Temple University of the Commonwealth System of Higher Education
Beasley School of
Project on Harm Reduction in the
Health Care System
Date: December 11. 1999
Subject: Prescribing and Dispensing Injection
Equipment in Maine
Numerous medical organizations and even the federal government itself now recommend that injection drug users employ a new, sterile syringe each time they inject.(1) Unfortunately, the number of sterile syringes required to follow this standard -- approximately one billion(2) -- exceeds the available supply by many millions. The continuing shortage of syringes contributes to the spread of HIV, and is thus a major health problem. Many commentators have suggested that the health care system can help increase access to safe injection equipment through prescription, pharmacy sales and other measures such as hospital or clinic-based needle exchange programs (NEPs).(3)
This Memorandum assesses the legality, under Maine law, of physician prescription and pharmacy sale of injection equipment to patients who are known to be injecting illegal drugs. It assumes that ensuring a patient's access to sterile injection equipment is clinically effective and conducive to public health, is ethical, and constitutes only one facet of the care the patient is receiving from the physician. These assumptions are justified and discussed in two companion reports: Zita Lazzarini, Ethical Issues in Prescribing and Dispensing Syringes to Injection Drug Users, and Josiah Rich, Syringe Prescription in Rhode Island: A Case Study. The risk of malpractice liability is discussed in a third companion piece, Professional Liability in the Prescription and Dispensing of Sterile Injection Equipment to IDU Patients, by Maxwell Mehlman.
We conclude that physicians may legally prescribe and pharmacists may legally dispense syringes to injection drug users (IDUs) as a health care intervention to prevent a patient acquiring or transmitting HIV.
I. The Regulatory Scheme
Controlled Substances Law Generally
Controlled substances are governed by two separate sections of the Maine Code. The Controlled Substances Act, Me. Rev. Stat. Ann. tit. 17-A, §1101 et seq., which does not include provisions covering prescriptions by licensed physicians. The title covering "Human Services" includes a chapter titled "Marijuana and Scheduled Drugs," id. tit. 22, §2383 et seq., which does discuss authorizes possession of controlled substances and prescription drugs by a "person to whom or for whose use any scheduled drug, prescription drug or controlled substance has been prescribed, sold or dispensed for a legitimate medical purpose by a physician, dentist, podiatrist, pharmacist or other person acting in the usual course of professional practice and authorized by law or rule to do so." Id. 2383-B.
The same provision sets out specific rules for hypodermic apparatuses.(4)
Except as otherwise authorized or restricted, the following persons are authorized to possess, furnish and have control of scheduled or prescription drugs, controlled substances or hypodermic apparatuses:
E. Physicians, dentists, podiatrists, pharmacists or other persons authorized by law or rule to administer, dispense, prescribe or sell scheduled or prescription drugs, controlled substances or hypodermic apparatuses while acting within the course of their professional practice; and
F. With regard to the possession or furnishing of hypodermic apparatuses, persons authorized by the Bureau of Health pursuant to a hypodermic apparatus exchange program, certified under chapter 252-A [the Needle Exchange Act] while acting within the scope of their employment under such programs.
Id. "Furnish" is defined in the controlled substances act to mean, among other things, "[t]o furnish, give, dispense, administer, prescribe, deliver or otherwise transfer to another." Id. Tit. 17-A § 1101(18).
The criminal code section on controlled substances includes restrictions on trafficking, furnishing and possessing hypodermic apparatuses. The trafficking and furnishing statute states that:
1. A person is guilty of trafficking in hypodermic apparatuses if the person intentionally or knowingly trafficks in one or more hypodermic apparatuses, unless the conduct that constitutes such trafficking is:
A. Expressly authorized by Title 32, section 13787-A [the statute within the pharmacy act governing the sale of hypodermic apparatus].
1-A. A person is guilty of furnishing hypodermic apparatuses if the person intentionally or knowingly furnishes 11 or more hypodermic apparatuses, unless the conduct that constitutes such furnishing is expressly authorized by Title 22, section 2383-B [the statute governing lawfully possessed and furnished prescription drugs, controlled substances or hypodermic apparatuses].
2. Trafficking in hypodermic apparatuses in a Class C crime. Furnishing hypodermic apparatuses is a Class D crime.
Me. Rev. Stat. Ann. tit. 17-A, §1110.
Traffick is defined as:
A. To make, create, manufacture;
B. To grow or cultivate;
C. To sell, barter, trade, exchange or otherwise furnish for consideration; or
D. To possess with the intent to do any act mentioned in paragraph C.
Me. Rev. Stat. Ann. tit. 17-A, §1101.
The statute governing the possession of hypodermic apparatuses states:
1. A person is guilty of illegal possession of hypodermic apparatuses if the person intentionally or knowingly possesses 11 or more hypodermic apparatuses, unless the conduct that constitutes such possession is:
A. Expressly authorized by Title 22, section 2383-B [the statute governing lawfully possessed and furnished prescription drugs, controlled substances or hypodermic apparatuses].
2. Illegal possession of hypodermic apparatuses is a Class D crime.
Me. Rev. Stat. Ann. tit. 17-A, §1111.
Pharmacy law completes the regulatory scheme.
1. Authorized seller. A hypodermic apparatus, as defined in Title 17-A, section 1101, subsection 2, may be sold by a manufacturer or dealer of embalming supplies, manufacturer or dealer of medical or dental supplies, wholesale druggists, manufacturing pharmacist, pharmacist, veterinarian, agricultural supply store or manufacturer of surgical instruments.
2. Purchaser. Any person who is 18 years of age or older may purchase a hypodermic apparatus from a seller described in subsection 1.
3. Criminal immunity. Immunity from criminal prosecution is governed by the following.
A. A seller described in subsection 1 is "expressly authorized" within the meaning of Title 17-A, section 1110, subsection , paragraph A.
B. A seller described in subsection 1 or a purchaser described in subsection 2 is "expressly authorized" within the meaning of Title 17-A, section 1111, subsection 1, paragraph A.
4. Immunity limited. This section does not limit prosecution for violation of any law prohibiting or regulating the use, possession, dispensing, distribution or promotion of controlled substances, scheduled drugs or drug paraphernalia.
Me. Rev. Stat. Ann. tit. 32, §13787-A.
Drug Paraphernalia Law
The criminal code also includes a drug paraphernalia provision, Me. Rev. Stat. Ann. tit. 17-A, §1111-A, based on the Justice Department's model act, reprinted in Annotation, Validity, under Federal Constitution, of So-called "Head Shop" Ordinances or Statutes, Prohibiting Manufacture and Sale of Drug Use Related Paraphernalia, 69 A.L.R. Fed. 15 (1984 & Supp. 1998); see generally New England Accessories Trade Assoc. v. Tierney, 528 F.Supp 404, 406-7 (D. Me. 1981). The statute refers to injection in the roster of drug-use practices that contribute to defining paraphernalia under the first part of the definition, but does not include "hypodermic apparatus" in its list of items that can qualify as drug paraphernalia under some circumstances:
For purposes of this section, drug paraphernalia does not include hypodermic apparatus. Possession of, furnishing or trafficking in hypodermic apparatus constitute separate offenses under sections [17-A] 1110 and 1111.
Me. Rev. Stat. Ann. tit. 17-A, §1111-A (2).
Needle Exchange Programs
The legislature has recently created a law which governs the exchange of hypodermic apparatuses. This law allows the Bureau of Health to certify exchange programs which must have procedures for the safe disposal of hypodermic apparatuses, tracking the number of hypodermic apparatuses distributed and collected, and drug abuse prevention and treatment education. Me. Rev. Stat. Ann. tit. 22, §1341. Regulations created under this chapter only allow for one-for-one exchanges with an authorized needle exchange program. Code Me. R. §10 144 252.
There are no other regulations within the administrative code covering the prescription or dispensing of hypodermic apparatuses.
Maine's legislature has legalized the possession of up to ten hypodermic apparatuses, Me. Rev. Stat. Ann. tit. §1111 (1). Syringes in this number can be prescribed, dispensed, and purchased without violating any law. This memo therefore focuses on whether the prescribing and dispensing of syringes in numbers greater than ten is legal in Maine.
The regulatory scheme is complicated, and has been changed to make syringes more accessible. Essentially, it applies as follows to physician prescription and pharmacy sales. Section 2383-B of the Human Services title authorizes physicians to prescribe and pharmacists to dispense needles " while acting within the course of their professional practice" except as "otherwise ... restricted."
Section 1110 of the crimes code variously prohibits trafficking and furnishing of syringes. Trafficking arguably includes sale by a pharmacist, but does not include writing a prescription, but trafficking is only illegal if it is not authorized by section 13787-A of the pharmacy code. This provision, in turn, explicitly authorizes pharmacists to traffick without violating section 1110. Subsection 1-A of section 1110 prohibits furnishing needles. Furnishing embraces both prescribing and dispensing, but 1-A excludes from prohibition furnishing authorized under section 2383-B, which, as we have noted, allows physicians and pharmacists to furnish syringes. Likewise, section 1111, which prohibits possession of syringes, would allow a patient to possess syringes properly prescribed under 2383-B. Prescribing, dispensing and possessing injection equipment to prevent disease transmission during illegal drug use are thus all authorized under Maine law, provided that the syringe was prescribed and dispensed by a pharmacist or physician acting within the course of professional practice.
Maine courts have not interpreted this requirement, but it has been the subject of considerable judicial explanation in other states applying similar controlled substance provisions. In determining whether a prescription arises within the usual course of professional practice, courts may consider such matters as whether a bona fide physician-patient relationship existed, whether other care was provided, whether proper records were kept of the encounter, whether the prescription was based on a proper history or individualized assessment of the patient's risk factors, efforts to provide other harm reducing services, follow up and so on. See generally United States v. Moore, 423 U.S. 122, 142-43, 96 S.Ct. 335, 345 ("The evidence presented at trial was sufficient for the jury to find that respondent's conduct exceeded the bounds of "professional practice." As detailed above, he gave inadequate physician examinations or none at all. He ignored the results of the tests he did make. ... He did not regulate the dosage at all, prescribing as much and as frequently as the patient demanded. He did not charge for medical services rendered, but graduated his fee according to the physician."). A physician prescribing syringes to bona fide patients in his regular office or in a clinic, keeping records and providing other treatment services, would not be at risk of failing this test.(5)
Conclusion: Physicians may prescribe and pharmacists may dispense syringes in amounts exceeding ten, in the usual course of practice, to IDU patients as a means of preventing disease transmission.
III. How Might Maine Law Be Changed or Clarified to Promote Access to Sterile Injection Equipment for IDUs Through the Health Care System?
This Memorandum has concluded that physicians may prescribe and pharmacists may dispense sterile injection equipment to IDUS as a health-care intervention to prevent the transmission of blood-borne pathogens. Nevertheless, several legal measures would add clarity to the legal situation or otherwise protect public health by enhancing access to safe injection equipment.
A. Changes in Statutes or Regulations
1. The legislature should amend the prescription and hypodermic apparatus statutes to legalize the over-the-counter sale of injection equipment without restriction as to number.
2. The Medical and Pharmacy Boards have the power to and should issue regulations explicitly stating that providing sterile injection equipment to IDU patients in order to prevent transmission of a serious communicable disease is a medical practice. Me. Rev. Stat. Ann. tit. 32, §3269 (7) (Medical Licensure Board authority); Id. tit. 32, §13720 (Pharmacy Board authority).
3. The Pharmacy Board should require training in the theory and practice of harm reduction as part of mandated continuing education. Me. Rev. Stat. Ann. tit. 32, §13735. Similarly, the Board of Licensure in Medicine has the authority to create regulations requiring continuing education. Id. tit. 32, §3270-B. The Medical Board should take advantage of this position to require similar training procedures in its continuing education regimen.
B. Declaratory Judgment
A practitioner wishing to prescribe or dispense injection equipment could also consider bringing an action for a declaratory judgment. Me. Rev. Stat. Ann. tit. 14, §5951 et seq. An individual has standing to bring an action for declaratory judgment "only in cases where a genuine controversy exists." National Hearing Aid Ctrs., Inc. v. Smith, 376 A.2d 456, 458 (1977). Also, any request for declaratory judgment "must be ripe for judicial consideration and action." Wagner v. Secretary of State, 663 A.2d 564, 567 (1995). Furthermore, the action "requires the existence of a controversy so that the judgment rendered will not be advisory in effect." Chandler v. Dubey, 378 A.2d 1096, 1099 (1977). A declaratory judgment would thus probably be available to test the legality of prescribing and dispensing if, but only if, a practitioner intending to do so was exposed to a serious threat of prosecution.
C. Attorney General's Opinion
The governor, members of the legislature and the head of the state department or any of the state agencies, but not individual citizens, can request an opinion of the attorney general on questions of law. Me. Rev. Stat. Ann. tit. 5, §195.
1. U.S. Public Health Service & Infectious Diseases Society of America, Guidelines for the Prevention of Opportunistic Infections in Persons Infected with Human Immunodeficiency Virus, 48(RR10) MMWR 1 (1999); U.S. Public Health Service, HIV Prevention Bulletin: Medical Advice for Persons Who Inject Illicit Drugs (May 8, 1997); accord J. Normand, D. Vlahov, & L. Moses eds. Preventing HIV Transmission: The Role of Sterile Needles and Bleach (1995) (National Academy of Sciences); Statements/Resolutions/Policies on Increased Access to Clean Needles and Syringes (collected at http://www.sfaf.org/prevention/needleexchange/statements.html); T. Stephen Jones and David Vlahov, Use of Sterile Syringes and Aseptic Drug Preparation Are Important Components of HIV Prevention Among Injection Drug Users, 18 J Acquir. Immune Defic. Syndr. S1 (Supp. 1, 1998).
2. Peter Lurie, T. Stephen Jones & J. Foley J, A Sterile Syringe for Every Drug User Injection: How Many Injections Take Place Annually, and How Might Pharmacists Contribute to Syringe Distribution? 18 J Acquir. Immune Defic. Syndr. S45 (Supp. 1, 1998).
3. Id.; Scott Burris, Peter Lurie, Daniel Abrahamson, and Josiah Rich, Physician Prescribing of Safe Injection Equipment to Prevent HIV Infection: Time for Action, __ Annals of Internal Medicine __ (2000); T. Stephen Jones, Should Pharmacists Sell Sterile Syringes to Injection Drug Users? 39 J Am Pharm Assoc 1 (1999); Alvin Novick, A Duty to Care: Sterile Injection Equipment and Illicit-drug Use, 11 AIDS & Pub. Pol'y J. 63 (1996).
4. "Hypodermic apparatus" is defined within the chapter covering drugs as "hypodermic syringe, hypodermic needle or any instrument designed or adapted for the administration of any drug by injection." Me. Rev. Stat. Ann. tit. 17-A, §1101 (2).
5. Controlled substance prescription laws also commonly require that the prescription be for a "legitimate medical purpose." Courts in other jurisdictions have described a legitimate medicinal or therapeutic purpose as one that is "'recognized' or 'accepted'" by the medical profession. Hurwitz v. Board of Medicine, 1998 WL 972259, *1 (Va. Cir. Ct. 1998). Such acceptance or recognition must be shown by competent medical evidence. Id. One measure of legitimacy is whether a physician "render[s] proper medical care to his patients." Greenspan v. Osherhoff, 232 Va. 388, 398, 351 S.E.2d 28, 35 (1986). It is often said to be the burden of the prosecution to prove not simply that some physicians disagree with the practice at issue, but that "'no' responsible segment of the medical profession exists which accepts appellant's methods." See, e.g., Commonwealth v. Salameh, 421 Pa.Super. 320, 324, 617 A.2d 1314, 1316 (1992), appeal denied, 536 Pa. 641, 639 A.2d 26 (1994).(6)
6. In Pennsylvania, for example, courts have recognized that "'(i)n making a medical judgment concerning the right treatment for an individual patient, physicians require a certain latitude of available options.' ... Hence, '(w)hat constitutes bona fide medical practice must be determined upon consideration of evidence and attending circumstances.'" Commonwealth v. Possinger, 264 Pa.Super. 332, 339, 399 A.2d 1077, 1080 (citations omitted).