CMS SOM App. W, Tag C-1018

(v) Procedures for reporting adverse drug reactions and errors in the

administration of drugs.

Interpretive Guidelines §485.635(a)(3)(v)

CAH staff must report all drug (medication) administration errors and all adverse drug

reactions. This required reporting includes two distinct steps in the reporting of drug

(medication) administration errors and adverse drug reactions. The first and highest

priority reporting relates to the care of the patient, at time of occurrence. The second

reporting step is related to the CAH-wide Quality Assurance review as addressed in

§485.641(b).

Medication administration error:

The National Coordinating Council Medication Error Reporting and Prevention

definition of a medication error is “Any preventable event that may cause or lead to

inappropriate medication use or patient harm while the medication is in the control of

the health care professional, patient, or consumer. Such events may be related to

professional practice, health care products, procedures, and systems, including

prescribing; order communication; product labeling, packaging, and nomenclature;

compounding; dispensing; distribution; administration; education; monitoring; and

use.” A medication administration error is one that occurs in the phase of the

medication process where the drug actually enters the patient by one of various

possible routes, e.g., orally, intravenously, etc.

• Adverse drug reaction:

The American Society of Health-System Pharmacists (ASHP) defines an adverse

drug reaction (ADR) as “Any unexpected, unintended, undesired, or excessive

response to a drug that:

1. Requires discontinuing the drug (therapeutic or diagnostic)

2. Requires changing the drug therapy

3. Requires modifying the dose (except for minor dosage adjustments)

4. Necessitates admission to a hospital

5. Prolongs stay in a health care facility

6. Necessitates supportive treatment

7. Significantly complicates diagnosis

8. Negatively affects prognosis, or

9. Results in temporary or permanent harm, disability, or death.

Consistent with the definition, an allergic reaction (an immunologic hypersensitivity

occurring as the result of unusual sensitivity to a drug) and an idiosyncratic reaction

(an abnormal susceptibility to a drug that is peculiar to the individual) are also

considered ADRs.”

Patient Care

In the case of ADRs or medication administration errors that are not caught before they

reach the patient, a “report” must be made to a practitioner responsible for the care of the

patient.

For example, if a medication actually is administered to a patient when it should not

be, or the wrong dose is administered, or the wrong route of administration is used,

etc., or a medication that should have been administered to the patient has not been

administered in a timely manner, then the medication administration error has reached

the patient and must be reported to the responsible practitioner.

If, on the other hand the wrong dose of a drug is prepared for a patient, but a nurse

catches this and does not give that dose to the patient, then a medication

administration error has occurred, but the error has not reached the patient, and thus

does not need to be reported to the responsible practitioner.

Not every medication administration error that reaches the patient causes harm or has the

potential to cause harm; it depends both on the drug and on the patient’s condition.

In the case of all ADRs and any medication administration error that has harmed or has

reached the patient and could potentially cause harm, the report to a practitioner must be

made immediately after the staff identify the adverse reaction or (potentially) harmful

error, to enable a timely assessment and intervention. The report must be made directly

in a manner that confirms a practitioner received the report, for example, via a phone call.

If the impact of the medication error that reached a patient is unknown, the error must be

reported to a practitioner immediately. Documentation of the error or reaction, including

notification to the practitioner, must be in the patient’s medical record.

Medication administration errors that have reached the patient but result in no harm and

do not have the potential to cause harm can be reported to a practitioner during usual

working hours. For example, if an over-the counter analgesic dose is missed during the

night shift, it can be reported first thing in the morning as no further intervention would

be required by the practitioner. CAHs should provide clinical staff with expected

guidance on how to respond to these situations.

Quality Assurance/Improvement Reporting:

Reduction of medication administration errors and ADRs may be facilitated by effective

internal CAH reporting that can be used to assess vulnerabilities in the medication

process and implement corrective actions to reduce or prevent reoccurrences. To facilitate

reporting, the CAH must educate staff on medication administration errors and ADRs

including the criteria for those errors and ADRs that are to be reported for quality

assurance/improvement purposes, and how, to whom and when they should be reported.

Reporting for quality assurance/improvement purposes covers all identified medication

errors, regardless of whether or not they reach the patient, and those ADRs meeting the

criteria specified in the CAH’s policies.

For Information Only - Not Required/Not to be Cited

To improve staff willingness to report medication errors and ADR incidents, CAHs are

encouraged to adopt a non-punitive approach that focuses on system issues rather than

individual health care professionals. A non-punitive approach is likely to encourage

reporting by those who otherwise may fear retribution or CAH disciplinary action.

In addition to internal staff reporting, the CAH is expected to take other steps to identify

medication administration errors and ADRs. Reliance solely on staff-generated incident

reporting fails to identify the majority of adverse drug events. Proactive identification

includes observation of medication passes, concurrent and retrospective review of

patient’s clinical records, implementation of medication usage evaluations for high-alert

drugs, and identification of indicator drugs that, when ordered, automatically generate a

drug regimen review for a potential adverse drug event.

The CAH must assess the effectiveness of its internal reporting system to determine

whether or not it is identifying as many medication errors and ADRs that would be

expected for the size and scope of services provided by the CAH. In making such

assessments the CAH could refer to established benchmarks or studies on error or ADR

rates published in peer-reviewed journals.

For Information Only – Not Required/Not to be Cited

CAHs are encouraged to participate in state-wide and national patient safety

organizations for reporting of drug administration errors, ADRs, and drug

incompatibilities. National organizations include, but are not limited to, the FDA

MedWatch Reporting Program and the Institute for Safe Medication Practices (ISMP)

Medication Errors Reporting Program. These organizations, along with other patient

safety organizations, collect and analyze data, identify trends, and provide feedback

and recommendations to health care organizations to reduce the risk of medication

related errors and events.

Survey Procedures §485.635(a)(3)(v)

• Assess whether the CAH ensures that medication administration errors and ADRs are

reported to practitioners in a timely manner.

o Are nursing staff familiar with the concepts of medication errors that do and

do not reach the patient, as well as ADRs?

o Ask nursing staff what they would do in the case of a medication

administration error that reaches the patient or an adverse drug event.

o Ask nursing staff if they can provide examples of cases where they needed to

report an ADR. Is the report to the practitioner documented in the medical

record?

o Review records of medication errors and ADRs to determine that they are

reported immediately in accordance with written procedures, and that

medications administered and/or drug reactions are promptly recorded in the

patient’s medical record.

• Can the CAH demonstrate that it has a system for reporting/identifying ADRs and

medication administration errors for quality assurance/improvement purposes?

• Interview CAH staff (nursing, pharmacy and medicine) to ascertain awareness of the

CAH’s policy on reporting medication administration errors and ADRs for quality

improvement purposes

• Does the CAH have evidence of training staff on reporting expectations?

• Does the CAH rely only upon internal staff incident reporting or does it use other

methods to identify potential/actual medication errors and ADRs, as well?

Ask the individual responsible for the QA program to demonstrate how the CAH

determines if the number of medication administration errors and ADRs reported is

consistent with the size and scope of services provided by the CAH.

• Review QA activities for medication administration errors and ADRs to

determine if, upon analyses of the reports, potential corrective actions are

identified and implemented, if appropriate.