Adverse Drug Reactions

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  • ADVERSE DRUG REACTIONS

  • OVERVIEW

  • STATISTICS5% of adults are allergic to one or more medications6 10% of ADRs result from a drug allergy3% of hospital admissions are due to ADRs28% of ADRs are preventableDrugs 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 DeathStudy: Drug reactions kill an estimated 100,000 a yearApril 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 rememberADRs

  • Common Causes of ADRsFailing 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 ADRPharmaceutical causesdecreasing particle size or changing excipients Pharmacokinetic causesdiazepam aminoglycosidesPharmacodynamic causesincreased 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:DoseDurationInherent toxicity of the agentPharmacodynamic propertiesPharmacokinetic properties

  • Six Classifications of ADRType AType BType CType DType EType F(Augmented)(Bizarre)(Continuous)(Delayed)(Ending of Use)(Failure of Efficacy)

  • Type A Reactions or Augmented Activity (pharmacological) of a drug

    Extension EffectsAdverse Effects

  • Extension Effects predictabledose-related responses prevention: Adjustment of dosage regimen

  • Examples of Extension EffectsBenzodiazepinesFurosemide

    Heparin, warfarin

    insulin sedation water and electrolyte imbalance spontaneous bleeding

    hypoglycemia

  • Adverse Effects predictable, dose-dependent reactions unrelated to the goal of therapyoften 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 EffectsINH, Rifampicin, PZA streptomycincaptoprilsimvastatinnitratespropranololtetracycline hepatotoxicity ototoxicity, nephrotoxicity cough rhabdomyolysis headache bronchial asthma hypoplasia of the teeth

  • Type B Reactions or Bizarre aBnormal effectsUnrelated from the drugs known pharmacological actions

  • Characteristics of Bizarre Reactions no formal dose-response curve (penicillin hypersensitivity anaphylaxis)reaction disappears on discontinuation of the drugrecognizable as an immunological reactionundetectable during conventional testinglittle or no relation to the usual pharmacological effects of the drugdelay between exposure to the drug and the occurrence of the subsequent adverse reaction

  • Example of Bizarre ReactionsHypersensitivity reactionsStevens-Johnsons SyndromeHemolytic anemia

  • Type C Reactions or Continuous long term effects are usually related to the dose and duration of treatment

    ExamplesethambutolNSAIDs

  • Type D Reactions or Delayed Carcinogenesis

    Teratogenesis

    Examples: thalidomide, vitamin A

  • Type E Reactions or Ending of UseWithdrawal Syndromes

    Examples:benzodiazepinesclonidinecorticosteroidsopioids

    rebound insomnia, agitation rebound hypertension acute adrenal insufficiency narcotic withdrawal

  • Type F Reactions or Failure of Efficacy Counterfeit medicinesUnderdosing of medicationsDrug interactions

  • Exercises

  • Example #1An 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 #2A 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 #3A 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 #4A 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 patients status.Adverse Effect

  • ADR REPORTING

  • Why report ADRs?To prevent drug-induced human sufferingTo 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 fromParticipatingHospitalsReports fromPrivate PractitionersReportfromDrug Mfr.Traders/Outlets

    ReportsonClinicalInvestiga-tionsReportsfromRegulatoryAuthorities

    Reports fromIntlADR CentersBFAD ADR UNITNADRACWHO Collaborating CenterDirector - BFADSecretary ofHealth - DOHADR Monitoring System

  • REPORTING SCHEMENADRAC (Trend Analysis)

    CASEReporter Fills Out a FormHospital Therapeutic CommitteesADRMP Office (Central Database)WHOWHO

  • THE PGH ADVERSE DRUG REACTION REPORTING SCHEME

  • How do we report ADRs?STEP 1 : Fill out the RED ALERT CARDSPGH FORM # P 60170PGH 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.

  • 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 CONFIDENTIALIMPORTANT!!!!

  • 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 REACTIONS1. 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 REACTIONS2. Use as few drugs as possible. Balance the seriousness of possible reactions against the beneficial effects of each drug that is being considered.

  • 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

  • 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.


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