OASIS Alert

What is a Clinically Significant Medication Issue?

The Centers for Medicare & Medicaid Services leaves it to the provider's clinical judgment to determine whether a medication issue is "clinically significant." But the issue must pose an actual or potential threat to the patient's health or safety, says Judy Adams, RN, BSN, HCS-D, HCS-O with Adams Home Care Consulting in Chapel Hill, N.C. Examples of clinically significant medication issues include:

  • Drug reactions. These are adverse reactions or consequences of taking a drug. A drug reaction may be a secondary effect of a medication that is undesirable and different from therapeutic or any response to a medication that is noxious, and unintended effect such as a rash.
  • Ineffective drug therapy such as an analgesic that does not relieve pain.
  • Side effects. These expected, well known reactions occur with a predictable frequency and may or may not constitute an adverse consequence. For example, bleeding is a side effect of anticoagulant use.
  • Drug-to-drug and drug-to-food interactions. Serious drug-to-drug, drug-to-food or drug-to-disease interactions can alter absorption, distribution, metabolism, or elimination. These interactions may increase or decrease the effectiveness of the medication or increase the potential for adverse consequences.
  • Duplicate therapy. Is your patient prescribed both a generic and a brand name drug that are equivalent?
  • Omissions. Is your patient missing drugs from an ordered regimen?
  • Dosage errors. Is your patient's dose too high or too low?
  • Noncompliance with a medication regimen can be purposeful or accidental; due to impairment or decline in individual's mental or physical condition or functional or psychological status.

Examples of Clinically Significant Medication Issues

  • The patient's list of medications from an inpatient facility discharge list does not match the medications the patient has in the home.
  • The diagnoses or symptoms for which the patient is taking a medication are not adequately controlled.
  • The patient seems confused about when or how to take medications. This indicates a high risk for medication errors.
  • The patient has not obtained prescribed medications or indicates he will not take one or more of them due to financial, access, cultural, or other issues.
  • The patient exhibits signs and symptoms that are clinically significant adverse reactions from medications he is taking.
  • The patient takes multiple non-prescribed medications (such as herbs or over-the-counter medications) that could interact with prescribed meds.
  • The patient has a complex medication plan with medications prescribed by multiple doctors and/or obtains then from multiple pharmacies, putting her at high risk of medication interactions.

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