Medication Errors, types, reporting, prevention

Medication errors, types, RCA (Root Cause Analysis), Preventing Strategies

1. Medication Errors Dr . Ankit Gaur.,  PharmD ,  MSc , MBA,  RPh Clinical Pharmacologist  Coordinator Medical Device Adverse Event Monitoring Centre (MDMC) Coordinator ADR Monitoring Centre (AMC) Kailash Hospital & Heart Institute Mobile: [phone]

2. 13-02- 2023 2

3. How medications affect patient sa f M e e d t i y c a ? ti o ? n safety issues Adverse drug reactions Usage of Hazardous drugs like chemotherapy, narcotics IV infusion therapy issues Radioactive drugs Medication errors

4. What is a Medication Error ? Any PREVENTABLE event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. ISMP 2001

5. Medication Errors Over 770,000 patients injured every year. USFDA - At least 1 death occurs per day and 1.3 million people injured each year. For India the extrapolated figures would be: 400,000 deaths due to Adverse Drug Reaction and 720,000 Adverse Events per annum More people die then Motor Vehicle Accidents or AIDS Serious mistakes involving prescription drugs occur in 3% to 7% of hospital inpatients. Considered worse than a crime Serious economic consequences like extended hospital stays, additional treatment Malpractice Litigation. Agency for Health Research and Quality, 2001 Food and Drug Administration (FDA) website , www.fda.org last accessed on 21 st August,2020

6. Global Calculations which include 186 countries : IMS MIDAS, 2009 and 2011; World Bank 2009; WHO 2009; USD in 2011

7. Economic burden of Medication error In 2007, the National Patient Safety Agency estimated that preventable harm from medication could cost over £750 million annually in England. Adverse Drug Reactions are becoming a global issue because of: Increasingly complex medical needs Introduction of many new medications This has led to the World Health Organization’s Third Global Patient Safety Challenge: Medication Without Harm. https://qualitysafety.bmj.com/content/30/2/96

8. First Challenge - 2005 Clean care is safer care WHO’s Global Patient Safety Challenges Second Challenge - 2007 Safe Surgery Save Lives Medication Without Harm Third Challenge - 2017 Medication without Harm Currently ongoing

9. Risk factors for ICU medication errors Eric Camiré et al. CMAJ 2009;180:936- 943

10. Risk factors for ICU medication errors Eric Camiré et al. CMAJ 2009;180:936- 943

11. Medication Errors : Indian Experience M Parihar, G PR Passi. Medical Errors in pediatric practice. Ind Pediatrics 45 2008; 586- 89. Prospective study in a Teaching Hospital at Indore, MP - 1286 children in PICU Out of the total 457 errors identified, medication errors 313 (68.5%) Majority were dosing errors (45.5%) Morbidity was nil in 375 (82%), mild in 49 (10.7%), moderate in 22 (4.8%) and severe in 11 (2.4%) errors .

12. RCA of Medication Error Note: Errors are more frequent during “Prescription” and “Administration” stage Medication Errors Transcription Administration Prescription Route not Specified Order without Time Interval Order without an Indication Order Illegible Order with Dose Inappropriate Order without Dose Order without Frequency Drug Changed without Discontinuing Previous One Order not at all transcribed Order transcribed Incorrectly Allergy not Documented on Order Sheet Drug Administered Dispensing Wrong Preparation Dispensed Diluted Drug Dispensed Wrong Drug Dispensed Dose missed because of transcription Incorrect Entry of Order in Pharmacy Module Scheduled dose not documented as administered without Physician Order Drug Administered to a Wrong patient Infusion rate Error Wrong Drug Administered Wrong Dose, Route, Frequency, Dosage Storage, Packaging & Labeling Mixing of Bottles & Drugs that are similar Improper Storage leading to mixing of Drugs Inappropriate or Illegib le Labeling of Containers in appearance Improper Review of Instructions for use / warnings/ precautions Patient Response Patient not following the Physician Prescription, Dose and Orders Expired Drug Dispensed Improper Recording of Allergy not Documented on Patient ADR Medication Adm Record Improper Assessment of Drug Efficacy

13. Common causes of medication errors • Human-related • System-related • Medication-related

14. Human-Related Factors Providers Over-worked Under-trained Competence Distracted Illness Stressed Patients In a hurry Health literacy level Do not understand the medication/use Trust providers to not make mistakes

15. System-Related Factors Lack of communication Poor workflow Disorganized workspace Inadequate tools to complete work Lack of supervision  

16. Medication-Related Errors Look-alike/sound-alike medications Multiple dosage forms, strengths and calculations Verbal orders

17. THE 7 -R ’ S Right Drug Right Route Right Time Right Dose Right Patient Right Dosage Form Right Documentation World Health Organization WHO, Patient Safety Curriculum Guide

18. Types of Medication Errors Medication errors include Prescribing Error Dispensing Error Documentation Error Administration Error Transcription Error Indent Error

19. A clinically meaningful prescribing error occurs when, as a result of a prescribing decision or prescription writing process, there is an unintentional significant (1) reduction in the probability of treatment being timely and effective or ( 2) increase in the risk of harm when compared with generally accepted practice” . It includes: Incorrect Prescription Illegible Handwriting Drug allergy not identified Irrational combinations Out of list abbreviations Prescribing Error:

20. Dispensing Error A  dispensing error  is a discrepancy between a prescription and the medicine that the pharmacy delivers to the patient or distributes to the ward on the basis of this prescription, including the  dispensing  of a medicine with inferior pharmaceutical or informational quality 

21. Dispensing Errors: The Numbers 98.3% accuracy in dispensing medications Therefore, 1.7% inaccuracy rate Over 3 billion medications dispensed per year 4 errors per day per 250 prescriptions filled Over 51 million dispensing errors per year Flynn E, et al. J Am Pharm Assoc. 2003;43:191 – 200.

22. Most Prevalent Dispensing Errors Dispensing incorrect medication, dosage strength, or dosage form Dosage miscalculations Failure to identify drug interactions or contraindications

23. Sound- alike drugs Avanza (Mirtazapine) Avandia (Rosiglitazone) Diamox (Acetazolamide) Zimox (Amoxycillin) Glynase (Glyburide) Zinase (Serratiopeptidase) Incidal (Cetrizine) Inderal (Propanolol) Brand name in black Non proprietary name in blue Thousands more, some reported, Most not !!

24. Look- alike drugs Domstal (Domperidone) Alprax (Alprazolam) Zyloric (Allopurinol) Buscopan (Hyoscine) Lasix (Fursemide) Avil ( Pheniramine ) Veltam (Tamsulosin) Pantium (Pantoprazole) Brand name in black Non proprietary name in blue Thousands more, some reported, Most not !!

25. Ampoules of Bupivacaine (Sensovac Heavy) and Tranexamic acid (Nexamin) look alike

26. http://www.patientensicherheit.ch/de/publikationen/Quick-Alerts.html

27. Dispensing Errors: Common Causes Work environment Workload Distractions Work area Use of outdated or incorrect references LASA drugs (Look Alike Sound Alike)

28. Example of dispensing error A physician writes an order for primidone ( Mysoline ) for a 12-year old boy with a seizure disorder. Misreading the physician’s handwriting, the pharmacist mistakenly fills the order with prednisone. For 4 months, the boy receives prednisone along with his seizure medications, causing steroid-induced diabetes. The diabetes goes unrecognized, and he dies from diabetic ketoacidosis …because the drug was LASA drug that lead to Dispensing Error

29. Administration Error: A drug administration error may be defined as a discrepancy between the drug therapy received by the patient and the drug therapy intended by the prescriber. Administration errors account for 26% to 32% of total medication errors. It involved wrong patient, wrong route of administration, wrong drug, wrong dose, wrong method, wrong time.

30. CAUSES OF ADMINISTRATION ERRORS: Lack of perceived risk Lack of available technology Lack of knowledge of the preparation or administration procedures Complex design of equipment. CONTRIBUTING FACTORS TO DRUG ADMINISTRATION ERRORS: Failure to check the patient’s identity prior to administration Environmental factors such a noise, interruptions ,poor lighting Wrong calculation to determine the correct dose

31. Example of administration error A critical care nurse tries to catch up with her morning medications after her patient’s condition changes and he requires several procedures. He is intubated , so she decides to crush the pills and instill them into his nasogastric (NG) tube. In her haste to give the already-late medications, she fails to notice the “Do not crush” warning on the electronic medication administration record. She crushes an extended-release calcium channel blocker and administers it through the NG tube. An hour later, the patient’s heart rate slows to asystole , and he dies…because of Administration error

32. Transcription Error Transcription is a process of making an identical copy of prescription in the medical records. Error that occurs during this process is known as Transcription Error. Several sheets of paper and stages from physician’s order to drug delivery may cause confusion and add to the possibility of transcription errors. Contributing factors include incomplete or illegible prescriber orders; incomplete or illegible nurse handwriting; use of abbreviations; and lack of familiarity with drug names. In addition to errors associated with transcribing the drug name, there is also opportunity for errors when transcribing the dose, route or frequency.

33. Indent Error Error that occurs during the process of indenting It includes wrong drug, wrong strength, Wrong dose, Wrong route and frequency.

34. Categorization of medication Errors: Category Event A Circumstances or event that has a capacity to cause error. B Error occurred but didn’t reach the patient. C An error occurred that reached the patient but did not cause any harm. D An error occurred that reached the patient and required monitoring to confirm that it resulted in no harm to the patient and /or required intervention to preclude harm. E An error occurred that may have contribute to or resulted in temporary harm to the patient and required intervention.

35. Category Event F An error occurred that may have contribute to or resulted in temporary harm to the patient and required transfer to other unit/critical care. G An error occurred that may have contribute to or resulted in permanent harm of the patient. H An error occurred that required intervention to sustain life. I An error occurred that may have contribute to or resulted in patient.

36. Medication Errors signify faulty systems and not faulty professionals Swiss Cheese Model of Risk analysis & management

37. Human factors that lead to medication errors Mental Slip Having the knowledge, but not using it Lack of knowledge Poor handwriting Lack of understanding Stress Improper label reading Bhowmick et al. Medication errors reported in tertiary care private hospital in Eastern India : 3 years experience. IJBCP 2020

38. Look- alike or sound- alike (LA/SA) drugs Tens of thousands of drugs currently in the market, the potential for error due to confusing drug names is significant Look- alike or sound- alike (LA/SA) health products refer to names of different drugs that have orthographic similarities and/or similar phonetics (i.e. similar when written or spoken). These similarities may pose a risk to health by contributing to medical errors in prescribing, documenting, dispensing or administering a product The increasing potential for LASA medication is recognized by NABH and requires each accredited organization to identify a list of look- alike or sound alike drugs.

39. Abbreviations can kill!! Abbreviations Although widely used in prescription writing, abbreviations can kill!! Most of the time, prescribers invent their own. Secondly, different individuals/pharmacists may assume or interpret abbreviations differently. Please stick to standard abbreviations

40. Abbreviations must be avoided Some examples that illustrate the pit falls are- HCT 250mg intended drug hydrocortisone but dispensed hydrochlorthiazide. AZT – intended drug was zidovidine but mistaken for azathioprine.

41. Recommended strategies for prevention

42. Preventing Medication Errors At Doctor level Ensuring prescription legibility through “Write in Capital Letters” policy Medication orders and prescription to include both generic and brand name along with dose, strength, directions for use Implementation of “Verbal order policy” for oral orders Protocols for High risk Medication ( e.g Anticoagulant) usage Usage of standardized abbreviations & acronyms through out the organization Active surveillance by the Dedicated Clinical Pharmacologist Introduction of Hospital Formulary “Tall man” (mixed case) lettering to emphasize drug name differences ( example RABE prazole and ARIP iprazole) Bhowmick et al. Medication errors reported in tertiary care private hospital in Eastern India : 3 years experience. IJBCP 2020

43. Preventing Medication Errors At Nursing Level Labeling all medications before preparing All medicines and labels to be verified by two qualified nursing professionals before administration Not more than one medication is labeled at one time All medications found unlabeled should be discarded immediately Continuous training and updation on LASA and High risk medication and Medication Error reporting Separate storing of LASA and High risk medication Active surveillance by Dedicated Clinical Pharmacologist & Nursing Educators Bhowmick et al. Medication errors reported in tertiary care private hospital in Eastern India : 3 years experience. IJBCP 2020

44. Checking by 2 nurses Medication Reconciliation

45. Proper labeling of all infusions

46. Drugs Labeled in Medication Racks

47. Preventing Medication Errors At Pharmacist level Ensuring dispensing in carried out by competent individuals Separate storing of LASA and High risk medication Implementation of Medication error reporting culture Continuous training and updation on LASA and High risk medication Training on Hospital Formulary and Good Pharmacy Practices Active surveillance by Dedicated Clinical Pharmacologist

48. Preventing Medication Errors At Management level Development of a blame free & punishment free culture of medication error reporting Punitive action is not an effective way to prevent recurrence Medication error does not signify faulty personnel It signifies faulty systems that need to be made safer Establishment of an active reporting system which does not lead to blaming and shaming of the individual care provider Dedicated personnel (Clinical Pharmacologist)/ Team to lead, collect and analyze Medication errors & device strategy for process improvement

49. Summary Medication errors are common entity in hospitals including ICUs. There is gross under- reporting of MEs. Active Pharmacovigilance activities can detect Medication errors and prevent them Safety improvement activities include identification, reporting and analysis of the errors by dedicated team lead by the Clinical Pharmacologist. Goal is to develop a culture of patient safety and “fault tolerant” health care system