Page 1167 - Basic _ Clinical Pharmacology ( PDFDrive )

CHAPTER 65 Rational Prescribing & Prescription Writing 1153

TABLE 65–3 Classification of controlled substances. regarding the risk of patient tolerance and addiction—continues
(See Inside Front Cover for examples.) to hamper adequate treatment of patients with terminal condi-
tions. This has been shown to be particularly true in children and
Potential elderly patients with cancer. There is no excuse for inadequate treat-
Schedule for Abuse Other Comments
ment of pain in a terminal patient; not only is addiction irrelevant
I High No accepted medical use; lack of in such a patient, it is actually uncommon in patients who are being
accepted safety as drug. treated for pain (see Chapter 31). Unfortunately, the initiative
II High Current accepted medical use. Abuse begun several years ago to manage pain more actively has led to
may lead to psychological or physical the overuse of opioids in patients with chronic pain, a condition
dependence.
that does not respond well to these drugs. Chronic use of oxy-
III Less than I Current accepted medical use. codone, hydrocodone, and methadone has resulted in a marked
or II Moderate or low potential for physical
dependence and high potential for increase in habituation, overdoses, and deaths. As a result, most
psychological dependence. professional authorities now advise limiting the use of any opioid
IV Less than III Current accepted medical use. Limited to acute pain only and the use of NSAIDs and other nonaddicting
potential for dependence. therapies in chronic conditions.
V Less than IV Current accepted medical use. Limited Some states have recognized the underutilization of pain
dependence possible. 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 pre-
relicensure such as continuing education. If these requirements are scription for a Schedule II substance for a patient under hospice
met, the prescriber is licensed to order dispensing of drugs. care or living in a skilled nursing facility or in cases in which the
The FDA Amendments Act of 2007 gave the FDA authority patient is expected to live less than 6 months, provided that the
to require a Risk Evaluation and Mitigation Strategy (REMS) prescriber countersigns the order (by fax); the word “exemption”
from manufacturers to ensure that the benefits of a drug or bio- with regulatory code number is written on a typical prescription,
logical product outweigh its risks. The goal of this strategy is to thus providing easier access for the terminally ill.
inform physicians of the emphasized risks and benefits. Further-
more, some drugs have “boxed warnings” to elucidate their risks Labeled & Off-Label Uses of Drugs
as part of FDA-mandated labeling.
The federal government and the states further impose special In the USA, the FDA approves a drug only for the specific uses
restrictions on drugs according to their perceived potential for proposed and documented by the manufacturer in its New Drug
abuse (Table 65–3). Such drugs include opioids, hallucinogens, Application (see Chapter 1). These approved (labeled) uses or indi-
stimulants, depressants, and anabolic steroids. Special require- cations are set forth in the package insert that accompanies the drug.
ments must be met when these drugs are to be prescribed. The For a variety of reasons, these labeled indications may not include all
Controlled Drug Act requires prescribers and dispensers to register the conditions in which the drug might be useful. Therefore, a cli-
with the Drug Enforcement Agency (DEA), pay a fee, receive a nician may wish to prescribe the agent for some other, unapproved
personal registration number, and keep records of all controlled (off-label), clinical condition, often on the basis of adequate or even
drugs prescribed or dispensed. Every time a controlled drug is compelling scientific evidence. Federal laws governing FDA regula-
*
prescribed, a valid DEA number must appear on the prescrip- tions and drug use place no restrictions on such unapproved use.
tion. In the USA, there is an opioid epidemic with an increase in Even if the patient suffers injury from the drug, its use for
overdoses. To combat this public health trend, prescriber educa- an unlabeled purpose does not in itself constitute “malpractice.”
tion, tracking of prescribing patterns, limitations on amounts However, the courts may consider the package insert labeling as a
prescribed, and target education are being instituted. complete listing of the indications for which the drug is consid-
Prescriptions for substances with a high potential for abuse ered safe unless the clinician can show that other use is considered
(Schedule II drugs) cannot be refilled without a new prescription. safe by competent expert testimony.
However, multiple prescriptions for the same drug may be written
with instructions not to dispense before a certain date and up to Drug Safety Surveillance
a total of 90 days. Prescriptions for Schedules III, IV, and V can Governmental drug-regulating agencies have responsibility for mon-
be refilled if ordered, but there is a five-refill maximum, and in no itoring drug safety. In the USA, the FDA-sponsored Med Watch
case may the prescription be refilled after 6 months from the date program collects data on safety and adverse drug effects (ADEs)
of writing. Schedule II drug orders may not be transmitted over
the telephone, and some states require a tamper-resistant security *
“Once a product has been approved for marketing, a physician may
prescription blank to reduce the chances for drug diversion. prescribe it for uses or in treatment regimens or patient populations that
These restrictive prescribing laws are intended to limit the are not included in the approved labeling. Such ‘unapproved’ or, more
amount of drugs of abuse that are made available to the public. precisely, ‘unlabeled’ uses may be appropriate and rational in certain
Unfortunately, the inconvenience occasioned by these laws— circumstances, and may, in fact, reflect approaches to drug therapy that
have been extensively reported in medical literature.”–FDA Drug Bull
and an unwarranted fear by medical professionals themselves 1982;12:4.