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 23, 1999

Subject: Prescribing and Dispensing Injection Equipment in Colorado

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 Colorado law, of physician prescription and pharmacy sale of injection equipment to patients who are known to be injecting illegal drugs. It assumes that ensuring a patient's access to sterile injection equipment is clinically effective and conducive to public health, is ethical, and constitutes only one facet of the care the patient is receiving from the physician. These assumptions are justified and discussed in two companion reports: Zita Lazzarini, Ethical Issues in Prescribing and Dispensing Syringes to Injection Drug Users, and Josiah Rich, Syringe Prescription in Rhode Island: A Case Study. The risk of malpractice liability is discussed in a third companion piece, Professional Liability in the Prescription and Dispensing of Sterile Injection Equipment to IDU Patients, by Maxwell Mehlman.

We conclude that physicians may legally prescribe and pharmacists may legally dispense syringes to injection drug users (IDUs) as a health care intervention to prevent a patient acquiring or transmitting HIV.

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 Colorado 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 Colorado is governed by the Colorado Medical Practice Act, Colo. Rev. Stat. Ann. §12-36-101 et seq., with regulations found in volume 3 section 713-1 et seq. of the Colorado Code of Regulations. The Act vests in the State Board of Medical Examiners [the "Board"] the power to adopt such regulations as are necessary or proper to carry out the purposes of that Act. Colo. Rev. Stat. Ann. §12-36-104(1)(a).

Colorado 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 prescription of which is consistent with the accepted standard of care. According to the Medical Practice Act, unprofessional conduct includes: . .

(f) Any conviction of any offense of moral turpitude, a felony, or a crime that would constitute a violation of this article. For purposes of this paragraph (f), "conviction" includes the entry of a plea of guilty or nolo contendere or the imposition of a deferred sentence.

(g) Administering, dispensing, or prescribing any habit-forming drug, as defined in section 12-22-102(13), or any controlled substance, as defined in section 12-22-303(7), other than in the course of legitimate professional practice;

(h) Any conviction of violation of any federal or state law regulating the possession, distribution, or use of any controlled substance, as defined in section 12-22-303(7), and, in determining if a license should be denied, revoked, or suspended, or if the licensee should be placed on probation, the board shall be governed by section 24-5-101, C.R.S. For purposes of this paragraph (h), "conviction" includes the entry of a plea of guilty or nolo contendere or the imposition of a deferred sentence.. . .

(n) Violating, or attempting to violate, directly or indirectly, or assisting in or abetting the violation of or conspiring to violate any provision or term of this article;. . .

(p) Any act or omission which fails to meet generally accepted standards of medical practice;. . .

(u) Violation of any valid board order or any rule or regulation promulgated by the board in conformance with law;. . .

(ff) Any violation of the provisions of section 12-36-202 or any rule or regulation of the board adopted pursuant to that section;

Colo. Rev. Stat. Ann. §12-36-117(1).

A court will assess a practice alleged to be unprofessional and beneath the standard of acceptable care by considering what the practitioner has done in the particular circumstances, and by comparing his conduct with what a similarly situated segment of the medical profession says should have been done. Colo. State Bd. of Medical Examiners v. Thompson, 944 P.2d 547(1996); Colo. State Bd. of Medical Examiners v. McCrosky, 940 P.2d 1044(1996).

The Board may revoke or suspend the license, or otherwise discipline a licensee for unprofessional conduct. Colo. Rev. Stat. Ann. §12-36-118(5)(g)(III).

Controlled Substances Law Generally

Prescribing powers are defined with respect to certain drugs in the Uniform Controlled Substances Act of 1992 ("the Controlled Substances Act"). Because syringes do not fall within the definition of "controlled substances,"⁽⁴⁾ these rules are relevant only by analogy. The "Prescriptions" regulation, which requires a prescription for the dispensing of a substance listed in schedules II, III, IV, or V, also states:. . .

(5) 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.

Colo. Rev. Stat. Ann. §18-18-308. Both relevant requirements - purpose of medical treatment and dispensing in the ordinary course of business -- must be satisfied for a prescription to be valid. See generally McKay v. State Board of Medical Examiners, 103 Colo. 305, 86 P.2d 232 (1938); Colorado State Bd. of Medical Examiners v. Slonim, 844 P.2d 1207 (1992).

The Controlled Substances Act has a specific section setting out violations and penalties dealing with controlled substances. Colo. Rev. Stat. Ann. §18-18-401 et seq.

(1)(a) Except as authorized by part 3 of article 22 of title 12, C.R.S., or by part 2 or 3 of this article, it is unlawful for any person knowingly to manufacture, dispense, sell, distribute, possess, or to possess with intent to manufacture, dispense, sell, or distribute a controlled substance; or induce, attempt to induce, or conspire with one or more other persons, to manufacture, dispense, sell, distribute, possess, or possess with intent to manufacture, dispense, sell, or distribute a controlled substance.

Colo. Rev. Stat. Ann. §18-18-405. Violators are guilty of a felony, the class determined by the substance's schedule and by any extenuating circumstances.⁽⁵⁾

Drug Paraphernalia Law

The Controlled Substances Act includes a drug paraphernalia provision, Colo. Rev. Stat. Ann. §18-18-425 et seq., loosely 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 provides a tripartite definition of "drug paraphernalia." First, it defines drug paraphernalia generally as "all equipment, products, and materials of any kind which are used, intended for use, or designed for use" with a controlled substance. Second, it lists seven types of items as examples of drug paraphernalia. Finally, it offers eleven factors to be considered when determining whether an item is drug paraphernalia.

Following the Model Act, 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 removed the words "[h]ypodermic syringes, needles and other objects used, intended for use, or designed for use in parenterally injected controlled substances into the human body" in its list of items that can qualify as drug paraphernalia under some circumstances. Colo. Rev. Stat. Ann. §18-18-426. The eleven factors a court may consider, in addition to all other relevant factors, are:

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

(b) The proximity of the object to controlled substances;

(c) The existence of any residue of controlled substances on the object;

(d) Direct or circumstantial evidence of the knowledge of an owner, or of anyone in control of the object, or evidence that such person reasonably should know, that it will be delivered to persons who he knows or reasonably should know, could use the object to facilitate a violation of sections 18-18-425 to 18-18-430;

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

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

(g) National or local advertising concerning its use;

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

(i) Whether the owner, or anyone in control of the object, is a supplier of like or related items to the community for legal purposes, such as an authorized distributor or dealer of tobacco products;

(j) The existence and scope of legal uses for the object in the community;

(k) Expert testimony concerning its use.

Colo. Rev. Stat. Ann. §18-18-427(1).

The Drug Paraphernalia Act states:

Any person who sells or delivers, possesses with intent to sell or deliver . . . equipment, products, or materials knowing, or under circumstances where one reasonably should know, that such equipment, products, or materials could be used as drug paraphernalia commits a class 2 misdemeanor.

Colo. Rev. Stat. Ann. §18-18-429. A class 2 misdemeanor is subject to a fine of up to $1,000 or imprisonment of up to twelve months, or both. Colo. Rev. Stat. Ann. §18-1-106.

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 the usual course of professional treatment, and (2) accords with the generally accepted standards of medical practice. This is a variant of the controlled substances prescription standard that applies in one form or other in nearly all states. Generally these hold that a prescription for a controlled substance is legal if it is written by a practitioner in good faith, in the usual course of practice, for a legitimate medical purpose. See, e.g., Tex. Health & Safety Code Ann. § 481.071; S.D. Codified Laws §22-42-4.2,5; Commonwealth v. West, 270 Pa.Super. 301, 411 A.2d 537 (1979). Both the Colorado and the national standard address the essential logical elements of validity for any prescription, and are consistent with the standards of professional conduct set out in Colorado medical licensure law. We therefore assume that the Colorado standard would be the one, or equivalent to the one, that a court would apply in assessing the propriety of a syringe prescription. 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 Colorado cases have clearly defined "course of professional treatment" as used in this test, but see y McKay v. State Board of Medical Examiners, 103 Colo. 305, 86 P.2d 232 (1938); Colorado State Bd. of Medical Examiners v. Slonim, 844 P.2d 1207 (1992) (applying medical practice and controlled substances laws to physicians). There is, however, ample case law applying equivalent standards under other states' and federal law. In determining whether a prescription arises within the usual course of professional practice, courts would probably consider such indicia 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 not be at risk of failing this test.

Finally, a prescription, to be valid, must accord with prevailing standards of proper professional practice. In Colorado, a failure to meet professional standards in treatment must normally be shown by expert medical testimony that the physician failed to possess and exercise that reasonable degree of learning and skill ordinarily possessed and exercised by members of his or her school of medicine in similar circumstances. Short v. Downs, 36 Colo.App. 109, 537 P.2d 754 (1975). The standard of care determined by the expert testimony will help the finders of fact evaluate the appropriateness of the physician's treatment choice, even if it differs from those followed by other skilled practitioners. People ex rel. Woodard v. Brown, 770 P.2d 1373, 1379(1989). In other states, case law suggests a standard looking to whether or not other physicians would regard the practice as legitimate, see, e.g. 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.

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?

The drug paraphernalia law is the one serious possibility. 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 prescription provisions of the Medical Practice and Controlled Substances Acts, and not by the more general drug paraphernalia law, for purposes of this analysis, we will assume that syringes are drug paraphernalia.

The law prohibits any person from selling or delivering, or "possess[ing] with intent to sell or deliver . . . equipment, products, or materials knowing, or under circumstances where one reasonably should know, that such equipment, products, or materials could be used as drug paraphernalia." Colo. Rev. Stat. Ann. §18-18-429.

Delivery means to "transfer or attempt to transfer a substance, actually or constructively, from one person to another, whether or not there is an agency relationship." Colo. Rev. Stat. Ann. §18-18-102. 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.

Nor does the concept of a constructive delivery embrace the writing of a prescription.

A constructive delivery is effectuated when, without actual transfer of the goods or their symbol, the conduct of the parties is such as to be inconsistent with any supposition other than there has been a change in the nature of the holding. There may be a completed delivery . . . [if] nothing further remains to be done by either party to complete the sale.

Jelen and Son, Inc. v. Bandimere, 801 P.2d 1182, 1186(1990)(citations and internal quotations omitted). Ordinarily and as a matter of logic, constructive delivery requires "actual or constructive possession [of the syringe] prior to transfer." Commonwealth v. Zimmerman, 3 D & C. 4ths 381, 385-85 (Common Pleas Lebanon Cty 1989). Whatever his intent, a physician writing a prescription to be filled at a pharmacy does not have possession of the syringe.

It is well established that possession can exist without physical contact so long as the defendant has dominion and control over the drug. United States v. Cox, 2 Cir., 277 F.2d 302, 303. Such dominion and control without physical custody has been termed 'constructive,' as opposed to actual, possession. Physical custody by an employee or agent whom one dominates, or whose actions one can control, is sufficient to constitute such constructive possession by the principal.

United States v. Hernandez, 290 F.2d 86, 90 (2d. Cir. 1961), quoted with approval in People v. Storr, 186 Colo. 242, 247, 527 P.2d 878, 881(1974). The authority to write a prescription for a syringe does not give the physician the ability to exercise dominion over it; like the patient, he would have to go to the pharmacy and purchase the syringe in order to complete the sale and possess it. Likewise, though his prescription would facilitate the purchase, it does not create an agency relationship with the pharmacist. The physician cannot set the price, or compel the sale. Hence the physician cannot be said to constructively possess the syringe.⁽⁶⁾

Conclusion: Writing a prescription for a syringe does not violate any Colorado 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 Colorado is governed by the Pharmacy Act, Colo. Rev. Stat. Ann. §12-22-101 et seq., with regulations found in 3 Colo. Code Regs. §719-1 et seq. of the Colorado Code of Regulations. The Act vests in the State Board of Pharmacy power to adopt such regulations as are deemed necessary to carry out the purposes of that Act. Colo. Rev. Stat. Ann. §12-22-108. The Act also authorizes the Board of Pharmacy to control and regulate the sale of devices, but the board has not promulgated any regulations governing the sale of devices. Colo. Rev. Stat. Ann. §12-22-112(2).

The disciplinary provisions of the Pharmacy Act authorize action against the license of a pharmacist who. . .

(b) Is guilty of the commission of a felony or has had accepted by a court a plea of guilty or nolo contendere to a felony;

(c) Has violated any of the provisions of this part 1, the lawful rules and regulations of the board, or any state or federal law pertaining to drugs.

Colo. Rev. Stat. Ann. §12-22-125(1).

Like the Board of Medical Examiners, the Board of Pharmacy has the authority to punish licensees for unprofessional conduct. See generally Mitchell v. Klapper, 626 P.2d 1163(1980); People v. Caponey, 647 P.2d 668(1982). The Board has promulgated regulations setting out general rules of professional conduct. 3 Colo. Code Regs. §719-1 et. seq. These regulations specify that:

A pharmacist shall at all times conduct his/her profession in conformity with all federal and state drug laws, rules and regulations; and shall uphold the legal standards of the current official compendia.

3 Colo. Code Regs. §719-1.00.11.

A pharmacist shall not be a party or accessory to any fraudulent or deceitful practice or transaction in pharmacy, nor discredit his/her profession.

3 Colo. Code Regs. §719-1.00.12. The Board has also set out regulations dealing with dispensing. 3 Colo. Code Regs. §719-3 et. seq.

Medical need No licensee or registrant shall compound, dispense, deliver or distribute any drug to any person in such quantity or in any situation where the licensee or registrant knows or reasonably should know said drug has no recognized medical utility or application. Violation of this rule shall constitute prima facie proof of violation of C.R.S. 12-22-125.

3 Colo. Code Regs. §719-3.00.20.

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). The Pharmacy Act states that:

(6) No civil or criminal liability or administrative sanction may be imposed on a pharmacist for action taken 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.

Colo. Rev. Stat. Ann. §18-18-308.

Controlled Substance and Drug Paraphernalia Laws

The controlled substances and paraphernalia discussed in I.A. above are also applicable to pharmacists. The regulations for the Controlled Substances Act make clear that a pharmacist has an independent responsibility to ensure that controlled substances are properly prescribed:

Each time a prescription drug or device is dispensed in a prescription drug outlet, a pharmacist shall make the final evaluation of the transaction. At the time of such final evaluation, the pharmacy shall take whatever action is necessary to ensure that the container, label, and prescription drug or device dispensed, as well as all records relating to the transaction are complete, accurate, and appropriate.

3 Colo. Code Regs. §719-3.00.50.

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 Colorado law. Ordinarily, the pharmacist is required to fill a valid prescription.⁽⁷⁾ The next question is whether filling the prescription would be prohibited under any other provision of law.

1. U.S. Public Health Service & Infectious Diseases Society of America, Guidelines for the Prevention of Opportunistic Infections in Persons Infected with Human Immunodeficiency Virus, 48(RR10) MMWR 1 (1999); U.S. Public Health Service, HIV Prevention Bulletin: Medical Advice for Persons Who Inject Illicit Drugs (May 8, 1997); accord J. Normand, D. Vlahov, & L. Moses eds. Preventing HIV Transmission: The Role of Sterile Needles and Bleach (1995) (National Academy of Sciences); Statements/Resolutions/Policies on Increased Access to Clean Needles and Syringes (collected at http://www.sfaf.org/prevention/needleexchange/statements.html); T. Stephen Jones and David Vlahov, Use of Sterile Syringes and Aseptic Drug Preparation Are Important Components of HIV Prevention Among Injection Drug Users, 18 J Acquir. Immune Defic. Syndr. S1 (Supp. 1, 1998).