Temple University of the Commonwealth System of Higher Education
Beasley School of Law
Project on Harm Reduction in the Health Care System
Memorandum
Date: November 10, 1999
Subject: Prescribing and Dispensing Injection Equipment in Massachusetts
INTRODUCTION
Numerous medical organizations and even the federal government itself now recommend that injection drug users (IDUs) 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 Massachusetts law, of physician prescription and pharmacy sale of injection equipment to patients who are known to be injecting illegal drugs. It assumes that the ensuring of a patient's access to sterile injection equipment is clinically effective and conducive to public health, 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 IDUs as a health care intervention to prevent a patient acquiring or transmitting HIV.
This Memorandum addresses the following specific questions:
1) May a physician legally prescribe sterile injection equipment to an IDU patient?
2) May a pharmacist legally fill such a prescription?
3) How might Massachusetts law be changed or clarified to promote access to sterile injection equipment for IDUs through the health care system?
I. May a Physician Legally Prescribe Sterile Injection Equipment to an IDU Patient?
Answering this question requires a two-step analysis. We determine first whether prescription of sterile injection equipment is consistent with the general law governing medical practice. If so, we then ask whether any other law, such as a drug paraphernalia provision, prohibits prescription of syringes to an IDU patient. We begin with an overview of the regulatory environment.
A. The Regulatory Scheme
Medical Licensure Law
The practice of medicine in Massachusetts is governed by the Medical Practice Act, Mass. Gen. Laws ch. 112 § 2, et seq., with regulations found in title 243, Sections 1.00 through 2.10 of the Code of Massachusetts Regulations. The Board of Registration in Medicine is authorized to promulgate regulations. Mass. Gen. Laws ch. 112 § 2. "The board shall, after proper notice and hearing, adopt rules and regulations governing the practice of medicine in order to promote the public health, welfare, and safety and nothing in this section shall be construed to limit this general power of the board." Mass. Gen. Laws ch. 112 § 5.
Massachusetts medical licensure law is silent on the physician's general authority to write prescriptions for or dispense drugs and devices. Leaving aside any limitations imposed by other laws, a physician is free to prescribe any drug or device she believes will benefit the patient and the prescriptions of which is consistent with proper professional conduct. According to the Medical Practice Act, the Board also has the power to take disciplinary action against a physician and limit, revoke, or suspend a license upon finding that the physician:
(b) is guilty of an offense against any provision of the laws of the commonwealth relating to the practice of medicine, or any rule or regulation adopted thereunder;
(c) is guilty of conduct which places into question the physician's competence to practice medicine, including but not limited to gross misconduct in the practice of medicine or of practicing medicine fraudulently, or beyond its authorized scope, or with gross incompetence, or with gross negligence on a particular occasion or negligence on repeated occasions;
...
(f) is guilty of knowingly permitting, aiding or abetting an unlicensed person to perform activities requiring a license for purposes of fraud, deception or personal gain, excluding activities permissible under any provision of the law of the commonwealth relative to the training of medical providers in authorized health care institutions and facilities;
...
(h) is guilty of violating any rule or regulation of the board, governing the practice of medicine.
Mass. Gen. Laws ch. 112 § 5.
The Board of Registration in Medicine has issued regulations, but they do not govern the prescription and dispensing of drugs and controlled substances. The board does not add any disciplinary actions.
Controlled Substances Act Generally
The Massachusetts Controlled Substances Act, Mass. Gen. Laws ch. 94C § 1 et seq., states that "an ultimate user or research subject may lawfully possess or administer a controlled substance at the direction of a practitioner in the course of his professional practice." Mass. Gen. Laws ch. 94C § 7(d)(10). As under the medical licensure law, the term "controlled substance" does not include a device such as a syringe, so the prescribing rules set out below are relevant only by analogy if at all.
(a) A physician, ... in good faith and in the course of a professional practice for the alleviation of pain and suffering or for the treatment or alleviation of disease, may possess such controlled substances as may reasonably be required for the purpose of patient treatment and may administer controlled substances or may cause the same to be administered under his direction by a nurse.
Mass. Gen. Laws ch. 94C § 9. In addition,
(b) Notwithstanding the provisions of section seventeen [requiring a prescription in order to dispense controlled substances], a physician, ... when acting in good faith and in the practice of medicine, ... may dispense by delivering to an ultimate user, a controlled substance in a single dose or in such quantity as is, in the opinion of such physician, ... essential for the treatment of the patient; provided, however, that such amount or quantity of such controlled substance shall not exceed the amount needed for the immediate treatment(4) of the patient and that all such controlled substances required by the patient as part of such treatment shall be dispensed by prescription to such ultimate user in accordance with the provisions of this chapter.
Id. In addition, Section 18 states, "A prescription for a controlled substance may be issued only by a practitioner who is: (1) authorized to prescribe controlled substances; and (2) registered pursuant to the provisions of this chapter. Mass. Gen. Laws ch. 94C § 18.
Section 19 of Mass. Gen. Laws ch. 94C states that in order to be valid, a prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of his professional practice. In addition, "the responsibility for the proper prescribing and dispensing of controlled substances shall be upon the prescribing practitioner, but a corresponding responsibility shall rest with the pharmacist who fills the prescription." Mass. Gen. Laws ch. 94C § 19(a). "An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section one and the person knowingly filling such a purported prescription as well as the person issuing it, shall be subject to the penalties provided by section 32 et seq., as applicable." Id. Section 19(c) disallows a prescription issued to a drug dependent person for the purpose of continuing his dependence upon such drugs.
Within the Controlled Substances Act, Massachusetts has a provision dealing with needle exchange in the state. It allows syringes and needles to be distributed and if the individual program is approved by the department of public health.
(f) Notwithstanding any general or special law to the
contrary, needles and syringes may be distributed or possessed as part of a pilot program
approved by the department of public health in accordance with section two hundred and
fifteen of chapter one hundred and eleven (Pilot program for exchange of needles) and any
such distribution or exchange of said needles or syringes shall not be a crime.
The department of public health shall ensure that individuals participating in a pilot
needle exchange program will be encouraged to seek and will be placed in contact with
substance abuse treatment and health care.
Mass. Gen. Laws ch. 94C § 27.
Needle Exchange Law
Massachusetts has a separate needle exchange law in section 215 of chapter 111.
The department of public health is hereby authorized to promulgate rules and regulations for the implementation of not more than ten pilot programs for the exchange of needles in cities and towns within the commonwealth upon nomination by the department. Local approval shall be obtained prior to implementation of each pilot program in any city or town. Not later than one year after the implementation of each pilot program said department shall report the results of said program and any recommendations by filing the same with the joint legislative committees on health care and public safety.
Mass. Gen. Laws. ch. 111, § 215.
Syringe Prescription Law
The Controlled Substances Act includes specific provisions regulating sale, control/possession, and prescription of hypodermic syringes.
(a) No person, not being a physician, ... registered under
the laws of this commonwealth, or of the state where he resides, or a registered embalmer,
manufacturer of or dealer in embalming supplies, pharmacist, wholesale druggist,
manufacturing pharmacist, manufacturer of or dealer in surgical supplies, ... articles, or
a person who has received a prescription issued under subsection (c), ... shall
have in his possession a hypodermic syringe, hypodermic needle, or any instrument adapted
for the administration of controlled substances by injection.
(b) No such syringe, needle or instrument shall be delivered or sold to, or exchanged
with, any person except a pharmacist, ... , physician, ...or a person
who has received a written prescription issued under subsection (c) ...
(c) A physician may issue to a patient under his immediate charge a written prescription
to purchase, or may issue an oral prescription to a pharmacist on behalf of said patient
to purchase, from a pharmacist only, any of the instruments specified in subsection (a).
Such prescription shall contain the name and address of the patient, the description of
the instrument prescribed and the number of instruments prescribed. The pharmacist filling
the prescription shall record upon the face of said prescription, over the signature
of the pharmacist making the sale, the date of such sale. Such prescription may be renewed
or refilled for one year unless the physician indicates otherwise on the prescription, and
each refilling shall be noted upon the prescription. No prescription for such instruments
shall be refilled after one year from date of issue. The pharmacist filling the
prescription shall dispense any such instrument in a sanitary container which shall
completely enclose such instrument, and shall affix to said container a label bearing (1)
the name and address of the pharmacy, and if said pharmacy is in a hospital, the name and
address of said hospital, (2) the name and address of the patient, (3) the file number of
the prescription, and (4) the name of the physician prescribing the same. The person to
whom the prescription is issued shall keep such instrument in said container at all times,
except when such instrument is in actual use or is in the process of being cleaned.
(d) A record shall be kept by the person selling such syringes, needles or instruments,
which shall give the date of the sale, the name and address of the purchaser and a
description of the instrument. This record shall be open to inspection pursuant to a
judicial warrant or to the provisions of section thirty (administrative inspection of
controlled premises).
(e) No person except ... a pharmacist or wholesale druggist, which
pharmacist or wholesale druggist is licensed under the provisions of chapter one hundred
and twelve (Registration of Certain Professions and Occupations), shall sell, offer for
sale, deliver, or have in possession with intent to sell hypodermic syringes, hypodermic
needles or any instrument adapted for the administration of controlled substances by
injection, unless licensed so to do by the department. ... No person except a person
listed in subsections (b) or (c) shall obtain, receive or purchase a hypodermic syringe,
hypodermic needle or any instrument adapted for the administration of controlled
substances by injection, unless licensed so to do by the department, or by a local board
of health ...
Mass. Gen. Laws ch. 94C § 27. The penalty for violation of this act is defined in Mass. Gen. Laws ch. 94C § 38.
Any person who knowingly violates any provision of subsection (a) of section twenty-four, or of section twenty-five, twenty-six or twenty-seven shall be punished by imprisonment for not more than one year or by a fine of not more than one thousand dollars, or both. Whoever violates any of the provisions of any of said sections after one or more prior convictions of a violation of any provision of this chapter or of a provision of prior law relating to the sale or manufacture of narcotic drugs or harmful drugs as defined in said prior law shall be punished by imprisonment for not more than two years or by a fine of not more than two thousand dollars, or both.
Id.
Drug Paraphernalia Law
The Massachusetts Drug Paraphernalia Act, 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), is found in the Controlled Drug Act, specifically Mass. Gen. Laws ch. 94C § 32I. The act provides a tri-partite definition of "drug paraphernalia." First, it defines drug paraphernalia generally as "all equipment, products, devices and materials of any kind which are primarily intended or designed for use in ... injecting, ... or otherwise introducing into the human body a controlled substance in violation of this chapter. Mass. Gen. Laws ch. 94C § 1. Second, it lists twelve types of items as examples of drug paraphernalia, including " hypodermic syringes, needles and other objects used, primarily intended for use or designed for use in parenterally injected controlled substances into the human body." Id. Finally, it offers eleven factors to be considered when determining whether an item is drug paraphernalia.
(a) the proximity of the object, in time
and space, to a direct violation of this chapter;
(b) the proximity of the object to controlled substances;
(c) the existence of any residue of controlled substances on the object;
(d) instructions, oral or written, provided with the object concerning its use;
(e) descriptive materials accompanying the object which explain or
depict its use;
(f) national and local advertising concerning its use;
(g) the manner in which the object is displayed for sale;
(h) whether the owner, or anyone in control of the object, is a supplier of like or
related items to the community, such as a licensed distributor or dealer of tobacco
products;
(i) direct or circumstantial evidence of the ratio of sales of the object to the total
sales of the business enterprise;
(j) the existence and scope of legitimate uses for the object in the community;
(k) expert testimony concerning its use.
Id.
The law prohibits any person from selling, or possessing with purpose to use or sell, drug paraphernalia, if the person knows or reasonably should know that the equipment, product, or material will be used as drug paraphernalia. Mass. Gen. Laws ch. 94C § 32I. "Whoever violates any provision of this paragraph shall be punished by imprisonment in jail or house of correction for not less than one nor more than two years, or by a fine of not less than five hundred nor more than five thousand dollars, or both." Mass. Gen. Laws. ch. 94C § 32I. The law does not prohibit mere possession of drug paraphernalia.
B. Analysis
The first question is whether prescription of sterile injection equipment to IDUs is generally authorized under statutes governing medical practice. The syringe prescription law, Mass. Gen. Laws ch. 94C § 27 prohibits selling, furnishing, or giving hypodermics to any person other than a physician or pharmacist without a prescription. It explicitly authorizes prescription to a patient, requiring only that the patient be under the physician's "immediate charge."
Arguably, no further analysis is required. We assume, however, that the authority granted under the prescription statute would be construed to require that the prescription comport with general medical standards. Although Massachusetts law does not set out explicit standards for prescribing generally, the law and regulations governing the prescription of controlled substances set out the standard that would almost certainly be borrowed by courts in a syringe prescription case. Under this standard, a prescription is valid if it is issued for a legitimate medical purpose by a practitioner acting in the usual course of his professional practice. Mass. Gen. Laws. ch. 94C § 19(a). (A similar standard is used throughout the country.) A prescription for sterile injection equipment, issued to a patient who cannot or will not enter drug treatment, for the purpose of preventing the transmission of a serious communicable disease during injection, would seem to be well within the parameters of allowable discretion set by this standard.
No cases in Massachusetts have assessed the legality of a syringe prescription, let alone one to an IDU. There are no reported cases of a physician being prosecuted for misprescribing controlled substances, other than instances of drug pushing. 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 State v. Young, 406 S.E.2d 758, 771 (W.Va. 1991) (prescription written on street to patient who had not been properly examined was not in course of professional practice). 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 physical 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."). To prove that the physician is acting outside the usual course of professional practice,
it must be shown that the registered practitioner's malpractice was intentional, that is,
his or her state of mind was such that he or she was not intending to treat the "patient's" underlying condition, but, instead, was intending merely to satisfy the desire of the "patient" for the controlled substance.
Young, 406 S.E.2d at 770-71 (citations omitted). 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 prong of the test.
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).(5) Unanimity of medical opinion is not required. See, e.g., Glover v. Board of Medical Quality Assurance, 231 Cal.App.3d 203, 282 Cal.Rptr. 137 (1991). See generally S.E. Stone, The Investigation and Prosecution of Professional Practice Cases under the Controlled Substances Act: Introduction to Professional Practice Case Law. 21 Drug Enforcement 23 (1983). There is ample support for the position that prescribing sterile injection equipment comports with treatment principles accepted by a responsible segment of the medical profession. See Zita Lazzarini, Ethical Issues in Prescribing and Dispensing Syringes to Injection Drug Users, and Josiah Rich, Syringe Prescription in Rhode Island: A Case Study. Given this medical evidence, it would also be difficult to argue that providing sterile injection equipment falls beneath the minimal standards of professional practice set forth in the laws governing the practice of medicine.
Conclusion: A prescription for sterile injection equipment to an IDU patient is consistent with the standard for a valid prescription under Massachusetts laws governing the physician's authority to prescribe.
We turn now to the second question: Do any other laws prohibit physicians from prescribing sterile injection equipment to IDU patients?
The main possibility is the drug paraphernalia law. As we will discuss further in the pharmacy analysis below, we have concluded that the syringe prescription law, rather than the drug paraphernalia law, governs prescribed syringes. For purposes of this portion of the analysis, however, we will assume that syringes are covered by the general provisions of the drug paraphernalia law.
The law prohibits any person from knowingly using or selling, or possessing with purpose to use or sell, drug paraphernalia, if the person knows or reasonably should know that the equipment, product, or material will be used as drug paraphernalia. Mass. Gen. Laws ch. 94C § 32I. This memorandum has already concluded that syringe prescription is authorized within the laws governing medical practice and prescription generally (indeed, if it were not, this provision would prohibit possession or distribution of needles for any purpose). Even if syringe prescription were not authorized by law, a physician who writes a prescription does not "sell" a syringe to the patient. In the absence of a special definition in the statute, these words are given their ordinary meaning, which does not embrace facilitating the later purchase of a syringe by writing a prescription. (6)
Conclusion: Writing a prescription for a syringe does not violate any Massachusetts law. A physician may therefore legally prescribe injection equipment to an IDU patient.
II. Does Dispensing a Needle by a Pharmacist to an IDU Based on a Physician's Prescription Violate Massachusetts' Drug Paraphernalia or Syringe Prescription Laws?
A. The Regulatory Scheme
Medical Licensure Law
The practice of pharmacy in Massachusetts is governed by the Pharmacy Act, Mass. Gen. Laws ch. 112 § 24, with regulations found in title 247, Sections 1.00 through 11.15, and title 105, Sections 722.001 through 722.100 the Code of Massachusetts Regulations. The Act vests in the State Board of Registration in Pharmacy power to adopt such rules and regulations pursuant to this chapter. Mass. Gen. Laws ch. 112 § 30.
Pharmacists are governed by the hypodermic prescription provision, Mass. Gen. Laws ch. 94C § 27, described above. No other provisions of pharmacy law or regulations explicitly address syringes.
The Pharmacy regulations contain a code of professional conduct for pharmacists:
(1) A registered pharmacists shall at all times conduct professional activities in conformity with federal, state and municipal laws, ordinances, and/or regulations of the Board.
(2) A pharmacist shall not dispense drugs, devices, or other substances in a manner which is intended, either directly or indirectly, to circumvent the law.
(3) A pharmacist shall observe the standards of the current United States Pharmacopoeia...
(5) While on duty, a pharmacist shall be responsible for the proper preservation and security of all drugs in the pharmacy or pharmacy department, including the proper refrigeration and storage of said drugs.
(6) A pharmacist shall not engage in any fraudulent or deceptive act.
...
(9) A pharmacist shall not in any way aid or abet the unlawful practice of pharmacy
...
(13) A pharmacist, pharmacy, pharmacy department, pharmaceutical organization or pharmacy corporation shall not provide any practitioner with prescription blanks which refer to any pharmacist, pharmacy or pharmacy department.
...
Mass. Regs. Code tit. 247, § 9.01.
A pharmacist is authorized to dispense medications ordered by a valid prescription, and is ordinarily expected to do so in the absence of a good reason to refuse. Strauss S. The Pharmacist and the Law. Baltimore MD: Williams & Wilkins, 1980:29-31; Steven W. Huang, The Omnibus Reconciliation Act of 1990: Redefining Pharmacists' Legal Responsibilities, XXIV Am. J. L & Med. 417 (1998).
Controlled Substance and Drug Paraphernalia Laws
The controlled substance and paraphernalia laws discussed in I.A. above are also applicable to pharmacists. The Controlled Substance Act makes it clear that a pharmacist has an independent responsibility to ensure that controlled drugs are properly prescribed. "The responsibility for the proper prescribing and dispensing of controlled substances shall be upon the prescribing practitioner, but a corresponding responsibility shall rest with the pharmacist who fills the prescription." Mass. Gen. Laws ch. 94C § 19(a).
B. Analysis
We have concluded above that a physician's prescription for sterile injection equipment, written under the factual conditions assumed for purposes of this Memorandum, is valid under Massachusetts law. The syringe prescription statute does not set any additional substantive standards for a syringe prescription, but rather simply requires a prescription as a condition of sale. Ordinarily, the pharmacist is required to fill a valid prescription. The next question is whether filling the prescription would be prohibited under any other provision of law.
The main possibility is the paraphernalia law. The pharmacist is undoubtedly transferring the syringe, so if a syringe is drug paraphernalia in this situation, then the transfer is illegal. Whether something is drug paraphernalia depends, in narrowest terms, upon whether the seller knows or has reason to know that it will be used for illegal drug use. Mass. Gen. Laws ch. 94C § 32I. In all cases in which the pharmacist does not in fact know or have reason to know that the patient intends to use the syringe to inject illegal drugs, the pharmacist does not violate the paraphernalia law even if in fact the item will be used for drug abuse. Com. v. Jasmin, 487 N.E.2d 1383, 396 Mass. 653 (1986). Compliance with the rules on dispensing injection equipment, and reliance on the physician's prescriptions, would not be legally decisive in a paraphernalia prosecution, but would likely provide strong support for the claim that the pharmacist was not acting with the intent required to violate the paraphernalia law.
Conclusion: Dispensing sterile injection equipment to an IDU does not violate Massachusetts law where the pharmacist does not and reasonably should not know the patient is not authorized to possess a hypodermic.
Many pharmacists will have occasion to learn or reasonably suspect that a patient presenting a valid syringe prescription is an IDU likely to use the syringes for illegal drug injection. The analysis of this situation begins with the Controlled Substances Act, and more specifically with the proper interpretation of two overlapping, and potentially conflicting, provisions: the syringe prescription law and the drug paraphernalia law. Syringe prescription to IDU patients raises the possibility that an act that is legal under one part of the statute is a crime under another. This presents a classic problem of statutory construction.
The syringe law, by its plain terms, authorizes physicians to prescribe needles for any purpose. It is reasonable to assume that the legislature did not intend thereby to free physicians from their general obligations to meet professional standards in prescribing or dispensing syringes, but, as we have shown above, syringe prescription for the purpose of preventing bloodborne disease in IDU patients meets the basic standard commonly used to assess the legality of a prescription. The paraphernalia law, by its plain terms, does not prohibit a physician prescribing a needle to an IDU patient.
The conflict between the two statutes arises when the patient presents the prescription to the pharmacist. The hypodermic possession and sale statute authorizes the patient to purchase and the pharmacist to sell a needle upon presentation of the prescription (or its oral receipt), so long as the pharmacist complies with various record-keeping and packaging rules. The paraphernalia law does not prohibit the patient from buying or subsequently possessing the needle, because it only prohibits possession with the intent to sell. Likewise, the paraphernalia law would not prohibit the pharmacist from giving the patient the needle at no cost. If it applies, however, the paraphernalia law would prohibit the pharmacist from selling the needle if the pharmacist knew or should have known that the buyer intended to use the syringe for illegal drug use. Construing the paraphernalia law to apply to syringe prescriptions thus produces the absurd result that a physician may legally prescribe, a patient legally possess, and a pharmacist legally deliver a syringe for the purpose of preventing disease transmission during drug use, as long as the pharmacist does not charge for the item, but that selling the syringe is a crime.
Both the general canons of construction, and a concern for fulfilling the intent of the legislature, compel the conclusion that the prescription statute alone governs provision of syringes in the health care system. In Massachusetts, the object of all interpretation and construction of laws is to ascertain and effectuate the intent of the legislature. A faithful effort to determine legislative intent should be guided by both the language of the statute and the expressed purposes of the lawmakers who wrote it. See, e.g., Commissioner of Revenue v. Dupee, 423 Mass. 617, 620, 670 N.E.2d 173 (1996); Industrial Fin. Corp. v. State Tax Comm'n, 367 Mass. 360, 364, 326 N.E.2d 1 (1975). A court is "is obliged to give ambiguous, imprecise, or faultily drafted statutes a 'reasonable construction,' with the primary goal of construing the statute to carry out the legislative intent....' Our objective is to confer upon the statute as a whole an internal consistency." Bartlett v. Greyhound Real Estate Fin. Co., 41 Mass.App.Ct. 282, 286, 669 N.E.2d 792 (1996) (internal citations omitted). Whenever a more specific provision of a statute seems to conflict with a more general one, or two related statutes are in apparent conflict, court should try to "construe them so as to constitute an harmonious whole, consistent with the legislative purpose." Independence Park, Inc. v. Board of Health of Barnstable, 403 Mass. 477, 480, 530 N.E.2d 1235 (1988); Atkinson v. Ipswich, 34 Mass.App.Ct. 663, 615 N.E.2d 200 (1993). Where a conflict cannot be reconciled, the specific, rather than the general one, ordinarily applies, particularly where the specific one is more recent. See Torres v. Fidelity & Guar. Life Ins. Co., 34 Mass.App.Ct. 376, 378, 611 N.E.2d 733 (1993); 2B Singer, Sutherland Statutory Construction § 51.02, at 121 (5th ed. 1992). There is a clear conflict between the paraphernalia and syringe statutes, a conflict that is properly resolved by applying the more specific hypodermic possession and sale law to health care professionals fighting disease.
The hypodermic possession and sale law is the more specific provision. It focuses exclusively upon hypodermic syringes and needles, while the paraphernalia law applies to "all equipment, products, devices and materials of any kind which are primarily intended or designed for use in planting, propagating, cultivating, growing, harvesting, manufacturing, compounding, converting, producing, processing, preparing, testing, analyzing, packaging, repackaging, storing, containing, concealing, injecting, ingesting, inhaling or otherwise introducing into the human body a controlled substance in violation of this chapter." Mass. Gen. Laws ch. 94C § 1. The hypodermic possession and sale statute sets out a complete regulatory scheme, specifying authorized users and possessors throughout the stream of commerce, and addressing the full range of allowable syringe uses, down to their use and possession for purposes of capital punishment. (7) The paraphernalia law applies only to manufacturing or possessing paraphernalia with an intent to sell for illegal drug use. The hypodermic possession and sale provision addresses itself specifically to health care professionals prescribing and dispensing syringes in the course of medical treatment. The paraphernalia law addresses the broad problem of commercial trade in the accouterments of drug use.
These differences reflect very different legislative intentions. While both statutes are generally concerned with reducing illegal drug use by restricting access to drug use equipment, both their specific targets and their approach are quite different. The hypodermic possession and sale law is a carefully wrought regulatory scheme first put in place in 1917 and amended 13 times since, most recently in 1993 when the legislature allowed oral prescriptions and added section (f) on needle exchange programs. It deliberately makes physicians the gate-keepers to needles being used within the health care system, and gives them broad discretion to determine when syringe use is medically important. The drug paraphernalia law was passed in 1981, as part of a national trend, led by the federal government, to eliminate what had become an enormous retail trade in the equipment necessary to use illegal drugs. See generally Lawrence O. Gostin, Zita Lazzarini. Prevention of HIV/AIDS Among Injection Drug Users: The Theory and Science of Public Health and Criminal Justice Approaches to Disease Prevention, 46 Emory L.J. 587 (1997). (describing origins of drug paraphernalia statutes). By 1976, between fifteen and thirty thousand "head shops" did an annual three billion dollar business in such items as rolling papers, bongs and freebasing kits. Gostin & Lazzarini, supra, at 611-12 (reviewing Congressional investigation of paraphernalia problem). Massachusetts followed the national trend and enacted legislation that incorporated the Model Drug Paraphernalia Act's definition (including its mention of syringes). The act was clearly aimed at the commercial head shop trade. There is no indication that the legislature intended to introduce a new layer of regulation to medical practitioners or pharmacists by limiting their discretion to provide medical devices necessary for the care or prevention of disease in the usual course of their professional practices. It has been amended only once, in 1987, when the legislature added a section dealing with warning notices in shops selling tobacco rolling papers. When the legislature inserted a provision authorizing certain needle exchanges, it placed the provision in the hypodermic possession and sale law, not the drug paraphernalia law.(8)
Prosecution practices provide further support to the interpretation advanced in this memo. "Where the language of a statute is of doubtful import, the contemporaneous construction put upon it by officers thereby charged with performance of public duties is strong evidence of its meaning. The understanding and application of statutory words susceptible of different meanings, through years of practice, and sanctioned by the acquiescence of the Legislature, is significant of the intention with which they were employed originally. Packard v. Richardson, 17 Mass. 122, 144, 9 Am. Dec. 123; Brown v. U. S., 113 U. S. 568, 571, 5 Sup. Ct. 648, 28 L. Ed. 1079, and cases cited; In re Washington Street Asylum & Park R. R. Co., 115 N. Y. 444, 447, 22 N. E. 356. See, also, cases collected in Bates & Guild Co. v. Payne, 194 U. S. 106, 111, 24 Sup. Ct. 595, 48 L. Ed. 894." Burrage v. Bristol County, 210 Mass. 299, 96 N.E. 719 (1911). There have been no reported cases of prosecutions for the sale of needles under the paraphernalia statute. The only reported prosecution for a needle-related offense was Commonwealth v. Leno,415 Mass. 835, 616 N.E.2d 453 (1993), in which a group of needle exchange providers were charged with violating the hypodermic possession and sale law.
Finally, the rule of lenity would also support the view that the paraphernalia law does not apply to pharmacy sales by prescription. It is a basic principle of state law "that criminal statutes are to be strictly construed against the Commonwealth and in favor of the defendant." Commonwealth v. Valchuis, 40 Mass.App.Ct. 556, 558, 665 N.E.2d 1030 (1996) (internal citations omitted); Commonwealth v. Kerr, 409 Mass. 284, 286, 565 N.E.2d 1201 (1991) (any "reasonable doubt" as to a statute's meaning must be resolved in criminal defendant's favor). The rationale for the rule is the injustice of convicting a person without clear notice to him that his contemplated conduct is unlawful, as well as notice of the penalties. See, e.g., Com. v. Broughton, 390 A.2d 1282, 257 Pa.Super. 369 (1978). Given the obvious ambiguity in the proper interpretation of the paraphernalia and prescription provisions, lenity requires a court to hold that a practitioner acting legally under the latter provision cannot be charged with violating the latter, whose applicability to health care activities is questionable at best.
Conclusion: Dispensing sterile injection equipment by prescription to known IDUs probably does not violate Massachusetts law.
III. How Might Massachusetts 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 paraphernalia statutes to legalize the over-the-counter sale of injection equipment under all circumstances. It should remove the record-keeping requirements that can deter IDUs from buying syringes.
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 an acceptable medical/pharmacy practice. Mass. Gen. Laws ch. 112 § 5 (Medical), Mass. Gen. Laws ch. 112 § 30 (Pharmacy).
3. The Pharmacy Board should require training in the theory and practice of harm reduction as part of mandated continuing education. Mass. Gen. Laws ch. 112 § 24A (Pharmacy).
B. Declaratory Judgment
Declaratory judgments are available to people whose contemplated conduct could subject them to criminal prosecution. The applicable statute is Mass. Gen. Laws ch. 231A et seq. A brief review of the case law indicates that an "actual controversy is essential to the granting of declaratory relief, and the mere assertion of possibilities does not present a dispute between the parties." District Attorney for Hampden Dist. v. Grucci 427 N.E.2d 743, 384 Mass. 525 (1981). An "actual controversy" is a real dispute caused by assertion by one party of a legal relation, status or right in which he has a definite interest and denial of such assertion by another party also having a definite interest in subject matter where circumstances attending dispute plainly indicate that unless matter is adjusted such antagonistic claims will almost immediately and inevitably lead to litigation. Bunker Hill Distributing, Inc. v. District Attorney for Suffolk County, 379 N.E.2d 1095, 376 Mass. 142 (1978); District Attorney for Suffolk Dist. v. Watson, 411 N.E.2d 1274, 381 Mass. 648 (1980). Questions of statutory interpretation, by themselves, do not rise to level of "actual controversy." Woods Hole v. Martha's Vineyard Commission, 405 N.E.2d 961, 380 Mass. 785 (1980). A declaratory judgment would thus probably be available to test the legality of prescribing and dispensing if and when a practitioner was exposed to a serious threat of prosecution.
C. Attorney General's Opinion
The Attorney General shall give his opinion upon questions of law submitted to him by the governor and council or by either branch of the general court. Mass. Gen. Laws ch. 12, § 9.
D. Consultation with Local Law Enforcement Officials
In an environment of legal uncertainty, a reasonable interpretation of the law supporting the legality of pharmacy sales to known IDUs by prescription may be enough to allow action. In any given community, direct contact with health and law enforcement officials may establish that they do not believe the practice to be illegal, or are not interested in prosecuting pharmacists. Many needle exchange programs operate successfully for long periods under such informal dispensations. See Scott Burris, Heather Gallagher, Joseph Grace and David Finucane, The Legal Strategies Used in Operating Syringe Exchange in the United States, 86 Am. J. Pub. Health 1161 (1996).
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. Atlanta, GA and Rockville, MD: U.S. Public Health Service, 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, 11AIDS & Pub. Pol'y J. 63 (1996).
For the purposes of this section the words "immediate treatment" shall mean the quantity of a controlled substance which is necessary for the proper treatment of the patient until it is possible for him to have a prescription filled by a pharmacy.
5. 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).
6. It should be noted that courts interpreting controlled substances laws have sometimes interpreted terms like "sell," "dispense," "furnish" or "distribute" to embrace the writing of a prescription for a controlled substance. See, e.g., Jin Fuey Moy v. United States, 254 U.S. 189, 41 S.Ct. 98, 65 L.Ed. 214 (1920); United States v. Thompson, 624 F.2d 740 (C.A.5, 1980); Commonwealth v. Comins, 371 Mass. 222, 356 N.E.2d 241 (1976), certiorari denied (1977), 430 U.S. 946, 97 S.Ct. 1582, 51 L.Ed.2d 793; State v. Moody, 393 So.2d 1212 (La. 1981). See generally Christopher Vaeth, State Law Criminal Liability of Licensed Physician for Prescribing or Dispensing Drug or Similar Controlled Substance, 13 A.L.R.5th 1, 73-84 (1993). Massachusetts decisions have interpreted the term "dispense" to include prescribing. See Commonwealth v Comins, 371 Mass. 222, 356 N.E.2d 241, cert. denied, 430 U.S. 946 (1976).
Although a physician who prescribes a syringe does sell a needle to the patient, and therefore could not be said to engage in conduct potentially covered by the paraphernalia statute, there is a risk that prescribing a syringe could be prosecuted as aiding and abetting a violation of the paraphernalia statute that would occur when the pharmacist sold the syringe, or for conspiracy to violate the paraphernalia statute. These charges are available to a motivated prosecutor. The risk to the physician is slight, however, for several reasons. Such a prosecution would be unusual: there is no reported case in Massachusetts of a charge of aiding and abetting a paraphernalia violation, nor are either conspiracy or accomplice charges commonly deployed where the core offense is so minor an offense. More importantly, both crimes depend upon the underlying illegality of providing sterile injection equipment by prescription. Our analysis suggests that this behavior is not a crime. With a valid prescription, a patient is not violating the paraphernalia law when he purchases the needle, and the physician, or pharmacist, cannot be his accomplice or co-conspirator.
7. The prescription statute authorizes possession by "a person authorized to administer a sentence of death imposed under the provisions of chapter two hundred and seventy-nine while in the performance of his lawful duties thereunder." Mass. Gen. Laws ch. 94C § 27(b).
8. The focus on head shops is evident in the factors provided to guide the judicial determination of whether an item is paraphernalia. Mass. Gen. Laws. ch. 94C § 1. These plainly apply to commercial enterprises depending on illicit drug use for their business. The fact that a pharmacist is a legitimate supplier of legal syringes to the community (factor j), derives only a small fraction of sales from syringes (factor k) and that syringes have legitimate uses in the community quite apart from the legitimate purpose of preventing disease transmission (factor l) all support a finding that syringes provided for legitimate medical purposes are not "drug paraphernalia" under the statute. Further support would come from expert testimony (factor m). A contrary interpretation would, moreover, lead to absurd results. For example, a pharmacist who sells needles to a diabetic knowing that he is a drug user who will probably use some of the needles for heroin as well as insulin would be violating the law were it construed to apply to health care providers in this way.
There is precedent to support this interpretation. In Spokane Health District v. Brockett, 120 Wash. 2d 140, 839 P.2d 324 (1992), the Supreme Court of Washington was faced with the question of whether needle exchange programs operated by health authorities under their general powers were prohibited by the Washington drug paraphernalia statute. The Court wrote:
It is undisputed the needles at issue in this case are "drug paraphernalia". Those distributing the needles know they will be used to inject controlled substances unlawfully. Nevertheless, plaintiffs argue, the needle exchange program is authorized under the Washington Constitution, statutes granting broad powers to local health officials, and the omnibus AIDS act. Therefore, they conclude, the drug paraphernalia act, which is aimed at criminal conduct, simply does not apply to their actions. We agree, finding the SCHD's needle exchange program permissible under the constitution and statutes of this state.
120 Wash.2d 140, 147, 839 P.2d 324, 327-28. Like the health officials in Brockett, physicians and pharmacists in Massachusetts are given discretion by statute to practice their professions, and, more specifically, to prescribe and dispense injection equipment. Cf. Leno, supra (distinguishing Brockett in needle exchange case on ground that lay exchangers had no statutory basis for acting). The law that controls their decisions about prescribing or dispensing medication are the professional practice and controlled substances laws, not a paraphernalia law aimed at commercial drug businesses. Indeed, were the drug paraphernalia law to apply to legitimate disease prevention activities, it would be illegal to even provide IDUs with bleach for sterilizing needles or alcohol pads for disinfecting an injection site, Brockett, 120 Wash.2d 140, 148, 839 P.2d 324, 328, yet these are universally accepted measures.