Reducing Medication Errors – Update 2007

1. Reducing Medication Errors – Update 2007 David B. Brushwood, R.Ph., J.D. The University of Florida College of Pharmacy

2. Learning Objectives • Describe the threats to quality that are present in pharmacy practice. • Describe techniques and procedures that can be used to reduce pharmacy errors. • Develop practices that will facilitate pharmacy error detection and prevention. • Facilitate the development of collaborative practices that are sensitive to risk management concerns.

3. Types of Tort Liability Intentional Negligence Strict Liability Product Liability Nuisance Defamation Elements of Negligence Action or Omission Duty of Care Breach of Duty Actual Cause Proximate Cause Damages Liability For Medication Errors

4. Traditional Pharmacist Negligence • Order Processing Error • Wrong drug • Wrong directions • Wrong strength • Wrong dosage form • Wrong patient • Other Errors • Breach of confidentiality • Improper compounding

5. Emerging Pharmacist Liability • Courts are now dealing with expanded pharmacist ability an recognition of preventable problems with drug therapy. • Basic Rule: No “generalized” duty to warn. • Exceptions: • Obvious inadequacy on the face of the order. • Special knowledge of the pharmacist. • Increased consumer expectation through advertising or other affirmation. • Voluntary undertaking to provide service.

6. Error in Medicine • “Forgive and Remember” • Charles Bosk • “That humans make 0.1 percent errors on prescriptions may be forgivable; that hospitals don’t take obvious actions to protect themselves and patients, well within state-of-the-art, is not.” • Michael Millenson • “Almost all accidents result from human error, it is now recognized that these errors are usually induced by faulty systems that ‘set people up’ to fail. The great majority of effort in improving safety should focus on safe systems, and the health care organization itself should be held responsible for safety.” • The IOM Report

7. CQI as a Risk Management System RPh. & P.T. dispense according to established Procedures Quality related event occurs Incident Reports and near-miss documentation Quality Supervisor Reviews Quality Consult held Quality Supervisor Reviews Management Kept Informed of Progress Quality Inservice Developed Management Reviews Policies and Adjusts PRN

8. (2) "Quality‑Related Event" means the inappropriate dispensing of a prescribed medication including: (a) a variation from the prescriber's prescription order, including, but not limited to: 1. dispensing an incorrect drug; 2. dispensing an incorrect drug strength; 3. dispensing an incorrect dosage form; 4. dispensing the drug to the wrong patient; or 5. providing inadequate or incorrect packaging, labeling, or directions. (b) a failure to identify and manage: 1. over‑utilization or under‑utilization; 2. therapeutic duplication; 3. drug‑disease contraindications; 4. drug‑drug interactions; 5. incorrect drug dosage or duration of drug treatment; 6. drug‑allergy interactions; or 7. clinical abuse/misuse. CQI and the Florida BOP • 64B16‑27.300 Standards of Practice ‑‑ Continuous Quality Improvement Program. • (1) "Continuous Quality Improvement Program" means a system of standards and procedures to identify and evaluate quality‑related events and improve patient care.

9. CQI Components • P&P Manual • CQI Committee • Record QREs • Review Record at least once every 3 months • staffing levels • workflow • technological support • Summarization Document • Protection from Discovery

10. Get It In Writing

11. Enforcement Activity • Inspector looks for evidence of CQI program and compliance. • Inspector is educator and enabler, to prevent errors not react to them. • Punishment for failure to conduct CQI, not for failure to be perfect.

12. Changing the Face of Medication Errors • Facts of the Powers case • Patient had visited physician at least 25 times in 6 months. • Prescriptions for OxyContin, Percocet, Soma Xanax, Valium • Patient died from “combined drug overdose (oxycodone, diazepam).” • Allegations of negligence in Powers case • Rxs filled too frequently • Two opioids are “contraindicated,” opioid and benzodiazepine are “contraindicated.” • High doses of opioids indicate addiction. • Court of Appeals (intermediate court) • Reversed dismissal of case by trial court. • Certified question to Supreme Court due to prior precedent.

13. Prior Relevant Florida Case Law • McLeod case • Pharmacist has no duty to warn that drug is defective. • Pysz case • Pharmacist has no duty to warn that single C-II hypnotic may be addictive. • Sharp case • LTCF has no duty to perform DRR, but amendment permitted. • Johnson case • OBRA-90 does not establish private right of action. • Sanderson case • Pharmacist who voluntarily undertakes to counsel must do so with due care. • Dee case • Duty to inquire when C-II Rx is 4 months old.

14. Powers Case Arguments to Florida Supreme Court • Polarized adversarial perspective of litigation does not reflect “radical center” viewpoint. • Pharmacy Argument • McLeod established “clear line” limiting pharmacist liability to order processing error. • Expanded liability for pharmacist would jeopardize physician-patient relationship. • Patient Argument • Pharmacists have the ability to discern problems. • Patients expect pharmacists to consult when problems arise.

15. Florida Supreme Court Decision • “We have determined that there is no actual conflict and that we should exercise our discretion and discharge jurisdiction of this cause.” • Effect of opinion is to reinstate case against pharmacy. • All previous opinions are good law. • Case now continues in preparation for trial.

16. Types of Competence Technical Judgmental Ability Knowledge Skill These are factors within a professonal role. Types of Care Normative What should be done under ordinary circumstances. Quasi-normative What should be done under special circumstances. These are factors of professional role. Establishing the Standard of Care in Pharmacy To avoid liability for medication errors a pharmacist must be competent and caring.

17. Collaborative Drug Therapy Management in Florida 64B16-27.830 • Prescriber Care Plan • Initial drug therapy. • Labs to be ordered, monitored, interpreted. • Conditions for execution of subsequent orders. • Contact with physician. • Transferable Patient Care Record • Patient-Specific Orders • Progress Notes • Pharmacy • Distinct Pharmaceutical Care area (sit down). • CQI Program

18. Collaborative Practice • This is teamwork. Welcome to the team. • We are all equal, but some are more equal than others. • Problems with pharmacists on the team. • The “thin skinned” pharmacist. • “The doctor ignored me and treated me like a child. I’ll never make a another recommendation to her.” • “Fraidy Cat” pharmacist. • “My doctors accept 100% of the recommendations I make.” • “Rambo” pharmacist. • “I am going to document in the patient’s chart the evidence that supports my views and force them to respect me as the drug expert.”

19. Documentation • It is the most important activity, because it endures. • “If if isn’t documented, then it didn’t happen.” • Established evidence of the value of consultant pharmacy services. • Payors • Surveyors • Inspectors • Lawyers • However… There are risk management implications of documentation. It is a source of errors.

20. Beginning the Progress Note • Strongly Recommend ….. • Recommend ….. • Suggest …… • Consider ….. • Perhaps consider ….. • The degree of “handcuffing” decreases as the list continues down from top to bottom.

21. Hypothetical #1Documenting Patient Interviews and Observations • A new patient Rx for BP med you suspect may affect mental status. • You note: “Hypertension: [Drug] started yesterday for BP 160/105. Pt has 3 year Hx of being disoriented to time and place, but alert. No other complaints. Will monitor BP and possible sedation secondary to [Drug].” • Next two times: “Disoriented as to place and time, alert, no complaints.” • 4th time your findings are same, but patient less alert. You write: “Hypertension: Patient’s BP 140/90 indicates less anxious. ___________________ [Drug] side effect suspected. Consider change to [Drug], much less sedation.

22. Fill In The Blank • “No change except less alert.” • “Disoriented as to place and time, less alert.” • “Disoriented as to place and time, no complaints.” • “Disoriented as to place and time, less alert, no complaints.” • “Mental status observed—no change. Less alert, no complaints.” • “Mental status observed, shows patient less alert but there are no complaints.”

23. Hypothetical #2Documenting an Error • New chemo order, patient has experienced unanticipated nausea. Order for quantity in 3 divided doses. PCP reflects this quantity 3 times daily. You correct it. You do not know if there will be permanent injury • You write: Drug overdose: ___________. Continue monitoring for toxicity.

24. Fill In The Blank • “Problem with Dose. Reduction Made.” • “Complaints of severe nausea. Dose reduced consistent with order.” • “Patient complains of nausea and other adverse effects typical of high dose chemotherapy. Miscommunication caused overdose. Dose reduced.” • Adverse effects for the past two days were far more severe than usual. Should have given this more attention. Dose reduced.” • “Suddenly realized dose too high. Patient previously not experiencing problems. Dose reduced. Injury probably not serious.” • “Patient repeatedly complained of nausea and other adverse effects associated with chemotherapy, but I did not believe this was dose related. For the first time noticed dose higher than ordered, and reduced dose immediately. Extent of injury unknown.”

25. Hypothetical #3Documenting Blame • PCP for new patient with OA. Pt says pain excruciating for 3 years. FP treated with ASA 325mg tid; did not believe pain severe, distrusted NSAIDs. • You write: Osteoarthritis. ____________. Severe pain for 3 years. Pursuant to PCP, Rx ASA 600mg PO q4h regimen.

26. Fill In The Blank • “Patient says family practitioner undertreated the pain.” • “Patient says her famly practitioner treated her with aspirin.” • “Patient says her family practitioner has been treating the pain.” • “Patient says her family practitioner would not give her anything stronger than aspirin.” • “Patient says her family practitioner did not believe pain was real and gave her only aspirin.” • “Patient says she was followed by her family practitioner who did not recognize seriousness of pain.”

27. Hypothetical #4Patient Expectations • Pursuant to PCP, Pt will have gentamicin for up to 4 weeks. Informed Consent has been given, OBRA-90 has been complied with. She has been told many times about potential toxicity. Patient asks, “How do you think I will do on this medication?” • What should you say?

28. Select the Best Choice • “Serious side effects are exceedingly rare.” • “It’s a safe drug and you can expect to do just fine.” • “It is routine drug therapy and nothing much ever goes wrong.” • “You can be optimistic. Serious adverse effects are not common.” • “Everyone I know who has used this drug did very well.” • “If you believe everything is going to turn out fine, then it will.”

29. Doing The Right Thing May Not Be Enough • The Seven Cs • Be Correct—Accuracy with no coverups. • Be Complete—Necessary for quality care. • Be Concise—No “told ya so” notes. • Be Consistent—Don’t break a pattern. • Be Cautious—This is enduring material. • Be Concerned—And let it show. • Be Caring—The patient comes first.