Recognizing Adverse Drug Events

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Adverse Drug Events
    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
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.
                    ADE Training Overhead            2
  Older Adults and Medications
• Older adults make up 13% of
• Account for:
  – About 30% of prescribed
  – About 40% of over-the-counter
• At least 90% take at least one
  prescription medication
• 12% use ten or more per week
                    ADE Training Overhead   3
Prescription Drug Spending
       Will Increase

         ADE Training Overhead   4
Who Takes the Most Medications?
• Women
• Individuals with
  multiple health
• Frail elderly
• Nursing home

                 ADE Training Overhead   5
Medications Most Commonly Used
        in the Community

 •   Analgesics
 •   Diuretics
 •   Cardiovascular
 •   Sedative-hypnotics

                 ADE Training Overhead   6
Medications Most Commonly Used
      in the Nursing Home
                  •   Antipsychotics
                  •   Sedative-hypnotics
                  •   Diuretics
                  •   Antihypertensives
                  •   Analgesics
                  •   Cardiovascular
                  •   Antibiotics
           ADE Training Overhead           7
We Must Always Ask:

                • Do the potential
                  benefits outweigh
                  the potential risks
                  for this individual?

      ADE Training Overhead              8
          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

                  ADE Training Overhead       9
      Other Drug Interactions
• Drugs can interact
  with other things as
  – A physical
  – Food
  – Alcohol

                 ADE Training Overhead   10
 Drug Interaction Warnings
Antacids (drugs for relief of     Ask a doctor or pharmacist before use if you
    acid indigestion,                 are:
    heartburn, and/or sour         Allergic to milk or milk products if the
    stomach)                          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        Ask a doctor or pharmacist before use if you
    temporarily relieve runny         are taking:
    nose or reduce sneezing,       Sedatives or tranquilizers
    itchy eyes or throat)          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.

                           ADE Training Overhead                                  11
 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

                ADE Training Overhead        12
 How Do Drug Interactions Occur?

• An increase or decrease in any of the
  – Absorption
  – Distribution
  – Metabolism
  – Elimination

                   ADE Training Overhead   13
• A change in blood flow to the
• 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

                     ADE Training Overhead   14
   Metabolism and Elimination
An increase                          leads to a decrease
in enzyme activity                   in drug concentration
                                     and effect

A decrease                           leads to an increase
in enzyme activity                   in drug concentration
                                     and effect

                     ADE Training Overhead               15
     Drug Interactions Can Have
         Unintended Effects

• Decreasing the intended effects of the
  drug (drug is eliminated too fast)


• Increasing the negative effects of the drug
  (can lead to toxicity)
                  ADE Training Overhead         16
Examples of Drug-drug Interactions
Patients Who ended             Were:           To have
taking: up in                                  taken this
         hospital                              drug in past
         with:                                 week:
Glyburide Hypoglycemia         6 times more Co-trimoxazole

Digoxin     Digoxin toxicity 12 times          Clarithromycin
                             more likely

(ACE)       Hyperkalemia       20 times        Potassium-
inhibitor                      more likely     sparing diuretic
                       ADE Training Overhead                 17
         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

                    ADE Training Overhead            18
       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
                 ADE Training Overhead     19
How Body and Medications Interact

• Pharmacokinetics – what the body
  does to the medication

• Pharmacodynamics – what the
  medication does to the body
                ADE Training Overhead   20
        “Anticholinergic” Effects

•   Dry mouth
•   Dry skin
•   Constipation
•   Urinary retention
•   Ataxia
•   Can also bring on dementia/delirium

                  ADE Training Overhead   21
 Other Issues With Medication Use
          and Older Adults
• Appropriateness
• Multiple medical
• Multiple physicians
• Polypharmacy
• Underuse
• Cost
• Noncompliance
• Lack of research

                   ADE Training Overhead   22
     Signals of Possible Medication

•   Falls                    •   Sleep disorders
•   Restlessness             •   Weight loss
•   Confusion                •   Bowel changes
•   Loss of memory           •   Incontinence
•   Constipation             •   Dizziness

                 ADE Training Overhead             23
          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.”
                 ADE Training Overhead     24
         The Main Points
• Medications are not to be given or
  taken lightly – especially by older
• 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
               ADE Training Overhead    25
          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.
                   ADE Training Overhead         26
• 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
                   ADE Training Overhead             27
Side Effects vs. ADEs
                      Take medication

                 Symptoms – Side effects

               Injuries – Adverse drug events

         Yes                                No

   Preventable:                          Not –preventable:
Adverse drug event                      Adverse drug reaction

                   ADE Training Overhead                        28
           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
                    ADE Training Overhead          29
            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
                       ADE Training Overhead     30
 Drug Allergies - Anaphylaxis
• Anaphylactic (an-uh-fuh-LAK-tik)
  reaction: A severe allergic
  reaction that can be life-
• Rare responses but dangerous!
• Medical help is needed and
  should be sought immediately.
• Call 911 or take the individual to
  the emergency room.

                   ADE Training Overhead   31
        Anaphylaxis Symptoms
•   Hives                         •   Swelling in the throat
•   Itching                       •   Irregular heartbeat
•   Feeling warm                  •   Nausea and vomiting
•   Flushing                      •   Diarrhea
•   Wheezing                      •   Abdominal cramping
•   Dizziness or

                      ADE Training Overhead                32
      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
                 ADE Training Overhead      33
 Most at Risk of Allergic Reaction:
• Already have allergies in
• Take a drug often
• Take a drug in large
• Take a drug in shots
  rather than pills

                 ADE Training Overhead   34
Common Symptoms From ADEs
    •   Confusion
    •   Nausea
    •   Decreased balance
    •   Change in bowel pattern
    •   Sedation
    •   Orthostatic hypotension

              ADE Training Overhead   35
       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
                    ADE Training Overhead           36
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

      ADE Training Overhead          37
    Found Those Most at Risk:
• New residents
• Residents with multiple medical conditions
• Residents taking multiple medications (five or
• Residents taking psychoactive medications,
  opioids, or anti-infective drugs

• Those at lower risk:
  – Residents taking nutrients/supplements
  – Men
                    ADE Training Overhead          38
 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
                ADE Training Overhead      39
      ADEs by Classification:
• 578 (38%) were categorized as serious,
  life-threatening, or fatal:

    • Significant                 945     (62.0%)
    • Severe                      431     (28.3%)
    • Life-threatening            136     ( 8.9%)
    • Fatal                        11     ( 0.7%)

                  ADE Training Overhead             40
                    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
                        ADE Training Overhead                 41
Most Commonly Involved Drugs:

•   Cardiovascular                            26.0%
•   Antibiotics/anti-infectives               14.7%
•   Diuretics                                 13.3%
•   Nonopioid analgesics                      11.8%
•   Anticoagulants                             7.9%
•   Hypoglycemics                              6.8%

                      ADE Training Overhead           42
         Most Common ADEs:

•   Gastrointestinal tract events          22.1%
•   Electrolyte/renal                      16.7%
•   Hemorrhagic                            12.7%
•   Metabolic/endocrine                     9.5%
•   Dermatologic (skin) /allergic           7.9%

                   ADE Training Overhead           43
What Kind of Errors Led to ADEs?

                        • Prescribing
                        • Monitoring
                        • Patient adherence

            ADE Training Overhead             44
             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
                   ADE Training Overhead          45
     Individuals at Increased Risk of
•   Older, especially age 80+
•   More co-morbidity
•   Multiple medications
•   Individuals taking medications in these
       •   Anticoagulants
       •   Antidepressants
       •   Antibiotics
       •   Cardiovascular drugs
       •   Diuretics
       •   Hormones
       •   Corticosteroids
                        ADE Training Overhead   46
   ADE Error Prevention for 65+
            Reason                                   Intervention
Multiple drug use                    Review medication indications
Age-related physiologic              Appropriate dose adjustments and
alterations in metabolism,           decisions, with careful consideration
excretion, or drug effects           of comorbidities
Drug knowledge dissemination, Computerization, physician order
allergy checking, and dispensing entry, decision support, and bar-
                                 coding technology
Underprescribing                     Avoid age bias
Falls due to medications             Limit psychoactive pharmacotherapy
Delirium due to medications          Appropriate drug and dosing
                                     indications and nonpharmacological
                                     approaches to insomnia
                             ADE Training Overhead                       47
          The Main Points

• Adverse drug events are common
• Adverse drug events can be

• Never take use of medications lightly
  – especially among older adults!
• Benefits vs. risks
                ADE Training Overhead     48
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
3. Describe the safe use of over-the-counter pain
4. Understand concerns about use of insulin for
5. Discuss safety issues with cholesterol lowering
                   ADE Training Overhead         49
     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.

                 ADE Training Overhead         50
               Beers’ List
• Effort led by Dr. Mark Beers
• Panel of experts in geriatric medicine and
• 1991 – First published for nursing home
• 1997 – Expanded to cover all older adults
• 2003 – Updated

                 ADE Training Overhead         51
      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

                    ADE Training Overhead    52
    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)
                        ADE Training Overhead         53
   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

                     ADE Training Overhead          54
   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)
                       ADE Training Overhead       55
             Zhan Appropriateness
•   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    ADE Training Overhead           56
    Should “Always Be Avoided” for
•   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)
                       ADE Training Overhead     57
     “Rarely Appropriate” for 65+
•   Chlordiazepoxide (Librium)
•   Diazepam (Valium)
•   Propoxyphene (Darvon products)
•   Carisoprodol (Soma)
•   Chlorzoxazone (Paraflex)
•   Cyclobenzeprine (Flexeril)
•   Metaxalone (Skelaxin)
•   Methocarbamol (Robaxin)

                   ADE Training Overhead   58
OTC Pain Relievers

  • Analgesics
  • Antipyretics
  • Nonsteroidal anti-inflammatory
    drug (NSAID)
  • Acetaminophen

       ADE Training Overhead     59
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
  – Are over 60
  – Take prescription blood thinners (example,
  – Have previous stomach ulcers or other
    bleeding problems
  – Take steroid medications or other NSAIDs
                  ADE Training Overhead          60
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

                  ADE Training Overhead           61
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.

                 ADE Training Overhead      62
• People with diabetes have a problem
  with high blood sugar, so they may
  have to take insulin
• Too much insulin can cause low blood
• 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!
                  ADE Training Overhead   63
   Cholesterol-Lowering Drugs
• Can be very beneficial for a lot of people

• Can have dangerous side effects:
  – Myositis, a severe muscle inflammation
  – Can develop into rhabdomyolysis, which can
    be fatal

                 ADE Training Overhead           64
            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?”
                   ADE Training Overhead            65
     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
3. Understand how to read drug labels.
              ADE Training Overhead   66
    How to Get Best Results With
• 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          ADE Training Overhead         67
       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.
                      ADE Training Overhead             68
                 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.
                  ADE Training Overhead        69
          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

                   ADE Training Overhead            70
   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
• Use graphics to make it easier to read

                     ADE Training Overhead        71
              Drug Labels
•   Active Ingredients
•   Purpose
•   Uses
•   Warnings
•   Directions
•   Other Information
•   Inactive Ingredients
•   Questions or Comments
                 ADE Training Overhead   72
    “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.

                   ADE Training Overhead            73