Kristen L. Goliak, PharmD

LEARNING OBJECTIVES

•  Know the laws that govern patient counseling.

•  Outline the communication skills that are essential to an effective patient counseling session.

•  Describe patient counseling techniques used in inpatient, outpatient, and community healthcare settings.

•  Identify the benefits and challenges of patient counseling.

•  Create patient education materials to enhance patients’ understanding of medications.

•  Use appropriate techniques to counsel patients in the inpatient, outpatient, and community healthcare settings.

KEY TERMS

•  Communication

•  HIPAA (Health Insurance Portability and Accountability Act of 1996)

•  OBRA ‘90 (Omnibus Budget Reconciliation Act of 1990)

•  Patient counseling

•  Pharmaceutical care

•  QuEST

INTRODUCTION

Patient counseling is at the core of what pharmacists do in the provision of pharmaceutical care.¹ The term patient counseling itself, though, is difficult to define, because it is often used interchangeably with the term patient education and can have various meanings within multiple disciplines. According to the Merriam-Webster Dictionary, to counsel means “to advise or give a recommendation about what should be done,” whereas to educate means “to inform or provide with information.”² Patient Counseling: Settings and Techniques

In an attempt to better distinguish between these terms in the realm of the provision of health care to patients, Edward Bartlett, an editor for the international and interdisciplinary journal Patient Education and Counseling, surveyed the journal’s board members with regard to how they would define patient education and patient counseling. The board members defined patient education as “a planned learning experience using a combination of methods such as teaching, counseling, and behavior modification techniques that influence patients’ knowledge and health behavior” and patient counseling as “an individualized process involving guidance and collaborative problem-solving to help the patient to better manage the health problem.” Thus, according to Bartlett, patient counseling is a component of patient education.³

This chapter will focus on patient counseling as a means of educating patients with regard to their drug therapy with the goal of ensuring optimal medication therapy outcomes in the areas of adherence to the intended medication regimen, benefits from therapeutic effect, and awareness of and protection from adverse medication effects.

LAWS THAT GOVERN PATIENT COUNSELING

The ongoing changes within the healthcare system have been instrumental in the evolution of the pharmacist’s role from behind the counter to the forefront of health care. Besides the traditional medication dispensing responsibility, pharmacists in all settings have been called upon to promote positive health outcomes by taking on a proactive role in educating and counseling their patients. This task involves obtaining a thorough patient profile and drug utilization review, disseminating pertinent drug and medical information, and confirming patients’ understanding of their specific medication regimen and monitoring plan. Patient counseling has been shown to facilitate the establishment of a collaborative pharmacist–patient relationship that ensures improved adherence, safety, and disease state management and enhanced patient care.⁴ Because of the widespread use of medications for various medical conditions, patient counseling has been mandated by the government within the provision of pharmacy practice.

The foundation of patient counseling laws dates back to 1990 when the U.S. Food and Drug Administration (FDA) was called upon to address the issue of rampant “mismedication.” This national epidemic plagued the healthcare system by reducing quality of care and increasing medical costs and unnecessary spending.^5,6 The FDA

recognized the important role that pharmacists could have in resolving this problem. Pharmacists were identified as the “last line of defense” due to their ability to aptly assess and rectify prescription errors and deficiencies prior to medication dispensing. In addition, pharmacists could serve as “drug experts” and be entrusted to provide important oral and written information to improve the understanding and use of medications.⁶ In conjunction with the FDA and the Department of Human and Health Services, the U.S. Congress enacted the Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90), which included these new responsibilities for pharmacists, specifically for Medicaid beneficiaries.

OBRA ‘90 mandates prospective drug utilization review (ProDUR) and maintenance of patient records in pharmacy practice for Medicaid pharmacy programs and providers and sets patient counseling standards. Under OBRA ‘90, an offer to counsel the patient, caregiver, or representative must be made before dispensing a prescription.⁷ Patient counseling must be conducted by a registered pharmacist or pharmacy intern under the supervision of a registered pharmacist. Pharmacy technicians and other pharmacy personnel may inform the patient of the availability of patient counseling, but they may not provide any drug or medical information. If face-to-face counseling is not possible, the pharmacist may provide patient counseling via telephone and provide a toll-free telephone number for long-distance calls. With recent developments in technology, such as telemedicine/telepharmacy, a novel approach to broadcasting clinical health care at a distance, it is now possible to conveniently deliver patient counseling in a personal and interactive manner even if the pharmacist and the patient are not in close physical proximity.

If the patient accepts the offer, the counseling must include the following:⁷

•  Name of the drug (i.e., both the generic name and trade/brand name)

•  Intended use of drug and expected action (i.e., the main indication of the drug and how it is intended to affect the patient)

•  Route, dosage form, dosage, and administration schedule (i.e., how the patient should take the medication, how the medication is supplied, the strength of the medication, and how often it should be administered)

•  Common side effects that may be encountered, steps that can be taken to help avoid the side effects, and action to be taken if they occur (i.e., listing the common side effects as well as concerning side effects that a patient should watch for)

•  Techniques for self-monitoring of drug therapy (i.e., how a patient can monitor the efficacy of a newly prescribed medication, for example, by self-checking blood pressure in the case of a new hypertension drug)

•  Proper storage (i.e., how the patient should store the medication, for example, at room temperature or in the refrigerator)

•  Potential drug–drug and drug–food interactions or other therapeutic contraindications (i.e., prescription and over-the-counter medications that a patient should avoid when taking a given medication; how food consumption should be separated from certain medication administration times)

•  Prescription refill information (i.e., if there are any refills remaining or if the patient needs to contact the prescriber for a refill)

•  Action to be taken in the event of a missed dose (e.g., taking the missed dose as soon as remembered, but not doubling up on the dose)

Table 6.1 outlines the counseling requirements of OBRA ‘90.

OBRA ‘90 advocates for states to adopt their own rules and regulations regarding patient counseling, which has extended the application of the new requirements beyond Medicaid recipients to all patients.⁸ Each state’s Board of Pharmacy was assigned responsibility for implementing and ensuring that the OBRA ‘90 requirements were implemented in every pharmacy. Since the passage of OBRA ‘90, 36 states now require some type of counseling for all patients.⁹ Most states require pharmacists to provide patient counseling for new prescriptions only and to offer counseling for refill prescriptions.^10–12 However, a few states, such as Wisconsin, require pharmacists to counsel patients on all of their prescriptions.^13,14 In addition, patient counseling is required before dispensing a medication to a new patient in the pharmacy and if an existing prescription’s dose, strength, route of administration, or directions has been changed.^10–12,14 Overall, the regulation of patient counseling among states varies in scope, stringency, and duration.¹³

Pharmacy personnel are responsible for documenting the offer to counsel in the patient’s permanent medical records and/or institution-specific patient profile system. Under OBRA ‘90, the pharmacist is required to record the acceptance or refusal of an offer to counsel and to note the perceived level of the patient’s understanding of the information. Some pharmacies use a logbook to note fulfillment of the offer-to-counsel requirement by having the patient, caregiver, or representative sign and waive the service. All documentation must adhere to federal and state laws with regard to patient privacy and confidentiality.^7,8

TABLE 6.1 Overview of OBRA ‘90 Counseling Requirements

Pharmacists are in violation of the offer-to-counsel requirement if they fail to provide the complete drug information as required by OBRA ‘90. Pharmacists and pharmacies will be cited by the state’s Board of Pharmacy for any violations and may even face suspension or revocation of their license/permit to practice/operate for failing to uphold one of their primary duties as direct-care providers, increasing the risk of prescription errors and potentially putting a patient’s health at risk. A state’s Board of Pharmacy may conduct random pharmacy visits and/or employ a “secret shopper” to investigate if the law is being followed.^7,8

Over time, patient counseling has been supplemented by the use of medication guides that properly address how to avoid serious side effects from specific medications. According to the FDA, medication guides do not replace the one-on-one, dynamic relationship between a pharmacist and a patient, but rather serves as an important tool for both parties to ensure adherence and quality patient care.¹⁵ Medication guides will be discussed in detail later in this chapter.

COMMUNICATION FOR EFFECTIVE PATIENT COUNSELING SESSIONS

When pharmacists counsel patients on their drug therapy, two-way communication should be employed to ensure that patient-centered service is being provided.¹⁶ Within this transactional communication model, the pharmacist and patient are deemed experts of their own domains; for pharmacists, this domain is drug therapy knowledge and for patients it is their daily routine as well as their overall health and well-being.¹⁷ As such, both the pharmacist and the patient must come to a mutual understanding about their roles and responsibilities with regard to the patient counseling session.⁴ The pharmacist’s role within this counseling session is to verify that the patient has sufficient understanding, knowledge, and skill to follow the pharmacotherapeutic regimen and monitoring plan. To accomplish this, the pharmacist must assess the patient’s agenda, knowledge, and preferences toward drug therapy within the counseling session in order to tailor the drug therapy regimen and monitoring plan in a manner that will ensure optimal outcomes and patient adherence. The patient’s role, in turn, is to adhere to the pharmacotherapeutic regimen, self-monitor for drug effects, and report his or her experiences to the pharmacist or other members of the healthcare team.

The counseling session should be designed in a manner whereby the pharmacist is in control of the session but the patient is doing much of the talking.¹⁷ This structure enables patients to freely express their concerns about a drug therapy regimen and to ask questions about any information that remains unclear. To successfully accomplish this, the pharmacist will typically want to ask mostly open-ended questions with some close-ended questions. A successful balance of both open- and close-ended questions will enable the pharmacist to acquire the most important information from the patient.

During the counseling session, it is important that the pharmacist use appropriate language and terminology with the patient. The pharmacist should avoid using medical jargon and should use terms that the patient will understand. The pharmacist should listen attentively to the patient and avoid distractions, such as the phone ringing or another customer trying to get his or her attention. The pharmacist should maintain control of the counseling session through the use of appropriate questions and redirect the patient back to the conversation, if needed. Finally, the pharmacist will want to organize the information in the counseling session so that it is presented to the patient in a logical order. Table 6.2 outlines the essential communication features of an effective patient counseling session.

ADAPTING PATIENT COUNSELING BASED ON THE ENVIRONMENT

The communication essentials for a patient counseling session that have been discussed thus far can be employed in a variety of settings, whether at the hospitalized patient’s bedside prior to discharge, in a physician’s office upon receipt of a new medication for an acute or chronic condition, or in the community pharmacy when a patient presents for advice on self-care treatment. Although each setting may require a slight adaptation to the communication model based on the barriers of the particular setting, pharmacists should remain true to the basic principles of the model to ensure a successful counseling session in any environment.

Counseling a Patient in the Hospital Setting

In the hospital setting, patient counseling has been shown to improve medication adherence, prevent drug-related problems, and reduce healthcare costs.^18–21 The counseling session in this setting traditionally occurs at hospital discharge. It is imperative that prior to the session a final medication reconciliation is performed in which the pharmacist, or designated healthcare provider, compares the medications a patient is presently taking within the hospital to the medications that the patient was taking prior to admission. The purpose of this is to prevent any duplication, omission, or unnecessary medications from being prescribed at discharge, as well as to serve as an additional review for dosage errors and potential drug interactions. The session often occurs at the patient’s bedside just prior to discharge, and it is ideal if new medication orders can be filled and present for the counseling session. The presence of the medication bottles at the time of the session will allow for visual recognition of oral medications or demonstration of appropriate administration of devices or injectable medications, such as inhalers or insulin. When this is not possible, visual aids and/or demonstration devices can serve as a suitable substitute. It is important to focus the discharge counseling session on those medications of priority, because the pharmacist’s time with the patient is often limited and the patient may be overwhelmed and distracted by the arrangements for the impending discharge home. Therefore, the session should be prioritized to focus on reviewing the following medications with the patient: those that are newly prescribed, those in which a dose has been changed since admission to the hospital, those that have been discontinued since admission, and those with which the patient was nonadherent prior to admission. Furthermore, The Joint Commission (a nonprofit organization that accredits and certifies healthcare organizations and programs in the United States) requires that the importance of medication management be addressed with the patient and written information about the medications be provided.²² Additionally, evidence suggests that a follow-up phone call occurring postdischarge by a qualified healthcare provider, such as a pharmacist, can additionally aid in patient medication adherence and subsequently reduce hospital readmissions.^19,23,24

TABLE 6.2 Essential Communication Features of an Effective Patient

Counseling a Patient in the Ambulatory Care Setting

In the ambulatory care setting, pharmacists often work collaboratively with physicians to provide patient medication counseling services. These counseling services are often centered on medications with narrow therapeutic indexes, complex administration regimens or techniques, stringent monitoring requirements, significant dietary or drug interactions, or patient adherence barriers. Patients who are provided drug samples should also be counseled, because they are often given limited information on the medication provided.²⁵ Prior to the patient counseling session in an ambulatory care setting, it is important that the pharmacist clarifies with the physician, or referring healthcare provider, the intended goals for the session to ensure that they are met. It is ideal if the medications to be addressed are present at the session; however, this is not often possible unless there is a pharmacy on site or if the patient brings the medication to the appointment. As such, it is appropriate and beneficial for the pharmacist to come prepared to substitute with visual aids and/or demonstration devices when possible. The Joint Commission further requires, as it does with inpatient discharge counseling, that the importance of medication management be addressed with the patient and written information about the medications be provided.²⁶ After counseling, patients determined to be high risk or who require stringent drug monitoring should be considered for follow-up evaluation by the pharmacist via either a repeat visit to the clinic or an alternative mode of follow-up (e.g., phone, Internet).

Counseling a Patient in the Community Pharmacy Practice Setting

In the community pharmacy setting, as discussed previously, patient counseling is legally required to be offered on all new prescriptions at the time they are dispensed. It is also prudent to offer counseling to patients on refill medications, especially if the patient has a complex administration regimen or does not return for refills in a timely manner, and on over-the-counter (OTC) medications and products. Community pharmacists are in a unique position because they have the opportunity to interface with patients about their medications each time they pick up a new prescription or refill and are often present when patients are making self-care decisions. In fact, pharmacists are often the only healthcare provider accessible at the time a patient is making a decision on the purchase of an OTC medication or product for self-care use, and they can have a demonstrated impact on the effectiveness and safety of these choices.²⁷ Community pharmacists must capitalize on these counseling opportunities by encouraging and supporting patients on their prescription therapy progress and self-care choices. Unfortunately, community pharmacists are often restricted by workload demands that affect their ability to spend adequate time with patients at each of these encounters. Therefore, pharmacists should seek alternate methods for follow-up communication with patients about their medications and self-care choices via telephone or the Internet when possible.

Counseling a Patient in a Nontraditional Setting

All the settings for counseling sessions discussed thus far are met by barriers of workload demand. As such, both the telephone and the Internet are acceptable modes by which to communicate or supplement communication with patients about their medications. Of course, face-to-face encounters are the preferred mode for patient counseling of medications, and in some states it is the mandated mode, but this may not be possible in some instances.²⁸ Fortunately, the advent of telepharmacy via videoconferencing has allowed for some patients and pharmacists to meet “face-to-face” despite being at a distance. This has been particularly beneficial in rural settings where the patient may live many miles away from a healthcare facility or a pharmacy. Of course, connections via these nontraditional routes often involve special equipment and software and training for both the provider and patient. As such, significant costs may be involved in providing counseling via these nontraditional modes. Pharmacists must be very attentive to the patient’s tone and word choice when engaging via these non-traditional formats, because in the absence of video nonverbal cues cannot be assessed.

Regardless of the setting, it is important that the counseling session occurs in a location where both the pharmacist and patient are comfortable and free from distractions and where the confidentiality of the encounter can be maintained. It is also recommended that the pharmacist position him or herself at eye level with the patient and use open body language to enhance communication. This will help to ensure a more constructive information exchange between the patient and pharmacist, as well as ensure compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations. Studies have shown that pharmacists will spend more time counseling a patient in a private setting and, in turn, the patient may feel more comfortable asking questions and receive a greater benefit from the session.²⁹

BENEFITS OF PATIENT COUNSELING

Patient counseling offers several known benefits.³⁰ Patient counseling helps to improve patient quality of life and health-related outcomes, leading to better quality of care. Patients who receive counseling also feel more satisfied with the care that they are receiving. Through this increased satisfaction, the communication lines between the patient and the pharmacist can open up. Counseling also helps patients to become more informed, active participants in their health care and improves their overall health. Patient counseling can also help to improve patient adherence and compliance while minimizing adverse events and medication errors. Self-treatment may also increase as a result of patient counseling, and patients may be able to make better medication-related decisions concerning their medication regimen. In addition, the minimization of adverse events decreases both direct and indirect costs for patients and the healthcare system.

CHALLENGES OF PATIENT COUNSELING

The pharmacist faces many challenges in providing patient counseling within the inpatient, ambulatory care, and community settings. Workload is the most commonly reported challenge by pharmacists. However, it has been found that the relationship between offering counseling and workload demands is not linear.²⁹ This may mean that although some pharmacists find workload demands to be a barrier to offering counseling, others do not. Patients often report that the brevity of the encounter is a challenge, discouraging them from asking questions to help clarify information received.³¹ This challenge may also be a result of pharmacists’ workload demands.

Other challenges to patient counseling can include the lack of a private setting for the encounter. In fact, many pharmacies have redesigned space for this encounter since the OBRA ‘90 mandate. These spaces should be designed in a manner to allow for a private and confidential conversation to occur within a comfortable environment that is well lighted, temperature controlled, and that has adequate seating that can be rearranged as needed.

Another challenge that can arise is the primary language of the patient. Pharmacies must have the means to communicate with patients through the use of interpreters. Meeting this need may involve the employment of bilingual staff or the use of technology to assist in these counseling sessions. Technology has advanced to the point that language interpretation services may just be a web conference or a phone call away.

The lack of effective communication skills on the part of the pharmacist may be an unrecognized challenge to the counseling encounter. Studies have shown that the pharmacist’s age or time since graduation may contribute to the lack or ineffectiveness of the counseling encounter.³² It is thought that older pharmacists or those who graduated from pharmacy schools prior to the enactment of the OBRA ‘90 mandate may not have benefited from a curriculum that developed communication skills required for patient counseling and thus may be uncomfortable in providing counseling. Today, all colleges of pharmacy must include the development and assessment of communication skills within their curriculum, as mandated by Accreditation Council for Pharmacy Education (ACPE) standards, although the manner in which it is assessed may differ significantly.³³ This means that although younger pharmacists or recent graduates may have benefited from a curriculum that encompassed effective communication skills, all pharmacists can still benefit from continued education in this area to further refine their skills.

All in all, the challenges of patient counseling can be overcome with appropriate planning on the part of the pharmacist. This planning may include construction or identification of a private counseling area for the session or a discussion with pharmacy staff to limit distractions during the interaction. Although a face-to-face encounter is ideal for the patient counseling session, it may be necessary to follow-up with a patient over the phone to verify understanding and completeness of the information provided. The pharmacist should also recognize the needs of each patient with regard to what might be required to ensure a successful session (i.e., presence of an interpreter if the patient does not speak English or a large-print prescription label if the patient has vision loss or difficulty reading prescription instructions). Finally, all pharmacists should continually evaluate the effectiveness of their personal communication skills and work to refine them in a manner that is professional and adaptable within any patient counseling session.

PATIENT COUNSELING TECHNIQUES

The pharmacist can approach the patient counseling encounter in a number of different ways. Berger suggests a 29-item checklist for effective patient counseling, whereas Rantucci proposes a five-phase approach to the pharmacist–patient counseling session.^17,30 Berger and Rantucci are both recognized in the field of pharmacy for their research on communication and, although they identify similar objectives that must be met during the patient counseling session, they recommend slightly different approaches.

We propose a 10-step modified version to the patient counseling encounter:

  1.  Introduce yourself and state the purpose of the counseling session.

  2.  Confirm that you are speaking to the patient or the patient’s agent and request time to speak with him or her.

  3.  Verify that the patient’s pertinent profile information is up to date and accurate to ensure that all patient factors are considered.

  4.  Partake in a discussion to assess the patient’s understanding of the medication prescribed or selected.

  5.  Teach to the gaps or inaccuracies in understanding of the medication prescribed or selected.

  6.  Provide any additional relevant information to ensure a successful outcome.

  7.  Address any patient concerns with regard to therapy and the regimen prescribed, as necessary.

  8.  Verify patient understanding of the information provided.

  9.  Supply a written summary of any information deemed necessary to support the encounter.

10.  Conclude the encounter and provide contact information should the patient have further questions.

Regardless of the approach utilized, all patient counseling encounters should begin with the pharmacist introducing him or herself to the patient and confirming that he or she is speaking to the patient or patient’s agent. The pharmacist should then explain the purpose and importance of the patient counseling session and ask the patient if he or she has time to discuss the medication. Once the patient has agreed to participate in the patient counseling encounter, the pharmacist should verify the patient profile information for updates and accuracy.

Counseling a Patient on a New Prescription

If the counseling session is intended to educate the patient on a newly prescribed medication, the pharmacist should proceed to ask three prime questions, as defined by the Indian Health Services (IHS) (Table 6.3). The three prime questions can be utilized in a variety of healthcare settings, but they were designed with the community pharmacy or ambulatory care clinic encounter in mind.

Asking these three questions enables the pharmacist to assess whether a patient knows the following with regard to the medication: (1) the indication, (2) how to properly take or apply the medication (including route, frequency, time of day, and whether to take on an empty or full stomach), and (3) the expected benefits from taking the medication and the potential side effects (including what to do if experienced). The three prime questions are an excellent example of open-ended questions that facilitate an interactive conversation between the pharmacist and the patient.³⁴ The pharmacist should listen carefully to the patent’s responses with attention and empathy. When listening to the patient, the pharmacist should observe any verbal or nonverbal cues that may indicate any concerns the patient may have with the medication. Upon assessment of the patient responses to the three prime questions, the pharmacist can teach to the gaps or inaccuracies in the information, tailor the medication regimen to the patient’s daily routine, and address any concerns a patient may have with regard to taking the medication.³⁵ When teaching to the gaps and inaccuracies, pharmacists should use a process of “show and tell,” asking patients to demonstrate how they use their medication device or to tell them how they use their medication so that the patients can associate what is being discussed with a visual reference to the actual pill or device.

TABLE 6.3 The Three Prime Questions for New Prescriptions