Adverse Drug Event (ADE): an injury resulting from the use of a drug 15
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): a response to a drug which is harmful or unpleasant and unintended, which occurs at doses normally used in man for prevention, diagnosis, or treatment of disease.15
Best Possible Medication History (BPMH): a 'snapshot' of the patient's actual medication use (both prescribed and non-prescribed), which may be different from what is contained in their records, capturing the name, dose, frequency, and route of administration for each. 16
Medication Reconciliation: the act of acquiring a best possible medication history 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) 16
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 17
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). Adverse drug events may include cases of provider error, non-adherence, or incorrect dosages. 15
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, events related to non-adherence (not taken according to instructions) or dosing problems are examples of adverse drug events. 15
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 medication review?
Medication reconciliation is conducted to ensure that the provider has a complete record and understanding of the prescription and non-prescription 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. 16
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.
The 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.” 18
What adverse drug event reporting is currently required?
As of December 16th, 2019, it is mandatory for healthcare institutions to report serious adverse drug reactions (a subset of adverse drug events) to Health Canada, as per Vanessa’s Law.
Additionally, pharmaceutical manufacturers are required to report adverse drug reactions to Health Canada that are reported to them by physicians, patients, etc. 19
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”, that until recently could only be populated (entered) from community pharmacies. 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. Pharmacists identified adverse drug events in 2,284 patients (21.1%; 95% confidence interval 20.3-21.9%), of which zero (0%; 95% confidence interval 0.0-0.03%) were reported within this field (unpublished data).
The BC Patient Safety & Learning System is to be used across British Columbia for the reporting of serious adverse drug reactions to Health Canada for Vanessa’s Law. 20 ActionADE is currently supporting the collection of this information for Vanessa’s Law reporting at pilot hospital sites.
Who is currently using the ActionADE application?
The data is currently entered into the ActionADE application by:
- hospital-based physicians
- hospital-based pharmacists
- hospital-based nurse practitioners
The data generated in ActionADE about adverse drug events is being communicated to Health Canada for Vanessa’s Law reporting at pilot sites.
Why aren’t all 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). 12 13 21
ActionADE is being piloted as a new way to both improve patient care and facilitate adverse drug event reporting to Health Canada for surveillance and pharmacovigilance.
Is “e-Prescribing” related to ActionADE?
The ActionADE application is not the same as e-Prescribing.
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.” 22
While e-Prescribing (as envisioned by Canada Health Infoway), electronically creates and transmits data about a patient’s prescription, the ActionADE application electronically creates and transmits data about a patient’s previous adverse drug events. ActionADE can be used in conjunction with e-Prescribing functions within the clinical information systems used in the healthcare system, but would not replace e-Prescribing. By enabling standardized documentation of adverse drug events, ActionADE can supplement e-Prescribing functions. The design of ActionADE has been undertaken so that it can support current and future e-Prescribing functions.