Temple University of the Commonwealth System of Higher Education
Beasley School of Law
Project on Harm Reduction in the Health Care System
Date: December 7, 1999
Subject: Prescribing and Dispensing Injection Equipment in Nebraska
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 Nebraska 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 syringes to injecting drug users (IDUs) as a health care intervention to prevent a patient acquiring or transmitting HIV. Pharmacists who have no reason to know that the purchaser is going to use the syringe to inject illegal drugs do not violate any law in filling the prescription. Pharmacists dispensing these syringes with knowledge of the intended use may violate Nebraska law, 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 a such a prescription?
3) How might Nebraska 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
Professional Licensure Law
The practice of medicine in Nebraska is governed by the Medical Practice Act, Neb. Rev. Stat. §71-1,102 et seq., with regulations found in Neb. Admin. R. & Regs. 172.88.001 et seq. The Department of Health and Human Services Regulation and Licensure has the authority to adopt such regulations as are reasonably necessary to carry out the purposes of the licensure law, including authority to promulgate regulations defining the "accepted standard of care" that all practitioners must meet or suffer disciplinary action from the Director of Regulation and Licensure. Neb. Rev. Stat. §71-169; Id. §71-150.
Nebraska 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 Uniform Licensing Law, a physician faces suspension, revocation or restriction of a license upon a showing to the Director that a physician has committed certain acts deemed to be unacceptable. Neb. Rev. Stat. §71-147. A practitioner faces potential punishments for the following acts:..
(2) Grossly immoral or dishonorable conduct evidencing unfitness or lack of proficiency sufficient to meet the standards required for practice of the profession in this state;..
(4) Conviction of a misdemeanor or felony under state law, federal law, or the law of another jurisdiction and which, if committed within this state, would have constituted a misdemeanor or felony under state law and which has a rational connection with the applicant's, licensee's, certificate holder's, or registrant's fitness or capacity to practice the profession;..
(10) Unprofessional conduct;...
(13) Distribution of intoxicating liquors, controlled substances, or drugs for any other than lawful purposes;...
(17) Violation of the Uniform Controlled Substances Act or any rules and regulations adopted pursuant to the act;
Id. In order to clarify the meaning of "unprofessional conduct," the legislature included a statute that explains:
For the purposes of section 71-147, unprofessional conduct shall mean any departure from or failure to conform to the standards of acceptable and prevailing practice of a profession or occupation or the ethics of the profession or occupation, regardless of whether a person, patient, or entity is injured, or conduct that is likely to deceive or defraud the public or is detrimental to the public interest, including, but not limited to:..
(19) Prescribing, administering, distributing, dispensing, giving, or selling any controlled substance or other drug recognized as addictive or dangerous for other than a medically accepted therapeutic purpose;...
(21) Such other acts as may be defined in rules and regulations adopted and promulgated by the board of examiners in the profession of the applicant, licensee, certificate holder, or registrant with the approval of the department.
Neb. Rev. Stat. §71-148.
The regulations governing the practice of medicine include further grounds on which the department may deny, refuse renewal of, or discipline a licensee:
The Department may deny, refuse renewal of, limit, suspend, or revoke licenses or permits for any of the following grounds:...
012.03B Grossly immoral or dishonorable conduct evidencing unfitness or lack of proficiency sufficient to meet the standards required for practice of the profession in this state....
012.03D Conviction of a misdemeanor or felony under state law, federal law, or the law of another jurisdiction and which, if committed within this state, would have constituted a misdemeanor or felony under state law and which has a rational connection with the applicant's, licensee's, or permittee's fitness or capacity to practice the profession....
012.03J Unprofessional conduct, which term includes all acts specified in Neb. Rev. Stat. §71-148 and such other acts as specified in Sections 012 and 013 of these regulations....
012.03M Distribution of intoxicating liquors, controlled substances or drugs for any other than lawful purposes....
012.03P Violation of the Uniform Controlled Substances Act or any rules and regulations adopted pursuant to the act.
Neb. Admin. R. & Regs. 172-88-012. The regulations go on to define "unprofessional conduct":..
013.06 Except as otherwise permitted by law, prescribing, selling, administering, distributing, ordering, or giving to an habitue or addict or any previously drug dependent, any drug legally classified as a controlled substance;
013.07 Violating any federal law or regulation relating to controlled substances;..
013.11 Use of any therapy, drug or device in a manner inconsistent with the federal Food, Drug and Cosmetic Act;...
013.14 Prescribing, selling, administering, or distributing, any drug legally classified as a prescription drug other than for proper medical purposes;...
013.18 Any conduct or practice outside the normal standard of care in the State of Nebraska which is or might be harmful or dangerous to the health of the patient or the public;...
013.24 Failure to keep and maintain adequate records of treatment or service; adequate records means legible medical records containing, at a minimum, sufficient information to identify the patient, support the diagnosis, justify the treatment, accurately document the results, indicate advice and cautionary warnings provided to the patient and provide sufficient information for another practitioner to assume continuity of the patient's care at any point in the course of treatment; and, when investigative or unproved therapies are utilized, the records must include written informed patient consent.
Neb. Admin. R. & Regs. 172-88-013. See Curry v. State 242 Neb. 695, 496 N.W.2d 512 (1993) ("unprofessional conduct" limited to enumerated forms).
Controlled Substances Act Generally
In most states, the Uniform Controlled Substance Act ["the Controlled Substances Act"], Neb. Rev. Stat. §28-401 et seq., provides some basic standards for the validity of a prescription that can be applied by analogy to syringes and other items that do not strictly fall within the definition of controlled substance. Nebraska's act, however, while it assumes that properly registered physicians and pharmacists can prescribe or dispense controlled substances, do not specify any additional criteria.(4)
Drug Paraphernalia Law
The Controlled Substances Act also includes a drug paraphernalia provision, Neb. Rev. Stat. §28-439 et seq., based in part on the Justice Department's model act, reprinted in Annotation, Validity, under Federal Constitution, of So-called "Head Shop" Ordinances or Statutes, Prohibiting Manufacture and Sale of Drug Use Related Paraphernalia, 69 A.L.R. Fed. 15 (1984 & Supp. 1998). See generally Casbah, Inc. v. Thone, 651 F.2d 551 (8th Cir. 1981). The paraphernalia law makes it unlawful "for any person to use, or to possess with intent to use, drug paraphernalia to ... inject, ... or otherwise introduce into the human body a controlled substance in violation of sections 28-101, 28-431, 28-439 to 28-444. Any person who violates this section is guilty of an infraction." Neb. Rev. Stat. §28-441. The paraphernalia law also makes it unlawful to "deliver, possess with the intent to deliver, or manufacture with the intent to deliver, drug paraphernalia, knowing, or under circumstances where one reasonably should know, that it will be used to ... inject, ... or otherwise introduce into the human body a controlled substance in violation of sections 28-101, 28-431, and 28-439 to 28-444." Id. §28-442. Violation of this section is a Class II misdemeanor, id., punishable by up to six months imprisonment, or up to a one-thousand dollar fine, or both. Id. §28-106. Delivery of drug paraphernalia to a person under eighteen years of age who is at least three years younger than the violator is guilty of a Class I misdemeanor, id. §28-443, punishable by up to one year imprisonment, or a fine up to one-thousand dollars, or both. Id. §28-106.
For the purposes of the drug paraphernalia provisions drug paraphernalia is defined:
[D]rug paraphernalia shall mean all equipment, products, and materials of any kind which are used, intended for use, or designed for use, in ... injecting, ... or otherwise introducing into the human body a controlled substance in violation of sections 28-101, 28-431, and 28-439 to 28-444 or the Uniform Controlled Substances Act. It shall include, but not be limited to, the following:..
(3) Hypodermic syringes, needles, and other objects used, intended for use, and designed for use in parenterally injecting controlled substances into the human body;
Neb. Rev. Stat. §28-439. The statute provides a list of factors to be used in determining whether a particular item is drug paraphernalia in a particular case:
(1) Statements by an owner or by anyone in control of the object concerning its use;
(2) 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;
(3) The proximity of the object, in time and space, to a direct violation of this act;
(4) The proximity of the object to any controlled substance;
(5) The existence of any residue of a controlled substance on the object;
(6) Direct or circumstantial evidence of the intent of an owner, or of anyone in control of the object, to deliver it to any person whom he or she knows, or should reasonably know, intends to use the object to facilitate a violation of sections 28-101, 28-431, and 28-439 to 28-444. The innocence of an owner, or of anyone in control of the object, as to a direct violation of sections 28-101, 28-431, and 28-439 to 28-444 shall not prevent a finding that the object is intended for use, or designed for use as drug paraphernalia;
(7) Instructions, oral or written, provided with the object concerning its use;
(8) Descriptive materials accompanying the object which explain or depict its use;
(9) National and local advertising concerning its use;
(10) The manner in which the object is displayed for sale;
(11) 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;
(12) Direct or circumstantial evidence of the ratio of sales of the object or objects to the total sales of the business enterprise;
(13) The existence and scope of any legitimate use for the object in the community; and
(14) Expert testimony concerning its use.
Id. § 28-440.
Nebraska law nowhere sets out an explicit standard for assessing the legality of a prescription for a drug or medical device such as a syringe. In other states, courts and controlled substances law use a standard that upholds a prescription 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). This is a standard that covers the essential logical elements of validity for any prescription, and is consistent with the standards of professional conduct set out in Alabama medical licensure law. We therefore assume that it would be the standard, or equivalent to the standard, 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.
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., In the Matter of DiLeo, 661 So.2d 162, 168 (La. Ct. App. 1995)(finding that a physician was acting in good faith when prescribing medications to patients experiencing pain symptoms); see also Commonwealth v. Larsen, 452 Pa.Super. 508, 682 A.2d 783 (1996). A physician who is providing injection equipment to IDU patients out of a sincere desire to prevent disease transmission, without pecuniary motive, and who does so openly under a reasonable claim of legality, should have no difficulty meeting this prong of the standard.
In determining whether a prescription arises within the usual course of professional practice, courts may consider such matters as whether a bona fide physician-patient relationship existed, whether other care was provided, whether proper records were kept of the encounter, whether the prescription was based on a proper history or individualized assessment of the patient's risk factors, efforts to provide other harm reducing services, follow up and so on. See generally United States v. Moore, 423 U.S. 122, 142-43, 96 S.Ct. 335, 345 ("The evidence presented at trial was sufficient for the jury to find that respondent's conduct exceeded the bounds of "professional practice." As detailed above, he gave inadequate 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."). 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.
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). Similar deference is built into Nebraska's law. 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 general standards of prescription validity.
We turn now to the second question: Do any other laws prohibit physicians from prescribing sterile injection equipment to IDU patients?
The most serious possibility is the drug paraphernalia act. 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 definitions in the §28-401, and not by the more general drug paraphernalia law, for purposes of this analysis, we will assume that syringes are drug paraphernalia.
The paraphernalia law makes it unlawful to "deliver, possess with the intent to deliver, or manufacture with the intent to deliver, drug paraphernalia, knowing, or under circumstances where one reasonably should know, that it will be used to ... inject, ... or otherwise introduce into the human body a controlled substance in violation of sections 28-101, 28-431, and 28-439 to 28-444." Id. §28-442.
Delivery is defined with the Controlled Substances Act, which also includes the drug paraphernalia statutes, as "the actual, constructive, or attempted transfer from one person to another of a controlled substance, whether or not there is an agency relationship." Neb. Rev. Stat. §28-401(13). Regardless, delivering drug paraphernalia necessarily requires possession by the deliverer whether that possession be actual or constructive. A physician who writes a prescription for an item does not actually possess and 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 constructive possession embrace the writing of a prescription. One constructively possesses a controlled substance "when one knows of the nature or character of the substance and of its presence and has dominion or control over it." State v. DeGroat, 508 N.W.2d 861, 865 (1993)(citations omitted). The authority to write a prescription for a syringe does not give the physician the ability to maintain control and exercise dominion over it; like the patient, he would have to go to the pharmacy and purchase the syringe in order to possess it, and so cannot be said to constructively possess it. Whatever his intent, a physician writing a prescription to be filled at a pharmacy does not have actual or constructive possession of the syringe.(6)
Conclusion: Writing a prescription for a syringe does not violate any Nebraska 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 Nebraska's Drug Paraphernalia Laws?
A. The Regulatory Scheme
Professional Licensure Law
The practice of pharmacy in Delaware is governed by Neb. Rev. Stat. §71-1,142 et seq., with regulations found in Neb. Admin. R. & Regs. 172.128.001 et seq. As in the case of medical practice act, The Department of Health and Human Services Regulation and Licensure has the authority to adopt such regulations as are reasonably necessary to carry out the purposes of the licensure law. Neb. Rev. Stat. §71-169; §71-1,147.09. The Pharmacy Board of Examiners may also promulgate regulations with approval from the Department. Id. §71-161.09.
Pharmacists face the same restrictions on practice as noted in section I.A. above. See, Neb. Rev. Stat. §71-147; Id. §71-148; see Neb. Rev. Stat. §71-1,147.10.
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 discussed in I.A. above are also applicable to pharmacists.(7)
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 Nebraska law. 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.
One candidate is the drug paraphernalia law. The pharmacist is undoubtedly transferring the syringe, so if a syringe is drug paraphernalia in this situation, then the transfer is illegal. We thus come to the fundamental question of whether a syringe dispensed by a valid prescription, for legitimate medical reasons, falls within the definition of "drug paraphernalia" under Nebraska law.
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. Neb. Rev. Stat. §28-442. 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.
Conclusion: Dispensing sterile injection equipment to an IDU does not violate Idaho law where the pharmacist does not and reasonably should not know that the patient intends to use the equipment to illegally inject drugs.
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 most cautious view is that dispensing under these circumstances would violate the paraphernalia law. The paraphernalia statute may be read as a limitation on the practitioner's authority to prescribe or dispense. General medical practice law, on this reading, allows a pharmacist to fill a prescription with a valid medical purpose and, in the course of medical practice, except when the practitioner knows or should have known the patient intends to use the item for drug use, when the drug paraphernalia provision interposes its prohibition. This reading is consistent with the plain meaning of the paraphernalia statute, which prohibits any person, without exception for health care providers, from providing drug paraphernalia to someone knowing it will be used to ingest illegal drugs.
It does not follow, however, that this cautious reading is the correct reading. It may reasonably be argued that the paraphernalia act does not and was not intended to regulate health care professionals acting within the scope of their professional practice, and that the interpretive guidance included in the statute provides a clear basis for excluding syringes sold by prescription for disease prevention purposes.
Nebraska courts will not review the intent of the legislature where a statute is unambiguous, see, e.g. State v. Havorka, 355 N.W.2d 343, 346 (1984). In Havorka, the Nebraska Supreme Court clearly established that "if the statute is ambiguous the court, if possible, should attempt to discover the legislative intent, but that if the language is unambiguous there is no necessity for construction and this court has no jurisdiction to change the language." The paraphernalia law, however, is unambiguous but also unusually broad, see Casbah, Inc. v. Thone, 651 F.2d 551 (8th Cir. 1981), requiring an understanding of legislative intent in order to set its proper bounds. Simply applying the law to the health care system can 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. Where the statute seems to limit the discretion of health care practitioners exercised under another regulatory scheme, it is both necessary and appropriate to consider the intention of the legislature.
In construing a statute this court must look to the statutory objective to be accomplished, the evil and mischief to be remedied, or purpose to be served, and then place on the statute a reasonable or liberal construction which best achieves the purpose of the statute, rather than a construction defeating the statutory purpose. Further, in determining the meaning of a statute, this court will, if possible, ascertain the legislative intent from the language of the act. As far as practicable, we must give effect to the language of a statute and reconcile different statutory provisions so that parts of a statute are consistent, harmonious, and sensible. Also, we must give effect, if possible, to the several parts of a statute to avoid rejection of a sentence, clause, or word as meaningless or superfluous.
Rosnich v. Marks, 357 N.W.2d 186, 188 (1984).
There is likely nothing in the legislative history to suggest that the paraphernalia law was intended to regulate legitimate medical and pharmacy practice. The Nebraska law was passed in 1980 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). The model statute, adopted with little change by Nebraska, was broadly phrased to encompass the range of items sold at head shops, and focused on the knowledge of illicit use as the test of criminal intent. There is no indication in the history of either the model or Nebraska's act to suggest, however, that it was intended to interfere with good medical care.
This is evident in the factors provided to guide the judicial determination of whether an item is paraphernalia. Neb. Rev. Stat. §28-440. These plainly apply to commercial enterprises depending on illicit drug use for their business. The fact that a pharmacists is a legitimate supplier of legal syringes to the community (factor 11) and that syringes have legitimate uses in the community quite apart from the legitimate purpose of preventing disease transmission (factor 13) supports a finding that syringes provided for legitimate medical purposes are not "drug paraphernalia" under the statute. Further support would come from expert testimony (factor 14), which would emphasize that prescribing and dispensing syringes prevents disease in the patient and those with whom he or she might later share sex or needles.
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 that 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 Nebraska are likely given broad discretion to practice their professions. The law that controls their decision about prescribing or dispensing medications 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.
Conclusion: Dispensing sterile injection equipment to known IDUs may violate Nebraska law, although the contrary conclusion is also very reasonable.
III. How Might Nebraska 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 clearly prescribe sterile injection equipment to IDUs as a health-care intervention to prevent the transmission of blood-borne pathogens, but that some doubt surrounds the question of whether pharmacists may dispense needles pursuant to the prescription. 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.
2. The Department of Health and Human Services Regulation and Licensure 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 practice. Neb. Rev. Stat. §71-169; §71-1,147.09 (authority to create regulations for pharmacists); Id. §71-169; Id. §71-150 (authority to create regulations for physicians).
3. The Department of Health and Human Services Regulation and Licensure should require training in the theory and practice of harm reduction as part of mandated continuing education for pharmacists. Neb. Rev. Stat. §71-1,144.01. Similarly, the Department has the authority to create regulations requiring continuing education for physicians. Id. §71-169; Id. 71-150. The Department should take advantage of this authority to require similar training procedures.
B. Declaratory Judgment
A practitioner wishing to prescribe or dispense injection equipment could also consider bringing an action for a declaratory judgment. Neb. Rev. Stat. §25-21,150. In order for an individual to bring an action for declaratory judgment there must be "a present actual controversy where only justiciable issues are presented, and all interested persons are made parties to the proceedings." Nebraska Mid-State Reclamation Dist. v. Hall County, 41 N.W.2d 397, 405 (1950). A declaratory judgment would thus probably be available to test the legality of prescribing and dispensing if a practitioner intending to do so was exposed to a serious threat of prosecution.
C. Attorney General's Opinion
It is among the duties of the Attorney General to provide his or her opinion upon all questions of law to the Governor, head of any executive department, heads of certain state offices, but not to individuals citizens. Neb. Rev. Stat. §84-205(4).
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 (May 8, 1997); accord J. Normand, D. Vlahov, & L. Moses eds. Preventing HIV Transmission: The Role of Sterile Needles and Bleach (1995) (National Academy of Sciences); Statements/Resolutions/Policies on Increased Access to Clean Needles and Syringes (collected at http://www.sfaf.org/prevention/needleexchange/statements.html); T. Stephen Jones and David Vlahov, Use of Sterile Syringes and Aseptic Drug Preparation Are Important Components of HIV Prevention Among Injection Drug Users, 18 J Acquir. Immune Defic. Syndr. S1 (Supp. 1, 1998).
2. Peter Lurie, T. Stephen Jones & J. Foley J, A Sterile Syringe for Every Drug User Injection: How Many Injections Take Place Annually, and How Might Pharmacists Contribute to Syringe Distribution? 18 J Acquir. Immune Defic. Syndr. S45 (Supp. 1, 1998).
3. Id.; Scott Burris, Peter Lurie, Daniel Abrahamson, and Josiah Rich, Physician Prescribing of Safe Injection Equipment to Prevent HIV Infection: Time for Action, __ Annals of Internal Medicine __ (2000); T. Stephen Jones, Should Pharmacists Sell Sterile Syringes to Injection Drug Users? 39 J Am Pharm Assoc 1 (1999); Alvin Novick, A Duty to Care: Sterile Injection Equipment and Illicit-drug Use, 11 AIDS & Pub. Pol'y J. 63 (1996).
4. The definition section does characterize a practitioner, including a physician or pharmacist, as one licensed to prescribe or dispense drugs "in the course of professional practice or research." Id. §28-401.
5. In Pennsylvania, 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 (5th Circ. 1980); Commonwealth v. Comins, 371 Mass. 222, 356 N.E.2d 241 (1976), certiorari denied, 430 U.S. 946, 97 S.Ct. 1582, 51 L.Ed.2d 793 (1977); 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 Substances, 13 A.L.R.5th 1, 73-84 (1993). This interpretation, however, is not supported by Nebraska law.
Although a physician who prescribes a syringe does not physically provide 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 dispensed the syringe, or for conspiracy to violate the paraphernalia statute. Neb. Rev. Stat. §28-206. (Conspiracy to commit a misdemeanor is not a crime in Nebraska. See Neb. Rev. Stat. §28-202.) Such a charge is 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 Nebraska of a charge of aiding and abetting a paraphernalia violation or other such misdemeanor. More importantly, both crimes depend upon the underlying illegality of providing sterile injection equipment by prescription. Our analysis suggests that this behavior is arguably 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, does not aid or abet a crime.
7. Gostin and Lazzarini's survey of pharmacy rules and regulations reported that "pharmacists are expected to exercise their professional judgment at the time of sale" of a syringe, but provided no citation for this rule. 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, 638 (1997) We found no such provision in the statutes or regulations.