1. Managing Pharmaceuticals to Reduce Medication Errors August 26, 2003
Susan M. Proulx, Pharm.D.
President, Med-E.R.R.S.
Subsidiary of ISMP (

2. Mission of ISMP Translate errors into education
Encourage voluntary reporting
Help prevent medication errors by productively interacting with:
Regulatory agencies
Professional organizations
Practitioners
Healthcare institutions
Pharmaceutical industry

3. Med-E.R.R.S.
Wholly-owned subsidiary of the Institute for Safe Medication Practices (ISMP), incorporated in 1997
Med-E.R.R.S. Board of Trustees
Works with the pharmaceutical industry in pre-market phase to evaluate product labeling, packaging, and nomenclature for safety
Works in post-marketing phase to help monitor and evaluate potential and actual medication errors that have been reported

4. Who can help manage pharmaceuticals to reduce medication errors?
Should be collaborative approach between:
Government (FDA and other healthcare agencies)
Pharmaceutical industry
Practitioners and healthcare systems

5. The FDA should work with drug manufacturers, distributors, pharmacy benefits managers, health plans and other organizations to assist clinicians in identifying and preventing problems in the use of drugs.

6. Recommendation 7.3 The Food and Drug Administration (FDA) should increase attention to the safe use of drugs in both pre- and post-marketing processes through the following actions:

7. develop and enforce standards for the design of drug packaging and labeling that will maximize safety in use.
require pharmaceutical companies to test (using FDA-approved methods) proposed drug names to identify and remedy potential sound-alike and look-alike confusion with existing drug names
work with physicians, pharmacists, consumers, and others to establish appropriate responses to problems identified through post-marketing surveillance, especially for concerns that are perceived to require immediate response to protect the safety of patients

8. New FDA proposed guidances
FDA is in the process of eliciting responses for several new proposed guidances relating to medication safety:
Safety reporting requirements (“The tome”)
Pre-marketing risk assessment
Risk management programs
Pharmacovigilance practices

9. New FDA proposed guidances
Most of these proposed guidances have an aspect related to safety and medication error reduction:
pre-marketing risk assessment of product’s name and packaging/labeling
post-marketing surveillance as part of risk management program
increased medication error reporting

10. Medication Error (Based on NCC MERP definition)
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 or consumer.
Potential error (Category A)
Actual error (Categories B – I)

11. Medication Error (cont.)
Actual medication error
Involves an identifiable patient, whether or not the product was administered or, if administered, whether or not the error results in a serious suspected adverse drug reaction (SADR), non-serious SADR or no SADR

12. Category E error An error occurred that may have contributed to or resulted in temporary harm to the patient and required intervention (from ISMP Medication Safety Alert! May 15, 2003)
A covering physician admitted a patient with Hodgkin’s lymphoma to a medical unit. At home, the patient had been taking hydromorphone (DILAUDID) 2 to 4 mg orally for pain. The covering physician prescribed the same medication, but also wrote an order for hydromorphone 2 to 4 mg IV every 3 hours for pain if the patient was unable to tolerate oral fluids. Like the physician, the nurses on the unit did not recognize that oral and IV dosing of this product, as with most opiate analgesics, is quite different.

13. Category E error (cont.)
In converting an oral hydromorphone dose to IV, the generally accepted equianalgesic dose is between 3 to 1 and 5 to 1. A nurse administered 4 mg IV and the patient developed respiratory depression and became unresponsive. Two doses of naloxone IV reversed the effects of the medication. The following morning, a pharmacist investigated the use of naloxone to uncover whether an error or other adverse drug event had occurred. He discovered the problem and corrected the dosing error.

14. Category I error An error occurred that may have contributed to or resulted in the patient’s death. (from ISMP Medication Safety Alert! May 15, 2003)
An ED physician prescribed labetalol 20 mg IV push for a patient experiencing a hypertensive crisis. A nurse retrieved the drug quickly, but the patient was in the process of being transported to radiology. On the way, the nurse administered the medication in a matter of seconds. The patient immediately arrested and was unable to be resuscitated. Later, staff discovered several other cases where rapid IV push of labetalol may have contributed to patient harm.

15. Medication Error (cont.)
Potential medication error
Does not involve a patient but rather describes information or complaint about a product name, labeling or packaging similarities

16. Examples of potential medication errors (nomenclature)
“The new drug Emend sounds like M-End Liquid, which is made in Tennessee and often used in the surrounding area. They will sound the same on a called in Rx.”
“New medication just released: "Cardizem LA." This will cause a lot of errors, being confused with Cardizem CD and Cardizem SR. Another sound alike error.”

17. Example of potential medication errors (packaging)
“I am writing about my concern over 2 look alike labels for lidocaine. Lidocaine 1% and lidocaine 2% have similar labels. They are both blue and white and both have blue tops. They are both 20 ml. There have been a few instances where these drugs have been stocked incorrectly by pharmacy personnel due to the similar appearance of the labels. I don't know of any instances where patients were harmed, but the potential is definitely there. I suggest that the manufacturer change the color of one of the labels, so there is less chance of a mix-up.”

18. Pharmaceutical Industry
One of the most frequent causes of pharmacy medication dispensing errors is failure to accurately identify drugs, most prominently due to look-alike and sound-alike drug names.
Leape et al. JAMA 1995; 274:35-43

19. Approximately % of medication errors reported to the USP-ISMP Medication Error Reporting Program (MERP) and FDA MEDWatch Program are related to problems with product labeling, packaging or nomenclature.

20. Require pharmaceutical companies to test (using FDA-approved methods) proposed drug names to identify and remedy potential sound-alike and look-alike confusion with existing drug names

21. Nomenclature Related Problems Look or Sound Alike
Celebrex-Cerebyx
Chlorpromazine-Chlorpropamide
Avandia-Coumadin
Atgam-Thymoglobulin
Isordil-Plendil
Zyprexa/Zyrtec
Arthritis/Seizures
Antipsychotic,other/ Diabetes
Diabetes/Anticoagulant
Different Doses
CHF/Blood Pressure
Antipsychotic/
Antihistamine

22. The Med-E.R.R.S. Process
A two-part process to test potential trademarks using the ERRS™ model, a variation of Failure Mode and Effects Analysis (FMEA)
Takes into account practitioner input and expertise of the Med-E.R.R.S. staff

23. Key Points of Trademark Safety Testing Process
Importance of practitioners, experts
Analysis of product in its clinical setting through the use of Failure Mode and Effects Analysis (FMEA)
Review of medication error literature
Qualitative process

24. Order for Vantin 200mg misread as Vasotec 20mg

25. Hospital order written for Foradil bid interpreted as Toradol bid Patient with history of arthritis pain and COPD. Potential medication error caused by look alike drug names. Caught before medication was administered.

26. Develop and enforce standards for the design of drug packaging and labeling that will maximize safety in use.

32. Practitioners and Healthcare Systems
Medication errors have much more to do with breakdown in the system than with anyone’s competency

34. Establish Nonpunitive Environment
“Drive out fear” by reducing emphasis on punishment
ADEs are always opportunities to learn about the system
Punishment (e.g., sanctions, embarrassment, remedial education) drives errors underground where no one can learn from them, leaving system unchanged

35. Dangerous Abbreviations
In our April 17, 2002 issue, we mentioned possible confusion between INVANZ (ertapenem), a new antibiotic, with
AVINZA (morphine sulfate extended release). This week, we heard that a physician wrote an order for Invanz 1 g IV q 24 h and the pharmacist misinterpreted this as “IV Vanc” 1 g q 24. The patient received one dose of vancomycin, but suffered no harm. Word stems used for drug names (like “Vanc”) are prone to misinterpretation. In this case, the prescriber had not used a word stem when writing the order, but if the pharmacist had called to verify his interpretation of what he thought was a word stem, the error could have been avoided.

36. Poor Handwriting
In the other case, a nurse misread an order for 2 mg of AMARYL (glimepiride) as 12 mg because there was insufficient space between the last letter in the drug name and the numerical dose see figures on our web site). But in this case, the pharmacist processed the order correctly and the error never reached the patient. That’s because the profile on the automated dispensing cabinet stated the dose correctly. Adequate spacing between the drug name and the dose also is crucial on medication history forms, preprinted order forms, and electronic formats such as the pharmacy computer, computer-generated medication administration records, and computerized order entry systems. For example, even a clearly typed order for 25 mcg of LEVOXYL (levothyroxine) could be misread as
125 mcg if it appears without proper spacing as Levoxyl25 mcg, especially since both strengths are available.

37. Confusing Symbols
When a pharmacist received a call from a nursing unit to request a patient’s “missing” trazodone dose, he couldn’t find an order on the patient’s computer profile or among the most recent orders received that day. The pharmacist then called the nurse to ask for a copy of the original order. The faxed copy was recognized right away as one that had been sent to the pharmacy earlier in the day, but it had been interpreted as an order to increase amiodarone. An arrow up was used to signify the word increase,” but it looked like a “T” (see below). After the pharmacist explained that trazodone would not be given in a dose above 600 mg a day, the nurse looked more closely and realized it was indeed an order to increase amiodarone. At least two nurses had looked at this order and
believed it was for trazodone. Here’s another good reason to avoid using symbols in place of words when prescribing.

38. Confusion between Medication and Test
In a single hospital there were two near misses where pharmacists confused orders for the lab test, anti-factor Xa expressed as “Anti-Xa”), with the low molecular weight heparin product, ARIXTRA (fondaparinux). The similarities in appearance when the drug or lab test is handwritten are striking. Prescribers occasionally write for Anti-Xa levels when monitoring low molecular weight heparin therapy in certain patients such as those who are obese, have renal insufficiency, or an increased risk of bleeding. Thus, pharmacists assumed that an order for “Anti-Xa 5-6 hours after PM dose of LOVENOX” (enoxaparin) was actually an order to start Arixtra 5-6 hours after the evening dose of Lovenox (see the order below). Arixtra is available only in a 2.5 mg syringe with retractable needle, and approved only for once daily dosing subcutaneously. Therefore it’s conceivable that prescribers may assume it isn’t necessary to write a complete order beyond “start Arixtra.” Thus, an order for the lab test, which would not include a dose or route, could result in a medication error if a nurse or pharmacist accepted an incomplete order. It’s also conceivable that an error could happen if an order for Arixtra is seen as anti-Xa. To prevent the error, the lab test should be ordered as “anti-factor Xa.” Orders for Arixtra should always specify drug, dose, route and frequency.

39. Confirmation Bias due to New Product
This prescription was read as Zestril, but was written as Zetia.  It's not hard to read Zetia, people just don't seem to have it programmed in their minds yet.  We've seen (and I think I've sent) examples of like Rxs where Zetia was clear enough.

40. Who would imagine?
This is the 6th case I've seen this year for confusion between Lipitor and Zyrtec.  This one was read as Zyrtec but was written for Lipitor

42. Primary Principles in Error Reduction
Reduce or eliminate the possibility of errors
Make errors visible
Minimize the consequence of errors
Report and analyze internal errors
Report errors externally

43. Reduce or Eliminate the Possibility of Errors
Failure Mode and Effects Analysis (FMEA) of new medications and devices
- review new medications for error potential
- review new devices and equipment for error prone use
Identify hazardous conditions
System redesign/Decrease complexity/CPOE
Standardize/Formulary control/Monitor use
Involve all team members (including patients)

44. Make Errors Visible Pharmacy IT systems/CPOE Computer alerts
Warnings/reminders
Double check systems
Triggers (markers)
Clinical Pharmacists (high risk patients)
Bar coding

45. System of Independent Checks (redundancies)
Independent Double Check
- Identify > 90% of errors
- Focus on “high alert” medications (e.g., opiates, IV anticoagulants, chemotherapy , insulin)
Self Check
- Identify > 80% of errors

46. Minimize the Consequence of Errors
Decrease amount of stock available
Triggers (markers)
Pharmacist rounds
Available antidotes

47. Report and Share Errors
Report and share internal errors
- identify individual “responsible” for the project
- culture change with team approach
- share reports/high risk patients/new protocols
Report errors externally
- report to USP-ISMP MERP ( or or FDA MedWatch

48. Collaborative Effort
All parties have a role in reducing medication errors
Important to provide input and share information
New guidances by FDA for labeling, packaging and nomenclature may help standardize error reporting and reduce errors.