, misused psychotherapeutic drugs are acquired using prescriptions obtained from physicians who are lenient in prescribing controlled substances. In addition, medication prescribing pads may be stolen from physicians’ offices and used to write fraudulent prescriptions for psychotherapeutic drugs.
A particular issue with regard to manufacturing and distribution involves methamphetamine, which began many years ago as a prescription drug. In more recent years, methamphetamine for nonmedical use has been manufactured outside the legitimate pharmaceutical industry by illicit laboratories and distributed through illegal trafficking. With the assignment of methamphetamine (e.g., Desoxyn®) to DEA Schedule II, legitimate prescribing of methamphetamine is rare. It might be said that methamphetamine has moved from being a prescription drug to being principally a street drug. NSDUH and other epidemiological surveys have continued to collect data on methamphetamine use under the rubric of nonmedical use of prescription drugs. For information on future changes to NSDUH that will recognize methamphetamine’s role as a street drug, refer to Chapter 8.