- Email: [email protected]
View Point: Collaborative Practice Agreements—Further Evidence of Acceptance and Success
VIEWPOINT
Collaborative Practice AgreeRlents-Further Evidence of Acceptance and Success Dale B. Christensen
Pharmaceutical care as a concept is more than a quartercentury old. Yet, as a type of practice it is still in its infancy. A sociologist might well ask, why is this process taking so long? Pharmacists know the answer-obstacles and disincentives of all kinds exist in the real world of practice. A collaborative practice arrangement with a prescriber is a central ingredient in a pharmaceutical care practice. Modification of state laws and regulati<;ms to allow collaborative practice arrangements that enable pharmacists to initiate and modify drug therapy has been a long-sought goal of many state pharmacy professional organizations. Changing laws and regulations takes considerable time, effort, and financial resources, all usually in short supply. We can trace collaborative practices involving pharmacists to the Indian Health Service in the early 1970s and to successfullegislative efforts in such pioneering states as Washington, California, and Mississippi in the late 1970s. I was privileged to be involved in the formulation of the Washington regulations. It is comforting to note that practice models
Vol. 41, No.1
JanuarylFebruary 2001
involving pharmacists, nurses, and physician assistants working collaboratively with physicians are slowly becoming the norm. Currently, more than half of the 50 states have some form of collaborative practice legislation, passed in most cases within the past 5 or so years. The article by Sommers et al. l in this issue of JAPhA (pages 60-6) presents a community-based pharmaceutical care practice to prevent unwanted pregnancies and highlights a specific type of collaborative practice arrangement authorized by Washington State Board of Pharmacy regulations. The study is important in several respects. Despite its limitations (dutifully noted by the authors), the service described by Sommers et al. must be judged a success from the perspective of the patient. Although the number of women taking advantage of the service was not reported, 760 of them returned surveys. Patients were overwhelmingly (90% or more) satisfied with most qualitative dimensions of pharmacist care, including the respect accorded to the patient, the nature and completeness of the written and verbal instructions offered by the pharma-
cist, the opportunity to ask questions, and the explanations received. Encounters between patients and the pharmacists providing the service lasted an average of 11 to 15 minutes, and more than 80% of pharmacists were able to provide adequate privacy. The program must also be judged successful from a public policy perspective. The developers of this service could not have selected a more controversial therapeutic area in which to demonstrate a community-based collaborative practice arrangement. Some administrators and health care personnel erroneously equate the dispensing of a "morning after" pill with the dispensing of an abortifacient such as RU-486, despite the clear differences in their pharmacologic actions. It is noteworthy that the service was well received not only by women who took advantage of it but also by the Washington State Medicaid program, which agreed to reimburse pharmacists for the service. With legislation enabling collaborative practice arrangements being considered on almost an annual basis in many of the remaining states, it is appropriate to ask a few basic questions. Do collaborati ve practice agreements work, and do they accomplish their intent? Do they serve patients? And, finally, how satisfactory are such arrangements to the practitioners and patients who are party to them? There have been relatively few evaluative studies of the effectiveness of laws permitting pharmacists to practice in this manner. The earliest examples are descriptions of
the Indian Health Service experience and several studies conducted in California in the late 1970s and early 1980s pursuant to special legislation passed with the proviso that the practice arrangements be evaluated. 2--6 These studies consistently showed that pharmacists practicing in these new roles were as effective as physicians in rendering care, in such diverse settings as nursing homes and mental health centers. Although few studies have focused on implementation of a specific law or regulation, an extensive literature exists that describes or assesses the effectiveness of pharmacists performing clinical functions in institutional settings where collaborative practice arrangements are at least implicitly assumed to exist. 7- 10 How well collaborative arrangements work in ambulatory settings where the level of organizational control offered by institutional settings does not exist is much less clear. A MEDLINE search revealed only one recent article. In a descriptive study, Fuller et al. ll explored the nature of collaborative practice protocols in the State of Washington (across all settings) and prescriber and pharmacist satisfaction with such arrangements. 11 The authors found that formalized protocol arrangements between prescriber and pharmacist were long-lasting, averaging about 6 years. Most prescribers (98%) and pharmacists (95 %) were satisfied or highly satisfied with the protocol arrangements, and both generally agreed that the protocols increase patient convenience and the quality of patient care.
Journal of the American PhannaceuticaJ Association
15
VIEWPOINT
However, most of the protocols on file at the time of the study existed in medical clinic or managed care practice settings. From a health professional/ regulatory perspective, the high level of satisfaction among prescribers and pharmacists reported by Sommers et al. indicates that collaborative arrangements can be successfully carried out in community settings where prescriber and patient are not in close proximity to one another. The finding that satisfaction among pharmacists and prescribers who had emergency contraceptive prescribing experience was at 92% is especially noteworthy in this respect. Interestingly, there were more than twice as many chain pharmacist survey respondents as independents, and their level of satisfaction with their participation was significantly higher than that of pharmacists practicing in independent settings. Most respondents (80% or more) reported that they entered into this arrangement as a way to meet patient needs, and most feIt a professional responsibility to participate. The longevity
16
of the program (now 2.5 years and counting) also speaks to its acceptance and success. A related policy question is, Who should be allowed to engage in such collaborative practice arrangements? The Washington law and regulations are clear: any licensed pharmacist can engage in a collaborative practice arrangement. No special training or advanced degree is required, and the designation of who is and who is not a qualified applicant is left to the prescriber (subject to regulatory board oversight). Other states have taken a different approach, requiring a higher degree (e.g., PharrnD), a certificate, and a practice requirement. In most cases, I think this is an unnecessary restriction. The Washington Emergency Contraceptive Pills program exemplifies a type of self-contained collaborative practice protocol that can be impJemented easily and disserninated widely in practice for the ultimate benefit of the patient. Other examples are the prescribing and administration of flu shots by pharmacists who complete a CDC-approved training program and the initi-
Journal of the American Phannaceutical Association
ation of fluoride prescriptions for children in areas without fluoridated water. For these types of limited services, it is hard to justify the necessity for more extensive formalized training. I urge continued modification of state board of pharmacy regulations to allow collaborative practices. Such arrangements serve the public health as well as the profession of pharmacy. Dale B. Christensen, PhD, is professor and chairman, Department of Pharmaceutical Policy and Evaluative Sciences, School of Pharmacy, University of North Carolina, Chapel Hill. See related article on page 60.
References 1. Sommers SO, Chaiyakunapruk N, Gardner JS, Winkler J. The emergency contraception collaborative prescribing experience in Washington State. J Am Pharm Assoc. 2001; 41:60-6. 2. Streit RM. A program expanding the pharmacist's role .
JAm Pharm Assoc. 1973; NS13:434-6. 3. Anderson PO, Taryle OA. Pharmacist management of ambulatory patients using formalized standards of care. Am J Hosp Pharm. 1974;31:254--7.
4. Matiella A, Mease KO, Caplan MF. Portrait of a pharmacy primary care program. JAm Pharm Assoc. 1976;NS16: 455-9. 5. Stimmel GL, MeG han WF, Wincor MZ, et al. Comparison of pharmacist and physician prescribing for psychiatric inpatients. Am J Hosp Pharm. 1982;39:148H. 6. Stimmel GL, McGhan WF. The pharmacist as prescriber of drug therapy: the USC pro· ject. Drug Intelf Clin Pharm. 1981 ;15:665-72. 7. Reinders TP, Steinke WE. Pharmacist management of anticoagulant therapy in ambulant patients. Am J
Hosp Pharm. 1979;36:645-8. 8. Davis S. Evaluation of pharo macist management of strep· tococcal throat infections in a health maintenance organiza· tion . Am J Hosp Pharm . 1998;35:561-6. 9. Hatoum HT, Catizone C, Hutchinson RA, Purohit A. An eleven-year review of the pharmacy literatu re: docu· mentation of the value and acceptance of clinical pharo macy. Drug Intelf Clin Pharm . . 1986;20:33-48. 10. Singhal PK, Raisch OW, Gupchup GV. The impact of pharmaceutical services in community and ambulatory care settings: evidence and recommendations for future research. Ann Pharmacother. 1999;33:1335-55. 11. Fuller TS, Christensen DB, Williams OL. Satisfaction with prescriptive authority proto· cols. J Am Pharm Assoc. 1996;NS36:739-45.
January/February 2001
Vol. 41, No.1
Collaborative Practice AgreeRlents-Further Evidence of Acceptance and Success Dale B. Christensen
Pharmaceutical care as a concept is more than a quartercentury old. Yet, as a type of practice it is still in its infancy. A sociologist might well ask, why is this process taking so long? Pharmacists know the answer-obstacles and disincentives of all kinds exist in the real world of practice. A collaborative practice arrangement with a prescriber is a central ingredient in a pharmaceutical care practice. Modification of state laws and regulati<;ms to allow collaborative practice arrangements that enable pharmacists to initiate and modify drug therapy has been a long-sought goal of many state pharmacy professional organizations. Changing laws and regulations takes considerable time, effort, and financial resources, all usually in short supply. We can trace collaborative practices involving pharmacists to the Indian Health Service in the early 1970s and to successfullegislative efforts in such pioneering states as Washington, California, and Mississippi in the late 1970s. I was privileged to be involved in the formulation of the Washington regulations. It is comforting to note that practice models
Vol. 41, No.1
JanuarylFebruary 2001
involving pharmacists, nurses, and physician assistants working collaboratively with physicians are slowly becoming the norm. Currently, more than half of the 50 states have some form of collaborative practice legislation, passed in most cases within the past 5 or so years. The article by Sommers et al. l in this issue of JAPhA (pages 60-6) presents a community-based pharmaceutical care practice to prevent unwanted pregnancies and highlights a specific type of collaborative practice arrangement authorized by Washington State Board of Pharmacy regulations. The study is important in several respects. Despite its limitations (dutifully noted by the authors), the service described by Sommers et al. must be judged a success from the perspective of the patient. Although the number of women taking advantage of the service was not reported, 760 of them returned surveys. Patients were overwhelmingly (90% or more) satisfied with most qualitative dimensions of pharmacist care, including the respect accorded to the patient, the nature and completeness of the written and verbal instructions offered by the pharma-
cist, the opportunity to ask questions, and the explanations received. Encounters between patients and the pharmacists providing the service lasted an average of 11 to 15 minutes, and more than 80% of pharmacists were able to provide adequate privacy. The program must also be judged successful from a public policy perspective. The developers of this service could not have selected a more controversial therapeutic area in which to demonstrate a community-based collaborative practice arrangement. Some administrators and health care personnel erroneously equate the dispensing of a "morning after" pill with the dispensing of an abortifacient such as RU-486, despite the clear differences in their pharmacologic actions. It is noteworthy that the service was well received not only by women who took advantage of it but also by the Washington State Medicaid program, which agreed to reimburse pharmacists for the service. With legislation enabling collaborative practice arrangements being considered on almost an annual basis in many of the remaining states, it is appropriate to ask a few basic questions. Do collaborati ve practice agreements work, and do they accomplish their intent? Do they serve patients? And, finally, how satisfactory are such arrangements to the practitioners and patients who are party to them? There have been relatively few evaluative studies of the effectiveness of laws permitting pharmacists to practice in this manner. The earliest examples are descriptions of
the Indian Health Service experience and several studies conducted in California in the late 1970s and early 1980s pursuant to special legislation passed with the proviso that the practice arrangements be evaluated. 2--6 These studies consistently showed that pharmacists practicing in these new roles were as effective as physicians in rendering care, in such diverse settings as nursing homes and mental health centers. Although few studies have focused on implementation of a specific law or regulation, an extensive literature exists that describes or assesses the effectiveness of pharmacists performing clinical functions in institutional settings where collaborative practice arrangements are at least implicitly assumed to exist. 7- 10 How well collaborative arrangements work in ambulatory settings where the level of organizational control offered by institutional settings does not exist is much less clear. A MEDLINE search revealed only one recent article. In a descriptive study, Fuller et al. ll explored the nature of collaborative practice protocols in the State of Washington (across all settings) and prescriber and pharmacist satisfaction with such arrangements. 11 The authors found that formalized protocol arrangements between prescriber and pharmacist were long-lasting, averaging about 6 years. Most prescribers (98%) and pharmacists (95 %) were satisfied or highly satisfied with the protocol arrangements, and both generally agreed that the protocols increase patient convenience and the quality of patient care.
Journal of the American PhannaceuticaJ Association
15
VIEWPOINT
However, most of the protocols on file at the time of the study existed in medical clinic or managed care practice settings. From a health professional/ regulatory perspective, the high level of satisfaction among prescribers and pharmacists reported by Sommers et al. indicates that collaborative arrangements can be successfully carried out in community settings where prescriber and patient are not in close proximity to one another. The finding that satisfaction among pharmacists and prescribers who had emergency contraceptive prescribing experience was at 92% is especially noteworthy in this respect. Interestingly, there were more than twice as many chain pharmacist survey respondents as independents, and their level of satisfaction with their participation was significantly higher than that of pharmacists practicing in independent settings. Most respondents (80% or more) reported that they entered into this arrangement as a way to meet patient needs, and most feIt a professional responsibility to participate. The longevity
16
of the program (now 2.5 years and counting) also speaks to its acceptance and success. A related policy question is, Who should be allowed to engage in such collaborative practice arrangements? The Washington law and regulations are clear: any licensed pharmacist can engage in a collaborative practice arrangement. No special training or advanced degree is required, and the designation of who is and who is not a qualified applicant is left to the prescriber (subject to regulatory board oversight). Other states have taken a different approach, requiring a higher degree (e.g., PharrnD), a certificate, and a practice requirement. In most cases, I think this is an unnecessary restriction. The Washington Emergency Contraceptive Pills program exemplifies a type of self-contained collaborative practice protocol that can be impJemented easily and disserninated widely in practice for the ultimate benefit of the patient. Other examples are the prescribing and administration of flu shots by pharmacists who complete a CDC-approved training program and the initi-
Journal of the American Phannaceutical Association
ation of fluoride prescriptions for children in areas without fluoridated water. For these types of limited services, it is hard to justify the necessity for more extensive formalized training. I urge continued modification of state board of pharmacy regulations to allow collaborative practices. Such arrangements serve the public health as well as the profession of pharmacy. Dale B. Christensen, PhD, is professor and chairman, Department of Pharmaceutical Policy and Evaluative Sciences, School of Pharmacy, University of North Carolina, Chapel Hill. See related article on page 60.
References 1. Sommers SO, Chaiyakunapruk N, Gardner JS, Winkler J. The emergency contraception collaborative prescribing experience in Washington State. J Am Pharm Assoc. 2001; 41:60-6. 2. Streit RM. A program expanding the pharmacist's role .
JAm Pharm Assoc. 1973; NS13:434-6. 3. Anderson PO, Taryle OA. Pharmacist management of ambulatory patients using formalized standards of care. Am J Hosp Pharm. 1974;31:254--7.
4. Matiella A, Mease KO, Caplan MF. Portrait of a pharmacy primary care program. JAm Pharm Assoc. 1976;NS16: 455-9. 5. Stimmel GL, MeG han WF, Wincor MZ, et al. Comparison of pharmacist and physician prescribing for psychiatric inpatients. Am J Hosp Pharm. 1982;39:148H. 6. Stimmel GL, McGhan WF. The pharmacist as prescriber of drug therapy: the USC pro· ject. Drug Intelf Clin Pharm. 1981 ;15:665-72. 7. Reinders TP, Steinke WE. Pharmacist management of anticoagulant therapy in ambulant patients. Am J
Hosp Pharm. 1979;36:645-8. 8. Davis S. Evaluation of pharo macist management of strep· tococcal throat infections in a health maintenance organiza· tion . Am J Hosp Pharm . 1998;35:561-6. 9. Hatoum HT, Catizone C, Hutchinson RA, Purohit A. An eleven-year review of the pharmacy literatu re: docu· mentation of the value and acceptance of clinical pharo macy. Drug Intelf Clin Pharm . . 1986;20:33-48. 10. Singhal PK, Raisch OW, Gupchup GV. The impact of pharmaceutical services in community and ambulatory care settings: evidence and recommendations for future research. Ann Pharmacother. 1999;33:1335-55. 11. Fuller TS, Christensen DB, Williams OL. Satisfaction with prescriptive authority proto· cols. J Am Pharm Assoc. 1996;NS36:739-45.
January/February 2001
Vol. 41, No.1