PROPOSED RULES
(Board of Pharmacy)
Original Notice.
Preproposal statement of inquiry was filed as WSR 98-11-065.
Title of Rule: Patient counseling required.
Purpose: Require pharmacists to provide patient counseling on all new prescriptions, and as needed on prescription refills, to assure that patients take their medications appropriately to receive optimal therapeutic outcomes.
Statutory Authority for Adoption: RCW 18.64.005(7).
Statute Being Implemented: RCW 18.64.005(7).
Summary: The proposed amendment clarifies a rule that was adopted twenty-five years ago requiring pharmacists to provide patient counseling on all new prescriptions and as needed on refill prescriptions.
Reasons Supporting Proposal: The proposed amendment clarifies the board's position regarding counseling. The proposed amendment promotes public health by assuring that patients receive the information necessary to appropriately take their medication, reduce the potential for medication errors and drug related morbidity and mortality.
Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: D. H. Williams, 1300 Quince Street S.E., Olympia, WA 98504, (360) 236-4828.
Name of Proponent: Washington State Board of Pharmacy, governmental.
Rule is not necessitated by federal law, federal or state court decision.
Explanation of Rule, its Purpose, and Anticipated Effects: The proposed rule clarifies the board's expectations of the pharmacist in the area of patient counseling. The board expects the pharmacist to directly counsel the patient or the patient's agent on the use of drugs or devices. The pharmacist is expected to use his or her professional judgement to determine the extent of counseling necessary to promote the safe administration of the prescription. It is anticipated that the proposed rule will promote public health and safety by providing patients with the information necessary to make well informed decisions regarding medication use, reduce the potential for mediation errors and drug related morbidity and mortality.
Proposal Changes the Following Existing Rules: Clarifies existing rule on patient counseling.
A small business economic impact statement has been prepared under chapter 19.85 RCW.
| Standard Industrial Code: | 512 |
| Economic Activity: | Drugs, Drug Proprietor & Druggists' Sundries |
| Minor Cost Threshold: | $300 |
Does the cost of the proposed rule exceed the threshold where an SBEIS is required? The cost to implement the proposed amendment to the patient counseling rule is below the minor threshold of $300 so an SBEIS is not required.
A copy of the statement may be obtained by writing to Lisa Salmi, P.O. Box 47863, Olympia, WA 98504-7863, phone (360) 236-4828, fax (360) 586-4359.
RCW 34.05.328 applies to this rule adoption. These rules are significant under section 201, chapter 403, Laws of 1995 because they adopt substantive provisions which subject the violator to penalty or sanction. The agency has conducted the additional analysis required under section 201.
Problem Statement: Inappropriate use of prescription medications is a serious public health issue.
Background: Pharmacists are the principle resource to patients and other health professionals in assuring appropriate use and optimal therapeutic outcomes from drugs. To assure patients take their medications appropriately, the Board of Pharmacy has required pharmacists to provide patients with information or counseling on all new prescriptions and as needed on refill prescriptions. A pharmacist may not delegate the professional responsibility to counsel patients regarding their medications.1 The board adopted this rule approximately twenty-five years ago.
Over fifty million prescriptions are filled each year by Washington pharmacies. It is estimated that approximately 40% of the fifty million prescriptions filled each year require patient counseling. Each time a prescription is filled, the pharmacist has an opportunity to assure optimal therapeutic outcomes for that patient.
Studies have shown that patient's compliance with prescribed drug regimens is poor. A Food and Drug Administration (FDA) review of fifty studies concluded that noncompliance rates averaged from 30 to 50%.2 An essential step in increasing compliance is to improve the information patients receive concerning their medications. The pharmacist's role in improving compliance is clear, the pharmacist must ensure that patients receive the information necessary to make well-informed choices about their medication use.
In addition to compliance problems, drug-related morbidity and mortality has also been identified as a serious problem in the United States. The Food and Drug Administration estimates that hospitalizations caused by the improper use of prescription drugs cost an estimated twenty billion per year. In 1995, drug-related morbidity and mortality was estimated to cost $76.6 billion in the outpatient or ambulatory setting.3
The media has also been particularly critical of errors committed by health professionals. In November 1999, the Institute of Medicine (IOM) released its report on medical mistakes. The IOM reports that medical mistakes are not limited to high profile surgical errors such as amputating the wrong limb. Understated errors, such as delays in diagnosing a disease, failure to conduct testing and medication mistakes, contribute to the large number of patients who are harmed each year by medical mistakes. The report quoted studies estimating that at least 44,000 and perhaps as many as 98,000 hospitalized patients die every year from medical errors.
FDA Commissioner Jane E. Henney recently told a group of 6,000 pharmacists that pharmacists must ensure that patients receive information about how to use their medications appropriately. The role of pharmacists in informing their patients about the risk of drugs is "extremely important as we work together to protect the public health." The report released by the IOM underscores the fact that most injuries and deaths from medications are from known adverse effects.
Errors attributed to pharmacists incorrectly deciphering a physician's poor handwriting and "sound-alike" medication mix-ups could be reduced with patient counseling. Drug names that sound or look alike can contribute to the pharmacist selecting the wrong medication. Patients receiving the wrong medication is an example of a recurring medication error that could be reduced by the pharmacist counseling patients on their medications. An example of an error that is frequently reported to the board is when a patient receives the medication Prilosec instead of Prozac (or vice-versa). This error could be easily identified during patient counseling when the pharmacist explains to the patient that the medication they are taking is used to treat an ulcer or gastroesophageal reflux disease. If the patient informs the pharmacist that they believed their physician prescribed a drug to treat depression (or other disease state), this should alert the pharmacist that it is possible that an error has been made and he or she needs to investigate the matter.
Congress recently passed legislation ordering the Agency for Health Care Policy and Research to look for strategies to reduce medical mistakes. Patient counseling could play an important role in reducing medication mistakes. When the pharmacist informs the patient of the purpose of the medication, dose, side effects and route of administration for example, not only does this provide the patient with the information they need to appropriately take their medication, it also provides an additional opportunity to assure that the right patient receives the correct medication. The Institute of Medicine is also calling for "rigorous changes" throughout the health care system to cut the enormous number of deaths and injuries from medical errors. The proposed rule is a proactive approach to reducing errors committed by health professionals.
Over the years, the board has been concerned that pharmacists were not complying with the rule. Enforcement of the rule has been problematic for the board. When a board of Pharmacy investigator is present in the pharmacy, the pharmacist will almost always counsel patients on their medications. However, patients report that they are not receiving counseling. The board has had to rely on "secret shoppers" to determine if counseling is taking place. In 1993, the board surveyed one hundred eight pharmacies to determine the level of counseling being provided in Washington state. The study validated the board's concerns, 66% of the pharmacies surveyed failed to provide adequate counseling.
At the same time, Congress underscored the counseling role of pharmacists by including it as one of the components of the drug utilization review requirements it incorporated into the Medicaid program. The program stipulates the pharmacist must offer to counsel each Medicaid beneficiary who presents a prescription and the state governments must establish standards for counseling of these individuals.4 The states responded by enacting patient counseling laws that applied not only to Medicaid beneficiaries, but also to all patients. According to the National Boards of Pharmacy, forty-six states required face-to-face counseling by the pharmacist by 1996.
In 1996, the board established a workgroup to examine the issue of patient counseling. The workgroup presented the board with their findings including a number of recommendations to improve pharmacist's compliance with the rule. A number of stakeholders did not agree with the recommendations of the workgroup. While they supported pharmacist-patient counseling, they expressed concerns about unique patient needs or difficulties that go beyond a basic level of patient education.
As a result, the board asked the concerned parties to work together and a second workgroup was created. This workgroup met on multiple occasions over the next six months to develop proposed amendments to strengthen the rule. Both of the workgroups identified the pharmacist's lack of a clear understanding of the board's expectations of the pharmacist in the area of patient counseling as a barrier to compliance. The proposed rule and guidelines clearly illustrate the board's expectations of the pharmacist.
The board held multiple open forums to discuss proposed amendments to the rule and receive comments from pharmacists and interested parties. The stakeholder group held lengthy, focused discussion on the issues when drafting the proposed rule. In September 1999, the board determined the proposed rule was too detailed and did not adequately give the pharmacist the ability to utilize his or her own profession when counseling patients. The board developed new language for the rule. Stakeholders and interested parties agreed that the language proposed by the board was preferable to the previous proposal.
The proposed rule clearly states the board's expectations in the area of counseling. The proposed amendments do not expand current counseling requirements, rather they are intended to clarify the board's intentions.
Goal: To educate the public in the use of drugs and devices dispensed upon prescription to promote safe administration of the drug and the optimal therapeutic outcome for that prescription.
Principle Components: The proposed rule does not impose additional requirements upon the pharmacist. Patient counseling has been required in the state of Washington for twenty-five years. Pharmacists report a lack of clear understanding of the board's expectations in the area of patient counseling. The proposed rule and implementing guidelines clearly delineate the board's expectations of the pharmacist for patient counseling.
CURRENT WAC 246-869-220 Patient information required.
Except in those cases when the prescriber has advised that the
patient is not to receive specified information regarding the
medication:
(1) In order to assure the proper utilization of the medication or device prescribed, with each new prescription dispensed by the pharmacist, in addition to labeling the prescription in accordance with the requirements of RCW 18.64.245 and WAC 246-869-210, the pharmacist must:
(a) Orally explain to the patient or the patient's agent the directions for use and any additional information, in writing if necessary, for those prescriptions delivered inside the confines of the pharmacy; or
(b) Explain by telephone or in writing for those prescriptions delivered outside the confines of the pharmacy.
(2) In those instances where it is appropriate, when dispensing refill prescriptions, the pharmacist shall communicate with the patient or the patient's agent, by the procedure outlined in subsection (1)(a) or (b) of this section or the patient's physician regarding adverse effects, over or under utilization, or drug interaction with respect to the use of medications.
(3) Subsections (1) and (2) of this section shall not apply to those prescriptions for inpatients in hospitals or institutions where the medication is to be administered by a nurse or other individual authorized to administer medications.
(4) In the place of written statements regarding medications, the pharmacist may use abstracts of the Patient USP DI 1988 edition, or comparable information.
PROPOSED WAC 246-869-220 Patient counseling. The purpose
of this counseling requirement is to educate the public in the
use of drugs and devices dispensed upon a prescription. The
pharmacist shall directly counsel the patient or patient's agent
on the use of drugs or devices. An offer to provide direct
counseling and information about the drug and how to reach the
pharmacy shall be provided in writing for prescriptions delivered
outside of the pharmacy. The pharmacist shall determine the
extent of counseling efforts by what is reasonable and necessary
under the circumstances to promote safe administration and the
optimal therapeutic outcome for that prescription.
The requirements of this rule shall apply to all prescriptions except where a medication is to be administered by a licensed health professional authorized to administer medications.
Alternatives to Rule Making: The board originally
considered adopting a very specific, detailed rule. The original
rule required pharmacists to use an interactive method to
exchange information with the patient. The proposed rule
outlined exactly how the pharmacist should counsel the patient
and required the pharmacist to document any patient-related
difficulty in the pharmacist's effort to effectively covey
essential information or a patient's refusal to engage in patient
counseling. The original proposal did not allow the pharmacist
much flexibility in applying his or her professional expertise or
judgment when counseling patients.
Another option considered by the board was to do nothing and allow the profession to solve the problem. However, taking a "do nothing" stance does not achieve the board's goal to minimize adverse drug outcomes. In 1994, the board considered mandating pharmacist's participation in an interactive patient counseling educational program. Responding to objections from the profession, the board abandoned the requirement for mandatory training and instead granted pharmacists a one-time incentive for participating in patient counseling continuing education. Very few pharmacists took advantage of the incentive by participating in the training.
Rule-making Requirements of the Administrative Procedure Act: State agencies must satisfy specific legal and policy criteria before adopting or amending regulations. These criteria come from two sources: The Administrative Procedure Act (RCW 34.05.328) and the Executive Order on Regulatory Improvement (No. 97-02). These sources set up complementary, but slightly different review requirements.
The Administrative Procedure Act deals solely with adopting or amending regulations. Before adopting a rule the Administrative Procedure Act (RCW 34.05.328) requires state agencies to:
(c) Determine that the probable benefits of the rule are greater than its probable costs, taking into account both the qualitative and quantitative benefits and costs and the specific directives of the statute being implemented;
(d) Determine, after considering alternative versions of the rule and the analysis required under (b) and (c) of this subsection, that the rule being adopted is the least burdensome alternative for those required to comply with it that will achieve the general goals and specific objectives stated under (a) of this subsection;
(e) Determine that the rule does not require those to whom it applies to take an action that violates requirements of another federal or state law;
(f) Determine that the rule does not impose more stringent performance requirements on private entities than on public entities unless required to do so by federal or state law;
(g) Determine if the rule differs from any federal regulation or statute applicable to the same activity or subject matter and, if so, determine that the difference is justified by the following:
(i) A state statute that explicitly allows the agency to differ from federal standards; or
(ii) Substantial evidence that the difference is necessary to achieve the general goals and specific objectives stated under (a) of this subsection; and
(h) Coordinate the rule, to the maximum extent practicable, with other federal, state and local laws applicable to the same activity or subject matter.
When making these determinations, the department must assemble documentation of "sufficient quality and quantity so as to persuade a reasonable person that the determinations are justified."
In addition, the Executive Order on Regulatory Improvement (No. 97-02) directs state agencies to ensure that "[a]ny new rules or significant amendments... shall be consistent with its [seven review criteria]..."5
1. Need. Is the rule necessary to comply with the statutes that authorize it? Is the rule obsolete, duplicative, or ambiguous to a degree that warrants repeal or revision? Have laws or other circumstances changed so that the rule should be amended or repealed? Is the rule necessary to protect or safeguard the health, welfare, or safety of Washington's citizens?
2. Effectiveness and Efficiency. Is the rule providing the results that it was originally designed to achieve in a reasonable manner? Are there regulatory alternatives or new technologies that could more effectively or efficiently achieve the same objectives?
3. Clarity. Is the rule written and organized in a clear and concise manner so that it can be readily understood by those to whom it applies?
4. Intent and Statutory Authority. Is the rule consistent with the legislative intent of the statutes that authorize it? Is the rule based upon sufficient statutory authority? Is there a need to develop a more specific legislative authorization in order to protect the health, safety, and welfare of Washington's citizens?
5. Coordination. Could additional consultation and coordination with other governmental jurisdictions and state agencies with similar regulatory authority eliminate or reduce duplication and inconsistency? Agencies should consult with and coordinate with other jurisdictions that have similar regulatory requirements when it is likely that coordination can reduce duplication and inconsistency.
6. Cost. Have qualitative and quantitative benefits of the rule been considered in relation to its cost?
7. Fairness. Does the rule result in equitable treatment of those required to comply with it? Should it be modified to eliminate or minimize any disproportionate impacts on the regulated community? Should it be strengthened to provide additional protection?
Benefit Cost Analysis (RCW 34.05.328 (1)(c)): The proposed rule does not impose an additional cost to the licensee. Patient counseling has been required in the state of Washington for twenty-five years. The proposed amendments to the rule and implementing guidelines reinforce the expectations of the board.
Least Burdensome Alternative (RCW 3.05.328 [34.05.328] (1)(d)): The board originally proposed a very specific, detailed rule. After much discussion with stakeholders, the prescriptive rule was abandoned in favor of the proposed rule that allows pharmacists to use their professional expertise and judgment when counseling patients.
The board also considered mandating training in patient counseling. The mandate was discarded and instead the board offered pharmacists a one-time continuing education incentive for participating in patient counseling training. The incentive approach to improve compliance with the board's patient counseling rule was not successful. Very few pharmacists participated in the training.
Does Not Violate Another Federal or State Law (RCW 34.05.328 (1)(e)): This rule does not violate other federal or state laws.
Does Not Impose more Stringent Performance Requirements on Private Entities than on Public Entities (RCW 34.05.328 (1)(f)): This rule does not impose more stringent performance requirements on private entities than on public entities.
Justify Differences from any Federal Regulation or Statute Applicable to the Same Activity (RCW 34.05.328 (1)(g)): Federal statutes and regulations stipulate the pharmacist must offer to counsel each Medicaid beneficiary who presents a prescription. Washington state rule requires the counseling of all patients, not just Medicaid beneficiaries.
Coordinate the Rule, to the Maximum Extent Practicable, with Other Federal, State, and Local Laws Applicable to the Same Activity (RCW 34.05.328 (1)(h)): The rule complies with federal laws.
1 Department of Health, Washington State Board of Pharmacy rule, WAC 246-863-095(1)(b) Pharmacist's Professional Responsibilities
2 Federal Register, August 24, 1995 21 CFR Part 201
3 Johnston & Bootman, Drug-Related Morbidity and Mortality, A Cost-of-Illness Model, Archives of Internal Medicine, Volume 155, October 9, 1995.
4 The Omnibus Budget Reconciliation Act of 1990
5 In addition to the seven review criteria, the Executive Order requires state agencies to consult with major stakeholders while reviewing a
regulation. The department's efforts to involve stakeholders in the development of this rule is discussed in the Small Business Economic Impact
Statement accompanying this rule.
Hearing Location: Wyndham Garden Hotel, 18118 Pacific Highway South, SeaTac, WA, on September 8, 2000, at 10:00 a.m.
Assistance for Persons with Disabilities: Contact Lisa Salmi by August 15, 2000, TDD (800) 833-6388, or (800) 525-0127.
Submit Written Comments to: P.O. Box 47863, Olympia, 98504, fax (360) 586-4359, by August 30, 2000.
Date of Intended Adoption: September 8, 2000.
June 22, 2000
D. H. Williams
Executive Director
OTS-4023.1
AMENDATORY SECTION(Amending Order 277B, filed 5/28/92, effective
6/28/92)
WAC 246-869-220
Patient ((information)) counseling
required.
((Except in those cases when the prescriber has
advised that the patient is not to receive specified information
regarding the medication:
(1) In order to assure the proper utilization of the medication or device prescribed, with each new prescription dispensed by the pharmacist, in addition to labeling the prescription in accordance with the requirements of RCW 18.64.245 and WAC 246-869-210, the pharmacist must:
(a) Orally explain to the patient or the patient's agent the directions for use and any additional information, in writing if necessary, for those prescriptions delivered inside the confines of the pharmacy; or
(b) Explain by telephone or in writing for those prescriptions delivered outside the confines of the pharmacy.
(2) In those instances where it is appropriate, when dispensing refill prescriptions, the pharmacist shall communicate with the patient or the patient's agent, by the procedure outlined in subsection (1)(a) or (b) of this section or the patient's physician regarding adverse effects, over or under utilization, or drug interaction with respect to the use of medications.
(3) Subsections (1) and (2) of this section shall not apply to those prescriptions for inpatients in hospitals or institutions where the medication is to be administered by a nurse or other individual authorized to administer medications.
(4) In the place of written statements regarding medications, the pharmacist may use abstracts of the Patient USP DI 1988 edition, or comparable information.)) The purpose of this counseling requirement is to educate the public in the use of drugs and devices dispensed upon a prescription.
(1) The pharmacist shall directly counsel the patient or patient's agent on the use of drugs or devices.
(2) For prescriptions delivered outside of the pharmacy, the pharmacist shall offer in writing, to provide direct counseling and information about the drug, including information on how to contact the pharmacist.
(3) For each patient, the pharmacist shall determine:
(a) The amount of counseling that will be necessary to promote safe administration of the medication; and
(b) The optimal therapeutic outcome for that patient from the prescription.
(4) This rule applies to all prescriptions except where a medication is to be administered by a licensed health professional authorized to administer medications.
[Statutory Authority: RCW 18.64.005. 92-12-035 (Order 277B), § 246-869-220, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. 91-18-057 (Order 191B), recodified as § 246-869-220, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005. 89-04-016 (Order 223), § 360-16-265, filed 1/23/89.]