on med error
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Medication errors are a serious problem, causing over 1 million injuries and 100,000 deaths annually in the US. The elderly and children are most at risk. Common types of errors include administration of the wrong drug or wrong dosage, drug allergic reactions, narcotic overdoses, anticoagulant errors, insulin errors, drug interactions, pharmacy dispensing mistakes, inadequate warnings, infusion pump errors, incorrect pediatric dosages, confusing packaging, similar drug names, and improper abbreviations. Many errors are preventable through diligence and safety practices.
on med error
- 1. Medication Errors - the Annual Toll: FACTS: In 2008 - 3.5 Billion Prescriptions were written, filled and dispensed in US 1% error rate or 35 Million “Medication Errors” occurred in Hospitals, SNFs, at Errors” SNFs, home “Medication Errors” cause 1,000,000 serious injuries annually Errors” “Medication Errors” cause 100,000 deaths annually Errors” More deaths annually in U.S. from Medication Errors than auto accidents and work place injuries combined Nearly all medication errors are preventable. The Elderly and Children are at greatest risk for serious injury due to medication errors Source: Institute of Medicine, National Academy of Sciences. Preventing Medication Errors Report
- 2. Conventional Wisdom / Statement of the Obvious Most serious medication errors result from administration of either: the wrong drug or medication; in the wrong dosage; to the wrong patient; at the wrong time. Or a combination of any of all of these events
- 3. 2 Objectives of this Web Seminar: Identity 12 specific types of medication errors made daily in hospitals, pharmacies, nursing homes and in medical offices and clinics Provide tips, medical resources and litigation tools that savvy PI injury attorney can use to recognize, investigate and successfully (and cost effectively) litigate and settle these serious injury or death cases.
- 4. THE TOP 12 LIST : 1. Allergic / Anaphylactic Reactions 2. Narcotic pain medication “over dosage” 3. Anti-coagulant (Coumadin) dosage error 4. Insulin administration error 5. Adverse Medication “Interactions” 6. Pharmacy dispensing errors 7. Inadequate warnings or instructions 8. Drug infusion pump programming error 9. Miscalculation of proper pediatric dosage 10. Confusing drug packaging 11. “Similar Drug Name” Confusion 12. Use of error prone abbreviations
- 5. 1. Allergic / Anaphylactic Reactions Physiology of a drug “allergic reaction” A person may have a genetic predisposition or sensitivity to a specific medication, or have a limited tolerance When a person is 1st exposure to a drug to which he/she has a “sensitivity”, their immune system produces an antibody, (immunoglobulin E or IgE) which is stored on special cells When a person is exposed to the drug again, or in amounts in excess of their tolerance levels, the antibodies can trigger release of chemicals called “mediators” which can trigger a widespread systemic reaction to the drug, called an “allergic reaction.” Most severe reactions can be cardiac, pulmonary or skin reactions Anaphylactic reaction (shock) severe reaction to a drug to which a person has an extreme sensitivity
- 6. Anaphylactic Reaction Serious allergic reaction - can be life threatening. Characteristics of anaphylaxis / anaphylactic shock include: Severe Skin reaction: Hives, itching, redness/flushing, warmth, (S.J.S) warmth, Cardiac reaction: Arrest, tachycardia, abnormal cardiac rhythm Respiratory reaction: SOB, wheezing, throat tightness, tachypnea Circulatory reaction: Loss of consciousness, syncope (fainting), due to hypotension (decrease in blood pressure) Edema / Swelling : Face, tongue, lips, throat, joints, hands, or feet Most occur within one hour of taking the drug, and many occur within minutes or even seconds. Requires immediate examination and treatment in a hospital ER Medical Tx : Anti-histamines (Benadryl), steroids (Prednisone), Epinephrine
- 7. Most Common Drugs Allergies: Painkillers (analgesics) Narcotics: morphine, codeine, demerol, hydrocodone, etc. NSAIDS (non-steroidal anti-inflamatory drugs) Aspirin, Ibuprofen, indomethacin Antibiotics: Penicillin Sulfa drugs (Septra, Bactrim) Erythromycin Tetracyclicline Antiseizure medications Dilantin , Tegretol and others
- 8. Meritorious Allergic Reaction Cases: Prescription or administration of drug to which patient has a known or documented allergy or reaction: - Patient questionnaire, intake forms: allergies? - Family Hx of medication allergy or reaction? - Patient wrist band / Medic-alert bracelet - Hospital admission forms - Stickers on office / hospital chart (RTPD - original ) - EMR (electronic medical records) - Anesthesia record / chart “Serious injury” requiring hospitalization / extended treatment “Cross Reactivity” issues: Brand Name vs. Generic Name issues – different “inactive ingredients” to which Pt may be allergic
- 9. 2. Narcotic pain medication “over dosage” Narcotic pain relievers – “Opioids” include: Morphine, demerol, codeine, hydrocodone, dilaudid, oxycontin Among most commonly prescribed medications today Used to Tx moderate to severe chronic & acute pain Physiological effects: Central nervous system depression Profound respiratory depression Nausea, vomiting , possible aspiration of emeses Possible Injuries: Death Hypoxic brain injury Aspiration pneumonia, pulmonary infections
- 10. Meritorious narcotic “overdose” cases: - Wrong (excessive) dose administered - Rx: 10 “mcgs” (micrograms) but 10 “mgs” (milligrams) given - Rx: “QD” ( 1 x per day), but med given “QID” (4x / day) - Fentanyl transdermal patch leak - Symptoms of respiratory distress misinterpreted as pain response, and RN administered additional narcotic - Multiple care-givers fill same order ( 3 pain shots in ER) - Incorrect dosage instructions typed on bottle by pharmacy technician - “apply 1 patch every 3 hours” - should have been “ 1 every 3 days” - Excessive pediatric dosage - OD due to “Synergestic” multiplier effect of other meds,
- 11. 3. Coumadin / Heparin Anti-coagulant Dosage Error Anticoagulants / Anti-Thrombotic Tx prescribed for a variety of conditions: Treatment of current DVT, PE, Venous thromboemboism Cardiac rhythm disturbance: Atrial fibrilation Prosthetic heart valve Significant risks of anticoagulants: If blood level too high (supratheraputic) - significant risk of bleeding - If blood level too low (subtheraputic) - significant risk of clot/ Pe/ DVT INR Monitoring required for patients on anticoagulants Requires regular blood tests “INR” levels “Target” theraputic range usually 2.0 – 3.5 Often requires frequent / daily dosage adjustments
- 12. Meritorious Coumadin Error Cases: MD fails to order INR labs w/ sufficient frequency Coumadin Clinic failure to promptly communicate INR levels / dose adjustments to patient, nursing home (typically w/in 2 days of INR check - phone & Fax) Failure of health care provider / nursing home to diligently follow dose adjustment instructions MD misinterpreting EMR (electronic med record) INR results and prescribed excessive doses Pharmacist mis-calculating proper dose adjustments post INR ( Is Coumadin clinic using proper protocol?)
- 13. 4. Insulin Administration Errors Insulin an injectable drug diabetics use to control blood sugar levels Insulin administration errors are associated with serious risks & complications Insulin administration errors continue to be common in hospitals and SNFs Most Common Types of Insulin Administration Errors: Omission errors / missed dose - leading to hyperglycemia Improper dose / quantity - leading to either hyper or hypo glycemia Numerous types of insulin products (~ 23 different brands) further amplify the potential for errors to occur. Potential Injuries: - Diabetic coma / death / cerebral edema / severe neurological injury
- 14. 5. Adverse Medication “Interactions” Most drugs are metabolized by enzymes in the liver Drug “interactions” can occur when one drug interferes with metabolization of another drug by the liver This can produce a wide range of adverse reactions: Renal failure, seizures, cardiac and pulmonary Many such adverse “interactions” are recognized and catalogued, charted and tracked by pharmacy and hospital computers See: Types of drugs that frequently cause adverse “interactions”: - Antibiotics: Cipro, Erythromycin - Anticoagulants: Heparin & Coumadin - Anticonvulsants: Phenotin, Diazepam - Cardiac meds: Digoxin,
- 15. Meritorious Drug Interaction Cases: Physician/hospital failed to obtain or maintain list of - Patient’s current medications - Patient’s past medication reactions (if any) - Family Hx of any medication reaction/interaction Physician knowledge deficit re meds most likely to interact with other meds ( anticonvulsants, antibiotics, anticoagulants, cardiac meds, insulin) - Physician or pharmacist fails to check : - Pocket / iphone / Blackberry reference source Eg. Epocrates - Computer data base / On line resources for drug interactions
- 16. 6. Pharmacy Dispensing Errors From ’00 – ‘10 growth # of drug prescriptions & # of pharmacies 2008 > 3.5 billion prescriptions written & filled in U.S. More pharmacies, mores pharmacists, increased reliance on pharmacy technicians for more complex tasks 1% estimated error rate = 350 million errors !! Out Patient pharmacy error rate higher than In Patient error rate More Pharmacy Drug Dispensing Errors of every type: Wrong drug ( confusing drug names) Wrong patient ( Patient A’s meds given to Patient B) Wrong dosage instructions ( # of pills to take per day, # of x to take) Failure to check Pt’s other meds Rx’d for possible interaction Wrong pills put into bottle with correct label and instructions for prescribed medication Wrong instruction label put on pill bottle Wrong warning / instruction sheet with medication bottle
- 17. Litigation tips re claims vs. Pharmacies: All Chain Pharmacies competing for lucrative business All want to avoid negative publicity and headlines about lawsuits All want to settle claims expediently and confidentially All will settle meritorious claims as soon as claim documented Settlement Strategies: - Instruct clients to save pills bottles, pills, & warning sheets - Request All records from Rx’ing MD & Pharmacy - Request All records & billings from ER, Tx’ing MDs, Hospital, SNF, etc. - Even “modest” injuries can be worth pursuing - Consider written report from Pharmacologist re causation and damages - - Detailed pre-lit “Demand Letter” will reap solid results
- 18. 7. Inadequate Instructions & Warnings: Multiple Sources of Medication Instructions & Warnings to Patients: Prescribing Physician, NP Dispensing Pharmacist Nurses administering medications Hospital, Surgery Center “Patient Discharge Instructions” Drug / Medication Labels and Package Inserts PDR, Medication / Drug Texts & Compendiums Direct Advertising by drug manufacturer Internet Sources: Range from excellent to wrong information
- 19. Basis of “Inadequate” information or warnings: Confusing, incomplete verbal instructions Failure to warn of interactions with other meds, OTC, herbs, foods “Medicalese” – polysyllabic medical words and phrases ESL – English as second language for many patients Inconsistent labeling standards Confusing, Inconsistent dose , administration instructions Illegible small print on drug / medication inserts
- 20. Potential Meritorious Cases MD, Pharmacist, RN, etc. - fails to give any instructions at all MD, Pharmacist, RN, etc. - gives incomplete or wrong info “No this medication (Norco) does not contain any .narcotic…” .narcotic…” “Even if you have reacted to Septra, this Bactrim is safe for you…” Septra, you…” “It is safe to use steroid containing eyedrops for up to 6 months…” months…” “This medication is safe for children……..” children……..” Wrong warning label, package insert provided to patient Failure to advise Pt when to stop, discontinue or reduce dose Failure to provide Pt with contact information for questions (especially problematic following hospital, surgery center dischages)
- 21. 8. Drug infusion pump programming error
- 22. IV Infusion Pumps : IV Infusion pumps are involved in 1/3 serious med errors IV medication administration error is 3x more likely to cause death or serious injury than oral or IM admin Drug flows directly into blood stream and to critical organs, with immediate physiological effect Common programming errors: flow rate, total dosage Most frequent IV Infusion Pump errors involve: Narcotic pain medications, Insulin & Anticoagulants Miscalculation of proper dose, “ free flow” of meds New “Smart Pump” Programs More “user friendly software” to reduce errors More “automatic” warnings re med, pt, dosages, etc.
- 23. 9. Miscalculation of proper pediatric dosage: Pediatric medication errors are an enormous problem nationally Key Factors: Meds Instructions frequently give: “adult dose” vs. “child’s dose” “Children” vary so much in weight: Infant or toddler weight may be fraction of 10 yr olds weight Lower weight / body mass / intravascular volume means a much narrower margin of error in correct dosage for “children” Most drugs - not tested in large #s of children to establish “safe” dosage Medication errors occur with same frequency in adults and children Serious injuries or death are 7x more common in children “Most of serious injuries & deaths prevented if providers wrote orders using computers that included dose checking.“ Source: (Institute for Safe medication Practices 2002 Report )
- 24. 10. Confusing Drug Packaging Example: Lanoxin (Digoxin / Digitalis) powerful cardiac drug The dropper utilizes "cc" for dosing The packaging states "mL" for milliliters, also references “mcg” for micrgrams "mL" mcg” Confusing for a patient who may be unaware that 1 cc = 1 mL or 1ml = 1000 mcg
- 25. Confusing Drug Packaging: Children’s Tylenol Blister package exhibits confusing labeling Could accidentally double the typical dose of medication given to small children. Front of the carton states "medicine per dose 80 mg," Individual blister packs that contain either one or two 80 mg tablets are all labeled "Children's Tylenol 80 mg" Over-the-counter product of potentially high risk medication given to young children.
- 26. 11. “Similar Drug Name” Confusion In U.S. > 10,000 FDA approved “prescription” drugs >100,000 OTC “over the counter” medications available - MANY of these drugs have similar looking / sounding names - “Similar Drug Name” confusion is frequent cause of the “wrong drug” being given to a patient by nurse or pharmacy - Similar sounding name: verbal or telephone order confusion - Similar looking name: written prescription confusion - Death or serious injury can result from such confusion Miscalculation of proper pediatric dosage -www.ismp.org/Tools/confuseddrugnames.pdf - 8 page List of “most frequently confused” drug Names > 600 entries - Allega – Viagra Cedax - Cidex - Alprazolam – Lorazepam Cozaar – Zocor - Amicar - Omacar Dynacirc - Dynacin - Aricept – Aciphex Lunesta - Neulasta - Benazepril – Benadryl Panalor – Pamelor - Flowmax – volmax Zantac - Zyrtec
- 27. 12. Use of error prone abbreviations Use of “similar looking” abbreviations leads to frequent errors: Wrong dug: “DPT” – demerol, phenergan, tegretol vs. - diptheria, pertusses, tetanus Wrong dosage: “mg” milligram vs. “mcg” microgram ( 1000 x difference) Wrong administration schedule “qd” 1 each day vs. “qid” 4 x per day (4x difference) Wrong location of administration of medication: OD, OS, OU R eye, L eye, Each eye Wrong route / method of drug administration: IV, IM, IN Intravenous, Intramuscular, Intranasal Institute for Safe Medication Practices List of error prone Abbreviations, Symbols and Dose Designations: http://www.ismp.org/Tools/errorproneabbreviations.pdf
- 28. RESOURCES: MEDICATION SAFETY WEBSITES 1. Institute for Safe Medication Practices 7. Health Care Choices www.ismp.org www.healthcarechoices.org 8. Health Grades 2. FDA MedWatch www.healthgrades.com www.fda.gov/medwatch/index.html 9. Institute for Healthcare Improvement 3. National Center For Patient Safety www.ihi.org/ihi www.patientsafety.gov 10. P.U.L.S.E. (Persons United Limiting 4. Agency for Healthcare Research and Quality Substandards and Errors in Healthcare) www.ahrq.gov www.pulseamerica.org 5. Center for Improving Medication 11. Partnership for Patient Safety (P4PS) Management www.p4ps.org www.learnaboutrxsafety.org 12. Patient Advocate Foundation 6. Consumers Advancing Patient Safety (CAPS) National Coordinating Council for Medication Error www.patientsafety.org Reporting and Prevention http://www.nccmerp.org/consumerInfo.htm http://www.nccmerp.org/consumerInfo.htm l
- 29. INTERNET RESOURCES FOR DRUG INTERACTIONS http://medicine.iupui.edu/clinpharm/DDIs/clinicalTable.asp Chart www.arizonacert.org Drug interactions www.drug-interactions.com P450 mediated drug interactions www.torsades.org Drug induced arythymias www.penncert.org Antibiotics www.deri.duke.edu/research/fields/certs.html Cardiovascular Meds www.ascpt.org Clinical Pharmacology www.epocrates.com Smart Phone accessible data base
- 30. Internet Sources for Pharmaceutical Information: www.drugs.com www.nlm.nih.gov/medlineplus/druginformation www.rxlist.com www.webmd.com/drugs www.fda.gov/Drugs www.medicinenet.com/medications www.rxlist.com/pill-identification-tool/article.htm www.drugwatch.com
- 31. Physician / Hospital Records to Obtain: MD Office chart Hospital Records, EMR (electronic) : Pt intake questionnaire Pt registration form Current Medication List Admitting History & Physical List of allergies, drug reactions MD Orders Medication refill sheet, orders MD Progress notes Medication administration records Consultation Reports Pharmacy refill requests Operative Notes Out patient visit MD, NP, RN notes Intra-operative nursing notes Intra- List of Medication samples given PT Anesthesia Record Previous MD office charts PACU Records Telephone, email communications with Medication Administration Reports patient or family Nursing Graphic All EMR (Electronic Medical Records) Laboratory Reports Hospital pharmacy records Discharge Notes Discharge Instructions All Billlings for medications, devices, etc. All EMR records
- 32. Pharmacy Records to Obtain: Physician / MD Prescriptions (RX’s) (RX’ Patient Communications / warnings Handwritten / hard copy Fax’d prescription orders Fax’ Log of Telephone calls, communications Email, EMR prescriptions with patient, family member, or SNF staff All medication refill orders Copy of all Instruction / drug detail sheets Telephone log of communications with given to patient with any medication prescribing MD re any med Rx Medications Provided All Docs re Patient Medication Reaction(s) Reaction(s) All hard copy records Notes re Pt reports of reaction All computer / EMR records EMR / Computer records Records of all drug warnings, instructions, SNF records / reports of Med Reactions Pharmacist advice / warnings to Pt All billings to Pt , Medicare or Health Insurance company for medications Billing Records to: Directly to Patient Drug Interaction Searches Medicare / Medicaid All records of any searches for possible drug interaction with other Pt meds Private Health Plan Records of Notice to Rx’ing MD or Pt of any possible Rx’ Other 3pr party payer (family) drug interactions