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, although the contrary conclusion is also reasonable.

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 Missouri 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 Missouri is governed by the Medical Practice Act, Mo. Ann. Stat. §334.010 et seq., with regulations found in Division 150 of title 4 of Missouri's Code of State Regulations. The Act vests in the State Board of Registration for the Healing Arts ["the board"], the power to adopt regulations to carry out the purposes of that Act. Mo. Ann. Stat. §334.125.

Controlled Substances Law Generally

Prescribing powers are defined with respect to controlled substances in the Comprehensive Drug Control Act of 1989 [the controlled substances act], Mo. Ann. Stat. §195.005 et seq. The Act's prescription provision states:

A physician . . . in good faith and in the course of his professional practice only, may prescribe, administer, and dispense controlled substances . . .

Mo. Ann. Stat. §195.070(1). The Department of Health regulations also specify that a practitioner may:

Dispense only to individuals with whom the practitioner has established and documented a practitioner/patient relationship. An individual practitioner shall not dispense under the order of another practitioner not practicing at that location.

The statute refers to injection in the roster of drug-use practices that contribute to defining paraphernalia under the first part of the definition, and includes "[h]ypodermic syringes, needles and other objects used, intended for use, or designed for use in parenterally injecting controlled substances . . . into the human body" in its list of items that can qualify as drug paraphernalia under some circumstances. Mo. Ann. Stat. §195.010(17)(k). The fourteen factors to be considered are:

(a) Statements by an owner or by anyone in control of the object concerning its use;

(b) Prior convictions, if any, of an owner, or of anyone in control of the object, under any state or federal law relating to any controlled substance or imitation controlled substance;

(c) The proximity of the object, in time and space, to a direct violation of sections 195.005 to 195.425;

(d) The proximity of the object to controlled substances or imitation controlled substances;

(e) The existence of any residue of controlled substances or imitation controlled substances on the object;

(f) Direct or circumstantial evidence of the intent of an owner, or of anyone in control of the object, to deliver it to persons who he knows, or should reasonably know, intend to use the object to facilitate a violation of sections 195.005 to 195.425; the innocence of an owner, or of anyone in control of the object, as to direct violation of sections 195.005 to 195.425 shall not prevent a finding that the object is intended for use, or designed for use as drug paraphernalia;

(g) Instructions, oral or written, provided with the object concerning its use;

(h) Descriptive materials accompanying the object which explain or depict its use;

(i) National or local advertising concerning its use;

(j) The manner in which the object is displayed for sale;

(k) Whether the owner, or anyone in control of the object, is a legitimate supplier of like or related items to the community, such as a licensed distributor or dealer of tobacco products;

(l) Direct or circumstantial evidence of the ratio of sales of the object to the total sales of the business enterprise;

(m) The existence and scope of legitimate uses for the object in the community;

(n) Expert testimony concerning its use;

Mo. Ann. Stat. §195.010(17).

The law makes it unlawful "to deliver, [or] possess with intent to deliver . . . drug paraphernalia, knowing, or under circumstances where one reasonably should know, that it will be used to . . .inject, ingest, inhale, or otherwise introduce into the human body a controlled substance . . . in violation of [the act]." Mo. Ann. Stat. §195.235(1). Violation of this provision is a class D felony, subject to a fine of up to $5,000. Mo. Ann. Stat. §560.011(1)(1). Violators are also subject to imprisonment of up to five years. Mo. Ann. Stat. §558.011(1)(4).

B. Analysis

In the absence of an explicit standard for syringe prescription in Missouri, we assume that the validity of a prescription is based on the standard of the Medical Practice Act and the Controlled Substances Act. A prescription is valid if it is written (1) in good faith, (2) in the usual course of professional practice, and (3) for a legitimate medical purpose. This standard is congruent with the requirements of professional conduct, and is the standard used throughout the country to assess the legality of prescriptions for controlled substances. 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.

Although they have not explicitly defined the terms, Missouri courts have treated the first two requirements as clear and readily understandable to practitioners. See generally State v. Kane, 586 S.W.2d 812 , 814-15 (1979); State v. Bridges, 398 S.W.2d 1(1966). The cases, none of which involve situations comparable to those at issue here, offer scant further insight. In normal usage, "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., Kane, 586 S.W.2d at 814("A doctor who prescribes a potentially dangerous drug without first making some attempt to determine the physical condition or health needs of the person for whom he writes the prescription is not acting in good faith and in the usual course of his practice.")(citation omitted); People v. Lonergan, 219 Cal.App.3d 82, 90, 267 Cal.Rptr. 887, 892(1990)( "Good faith is that state of mind denoting honesty of purpose, freedom from intention to defraud, and, generally speaking, means being faithful to one's duty or obligation." ). A physician who is providing syringes to a patient who cannot or will not enter drug treatment, and whose injection drug use places him at high risk of contracting or spreading a communicable disease, should have no difficulty satisfying the "good faith" prong of the prescription standard.

In determining whether a prescription arises out of the usual course of professional practice, a court will consider whether a bona fide doctor-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 Bridges, 398 S.W.2d at 4 ("The phrases 'usual course of business or practice' of such persons as physicians and surgeons . . . are in such common use that any reasonable man can determine their meaning. Surely, one licensed as a physician knows when he is acting in the usual course of his practice of medicine."); accord United States v. Moore, 423 U.S. 122, 142-43, 96 S.Ct. 335, 345(1975)("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 not be at risk of failing this test.

Missouri courts have also not clarified the meaning of a "legitimate medical purpose." In other states, case law suggests a standard 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); Commonwealth v. Salameh, 421 Pa.Super. 320, 324, 617 A.2d 1314, 1316 (1992), appeal denied, 536 Pa. 641, 639 A.2d 26 (1994). A practice is not illegitimate simply because some physicians disagree with the practice at issue, but only where no responsible segment of the medical profession exists which accepts appellant's methods. See Glover v. Board of Medical Quality Assurance, 231 Cal. App.3d 203, 208(1991)("As long as the differences of opinion are legitimate, we have no dispute with the notion that different methods of treatment can all be considered acceptable medical practice."); accord Lonergan, 219 Cal.App.3d 82, 91, 267 Cal.Rptr. 887, 893("[The fact that a Physician might have . . . acted in a fashion different from that of other practitioners is immaterial if the Physician acted in good faith.")⁽⁹⁾ Expert testimony and attending circumstances will then help the factfinder determine the legitimacy of the physician's actions.⁽¹⁰⁾ 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.

Conclusion: A prescription for sterile injection equipment to an IDU patient is consistent with the standard for a valid prescription under the Medical Practice Act 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? There are two main possibilities.

Mo. Ann. Stat. §334.106, the provision prohibiting a physician from prescribing controlled substances to a known drug dependent person for the purpose of maintaining their addiction, could be the basis of an argument that providing sterile injection equipment must also be illegal. Per this argument, providing syringes enables drug users to violate the law, and is therefore inconsistent with the basic purposes of the act.

This argument has a common-sense appeal, but should fail on at least two grounds. First, the plain language of the prohibition does not embrace syringes, and it is a cardinal rule of Missouri statutory construction that criminal laws are to be strictly construed against the state.

State v. Dougherty, 216 S.W.2d 467, 471, 358 Mo. 734, 741(1949). Under this rule, a court should not read a criminal statute as prohibiting conduct it does not explicitly prohibit. Second, even if we accept the analogy between providing controlled substances and providing sterile equipment for injecting them, the provision itself makes an exception for prescriptions necessary to treat some other malady. Mo. Ann. Stat. §334.106(4). Preventing the spread of infectious disease, while not literally curing or treating a disease, is a plainly acceptable medical intervention, and so would seem to fall well within a broad interpretation of the provision.

A more serious possibility is the drug paraphernalia law. As we will discuss further in the pharmacy analysis below, syringes can be drug paraphernalia under some circumstances. Although it may be argued that prescription of syringes is governed by the specific prescription provisions applicable to physicians, and not by the more general drug paraphernalia law, for purposes of this analysis, we will assume that syringes are drug paraphernalia.

The law makes it unlawful "to deliver [or] possess with intent to deliver . . . drug paraphernalia, knowing, or under circumstances where one reasonably should know, that it will be used to . . . inject, ingest, inhale, or otherwise introduce into the human body a controlled substance" in violation of the act. Mo. Ann. Stat. §195.235(1).

Delivery is defined as "the actual, constructive, or attempted transfer from one person to another of drug paraphernalia or of a controlled substance . . . whether or not there is an agency

relationship, and includes a sale." Mo. Ann. Stat. §195.010(8). A physician who writes a prescription for an item is not actually transferring possession of that item to the patient, but merely providing the patient with instructions and authorization for the pharmacist who will transfer possession by dispensing the prescription.

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).

7. The Food, Drugs, and Cosmetics Act states:

(3) The term "device" . . . means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or to affect the structure or any function of the body of man or other animals;

Mo. Ann. Stat. §196.010(1).

8. The paraphernalia provision is scattered over Mo. Ann. Stat. §§195.010, 195.140, 195.233, 195. 235, and 195.244.

10. Significantly, a physician is not limited to only presenting expert medical witnesses to support the legitimacy of prescribing syringes to IDU's to prevent the spread of HIV. Missouri courts have shown a willingness to consider the testimony of any witness whose area of expertise is relevant to the issue at hand. Therefore, a physician would be able to offer testimony from researchers, syringe exchange programs participants, and others familiar with the beneficial aspects of this practice.

11. 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). This interpretation, however, is not supported by Missouri law.

Additionally, there is little risk that prescribing a syringe could be prosecuted as aiding and abetting a violation of the paraphernalia statute that would occur when the pharmacist dispensed the syringe, or for conspiracy to violate the paraphernalia statute. Although this charge is available to a motivated prosecutor, such a prosecution would be unusual: there is no reported case in Missouri of a charge of aiding and abetting a paraphernalia violation. In fact, there are no reported cases of unlawful delivery of paraphernalia since the old drug paraphernalia act, Mo. Ann. Stat. §195.020, was repealed in 1989. More importantly, the crime depends 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.

13. It has been reported that the pharmacy board states that pharmacists have an ethical obligation to decide whether needles will be used for legal purposes. 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). It was also reported that a pharmacist was disciplined in the early '90s for failing to fulfill this duty. Id. No further information was provided, and this author was unable to verify these reports.