We all know the importance of monitoring a patient’s response to medications. So how do we assure that our processes meet CMS expectations? The regulations at §482.23(c) form the basis for this discussion.

Per CMS: “Observing the effects medications have on the patient is part of the multi-faceted medication administration process. Patients must be carefully monitored to determine whether the medication results in the therapeutically intended benefit, and to allow for early identification of adverse effects and timely initiation of appropriate corrective action.”

Monitoring needs to be Comprehensive
The scope of assessing a patient’s response to medication depends on the type of medication (including the dose, route, and frequency of administration) as well as the patient’s prior history or experience with the drug. CMS will expect that staff and practitioners review the following as appropriate:

• Clinical and laboratory date to evaluate the effect and efficacy of the medication and to anticipate any issues around toxicity or adverse effects. For some medications, including opioids, this may include clinical data such as respiratory status, blood pressure, and oxygenation and carbon dioxide levels;
• Physical signs and clinical symptoms relevant to the patient’s medication therapy, including but not limited to, somnolence, confusion, agitation, unsteady gait, pruritus, etc.
• Factors that may place patient’s at risk including, but not limited to, age, altered liver and kidney function, a history of sleep apnea, patient weight (obesity may increase apnea or smaller patients may be more sensitive to dose levels of medications), asthma, history of smoking, drug-drug interactions, and first-time medication use.

Assure that Providers Communicate
It’s essential that the healthcare team communicate all relevant information regarding a patient’s medication risk factors and monitoring requirements. CMS will expect that “this occurs during hand-offs of the patient to other clinical staff, such as when patients are transferred internally from one unit to another, during shift report at change of shift, etc. This would apply to hand-offs involving not only nursing staff, but also to any other types of staff who administer medications, e.g., respiratory therapists.”

Get Patient Feedback
Per CMS, “as part of the monitoring process, staff are expected to include the patient’s reports of his/her experience of the medication’s effects. Further, when monitoring requires awakening the patient in order to assess effects of the medications, the patient and/or the patient’s representative must be educated about this aspect of the monitoring process. In addition, hospitals are encouraged to educate the patient and his/her representative and/or family members about notifying nursing staff promptly when there is difficulty breathing or other changes that might be a reaction to medication.”

Your hospital’s policies and procedures are expected to address how the manner and frequency of monitoring, considering patient and drug risk factors, are determined. This includes information to be communicated at shift changes, and the method(s) of communication.

Document, Document, Document
Like most aspects of care, documenting a patient’s response to medications is critical. The entire body of the medical record can serve as evidence of said monitoring. For example, periodic obtaining/reviewing of laboratory values would be evidence of monitoring medications that carry renal impairment issues. Proper documentation of medications administered, the patient’s response to those medications, and any subsequent actions taken is essential.

Rick's clinical background is in critical care nursing with a focus in cardiovascular and trauma service lines. He has held both clinical and executive management level positions in Quality, Risk, Education, Infection Control, and Regulatory Compliance.

Rick is a regular speaker at numerous state and national conferences on the federal regulations and accreditation standards, and is host of CIHQ's popular monthly webinars addressing key compliance challenges in today's environment.

Rick is nationally certified in healthcare accreditation, and serves as Chair of the Board of Examiners for the Healthcare Accreditation Certification Program (HACP). Rick has a degree in Nursing with a Master's Degree in Health Services Administration.