Medication Errors Detected Among Spontaneously Reported .
Medication errors detected amongspontaneously reported ADRs to HALMEDViola Macolić ŠarinićPrague , 28.10.2015.
For public health2
Aim of the studyThe objective of the study was to:ü identify,ü evaluate andü describe medication errors (MEs)among the spontaneously reported ADRs to the Croatian Agencyfor Medicinal Products and Medical Devices (HALMED).3
Method! A retrospective observational study was performed on the first200 spontaneously reported ADRs in 2013! The previously validated “P-method” 1 was employed tosystematically detect MEs in individual case safety reports(ICSR) sent to the Croatian Pharmacovigilance Centre (PVC) atHALMED! ME that lead to ADR identified by reporter as well as MEsuspected by assessor are described1Soulaymani-Bencheikh R, Khattabi A, Benabdallah G, Alj L, Sefiani H, Hedna K, Ouammi L, Olsson S, Pal SN. Assessment of a new instrument for detecting preventableadverse drug reactions. Drug Saf. 2015 Apr;38(4):383-934
Method (cont.)! Additionally, ME were categorized according to „Good practiceguide on recording, coding, reporting and assessment ofmedication errors”:!!!!!!!!medication errors associated with adverse reaction(s),medication errors without harm,intercepted medication errors andpotential medication errors5
ResultsComorbidities:1,6 1,1(range 0-6)Age:51,7 23,7(range 8 months to 93years)45 MEwith ADRs94 MENumber ofmedicines:2,5 1,8(range 1-13)Gender:75 M, 125 F200 ICSRs6
Medication errors ! Number of ICSR with medicationerrors associated with adverse reactionaccording to primary source orassessorICSRs with ADRs not caused byMedication errors (160).ICSRs with ADRscaused byMedication errors (34)80%17%3%Not assessable forMedication errors (6)26 ICSR 1 ME with harm5 ICSR 2 ME with harm3 ICSR 3 ME with harm7
NUMBER OF ICSRS REPORTED AS SERIOUS VS. NON-SERIOUS ADRSOut of 71 (35,5 %) spontaneously reported serious ADRs, 14(19,7 %) were caused by medication errors8
Number of ICSRs with medication errors associated withADRs according to primary sourceIn Only 3 ICSR out of 34 (9 %) with ADR/ADRs suspected to be caused byMedication Errors the primary source hasclearly stated that a medication error hasoccurred9
THE MOST COMMONLY IDENTIFIED MEDICATION ERRORSThe two most commonly identifiedpreventability criteria for ADR occurrencewere: ! “Incorrect dose” 28,3 %; ! “Documented hypersensitivity toadministered drug” reported in 17,4 %of MEs associated with ADRs .Among MEs without harm: ! “Labelled drug-druginteraction” (32.7%) was the mostcommonly identified type of ME.10
THE PERCENTAGE OF MEDICATION ERRORS AMONG THEDIFFERENT MEDICINES11
Discussion and ConclusionGood practice guide on recording, coding, reporting andassessment of medication errors12
Discussion and Conclusion (cont.)Good practice guide on recording, coding, reporting andassessment of medication errors13
Discussion and Conclusion (cont.)! High number of additional cases should be followed up! Additional burden to NCAs, MAHs, HCPs#! Process of identifying ME is very sensitive and relationshipbetween reporter and national pharmacovigilance center shouldbe taken into account! Not all follow up are sucesfull1Anton C, Cox AR, Ferner RE. Improving follow-up rates in spontaneous adverse drug reaction reporting: effectiveness of a targetedletter used by a regional centre in the UK. Drug Saf. 2009;32(12):1135-40.114
Discussion and Conclusion (cont.)Improving number of cases with medication errors associated withadverse reaction reported by primary source:! Education of reporters! Improving reporting forms (decision tree)! Liability for Medication errors by HCPs15
For safe and effective medicines.www.halmed.hr
!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
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
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.
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 .
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
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.
a. Read medication administration plan b. Read label 4. Observe student prepare and take medication as per medication plan 5. Document as required or stated in plan a. By unlicensed school staff member b. By student RECORDING MEDICATION ADMINISTRATION 1. Use Medication Administration Daily Log (paper or computer) 2. Record in ink only if using .
AUTOMOTIVE THERMAL MANAGEMENT TECHNOLOGY 2 INTERNATIONAL COUNCIL ON CLEAN TRANSPORTATION WORKING PAPER 2016-18 BACKGROUND Automakers are applying new powertrain technolo-gies in order to meet government regulations. Thermal management techniques can improve powertrain and passenger comfort system efficiencies and are also
