(2003)

88 Op. Att'y Gen. 88
Maryland Attorney General Reports·Decided April 30, 2003·Published

Opinion

Dear Peter Beilenson,

You have requested our opinion concerning a proposed program of the Baltimore City Health Department to prevent deaths from heroin overdoses. The program, called "Staying Alive," would teach illicit drug users how to reduce the risk of overdose and would distribute naloxone, a drug used to treat overdoses, to heroin users. An individual receiving naloxone would be instructed how to administer the drug to other illicit drug users. You pose two questions:

(1) Would a physician who prescribes naloxone as part of the Staying Alive program be subject to criminal prosecution or professional censure?

(2) Would an individual to whom naloxone is prescribed be vulnerable to criminal prosecution if that individual administered the drug to someone experiencing a heroin overdose?

For the reasons set forth in this opinion, the answers to your questions are as follows:

(1) A physician who prescribed naloxone to a participant in the Staying Alive program for treatment of that participant would not be liable for criminal prosecution or professional censure. However, if the physician prescribed the drug to a participant with the understanding that the participant would administer it to another individual who was not a patient of the physician, the physician might be subject to criminal prosecution and disciplinary action for aiding the unauthorized practice of medicine and for violation of State laws relating to prescription drugs.

Naloxone is believed to displace heroin at those receptors and thus to trigger the individual's breathing mechanisms. Burris, supra, at p. 238. (2) Similarly, a participant in the Staying Alive program would not be liable to criminal prosecution if the participant were prescribed naloxone for the participant's own use. However, if the participant were prescribed the drug on the understanding that he or she would administer it to another person, the participant might be subject to criminal prosecution for the unauthorized practice of medicine, for the unlicensed provision of emergency medical services, and for violation of State laws pertaining to prescription drugs.

These legal impediments may be eliminated if legislation were enacted to provide exceptions to the laws relating to prescription drugs and the practice of medicine. In the meantime, the Health Department could appeal to the appropriate prosecuting and regulatory agencies to exercise their prosecutorial discretion to permit the Health Department to operate a pilot program without fear of prosecution.

I
Background
A. Naloxone

Death from a heroin overdose is usually the result of respiratory failure. Naloxone hydrochloride ("naloxone") is an injectable "opiate antagonist" — i.e., it reverses the depressive effects of drugs like heroin on the respiratory system. Treatment with naloxone can reverse respiratory failure in a few minutes.1 Burris, et al., Legal Aspects of Providing Naloxone to Heroin Users in the United States, 12 Int'l. J. Drug Policy 237, 238 (2001). The drug has been used in medical settings for 30 years and is considered the standard of care for treating heroin overdoses. As a result, naloxone is routinely used by emergency medical personnel to offset the effects of heroin. See id. at pp. 237-39.

Naloxone has a low risk of side effects and no potential for abuse. Burris, supra, at pp. 238-39. It is not a controlled dangerous substance. See 21 C.F.R. § 1308.12(b)(1) (excluding naloxone from Schedule II); Annotated Code of Maryland, Criminal Law Article ("CR"), § 5-403(b)(2) (same). However, the Food and Drug Administration has not licensed it for "over-the-counter" distribution. Instead, under federal and State law, it is only available pursuant to a prescription. See USP DI, Approved Drug Products and Legal Requirements (23rd ed. 2003) (including naloxone on list of prescription drugs); see also21 U.S.C. § 353(b)(1); Annotated Code of Maryland, Health-General Article ("HG"), § 21-220(a).

B. "Staying Alive"

You advise that there are 40,000 injection drug users in Baltimore City. During the past year approximately 340 drug users in the City died from overdoses. Nine out of ten of those deaths were attributed to heroin overdoses. Approximately 50 percent of heroin addicts experience at least one non-fatal overdose, and 70 percent of users witness an overdose by another addict. Most heroin overdoses occur in the presence of another person, often an "injection partner" of the overdose victim. Burris, supra, at pp. 237, 239.

In response, the Baltimore City Health Department has designed the Staying Alive program with the goal of reducing drug overdose deaths in Baltimore City. The program will educate illicit drug users in overdose prevention and management. Health educators will train participants in various first aid skills, including rescue breathing. In addition, the program will provide detailed instruction on naloxone and its effects on a heroin overdose.

Program staff will teach participants how to administer the drug by intramuscular injection.

An illicit drug user who completes the education course will receive a certificate from the Health Commissioner, together with an overdose response kit. Each overdose response kit will include a vial of naloxone, ten single-use intramuscular needles and syringes, a packet of alcohol swabs, and a packet of protective mouth barriers for rescue breathing.

The Health Department hopes to reach a total of 2,500 injection drug users and to distribute 800 overdose response kits in the highest risk areas of the City during the first two years of the program. Researchers at Johns Hopkins University and the University of Maryland will help evaluate the effect of the program.

You state that public health agencies in several other jurisdictions have implemented naloxone distribution programs in order to reduce the number of deaths from heroin overdose and have reported positive results.

You ask whether physicians involved in such a program in Maryland could be vulnerable to professional discipline, and whether physicians and participating drug addicts could be subject to criminal prosecution.

II
Analysis
As a general rule, State law accords broad discretion to physicians to prescribe drugs for their patients, particularly drugs that are not controlled substances. However, the Staying Alive program, as it is currently envisioned, would provide for the dispensing and distribution of naloxone beyond the physician-patient relationship. As we understand it, a physician would prescribe and dispense naloxone to a heroin addict who participates in the program with the understanding that the participant would later administer the drug to another drug user, perhaps an "injection partner" of the participant, if the participant believed that the other individual was suffering a heroin overdose. The physician would not necessarily have a physician-patient relationship with the individual to whom the drug would be administered — indeed, that person might well be unknown to either the physician or the program. In essence, the participating addict would be enlisted as a specialized emergency medical technician for heroin overdoses.

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(2003), 88 Op. Att'y Gen. 88 (Md. 2003).

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