adverse drug reactions for pharmacy students
TRANSCRIPT
ADVERSE DRUG
REACTIONS
OVERVIEW
STATISTICS
5% of adults are allergic to one or more medications
6 – 10% of ADRs result from a drug allergy 3% of hospital admissions are due to ADRs 28% of ADRs are preventable Drugs associated with ADRs: 29% analgesics,
10% sedatives, 9% antibiotics, and 7% antipsychotics.
PGH: Antibiotics (35%), anti-TB meds (34%), anticonvulsants and ASA/NSAIDS (10% each)
ADRs: 4th Leading Cause of Death
Study: Drug reactions kill an estimated 100,000 a year
April 14, 1998
What are Adverse Drug Reactions (ADRs)?
any response to a drug which is noxious and unintended and which occurs at doses used in man for prophylaxis, diagnosis or therapy
What is an adverse drug experience?
An undesirable drug effect, whether harmless, resulting from medications administered in a dosage normally given.
It becomes an adverse drug reaction when it is reported and subsequently evaluated to be secondary to the drug usage.
Key points to remember
ADRs
Common Causes of ADRs
Failing to take the correct dosages at the correct times
Overdosing Allergies to chemical components of the medicine Combining the medicine with alcohol Taking other drugs or preparations that interact with
the medicine Taking a medicine that was prescribed for someone
else.
Causes of ADR Pharmaceutical causes
decreasing particle size or changing excipients
Pharmacokinetic causes diazepam aminoglycosides
Pharmacodynamic causes increased sensitivity of target organs
in the body to drugs
Factors affecting Adverse Drug Reactions : Patient-related factors
Age Sex Genetic influences Concurrent diseases (renal,liver, cardiac) Previous adverse drug reactions Compliance with dosing regimen Total number of medications Misc. (diet, smoking, environmental exposure)
Factors affecting Adverse Drug Reactions :
Drug-related factors: Dose Duration Inherent toxicity of the
agent Pharmacodynamic
properties Pharmacokinetic properties
Six Classifications of ADR
Type A Type B Type C Type D Type E Type F
(Augmented)(Bizarre)(Continuous)(Delayed)(Ending of Use)(Failure of Efficacy)
Type A Reactions or Augmented Activity (pharmacological) of a drug
Extension Effects Adverse Effects
Extension Effects
predictable dose-related responses prevention: Adjustment of dosage djustment of dosage
regimenregimen
Examples of Extension Effects
Benzodiazepines Furosemide
Heparin, warfarin
insulin
– sedation– water and electrolyte
imbalance– spontaneous bleeding
– hypoglycemia
Adverse Effects
predictable, dose-dependent reactions unrelated to the goal of therapy
often produced by the same drug-receptor interaction responsible for the therapeutic effect, differing only in the tissue/s or organ/s affected
Example of Adverse Effects
INH, Rifampicin, PZA streptomycin captopril simvastatin nitrates propranolol tetracycline
– hepatotoxicity– ototoxicity, nephrotoxicity
– cough– rhabdomyolysis– headache– bronchial asthma– hypoplasia of the teeth
Type B Reactions or Bizarre
aBnormal effects Unrelated from the
drug’s known pharmacological actions
Characteristics of Bizarre Reactions no formal dose-response curve (penicillin
hypersensitivity – anaphylaxis) reaction disappears on discontinuation of the
drug recognizable as an immunological reaction undetectable during conventional testing little or no relation to the usual
pharmacological effects of the drug delay between exposure to the drug and the
occurrence of the subsequent adverse reaction
Example of Bizarre Reactions
Hypersensitivity reactions Stevens-Johnson’s Syndrome Hemolytic anemia
Type C Reactions or Continuous
long term effects are usually related to the dose and duration of treatment
Examples ethambutol NSAIDs
Type D Reactions or Delayed
Carcinogenesis
Teratogenesis
Examples: thalidomide, vitamin A
Type E Reactions or Ending of Use Withdrawal Syndromes
Examples: benzodiazepines clonidine corticosteroids opioids
– rebound insomnia, agitation
– rebound hypertension– acute adrenal insufficiency– narcotic withdrawal
Type F Reactions or Failure of Efficacy
Counterfeit medicines Underdosing of medications Drug interactions
Exercises
Example #1
An 8-day old female was diagnosed to have neonatal tetanus. Diazepam was used as the anticonvulsant with a dose of 0.2 mg/kg/dose q 4hrs. With persistence of spasms, the dose was increased to 0.5 mg/kg/dose up to the maximum dose of 1 mg/kg/dose but still no improvement. Higher doses of the same brand was also ineffective. The patient was later started on Midazolam drip which resulted in decreased frequency of spasms.
Type F
Example #2
A patient was maintained on clonidine 150 mcg BID and Aspirin 80 mg tab OD. Then the patient stopped his medications due to financial constraints. The patient suddenly experienced headache, dizziness and flushing due to increased blood pressure.
Type E
Example #3
A TB patient was started with fixed-dose anti-TB drugs for 6 months. After several days, the patient was noted for rashes. The patient sought consult and was advised to stop his anti-TB drugs. This resulted to remission of the rashes.
Type B
Example #4
A patient with chronic stable angina was given isosorbide dinitrate. After taking ISDN, the patient experienced dizziness and headache. The dose of ISDN was reduced which resulted to improvement of the patient’s status.
Adverse Effect
ADR REPORTING
Why report ADRs?
To prevent drug-induced human suffering
To avoid financial risks associated with unexpected risks
June 22, 1963 as amended on May 22, 1987 Republic Act 3720 “Food, Drugs and Devices and Cosmetics Act” Creation of Food and Drug Administration now Bureau of Food and DrugsApril 20, 1994 BFAD Memorandum Circular No. 5 s. 1994 Submission of ADR reports by pharmaceutical establishments and parties concernedJune 30, 1994 Department Order No. 345 - I s. 1994 Creation of National Adverse Drug Reaction Advisory Committee (NADRAC)
GOVERNMENT POLICY ON ADR REPORTING
Reports from
ParticipatingHospitals
Reports from
Private Practitioners
Reportfrom
Drug Mfr.Traders/Outlets
Reportson
ClinicalInvestiga-
tions
Reportsfrom
RegulatoryAuthorities
Reports fromInt’lADR
Centers
BFAD ADR UNIT
NADRAC WHO Collaborating Center
Director - BFAD
Secretary ofHealth - DOH
ADR Monitoring System
REPORTING SCHEMEREPORTING SCHEME
NADRACNADRAC
(Trend Analysis) (Trend Analysis)
CASECASE
Reporter Fills Out a Reporter Fills Out a FormForm
Hospital Hospital
Therapeutic Therapeutic CommitteesCommittees
ADRMP Office ADRMP Office
(Central Database)(Central Database) WHOWHO
WHOWHO
THE PGH ADVERSE DRUG REACTION REPORTING SCHEME
How do we report ADRs?
STEP 1 : Fill out the RED ALERT CARDSPGH FORM # P – 60170
PGH ADVERSE DRUG SURVEILLANCE ALERT CARD
(Clip this on chart front cover)
Name of patient:___________________________________Ward & Bed No.:__________________________________Name of suspect drug:______________________________Manufacturer:_____________________________________Lot/ Code No.:__________ (Retain empty vial or container)Describe the reaction:_______________________________ __________________________________________________________________________________________________Reporter: _________________________________________
(Please Print)
PLEASE NOTIFY: CENTRAL BLOCK PHARMACYLoc. 3163 / 3170
How do we report ADRs?
STEP 2: Complete the ADR REPORT FORM
The Resident - in - charge of the patient shall
complete the necessary report of ADR
circumstances.
STEP 2: Complete the ADR REPORT FORM
The Resident - in - charge of the patient shall
complete the necessary report of ADR
circumstances.
How do we report ADRs?
STEP 3: Submit the red alert card and the ADR report form to the Central Block Pharmacy for proper referral.
STEP 4: The Pharmacy will then compile the reports for review of the ADR Subcommittee and submission to the Bureau of Food and Drugs (BFAD).
Pharmacist
The ADR Report Form should include the following:
brand name of the suspect drug
the manufacturer (if generic)
the lot and batch number.
It should be done in duplicate.
ALL REPORTS ARE CONFIDENTIAL
IMPORTANT!!!!
Common reports rash caused by Oxacillin red face, fever secondary to Vancomycin
Uncommon reports hair loss due to anti thyroid agents neuroleptic malignant syndrome with risperidone
Examples of Reported ADRs
TEN COMMANDMENTS to reduce ADVERSE DRUG REACTIONS
1. Critically review the total condition of the patient. Be particularly careful when you prescribe to children, elderly, seriously ill, pregnant patients and those with renal, cardiac or liver diseases.
TEN COMMANDMENTS to reduce ADVERSE DRUG REACTIONS
2. Use as few drugs as possible. Balance the seriousness of possible reactions against the beneficial effects of each drug that is being considered.
3. Know well the drugs that you use. Compare the efficacy and safety of each of the available competitive medications that appear to be worthy of consideration for the patient.
TEN COMMANDMENTS to reduce ADVERSE DRUG REACTIONS
4. Do not change too readily from one drug you know to one you do not know. If you decide to use a new drug, know that drug.
TEN COMMANDMENTS to reduce ADVERSE DRUG REACTIONS
5. Do not hesitate to use textbooks and other references providing information on drug reaction and interaction.
TEN COMMANDMENTS to reduce ADVERSE DRUG REACTIONS
6. Be especially careful when prescribing drugs known to exhibit a large variety of reactions/ interactions.
TEN COMMANDMENTS to reduce ADVERSE DRUG REACTIONS
7. Be aware of interactions with certain foods, alcohol and even with household chemicals.
TEN COMMANDMENTS to reduce ADVERSE DRUG REACTIONS
8. Regularly make an inventory of the drugs your patient is receiving.
TEN COMMANDMENTS to reduce ADVERSE DRUG REACTIONS
9. Review your patient regularly for all the drugs used and especially those bought without prescriptions.
TEN COMMANDMENTS to reduce ADVERSE DRUG REACTIONS
TEN COMMANDMENTS to reduce ADVERSE DRUG REACTIONS
10. If your patient shows signs and symptoms not clearly explained by the course of illness, think of adverse drug reaction.