Adverse Drug Event (ADE): the unintended and harmful events associated with medication use
Adverse Drug Event Reporting: systematically documenting when patients experience negative, unintended consequences of medications. Includes information on the type and class of drug taken, and other relevant data about the event.
Adverse Drug Reaction (ADR): an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product.1
Best Possible Medication History (BPMH): created by consulting with multiple sources to compile a complete history of all medications the client is actually taking, capturing the name, dose, frequency, and route of administration for each.
Medication Reconciliation: the act of acquiring a BPMH using multiple sources (e.g., patients, families, community pharmacists, etc.) prior to prescribing medications at care transitions (e.g., when patients are admitted to hospital)
Medication Review: thinking critically about all medications the patient is currently taking, and how they might cause problems or interact with each other. Starts with creating a BPMH, and then goes on to critically assess the medications on the list
Frequently Asked Questions
What’s the difference between adverse drug events and adverse drug reactions?
Drawing from Nebeker, Barach, & Samore (2004): “Adverse drug events refer to harm caused by appropriate or inappropriate use of a drug whereas adverse drug reactions are a subset of these events, where harm is directly caused by a drug under appropriate use (i.e. at normal doses). ADEs may include cases of provider error, non-adherence, or incorrect dosages.1
To clarify adverse drug event vs reaction:
In all cases, adverse drug reactions are adverse drug events. But, not all adverse drug events are adverse drug reactions. For example, a medication-related error is an example of an adverse drug event. 2
There are many different definitions of both terms. We use adverse drug event because it describes more of the various different medication-related issues we’re interested in. However, Health Canada uses “adverse reaction” most often.
What is the difference between Medication Reconciliation and a medication review?
Medication Reconciliation is conducted to ensure that the provider has a complete record and understanding of the medications a patient has been taking (including doses and frequencies) when prescribing medications after transition points in care (e.g. admission, discharge).
In cases where there is previous medication information (e.g. from PharmaNet, a nursing home’s medication administration record), a provider will review the record with the patient and other sources (e.g., the family physician) to create the ‘best possible medication history’. Medication Reconciliation – also called MedRec – is an Accreditation Canada Required Organizational Practice.
A medication review starts with establishing a best-possible medication history, and includes a critical evaluation of the patient’s medications for any potential drug-related issues (e.g. medications that may be necessary or unnecessary, drug interactions, ADRs, inappropriate dosing). Medication review often results in recommendations to change, discontinue or even start new medications.
Institute for Safe Medication Practices Canada (ISMP) states that: “Medication reconciliation is intended to prevent medication errors at transition points in patient care, whereas medication review is intended to address drug-related problems arising over time.”3
What ADE reporting is currently required?
Physicians are currently required to report “serious adverse drug reactions” to their provincial regulatory body. But, new reporting requirements were legislated in fall 2014. However the details of the required reporting are yet to be determined. For more information on The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), click here.
Vanessa’s Law mandates that health care institutions also report these ‘serious adverse drug reactions’ (a subset of adverse drug events) to Health Canada. Additionally, pharmaceutical manufacturers are required to report adverse drug reactions to Health Canada that are reported to them by physicians, patients, etc.
How are adverse drug events currently reported & documented in BC institutions?
PharmaNet, British Columbia’s provincial drug information system, contains a 96-character free text field labeled “Adverse Reaction.” This is presently the only information about adverse drug events that can be communicated electronically between care providers and across healthcare sectors.
We evaluated its use in 10,807 patients in a quality improvement study, and the adverse drug event reporting statistics suggest this system isn’t working as intended. Pharmacists identified adverse drug events in 2,284 patients (21.1%; 95% confidence interval [CI] 20.3-21.9%), of which zero (0%; 95% CI 0.0-0.03%) were reported within this field (unpublished data2).
Who will use the ActionADE platform?
The ActionADE platform will be used by:
- hospital-based physicians
- hospital-based pharmacists
- community-based pharmacists
- family physicians
- & other healthcare providers.
The data it generates about adverse drug events will also be used by decision-making authorities (including the government) and researchers.
Why aren’t providers reporting adverse drug events?
Electronic adverse drug event reporting and documentation currently occurs within online systems hosted by organizations such as Health Canada. Such reporting websites collect adverse drug event data for research, post-market surveillance and regulatory purposes.
During the more than 350 hours of observations conducted by our team and workshops with diverse groups of care providers, we consistently heard that providers are motivated to report adverse drug events if the process directly benefits their patients (e.g., by providing information that stops re-prescription of culprit medications, or alerts physicians to underlying conditions for which certain drugs are contra-indicated).
But currently, adverse drug event reporting in Canada is cumbersome and time-consuming for busy practitioners, and the resulting adverse drug event reports cannot be used to support patient-level clinical care decisions.2 As a result, clinicians rarely report adverse drug events, because immediate patient care-related activities are seen as a higher priority than the data requests of external agencies.2
Is “e-Prescribing” related to ActionADE?
The ActionADE platform is related to e-Prescribing, but it is not the same as e-Prescribing.
Firstly, the term “e-prescribing” doesn’t mean the same thing to everyone. There are many possible interpretations of what e-Prescribing might mean (for example, some people define e-prescribing as when prescriptions are digitally generated, but then printed by physicians for patients to deliver in-person to pharmacists).
Canada Health Infoway defines e-Prescribing as:
“the secure, electronic creation and transmission of a prescription between an authorized prescriber and a patient’s pharmacy of choice using an electronic medical record or a standalone application, and pharmacy management software.”
While e-Prescribing (as envisioned by Canada Health Infoway), electronically creates and transmits data about a patient’s prescription, the ActionADE platform electronically creates and transmits data about a patient’s previous adverse drug events. The ActionADE platform would operate with or alongside any e-Prescribing functions in the healthcare system, but would not replace or conflict with e-Prescribing. Unfortunately, e-Prescribing alone is not sufficient to reduce rates of repeat ADEs, because it does not address issues of ADE documentation, reporting, or patient-specific alerts.