Medication Errors, The Law and Your License

Transcription

1 Medication Errors, The Law and Your License Presented by Joseph Bova, RPh PharmCon is accredited by the accreditation counsel for Pharmacy Education as a provider 1 of continuing pharmacy education

2 Medication Errors, The Law and Your License This presentation has been brought to you by PharmCon PharmCon is accredited by the accreditation counsel for Pharmacy Education as a provider of continuing pharmacy education Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity.

3 Medication Errors, The Law and Your License Accreditation: Pharmacists L03-P Pharmacy Technicians L03-T CE Credits: 1.0 Continuing Education Credit or 0.1 CEU for pharmacists/technicians Target Audience: Pharmacists & Technicians Expiration Date: Objectives: 1. State the scope of medication-related error in the U.S. 2. Identify the most commonly reported errors. 3. Understand ways healthcare workers can help reduce medication errors. 4. List abbreviations and symbols that should no longer be used. 5. Explain the role of the board of pharmacy and legal consequences of medication errors. 6. Explain the concept of root cause analysis as it relates to medication errors. This presentation has been brought to you by Pharmcon

4 Defining Errors: National Coordinating Council for Medication Error Reporting and Prevention 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. 4

5 Such events may be related to professional practice, health care products, procedures, and systems including: Prescribing Order communication Product labeling, packaging and nomenclature Compounding, dispensing, distribution; Administration Education Monitoring And use 5

6 Human Cost of Medication Errors: As many as 98,000 Americans estimated to die in hospitals annually from medical errors More than 7,000 deaths per year from medication errors 6

7 Errors in the Community Pharmacy Setting What Can Go Wrong: Drug Strength, form, quantity or entity Dose Patient (different family member) Filled for completely the wrong patient (Software issues ) 7

8 Wrong Directions: Wrong time..methotrexate for arthritis given weekly incorrectly dispensed DAILY..Whenever possible do not use every Monday that be be read as every morning (Know your patient and disease state) Prescribers should write INDICATION on rx Improper labeling or unclear directions 8

9 Causes. Lack of knowledge of the drug Lack of information about the patient Failure to follow accepted, well established rules Slips and memory lapses Transcription errors Faulty drug identity checking 9

10 Workload Long work shifts without adequate breaks Inadequate staff Do we sacrifice accuracy for speed? 10

11 Work Environment Lighting Interruptions Distractions Noise Unnecessary people- space Clutter 11

12 This? 12

13 Or this? 13

14 North Carolina BOP set standards A regulatory approach to workload In the interest of public protection, the North Carolina BOP ruled that a pharmacist may not work more than a 12 hour day or fill more than 250 prescriptions in a shift. If this law is not followed and there is a pharmacist error, a claim of morbidity or mortality can be argued in the courts. This law was recently upheld in the courts using the argument of public protection 14

15 Handwriting Prescriber/ pharmacist transcribing Never dispense guess work Look at the entire prescription/order 15

16 Communication Errors Faxes Other electronic means Security Telephone 16

17 Counting And Picking Errors Who selects the drug? Who interprets the rx? Do you scan Rxs and retrieve for checking? 17

18 Technology. Systems available for scanning, RX Checking and Tracking Kirby Lester..identifies and records who fills Rx Every stage of the dispensing process is downloaded to a database 18

19 Technology. The RxScan 3800 Barcode Scanner hooks up to your pharmacy system through it's keyboard connection. It complements your keyboard by allowing you to scan Rx number bar codes on labels and manufactures containers and automatically inserts the proper information into your application. It eliminates keypunching errors!!! The RxScan Ultra Prescription Verifier will scan the NDC number bar code on the patient label or receipt and by using a complex algorithm to match it to the scanned NDC number bar code on the stock drug container from which the prescription is to be filled. Then the RxScan Ultra displays the correct product on-screen. 19

20 Electronic prescribing. To help prevent and reduce medication errors, many groups have made computer prescribing a top priority. Currently, only 5-9% of U.S. hospitals use such systems. Computerized physician order entry (CPOE) is widely held as an answer to preventing medication errors. Physician order entry and electronic prescribing will reduce illegible scribbles...allow prescriptions to get to pharmacies quicker...reduce errors with similar drug names. Facilities using CPOE have shown error reduction rates between 17-81%. 20

21 Potential Cost Savings of e prescribing The Center for Information Technology Leadership estimates that the nationwide adoption of e-prescribing would prevent over 3 million adverse drug events annually Preventing nearly 1.3 million provider visits, more than 190,000 hospitalizations, and more than 136,000 life-threatening adverse drug effects 21

22 Savings Studies suggest that national savings from universal adoption of e-prescribing could be as high as 27 billion dollars each year from adverse drug event prevention and better utilization of drugs (e.g., generic prescribing, adherence to formulary, prevention of therapeutic duplication). 22

23 Electronic, cure all?? Not foolproof Lead to E-errors Unfamiliarity with software Minimum effective doses vs in stock 23

24 Paying MDs more. Congress considers mandate for Medicare e-prescribing Bipartisan bill would boost E&M payments for doctors who prescribe electronically but cut these reimbursements for physicians who don't. AMNews staff. Jan. 7,

25 E Prescribing Benefits: Saves time on renewal authorizations and new prescriptions Reduces the number of phone calls Eliminate transcribing errors 25

26 E Prescribing -Things to ensure Ensure patient freedom of choice Transmit data directly from prescriber to pharmacist Be secure (data encryption) Know the applicable laws in your state SureScripts as an example 26

27 Recipes for confusion Look alike & sound alike drugs are a major source of medication errors 27

28 Drugs With Similar Names Accupril Aciphex Accutane Accupril Aldara Alora Altace Artane Alupent Atrovent Ambien Amen Atarax Ativan Benylin Ventolin Bumex Permax Betoptic Betagan Calan Colace Celexa Celebrex Cerebyx Cefzil Cefol Chlorpromazine Chlorpropamide Cozaar Zocor Covera Provera Cyclobenzaprine Cyproheptadine Cytoxan Cytotec 28

29 Use Caution.Avoid Confusion Desyrel Diabeta Diazepam DoloBid Doxepin Efudex Estratest Flomax Fosamax Demerol Zebeta Ditropan SloBid Doxycycline Eurax Estratab Volmax Flomax Levbid Lorabid Lamictal Lamisil Lasix Luvox Methadone Methylphenidate Norflex Noroxin Paxil Plavix Paxil Taxol Pediapred Pediazole 29

30 Confusing drug names Omacor (omega 3 ecid ethyl esthers being mistakenly dispensed as Amicar (aminocaproic acid). Omacor is indicated for hypertriglyceridemia and Amicar is indicated to enhance hemostasis in patients with fibrinolysis 30

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36 Pulmicort Turbuhaler coming off patent..(200mcg) New Flexhalers: 90 mcg 180 mcg (equiv to 200 mcg dose) Only 120 puffs instead of 200 Reminyl Is now RAZADYNE Do not confuse with ROZEREM 36

37 Not all capsules are meant to be swallowed Foradil (aerolizer) Spiriva (handihaler) Actonel & Fosamax Actonel now available in 75mg tablets for monthly dosing (must be taken on 2 consecutive days) Fosamax D; now in 2 strengths of Vit D 5600 IU / week as compared to 2800 IU/ week 37

38 Choose carefully 38

39 Choose carefully.. 39

40 Look-alike/sound-alike drug names and other product-related issues ZYRTEC (cetirizine) and ZYPREXA (olanzapine) Mix-ups between the antihistamine, Zyrtec (cetirizine), and Zyprexa (olanzapine), an antipsychotic. Both drugs are available in 5 mg and 10 mg tablet strengths. 40

41 Recommendation Specify the medication s indication on prescriptions and ensure that patients know its purpose. Encourage patients never to leave the pharmacy without verifying with the pharmacist that the prescription matches what their doctor told them Counseling patients when presenting new prescriptions 41

42 Fentanyl patches High error potential Dosing errors, document Bioavailability affected by temperature Patches cannot be cut or punctured Disposal concerns 42

43 FDA Reports.. An elderly patient with rheumatoid arthritis died after receiving an overdose of methotrexate--a 10-milligram daily dose of the drug rather than the intended 10-milligram weekly dose. Some dosing mix-ups have occurred because daily dosing of methotrexate is typically used to treat people with cancer, while low weekly doses of the drug have been prescribed for other conditions, such as arthritis, asthma, and inflammatory bowel disease 43

44 Others One patient died because 20 units of insulin was abbreviated as "20 U," but the "U" was mistaken for a "zero." As a result, a dose of 200 units of insulin was accidentally injected.. A patient developed a fatal hemorrhage when given another patient's prescription for the blood thinner warfarin. A physician ordered a 260-milligram preparation of Taxol for a patient, but the pharmacist prepared 260 milligrams of Taxotere instead. 44

45 Verbal orders. In order to avoid confusion with spoken numbers, a dose such as 50 mg should be dictated as "fifty milligrams...five zero milligrams" to distinguish from "fifteen milligrams...one five milligrams. Instructions for use should be provided without abbreviations. For example, "1 tab tid" should be communicated as "Take/give one tablet three times daily." The entire verbal order should be repeated back to the prescriber, or the individual transmitting the order, using the principles outlined in these recommendations. All verbal orders should be reduced immediately to writing and signed by the individual receiving the order National Coordinating Council for Medication Error Reporting and Prevention. All Rights Reserved. 45

46 Error Prone Abbreviations, symbols and dose designations Zeros and decimal points U Units: Mistaken as a zero or a four (4) resulting in overdose. Also mistaken for "cc" (cubic centimeters) when poorly written. µg - Microgram : Mistaken for "mg" (milligrams) resulting in an overdose. 46

47 Error Prone Abbreviations, symbols and dose designations QD - Latin abbreviation for every day The period after the "Q" has sometimes been mistaken for an " I, " and the drug has been given "QID" (four times daily) rather than daily. Q.O.D. TIW AU, AS, AD National Coordinating Council for Medication Error Reporting and Prevention. All Rights Reserved. 47

48 Counseling, Patient Education and Medication Errors Not enough can be said about the importance of counseling, patient education and the avoidance of medication errors. Patients are the final link. If patients don't recognized their medication or if they take it incorrectly, then the potential for medication errors increase. 48

49 Counseling, Patient Education and Medication Errors Patient satisfaction is also a benefit of patient counseling. Patients feel counseling is important. Not only does it help them take their medications correctly, many patients feel more confident about using their medications 49

50 Medication Errors Most legal claims against pharmacists involve highrisk prescriptions such as warfarin (Coumadin), digoxin (Lanoxin), diabetes medications, levothyroxine (Synthroid, etc), and amitriptyline. Failure to counsel or warn of potential adverse drug reactions is the fastest growing segment of claims against pharmacists..improper systems may also cause the owner or supervisor to be charged 50

51 Involve patients in medication error prevention. Encourage patients to ask their prescribers and pharmacists about their medications or their medical history. Suggest that they always check their own medications. Patients can have the pharmacist double-check for them if they have concerns. An easy way is to have the patient open their bag and verify their prescriptions 51

52 Medication Error Prevention Patient Information Leaflets help patients better understand their medications Have drawbacks Effective communication skills Use of Open Ended Questions What did your doctor tell you this medication is for? How did your doctor tell you to take the medication? What did your doctor tell you to expect? 52

53 Medication Error Prevention Counseling Points Repeat the name of the patient Discuss use of the med and the directions The Storage The side effects 53

54 Medication Error Prevention In the will call area High Risks, unique prescriptions Use red stickers or other bold colors on Rxs waiting to be picked up so EVERYONE knows that the pharmacist needs to give this special attention (methotrexate as a good example) 54

55 Root Cause Analysis Root Cause Analysis (RCA) - A structured process for identifying the causal or contributing factors underlying adverse events or other critical incidents. Focus is on protocol or system, not the individual. Follow the path of this prescription.. Information put into computer correctly. Correct drug and strength selected. Label was correct and placed on proper container. Prescription picked up by the patient Patient calls pharmacy stating wrong medication was received. What happened? 55

56 Root Cause Analysis The prescription was placed in the wrong bag.. One study showed that this happened in 8% of the errors that were investigated 56

57 Root Cause Analysis What was the root cause of this error? Inattentive pharmacist? Inattentive technician? Environmental factors? Work flow design? Often find multiple root causes 57

58 Continuous Quality Improvement (CQI) Continuation of Root Cause Analysis Review of protocol, procedures, systems Eliminate potential for human errors Possible improvements include: Develop a system to make sure the correct bottle is in the correct bag Use clear bags Don t use bags at all Consider a show and tell with the patient while removing the bottle from the bag and checking the 58

59 Continuous Quality Improvement (CQI) Transferred Rxs What can go wrong? What is the solution? 59

60 Continuous Quality Improvement (CQI) Prescriptions should be legible Electronic transmission Include indication when appropriate Use metric system only Look at the entire prescription 60

61 Continuous Quality Improvement (CQI) Rxs should be reviewed by a pharmacist Patient profiles should be current Dispensing area should be free from clutter Arrange inventory to differentiate drugs Read the label at least 3 times Use an independent check by a second person Use scanner system to retrieve original rx and to check for accuracy 61

62 Recommendations for your patients. Check the label when you get a prescription to verify that you are receiving the proper medication. If possible, read back the prescription to your pharmacist or health care provider When possible, keep all medications in their original containers Know what to do if you miss a dose, and always contact your health care provider if you have any doubts Have all prescriptions filled at the same pharmacy Used with permission, US Pharmacist, March

63 Recommendations..Continued Read the patient information sheet that accompanies the medication. If you do not have an information sheet, request it from your pharmacist. Should there be a change in the color, size, shape or smell of your medication when it is refilled, notify your pharmacist immediately 63

64 Recommendations..Continued Do not share or take another person s medications. When in doubt about a medication, always consult your pharmacist and/or health care provider. And remember to ask about any possible side effects. Used with permission, US Pharmacist, March

65 Voluntary Reporting of Errors Establishing a non-punitive reporting program: initial goal of non-punitive policy is to increase the number of reports so that administrators have more data about system problems and are able to fix them. increase in the number of errors reported. reduction in medication errors. From USP reprinted with permission from US Pharmacist, May

66 Voluntary Reporting of Errors medwatch_online.cfm USP medication error reporting (MER) program U.S. Food and drug administration's MedWatch reporting program FDA

67 A Study of medication errors Released from the State of Massachusetts.. The Board of Registration in Pharmacy Forty-six of the 51 pharmacists involved in medication errors during this time period agreed to participate in the study. Thirty-four of these pharmacists provided valid data appropriate for statistical analysis.

68 Study Results: Rx Volume Fisher's Exact Test found no statistically significant differences between the number of prescriptions filled on the day of the alleged incident versus a typical working day.

69 Study Results: Type of Rx Handwritten prescriptions accounted for 45% of errors and 37% of errors were made on prescriptions phoned into the pharmacy. The study indicated that 63% of the errors were made filling new prescriptions while 37% were made on refills.

70 Study Results: Incorrect. In addition, the dispensing of incorrect drugs and/or incorrect strengths accounted for 88% of errors made

71 -and misinterpreted prescription (24%). Study Results: Reasons for Prescription Errors The study revealed that pharmacists perceived the following as causative factors for medication errors: -too many telephone calls (62%); -overload/unusually busy day (59%); -too many customers (53%); -lack of concentration (41%); -no one available to double check (41%); -staff shortage (32%); -similar drug names (29%); -no time to counsel (29%); -illegible prescription (26%);

72 Study Results: Counseling Pharmacists reported that an offer to counsel was made 88% of the time. However, no counseling was performed 65% of the time because pharmacists reported that patients refused counseling.

73 Study Conclusions Pharmacists reported that there were significantly fewer supportive personnel available on the day the medication error occurred Medication errors were more likely to occur when pharmacists reported being understaffed. A closer examination of staffing and appropriate pharmacist to technician/intern ratios should be included in future studies. Leaders of the pharmacy profession should encourage and support prospective research in this area to establish new standards for optimal patient care.

74 Handling Medication Errors Act quickly and professionally Recognize that your first objective is to minimize any potential ill effects for the patient Take all comments and questions that hint of a question seriously Give the patient your immediate attention Move to a private area if possible Acknowledge the concern that an error may have been made Tell the patient that you will check into it thoroughly

75 Handling Medication Errors Get the details of the situation by asking the patient important questions such as why they think an error occurred, whether the medication was taken, how much the patient took, and how they are feeling Check the original rx rather than the computerized version

76 Handling Medication Errors If the patient is upset, let him vent. Listen attentively to the concerns without saying things like calm down, we were so busy, no big deal, or these things happen Contact the patient s physician to explain the situation and determine the best course of action. Try to speak with the prescriber directly

77 Handling Medication Errors Explain the error to the patient without any excuses. Counsel the patient on potential side effects of the error Correct the mistake and if possible retrieve the incorrect prescription

78 Handling Medication Errors Don t be afraid to offer a sincere apology. Apologizing for inconvenience, or even for harm, is different from admitting liability. Thank them for their patience and understanding, or for noticing an error, if that was the case Document the occurrence and your actions. (reprinted with permission from Pharmacists Letter, June 2001)

79 Boards of Pharmacy & Medication Errors Generally involves a complaint Initiated by patient or family member. BOP turn over to Attorney General for investigation and further action if needed. Pharmacist may or may not see the complaint depending on the state. 79

80 Boards of Pharmacy & Medication Errors The BOP Outcome 1. No action. 2. Reprimand / Fines 3. License Suspension 4. License Revocation

81 Boards of Pharmacy & Medication Errors Complaint Investigations BOP and/or Attorney General gather information: In person interview with pharmacist. Mail a detailed questionnaire to out of state licensee. In person interview with the person making the complaint.

82 Boards of Pharmacy & Medication Errors Complaint Investigations - results Close case Close case with reprimand Move forward with administrative action

83 Questions?