From Confrontation to Collaboration: Collegial Accountability and the Expanding Role of Pharmacists in the Management of Chronic Pain

United States v. Workman , 990 F. Supp. 473, 475 (S.D.W.V. 1998).

See Ferro L.A. , “Collaborative Practice Agreements Between Pharmacists and Physicians: Some forward-thinking pharmacists are taking what may be the next logical step in the evolution of pharmaceutical care,” Journal of the American Pharmaceutical Association, 38 (1998): 655–666 (noting the lack of a clear consensus on what is permitted under collaborative practice agreements, but suggesting that, as a general rule, collaborative practice agreements between pharmacists and physicians permit the pharmacist to make specific types of changes in the drug therapy of a specific patient or group of patients, following a written protocol approved by the pharmacist and the physician). Arizona and Georgia recently became the 26th and 27th states to authorize collaborative practice under protocol by pharmacists. See “More States Join Movement to Pharmacist Participation in Drug Therapy Management,” American Journal of Health-System Pharmacy, 57 (2000): 1116–1117. The other states in which drug therapy management by pharmacists is currently authorized are Arkansas, California, Hawaii, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, South Dakota, Tennessee, Texas, Vermont, Virginia, and Washington.

See Grainger-Rousseau T.J. , “Therapeutic Outcomes Monitoring: Application of Pharmaceutical Care Guidelines to Community Pharmacy,” Journal of the American Pharmaceutical Association, 37 (1997): 647–661 (concluding that pharmacists can successfully implement drug therapy management in their practices, overcoming many obstacles to doing so). See also Borgsdorf L.R. Miano J.S. Knapp K.K. , “Pharmacist-Managed Medication Review in a Managed Care System,” American Journal of Hospital Pharmacy, 51 (1994): 772–777 (describing a pharmacist-managed medication review program that produced a savings of $644 per patient per year due to reduction in the number of unscheduled physician visits, urgent care visits, emergency room visits, and hospital days); Wilt V.M. , “Outcome Analysis of a Pharmacist-Managed Anticoagulation Service,” Pharmacotherapy, 15 (1995): 732–739 (describing a potential cost avoidance of $4,072.68 per person per year in a family practice setting when pharmacists manage drug therapy for improved outcomes of patients receiving warfarin therapy).

See Ferro , supra note 2. The therapies listed as being most frequently the subject of collaborative agreements between pharmacists and physicians are those that can be monitored by a pharmacist through a test of drug efficacy (i.e., blood glucose for diabetes, peak flow meter for asthma, blood lipids for hyperlipidemia, and the INR [International Normalized Ratio] for anticoagulation therapy). The efficacy of drug treatment for pain can also be monitored by a pharmacist through patient interviews regarding the level of comfort and pain sensation. See Bonomi A.E. Shikiar R. Legro M.W. , “Quality-of-Life Assessment in Acute, Chronic, and Cancer Pain: A Pharmacist's Guide,” Journal of the American Pharmaceutical Association, 40 (2000): 402–415 (describing the instruments currently available to pharmacists, and other health-care providers, through which an assessment can be made of the impact of pain on quality of life).

See 21 C.F.R. §§ 1306.11, 1306.12 (1999).

See 21 C.F.R. § 1306.05 (1999).

See Gasbarro R. , “Does the Rx Look Suspicious?,” American Druggist, 216 (1999): 48–51 (describing situations in which pharmacists have refused valid prescriptions, and advising pharmacists to attempt verification of a suspicious prescription before refusing to fill it). See also Vivian J.C. Brushwood D.B. , “Monitoring Prescriptions for Legitimacy,” American Pharmacy, 31, no. 9 (1991): 32–35 (describing the correlation between overly conservative pharmacy practice in avoidance of inappropriate dispensing and decreased access to pain medications for patients who have a legitimate need). Recent research has concluded that better communication between pharmacists and physicians may be necessary to enhance legitimate medical practice. Greenwald B.D. Narcessian E.J. , “Opioids for Managing Patients with Chronic Pain: Community Pharmacists' Perspectives and Concerns,” Journal of Pain and Symptom Management, 17 (1999): 369–375.

Drug Enforcement Administration, The Pharmacist's Manual: An Informational Outline of the Controlled Substances Act of 1970 (Washington, D.C.: U.S. Dep't of Justice, 1980): At 34.

See Joranson D.E. Gilson A.M. , “State Intractable Pain Policy: Current Status,” APS Bulletin (March/April, 1997): 7–9 (documenting a trend toward greater tolerance of opioid use in intractable pain). See also Bonomi A.E. , “Cancer Pain Management: Barriers, Trends and the Role of the Pharmacist,” Journal of the American Pharmaceutical Association, 39 (1999): 558–566 (describing an increased sense of freedom that health-care providers now have in the prescribing and dispensing of opioid analgesics to cancer patients).

See Morrison R.S. , ‘“We Don't Carry That’ — Failure of Pharmacies in Predominantly Nonwhite Neighborhoods to Stock Opioid Analgesics,” New Engl. J. Med., 342 (2000): 1023–1026 (reporting that of the pharmacies surveyed in the New York City area, 51 percent did not have in stock sufficient opioid supplies to provide adequate treatment for a single patient with severe pain).

See Joranson D.E. Gilson A.M. Ryan K.M. Maurer M.A. Nischik J.A. Nelson J.M. , Achieving Balance in Federal and State Pain Policy: A Guide to Evaluation (Madison, Wisconsin: The Pain & Policy Studies Group, University of Wisconsin Comprehensive Cancer Center, 2000) (a catalogue of the changes made by state legislatures and administrative agencies to improve the quality of pain management through clearer and more tolerant legal rules). It is available on-line at <http://www.med.wisc.edu/painpolicy/eguide2000/pdf/Evlguide.pdf>.

Florida law now provides that health-care professionals may substitute continuing education on “end-of-life care and palliative health care” for the mandatory continuing education on AIDS/HIV, as long as the licensee has completed an approved AIDS/HIV course in the immediately preceding relicensure period. Fla. Stat. 455.604 (1999).

The problem of informal policies-in-practice is compounded when regulators themselves either do not know the policies-on-paper or they fail to communicate them well to the regulated industry. This problem can, at least partially, be addressed through educational programs geared for regulators. See Joranson D.E. Gilson A.M. , “Improving Pain Management Through Policy Making and Education for Medical Regulators,” Journal of Law, Medicine & Ethics, 24 (1996): 344–47.

See Haislip G.R. , “Impact of Drug Abuse on Legitimate Drug Use,” Advances in Pain Research and Therapy, 11 (1989): 205–211 (concluding that the law is not a problem in providing an adequate supply of drugs, particularly narcotics, to patients for the treatment of intractable pain). DEA regulations formally acknowledge this perspective in a section that addresses availability of pain management medications: “This section is not intended to impose any limitations on a physician or authorized hospital staff … to administer or dispense narcotic drugs to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts.” 21 C.F.R. § 1306.07(c) (1999).

See Branding F.H. , “The Impact of Controlled Substance Federal Regulations on the Practice of Pharmacy,” Journal of Pharmacy Practice, 8 (1995): 130–137 (noting the significant relationship between the system of controlled substance distribution and the system of pharmacy practice). The effect on pharmacy practice of zealous enforcement has resulted in requests for relief from the U.S. Congress. See Conlan M. , “Lay Off! Pharmacy's Complaints About DEA Find an Ear in Congress,” Drug Topics, 142 (September 7, 1998): 70–71. The DEA has acknowledged the need to maintain a positive relationship with the pharmacy profession and to make life easier for patients and for pharmacists by removing burdensome and unnecessary regulations. See Chi J. , “DEA Scrambles to Repair Image, Build Electronic System,” Drug Topics, 143 (April 5, 1999): 54.

21 C.F.R. § 1306.04 (1999).

555 F.2d 258 (5th Cir. 1979).

972 P.2d 395 (Utah 1998).

See Vermont & 110th Med. Arts Pharmacy v. Board of Pharmacy, 177 Cal. Rptr. 807 (Cal. Ct. App. 1981).

See Ridley v. Goldman, No. 84-C4580, slip op. (N.D. Ill. Oct. 23, 1984) (available on LEXIS).

See, e.g., Karrick v. Johnson, 659 So. 2d 77 (Ala. 1995).

See Doucette W.R. , “Cancer Pain Management: Pharmacist Knowledge and Practices,” Journal of Pharmaceutical Care in Pain and Symptom Control, 5, no. 3 (1997): 17–31.

See Joranson D.E. Gilson A.M. , “Pharmacists' Knowledge of and Attitudes Toward Opioid Pain Medications in Relation to Federal and State Policies,” Journal of the American Pharmaceutical Association, 41 (2001): 213.

Pharmacists who participate as members of disease management teams can improve outcomes for patients and reduce costs of therapy. See Armstrong E.P. , “Disease Management: State of the Art and Future Directions,” Clinical Therapeutics, 21 (1999): 593–609. Educational activities by pharmacists have been shown to improve the satisfaction of patients with their pain management. See Ravnan S.L. , “Unique Pain Management Staff Education Program in a Community Hospital,” Hospital Pharmacy, 35 (2000): 498–503.

See Johnson J.A. Bootman J.L. , “Drug-related Morbidity and Mortality: A Cost-Of-Illness Model,” Archives of Internal Medicine, 155 (1995): 1949–1956.

See Huang , infra notes 35–36 and accompanying text.

602 F. Supp. 399 (S.D. Ill. 1985).

782 P.2d 1045 (Wash. 1989).

See id. at 1051.

See id. at 1053.

642 N.E.2d 514 (Ind. 1994).

See id. at 519.

The expansion of pharmacy practice into new areas of responsibility has not consistently been supported by judicial opinions that recognize an expanded legal duty for pharmacists to protect patients from problems with drug therapy. However, the prevailing view among scholarly commentators has been that legal duties for pharmacists should expand to include patient education and the prevention of problems with drug therapy. See, e.g., Fleischer L. , “From Pill-Counting to Patient Care: Pharmacists' Standard of Care in Negligence Law,” Fordham Law Review, 68 (1999): 165–187; Myhra A.G. , “The Pharmacist's Duty to Warn in Texas,” University of Texas Review of Litigation, 18 (1999): 28–82; Asbury R.P. , “Comment: Pharmacist Liability: The Doors of Litigation are Opening,” Santa Clara Law Review, 40 (2000): 907–939.

Codified at 42 U.S.C. § 1396r-8 (1999).

See Huang S.W. , “The Omnibus Reconciliation Act of 1990: Redefining Pharmacists' Legal Responsibilities,” American Journal of Law & Medicine, XXIV, no. 4 (1998): 417–442.

See id. at 434–444.

1 S.W.3d 519 (Mo. Ct. App. 1999).

See id. at 524.

See id. at 523, n.5.

See Doucette , supra note 22.

See Gilson , supra note 23.

See Grainger-Rousseau , supra note 3.

See Green J.A. Munger M.A. , “On the Fringes,” Pharmacotherapy, 9 (1989): 95–98 (describing the lag time between acceptance by pharmacists of new responsibilities for patient care and recognition of those responsibilities under administrative laws that govern the practice of pharmacy).

See Bonomi , supra note 9.

See, e.g., Temin P. , “The Origin of Compulsory Drug Prescriptions,” Journal of Law & Economics, 22 (1979): 91–105 (describing the almost accidental separation of medicinal drugs into two classes — Prescription and Non-Prescription — without statutory authority, but also without objection).

See id.

See, e.g., Mitchell C.N. , “Deregulating Mandatory Medical Prescription,” American Journal of Law & Medicine, XII, no. 2 (1986): 207–239 (arguing that public safety needs do not and cannot justify the mandatory prescription controls that are in place today).

See, e.g., Rook L.W. , “Listening to Zantac: The Role of Non-Prescription Drugs in Health Care Reform and the Federal Tax System,” Tennessee Law Review, 64 (1994): 107–153 (describing the growth in drugs being switched from prescription to non-prescription status, and arguing for insurance coverage of non-prescription drugs).

See Grainger-Rousseau , supra note 3 (describing improved outcomes for patients as a result of collaborative practice). The improvements in outcomes for patients produced by collaborative practice have led to reimbursement for pharmacy services within collaborative practices. See Poirer S. Buffington D.E. Memoli G.A. , “Billing Third Party Payers for Pharmaceutical Care Services,” Journal of the American Pharmaceutical Association, 39 (1999): 50–64.

508 A.2d 1247 (Pa. Super. Ct. 1986).

Id. at 1250.

See Grainger-Rousseau et al., supra note 3.

State boards of pharmacy have begun to shift their emphasis from the structure and process of pharmacy practice to the outcomes that pharmacists produce in their practice. Regulatory recognition of collaborative practice is just one example of the move toward outcomes-oriented regulation. See Nau D.P. Brushwood D.B. , “State Pharmacy Regulators' Opinions on Regulating Pharmaceutical Care Outcomes,” Annals of Pharmacotherapy, 32 (1998): 642–647.

See Bonomi , supra note 9. See also Bonomi , “Quality-of-Life Assessment in Acute, Chronic, and Cancer Pain: A Pharmacist's Guide,” Journal of the American Pharmaceutical Association, 40 (2000): 402–416 (describing the increasingly important role pharmacists play in pain management and the importance of quality-of-life assessment in the management of pain).

See 21 C.F.R. § 1306.13 (1999).

See 21 C.F.R. § 1306.11 (1999).

See Rich B.A. , “A Prescription for Pain: The Emerging Standard of Care For Pain Management,” William Mitchell Law Review, 26 (2000): 1–68 (suggesting that a prescriber who has been accused of inappropriate use of opioid analgesics will be able to successfully defend against the accusation by referring to evidence-based clinical practice guidelines validated by expert testimony).