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ASHP Statement on the Pharmacist’s Role in the Care of Patients with HIV Infection

Position

The American Society of Health System Pharmacists (ASHP) believes that pharmacists have a role in the care of patients infected with human immunodeficiency virus (HIV). Pharmacists have a responsibility to provide pharmaceutical care to these patients and, in states where it is authorized, can expand on that responsibility through collaborative drug therapy management.

Pharmaceutical care is the direct, responsible provision of medication-related care for the purpose of achieving definite outcomes that improve a patient’s quality of life.¹ Pharmacists establish relationships with patients to ensure the appropriateness of medication therapy and patients’ understanding of their therapy and to monitor the effects of that therapy. In collaborative drug therapy management, pharmacists enter into agreements with physicians who may authorize pharmacists to select appropriate medication therapies for patients who have a confirmed diagnosis and adjust them on the basis of patients’ responses.²

Clinicians who provide these services are responsible for the quality of care, the satisfaction of patients, and the efficient use of resources, as well as their own ethical behavior.³ High-quality, coordinated, and continuous medication management for patients should be measurable as a result of the provision of these services. The potential benefits to patients include access to medication information, the prevention and resolution of medication-related problems, improved outcomes, and increased satisfaction.⁴ Pharmacists are able to use medication-related encounters with patients to provide information and either resolve problems or make a referral for health care needs.

The purposes of this statement are to promote an understanding of the various ways in which pharmacists can provide or contribute to the provision of care for patients infected with HIV in integrated health systems and to suggest future directions for pharmacists to expand patient care services.

Background

HIV infection, like many other chronic illnesses, affects nearly every organ system of the body. HIV is pathogenic in some instances, and superinfection by bacteria, other viruses, or fungi is common in the advanced stages of HIV infection. Unlike some other illnesses, HIV infection can be prevented by curbing high-risk behaviors,⁵ so the illness still carries a social stigma among some who believe that they are not at risk. Among those at high risk for HIV infection are intravenous drug users and the severely mentally ill,⁶ whose conditions may discourage testing for HIV infection or disclosure of HIV status and can also hinder treatment. Discrimination against HIV-infected individuals in housing and employment persists and may impede the delivery of health care by disrupting the stability of home and work life.

Our understanding of the basic pathophysiology and immunology of HIV infection continues to evolve on an almost-daily basis, and drug development occurs at a rapid pace. Since 1990, the Food and Drug Administration (FDA) has averaged one new antiretroviral agent approval per year; several years have seen the approval of two or three new antiretrovirals.⁷ With these rapidly changing and complex therapeutic options, it is a challenge for many primary care providers to keep abreast of state-of-the-art strategies for managing HIV infection and provide comprehensive treatment for a relatively small population of patients. General practitioners know intuitively what has been shown in the literature: patients who are cared for by physician experts in HIV infection have better outcomes.^8–10 The advent of effective antiretroviral therapies has increased the need for clinicians with a broad knowledge of and experience managing HIV infection’s concomitant diseases. In addition, important drug–drug interactions exist between antiretroviral agents and drugs used to treat opportunistic infections, between antiretroviral agents and drugs used to treat non-HIV-related comorbidities, and among the antiretroviral agents themselves. Failure to recognize these drug–drug interactions may result in additional or exacerbated adverse effects, nonadherence, therapeutic failure, or irreversible drug resistance. HIV-infected patients require extraordinary counseling and education regarding their treatment, from the importance of adherence to ways to recognize and cope with long-term consequences of therapy. The complexity of pharmacotherapy for patients with HIV infection presents special challenges and opportunities for pharmacists interested in developing a specialized knowledge base about HIV treatment.

There are a range of places within integrated health systems where pharmacists are likely to interact directly with patients infected with HIV: outpatient pharmacies, ambulatory care clinics, inpatient settings, dialysis units, hospices, and home infusion and home health care companies. Pharmacists are often considered the most accessible health professional; they are frequently at the frontline in helping HIV-infected patients deal with barriers to medication access, managing adverse effects and drug interactions, and adhering to medication regimens. Because many HIV-infected patients feel disconnected from the community, compassion on the part of the pharmacist can forge a strong bond with the patient and perhaps enhance patient adherence to antiretroviral treatment.

Patients’ ability to adhere to antiretroviral regimens is essential to achieving the goals of drug therapy. Although the exact degree of adherence needed to ensure successful outcomes from drug therapy is not known, one study found that patients must take 95% of their doses to maintain drug levels that will achieve viral suppression, prevent drug resistance, and avert treatment failure.¹¹ Lack of adherence is often cited as the most common cause of the development of drug resistance and reduced effectiveness or therapeutic failure.¹² Mutations that lead to resistance to one drug may confer resistance to other drugs in the same therapeutic class, severely limiting future treatment options.^13,14

Causes of nonadherence are multifactorial and differ greatly from patient to patient. In general, adherence has not been related to patient age, race, sex, education level, socioeconomic status, or history of substance abuse.¹⁵ The principal factors associated with nonadherence to antiretroviral therapies appear to be patient-related, and include mental illness (particularly untreated depression), unstable housing, active substance abuse, and major life crises.^16,17 Some patients stop or reduce the dosage of antiretroviral medication because of adverse effects.^17–19 Other factors that have been shown to negatively affect adherence include inconvenient frequency of drug administration, dietary restrictions, and pill burden.¹⁷ A health care professional’s assessment of a patient’s ability to adhere to a medication regimen is a notoriously poor predictor of actual adherence.^20,21 In one study, the most important predictor of a patient’s lack of success with an antiretroviral regimen was the patient’s inability to keep appointments with the health care practitioner.²²

Responsibilities

Pharmacists involved in the care of HIV-infected patients participate with other members of the health care team (e.g., physicians, physician assistants, nurse practitioners, nurses, dietitians, social workers, case managers, and pastoral care providers) in the management of patients for whom medications are a focus of therapy. The pharmacist’s responsibility is to optimize the patient’s medication therapy. Because of the rapid changes in HIV treatment, pharmacists involved in the care of HIV-infected patients should commit themselves to weekly if not daily education from journals or other sources. Pharmacy services should be designed to support the various components of the medication-use process (ordering, dispensing, administering, monitoring, and educating) as individual steps or as they relate to one another in the continuum of care. Pharmacists should evaluate all components of the medication-use process to optimize the potential for positive patient outcomes.² Particular care is needed in the prescribing and dispensing phases because the names of many antiretroviral agents sound and look similar, especially when they are handwritten, and some physicians continue to refer to antiretroviral agents by their chemical or investigational names. Verification of the appropriateness of the antiretroviral cocktail and its dosages is important because dosing recommendations change frequently as more becomes known about individual drug pharmacokinetics and because drug–drug interactions may be used clinically to simplify or increase the efficacy of drug regimens. Pharmacists should screen the medication profile for potential drug–drug and drug–food interactions. A number of antiretroviral drugs cannot be taken with certain foods, and it is the responsibility of the pharmacist to ensure that the patient and caregivers (dietitians, nurses, family members, and friends) are aware of these dietary restrictions.

Pharmacists are responsible for assessing patients’ readiness to adhere to drug therapy, assisting in the design of therapeutic plans to increase the likelihood of adherence, assisting the patient in successful implementation of drug therapy, intervening when the patient states or intimates that he or she cannot or will not adhere to treatment, and providing ongoing monitoring of adherence. The public health implications of inconsistent adherence are much greater with antiretroviral agents than with other chronic medications. The pharmacist can promote patient adherence by considering the patient’s history of adverse effects when recommending a regimen; helping to develop a daily medication administration schedule that accommodates the patient’s sleep, work, and meal schedules; providing memory aids for medication taking; recruiting an adherence coach; and educating and motivating patients and caregivers.²³ To ensure a consistent supply of antiretroviral medications, patients need to be counseled to plan for medication refills so they are never without these medications. Pharmacists, along with other health care professionals, are responsible for postmarketing surveillance of adverse drug events. Suspected adverse drug events should be reported to the patient’s primary care provider and to FDA’s MedWatch program. Many antiretroviral medications were marketed with scant data about their long-term effects because FDA’s accelerated drug approval process allows certain drugs to be approved with only six months of clinical (Phase III) data. Pharmacists should also be aware of the potential for adverse events or drug interactions caused by dietary supplements and should report those as well.

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