CRITICAL ANALYSIS OF THE CONTENT AND ENFORCEMENT OF MANDATORY CONSULTATION AND PATIENT PROFILE LAWS Michael B. Nicholand Lucy W. Michael
See also page 1148.
This study evaluates the experience of 12 states that mandate that pharmacists provide consult services to patients and maintain drug profiles.
OBJECTIVE:
An analysis of each state's statutes and regulations was complemented by telephone interviews of state licensing board staff. DATA SOURCES:
RESULTS: Nine states specify the information to be provided during consultations, but only one (Florida) requires a comprehensive list of drug information, including adverse drug reactions, drug-drug interactions, directions for use, and necessary warnings. Eleven of the 12 states also require pharmacists to maintain patient drug profiles, but only 6 states specify the type of information to be included in profiles. State efforts to inform consumers about the pharmacist consultation requirement are limited, with only 7 states undertaking minimal promotional programs. The fact that no states reported any consumer consultation complaints or disciplinary actions against pharmacists for failure to consult illustrates the limited nature of mandatory consultation statutes and regulations.
The wide variety of requirements demonstrates that these laws do not represent a uniform standard of practice. The lack of documented evidence regarding implementation invites questions regarding their usefulness and reinforces the need for enhanced monitoring activities. CONCLUSIONS:
Ann Pharmacother 1992;26:1149-55. ALTHOUGH PRESCRIPTION MEDICATIONS provide relatively inexpensive solutions to many medical problems, they all too frequently create their own set of concerns. A variety of unfavorable medical events, including treatment failure and increased hospital readmissions, can be attributed to improper medication use.' A number of studies have dem-
MICHAEL B. NICHOL, Ph.D .. is an Assistant Professor, Department of Pharmaceutical Economics and Policy, School of Pharmacy, University of Southern California, PSC 700, 1985 Zonal Ave., Los Angeles, CA 90033; and LUCY W. MICHAEL, Pharm.D. is a Clinical Resident, Department of Pharmacy Services, University of Illinois at Chicago Hospitals and Clinics, Chicago, IL. Reprints: Michael B. Nichol, Ph.D. Adapted from a presentation at the 1992 American Pharmaceutical Association Annual Meeting, San Diego, CA, March IS, 1992.
onstrated that prescription medication misuse is both prevalent and costly. For example, one study showed that the overall incidence of adverse drug reactions was 12.4-15.3 percent in patients taking prescribed medications. Medication problems increased with the number of drugs taken by the patient: 10.8 percent of patients taking one drug experienced an adverse reaction, and 27 percent of those taking six or more drugs had an adverse drug reaction.' Miller found that 3.7 percent of all hospital admissions in seven hospitals were directly caused or strongly influenced by adverse drug reactions.' Caranasos et al. attributed 2.9 percent of all admissions to a major teaching hospital in Florida during a three-year period to drug-induced illness." More recent studies have consistently reinforced these earlier results.v" In fact, the state of California has estimated that the hospitalization of elderly patients for the treatment of adverse drug reactions costs the state $340 million per year," These figures are not surprising, as elderly patients are at particular risk for confusion because of polypharmacy and muddled medication instructions."'" At a minimum level of effectiveness, patient counseling can improve compliance and satisfaction.r'"? In its best light, patient consultation can potentially optimize patient care and therapeutic outcome by ensuring the appropriate administration of medications and reducing the confusion often associated with multiple drug therapy. Because they are the patient's final contact with the healthcare system before the initiation of drug therapy, pharmacists have both the opportunity and the training to monitor the therapy and prevent negative outcomes. Pharmacists can play an important role in preventing adverse drug reactions and drug interactions in addition to providing education to patients regarding the use of medications and the importance of compliance with therapy. One study of an elderly population demonstrated that pharmacist counseling can result in the use of fewer medications and improvements in the appropriateness of the treatment regimen." Unfortunately, the existing evidence indicates that pharmacists provide relatively little consultation to patients regarding both prescription and over-the-counter medications't-" and generally are not perceived to be significant primary providers of drug information by consumers."
The Annals ofPharmacotherapy •
1992 September, Volume 26 •
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Since 1981, a number of states have taken action to require pharmacists to accept a major role in providing patient consultation regarding drug use and monitoring drug therapy. As of 1989, 17 states and one federal district reported that pharmacists were required to provide drug consultation to patients." The primary goal of this article is to evaluate the specific provisions of mandatory consultation statutes and associated regulations, and to determine the extent to which states enforce these provisions. The secondary goal is to extend this analysis to patient profile systems, which can provide important information about the patient's medical and drug history for use during counseling. The first section of this article details the specific provisions of state pharmacy statutes and regulations that mandate consultations. The second section considers the actions these states have taken to enforce these policies. The third section provides similar information about state statutes and regulations regarding patient medication profiles, and the fourth section discusses the results. Conclusions, future research needs, and policy implications derived from our major fmdings constitute the final part of the article.
State Maruliltory Consultation The information presented in this article was compiled from the written pharmacy statutes and regulations from 12 of the 17 states and one federal district that reported that mandatory patient consultation had been enacted prior to 1990. 22 This year was selected as a benchmark to ensure that mature programs were assessed, rather than programs in states that have recently introduced this legislation. Six states were not surveyed because their patient consultation requirements are limited. In these cases, consultation was "encouraged" (Connecticut), or required only "if needed" (California, Colorado, District of Columbia, New York), or the state only required that "a pharmacist must be available to provide consultation" (Illinois). In 1990, the state of California passed legislation requiring pharmacist consultation," but the implementation of this standard has been postponed until November 1992. After abstracting information from state statutes, telephone interviews were conducted with pharmacy board staff members who were knowledgeable about the legal aspects of the practice of pharmacy in their state. This information augmented the legal description, but did not supplant it. Finally, a draft of the manuscript was sent to the executive director of each state board to allow comments and factual corrections. Three factors were investigated with regard to the state statutes and regulations on patient consultation by pharmacists: (1) whether the mandatory consultation provision appears in statute, regulation, or both; (2) whether the mandate specifies communication style (written, oral, or telephone); and (3) the type of information required to be communicated through consultation. These three factors can provide insight into the standards of practice adopted by the state, and the degree to which these standards reflect professional and consumer concerns. The 12 states that mandate consultation are split regarding their legal source: 7 states include mandatory consultation provisions as part of the state pharmacy statutes, and 7 states require consultation through regulation (Table 1). Two states, Kansas and Florida, mandate pharmacist con-
Table 1. Location of the Mandatory Consultation Provisions: Statute Versus Regulation STATE
Delaware Florida Kansas Maine Massachusetts New Jersey North Dakota Oregon Utah Washington West Virginia Wisconsin
STATUTE
REGULATION
no yes yes yes no no yes no yes yes no yes
yes yes yes no yes yes no yes no no yes no
Table 2. Method of Consultation for New Prescriptions8 STATE
ORAL
WRITTEN
TELEPHONE (if delivered)
Delaware Florida Kansas Maine Massachusetts New Jersey North Dakota Oregon Utah Washington West Virginia Wisconsin
yes no yes yes yes no yes no yes yes no no
yes no no yes yes no yes no no yes no no
yes no no yes no no yes no no yes no yes
•As specified in state statutes or regulations.
sultation through both state law and board of pharmacy regulations. Although some of the states that mandate consultation in pharmacy state statutes appear to have more stringent requirements than those that require consultation by regulation, the presence of a legal mandate does not appear to predict the aggressiveness of the state regarding specific provisions of the consultation requirement. The second parameter examined was the method used to transmit information to the patient. Three methods were considered in this investigation: (1) oral, (2) written, and (3) telephone consultation with a required statement about the availability of this method if the medications are delivered to the patient. Four states mention all possible methods (oral, written, telephone) as appropriate consultation techniques (Table 2). One state mentions both oral and written consultation, two states mention only oral consultation, and four states do not specify the method by which drug information is to be conveyed to the patient. One state does not specify the consultation technique, but does require the pharmacist to be available for telephone consultation if the prescription medication is delivered to the home. The third factor investigated was the content of the consultation: whether the statutes and regulations specify a minimum amount or type of information to be conveyed to the patient in the course of consulting (Table 3). We noted that 9 of the 12 states identify specific information to be communicated to patients, such as directions for the use of medication, possible adverse effects, expected response to the medication, drug-drug interactions, and warnings.
1150 • The AnnalsofPharmacotherapy • 1992 September, Volume26
Opinions
Three states do not specify the information they require to be communicated to patients, but rather depend upon the pharmacist's professional judgment to determine the need and content of consultation. Only 1 state (Florida) requires the pharmacist to provide consultation on all five topics, and only 1 other state (Oregon) includes four of the five topics. In most states, the burden of statutory interpretation, particularly as it relates to the specific information to be communicated to the patient, rests with the individual pharmacist. Implementation/Enforcement
Statutes that regulate the profession are not sufficient, in and of themselves, to accomplish the task of patient consultation. Only when they are accompanied by implementation and enforcement systems do statutes become powerful forces that can shape the profession. States that have developed and implemented a monitoring system are prepared to evaluate compliance with the law. Three enforcement factors were assessed: the extent to which pharmacists are required to document consultation, the use of promotional efforts to educate the public about mandated consultation, and the number of consumer complaints filed with the state pharmacy board. These three elements were selected because they indicate pharmacist and state agency commitment to mandatory consultation implementation. Telephone interviews with state board of pharmacy staff were conducted to establish the extent to which mandated consultation statutes and regulations are enforced in the 12 states. Eleven of the 12 states responded to our requests for information regarding the enforcement of these patient consultation provisions. The survey revealed that none of the 11 states require documentation of consultation nor do they uniformly monitor pharmacist consultation. Because no state guidance is provided regarding documentation, pharmacists must determine when it is necessary to record data about the encounter. Seven of the 11 states require inspectors to monitor the consultations by observation during routine inspections. Of the 4 states that do not monitor patient consultation during routine inspection, 1 considers the mandate to be "unenforceable," and another considers the opportunity to com-
municate to be a professional obligation rather than a strict law that must be enforced. The promotional activities of the state pharmacy boards to inform patients about their right to receive consultation varied considerably. Five of the 11 states reported using a promotional method of some kind, although only 2 state programs mentioned any type of systematic attempt to educate consumers about this mandate (Table 4). Comments by the staff members in states that do not make any special effort to inform consumers reveal important attitudes regarding this activity. One staff member indicated that the board felt no need for promotion as "people know about it." The pharmacy board of another state indicated that consultation is part of the practice and "is always done"; thus, no promotional strategies were adopted. A third state reported no promotional activities sponsored by the board, but indicated that senior citizen interest groups and the local media have promoted these services. Finally, an attempt was made to assess the methods by which the pharmacy boards resolve consumer complaints about mandated consultation and whether the boards consider these infractions to be serious violations of state law or regulation. We explored the nature of board enforcement by determining whether consultation complaints were handled differently than other types of complaints, the number of complaints received about pharmacist consultation services, the number of pharmacists specifically disciplined for failure to provide consultation services to patients, and the severity of the discipline used. All states reported that consumer complaints about consultation services would be resolved using standard procedures for complaints of any type. No board official from any state was able to recall the number of consultation complaints received by the board on a weekly, monthly, or even an annual basis. They were also unable to report the number of pharmacists who had been disciplined for consultation inadequacies. Upon further probing, none of the pharmacy board staff members could remember a single instance in which a consumer had complained about consultation or a pharmacist had been disciplined for not providing consultation. However, one state indicated that warning notices had been issued to pharmacies that did not have a system for consultation in place, and that disciplinary actions would be initiated in
Table 3. Information Required for Patient Consultation"
STATE
Delaware Florida Kansas Maine Massachusetts New Jersey North Dakota Oregon Utah
Washington West Virginia Wisconsin
REQUIRED INFORMATION SPECIFIED
ADR/RESPONSE
DRUG-DRUG INTERACTION
DIRECfIONS FOR USE
WARNINGS
no yes yes yes no yes yes yes yes yes yes no
no yes no no no no no yes yes no no no
no yes no no no yes no no no yes no no
no yes yes yes no yes yes yes yes yes yes no
no yes no no no no yes yes no no yes no
OTHER INFORMATION
yes yes no yes yes no yes yes" no yes yes yes
ADR =adverse drug reaction. •As specifiedin state statutes or regulations. bWhen necessary.
The Annalsof Pharmacotherapy • 1992 September, Volume 26 • 1151
the near future for failure to provide consultation. All states indicated that when a pharmacist had been identified as not meeting the requirements of the consulting mandate, there were usually more significant violations that served as the basis for disciplinary action. Recent action against two Kansas pharmacists reinforces this notion, as these professionals were disciplined primarily for inappropriate prescription labeling or brand exchange, but secondarily for failure to provide consultation."
PatientProfiles As noted earlier, a patient medication profile is a necessary precondition for appropriate patient consultation. Information such as allergies, adverse drug reactions, past idiosyncratic reactions to medications, drug history, and other medications taken concomitantly must be obtained before a pharmacist can effectively consult with the patient. Pharmacists generally do not have direct access to complete patient medical records (with the possible exception of some ambulatory care settings and health maintenance organizations); thus, they must acquire the information directly from the patient. Because it has been estimated that 70-80 percent of all patients receiving prescriptions use a single pharmacy.P a patient medication profile may provide adequate information for most consultations. Although the ac-
Table 4. Promotional Methods Employed by States STATE
PROMOTIONAL METHOD
Delaware Florida Kansas Maine Massachusetts New Jersey North Dakota Oregon Washington Utah West Virginia Wisconsin
media campaigns (emphasized on talk shows) continuing education programs for pharmacists video available from the state pharmaceutical association none none did not respond" public relations carnpaigns/vNotice to The Public" some media coverage public information brochure none none none
"Pharmacy board staff could not be contacted for interview.
curacy, reliability, and completeness of the profile may be compromised by limitations characteristic of patient selfreporting, a patient medication profile constitutes the only available alternative at this time. Therefore, it is not surprising that most of the states that mandate consultation also require maintenance of patient medication profiles. The statutes and regulations that govern required patient medication profiles in these states were examined in three areas: (1) the type and extent of information required, (2) the use of the profile, and (3) the duration it should be maintained. As with our investigation of mandatory consultation, the combination of these elements defmes a minimum standard of practice for patient care that identifies important situations in which the patient profile should be used, not to limit its use, but to clarify the intent of the law or the regulation. Because legal guidelines are subject to literal interpretation by clinicians and legal professionals, it is critical to defme a minimum standard of practice carefully and comprehensively. Ten states that mandate consultation also require pharmacists to maintain patient medication profiles. One state mandates patient profile maintenance only if the patient requests it (Utah), and another includes the requirement only for patients purchasing parenteral and enteral preparations (West Virginia). Five categories are used to defme the type and extent of information required: patient and drug identification, allergy, idiosyncratic reactions, adverse drug reactions, and chronic conditions (Table 5). Virtually all of these ten states complemented their requirements for specific information in the patient medication profile with a statement allowing pharmacists to use their professional judgment to obtain other pertinent information. Only one element, patient and drug identification information, is commonly required in the patient medication profile. Six states require information on allergies, idiosyncratic reactions, and chronic conditions to be recorded. Only one state (Wisconsin) explicitly requires the pharmacist to obtain information about adverse drug reactions. It is notable that state efforts to regulate patient profile activities can be characterized as "all or nothing": six states require their pharmacy professionals to collect nearly all of the relevant information, and the other five allow the pharmacist to determine which information should be collected.
Table 5. Information Recorded in Patient Profiles" STATE
PATIENT ID
ALLERGY
Delaware Florida Kansas Maine Massachusetts New Jersey North Dakota Oregon C Utah Washington West Virginiad Wisconsin
yes yes yes yes yes yes yes yes yes yes no yes
yes no no yes no yes yes" no no yes no
yes"
IDIOSYNCRATIC REACTIONS
ADVERSE DRUG REACTIONS
CHRONIC CONDITIONS
yes no no yes no yes yes no no yes no yes
no no no no no no no no no no no yes
yes no no yes no yes yes no no yes no yes
ID = identification. "As specified in state statutes or regulations. bMust indicate if none. 'Profile is maintained only if patient requests it. dFor enteral/parenteral compounding only.
1152
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The Annals ofPharmacotherapy •
1992 September, Volume 26
Opinions
Seven states mandate that pharmacists review patient medication proftles for possible drug interactions, allergies, or other contraindications before dispensing a new prescription (Table 6). Six states specifically require pharmacists to contact the prescriber if the review of the patient medication profile reveals the new therapy to be inappropriate or possibly harmful to the patient. Three states allow pharmacists to use patient medication proftles for prescription refill documentation. Monitoring and disciplinary actions are recognized as two key factors in ensuring compliance with the mandates. In contrast to the consultation mandate, evidence of compliance with these requirements should be reasonably easy to obtain. All of the ten states responded to our telephone requests for information regarding the monitoring of compliance with patient proftle requirements. Six states monitor maintenance of patient medication proftles during regular inspection, and two of these states indicated that inspectors monitor pharmacist use of the profiles during inspection. A third state uses patient complaints to monitor compliance with this requirement. The remainder of the states have not implemented any monitoring procedures for patient medication profile maintenance or use. Pharmacists who violate the patient profile requirement are subject to a variety of disciplinary actions, depending on the severity of the offense and its consequences. All states process patient profile violations in the same manner as other practice infractions. Most state board staff members reported that noncompliance with medication profile maintenance was viewed as a "symptom" of a more serious deficit in professional conduct, which required further inspection and investigation. It is important to note that none of the state officials interviewed was able to identify the number of pharmacists who have been disciplined specifically for violating the patient profile requirement, nor could they confirm that such action has been taken.
Discussion A number of observations can be drawn from this information on mandatory consultation and patient profiling. First, it appears that there has been considerable variation in the adoption and enforcement of these standards. The fact that some states consider mandatory consultation important enough to require legislation rather than regulation by their professional boards may reveal significant differences in legislative attitudes toward consumer protection and professional standards. The degree to which a communication style is mandated measures the completeness of the statutes and regulations. Statutes and regulations that specify the communication technique to be used in consultations reflect an understanding of the gap in consumer knowledge about drug therapy and recognize pharmacists' capability of bridging this gap. The extent to which the statutes and regulations address the content of the consultation (e.g., medication name, directions, adverse drug reactions, drug interactions) indicates the value of patient consultation as perceived by the regulators. The combined effects of these dimensions defme the performance standards for professional consultation and should ensure that quality patient care is provided by pharmacists. However, these results demonstrate a wide range of approaches for regulating this type of professional behavior.
Table 6. Use of Patient Profiles"
STATE
Delaware Florida Kansas Maine Massachusetts New Jersey North Dakota Oregon Utah Washington West Virginia" Wisconsin
REVIEW CONTACT BEFORE MDIF USE FOR DURATION OF DISPENSING NECESSARY REFILLS MAINTENANCE
yes no yes yes no yes yes no no yes no yes
yes no yes yes no yes yes no no yes no no
no no no no no yes no yes no no no yes
1y not specified 5y 5y not specified 5y 5y Iy Iy not specified not specified 5y
MD =physician. •As specified in state statutes or regulations. bFor enteral/parenteral compounding only.
Second, some states seem to reflect some ambivalence toward regulating professional counseling and profiling behavior. This can be illustrated by the important inconsistencies in some state statutes and regulations with regard to the information required to be communicated to the patient and the information that must be maintained on patient proftles (Tables 3 and 5). On one hand, two states with extensive consultation requirements also have explicit patient profile requirements (i.e., North Dakota, Washington). On the other hand, states such as Florida and Oregon require pharmacists to provide a full range of information during patient consultations, but do not require maintenance of this information on patient profiles. States such as Delaware and Maine require pharmacists to maintain extensive patient profiles, but do not require communication of these details to consumers during consultation. These inconsistencies call into question the commitment of these state programs to develop standards of practice. Third, it is also noteworthy that no state boards conduct aggressive promotional activities to inform consumers of their right to consultation. This element is particularly important because educating patients about these statutes and regulations may directly contribute to the effectiveness of their enforcement and reflects the significance of the mandate as viewed by the respective boards of pharmacy. Promotional activities are necessary because patients are not likely to know that pharmacists are required to provide information, nor are they likely to be aware of the value that can be gained. Given the limited knowledge of the average patient about medications and therapy, patient requests for consultation may be infrequent in the absence of any promotional program.
Policy Implications Regulating patient consultation and drug therapy management has always been a controversial matter. Many pharmacists and pharmacy boards consider patient consultation to be integral to the standard of pharmacy practice and they see no reason to specify such behavior in regulation; others feel that regulation is necessary to clarify professional responsibilities in patient care. Our study shows that the mandatory consultation statutes and regulations al-
The Annalsof Pharmacotherapy • 1992 September, Volume 26 •
JJ53
low pharmacists considerable latitude in their interpretation and implementation. Some states require pharmacists to consult with patients orally on any new prescriptions and the pharmacists can supplement this oral consultation with written material. Some states require only oral or written consultation, and others demand that pharmacists inform their patients that they are available for telephone consultation. The wide variation in this requirement indicates that there is little agreement regarding a minimal standard of professional practice. This variation could also signify that this area is sufficiently new, and so the standards are in an evolutionary stage. Any innovation by individual states may prove to be critical to the development of a professional consensus. Perhaps the time is ripe for the development and implementation of uniform approaches, such as the model legislation for patient counseling developed by the National Association of Boards of Pharmacy." It is also clear that additional effort must be expended in monitoring and promoting these requirements. Compliance with these regulations can be monitored in a number of ways, including direct observation, documentation, and patient complaints. Direct random observation may be the most expensive and most effective method, but the lack of resources available to pharmacy boards makes it the least likely method to be used. Direct observation during board inspection may be appropriate, but this is likely to mean that pharmacist compliance is monitored only annually or biennially, at best. Pharmacists' documentation of their performance could be considered burdensome and time consuming and may increase the cost of dispensing drugs. On the other hand, without documentation, it may be difficult for pharmacists to defend themselves against illegitimate patient complaints or perceived noncompliance with the law. Although patient complaints provide another tool with which consultation can be monitored, the information gap that exists between patients and pharmacists regarding required consultation makes the utility of this approach questionable. Although few states have used the media to educate the public about their legal rights to receive consultation, the level of public knowledge has not been evaluated. Because the asymmetry in information between professionally trained clinicians and the public has been welldocumented.f-" large-scale education campaigns and other methods to remind patients about their counseling entitlements are essential. Patient demand for these services may provide an effective way to ensure pharmacists' compliance with these statutes and regulations. Although legislation may aid in establishing the standard of practice, statutes must be combined with enforcement to accomplish this task. Monitoring and enforcement represent two parts of the standard-setting process and both must be present for the process to be viable. The information gained in our study leads to several rather obvious hypotheses: Either pharmacists in these states are providing appropriate consultation to all patients or state boards are not aggressively pursuing pharmacists who fail to counsel. An alternative hypothesis was mentioned by a state staff member, who noted that pharmacy boards may be providing a grace period to permit pharmacies and pharmacists to prepare for these requirements prior to initiating tough enforcement. However, 10 of the 12 states have required consultation since 1982. 29 It is not clear which of these hypotheses may explain the lack of enforcement activity evi-
1154 •
dent in these results, but these data certainly strengthen the importance of enforcement. This study does not address whether mandated counseling and patient profiling yield better patient care. However, these results do question whether the enactment of statutes and regulations predicts the extent to which they are then reflected in professional practice. This issue is particularly conspicuous as the Health Care Financing Administration and state governments begin to implement the patient profiling and mandatory counseling provisions of the 1990 Omnibus Budget Reconciliation Act. 30 It is impossible to predict whether these federal requirements will produce a fundamental change in the pharmaceutical care provided to Medicaid patients, but the need for monitoring and enforcement is reinforced by these fmdings. Further research regarding mandatory consultation and the use of patient drug profiles should focus on the extent to which these statutes do, in fact, change professional pharmacy practice and improve patient outcomes. Existing studies of mandatory patient consultation have been limited to investigations conducted in Washington state" and Kansas." Although both of these studies sampled a large number of pharmacists throughout their states, the fact that each pharmacist was tested only once calls into question whether normal practice was assessed. These studies do provide some indication that mandates may improve the level, but not necessarily the quality, of consultation. Future studies of the impact of mandatory consultation should attempt to determine whether it has improved quality of care. Additional cross-sectional studies may show that states with mandatory consultation experience improved patient compliance, fewer drug interactions, or fewer hospital admissions caused by adverse drug reactions. Until some demonstration of positive patient outcomes can be documented, the potential value of these laws will remain a mystery. ce
The authors express their appreciation to all state pharmacy boards and staff who participated in this study.
References I. Manasse HR. Medication use in an imperfect world: drug misadventuring as an issue of public policy, part I. AmJ HaspPharm 1989;46:929-
44. 2. Williamson J, Chopin JM. Adverse reactions to prescribed drugs in the elderly: a multicenter investigation. Age Ageing 1980;9:73-80. 3. Miller RR. Hospital admissions due to adverse drug reactions. ArchIn-
ternMed 1974;134:219-23. 4. Caranasos GJ, Stewart RH, Cluff LE. Drug-induced illness leading to hospitalization.JAMA 1974;228:713-7. 5. Hallas J, Harvald B, Gram LF, Grodum E, Brosen K, Haghfelt T, et aI. Drug related hospital admissions: the role of definitions and intensity of data collection, and the possibility of prevention. J Intern Med 1990;228:83-90. 6. Col N, Fanale JE, Kronholm P. The role of medication noncompliance and adverse drug reactions in hospitalizations of the elderly. Arch In-
ternMed 1990;150:841-5. 7. Lakshmanan MC, Hershey CO, Breslau D. Hospital admissions caused by iatrogenic disease. ArchInternMed 1986;146:1931-4. 8. Schneider JK, Mion LC, Frengley JD. Adverse drug reactions in an elderly outpatient population. Am J Hasp Pharm 1992;49:90-6. 9. Ives TJ, Bentz EJ, Gwyther RE. Drug-related admissions to a family medicine inpatient service. Arch Intern Med 1987;147:1117-20. 10. Steffen R. Medication risks among the elderly: cures, cautions, and con-
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Opinions sequences. Sacramento: AssemblyOfficeof Research, Stateof California Assembly, 1989. II. Tymchuk AJ. Readabilitylevels of over-the-counter medications commonly used by elderly people: a possible issue in compliance. Ed Gerontoll990;16:491-6. 12. Rosenberg JM, Dolinsky 0, Kirschenbaum HL, Wojcik LJ, Lomax JD. Elderly ambulatory care patients' knowledge about drugs. Hosp Pharm 1984; 19:289-301. 13. Moore SR, Kalu M, Yavaprabbas S. Receipt of prescriptiondrug information by the elderly.Drug IntellCUn Pharm 1983;17:920-3. 14. Ley P. Communicating with patients:improvingcommunication, satisfaction, and compliance. London:Croon Helm, 1988. 15. Buller MK, Buller DB. Physicians' communication style and patient satisfactionJ HealthSoc Behav 1987;28:375-88. 16. Myers ED, Calvert EJ.lnformation, compliance and side-effects: a study of patients on antidepressant medication. Br J CUn Pharmacol 1984;17:21-5. 17. Svarstad B. Physician-patientcommunication and patient conformity with medical advice. In: Mechanic D, ed. The growth of bureaucratic medicine. New York:John Wiley & Sons, 1976:220-38. 18. Hammarlund ER, Ostrom JR, Kethley AJ. The effectsof drug counselingand othereducational strategies on drug utilization of the elderly. MedCare 1985;23:165-70. 19. Morris LA. A survey of patients' receipt of prescriptiondrug information. Med Care 1982;20:596-605. 20. Dickson WM, Rodowskas CA. Verbalcommunications of community pharmacists. Med Care 1975;13:486-98. 21. Cutler NE, Lowe BF, Williams BR, Steckenreider J. Medicine,selfcare, and the independent elderly: pharmaceutical consultation as a community service.Final report, Administration on Aging Grant #90AT-0376,September1990. 22. National Association of Boards of Pharmacy. Survey of pharmacy law: 1988-1989.Park Ridge, IL, 1989. 23. 16Californiacode of regulations 1707.2. 24. Disciplinary actions. KansasStateBoard of PharmacyNews 1991; 12(1): 1,4.
25. Kirking OM, Thomas JW, Ascione FJ, Boyd EL. Detectingand preventingadversedrug interactions: the potential contribution of computers in pharmacies. Soc Sci Med 1986;22: 1-8. 26. National Association of Boards of Pharmacy, Omnibusbudget reconciliation act of 1990 patient counseling and drug use review requirements.Park Ridge, IL, 1992. 27. Peltzman S. Toward a more general theory of regulation.Z Law Econ 1976;19:211-48. 28. Graddy E. Interest groups or the public interest-why do we regulate healthoccupations?] HealthPolit PolicyLaw 1991;16:25-49. 29. National Association of Boards of Pharmacy. Survey of pharmacy law: 1981-1982.Park Ridge, IL, 1982. 30. American Society of Hospital Pharmacists. Summary of 1990 Medicaid drug rebatelegislation. Am] Hosp Pharm 1991;48:114-7. 31. Campbell RK, Baker DE, Jinks MJ, Evenson St. Amand LM. Compliancewith Washington state's professional practiceregulations: 1974 vs. 1987.Am Pharm 1989;NS29:42-8. 32. Ross SR, White SJ, Hogan LC, Godwin HN. The effectof a mandatory patientcounseling regulation on the counselingpractices of pharmacy practitioners. ContempPharmPract 1981;4:64-8.
EXTRACfO
Evaluar la experiencia de doce estados en los cuales se manda el aconsejamiento de pacientes y el mantenirniento de perfiles de medicamentos por el farmaceutico. OBJETIVO:
FUENTES DE INFORMACION: Se complement6 el analisis de los estatutos y regulaciones estatales con entrevistas telef6nicas con personal de las juntas de licenciatura de cada estado. RESULTADOS: Nueve estados especifIcan la informaci6n que debe proveerse durante las consultas, pero s610 un estado (Florida) requiere una lista comprehensiva de infonnaci6n de drogas incluyendo reacciones adversas, interacciones medicamentosas, direcciones para el U50, y precauciones necessarias. Once de los dace estados tambien requieren el mantenirniento de perfiles de medicamentos de cada paciente. Esfuerzos por parte de los estados para informar a los consumidores acerca del requerirniento de las consultas son limitados, con s610siete estados emprendiendo un programa promocional mfnimo. EI hecho de que ningunestado ha reportado quejas por parte de los consumidores, ni acciones disciplinarias contra farmaceuticos por no cumplir con los requerimientos, ilustra la naturaleza limitada de los estatutos y regulaciones de consulta mandatoria. CONCLUSIONES: La extensa diversidad en los requerirnientos de cada estado demuestra que estas leyes no representan un estandard uniforme de practica. La falta de evidencia documentada con respecto a la implementaci6n de estos requerirnientos invita preguntas acerca de su utilidad y refuerza la necesidad de mejor vigilancia de estas actividades.
CHRISTINADALMADY-ISRAEL
RESUME
Cette etude evalue l'experience des 12 etats americains qui requierrent de la part des pharmaciens la consultation aupres de leurs patients etla tenue de dossiers pharmacologiques.
OBJECI1F:
REVUE DE LITTERATURE: One analyse de la reglementation de chacun des etats a ete completeed'une entrevue telephonique avec Ie personnel de chacune des associations professionnelles concernees, RESULTATS: Neuf des 12 etatsspecifient l'information 11 transmenre aux
patients. C'est l'etat de la Floride qui possede la description la plus complete de l'infonnation 11 transmenre: les reactions indesirables, les interactions medicamenteuses, les directives d'utilisationetles avertissements. Onze des 12 etats requierrent du pharmacien la tenue d'un dossier pharmacologique mais seulement6 etats specifient quelles sontles informations qui doivent y etre inscrites. Les associations professionnelles ne font que Ires peu de promotion de ce service aupres du public. Seul 7 etats mentionnentl'utilisation de methodes promotionnelles plus ou moins varices. Aucun des 12 etats n'a enregistre de plaintes de la part du public au sujet de la consultation ou la tenue d'un dossier. CONCLUSIONS: La reglementarion actuelle laisse au pharmacien beaucoup de latitude dans l'interpretation etla mise en application de la consultation et de la tenue des dossiers. La variation existant entre les differents etats demontre une deficience au niveau de la standardisation de la pratique. Les evidences de l'utilite d'une telle pratique sont peu nombreuses et jusqu'a ce qu'on puisse en demontrer l'utilite, I'importance de la reglementation demeure un mystere, SUZANNE LAPLANTE
The Annals ofPharmacotherapy • 1992 September, Volume 26 • 1155
See also page 1148.
This study evaluates the experience of 12 states that mandate that pharmacists provide consult services to patients and maintain drug profiles.
OBJECTIVE:
An analysis of each state's statutes and regulations was complemented by telephone interviews of state licensing board staff. DATA SOURCES:
RESULTS: Nine states specify the information to be provided during consultations, but only one (Florida) requires a comprehensive list of drug information, including adverse drug reactions, drug-drug interactions, directions for use, and necessary warnings. Eleven of the 12 states also require pharmacists to maintain patient drug profiles, but only 6 states specify the type of information to be included in profiles. State efforts to inform consumers about the pharmacist consultation requirement are limited, with only 7 states undertaking minimal promotional programs. The fact that no states reported any consumer consultation complaints or disciplinary actions against pharmacists for failure to consult illustrates the limited nature of mandatory consultation statutes and regulations.
The wide variety of requirements demonstrates that these laws do not represent a uniform standard of practice. The lack of documented evidence regarding implementation invites questions regarding their usefulness and reinforces the need for enhanced monitoring activities. CONCLUSIONS:
Ann Pharmacother 1992;26:1149-55. ALTHOUGH PRESCRIPTION MEDICATIONS provide relatively inexpensive solutions to many medical problems, they all too frequently create their own set of concerns. A variety of unfavorable medical events, including treatment failure and increased hospital readmissions, can be attributed to improper medication use.' A number of studies have dem-
MICHAEL B. NICHOL, Ph.D .. is an Assistant Professor, Department of Pharmaceutical Economics and Policy, School of Pharmacy, University of Southern California, PSC 700, 1985 Zonal Ave., Los Angeles, CA 90033; and LUCY W. MICHAEL, Pharm.D. is a Clinical Resident, Department of Pharmacy Services, University of Illinois at Chicago Hospitals and Clinics, Chicago, IL. Reprints: Michael B. Nichol, Ph.D. Adapted from a presentation at the 1992 American Pharmaceutical Association Annual Meeting, San Diego, CA, March IS, 1992.
onstrated that prescription medication misuse is both prevalent and costly. For example, one study showed that the overall incidence of adverse drug reactions was 12.4-15.3 percent in patients taking prescribed medications. Medication problems increased with the number of drugs taken by the patient: 10.8 percent of patients taking one drug experienced an adverse reaction, and 27 percent of those taking six or more drugs had an adverse drug reaction.' Miller found that 3.7 percent of all hospital admissions in seven hospitals were directly caused or strongly influenced by adverse drug reactions.' Caranasos et al. attributed 2.9 percent of all admissions to a major teaching hospital in Florida during a three-year period to drug-induced illness." More recent studies have consistently reinforced these earlier results.v" In fact, the state of California has estimated that the hospitalization of elderly patients for the treatment of adverse drug reactions costs the state $340 million per year," These figures are not surprising, as elderly patients are at particular risk for confusion because of polypharmacy and muddled medication instructions."'" At a minimum level of effectiveness, patient counseling can improve compliance and satisfaction.r'"? In its best light, patient consultation can potentially optimize patient care and therapeutic outcome by ensuring the appropriate administration of medications and reducing the confusion often associated with multiple drug therapy. Because they are the patient's final contact with the healthcare system before the initiation of drug therapy, pharmacists have both the opportunity and the training to monitor the therapy and prevent negative outcomes. Pharmacists can play an important role in preventing adverse drug reactions and drug interactions in addition to providing education to patients regarding the use of medications and the importance of compliance with therapy. One study of an elderly population demonstrated that pharmacist counseling can result in the use of fewer medications and improvements in the appropriateness of the treatment regimen." Unfortunately, the existing evidence indicates that pharmacists provide relatively little consultation to patients regarding both prescription and over-the-counter medications't-" and generally are not perceived to be significant primary providers of drug information by consumers."
The Annals ofPharmacotherapy •
1992 September, Volume 26 •
]]49
Since 1981, a number of states have taken action to require pharmacists to accept a major role in providing patient consultation regarding drug use and monitoring drug therapy. As of 1989, 17 states and one federal district reported that pharmacists were required to provide drug consultation to patients." The primary goal of this article is to evaluate the specific provisions of mandatory consultation statutes and associated regulations, and to determine the extent to which states enforce these provisions. The secondary goal is to extend this analysis to patient profile systems, which can provide important information about the patient's medical and drug history for use during counseling. The first section of this article details the specific provisions of state pharmacy statutes and regulations that mandate consultations. The second section considers the actions these states have taken to enforce these policies. The third section provides similar information about state statutes and regulations regarding patient medication profiles, and the fourth section discusses the results. Conclusions, future research needs, and policy implications derived from our major fmdings constitute the final part of the article.
State Maruliltory Consultation The information presented in this article was compiled from the written pharmacy statutes and regulations from 12 of the 17 states and one federal district that reported that mandatory patient consultation had been enacted prior to 1990. 22 This year was selected as a benchmark to ensure that mature programs were assessed, rather than programs in states that have recently introduced this legislation. Six states were not surveyed because their patient consultation requirements are limited. In these cases, consultation was "encouraged" (Connecticut), or required only "if needed" (California, Colorado, District of Columbia, New York), or the state only required that "a pharmacist must be available to provide consultation" (Illinois). In 1990, the state of California passed legislation requiring pharmacist consultation," but the implementation of this standard has been postponed until November 1992. After abstracting information from state statutes, telephone interviews were conducted with pharmacy board staff members who were knowledgeable about the legal aspects of the practice of pharmacy in their state. This information augmented the legal description, but did not supplant it. Finally, a draft of the manuscript was sent to the executive director of each state board to allow comments and factual corrections. Three factors were investigated with regard to the state statutes and regulations on patient consultation by pharmacists: (1) whether the mandatory consultation provision appears in statute, regulation, or both; (2) whether the mandate specifies communication style (written, oral, or telephone); and (3) the type of information required to be communicated through consultation. These three factors can provide insight into the standards of practice adopted by the state, and the degree to which these standards reflect professional and consumer concerns. The 12 states that mandate consultation are split regarding their legal source: 7 states include mandatory consultation provisions as part of the state pharmacy statutes, and 7 states require consultation through regulation (Table 1). Two states, Kansas and Florida, mandate pharmacist con-
Table 1. Location of the Mandatory Consultation Provisions: Statute Versus Regulation STATE
Delaware Florida Kansas Maine Massachusetts New Jersey North Dakota Oregon Utah Washington West Virginia Wisconsin
STATUTE
REGULATION
no yes yes yes no no yes no yes yes no yes
yes yes yes no yes yes no yes no no yes no
Table 2. Method of Consultation for New Prescriptions8 STATE
ORAL
WRITTEN
TELEPHONE (if delivered)
Delaware Florida Kansas Maine Massachusetts New Jersey North Dakota Oregon Utah Washington West Virginia Wisconsin
yes no yes yes yes no yes no yes yes no no
yes no no yes yes no yes no no yes no no
yes no no yes no no yes no no yes no yes
•As specified in state statutes or regulations.
sultation through both state law and board of pharmacy regulations. Although some of the states that mandate consultation in pharmacy state statutes appear to have more stringent requirements than those that require consultation by regulation, the presence of a legal mandate does not appear to predict the aggressiveness of the state regarding specific provisions of the consultation requirement. The second parameter examined was the method used to transmit information to the patient. Three methods were considered in this investigation: (1) oral, (2) written, and (3) telephone consultation with a required statement about the availability of this method if the medications are delivered to the patient. Four states mention all possible methods (oral, written, telephone) as appropriate consultation techniques (Table 2). One state mentions both oral and written consultation, two states mention only oral consultation, and four states do not specify the method by which drug information is to be conveyed to the patient. One state does not specify the consultation technique, but does require the pharmacist to be available for telephone consultation if the prescription medication is delivered to the home. The third factor investigated was the content of the consultation: whether the statutes and regulations specify a minimum amount or type of information to be conveyed to the patient in the course of consulting (Table 3). We noted that 9 of the 12 states identify specific information to be communicated to patients, such as directions for the use of medication, possible adverse effects, expected response to the medication, drug-drug interactions, and warnings.
1150 • The AnnalsofPharmacotherapy • 1992 September, Volume26
Opinions
Three states do not specify the information they require to be communicated to patients, but rather depend upon the pharmacist's professional judgment to determine the need and content of consultation. Only 1 state (Florida) requires the pharmacist to provide consultation on all five topics, and only 1 other state (Oregon) includes four of the five topics. In most states, the burden of statutory interpretation, particularly as it relates to the specific information to be communicated to the patient, rests with the individual pharmacist. Implementation/Enforcement
Statutes that regulate the profession are not sufficient, in and of themselves, to accomplish the task of patient consultation. Only when they are accompanied by implementation and enforcement systems do statutes become powerful forces that can shape the profession. States that have developed and implemented a monitoring system are prepared to evaluate compliance with the law. Three enforcement factors were assessed: the extent to which pharmacists are required to document consultation, the use of promotional efforts to educate the public about mandated consultation, and the number of consumer complaints filed with the state pharmacy board. These three elements were selected because they indicate pharmacist and state agency commitment to mandatory consultation implementation. Telephone interviews with state board of pharmacy staff were conducted to establish the extent to which mandated consultation statutes and regulations are enforced in the 12 states. Eleven of the 12 states responded to our requests for information regarding the enforcement of these patient consultation provisions. The survey revealed that none of the 11 states require documentation of consultation nor do they uniformly monitor pharmacist consultation. Because no state guidance is provided regarding documentation, pharmacists must determine when it is necessary to record data about the encounter. Seven of the 11 states require inspectors to monitor the consultations by observation during routine inspections. Of the 4 states that do not monitor patient consultation during routine inspection, 1 considers the mandate to be "unenforceable," and another considers the opportunity to com-
municate to be a professional obligation rather than a strict law that must be enforced. The promotional activities of the state pharmacy boards to inform patients about their right to receive consultation varied considerably. Five of the 11 states reported using a promotional method of some kind, although only 2 state programs mentioned any type of systematic attempt to educate consumers about this mandate (Table 4). Comments by the staff members in states that do not make any special effort to inform consumers reveal important attitudes regarding this activity. One staff member indicated that the board felt no need for promotion as "people know about it." The pharmacy board of another state indicated that consultation is part of the practice and "is always done"; thus, no promotional strategies were adopted. A third state reported no promotional activities sponsored by the board, but indicated that senior citizen interest groups and the local media have promoted these services. Finally, an attempt was made to assess the methods by which the pharmacy boards resolve consumer complaints about mandated consultation and whether the boards consider these infractions to be serious violations of state law or regulation. We explored the nature of board enforcement by determining whether consultation complaints were handled differently than other types of complaints, the number of complaints received about pharmacist consultation services, the number of pharmacists specifically disciplined for failure to provide consultation services to patients, and the severity of the discipline used. All states reported that consumer complaints about consultation services would be resolved using standard procedures for complaints of any type. No board official from any state was able to recall the number of consultation complaints received by the board on a weekly, monthly, or even an annual basis. They were also unable to report the number of pharmacists who had been disciplined for consultation inadequacies. Upon further probing, none of the pharmacy board staff members could remember a single instance in which a consumer had complained about consultation or a pharmacist had been disciplined for not providing consultation. However, one state indicated that warning notices had been issued to pharmacies that did not have a system for consultation in place, and that disciplinary actions would be initiated in
Table 3. Information Required for Patient Consultation"
STATE
Delaware Florida Kansas Maine Massachusetts New Jersey North Dakota Oregon Utah
Washington West Virginia Wisconsin
REQUIRED INFORMATION SPECIFIED
ADR/RESPONSE
DRUG-DRUG INTERACTION
DIRECfIONS FOR USE
WARNINGS
no yes yes yes no yes yes yes yes yes yes no
no yes no no no no no yes yes no no no
no yes no no no yes no no no yes no no
no yes yes yes no yes yes yes yes yes yes no
no yes no no no no yes yes no no yes no
OTHER INFORMATION
yes yes no yes yes no yes yes" no yes yes yes
ADR =adverse drug reaction. •As specifiedin state statutes or regulations. bWhen necessary.
The Annalsof Pharmacotherapy • 1992 September, Volume 26 • 1151
the near future for failure to provide consultation. All states indicated that when a pharmacist had been identified as not meeting the requirements of the consulting mandate, there were usually more significant violations that served as the basis for disciplinary action. Recent action against two Kansas pharmacists reinforces this notion, as these professionals were disciplined primarily for inappropriate prescription labeling or brand exchange, but secondarily for failure to provide consultation."
PatientProfiles As noted earlier, a patient medication profile is a necessary precondition for appropriate patient consultation. Information such as allergies, adverse drug reactions, past idiosyncratic reactions to medications, drug history, and other medications taken concomitantly must be obtained before a pharmacist can effectively consult with the patient. Pharmacists generally do not have direct access to complete patient medical records (with the possible exception of some ambulatory care settings and health maintenance organizations); thus, they must acquire the information directly from the patient. Because it has been estimated that 70-80 percent of all patients receiving prescriptions use a single pharmacy.P a patient medication profile may provide adequate information for most consultations. Although the ac-
Table 4. Promotional Methods Employed by States STATE
PROMOTIONAL METHOD
Delaware Florida Kansas Maine Massachusetts New Jersey North Dakota Oregon Washington Utah West Virginia Wisconsin
media campaigns (emphasized on talk shows) continuing education programs for pharmacists video available from the state pharmaceutical association none none did not respond" public relations carnpaigns/vNotice to The Public" some media coverage public information brochure none none none
"Pharmacy board staff could not be contacted for interview.
curacy, reliability, and completeness of the profile may be compromised by limitations characteristic of patient selfreporting, a patient medication profile constitutes the only available alternative at this time. Therefore, it is not surprising that most of the states that mandate consultation also require maintenance of patient medication profiles. The statutes and regulations that govern required patient medication profiles in these states were examined in three areas: (1) the type and extent of information required, (2) the use of the profile, and (3) the duration it should be maintained. As with our investigation of mandatory consultation, the combination of these elements defmes a minimum standard of practice for patient care that identifies important situations in which the patient profile should be used, not to limit its use, but to clarify the intent of the law or the regulation. Because legal guidelines are subject to literal interpretation by clinicians and legal professionals, it is critical to defme a minimum standard of practice carefully and comprehensively. Ten states that mandate consultation also require pharmacists to maintain patient medication profiles. One state mandates patient profile maintenance only if the patient requests it (Utah), and another includes the requirement only for patients purchasing parenteral and enteral preparations (West Virginia). Five categories are used to defme the type and extent of information required: patient and drug identification, allergy, idiosyncratic reactions, adverse drug reactions, and chronic conditions (Table 5). Virtually all of these ten states complemented their requirements for specific information in the patient medication profile with a statement allowing pharmacists to use their professional judgment to obtain other pertinent information. Only one element, patient and drug identification information, is commonly required in the patient medication profile. Six states require information on allergies, idiosyncratic reactions, and chronic conditions to be recorded. Only one state (Wisconsin) explicitly requires the pharmacist to obtain information about adverse drug reactions. It is notable that state efforts to regulate patient profile activities can be characterized as "all or nothing": six states require their pharmacy professionals to collect nearly all of the relevant information, and the other five allow the pharmacist to determine which information should be collected.
Table 5. Information Recorded in Patient Profiles" STATE
PATIENT ID
ALLERGY
Delaware Florida Kansas Maine Massachusetts New Jersey North Dakota Oregon C Utah Washington West Virginiad Wisconsin
yes yes yes yes yes yes yes yes yes yes no yes
yes no no yes no yes yes" no no yes no
yes"
IDIOSYNCRATIC REACTIONS
ADVERSE DRUG REACTIONS
CHRONIC CONDITIONS
yes no no yes no yes yes no no yes no yes
no no no no no no no no no no no yes
yes no no yes no yes yes no no yes no yes
ID = identification. "As specified in state statutes or regulations. bMust indicate if none. 'Profile is maintained only if patient requests it. dFor enteral/parenteral compounding only.
1152
•
The Annals ofPharmacotherapy •
1992 September, Volume 26
Opinions
Seven states mandate that pharmacists review patient medication proftles for possible drug interactions, allergies, or other contraindications before dispensing a new prescription (Table 6). Six states specifically require pharmacists to contact the prescriber if the review of the patient medication profile reveals the new therapy to be inappropriate or possibly harmful to the patient. Three states allow pharmacists to use patient medication proftles for prescription refill documentation. Monitoring and disciplinary actions are recognized as two key factors in ensuring compliance with the mandates. In contrast to the consultation mandate, evidence of compliance with these requirements should be reasonably easy to obtain. All of the ten states responded to our telephone requests for information regarding the monitoring of compliance with patient proftle requirements. Six states monitor maintenance of patient medication proftles during regular inspection, and two of these states indicated that inspectors monitor pharmacist use of the profiles during inspection. A third state uses patient complaints to monitor compliance with this requirement. The remainder of the states have not implemented any monitoring procedures for patient medication profile maintenance or use. Pharmacists who violate the patient profile requirement are subject to a variety of disciplinary actions, depending on the severity of the offense and its consequences. All states process patient profile violations in the same manner as other practice infractions. Most state board staff members reported that noncompliance with medication profile maintenance was viewed as a "symptom" of a more serious deficit in professional conduct, which required further inspection and investigation. It is important to note that none of the state officials interviewed was able to identify the number of pharmacists who have been disciplined specifically for violating the patient profile requirement, nor could they confirm that such action has been taken.
Discussion A number of observations can be drawn from this information on mandatory consultation and patient profiling. First, it appears that there has been considerable variation in the adoption and enforcement of these standards. The fact that some states consider mandatory consultation important enough to require legislation rather than regulation by their professional boards may reveal significant differences in legislative attitudes toward consumer protection and professional standards. The degree to which a communication style is mandated measures the completeness of the statutes and regulations. Statutes and regulations that specify the communication technique to be used in consultations reflect an understanding of the gap in consumer knowledge about drug therapy and recognize pharmacists' capability of bridging this gap. The extent to which the statutes and regulations address the content of the consultation (e.g., medication name, directions, adverse drug reactions, drug interactions) indicates the value of patient consultation as perceived by the regulators. The combined effects of these dimensions defme the performance standards for professional consultation and should ensure that quality patient care is provided by pharmacists. However, these results demonstrate a wide range of approaches for regulating this type of professional behavior.
Table 6. Use of Patient Profiles"
STATE
Delaware Florida Kansas Maine Massachusetts New Jersey North Dakota Oregon Utah Washington West Virginia" Wisconsin
REVIEW CONTACT BEFORE MDIF USE FOR DURATION OF DISPENSING NECESSARY REFILLS MAINTENANCE
yes no yes yes no yes yes no no yes no yes
yes no yes yes no yes yes no no yes no no
no no no no no yes no yes no no no yes
1y not specified 5y 5y not specified 5y 5y Iy Iy not specified not specified 5y
MD =physician. •As specified in state statutes or regulations. bFor enteral/parenteral compounding only.
Second, some states seem to reflect some ambivalence toward regulating professional counseling and profiling behavior. This can be illustrated by the important inconsistencies in some state statutes and regulations with regard to the information required to be communicated to the patient and the information that must be maintained on patient proftles (Tables 3 and 5). On one hand, two states with extensive consultation requirements also have explicit patient profile requirements (i.e., North Dakota, Washington). On the other hand, states such as Florida and Oregon require pharmacists to provide a full range of information during patient consultations, but do not require maintenance of this information on patient profiles. States such as Delaware and Maine require pharmacists to maintain extensive patient profiles, but do not require communication of these details to consumers during consultation. These inconsistencies call into question the commitment of these state programs to develop standards of practice. Third, it is also noteworthy that no state boards conduct aggressive promotional activities to inform consumers of their right to consultation. This element is particularly important because educating patients about these statutes and regulations may directly contribute to the effectiveness of their enforcement and reflects the significance of the mandate as viewed by the respective boards of pharmacy. Promotional activities are necessary because patients are not likely to know that pharmacists are required to provide information, nor are they likely to be aware of the value that can be gained. Given the limited knowledge of the average patient about medications and therapy, patient requests for consultation may be infrequent in the absence of any promotional program.
Policy Implications Regulating patient consultation and drug therapy management has always been a controversial matter. Many pharmacists and pharmacy boards consider patient consultation to be integral to the standard of pharmacy practice and they see no reason to specify such behavior in regulation; others feel that regulation is necessary to clarify professional responsibilities in patient care. Our study shows that the mandatory consultation statutes and regulations al-
The Annalsof Pharmacotherapy • 1992 September, Volume 26 •
JJ53
low pharmacists considerable latitude in their interpretation and implementation. Some states require pharmacists to consult with patients orally on any new prescriptions and the pharmacists can supplement this oral consultation with written material. Some states require only oral or written consultation, and others demand that pharmacists inform their patients that they are available for telephone consultation. The wide variation in this requirement indicates that there is little agreement regarding a minimal standard of professional practice. This variation could also signify that this area is sufficiently new, and so the standards are in an evolutionary stage. Any innovation by individual states may prove to be critical to the development of a professional consensus. Perhaps the time is ripe for the development and implementation of uniform approaches, such as the model legislation for patient counseling developed by the National Association of Boards of Pharmacy." It is also clear that additional effort must be expended in monitoring and promoting these requirements. Compliance with these regulations can be monitored in a number of ways, including direct observation, documentation, and patient complaints. Direct random observation may be the most expensive and most effective method, but the lack of resources available to pharmacy boards makes it the least likely method to be used. Direct observation during board inspection may be appropriate, but this is likely to mean that pharmacist compliance is monitored only annually or biennially, at best. Pharmacists' documentation of their performance could be considered burdensome and time consuming and may increase the cost of dispensing drugs. On the other hand, without documentation, it may be difficult for pharmacists to defend themselves against illegitimate patient complaints or perceived noncompliance with the law. Although patient complaints provide another tool with which consultation can be monitored, the information gap that exists between patients and pharmacists regarding required consultation makes the utility of this approach questionable. Although few states have used the media to educate the public about their legal rights to receive consultation, the level of public knowledge has not been evaluated. Because the asymmetry in information between professionally trained clinicians and the public has been welldocumented.f-" large-scale education campaigns and other methods to remind patients about their counseling entitlements are essential. Patient demand for these services may provide an effective way to ensure pharmacists' compliance with these statutes and regulations. Although legislation may aid in establishing the standard of practice, statutes must be combined with enforcement to accomplish this task. Monitoring and enforcement represent two parts of the standard-setting process and both must be present for the process to be viable. The information gained in our study leads to several rather obvious hypotheses: Either pharmacists in these states are providing appropriate consultation to all patients or state boards are not aggressively pursuing pharmacists who fail to counsel. An alternative hypothesis was mentioned by a state staff member, who noted that pharmacy boards may be providing a grace period to permit pharmacies and pharmacists to prepare for these requirements prior to initiating tough enforcement. However, 10 of the 12 states have required consultation since 1982. 29 It is not clear which of these hypotheses may explain the lack of enforcement activity evi-
1154 •
dent in these results, but these data certainly strengthen the importance of enforcement. This study does not address whether mandated counseling and patient profiling yield better patient care. However, these results do question whether the enactment of statutes and regulations predicts the extent to which they are then reflected in professional practice. This issue is particularly conspicuous as the Health Care Financing Administration and state governments begin to implement the patient profiling and mandatory counseling provisions of the 1990 Omnibus Budget Reconciliation Act. 30 It is impossible to predict whether these federal requirements will produce a fundamental change in the pharmaceutical care provided to Medicaid patients, but the need for monitoring and enforcement is reinforced by these fmdings. Further research regarding mandatory consultation and the use of patient drug profiles should focus on the extent to which these statutes do, in fact, change professional pharmacy practice and improve patient outcomes. Existing studies of mandatory patient consultation have been limited to investigations conducted in Washington state" and Kansas." Although both of these studies sampled a large number of pharmacists throughout their states, the fact that each pharmacist was tested only once calls into question whether normal practice was assessed. These studies do provide some indication that mandates may improve the level, but not necessarily the quality, of consultation. Future studies of the impact of mandatory consultation should attempt to determine whether it has improved quality of care. Additional cross-sectional studies may show that states with mandatory consultation experience improved patient compliance, fewer drug interactions, or fewer hospital admissions caused by adverse drug reactions. Until some demonstration of positive patient outcomes can be documented, the potential value of these laws will remain a mystery. ce
The authors express their appreciation to all state pharmacy boards and staff who participated in this study.
References I. Manasse HR. Medication use in an imperfect world: drug misadventuring as an issue of public policy, part I. AmJ HaspPharm 1989;46:929-
44. 2. Williamson J, Chopin JM. Adverse reactions to prescribed drugs in the elderly: a multicenter investigation. Age Ageing 1980;9:73-80. 3. Miller RR. Hospital admissions due to adverse drug reactions. ArchIn-
ternMed 1974;134:219-23. 4. Caranasos GJ, Stewart RH, Cluff LE. Drug-induced illness leading to hospitalization.JAMA 1974;228:713-7. 5. Hallas J, Harvald B, Gram LF, Grodum E, Brosen K, Haghfelt T, et aI. Drug related hospital admissions: the role of definitions and intensity of data collection, and the possibility of prevention. J Intern Med 1990;228:83-90. 6. Col N, Fanale JE, Kronholm P. The role of medication noncompliance and adverse drug reactions in hospitalizations of the elderly. Arch In-
ternMed 1990;150:841-5. 7. Lakshmanan MC, Hershey CO, Breslau D. Hospital admissions caused by iatrogenic disease. ArchInternMed 1986;146:1931-4. 8. Schneider JK, Mion LC, Frengley JD. Adverse drug reactions in an elderly outpatient population. Am J Hasp Pharm 1992;49:90-6. 9. Ives TJ, Bentz EJ, Gwyther RE. Drug-related admissions to a family medicine inpatient service. Arch Intern Med 1987;147:1117-20. 10. Steffen R. Medication risks among the elderly: cures, cautions, and con-
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Opinions sequences. Sacramento: AssemblyOfficeof Research, Stateof California Assembly, 1989. II. Tymchuk AJ. Readabilitylevels of over-the-counter medications commonly used by elderly people: a possible issue in compliance. Ed Gerontoll990;16:491-6. 12. Rosenberg JM, Dolinsky 0, Kirschenbaum HL, Wojcik LJ, Lomax JD. Elderly ambulatory care patients' knowledge about drugs. Hosp Pharm 1984; 19:289-301. 13. Moore SR, Kalu M, Yavaprabbas S. Receipt of prescriptiondrug information by the elderly.Drug IntellCUn Pharm 1983;17:920-3. 14. Ley P. Communicating with patients:improvingcommunication, satisfaction, and compliance. London:Croon Helm, 1988. 15. Buller MK, Buller DB. Physicians' communication style and patient satisfactionJ HealthSoc Behav 1987;28:375-88. 16. Myers ED, Calvert EJ.lnformation, compliance and side-effects: a study of patients on antidepressant medication. Br J CUn Pharmacol 1984;17:21-5. 17. Svarstad B. Physician-patientcommunication and patient conformity with medical advice. In: Mechanic D, ed. The growth of bureaucratic medicine. New York:John Wiley & Sons, 1976:220-38. 18. Hammarlund ER, Ostrom JR, Kethley AJ. The effectsof drug counselingand othereducational strategies on drug utilization of the elderly. MedCare 1985;23:165-70. 19. Morris LA. A survey of patients' receipt of prescriptiondrug information. Med Care 1982;20:596-605. 20. Dickson WM, Rodowskas CA. Verbalcommunications of community pharmacists. Med Care 1975;13:486-98. 21. Cutler NE, Lowe BF, Williams BR, Steckenreider J. Medicine,selfcare, and the independent elderly: pharmaceutical consultation as a community service.Final report, Administration on Aging Grant #90AT-0376,September1990. 22. National Association of Boards of Pharmacy. Survey of pharmacy law: 1988-1989.Park Ridge, IL, 1989. 23. 16Californiacode of regulations 1707.2. 24. Disciplinary actions. KansasStateBoard of PharmacyNews 1991; 12(1): 1,4.
25. Kirking OM, Thomas JW, Ascione FJ, Boyd EL. Detectingand preventingadversedrug interactions: the potential contribution of computers in pharmacies. Soc Sci Med 1986;22: 1-8. 26. National Association of Boards of Pharmacy, Omnibusbudget reconciliation act of 1990 patient counseling and drug use review requirements.Park Ridge, IL, 1992. 27. Peltzman S. Toward a more general theory of regulation.Z Law Econ 1976;19:211-48. 28. Graddy E. Interest groups or the public interest-why do we regulate healthoccupations?] HealthPolit PolicyLaw 1991;16:25-49. 29. National Association of Boards of Pharmacy. Survey of pharmacy law: 1981-1982.Park Ridge, IL, 1982. 30. American Society of Hospital Pharmacists. Summary of 1990 Medicaid drug rebatelegislation. Am] Hosp Pharm 1991;48:114-7. 31. Campbell RK, Baker DE, Jinks MJ, Evenson St. Amand LM. Compliancewith Washington state's professional practiceregulations: 1974 vs. 1987.Am Pharm 1989;NS29:42-8. 32. Ross SR, White SJ, Hogan LC, Godwin HN. The effectof a mandatory patientcounseling regulation on the counselingpractices of pharmacy practitioners. ContempPharmPract 1981;4:64-8.
EXTRACfO
Evaluar la experiencia de doce estados en los cuales se manda el aconsejamiento de pacientes y el mantenirniento de perfiles de medicamentos por el farmaceutico. OBJETIVO:
FUENTES DE INFORMACION: Se complement6 el analisis de los estatutos y regulaciones estatales con entrevistas telef6nicas con personal de las juntas de licenciatura de cada estado. RESULTADOS: Nueve estados especifIcan la informaci6n que debe proveerse durante las consultas, pero s610 un estado (Florida) requiere una lista comprehensiva de infonnaci6n de drogas incluyendo reacciones adversas, interacciones medicamentosas, direcciones para el U50, y precauciones necessarias. Once de los dace estados tambien requieren el mantenirniento de perfiles de medicamentos de cada paciente. Esfuerzos por parte de los estados para informar a los consumidores acerca del requerirniento de las consultas son limitados, con s610siete estados emprendiendo un programa promocional mfnimo. EI hecho de que ningunestado ha reportado quejas por parte de los consumidores, ni acciones disciplinarias contra farmaceuticos por no cumplir con los requerimientos, ilustra la naturaleza limitada de los estatutos y regulaciones de consulta mandatoria. CONCLUSIONES: La extensa diversidad en los requerirnientos de cada estado demuestra que estas leyes no representan un estandard uniforme de practica. La falta de evidencia documentada con respecto a la implementaci6n de estos requerirnientos invita preguntas acerca de su utilidad y refuerza la necesidad de mejor vigilancia de estas actividades.
CHRISTINADALMADY-ISRAEL
RESUME
Cette etude evalue l'experience des 12 etats americains qui requierrent de la part des pharmaciens la consultation aupres de leurs patients etla tenue de dossiers pharmacologiques.
OBJECI1F:
REVUE DE LITTERATURE: One analyse de la reglementation de chacun des etats a ete completeed'une entrevue telephonique avec Ie personnel de chacune des associations professionnelles concernees, RESULTATS: Neuf des 12 etatsspecifient l'information 11 transmenre aux
patients. C'est l'etat de la Floride qui possede la description la plus complete de l'infonnation 11 transmenre: les reactions indesirables, les interactions medicamenteuses, les directives d'utilisationetles avertissements. Onze des 12 etats requierrent du pharmacien la tenue d'un dossier pharmacologique mais seulement6 etats specifient quelles sontles informations qui doivent y etre inscrites. Les associations professionnelles ne font que Ires peu de promotion de ce service aupres du public. Seul 7 etats mentionnentl'utilisation de methodes promotionnelles plus ou moins varices. Aucun des 12 etats n'a enregistre de plaintes de la part du public au sujet de la consultation ou la tenue d'un dossier. CONCLUSIONS: La reglementarion actuelle laisse au pharmacien beaucoup de latitude dans l'interpretation etla mise en application de la consultation et de la tenue des dossiers. La variation existant entre les differents etats demontre une deficience au niveau de la standardisation de la pratique. Les evidences de l'utilite d'une telle pratique sont peu nombreuses et jusqu'a ce qu'on puisse en demontrer l'utilite, I'importance de la reglementation demeure un mystere, SUZANNE LAPLANTE
The Annals ofPharmacotherapy • 1992 September, Volume 26 • 1155
