36C26318R0288-025.docx

DEPT. OF VETERANS AFFAIRS

BLACK HILLS HEALTH CARE SYSTEM

Policy PHARM-16 July 9, 2015

ALLERGIES & ADVERSE DRUG EVENT (ADE) REPORTING AND MONITORING

1. PURPOSE: To define and describe policy and procedures for defining , identifying , reporting, evaluating and recording of allergies and adverse drug events (ADEs) as required by VA Central Office and The Joint Commission (TJC). These are also referred to as ADR's (Adverse drug reactions) .

2. POLICY: Detection , monitoring , reporting, analysis and follow up actions relating to ADEs are important functions for provision of high quality patient care, risk management and continuous quality improvement. Adverse drug events will be identified and recorded in the electronic record for all patients by the clinician that becomes aware of the adverse drug event.

3. PROCEDURES/DEFINITIONS :

A. Adverse Drug Event. An Adverse Drug Event (ADE) is an injury resulting from the use of a drug. For the purposes of this Directive, this definition includes harm caused by the drug as a result of adverse drug reactions, drug-drug interactions , product quality problems, or drug overdoses (whether accidental or intentional) . Severity levels are:

1) Mild ADE. A mild ADE is an event that requires no intervention or minimal therapeutic intervention such as discontinuation of drug(s).

2) Moderate ADE. A moderate ADE is an event that requires active treatment of adverse reaction, or further testing or evaluation to assess extent of non-serious outcome .

3) Serious ADE. A serious ADE occurs when a patient's condition has one or more of the following outcomes (or requires medical intervention to prevent one of these outcomes) : death, a life-threatening experience, inpatient hospitalization (or a prolonged hospitalization) , a persistent or significant disability , or a congenital anomaly or birth defect.

4) ADE relating to a new drug: Occurs in a drug that was introduced into the market within the last three years.

B. Adverse Drug Reaction. An Adverse Drug Reaction (ADR) is a response to a drug which is noxious and unintended and which occurs at doses normally used in individuals for prophylaxis, diagnosis , or therapy of disease or for the modification of physiologic function . NOTE: There should be a causal or suspected link between a drug and adverse drug reaction. However, a causality assessment or association of the drug to the adverse drug reaction does not have to be established in order to report an adverse drug reaction or adverse drug event.

1) Historical ADR. A historical ADR is a past event or an event that reportedly occurred in the past at another health care setting . A historical ADR is defined in the CPRS system as "reported by the patient as occurring in the past; no longer requires intervention ."

2) Observed ADR. An observed ADR is defined in CPRS as a reaction that is "directly observed or occurring while the patient was on the suspected causative agent." NOTE:

Observed refers to a newly noted adverse outcome. Although the term implies that the provider of record made the diagnosis, the fact that a provider may not have visually "observed" an adverse drug reaction does not preclude reporting as "Observed."

3) Allergy. An allergy is an ADR mediated by an immune response (e.g., rash, hives).

C. Causality Assessment. A causality assessment is a determination whether there is a reasonable possibility that the drug caused or contributed to an adverse event. It includes assessing temporal relationships, de-challenge or re-challenge information, association (or lack of association) with underlying disease and the presence (or absence) of a more likely cause .

D. Medication Error. A medication error is a mishap that occurs during prescribing , transcribing , dispensing , administering , adherence , or monitoring a drug . NOTE: Not all medication errors lead to adverse outcomes.

E. Vaccine ADEs will be entered into a CPRS chart as Observed or Historical entries. If entered as Observed ADE entries they will be further classified as mild, moderate, or severe.

F. Side effects are NOT classified as ADRs and are defined as an expected , well-known reaction resulting in little or no change in patient management (e.g. drowsiness due to an antihistamine) . These are not reported to FDA but may be tracked in the patient's computerized record.

G. Identification of suspected ADEs :

1) All practitioners are to be aware of the definitions and the reporting process. This will be accomplished by education in Medical Staff meetings and service meetings.

2) Personnel who observe or identify a possible ADE are required to report it. This includes physicians , nurses, pharmacists, Laboratory , Respiratory Therapy , Radiology , Operating room and medical records staff.

3) Concurrent monitoring of drugs commonly used in management of ADEs (stat doses of epinephrine , corticosteroids , antihistamines) will also be used to identify ADEs .

H. Reporting ADEs :

1) ADE data is entered into CPRS by the provider or individual identifying the ADE. Standard Operating Procedure (SOP)-Entering Adverse Drug Reactions is available to all staff.

2) Information required for the report includes:

a) Date and time of occurrence;

b) Patient name and social security number;

c) Name of the medication and brief account of the incident; and

d) Any treatment given due to the ADE .

e) Historical vs. Observed ADE status

f) Mild, Moderate, or Severe rating if meeting observed ADE definition .

3) Documentation of the drug reaction will be made in the medical record.

4) ADE summaries will be reported to Pharmacy & Therapeutics Committee (P & T) and serious ADRs will be reported to both P&T and VAADERS . New drug ADEs and observed vaccine ADEs may also be sent to the VAADERS reporting system. Identification of alarming problems suspected to be related to drugs (e.g., clusters of cases of ADEs , suspicion of drug contamination , ineffectiveness , mislabeling, etc.) will be communicated to FDA. Patient consent is not required for release of such medical information to the FDA in accordance with the new "routine usage" provision. Observed ADEs will be reported to the VISN thru VA ADERS .

I. Evaluation of the Suspected ADE : Pharmacy will determine if a reportable ADE has occurred , and if reported as an observed ADE to ensure that observed definition is met. Consideration will include:

1) Review of the patient's medication and medical histories, whether or not medication was from a VA source , and where ADE occurred ;

2) Assessment of temporal relationships between the suspected reaction and drug administration ;

3) The results of drug withdrawal and drug rechallenge ;

4) Alternative explanations ; and

5) Literature review.

J. Monitoring and Follow Up of ADEs : ADE data will be reported to and reviewed by the P & T Committee locally and at VISN level. Conclusions , recommendations , actions and the evaluation of actions taken will be included in the reports of those committees .

K. Identification of patient allergies and adverse reactions:

1) Nursing will perform a review of a patient's allergies at each outpatient visit. Allergies will be reviewed at the time of admission by the clinical staff.

2) A clinical reminder to confirm allergies will identify those patients who have not had an annual review. Once the reminder has been satisfied , a yearly prompt will initiate the review.

3) Pharmacists review allergy information submitted .

4) A patient identification wristband will be used for all hospital or Community Living Center (CLC) patients who have allergies .

5) Allergy labels for charts or patient wristbands will be updated as necessary.

4. RESPONSIBILITIES :

A. The Director has overall responsibility for the ADE program.

B. Chief of Staff has responsibility for implementation of the ADE policy and procedures.

C. Chief, Pharmacy Service is responsible for day-to-day management of ADE-related functions . Pharmacy is also responsible for verification of allergies/adverse drug information.

D. Pharmacy and Therapeutics Committee is responsible for development and implementation of ADE policies and procedures.

E. Professional personnel are responsible for identifying and reporting ADEs , as well as updating this information in the electronic record.

5. REFERENCES:

M-2, Part 1, ASHP Guidelines on Adverse Drug Reaction Monitoring and Reporting. (www.ashp.org);

M-1, Part 1, Chapter 5; M-2 , Part 1, Chapter 17 VHA Handbook 1108.05 Outpatient Pharmacy Services VHA Directive 1070 Adverse Drug Event Reporting and Monitoring 6 . RESCISSION : BHHCS Policy COS-19 , dated 3/15/2012.

7. DATE OF COMPLETE REISSUANCE: June 2018

8. . FOLLOW-UP RESPONSIBILITY : Chief, Pharmacy Service image1.jpeg