D.9 REPORTING ADVERSE DRUG EVENTS.pdf

D.9 REPORTING ADVERSE DRUG EVENTS

36C25922R0102

DEPARTMENT OF VETERANS AFFAIRS HEALTH CARE SYSTEM

Oklahoma City, Oklahoma

Center Memorandum 119-12 July 31, 2018

REPORTING ADVERSE DRUG EVENTS

1. Summary: Center Memorandum 119-12, dated November 14, 2014 is revised with document format changes.

2. Purpose: This memorandum establishes written procedures for the reporting of adverse drug events at this medical center in accordance with The Joint Commission (TJC) Standards, Veterans Health Administration Directive and establishes a system of internal analysis and reporting.

3. Policy: It is the VHA and this medical center’s policy that all ADEs meeting the definition of an observed adverse drug reaction (ADR) are promptly reported in the VA Adverse Drug Event Reporting System (VA ADERS) and that ADRs observed in subjects participating in VA clinical trials research protocols are reported as appropriate.

4. Definitions: In compliance with TJC requirements and the Department of Veterans Affairs, the VA Health Care System Oklahoma City Pharmacy and Therapeutics Committee (P&T) has adopted the following 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 memorandum, this definition includes harm caused by the drug because 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) New Drug. A new drug ADE is an event that occurs with a drug that has been introduced into the market within the last three years. All events, regardless of severity

Center Memorandum 119-12, July 31, 2018 level, are required to be reported to the Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program MedWatch.

(5) Preventable ADE. A preventable ADE is an untoward event where information was available to the staff that, if used, could have minimized the adverse outcome (e.g.

previously documented allergy or improper patient compliance).

(6) Side Effect. A side effect is an expected and known effect of a drug that is not the intended therapeutic outcome. Since the term “side effect” tends to nominalize the concept of injury, it is recommended that these reactions are reported and monitored as an ADR.

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. There should be a causal or suspected link between the drug and the adverse 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 Reaction. An historical ADR is a past event or an event that reportedly occurred in the past at another health care setting. An historical ADR is defined in the Computerized Patient Record System (CPRS) as “reported by the patient as occurring in the past; no longer requires intervention.”

(2) Observed Reaction. As defined in CPRS, an observed ADR is a reaction that is “directly observed or occurring while the patient was on the suspected causative agent.” 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. Blinding: Blinding is a research methodology in which the investigators do not know a treatment assignment for any test subject. Clinical trials are often double-blind (or double-masked), meaning both subjects and investigators, as well as sponsor or investigator staff involved in the treatment or clinical evaluation of subjects, are unaware of each subject’s assigned treatment.

d. 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.

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

f. VAMedSAFE: VAMedSAFE is a Pharmacy Benefits Management (PBM) Center for Medication Safety with a mission to identify, track, and address preventable ADEs in the VA system with the primary focus on preventing ADRs. As a pharmacovigilance center, VAMedSAFE undertakes quality-improvement and safety initiatives that ultimately assess, monitor, and improve the safe and appropriate use of medications;

promote risk reduction efforts; and enhance education and communication of ADEs as well as potential ADEs on a national level.

g. Pharmacovigilance: Pharmacovigilance is a clinical science whose objectives are the surveillance, evaluation, and signal detection of the undesirable effects of pharmaceutical products (drugs, biologics, medicines) used for medical therapy or diagnosis.

h. Suspect Drug: A suspect drug is a drug product administered before the ADE began and is believed by the reporter, manufacturer, or the health care agency, to have contributed to its occurrence. It is “suspected” of being the cause of the ADE and this suspicion makes the ADE and ADR for reporting purposes. Types of suspect drugs include drug products or products of biologic origin (vaccines, blood product): non-prescription drugs; replacement drugs (hormones, vitamins, minerals, electrolytes, and fluids); non-active ingredients (excipients); or medical, surgical, and dental devices and their interactions with drugs.

i. VA Adverse Drug Events Reporting System (VA ADERS): VA ADERS is the

VHA intranet spontaneous ADE reporting system that standardizes reporting at the facility level, centralizes ADE data analysis, and improves the efficiency of ADE report coding used to categorize and classify symptoms associated with the event.

j. VA ADERS Data Cube: The VA ADERS Data Cube is a multidimensional database that stores the ADE data. The cube allows different views of the data to be quickly displayed.

5. Procedures:

a. Reporting.

(1) Documentation in CPRS. Healthcare providers, the patient, the patient’s family or caregiver can identify a suspected ADE; however, documentation in the patient’s record can only be performed by medical center personnel. Minimum information required is identification of the patient, age, gender and weight; a brief description of the adverse event, intervention and outcome; identification of the suspect medication, dose, route, and reaction.

(2) Adverse Reaction Tracking (ART). The preferred method of reporting events is to enter the information into the Allergy/ADR section of the patient’s CPRS.

Personnel using the ART are also encouraged to provide a brief description of the suspected event, interventions, and outcome. For instructions to enter ART records, follow this link ADE Instructions.

(3) Patient Incident Report (PIR). A suspected ADE that qualifies as a sentinel event or unplanned clinical occurrence that meet definitions in Center Memorandum OQSV-2 Patient Safety Improvement requirement to enter a Report of Special Incident Involving a Beneficiary, VA Form 10-2633, may be reported using the Veterans Health Information Systems and Technology Architecture (VistA) option “Brief Incident Edit” or the Joint Patient Safety Incident Reporting system (JPSR). The Office of Quality, Safety, and Value (OQSV) communicates such reports to the Pharmacy Quality Improvement Coordinator (119). Similarly, OQSV is notified of qualifying reports received through ART/JPSR.

(4) FDA MedWatch. MedWatch forms are available on the FDA website, however, should personnel decide to enter the incident directly, they are strongly encouraged to forward a copy to an ADE Monitor (119) to assure continuity of reporting. Entering the incident in the ART program/JPSR improves reporting continuity and saves personnel times since ART/JPSR entries are uploaded to VA ADERS and VA ADERS allows electronic reporting to FDA’s MedWatch and Center for Disease Control (CDC) VAERS programs.

(5) Medication Errors. For the purposes of ADE reporting, medication errors resulting in an adverse event are reported as outlined in Center Memorandum OQSV-2 Patient Safety Improvement and as an ADE.

b. Monitoring, Review and Analysis. All reports are reviewed by an ADE Monitor to determine the likelihood of a drug-induced effect. Confirmed reports are processed through VA ADERS and, if appropriate, forwarded to FDA MedWatch or VAERS.

(1) Provider Request for Follow Up. A healthcare provider may request a follow up report from the P&T Committee when an event report is not completed on initial observation of the incident. For example, it is not always possible to indicate the outcome of some events at the time of the initial report.

(2) VA ADERS Reporting. Processing the report through VA ADERS provides the

ADE Monitor with tools for probability analysis and data tabulation and reports for local analysis and comparisons with VA medical centers similar in size and scope. The Performance Improvement Subcommittee for Adverse Drug Events reviews VA ADERS reports for trends and provides recommendations to the P&T Committee. At a minimum, the review includes a description of all verifiable events reported; conclusion, recommendations, actions and evaluation of actions taken.

http://vaww.oklahoma.med.va.gov/clinical/pt/ADE09_08Ins.doc

(3) Pharmacy and Therapeutics Committee Role. Based on review of individual cases and subcommittee reports and recommendations, the P&T Committee passes medical center policy or actions, with concurrence of the Quality, Safety and Value Committee, to improve the safe and appropriate use of drugs and prevent future adverse occurrences. Committee actions are disseminated through the committee meeting minutes.

c. VA Approved Research Studies.

(1) Applicable to Research Studies. This memorandum is applicable to clinical trials if the research protocol requires the use of investigational drugs, comparator drugs or concurrent drugs, or any combination thereof (see VHA Handbook 1108.04 Investigational Drugs and Supplies, for definitions of these terms) if the drugs:

(a) Have been approved by the FDA;

(b) Are being used for an FDA approved indication and;

(c) Are being used at a dosage and in a patient population that is consistent with the official labeling of the drug.

(2) When reporting is required, the investigator is responsible for:

(a) Reporting the ADR through this procedure;

(b) Notifying the IRB and other specified groups responsible for study oversight or management per the protocol and facility research policies if the ADR also meets the definition of an adverse event, serious adverse event, or an unanticipated adverse event.

(3) Reporting in VA ADERS is not required if the investigational drugs, comparator drugs or concurrent drugs, or any combination thereof, are

(a) Under an Investigational New Drug or

(b) Used in a clinical trial in which the investigator does not know participants’ treatment assignment because of the use of a blinded methodology.

6. Responsibilities:

a. Pharmacy and Therapeutics Committee is responsible for developing and implementing the ADE reporting program. The individuals appointed by the P&T Committee as the ADE Monitors are the Facility Program Manager, Pharmacoeconomist/QA and the Clinical Pharmacist, Process Improvement, or designee.

b. Performance Improvement Subcommittee for Adverse Drug Events provides review and analysis and reports to the P&T Committee on a quarterly basis. The subcommittee disseminates applicable reports to affected services.

c. VA ADER Monitor is responsible for timely processing of reported ADEs through

VA ADERS and providing pertinent analytical reports to the Performance Improvement Subcommittee for Adverse Drug Events.

d. Medical Center healthcare personnel who either observes an ADE or receives a report of an ADE from a patient, family member, or caregiver is responsible for documenting the event in CPRS and reporting adverse events promptly to the patient’s primary provider of care. The primary provider of care may report the incident in CPRS instead of the initial healthcare personnel, if preferred.

7. References:

a. VHA Directive 1070 Adverse Drug Event Reporting and Monitoring, September

12, 2014

b. The Joint Commission Standard MM.07.01.03

c. Food and Drug Administration “What Is A Serious Adverse Event?” Updated January 10, 2014

d. VHA Handbook 1050.01 Patient Safety Improvement, March 4, 2011

e. VHA Handbook 1058.01 Research Compliance and Reporting Requirements, June 15, 2015

f. Medical Center Memorandum OQSV-2 Patient Safety Improvement, March 2,

8. Follow-up Responsibility: Pharmacy and Therapeutics Committee

9. Concurrence Responsibility: All Clinical Services Chiefs

10. Renewal Date: July 31, 2022

Wade Vlosich Health Care System Director

Appendix A –

Using ART in CPRS GUI 1

Adobe Acrobat Document