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Monitoring Medication Safety

Aug 11, 2013

I am participating in AADE13 by Virtual Meeting. I intended to kick back with my hot tea and listen to Monitoring Medication Safety: Key Issues by Laura Shane-McWhorter, PharmD. Well, there was so much interesting information I was frantically taking notes.  I will try to share the major points in this brief blog.

Laura began by sharing that verbiage describing patient medication safety was researched and that there are 39 different terms and definitions used by various organizations. This of course makes it very difficult to actually measure how often medications errors occur if everyone is using a different term or definition. 

Laura listed five main definitions found:

  • Adverse events
  • Medication errors
  • Adverse reactions
  • Near misses
  • Incidents

Laura stressed that there is a need for common language to allow healthcare professionals to communicate effectively and efficiently in preventing medication errors. She explained that medication errors are considered to be a preventable event that may cause or lead to inappropriate medication use. She listed three types of medication errors: prescribing or transcription of prescription errors, dispensing errors or administration errors.  Laura stressed that with most medication errors, no harm occurs.

In contrast, adverse drug events (ADEs), per Institute of Medicine definition, is described as an injury resulting from drug-related medical intervention. These can be preventable or non-preventable causes. ADEs cause harm – this phrase is used to describe consequences that result in negative clinical outcomes.

The World Health Organizations definition of adverse drug reactions is the response to a drug that is noxious and unintended and occurs at doses normally used for prophylaxis, diagnosis, disease therapy, or for modification of physiologic function. In other words, harm that can occur from a drug used under normal doses with normal use.

Most adverse events do not emerge until the drug has been used by millions of people.  Laura suggests that this is perhaps due to the wide and varied physiologic response to drugs when used by a large variety of patients. She referred to differences in pharmacogenetic profiles in individuals.

To monitor this, the FDA launched the Sentinel Initiative of 2008. The goal was to develop and implement long-term, electronic strategies to be proactive and complement systems already in place to track adverse events of regulated products. There are five strategies to identify problems:

  1. Pharmacovigilance – to identify and characterize adverse drug reactions
  2. MedWatch – Healthcare professionals can subscribe to the MedWatch e-list for notifications
  3. Data mining – uses mathematical processes to identify drug related events that occur in higher than normal rates
  4. Signal detection – finding of a higher than expected rate of occurrences
  5. Risk Evaluation Mitigation Strategies – a strategy to manage risks associated with a medication.  It is used to ensure that medication benefits outweigh the potential risks.

She went on to discuss specific drugs where adverse events are being monitored. Laura stressed the importance of open communication between healthcare professionals and organizations around the world to maintain patient safety.  As diabetes educators, our role is to be vigilant and proactive in assuring the safety of our patients.

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