The United States government recognizes two classes of drugs: (1) over-the-counter (OTC) drugs and (2) those that require a prescription from a licensed prescriber (Rx Only). OTC drugs are those that can be safely self-administered by the layman for self-limiting conditions and for which appropriate labels can be written for lay comprehension (see Chapter 63). Half of all drug doses consumed by the American public are OTC drugs. In 2014 in the USA, $373.9 billion was spent on prescription drugs and $30.7 billion was spent on OTC drugs, more than any other country.
Physicians, dentists, podiatrists, and veterinarians—and, in many states, specialized pharmacists, nurses, physician’s assistants, and optometrists—are granted authority to prescribe certain drugs (those bearing the federal legend statement, “Rx Only”) on the basis of their training in diagnosis and treatment (see Box: Who May Prescribe?). Depending on the state, mid-level practitioners may prescribe/furnish prescriptions. Pharmacists are authorized to dispense prescriptions pursuant to a prescriber’s order provided that the medication order is appropriate and rational for the patient. Nurses are authorized to administer medications to patients subject to a prescriber’s order.
Who May Prescribe?
The right to prescribe drugs has traditionally been the responsibility of the physician, dentist, podiatrist, or veterinarian. Prescribing now includes—in a number of states and in varying degrees—pharmacists, nurse practitioners, nurse midwives, physician’s assistants, and optometrists (see below; Table 65–2). In the future, physical therapists may be licensed to prescribe drugs relevant to their practice. The development of large health maintenance organizations has greatly strengthened this expansion of prescribing rights because it offers these extremely powerful economic bodies a way to reduce their expenses.
The primary organizations controlling the privilege of prescribing in the USA are the state boards, under the powers delegated to them by the state legislatures. Many state boards have attempted to reserve some measure of the primary responsibility for prescribing to physicians by requiring that the ancillary professional work with or under a physician according to a specific protocol. In the state of California, this protocol must include a statement of the training, supervision, and documentation requirements of the arrangement and must specify referral requirements, limitations to the list of drugs that may be prescribed (ie, a formulary), and a method of evaluation by the supervising physician. The protocol must be in writing and must be periodically updated.
The following rules govern prescribing by nonphysicians in the various states at the time of this writing.
In almost all states, nurse practitioners (NPs) and physician assistants (PAs) may prescribe with or without physician supervision depending on the state. Likewise, optometrists may prescribe selected formulary drugs for ophthalmologic indications.
Pharmacists can initiate prescriptions in three states: Montana, New Mexico, and North Carolina. They may practice with physicians in collaborative drug therapy management (CDTM) programs in 47 states—all except New York, Maine, Oklahoma, and Alabama. Pharmacists may prescribe controlled substances under physician supervision in California, Massachusetts, Montana, New Mexico, North Carolina, Ohio, and Washington.
New Mexico grants prescribing authority to medical psychologists with advanced training.
Because of the multiplicity of third-party payers (health insurers) and Medicare and Medicaid claimants, the concept of electronic processing of prescriptions (“e-prescribing”) has become urgent. (Further information about e-prescribing may be found at http://www.cms.gov/Medicare/E-Health/Eprescribing/.) To further standardize electronic prescription transmission and billing, the Centers for Medicare and Medicaid (CMS) issued regulations effective in 2008 requiring all US health care providers to obtain a National Provider Identification (NPI) number. This 10-digit identifier is issued by the National Plan and Provider Enumeration System (NPPES) at https://NPPES.cms.hhs.gov. The purpose of the NPI is to identify all health care transactions (and associated costs) incurred by a particular practitioner with a single number.
In addition to a health care provider’s unique identification number, some states require that prescriptions for controlled substances be written on tamper-resistant security prescription forms. The purpose of this legislation is to prevent forgeries and to tighten the control of prescription order forms.
The concept of a “secure” prescription form was expanded by the federal government in 2008 to all prescriptions written for Medicaid patients. Any prescription for a Medicaid patient must be written on a security form if the pharmacist is to be compensated for the prescription service. In turn, the use of “triplicate” prescription forms was eliminated and replaced with an online electronic transmission system whereby orders for Schedule II, Schedule III, and Schedule IV prescriptions are transmitted to a company that acts as a repository for these transactions. In California, it is called the CURES program (Controlled Substances Utilization Review and Evaluation System). Prescribers are provided with a record of who prescribed which controlled drug to which patient. Additional information about CURES may be found at http://oag.ca.gov/cures-pdmp.
In the USA, prescription drugs are controlled by the US Food and Drug Administration (FDA) as described in Chapter 1. The federal legend statement as well as the package insert are part of the packaging requirements for all prescription drugs. The package insert is the official brochure setting forth the indications, contraindications, warnings, and dosing for the drug.
The prescriber, by writing and signing a prescription order, controls who may obtain prescription drugs. The pharmacist may purchase these drugs, but they may be dispensed only on the order of a legally qualified prescriber. Thus, a prescription is actually three things: the prescriber’s order in the patient’s chart, the written order to which the pharmacist refers when dispensing, and the patient’s medication container with a label affixed.
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 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.
TABLE 65–2Prescribing authority of certain allied health professionals in selected states. ||Download (.pdf) TABLE 65–2 Prescribing authority of certain allied health professionals in selected states.
|State ||Pharmacists ||Nurse Practitioners ||Physician’s Assistants ||Optometrists |
|California ||Yes, under protocol1; must be trained in clinical practice ||Yes2 ||Yes, under protocol1 ||Yes; limited to certain drug classes |
|Florida ||Yes, according to state formulary; protocol not required ||Yes2 ||Yes2 ||Yes; limited to certain drug classes |
|Michigan ||Yes, under protocol; must be specially qualified by education, training, or experience ||Yes2 ||Yes2 ||Yes; limited to certain drug classes |
|Mississippi ||Yes, under protocol in an institutional setting ||Yes,2 under narrowly specified conditions ||No ||Yes; limited to certain drug classes |
|Nevada ||Yes, under protocol, within a licensed medical facility ||Yes2 ||Yes2 ||Yes; limited to certain drug classes |
|New Mexico ||Yes, under protocol, must be “pharmacist clinician” ||Yes; do not need physician supervision ||Yes2 ||Yes; limited to certain drug classes |
|North Dakota ||Yes, under protocol in an institutional setting ||Yes; do not need physician supervision ||Yes2 ||Yes; limited to certain drug classes |
|Oregon ||Yes, under guidelines set by the state board ||Yes; do not need physician supervision ||Yes2 ||Yes; limited to certain drug classes |
|Texas ||Yes, under protocol set for a particular patient in an institutional setting ||Yes; do not need physician supervision ||Yes ||Yes; limited to certain drug classes |
|Washington ||Yes, under guidelines set by the state board ||Yes; do not need physician supervision ||Yes2 ||Yes; limited to certain drug classes |
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.
TABLE 65–3Classification of controlled substances. (See Inside Front Cover for examples.) ||Download (.pdf) TABLE 65–3 Classification of controlled substances. (See Inside Front Cover for examples.)
|Schedule ||Potential for Abuse ||Other Comments |
|I ||High ||No accepted medical use; lack of accepted safety as drug. |
|II ||High ||Current accepted medical use. Abuse may lead to psychological or physical dependence. |
|III ||Less than I or II ||Current accepted medical use. Moderate or low potential for physical dependence and high potential for psychological dependence. |
|IV ||Less than III ||Current accepted medical use. Limited potential for dependence. |
|V ||Less than IV ||Current accepted medical use. Limited dependence possible. |
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.
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) 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.