Temple University of the Commonwealth System of Higher Education
Beasley School of Law
Project on Harm Reduction in the Health Care System
Memorandum
Date: December 2, 1999
Subject: Prescribing and Dispensing Injection Equipment in Wisconsin
INTRODUCTION
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 Wisconsin 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, 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.
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 Wisconsin 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 Practice Law
The practice of medicine in Wisconsin is governed by the chapter titled "Medical Practices," Wis. Stat. Ann. §448.01 et seq., with regulations found in sections Med 1.01 et seq. through Med 21.01 et seq. of the Wisconsin Administrative Code. The Act vests in the Medical Examination Board the power to adopt such regulations as are necessary to carry out the purposes of the chapter, including authority to promulgate regulations defining the "standards of practice" that all practitioners must meet or suffer disciplinary action from the Board. Wis. Stat. Ann. §448.40(1).(4)
Wisconsin medical licensure law is silent on the physician's general authority to write prescriptions for or dispense drugs and devices. Although the Board has a chapter of regulations titled "Standards for Dispensing And Prescribing Drugs," the chapter refers only to procedural, not substantive, issues, and does not address the prescription of devices such as a syringe. Wis. Admin. Code § Med 17.01 et seq.. 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 prescription of which is consistent with the accepted standard of care.(5)
Grounds for discipline by the Board includes "unprofessional conduct." Wis. Stat. Ann. §448.06(2). The statutes governing physicians state that:. . .
(4) "Unprofessional conduct" means those acts or attempted acts of commission or omission defined as unprofessional conduct by the board under the authority delegated to the board by s. 15.08 (5) (b) and any act by a physician, physician assistant in violation of ch. 450 [Pharmacy Act] or 961 [Controlled Substances Act].
Wis. Stat. Ann. §448.015. One of the Board's regulations gives a more detailed definition.
(2) The term "unprofessional conduct" is defined to mean and include but not be limited to the following, or aiding or abetting the same:
(a) Violating or attempting to violate any provision or term of ch. 448, Stats., or of any valid rule of the board.
. . .
(h) Any practice or conduct which tends to constitute a danger to the health, welfare, or safety of patient or public.
. . .
(p) Administering, dispensing, prescribing, supplying, or obtaining controlled substances as defined in s. 961.01 (4), Stats., otherwise than in the course of legitimate professional practice, or as otherwise prohibited by law.
. . .
(r) Conviction of any crime which may relate to practice under any license, or of violation of any federal or state law regulating the possession, distribution, or use of controlled substances as defined in s. 961.01 (4), Stats. . . .
Wis. Admin. Code § Med 10.02.
Conviction of a felony violation of the Controlled Substances Act is a separate ground for automatic suspension of a practitioner's medical license. Wis. Admin. Code § MED 10.02(2)(r).
The Pharmacy Board, pursuant to the authority granted them by the Pharmacy Act, has promulgated some prescription standards.
(1) Prescription orders for controlled substances shall be issued for a legitimate medical purpose by individual practitioners acting in the usual course of professional practice. . . . An order purporting to be a prescription order not issued in the usual course of professional treatment or in legitimate and authorized research is not a prescription order within the meaning and intent of ss. 450.01 (21) and 961.38, Stats. The person knowingly dispensing pursuant to such a purported order, as well as the person issuing it, shall be subject to the penalties provided for violation of the provision of law relating to controlled substances.
(2) A prescription order issued by a practitioner to obtain controlled substances for the purpose of general dispensing or administration to patients by the practitioner is not valid.
Wis. Admin. Code §Phar 8.04. Thus a practitioner may only issue prescriptions for a legitimate medical purpose in the usual course of legitimate professional practice.
Controlled Substances Law Generally
Prescribing powers are defined with respect to controlled substances in the Wisconsin Uniform Controlled Substance Act ["the Controlled Substances Act"]: . .
(4) A substance included in schedule V may be distributed or dispensed only for a medical purpose, including medical treatment or authorized research.
(4g) A practitioner may dispense or deliver a controlled substance to or for an individual or animal only for medical treatment or authorized research in the ordinary course of that practitioner's profession.
(4r) A pharmacist is immune from any civil or criminal liability and from discipline under s. 450.10 for any act taken by the pharmacist in reliance on a reasonable belief that an order purporting to be a prescription was issued by a practitioner in the usual course of professional treatment or in authorized research.
Wis. Stat. Ann. §961.38. Further,
The dispensing of schedule V substances is subject to the following conditions:
(1) That they be dispensed and sold in good faith as a medicine, and not for the purpose of evading this chapter.
Wis. Stat. Ann. §961.23. Thus, practitioners are required to dispense controlled substances in good faith, only for a medical purpose in the ordinary course of practice. The statute also states that a prescription is required for the dispensation of controlled substances. Wis. Stat. Ann. §961.38. No further substantive restrictions are stated for prescriptions written by a physician.
Drug Paraphernalia Law
The Controlled Substances Act includes a drug paraphernalia provision, Wis. Stat. Ann. §§961.571 through 961.575, 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). 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 specifically states:
(b) "Drug paraphernalia" excludes:
1. Hypodermic syringes, needles and other objects used or intended for use in parenterally injecting substances into the human body.
2. Any items, including pipes, papers and accessories, that are designed for use or primarily intended for use with tobacco products.
Wis. Stat. Ann. §961.571(1).
The state Supreme Court has interpreted the exemption section of the paraphernalia definition as it applies to items designed for use with tobacco products. In overturning a paraphernalia conviction invoilvoing a tobacco pipe that contained residue of an illegal controlled substance, the court ruled that the plain language of the exemption was controlling, in spite of the fact that the pipe would fit the definition of paraphernalia in its absence.
The State contends that construing the statute to exclude a tobacco pipe that contains residue of a controlled substance produces an unreasonable result and is contrary to the intent of the legislature. See State v. Mattes, 175 Wis.2d 572, 578, 499 N.W.2d 711, 713 (Ct.App.1993) (statutes should be construed to avoid absurd or unreasonable results). The stated purpose of ch. 161, Stats., is to deter drug trafficking and prevent a serious threat to the public health and safety. However, we must assume the legislature chose the language of S 161.571(1)(b)2, Stats., with a purpose. We may not second-guess the legislature by rewriting the plain language of a statute. This is true even where, as the State argues here, the plain language leads to a result seemingly at odds with the general purpose of the statute.
State v. Martinez, 210 Wis.2d 396, 404-405, 563 N.W.2d 922, 926(1997)(citations omitted).
B. Analysis
The Medical Practice Act and the Controlled Substances Act judge the validity of a prescription by essentially the same standard: it is valid if it is written (1) in good faith, (2) in the usual course of professional practice, and (3) accords with treatment principles accepted by a responsible segment of the medical profession. This standard is consistent with the standard used across the nation under the Uniform Controlled Substances Act, and we expect it, or a substantially similar standard, would be used by courts in a syringe prescription case. 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.
Wisconsin courts have asserted that these three requirements are clear and readily understandable to practitioners. Galang v. State Medical Examining Bd., 119 Wis.2d 168, 193-194, 349 N.W.2d 68, 79(1992). ("Accordingly, we hold that the standard utilized by the legislature . . .provides a standard for revocation sufficiently definite so that physicians should have no difficulty providing a standard of care which meets the requirement of professional conduct.") Wisconsin cases, none of which involve situations comparable to those at issue here, offer scant insight. In other jurisdictions, the normal usage of "good faith" entails a genuine concern for the well-being of the patient and others who might be infected through sharing injection equipment with the patient, and conduct devoid of malice or deception. See, e.g., Commonwealth v. Larsen, 452 Pa.Super. 508, 682 A.2d 783 (1996).(6)
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." ... [H]e 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 number of tablets desired. In practical effect, he acted as a large-scale "pusher" not as a 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 be acting within the usual course of practice.
On the third prong, it is 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.
We find this situation [of unprofessional conduct] to be analogous with negligence law. It is not the evidence that other physicians might have utilized a different treatment or procedure that proves negligence, but that 'reasonable care and skill usually possessed by physicians of the same school' was not exercised. Similarly, [the medical expert testifying] may not simply indicate that he would have utilized different measures. Rather, Janssen's testimony must unequivocally indicate that a minimally competent physician would have chosen a different course of treatment which would have avoided or minimized the unacceptable risks which the absence of a visual assessment entailed.
Gilbert v. State, Medical Examining Bd., 119 Wis.2d 168, 197, 349 N.W.2d 68, 81(1984)(citation omitted).(7)
In other states, case law suggests looking to whether or not other physicians would regard the practice as legitimate. See, e.g., Commonwealth v. Possinger, 264 Pa.Super. 332, 339, 399 A.2d 1077, 1081 (1979); cf. Greenspan v. Osherhoff, 232 Va. 388, 398, 351 S.E.2d 28, 35 (1986) (One measure of legitimacy is whether a physician "render[s] proper medical care to his patients."). 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); Commonwealth v. Salameh, 421 Pa.Super. 320, 324, 617 A.2d 1314, 1316 (1992) (prosecution must 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 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. 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 the medical practice law and the prescription provision of the Controlled Substances Act.
We turn now to the second question: Do any other laws prohibit physicians from prescribing sterile injection equipment to IDU patients?
In most states, the drug paraphernalia law is the only possible source of prohibition, because hypodermic needles and syringes are commonly explicitly included in the definition adapted from the model act. Wisconsin, which passed its paraphernalia law in 1989, after the connection between HIV and dirty needles had become clear, has decided to specifically exclude hypodermic syringes from the roster. No other law prohibits prescription of sterile injection equipment for the purpose of preventing disease.
Conclusion: Writing a prescription for a syringe does not violate any Wisconsin law. A physician may therefore legally prescribe injection equipment to an IDU patient.
II. May a Pharmacist Legally Fill a Such a Prescription?
A. The Regulatory Environment
Pharmacy Licensure Law
The practice of pharmacy in Wisconsin is governed by the Pharmacy Act, Wis. Stat. Ann. §§450.01- 450.18, with regulations found in Wis. Admin. Code §§ Phar 1.01 et seq. The statutes vests in the Pharmacy Examining Board power to adopt such regulations as are reasonably necessary to carry out the purposes of that statutes. Wis. Stat. Ann. §450.02.
The Pharmacy Examining Board has promulgated regulations setting out basic standards of pharmacy practice. The disciplinary provisions of the pharmacists act authorize the Pharmacy Examining Board to invoke discipline due to unprofessional conduct which includes, but is not limited to:
. . .
2. Violating this chapter or, subject to s. 961.38(4r), ch. 961 [the Uniform Controlled Substances Act] or any federal or state statute or rule which substantially relates to the practice of the licensee.
. . .
8. Violating any order of the board.
Wis. Stat. Ann. §450.10 (1)(a). Unprofessional conduct is clarified further within the regulations:
The following, without limitation because of enumeration, are violations of standards of professional conduct and constitute unprofessional conduct in addition to those grounds specified under s. 450.10 (1), Stats.:
(1) Administering, dispensing, supplying or obtaining a drug other than in legitimate practice, or as prohibited by law;
(2) Engaging in any pharmacy practice which constitutes a danger to the health, welfare, or safety of patient or public, including but not limited to, practicing in a manner which substantially departs from the standard of care ordinarily exercised by a pharmacist which harmed or could have harmed a patient;
Wis. Admin. Code § Phar 10.03.
Like the Board of Medical Examiners, the Pharmacy Examining Board has the authority to punish licensees for unprofessional conduct by reprimanding the licensee or denying, revoking, suspending or limiting the license or any combination thereof. Wis. Stat. Ann. §§15.08(5)(c), 450.10.
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 substances and paraphernalia statutes discussed in I.A. above are also applicable to pharmacists. Pharmacy regulations make clear that a pharmacist has an independent responsibility to ensure that controlled substances are properly prescribed.
Responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who dispenses the prescription. An order purporting to be a prescription order not issued in the usual course of professional treatment or in legitimate and authorized research is not a prescription order within the meaning and intent of ss. 450.01 (21) and 961.38, Stats. The person knowingly dispensing pursuant to such a purported order, as well as the person issuing it, shall be subject to the penalties provided for violation of the provision of law relating to controlled substances.
Wis. Admin. Code § Phar 8.04
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 Wisconsin law, including the prescription section of the Controlled Substances Act. We have also concluded that syringes are not covered under the state's drug paraphernalia law. Since the pharmacist is then filling a legitimate prescription there is no possibility that his conduct could be deemed to be unprofessional within the definition promulgated by the Pharmacy Examining Board.
Conclusion: Dispensing sterile injection equipment to an IDU does not violate Wisconsin law.
III. How Might Wisconsin 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 Board of Medical Examiners has 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 practice. Wis. Stat. Ann. §15.08(5)(b). The Pharmacy Examining Board has the same powers and should issue similar regulations. Id.; see also Wis. Stat. Ann. §450.02(3)(c).
2. The Pharmacy Board should require training in the theory and practice of harm reduction as part of mandated continuing education. Wis. Stat. Ann. §450.085; see also Wis. Stat. Ann. §15.08(6). The Board of Medical Examiners has the authority to designate acceptable continuing education programs and courses of study, and it should approve harm reduction as an acceptable program of study. Wis. Stat. Ann. §448.13(1)(a); see also Wis. Stat. Ann. §15.08(6).
B. Declaratory Judgment
A practitioner wishing to prescribe or dispense injection equipment could consider bringing an action for a declaratory judgment. Wis. Stat. Ann. §227.40. The broad language of the statute supports the possibility of bringing this before the courts:
The court shall render a declaratory judgment in such action only when it appears from the complaint and the supporting evidence that the rule or its threatened application interferes with or impairs, or threatens to interfere with or impair, the legal rights and privileges of the plaintiff.
Wis. Stat. Ann. §227.40(1). Decisions by Wisconsin courts indicate the court's willingness to apply this criterion broadly. See generally Wisconsin Hosp. Ass'n v. Natural Resources Bd., 156 Wis.2d 688, 701, 457 N.W.2d 879, 884(1990); Brandmiller v. Arreola, 199 Wis.2d 528, 544 N.W.2d 894(1996). A person may challenge a statute, even if their own conduct could be regulated by other statutes. Brandmiller, 199 Wis.2d at 546, 544 N.W.2d at 902. In challenging a statute, an individual may also hypothesize situations in which a statute or ordinance would intrude upon the rights of third parties. Brandmiller, 199 Wis.2d at 547, 544 N.W.2d at 902. A declaratory judgment would thus probably be available to either practitioners or the medical or pharmacy boards on behalf of practitioners to test the legality of prescribing and dispensing syringes.
C. Attorney General's Opinion
The statute dictating the duties of the Attorney General clearly states that opinions will only be granted upon request of the Governor, any officer, department, agency, board or commission of the state or any member of the legislature and to no others. Wis. Stat. Ann. §165.015.
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).
4. This authority is also provided under chapter 15, titled "Structure of the Executive Branch."
(5) General powers. Each examining board:
. . .
(b) Shall promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains, and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession.
(c) May limit, suspend or revoke, or reprimand the holder of, any license, permit or certificate granted by the examining board.
Wis. Stat. Ann §15.08. Further, Wis. Admin Code §227.11 (2) authorizes an agency to "promulgate rules interpreting the provisions of any statute enforced or administered by it."
5. The standard of care has been defined in tort law:
When a physician exercises that degree of care, diligence, judgment, and skill which physicians in good standing of the same school of medicine usually exercise in the same or similar localities under like or similar circumstances, having due regard to the advanced state of medical or surgical science at the time, he has discharged his legal duty to his patient.
Ahola v. Sincock, 6 Wis.2d 332, 348, 94 N.W.2d 566, 576(1959)(citations omitted).
6. The controlled substances act in neighboring Illinois defines good faith as:
The controlled substances act defines "good faith" in this context as
the prescribing or dispensing of a controlled substance by a practitioner in the regular course of professional treatment to or for any person who is under his treatment for a pathology or condition other than that individual's physical or psychological dependence upon or addiction to a controlled substance...
720 Ill. Comp. Stat. Ann 570/102(u).
7. Also, "physicians have the right, within the exercise of their medical judgment and discretion, to use a medical device for purposes that have not been approved by the Food and Drug Administration as long as the FDA has approved use of the medical device for some purpose." Staudt v. Froedtert Memorial Lutheran Hosp., 217 Wis.2d 773, 776-777, 580 N.W.2d 361, 362-363(1998). Therefore, even if syringes aren't specifically approved as dispensable to IDU's, a physician could use his own good faith judgment in prescribing them to prevent the spread of HIV.