Key Causes Of Medication Errors And Strategies For
Key Causes of Medication Errorsand Strategies for ImprovementWHO Global Challenge on Medication SafetyBonn GermanyMarch 29, 2017Allen J. Vaida, BSc., PharmDExecutive Vice PresidentInstitute for Safe Medication Practiceswww.ismp.org
Institute for Safe Medication Practices A Not-for Profit Charity (501c3)– multi-disciplinary (pharmacists, nurses, physicians) Interacts with but independent of regulatory,standard setting, or accrediting organization Relies on healthcare professionals and consumers tosupply information on medication errors (ISMPNational Medication Errors Reporting Program –MERP) Mission: To advance patient safety worldwide byempowering the healthcare community, includingconsumers, to prevent medication errors
WHO Global Challenge on MedicationSafety “Many countries lack data about medication safety “High-income countries are more likely to possesrobust medication safety systems However, errorsstill occur indicating that focused efforts maydiminish the threat” “Systems approach is needed to build a safety net tocatch errors before they reach the patient ratherthan solely relying on the actions of individuals”
What We are Hearing from Others Need for accurate medication histories/lists toimprove medication reconciliation at all transitions ofcare Need to focus efforts on high risk patients and highalert medications Issues with polypharmacy Need for better and authorized patientinformation/education Listen to and involve the patient
Other Key Causes of Medication Errors Similar medication –- Nomenclature, Labeling/Packaging Ambiguous display of concentration or strength Lack of warnings on ampules'/vials Unavailability of pre-mixed medications for intravenoususe leading to preparation of medications by nurses Lack of universal bar codes Lack of Harmonization within countries andinternationally Lack of medication safety ‘advocates’
US
US
Spain
Latin America - Colombia
US
Vaccine Error in Brasil
Spain
US
Canada
France
US
Outsourcing in the US
Malaysia and Saudi Arabia
Drug Shortages and Importation
Unsafe Products
Vaccine Diluent Packaging
Neuromuscular Blocking Agents Spain
Neuromuscular Blocking Agents New Zealand
United States Pharmacopeia (USP)Chapter 31Neuromuscular Blocking and Paralyzing Agents All injectable preparations of neuromuscular blockingagents and paralyzing agents must be packaged in vialswith a cautionary statement printed on the ferrules orcap overseals. Both the container cap ferrule and the capoverseal must bear in black or white print (whicheverprovides the greatest color contrast with the ferrule orcap color) the words: “Warning: Paralyzing Agent” or“Paralyzing Agent” (depending on the size of the closuresystem). Alternatively, the overseal may be transparentand without words, allowing for visualization of thewarning labeling on the closure ferrule.
With Warnings
Regulatory Achievements on anInternational Scale
Regulatory Improvements FDA/US – April 2016 Good Label and Package Practices Guide for Nonprescription Drugs and Natural Health Products Health Canada – June 2016 Good Label and Package Practices Guide forPrescription Drugs and Good Label and PackagePractices Guide for Non-prescription Drugs andNatural Health Products
Regulatory Improvements Council of Europe – June 2016 Resolution on good reconstitution practices inhealth care establishments for medicinal productsfor parenteral use and Resolution on the quality and safety assurancerequirements for medicinal products prepared inpharmacies for the special needs of patients
Regulatory Improvements European Medicines Agency (EMA) – June 2016 Described the key concepts of the European Unitgood practice guidance for defining, classifying,coding, reporting, evaluating and preventingmedication errors.Goedecke T, Ord K, Newbould V, Brosch S, Arlett P.Medication Errors: New EU Good Practice Guide on RiskMinimisation and Error Prevention. Drug Saf. 2016; 39 (6):491-500.
Still Work to be Done
IMSN Global Regulatory MeetingToronto October, 2016 Meet with regulators to share their views andconcerns on labelling, packaging and nomenclatureissues prone to medication errors and to furtherestablish a consensus on a shared action plan forimproving medication safety at the global level incoordination with the WHO Global Challenge onMedication Safety.
Additional Efforts Regulatory, Government, and Industry interventions– Universal bar codes– Harmonization of labelling/packaging and theavailability of ready to use products Improving regulatory agencies and industry efforts priorto the marketing authorization Raising awareness and learning from medication errorsreporting programs and pharmacovigilance efforts in allcountries Medication Safety Champions/Medication Safety Officersin hospitals and/or at a country level to help disseminatelearnings from other countries
Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products Health Canada –June 2016 Good Label and Package Practices Guide for Prescription Drugs and Good Label and Package Practices Guide
B.Known causes of medication errors include: confusing labeling and nomenclature, human and environmental factors and medication shortages C.Medication safety measures include barcoding, smart pumps, medication reconciliation and pharmacists D.Medication errors are the most common sentinel event reported. E.None of the above LEARNINGOBJECTIVES
!Additionally, ME were categorized according to „Good practice guide on recording, coding, reporting and assessment of medication errors”: !!medication errors associated with adverse reaction(s), !!medication errors without harm, !!intercepted medication
List some common medication errors and associated regulatory deficiencies. Identifying administrative supports for a successful medication pass. Describe the pharmacist role in reducing medication errors. Discuss medication administration processes to prevent errors.
We can overcome these medication errors by educating physicians, nurses regarding the areas where medication errors are more prone to occur. Key words: Medication error, Prescribing error, Dispensing error, Administration error, Documentation error, Transcribing error, EPA (Electronic prior authorization), Near miss, Missed dose. INTRODUCTION
Errors and Data Analysis Types of errors: 1) Precision errors - these are random errors. These could also be called repeatability errors. They are caused by fluctuations in some part (or parts) of the data acquisition. These errors can be treated by statistical analysis. 2) Bias errors - These are systematic errors. Zero offset, scale .
to safe medication practice 57 8.1.2 Practical methods to minimize harm from medication errors 58 8.1.3 Preventing medication errors 58 8.1.4 Making them visible 58 8.1.5 Mitigating their effect when they occur 59 8.1.6 Raising awareness, education and training 59 8.2 Prevention strategies for medicine regulators and industry 61
reporting errors including the US Food and Drug Administration's . MedWatch Reporting Program and . ISMP Medication Errors Reporting Program (MERP). Prior Committee Discussions . As part of its evaluation of medication errors and workforce issues, the Committee has discussed reporting requirements for medication errors and research available.
The NPSA have identified seven key actions to improve medication safety. These actions include: t Increased reporting and learning from medication incidents. t Implementation by NPSA of safer medication practice recommendations. t Improved staff skills and competence. t Minimization of d
