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same agents who pursue drug dealers. These agents do not show the same deference
to physicians as do boards of medical examiners’ investigators.
Drugs are a particularly touchy area for NPPs. The states vary widely in the laws
governing prescribing and dispensing drugs; some allow limited prescribing by nurse
practitioners or physician’s assistants, but many do not. Some laws are inconsistent.
Pharmacy laws may allow prescribing or dispensing by individuals who are
prohibited from this by the medical or nursing practice act. A physician should not
allow an NPP to write prescriptions without a clear understanding of the applicable
state laws and should not allow dispensing except under strict protocol.
Office dispensing has been very informal in the past, but heightened awareness of the
role of prescription drugs in drug addiction is causing states and the federal
government to tighten drug laws and their enforcement. For example, the federal
regulations on distributing drug samples are much more restrictive than in the past. A
physician must provide detailed information on a form mandated by the Food and
Drug Administration (FDA) before the drug company representative may leave
samples of prescription drugs. These samples must be kept secure and dispensed in
the same manner as other prescription drugs. Some states require samples to be
dispensed personally by physicians.
Physicians should contact their state board of pharmacy and local office of the Drug
Enforcement Administration (DEA) to obtain a copy of the restrictions on prescribing
drugs. If a clinic or physician group plans to buy drugs in bulk and package them for
dispensing, it should inquire about a pharmacy or dispensing license and a federal
repackaging permit. Most states allow physicians to dispense drugs if they bottle and
label the pills personally and give them to the patient directly, but the state and
federal government also impose substantial recordkeeping requirements on
physicians who do this.
5. Protocols
The term protocol is widely used in medical care to refer to a variety of documents.
This book uses protocol to refer to written orders directing the practice of nurses and
other NPPs. These protocols are not intended to be clinical algorithms; unlike clinical
algorithms, which are intended to assist medical decision making, protocols are
intended to circumscribe clinical decision making. [Hadorn DC, McCormick K,
Diokno A. An annotated algorithm approach to clinical guideline development.
JAMA. 1992;267:3311–3314.]
Few medical offices use the detailed, deterministic protocols described in this
section. Such protocols require substantial effort to compile and tailor to the needs of
an individual physician’s office. In the long term, however, they become time-
effective by rationalizing quality assurance efforts and the analysis of work flow in
the office. More important, systematically using structured protocols reduces the
burden of routine documentation of patient encounters. If an office relies on standard
protocols to determine the diagnosis and treatment of common conditions, these
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