Some states have recognized the underutilization of pain medications in the treatment of pain associated with chronic and terminal conditions. In California, upon receipt of a copy of the order from the prescriber, eg, by fax, a pharmacist may write a prescription for a Schedule II substance for a patient under hospice care or living in a skilled nursing facility or in cases in which the patient is expected to live less than 6 months, provided that the prescriber countersigns the order (by fax); the word “exemption” with regulatory code number is written on a typical prescription, thus providing easier access for the terminally ill.
Labeled & Off-Label Uses of Drugs
In the USA, the FDA approves a drug only for the specific uses proposed and documented by the manufacturer in its New Drug Application (see Chapter 1). These approved (labeled) uses or indications are set forth in the package insert that accompanies the drug. For a variety of reasons, these labeled indications may not include all the conditions in which the drug might be useful. Therefore, a clinician may wish to prescribe the agent for some other, unapproved (off-label), clinical condition, often on the basis of adequate or even compelling scientific evidence. Federal laws governing FDA regulations and drug use place no restrictions on such unapproved use. *
Even if the patient suffers injury from the drug, its use for an unlabeled purpose does not in itself constitute “malpractice.” However, the courts may consider the package insert labeling as a complete listing of the indications for which the drug is considered safe unless the clinician can show that other use is considered safe by competent expert testimony.
Governmental drug-regulating agencies have responsibility for monitoring drug safety. In the USA, the FDA-sponsored Med Watch program collects data on safety and adverse drug effects (ADEs) * “Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in the approved labeling. Such ‘unapproved’ or, more precisely, ‘unlabeled’ uses may be appropriate and rational in certain circumstances, and may, in fact, reflect approaches to drug therapy that have been extensively reported in medical literature.”–FDA Drug Bull 1982;12:4.
through mandatory reporting by drug manufacturers and voluntary reporting by health care practitioners. Practitioners may submit reports on any suspected adverse drug (or medical device) effect using a simple form obtainable from http://www.fda.gov/ medwatch/index.html. The FDA is expected to use these data to establish an adverse effect rate. It is not clear that the FDA has sufficient resources at present to carry out this mandate, but they are empowered to take further regulatory actions if deemed necessary. A similar vaccine-reporting program is in place to monitor vaccine safety (VAERS, vaccine adverse event reporting system). The FDA homepage can be found at https://vaers.hhs.gov.
The FDA has also increased requirements for labeling on drugs that carry special risks. Dispensers of medications are required to distribute “Med Guides” to patients when these medications are dispensed. These guides are generated by the manufacturers of the medications. In addition, pharmacists often provide patient educational materials that describe the drug, its use, adverse effects, storage requirements, methods of administration, what to do when a dose is missed, and the potential need for ongoing therapy.
The Cost of Prescriptions