OUTLINE
Professional Standards of Practice
General Guidelines for Patient Counseling
Elements for Patient Counseling
Assessment of Patient Consultations
I. PROFESSIONAL STANDARDS OF PRACTICE
A. Though it may seem that talking with a patient about his or her medications is a normal function of the pharmacist, this has not always been true. From the 1940s until the late 1960s, ethical codes for pharmacists advised them against discussing medications with their patients. There was concern that a pharmacist could disrupt the patient-physician relationship if he or she discussed topics such as therapeutic indications, side effects, and precautions with a patient. To illustrate the evolution in standards of practice concerning the level of patient interactions with the pharmacist, compare the following excerpt from the American Pharmacists Association (APhA) code of ethics published in 1952 to a recent definition of pharmaceutical care written decades later:
1. 1952: “The pharmacist does not discuss the therapeutic effects or composition of a prescription with a patient. When such questions are asked, he suggests that the qualified practitioner (physician or dentist) is the proper person with whom such matters should be discussed” (1).
2. 1998: “Pharmaceutical care is a patient-centered practice in which the practitioner (pharmacist) assumes responsibility for a patient’s drug-related needs and is held accountable for this commitment” (2).
Notice how the role of the pharmacist has shifted from holding a limited discussion with the patient concerning the use of a prescription medication to working cooperatively with the patient, in coordination with other health care providers (including the physician), to address all the patient’s health care needs.
B. The current codes of ethics and standards of practice promulgated by the APhA, the American Society of Health-System Pharmacists (ASHP), the American Association of Colleges of Pharmacy (AACP), and other pharmacy associations promote patient education as a primary professional responsibility of pharmacists.
1. The APhA Code of Ethics is a document intended to publicly state the principles that form the basis for the roles and responsibilities of pharmacists (3). Statements from this code that address the issue of patient consultation and pharmacist-patient communication include the following:
a. “Pharmacists are health professionals who assist individuals in making the best use of medications.”
b. “A pharmacist promotes the right of self-determination and recognizes individual self-worth by encouraging patients to participate in decisions about their health. A pharmacist communicates with patients in terms that are understandable. In all cases, a pharmacist respects personal and cultural differences among patients.”
c. “… a pharmacist promises to help individuals achieve optimum benefit from their medications, to be committed to their welfare, and to maintain their trust.”
2. The ASHP Guidelines on Pharmacist-Conducted Patient Education and Counseling provides more complete guidelines for the pharmacist on this area of practice (4). These guidelines, along with the APhA Code of Ethics, should be recommended reading for pharmacy students and pharmacists in all practice settings. The first paragraph in the introductory “Purpose” section emphasizes the influential role the pharmacist has in achieving better patient outcomes and improving the quality of life of each patient:
Providing pharmaceutical care entails accepting responsibility for patients’ pharmacotherapeutic outcomes. Pharmacists can contribute to positive outcomes by educating and counseling patients to prepare and motivate them to follow their pharmacotherapeutic regimens and monitoring plans. The purpose of this document is to help pharmacists provide effective patient education and counseling.
II. STATE LAW
A. Because professions such as pharmacy, medicine, and law are regulated by state laws, the legal responsibilities of these professionals vary from state to state. As part of their pharmacy practice acts, individual states have implemented pharmacist consultation requirements.
B. To provide more uniformity of regulation from state to state, the National Association of Boards of Pharmacy (NABP) mandated patient counseling and endorsed the development of model regulations in 1990. The Model Rules for the Practice of Pharmacy includes a section addressing patient consultation and lists specific elements for counseling (5).
1. Section 3 of the Model Rules for the Practice of Pharmacy states that
Upon receipt of a Prescription Drug Order and following a review of the patient’s record, a Pharmacist shall personally initiate discussion of matters which will enhance or optimize Drug therapy with each patient or caregiver of such patient.
The pharmacist is encouraged to consult with the patient or caregiver in person but may use the telephone, if necessary. The Model Rules further state that alternative means of communication, such as information leaflets, pictogram labels, or video programs, shall be used to supplement (not replace) the discussion when appropriate.
2. The elements (or matters) recommended in the Model Rules for discussion with patients include the following:
(a) The name and description of the Drug;
(b) the dosage form, dose, route of Administration, and duration of Drug therapy;
(c) intended use of the Drug and expected action;
(d) special directions and precautions for preparation, Administration, and use by the patient;
(e) common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
(f) techniques for self-monitoring Drug therapy;
(g) proper storage;
(h) prescription refill information;
(i) action to be taken in the event of a missed dose; and
(j) Pharmacist comments relevant to the individual’s Drug therapy, including any other information peculiar to the specific patient or Drug (5).
3. To further emphasize the importance of patient consultation, Section 6 of the Model Rules identifies the following as an act of unprofessional conduct on the part of a pharmacist or pharmacy: “Attempting to circumvent the Patient Counseling requirements, or discouraging the patient from receiving Patient Counseling concerning their Prescription Drug Orders” (6).
C. Though the NABP may recommend model pharmacy practice legislation, it is up to individual state governments to introduce and pass recommended legislation. States may and do customize such rules for their own purposes. Because all states have now codified requirements for patient counseling by pharmacists, consult the pharmacy practice act for the state in which you are practicing to determine the specific requirements of your state law on patient counseling.
III. FEDERAL LAW
A. If regulation of professional practice is left to the states, how does the federal government get involved? The federal government has a vested interest in keeping medical costs under control, particularly when it has to pay the bill. In 1990, the 101st Congress included in the Omnibus Budget Reconciliation Act (OBRA ’90) provisions aimed at controlling escalating medical costs for entitlement programs. Under OBRA ’90, pharmacists are held responsible for patient counseling and are required to perform a drug utilization review. This was the result of a series of studies issued by the Office of the Inspector General for the Department of Health and Human Services. These studies found that pharmacists who monitor drug therapy and help patients to use their medications appropriately were providing valuable medical services and ultimately reducing the costs of providing medical care (7–9). Though OBRA ’90 technically covered patients receiving care through various Medicaid programs, all states have now passed regulations that expand these services to all patients. Refer to Chapter 5 for more information on OBRA ’90 requirements for drug utilization review.
B. An excerpt from OBRA ’90 (42USC1396r-8) that is relevant to patient consultation requirements for pharmacists is given here (10). Note the similarity between the NABP’s Model Rules and the OBRA ’90 recommended elements that a pharmacist should discuss with a patient.
(I) The pharmacist must offer to discuss with each individual receiving benefits under this subchapter or caregiver of such individual (in person, whenever practicable, or through access to a telephone service which is toll-free for long-distance calls) who presents a prescription, matters which in the exercise of the pharmacist’s professional judgment (consistent with State law respecting the provision of such information), the pharmacist deems significant including the following:
(aa) The name and description of the medication.
(bb) The route, dosage form, dosage, route of administration, and duration of drug therapy.
(cc) Special directions and precautions for preparation, administration and use by the patient.
(dd) Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur.
(ee) Techniques for self-monitoring drug therapy.
(ff) Proper storage.
(gg) Prescription refill information.
(hh) Action to be taken in the event of a missed dose.
(II) A reasonable effort must be made by the pharmacist to obtain, record, and maintain at least the following information regarding individuals receiving benefits under this subchapter:
(aa) Name, address, telephone number, date of birth (or age) and gender.
(bb) Individual history where significant, including disease state or states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices.
(cc) Pharmacist comments relevant to the individual’s drug therapy.
Nothing in this clause shall be construed as requiring a pharmacist to provide consultation when an individual receiving benefits under this subchapter or caregiver of such individual refuses such consultation (10).
IV. GENERAL GUIDELINES FOR PATIENT COUNSELING
There are many excellent journal articles, books, and programs available to pharmacy students and pharmacists on the subject of patient education and counseling. The sections that follow in this chapter provide a basic introduction to this subject. Though this information is written primarily from the point of view of a patient receiving counseling in a community pharmacy, the principles can be easily applied to any practice setting.
A. Appropriate physical environment Discussion with patients or caregivers about health, pharmacotherapy, and other medical issues is a private activity. This aspect of patient counseling is critical and should be respected no matter what the practice site is—hospital room, clinic, busy community pharmacy, or drive-up window. Some means of conducting this activity in a confidential,
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