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Knowledge of clinical practice guidelines can protect pharmacists and patients.
The use of clinical practice guidelines (CPGs) for the medication management of patients with a wide variety of disease states has been common practice in health care settings for decades. Pharmacists in community practice may have encountered an increase in the number of dispensing situations requiring prior authorization. Often this can be attributed to insurers or pharmacy benefits management (PBM) firms making this a prerequisite because a CGP is applicable and may not have been followed, such as during step therapy for the treatment of hypertension or diabetes.
More than 10 years ago, the National Guideline Clearinghouse officially went live with its repository of clinical guidelines on the Internet, using that communication medium to disseminate information about contemporary practice standards. Due to the accessibility of the Internet, both health professionals and patients have access to the recommendations found in CPGs. This serves to increase understanding and encourage appropriate use of medications and at the same time fosters increased concerns or questions from patients.
CPGs are appropriately defined by the US Agency for Healthcare Research and Quality (AHRQ) as “Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical conditions.”1 They can define or recommend specific diagnostic, treatment, or prevention approaches, and are based on evidence from a systematic review of the published literature on a given disease or disorder. The extensive spectrum of clinical concerns covered by these types of guidelines includes diagnostic tests that are most appropriate in a given situation, fracture prevention measures for postmenopausal patients with osteoporosis, or informing the decision regarding use of surgical procedures versus other treatments for life-threatening conditions such as prostate cancer, to name a few.
Best current practice uses relevant findings from well-designed, systematic, randomized clinical trials to identify care options that are supported by evidencebased recommendations. “Evidence-based” treatment is the current phrase in vogue to describe best practices. A somewhat related concept that is also widely used is comparative effectiveness, defined as “A type of research that compares how different treatments, tests, or procedures for specific conditions have worked for others.”2 Both concepts relate to CPGs.
Practice guidelines have been tied in some way by numerous individuals or organizations to cost, quality, access, patient empowerment, professional autonomy, medical liability, competition, benefit design, utilization variation, bureaucratic micromanagement of health care, and much more.3 Organizations of health professionals in a particular field or specialty have developed CPGs as a means to maintain autonomy and to free professional decision making from external influences.4
Other entities that develop CPGs include voluntary health agencies, for example, the American Heart Association; insurance companies and health maintenance organizations/PBMs; governmental entities, such as the Centers for Disease Control and Prevention; and even individual hospitals and health systems. With so many different organizations creating guidelines, it is easy to get confused as to which guidelines are truly clinically significant and therefore deserve serious consideration.
The AHRQ supports evidence-based practice centers that conduct systematic reviews that government agencies, professional societies, and other groups can request and use when developing guidelines and other recommendations.5 The most comprehensive database available, the National Guideline Clearinghouse, is sponsored by AHRQ. This database provides an accessible and reliable mechanism for pharmacists, physicians, and other health professionals to access objective, detailed information on clinical practice guidelines and to further their dissemination, implementation, and use.6
Improving a patient’s quality of life through direct, responsible provision of medication-related care for the purpose of achieving definite outcomes is the cornerstone of pharmaceutical care.7 Therefore, responsibility for critically evaluating CPGs that specifically focus on medication-related treatment options can fall on the shoulders of pharmacy practitioners. Adopting explicit, systematic methods for reviewing well-collected evidence and then developing practice guidelines is an important strategy for reducing the opportunities for bias, whether the source of that bias might be intellectual and professional preconceptions, financial interests, or something else.5
Rigorously developed CPGs have the potential to greatly reduce the chances of patient harm, but CPGs are only 1 option for improving the quality of patient care; therefore, they should be critically evaluated by an expert review board before being implemented. Moreover, that process should be repeated periodically to take into account contemporary developments and advances in therapeutic knowledge and understanding. There is a fine line between treating individual patients based solely on the categorically appropriate CPG and deviating from this accepted practice because such a treatment recommendation could be wrong for that patient’s specific situation.
The development of CPGs is based in large part on the notion that they will optimize patient care and improve the quality of health care. However, given the scope of the millions of patient scenarios that practitioners deal with every day, it is impossible and unrealistic to assume that one will always be able to comply with an accepted CPG or protocol that applies to the patient. Deviations from CPGs must be carefully considered, thoroughly documented, and then explained to the patient to avoid any inkling of unjustified deviation from standard practice, or even negligence. It may be a good recommendation to seek corroboration from a colleague before deviating from agreed-upon CPGs.
In contemporary society, professional behavior and decision-making can unfortunately be heavily influenced by the concern for potential malpractice claims. This could deter clinicians from deviating from CPGs when appropriate because of a desire to follow a strict, overly cautious treatment plan. Conversely, in instances where the CPG has the potential to be viewed as lax and not adequately protective of patients, practitioners may be open to allegations of inadequate attention to care of the patient by failing to recommend an optimal treatment that differed from the CPG.
From the legal perspective, CPGs can be a sword that cuts both ways—compliance with recommendations in a CPG when treating a patient may well provide a legal defense should it be alleged that the practitioner performed in a substandard manner. Alternatively, deviating from the recommendations in a CPG may increase potential liability exposure by arming the injured patient with expert guidelines to support his or her position.
Clinical guidelines are normative standards and could be used as a tool to indicate customary care. They could be used as a tool for assessment of questionable decision making or conduct. Guidelines may be consulted by courts because they provide information about standards justified in relation to sound scientific and professional evidence rather than mere custom. Some commentators believe CPGs will define the requisite “standard of care” for treatment and have a major impact on medical liability litigation. Although CPGs cannot alone establish the applicable standard of due care under the circumstances, they can serve to buttress or reinforce expert testimony. Such guidelines may serve as a source of apposite information of probative value, provided they are the product of a recognized professional body, and prove to bear no relation to a body with a potential conflict of interest. Whether CPGs are used defensively or offensively, critical evaluation of the relevance and applicability of the CPG to the situation at hand is the sine qua non for establishing their relevance.
Appropriate prescribing of medications is often a pivotal issue in medical negligence claims. In some instances, both the prescriber and the pharmacist will be taken to task for alleged shortcomings when discharging their professional responsibilities.8 In such cases, the FDAapproved product labeling of the prescription medication in question may play the same role as a CPG by being used to establish the standard of care.
Negligence is defined as the failure to use that degree of skill and learning ordinarily used under the same or similar circumstances by the members of the defendant’s profession. As part of that, drug-related cases often see use of the approved product labeling to establish the standard of care, either by the plaintiff or defendant. It is reasonable to look to the wording of the official package insert to determine the standard of care for use of that medication when that prescription drug is implicated in causing legally cognizable damages.8 In state cases involving allegations of negligence in prescribing and monitoring use of medications, the product’s package insert has been a vital piece of evidence in determining a practitioner’s liability for damages.
CPGs have become a mainstay in clinical practice decision making. These guidelines cover a broad spectrum of disease states, diagnostic options, and treatment alternatives. CPGs have been proved effective for improving the quality of patient care and are beneficial when used in appropriate situations. However, they may not be applicable to all patient care scenarios. It is essential to critically evaluate CPGs and to be sure they were created using sound systematic, evidence-based medicine.
It has been observed that deviation from CPGs can have major legal implications for practitioners, and avoidance of these situations is crucial through consultation with peers and documentation. As the role of the pharmacist continues to evolve, being familiar with the origins and uses of CPGs and their potential contributions to clinical decision making is essential. PT
Ms. Ratermann is a third professional year PharmD student at the University of Kentucky and Dr. Fink is professor of Pharmacy Law and Policy at the University of Kentucky.