Related Experiment Video
Updated: May 28, 2025
11:38
High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents HPHC
Published on: May 10, 2016
12.1K
Development and validation of the national High-Risk Medicine Classification using the Delphi method
Elsi Similä1, Johanna Jyrkkä2, Marja Airaksinen3
1Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, University of Helsinki, 00014, Helsinki, Finland; Development and Information Services, Finnish Medicines Agency Fimea, FIMEA, Tampere/Kuopio, PL 55, 00034, Finland.
Research in Social & Administrative Pharmacy : RSAP
|February 9, 2025
Summary
This study developed the Finnish High-risk Medicine Classification (FIN-RiskMeds) to help manage medication risks. The classification identifies 38 high-risk medicines and their associated dangers to prevent errors.
Area of Science:
- Pharmacovigilance
- Medication Safety
- Health Policy
Background:
- High-risk medicines (HRMs) pose significant dangers due to potential severe consequences from medication errors.
- Effective risk management strategies are crucial for patient safety in healthcare settings.
Purpose of the Study:
- To develop a Finnish High-risk Medicine Classification (FIN-RiskMeds) for improved HRM risk management.
- To provide healthcare professionals with a standardized tool for identifying and managing HRMs.
Main Methods:
- The Delphi consensus method was employed, coordinated by the Finnish Medicines Agency (Fimea).
- A preliminary list of HRMs was compiled from existing resources and expert knowledge.
- Three rounds of Delphi surveys with 60 panelists and a public hearing achieved a 70% consensus threshold.
Main Results:
- The expert panel reached consensus on 38 high-risk medicines or medicine classes for the FIN-RiskMeds classification.
- Warfarin, methotrexate, and opioids demonstrated the strongest expert consensus.
- Detailed descriptions of serious consequences and key risks were established for all classified HRMs.
Conclusions:
- An expert-validated classification of HRMs and their risks has been established.
- Identifying HRMs and their risks across healthcare is essential for preventing medication errors.
- Developing robust medication processes is necessary to mitigate risks associated with HRMs.
Related Concept Videos
01:25Drug Regulation
1.3K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.3K
01:25Drug Classes and Categories
1.9K
Drugs can be classified according to their chemical composition or their intended therapeutic application. For instance, anti-infective agents that possess the ability to eliminate pathogens or suppress their growth and reproduction can be grouped based on the organisms they target or their chemical structure. Furthermore, drugs can be divided into prescription, nonprescription, or controlled substances. Prescription medications, such as antibiotics, require oversight from a licensed healthcare...
1.9K
01:19Pharmacovigilance
769
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
769
01:28Preclinical Development: Overview
4.2K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.2K
01:17Drug Nomenclature
1.6K
During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that...
1.6K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
114
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
114