THERAPEUTIC INDICATIONS FOR PRESCRIBED MEDICATIONS

To advocate that all healthcare professionals involved in a patient’s care have immediate access to the intended therapeutic purpose of prescribed medications in order to ensure safe and effective medication use; further,

To encourage all healthcare settings to optimize the use of clinical decision support systems with indications-based prescribing; further,

To advocate for implementation of a universal, interoperable coding system for labeled therapeutic indications that can be integrated throughout the medication-use process, enabling optimum clinical workflows and decision support functionality; further,

To advocate for federal and state laws and regulations to include diagnosis-based indication(s) on medication order(s) and prescription(s), and to allow the withholding of indication on medication prescription labels when patient privacy risks outweigh benefits.

Rationale

The Joint Commission (TJC) Comprehensive Accreditation Manual for Hospitals includes standards that specify that healthcare professionals involved in the medication-use process should have access to and use patient and medication information important in the prescribing, dispensing, administration, and monitoring of medications. In addition to its accreditation standards, TJC’s 2022 national patient safety goals for hospitals include improved staff communication (getting important test results to the right staff person on time) and safe use of medications (recording and passing along correct information about a patient’s medications). It is important to recognize that medication indications are used not only by pharmacists, nurses, and physicians but also other important members of the healthcare team, including but not limited to respiratory therapists, social workers, physical therapists, and others who utilize this information to guide patient care.

The Institue for Safe Medication Practices (ISMP) has offered recommendations, including clearly specified dosage form, drug strength, and complete directions on all prescriptions; indication on all outpatient prescriptions and on inpatient PRN orders; with name pairs known to be problematic, reducing the potential for confusion by writing prescriptions using both the brand and generic names; listing both brand and generic names on medication administration records and automated dispensing cabinet computer screens; and, whenever possible, determining the purpose of the medication before dispensing or administering it.

Several well-known studies have demonstrated reductions in wrong-patient errors and adverse events with the inclusion of indication on the prescription order. In 2010, Equale (Drug Saf. 2010; 33: 559-67) described the accuracy of indication information in electronic health records (EHRs). Galanter (J Am Med Inform Assoc. 2013;20:477–81) focused on preventing wrong-patient medication errors with the use of indication-based prescribing. Indication-based alerts resulted in an interception rate of 0.25 interceptions per 1000 alerts. One team of investigators conducted a trial of inpatient indication-based prescribing using computerized provider order entry with drugs commonly used off-label (Appl Clin Inf. 2011;2:94–103). Off-label prescription drug use without strong scientific evidence has also been associated with increased rates of adverse drug events (JAMA Internal Medicine 2016; 176:55-63). The authors suggested that use of and proper documentation of therapeutic indication can help improve surveillance and safety and decrease risk. This additional safety check is critical in limiting errors due to wrong and/or look-alike/sound-alike medications. In addition to error prevention, indication-based prescribing can improve patient engagement, patient education, and provide pharmacists with information that may be necessary for prior authorizations or claim processing. To foster successful implementation of indication-based prescribing in EHRs, several authors have documented the success of starting electronic prescriptions with a problem or indication list first before medications can be selected to reduce time and medication errors while maintaining clinician satisfaction.

In several countries, including Canada and Spain, the EHR includes indication as part of comprehensive documentation. ASHP first developed official policy on the importance of pharmacists’ access to indications in 1993. In 1996, the National Coordinating Council for Medication Error Reporting and Prevention recommended including the purpose of medication orders because of concerns about safety, unless considered inappropriate by the prescribers. In 1999, the Institute for Safe Medication Practices recommended including the purpose of prescribing on all written orders. In 2004, the National Association of Boards of Pharmacy (NABP) approved a resolution encouraging national and state medical associations to support legislative and regulatory efforts to require prescribers to include indications for all oral, written, and electronically transmitted prescriptions. In 2012, the United States Pharmacopeia made amendments to the standards for prescription container labeling to include “purpose-for-use” language. In 2015, the National Council of Prescription Drug Plans drafted language to recommend diagnosis and SNOMED indication be sent with any prescription. Despite these recommendations, few states have adopted any laws requiring inclusion of indication on all medication orders or prescriptions.

More recently, ISMP has recommended updating the five “rights” of patient, drug, dose, time, and route to include a sixth “right”: the right indication. They cite benefits of indication-based prescribing as (1) helping to prevent errors by narrowing medication choices; (2) empowering and educating patients, which helps increase patient adherence; (3) improving communications among the healthcare team, patients, and families; (4) facilitating medication reconciliation; (5) helping prescribers select the best medications for their patients; and (6) aiding in measuring drug effectiveness and learning from off-label use.

ASHP also has policy on off-label use that encourages the use of the three authoritative drug compendia, peer-reviewed literature, and consultation with experts in research and clinical practice to make specific coverage decisions. ASHP supports informed decision-making that promotes third-party reimbursement for drug products approved by the Food and Drug Administration (FDA) appropriately prescribed for unlabeled uses.

Implementation and use of interoperable clinical decision support systems with indications-based prescribing would be eased by agreement on a universal coding system for labeled therapeutic indications. The FDA, the National Council for Prescription Drug Programs, and other organizations should work collaboratively to select and implement such a system.

Furthermore, ASHP recognizes that there are circumstances in which it would be inappropriate to include diagnosis on a medication order, and encourages such exceptions in federal and state laws and regulations. One clear example of such an exception would be six protected categories of drugs (antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of transplant rejection, antiretrovirals, and antineoplastics), as including these may inadvertently result in breaches in patient privacy.