1. Recognizing Adverse Drug Events

2. ADE Training Overhead2 Module One: Medications and Older Adults - Objectives 1.Describe use of medications by older adults. 2.Define types of drug interactions and understand how they can occur. 3.Explain why it is important to know about drug interactions. 4.Identify age-related changes in the body and how they affect use of medications. 5.Outline issues with medication use by older adults, including the possibility that drug effects may not be identified.

3. ADE Training Overhead3 Older Adults and Medications Older adults make up 13% of population Account for: –About 30% of prescribed medications –About 40% of over-the-counter medications At least 90% take at least one prescription medication 12% use ten or more per week

4. ADE Training Overhead4 Prescription Drug Spending Will Increase

5. ADE Training Overhead5 Who Takes the Most Medications? Women Individuals with multiple health conditions Frail elderly Nursing home residents

6. ADE Training Overhead6 Medications Most Commonly Used in the Community Analgesics Diuretics Cardiovascular Sedative-hypnotics

7. ADE Training Overhead7 Medications Most Commonly Used in the Nursing Home Antipsychotics Sedative-hypnotics Diuretics Antihypertensives Analgesics Cardiovascular Antibiotics

8. ADE Training Overhead8 We Must Always Ask: Do the potential benefits outweigh the potential risks for this individual?

9. ADE Training Overhead9 Drug Interactions Drug-drug interaction: effects of a drug are altered when taken at the same time with one or more other drugs. The drug does not perform as expected. –Example: aspirin and prescription blood thinners such as Coumadin

10. ADE Training Overhead10 Other Drug Interactions Drugs can interact with other things as well: –A physical condition –Food –Alcohol

11. ADE Training Overhead11 Antacids (drugs for relief of acid indigestion, heartburn, and/or sour stomach) Ask a doctor or pharmacist before use if you are:  Allergic to milk or milk products if the product contains more than 5 grams lactose in a maximum daily dose  Taking a prescription drug Ask a doctor before use if you have:  Kidney disease Antihistamines (drugs that temporarily relieve runny nose or reduce sneezing, itchy eyes or throat) Ask a doctor or pharmacist before use if you are taking:  Sedatives or tranquilizers  A prescription drug for high blood pressure or depression Ask a doctor before use if you have:  Glaucoma or difficulty in urination due to an enlarged prostate gland  Breathing problems, such as emphysema, chronic bronchitis, or asthma When using this product:  Alcohol, sedatives, and tranquilizers may increase drowsiness  Avoid alcoholic beverages. Drug Interaction Warnings

12. ADE Training Overhead12 How Do Drug Interactions Occur? Taking two drugs that affect the body in the same way can make the impact stronger – an “additive” effect Some drugs cancel each other out Drug may affect the amount of a substance in the body which then affects the way another drug is processed

13. ADE Training Overhead13 How Do Drug Interactions Occur? An increase or decrease in any of the following: –Absorption –Distribution –Metabolism –Elimination

14. ADE Training Overhead14 Absorption A change in blood flow to the intestine Metabolism changes to the drug by the intestine A change in the speed with which things move through the intestine (“motility”) More or less stomach acidity Changes in the intestinal bacteria

15. ADE Training Overhead15 Metabolism and Elimination An increase leads to a decrease in enzyme activityin drug concentration and effect AND A decrease leads to an increase in enzyme activityin drug concentration and effect

16. ADE Training Overhead16 Drug Interactions Can Have Unintended Effects Decreasing the intended effects of the drug (drug is eliminated too fast) OR Increasing the negative effects of the drug (can lead to toxicity)

17. ADE Training Overhead17 Examples of Drug-drug Interactions Patients taking: Who ended up in hospital with: Were:To have taken this drug in past week: GlyburideHypoglycemia6 times more likely Co-trimoxazole DigoxinDigoxin toxicity12 times more likely Clarithromycin (ACE) inhibitor Hyperkalemia20 times more likely Potassium- sparing diuretic

18. ADE Training Overhead18 Age-Related Changes: Effects on Medications Total body water decreases  increased serum concentration of water-soluble drugs Change in body weight influences appropriate dosage and how long it stays in body: –More body fat  prolonged half-life –Less lean body mass  increased drug concentration Digestive system changes affect the speed of drugs getting into bloodstream

19. ADE Training Overhead19 Age-Related Changes: Effects on Medications Slower circulation may delay drugs getting to liver and kidneys Slow down of liver and kidneys affects time it takes for medication to break down and leave body Less absorption from transdermal patches Drug “receptor” sites may be different in older adults

20. ADE Training Overhead20 How Body and Medications Interact Pharmacokinetics – what the body does to the medication (absorption,etc.) Pharmacodynamics – what the medication does to the body

21. ADE Training Overhead21 “Anticholinergic” Effects Dry mouth Dry skin Constipation Urinary retention Ataxia Can also bring on dementia/delirium

22. ADE Training Overhead22 Other Issues With Medication Use and Older Adults Appropriateness Multiple medical conditions Multiple physicians Polypharmacy Underuse Cost Noncompliance Lack of research

23. ADE Training Overhead23 Signals of Possible Medication Problem Falls Restlessness Confusion Loss of memory Constipation Sleep disorders Weight loss Bowel changes Incontinence Dizziness

24. ADE Training Overhead24 Review of Issues Chronic health conditions are common among older people. There are physical changes that come with aging that affect how the medications are processed by the body. Drug effects appear unpredictably and may be assumed to be another health problem or “just old age.”

25. ADE Training Overhead25 The Main Points Medications are not to be given or taken lightly – especially by older people. It is harder for older bodies to process and metabolize medications. It is all too easy to mistake a medication problem for another health problem! Benefits vs. risks

26. ADE Training Overhead26 Module Two: Adverse Drug Events - Objectives 1.Define “adverse drug event,” both preventable and non-preventable, and give examples. 2.Understand the difference between an adverse drug event and side effects. 3.State why it is important to know about adverse drug events, how common they are, and how dangerous they can be. 4.Discuss drug allergies, what causes them, and identify common symptoms. 5.Know the term “anaphylaxis.” 6.Provide at least three examples of strategies to prevent adverse drug events.

27. ADE Training Overhead27 Definitions Side effect: an action of a drug other than the one for which it is being used. Adverse drug event (ADE): injury resulting from the medical use of a drug. –Preventable ADE: those that result from a medication error in prescribing, dispensing, administering, or monitoring –Nonpreventable ADE = Adverse drug reaction. An injury resulting from the medical use of a drug where no error is involved

28. ADE Training Overhead28 Side Effects vs. ADEs Take medication Symptoms – Side effects Injuries – Adverse drug events Preventable: Adverse drug event Not –preventable: Adverse drug reaction Error? YesNo

29. ADE Training Overhead29 Why Do We Need to Know About ADEs? Most common type of adverse event in hospital About 1/3 of drug-related hospitalizations and ½ drug-related deaths occur in people over age 60 3 to 10% of all hospital admissions for older patients are due to ADEs Reported incidence higher for older adults –2 to 10% in younger adults –20 to 25% in older adults In study of elderly veterans, 35% had at least one ADE in past year, and ¼ of those required visit to ER or a hospital admission

30. ADE Training Overhead30 Hospitals and ADEs Rate of ADEs in older hospitalized patients = 2 to 15% In 1994, it was estimated that ADEs ranked between the fourth and sixth leading causes of death in the U.S. 2 million+ patients have severe ADEs every year Due to ADEs, for every 1,000 patients admitted to the hospital: –3 will die –1 will suffer serious long-term disability Estimated cost of inpatient ADE ranges from $1,900 to $5,900

31. ADE Training Overhead31 Drug Allergies - Anaphylaxis Anaphylactic (an-uh-fuh-LAK-tik) reaction: A severe allergic reaction that can be life- threatening! Rare responses but dangerous! Medical help is needed and should be sought immediately. Call 911 or take the individual to the emergency room.

32. ADE Training Overhead32 Anaphylaxis Symptoms Hives Itching Feeling warm Flushing Wheezing Dizziness or lightheadedness Swelling in the throat Irregular heartbeat Nausea and vomiting Diarrhea Abdominal cramping

33. ADE Training Overhead33 Most Common Culprits: Penicillin-related antibiotics are the #1 most common – and penicillin allergies kill 400 people in the U.S. every year! Sulfa drugs Anti-seizure drugs Allopurinol (a drug for gout) Drugs for heart rhythm problems Local anesthetics

34. ADE Training Overhead34 Most at Risk of Allergic Reaction: Already have allergies in general Take a drug often Take a drug in large doses Take a drug in shots rather than pills

35. ADE Training Overhead35 Common Symptoms From ADEs Confusion Nausea Decreased balance Change in bowel pattern Sedation Orthostatic hypotension

36. ADE Training Overhead36 Classifications of ADEs Significant –falls without fractures, oversedation, rashes, hemorrhages not requiring transfusion or hospitalization without hypotension Serious – delirium, falls with fractures, hemorrhages requiring transfusions or hospitalization without hypotension Life-threatening – hemorrhage with associated hypotension, liver failure, hypoglycemic (low blood sugar) encepalopathy (brain disorder) Fatal

37. ADE Training Overhead37 Nursing Home Study High rates of adverse drug events (ADEs): –1.89 ADEs per 100 residents –About one-half (.96 per 100 residents) were preventable

38. ADE Training Overhead38 Found Those Most at Risk: New residents Residents with multiple medical conditions Residents taking multiple medications (five or more) Residents taking psychoactive medications, opioids, or anti-infective drugs Those at lower risk: –Residents taking nutrients/supplements –Men

39. ADE Training Overhead39 In a Community-Based Study: There were 1,523 adverse drug events among 30,397 Medicare patients 28% were considered preventable Overall rate = 50.1 per 1,000 person-years Rate of preventable adverse drug events = 13.8 per 1,000 person-years

40. ADE Training Overhead40 ADEs by Classification: 578 (38%) were categorized as serious, life-threatening, or fatal: Significant945 (62.0%) Severe431(28.3%) Life-threatening136( 8.9%) Fatal 11 ( 0.7%)

41. ADE Training Overhead41 11 Fatalities 4 fatal bleeding 1 peptic ulcer 1 neutropenia/infection 1 hypoglycemia (low blood sugar) 1 drug toxicity relating to lithium 1 drug toxicity relating to digoxin 1 anaphylaxis 1 from complications of antibiotic-associated diarrhea Of the more severe events, in addition to the fatalities, five (5) resulted in permanent disability, including a stroke.

42. ADE Training Overhead42 Most Commonly Involved Drugs: Cardiovascular26.0% Antibiotics/anti-infectives14.7% Diuretics13.3% Nonopioid analgesics 11.8% Anticoagulants 7.9% Hypoglycemics 6.8%

43. ADE Training Overhead43 Most Common ADEs: Gastrointestinal tract events 22.1% Electrolyte/renal 16.7% Hemorrhagic 12.7% Metabolic/endocrine 9.5% Dermatologic (skin) /allergic 7.9%

44. ADE Training Overhead44 What Kind of Errors Led to ADEs? Prescribing Monitoring Patient adherence

45. ADE Training Overhead45 If Projected to All Medicare Enrollees: 1,900,000 ADEs each year, among the 38 million Medicare enrollees Of these ADEs: –More than 180,000 that will be life-threatening or fatal –More than half of those could have been prevented

46. ADE Training Overhead46 Individuals at Increased Risk of ADEs: Older, especially age 80+ More co-morbidity Multiple medications Individuals taking medications in these categories: Anticoagulants Antidepressants Antibiotics Cardiovascular drugs Diuretics Hormones Corticosteroids

47. ADE Training Overhead47 ADE Error Prevention for 65+ ReasonIntervention Multiple drug useReview medication indications Age-related physiologic alterations in metabolism, excretion, or drug effects Appropriate dose adjustments and decisions, with careful consideration of comorbidities Drug knowledge dissemination, allergy checking, and dispensing Computerization, physician order entry, decision support, and bar- coding technology UnderprescribingAvoid age bias Falls due to medicationsLimit psychoactive pharmacotherapy Delirium due to medicationsAppropriate drug and dosing indications and nonpharmacological approaches to insomnia

48. ADE Training Overhead48 The Main Points Adverse drug events are common Adverse drug events can be dangerous Never take use of medications lightly – especially among older adults! Benefits vs. risks

49. ADE Training Overhead49 Module Three: Special Issues With Medications - Objectives 1.Explain why some medications are considered potentially inappropriate for older people. 2.Be familiar with the Beers’ list of potentially inappropriate medications and how it was developed. 3.Describe the safe use of over-the-counter pain relievers. 4.Understand concerns about use of insulin for diabetes. 5.Discuss safety issues with cholesterol lowering medications.

50. ADE Training Overhead50 Potentially Inappropriate Medications for Older Adults Have a risk of adverse outcomes that outweighs the potential benefit for most older patients. There are other alternative medications that are less likely to cause problems and be more effective.

51. ADE Training Overhead51 Beers’ List Effort led by Dr. Mark Beers Panel of experts in geriatric medicine and pharmacology 1991 – First published for nursing home residents 1997 – Expanded to cover all older adults 2003 – Updated

52. ADE Training Overhead52 Inappropriate Medications for Older Adults Not all physicians agree on the criteria Use continues to be a serious problem: –Adverse drug reactions –Worse physical function –Excess healthcare use

53. ADE Training Overhead53 Study (Feb. 2004) Showed: Inappropriate medications were prescribed for older patients in 8% of their doctor visits in 2000 Most likely: –If on multiple medications –Women twice as likely Most common: –Pain reliever propoxyphene (Darvon) –Antihistamine hydroxyzine (Vistaril, Atarax) –Antianxiety diazepam (Valium) –Antidepressant amitriptyline (Elavil) –Urinary tract relaxer oxybutynin (Ditropan)

54. ADE Training Overhead54 Study (Aug. 2004) Showed: Looked at medication records for over 750,000 older patients for 1999 Found 21% filled a prescription for one or more inappropriate medications –80% filled one prescription –16% filled two or more –4% filled three or more

55. ADE Training Overhead55 Study (Aug. 2004) Showed: Two medications responsible for 28.5% of total claims for Beers list drugs: –amitriptyline (Elavil) –diazepam (Valium) Others among the most common: –cyclobenzaprine (Flexeril) –doxepin (Sinequan) –hydroxyzine (Vistaril, Atarax) –oxybutynin (Ditropan) –promethazine (Phenergan) –indomethacin (Indocin and Indocin SR)

56. ADE Training Overhead56 Zhan Appropriateness Classification AA = Always should be avoided RA = Rarely appropriate SI =Some indications NC =Not classified Found among older patients: –3% using at least one of the 11 AA medications –9% using at least one of the 8 RA medications Most likely: –Multiple medications –Poorer health

57. ADE Training Overhead57 Should “Always Be Avoided” for 65+ Barbituates Flurazepam (Dalmane) Meprobamate (Miltown and Equanil) Chlorpropamide (Diabinese) Meperidine (Demerol) Pentazocine (Talwin) Trimethobenzamide (Tigan) Belladonna alkaloids (Donnatal and others) Dicyclomine (Bentyl) Hyoscyamine (Levsin and Levsinex) Propantheline (Pro-Banthine)

58. ADE Training Overhead58 “Rarely Appropriate” for 65+ Chlordiazepoxide (Librium) Diazepam (Valium) Propoxyphene (Darvon products) Carisoprodol (Soma) Chlorzoxazone (Paraflex) Cyclobenzeprine (Flexeril) Metaxalone (Skelaxin) Methocarbamol (Robaxin)

59. ADE Training Overhead59 OTC Pain Relievers Analgesics Antipyretics Nonsteroidal anti-inflammatory drug (NSAID) Acetaminophen

60. ADE Training Overhead60 Dangers of OTC Pain Relievers Acetaminophen – too much can lead to liver damage, especially if person takes 3+ alcoholic drinks a day NSAIDS – stomach bleeding. Increased risk: –Are over 60 –Take prescription blood thinners (example, Coumadin) –Have previous stomach ulcers or other bleeding problems –Take steroid medications or other NSAIDs

61. ADE Training Overhead61 Dangers of OTC Pain Relievers NSAIDS – also can cause reversible damage to the kidneys. Increased risk: –Over 60 –Have high blood pressure, heart disease, or pre-existing kidney disease –Take a diuretic

62. ADE Training Overhead62 Safe Use of OTC Pain Relievers Review the ACTIVE INGREDIENTS of any drug being considering A person with any of the risk factors listed earlier should talk to the doctor Take medication in the recommended doses – do not exceed them – and for only short periods of time.

63. ADE Training Overhead63 Insulin People with diabetes have a problem with high blood sugar, so they may have to take insulin Too much insulin can cause low blood sugar Try to give the person a fast-acting sugar such as orange juice or soda If it gets too low, the person can pass out. This is an emergency! Get help right away!

64. ADE Training Overhead64 Cholesterol-Lowering Drugs Can be very beneficial for a lot of people BUT... Can have dangerous side effects: –Myositis, a severe muscle inflammation –Can develop into rhabdomyolysis, which can be fatal

65. ADE Training Overhead65 The Main Points A number of medications are potentially inappropriate to use with older adults, because the risks outweigh the benefits or alternative medications are available that are safer and/or more effective. Even common medications should always be used with care Again, the important question is ALWAYS: Do the potential benefits of the medication outweigh the potential risks for the individual?”

66. ADE Training Overhead66 Module Four: Safe Use of Medications - Objectives 1.Identify seven or more questions that are appropriate to ask the healthcare professional when a new medication is prescribed. 2.List the steps involved to get the best results when taking medications. 3.Understand how to read drug labels.

67. ADE Training Overhead67 How to Get Best Results With Medications Legible prescription Get prescriptions filled at the same pharmacy Take the medicine in the exact amount and at the times that the doctor prescribes Use a pill organizer if needed or store all medications in their original containers Store medications in a place where they can be easily seen, but not in the bathroom Contact the doctor right away if the individual has any problems with the medicine or any new symptoms

68. ADE Training Overhead68 Rules for OTC Medicines 1.Always start by reading the label – all of it. 2.Look for an OTC medication that will treat only the current symptoms. 3.Know what to avoid when taking an OTC medicine. 4.When in doubt, ask before using an OTC medicine. 5.Take the medicine EXACTLY as stated on the label. 6.Use extra caution when taking more than one OTC drug product at a time. 7.Do not combine prescription medicines and OTC drugs without talking to the doctor first. 8.Make sure all doctors have a complete list of all the medicines being taken. 9.Don’t use OTC medicines after their expiration date.

69. ADE Training Overhead69 DO NOT! ⌦ Stop taking a prescription medicine unless the doctor says it is okay. ⌦ Double up on a dose if one is forgotten. ⌦ Mix alcohol with medicine unless the doctor says it is okay. ⌦ Use or take medicines in the dark. ⌦ Use or take medicines prescribed for someone else. ⌦ Give one’s medicine to someone else.

70. ADE Training Overhead70 Medication Record Keep an updated record of ALL their medicines – including prescription, over-the-counter, vitamins, and herbal medicines or supplements Dosage, frequency, and when the medicines were prescribed Drug allergies Always take this medication record when going to the doctor or the hospital Review all medications with the doctor on every visit or every six months

71. ADE Training Overhead71 New “Easy to Read” Format Must be in standardized easy to follow format Simple language must be used, for example: – “Uses” instead of “indications” – “Make worse” instead of “aggravate” – “Throw away” instead of “discard” – “Help” instead of “assistance” Must be in print that is large enough to read easily Use graphics to make it easier to read

72. ADE Training Overhead72 Drug Labels Active Ingredients Purpose Uses Warnings Directions Other Information Inactive Ingredients Questions or Comments

73. ADE Training Overhead73 “The Three Rs” – Main Points Respect that OTCs are serious medicine and must be taken with care. All medications have Risks as well as benefits. (Same as the question we keep asking!) Take Responsibility for learning about how to take medications safely. If in any doubt, ask healthcare provider first.