Citation Numbers: 88 Op. Att'y Gen. 88
Judges: J. JOSEPH CURRAN, JR.
Filed Date: 4/30/2003
Status: Precedential
Modified Date: 7/5/2016
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.
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
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.
The distribution of a prescription drug to a program participant, for administration to another individual unknown to the prescribing physician, raises issues under State laws governing the practice of medicine, the provision of emergency medical services, and the dispensing and distribution of prescription drugs.
A. Potential Liability of Physician
1. Possible Violations of Medical Practice Act
Prescribing medication is part of the practice of medicine as defined by the Maryland Medical Practice Act. See Annotated Code of Maryland, Health Occupations Article ("HO"), §
The Medical Practice Act allows a physician to delegate medical duties in accordance with "rules, regulations, and orders" of the Board of Physician Quality Assurance
The BPQA has adopted regulations governing the delegation of medical acts to individuals who are not otherwise regulated by a State licensing board. Those regulations require the delegating physician to:
(1) Evaluate the risk to the patient and the outcome of the delegated acts;
(2) Delegate only those technical acts that are customary to the practice of the supervising physician;
(3) Delegate only those technical acts for which the assistant has been trained;
(4) Be responsible for the acts of the assistant; and
(5) Supervise the assistant.
COMAR
These regulations pose a hurdle for the Staying Alive program, especially in that they require the physician to assess the outcome and risk to the patient (i.e., the overdosing addict) and to "supervise" the delegated act (i.e., the administration of naloxone). First, under the Staying Alive program as it is currently envisioned, the delegating physician would not necessarily have an opportunity to make an individualized assessment of outcome and risk with respect to the person to whom the drug is administered.
Second, it appears unlikely that the physician could provide the required supervision.
The regulations elaborate on the degree of supervision required when a physician delegates various types of "technical acts" to an unlicensed individual. See COMAR
provid[e] sample packets of medication, selected by a physician who is physically present at the time of selection, to patients as directed by the delegating physician and in conformance with [§ 12-102(a), (d), (f) of the Maryland Pharmacy Act4];
COMAR
Another portion of the BPQA regulations specifically allows a physician to delegate "preparing and administering injections limited to intradermal, subcutaneous, and intramuscular . . . ." This would apparently encompass a naloxone injection. However, the regulation authorizes such a delegation "with on-site supervision." COMAR
Thus, while the regulations appear to allow a physician to delegate a medical act such as an intramuscular injection to a trained lay person, they contemplate that the injection will be performed in the vicinity, and with the availability, of the delegating physician at the time of treatment.
The regulations also specifically provide that a physician may not delegate the act of dispensing medication or "initiating independently any form of treatment, exclusive of cardiopulmonary resuscitation." COMAR
HG §
In summary, if a physician provided naloxone to a participant in the program with the understanding that the drug would be administered to another unidentified individual, the physician would essentially be prescribing and dispensing a prescription drug to treat an individual that the physician had never met and knew little about. In that situation, the responsibility for diagnosing the overdose and administering the medication would have been delegated to the participant. However, there is no specific provision in the BPQA regulations that allows for the delegation to a lay person of the medical act of diagnosing and administering medication by intramuscular injection without supervision.
Under the BPQA regulations, a person assisting a physician who acts beyond the permissible scope of delegation by a physician is considered to be practicing medicine without a license. COMAR
HO §
2. Possible Violations of State Drug Laws
The Maryland Food, Drug, and Cosmetic Act ("the Act") sets forth various requirements related to prescription drugs. See HG §
Because the Staying Alive program contemplates the administration of naloxone to a person who may be unknown to the physician, it raises a question as to whether a prescription drug is being administered under the supervision of a "health practitioner."
Under the Act, an improperly dispensed drug is considered a "misbranded drug." A physician who dispenses a misbranded drug could be convicted for a violation of the Act.
HG §§
B. Potential Liability of Participant Who Administers Naloxone to Another Person
1. Possible Violations of Medical Practice Act
A participant in the Staying Alive program who received naloxone to administer to others might be vulnerable to criminal prosecution for the unauthorized practice of medicine.
As noted above, the definition of "practice medicine" in the Maryland Medical Practice Act includes prescribing and treating with medication. HO §
An individual who practices medicine without a license is subject to criminal prosecution. Such an offense is a misdemeanor punishable by imprisonment for up to 5 years and a fine of up to $50,000. HO §
2. Possible Violations of Emergency Medical Services Law
The administration of naloxone to a drug user experiencing an overdose is a form of emergency medical assistance that is separately regulated by State law. The Emergency Medical Services Law defines "emergency medical services" to include "medical services provided prehospital to prevent imminent death or aggravation of illness or injury . . ." Annotated Code of Maryland, Education Article ("ED")§
The Emergency Medical Services Law generally prohibits a lay person from providing emergency medical services without a license or certificate from the State Emergency Medical Services Board ("EMS Board"). E.D. §
However, there are a number of exceptions to the licensing requirement. For example, the licensing requirement does not apply to "an individual who is not engaged in providing emergency medical services on a regular basis who provides emergency medical services at the scene of a medical emergency in rare instances." E.D. §
3. Possible Violations of State Drug Laws
The participant could also face the same criminal liability under the Maryland Food, Drug, and Cosmetic Act as outlined above with respect to the physician. In addition, the unauthorized distribution of a prescription drug could violate the State criminal code. In particular, a person may dispense a prescription drug only pursuant to a prescription by an "authorized provider." Annotated Code of Maryland, Criminal Law Article ("CR"), §
As currently designed, a participant in the Staying Alive program would administer naloxone to an injection partner without a prescription specific to the person receiving the injection. Thus, it could be argued that the participant would be distributing the drug without legal authorization. In those circumstances, the participant may be subject to criminal prosecution under CR §
4. Immunity from Civil Liability
A participant who administered naloxone to an addict experiencing an overdose would likely be immune from civil liability to the addict. See Annotated Code of Maryland, Courts Judicial Proceedings Article, §
There is some debate about the wisdom of providing naloxone to a heroin addict in advance of an overdose. See Distributing "miracle drug" for heroin questioned; City's plan to let addicts give Narcon called unwise, Baltimore Sun, p. 1B (March 10, 2003). We express no opinion on the merits of such a policy.
C. Resolution of Legal Impediments to Program
These legal impediments to the Staying Alive program may be eliminated through modification of the program, or the enactment of legislation specifically designed to permit such a program.
1. Modification of Program
A physician and a program participant should not be at risk of criminal liability if, as part of the program, the physician establishes a patient-physician relationship with a drug user participant and prescribes naloxone for that participant.8 In our opinion, it is also permissible for the physician, in the course of prescribing the drug, to instruct another person, such as a family member or friend, how to assist the participant in administering the drug. For example, it would be permissible for a physician to provide naloxone to "injection partners" and to instruct each of them how to assist the other. In that case, neither of the participants would be engaging in the unauthorized practice of medicine. However, as a practical matter, it may be unlikely that an overdosing addict would be capable of initiating his or her own treatment, including administration of the drug.
2. Legislation
Appropriate legislation enacted by the General Assembly could resolve issues of potential criminal liability and professional discipline under State law.
A possible model for legislation authorizing a naloxone distribution program is the Insect Emergency Treatment Program enacted by the General Assembly in 1995. See HG §
In another analogous context, the General Assembly enacted legislation to remove legal clouds over sterile needle exchange programs targeted at injection drug users to inhibit the spread of HIV infection. See HG §
Finally, another state has enacted legislation that expressly authorizes naloxone distribution programs. To ensure that a program like Staying Alive would be lawful, the New Mexico Legislature amended its state laws to permit administration of naloxone by unlicensed persons in specific circumstances. That legislation allows an individual other than a licensed health care professional to administer an opioid antagonist, such as naloxone, as authorized by federal, state, or local regulations. Chapter 228, § 1, Laws of New Mexico 2001, codified at N.M. Stat. Ann. §§
The New Mexico Department of Health implemented that state's legislation by adopting regulations. The regulations permit a person other than a licensed health care professional to administer naloxone to another person and create an Opioid Antagonist Administration Program similar in some respects to Staying Alive. See New Mexico Administrative Code 7.32.7. The regulations strongly recommend that administration of the drug be coupled with a call for emergency medical services. Id. 7.32.7.8.
3. Exercise of Prosecutorial Discretion
In anticipation of proposing legislation, the City Health Department might appeal to the relevant enforcement agencies to exercise their prosecutorial discretion to permit a pilot program to be undertaken on a temporary basis. In particular, the Health Department could seek assurances from the relevant agencies that they would not institute criminal prosecution or professional disciplinary proceedings under narrowly defined circumstances tailored to the program.
Criminal prosecutors and administrative regulatory agencies enjoy a measure of prosecutorial discretion. For example, "it is well settled that the [State's Attorney's] determination of which criminal charges, if any, to bring is a matter of prosecutorial discretion. . . .As a general rule, whether the State's Attorney does or does not institute a particular prosecution is a matter which rests in his discretion." Beverly v. State,
Administrative agencies exercised similar discretion in setting enforcement priorities.
It is not uncommon for administrative regulatory agencies to provide "no action" or "business review" letters that articulate the agency's enforcement intentions under specified factual circumstances. See, e.g., COMAR
In the context of a proposed public health program involving naloxone distribution, a criminal prosecutor or administrative agency could determine that it would not be in the public interest to prosecute possible violations that arose out of a program designed to provide life-saving assistance to a population otherwise difficult to reach. Such an approach may be particularly appropriate when the program is designed as a temporary pilot project to assess its efficacy, and when the results of the pilot program would be available to the Legislature to evaluate the merits of creating statutory authorization for such a program on a more permanent basis. Such determinations could be embodied in a memorandum of understanding among the relevant agencies that carefully defined the circumstances under which the agencies would forgo prosecution. Of course, whether an agency would enter into such a memorandum of understanding or otherwise provide an assurance that it would not prosecute would be a matter within the purview of that agency.
(1) A physician who prescribed naloxone to a participant in the proposed Staying Alive program, for treatment of that participant, would not be liable to criminal prosecution or professional censure. However, if the physician prescribed the drug to a participant with the understanding that the participant would administer the drug to another individual who is not a patient of the physician, the physician may 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.
(2) Similarly, a participant in the program would not be liable to criminal prosecution if the participant were prescribed naloxone through the program 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 unidentified person, the participant may 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 the proposal is modified to provide for administration of naloxone only in the context of a physician-patient relationship.
Alternatively, legislative action could eliminate the possibility of criminal liability by tailoring exceptions pertinent to prescription drug requirements and to restrictions on the unauthorized practice of medicine and performance of emergency medical services. Pending enactment of such legislation, the City Health Department could seek assurances from the relevant prosecuting and regulatory agencies concerning their enforcement intentions.
J. Joseph Curran, Jr. Attorney General
Robert N. McDonald Chief Counsel Opinions Advice