Adverse drug reaction monitoring in patients of bronchial asthma and COPD with focus on methylxanthines - PowerPoint PPT Presentation

Loading...

PPT – Adverse drug reaction monitoring in patients of bronchial asthma and COPD with focus on methylxanthines PowerPoint presentation | free to download - id: 6d1c5e-MDg2O



Loading


The Adobe Flash plugin is needed to view this content

Get the plugin now

View by Category
About This Presentation
Title:

Adverse drug reaction monitoring in patients of bronchial asthma and COPD with focus on methylxanthines

Description:

Adverse drug reaction monitoring in patients of bronchial asthma and COPD with focus on methylxanthines Kavita Gulati Department of Pharmacology – PowerPoint PPT presentation

Number of Views:2
Avg rating:3.0/5.0
Date added: 24 April 2020
Slides: 35
Provided by: prof8159
Category:

less

Write a Comment
User Comments (0)
Transcript and Presenter's Notes

Title: Adverse drug reaction monitoring in patients of bronchial asthma and COPD with focus on methylxanthines


1
Adverse drug reaction monitoring in patients of
bronchial asthma and COPD with focus on
methylxanthines
  • Kavita Gulati
  • Department of Pharmacology
  • Vallabhbhai Patel Chest Institute
  • University of Delhi, Delhi-110007
  • SOPI-2010, LHMC, New Delhi, 27/11/2010,

2
Adverse Drug Reactions
  • A response to a drug that is noxious and
    unintended and that occurs at doses used in
    humans for prophylaxis, diagnosis, or therapy of
    disease, or for the modification of physiologic
    function
  • Excludes therapeutic failures, overdose, drug
    abuse, non-compliance, and medication errors

3
Adverse Drug Reactions
  • ADR contribute significantly to the morbidity and
    mortality and increased health costs
  • Over 2 million serious ADRs per year, responsible
    for 5 of hospital admissions, 1,00,000 deaths
    yearly
  • ADRs leading cause of morbidity, ahead of lung
    disease, diabetes, AIDS, Trauma

4
Need of ADR monitoring
  • India 4th largest producer of the
    pharmaceuticals in the world
  • Drugs prescribed (sometimes indiscriminately and
    irrationally) in various combinations
    (polypharmacy)
  • Large sections of population exposed
  • ADR contribute significantly to the morbidity and
    mortality and increased health costs
  • Clinical trial data not sufficient
  • A dire need for a scientific/systematic and
    uniform method to monitor ADRs

5
Pharmacovigilance methods
  • Spontaneous reports (most commonly)
  • PEM (prescription event monitoring)
  • Observational Studies(Case Control and Cohort
    Studies)

6
Spontaneous reporting
  • Unsolicited communication by health care
    professionals or consumers to a company,
    regulatory authority or any other organization
    (WHO, Regional Centers) that describes one or
    more Adverse Drug Reactions in patient who was
    given one or more medicinal products
  • It does not derive from a study or any organized
    data collection scheme

7
Causality assessment
  • Hutchison defined causality assessment as a
    method for eliciting a state of information
    about a particular drug-event connection as input
    and delivering as output a degree of belief about
    the truth of the proposition that the drug caused
    the event to occur

8
Causality Assessment scales
  • Naranjos scale
  • WHO causality assessment scale

9
Causality Assessment
  • Prior reports of reaction
  • Temporal relationship
  • De-challenge
  • Re-challenge
  • Dose-response relationship
  • Alternative etiologies
  • Past history of reaction to same or similar
    medication

10
  • Naranjo ADR Probability Scale
  • Naranjo CA. Clin Pharmacol Ther 198130239-45

11

12
Respiratory diseases
  • Respiratory diseases a major cause of hospital
    admissions
  • Obstructive airway disease (Bronchial Asthma and
    COPD) affect 5-7 population in industrialized
    countries
  • Several factors (allergy and smoking) contribute
    to their genesis
  • Optimization and rationalization of drug therapy
    key to effective management

13
Respiratory disease.
  • Drug therapy involves polypharmacy
  • Multiple routes of drug administration
    sometimes in the same individual
  • Complex drug drug interactions always a
    possibility
  • Long term drug usage compounds the problem
  • Drugs with narrow therapeutic indices

14
ADR monitoring in Asthma and COPD
  • 120 patients of bronchial asthma and COPD were
    selected from the VPCI OPD
  • Ethical clearance and GCP guidelines
  • Standard inclusion/exclusion criteria
  • Diagnosed by clinical features and PFT findings
  • ADR profile was recorded as per National
    Pharmacovigilance Programme proforma
  • Dechallenge and rechallenge were done wherever
    appropriate
  • Causality Assessment was done by using the
    Naranjos scale

15
SEX-WISE DISTRIBUTION OF MALES AND FEMALES
ENROLLED IN THE STUDY
16
GENERAL PROFILE OF DRUG TREATMENT AND ADVERSE
EFFECTS IN COPD
Drug Given No. of Patient Receiving the Drug No. of Patient Complaining of ADR Percentage
Inhaled Steroids 53 30 56
Inhaled Anticholinergics 44 10 22.7
Oral Theophylline 43 20 46.5
Oral Steroids 14 3 21.4
Antibiotics (Oral) 14 3 21.7
Short Acting ?2 agonist 55 3 5
N-acetyl cysteine 2 2 100
17
PERCENTAGE OF OUTPATIENTS RECEIVING DIFFERENT
DRUGS FOR TREATMENT OF COPD
LA b2 agonist
18
PERCENTAGE OF OUTPATIENTS COMPLAINING OF ADR WITH
DIFFERENT DRUGS USED FOR TREATMENT OF COPD

19
ADR profile with respiratory drugs
Drugs Br. Asthma COPD Profile
Inhaled steroids 54/60 (90) 30/60 (50) Sore throat,dysguesia,hoarseness,glossitis, others
Inhaled anticholinergics 25/40 (62) 10/44 (23) Dry mouth,thirst, urinary difficulty
Inhaled beta-2 agonists(SA) 15/35 (43) 3/55 (5) Hand tremors
Oral steroids 28/32 (87) 3/14 (21) Wt. gain, acne, cramps, mood changes
Oral theophylline 14/20 (70) 20/43 (46) Anxiety, dyspepsia, mus. spasm, paresthesia, etc
20
Results
  • Most ADRs mild to moderate, few were
    intolerable and required dose reduction ( oral
    steroid and theophylline)
  • 75 of patients complained of one or other ADR
  • 23 of COPD patients and 53 of bronchial
    asthma patients required oral steroids
  • Oral steroids were associated with incidence of
    ADRs - 21 (in COPD) and 87 (in br. asthma)
  • 84 of total patients received inhaled
    anticholinergics out of which ADRs were noted in
    41 patients

21
Theophylline
  • Bronchodilators and corticosteroids are the
    mainstay in the treatment of OADs
  • Recently a resurgence in the interest in
    theophylline due to anti-inflammatory and
    immunomodulatory effects reported
  • Low doses (lower than those needed to induce
    bronchodilation) exert beneficial effects
  • Judicious use could be of benefit in OAD in
    developing countries (reduces dose of steroids
    and a pharmacoeconomically viable drug

22
Prescription monitoring in obstructive airway
disease (theophylline)
Prescriptions Total No. With theophylline
All patients 120 63 52.6
Br. Asthma 60 20 33.3
COPD 60 43 71.6
23
Prescription audit in obstructive airway disease
(theophylline)
24
ADR incidence with theophylline
Patients Received Theophylline Showed ADRs
Br. Asthma 20 14 70
COPD 43 20 46.5
Total 63 34 53.9
25
ADVERSE EFFECT PROFILE IN COPD PATIENTS WITH ORAL
THEOPHYLLINE
ADR No. of Patients Percentage
Dyspepsia 13 65
Anxiety 12 60
Spasm of Muscles 6 30
Insomnia 2 10
Dizziness 2 10
Theophylline Withdrawal Induced Constipation 1 5
Paraesthesia 2 10
Others 1 5

26
PERCENTAGE OF DIFFERENT ADRs WITH ORAL
THEOPHYLLINE IN COPD PATIENTS
27
  • Adverse effect profile in patients with oral
    theophylline in bronchial asthma
  • --------------------------------------------------
    ----------------------------
  • ADR No. of Patients
  • --------------------------------------------------
    ----------------------------
  • Dyspepsia 09
    45
  • Anxiety
    10 50
  • Spasm of Muscles 07
    35
  • Insomnia
    08 40
  • Paresthesia 04
    20
  • Dizziness
    03 15
  • Others
    02 10
  • ------------------------------------------
    ------------------------------------------

28
Incidence of ADRs after theophylline in patients
of Bronchial Asthma
29
Causality assessment of ADRs due to oral
theophylline using the Naranjos scale
Highly Probable (9) Probable (5-8) Possible (1-4) Doubtful (0)
Oral Theophyllin Spasm of muscle of calves (most commonly) sternocleidomastoid, intercoastal muscles Dyspepsia Insomnia (3) Anxiety (4)Dizziness (5)Withdrawal induced Constipation (6)Paraesthesia (7)Colicky Pain (8)Diuresis
30
A comparative study
  • A prospective, open label, randomized, parallel
    design study was carried out to compare the
    efficacy and safety of two methylxanthines,
    namely theophylline and doxofylline in patients
    of bronchial asthma and COPD
  • A total of 60 patients, 30 each of bronchial
    asthma and COPD were enrolled for the study as
    per the laid down inclusion and exclusion
    criteria
  • Each group of 30 patients received standard
    treatment for asthma and COPD

31
Comparison of ADRs after theophylline and
doxofylline in bronchial asthma
anxiety
Muscle spasm
Dizziness
Sore throat
No ADRs
insomnia
No ADR
32
Comparison of ADRs after theophylline and
doxofylline in COPD
anxiety
anxiety
Muscle spasm
Dry mouth
insomnia
Tremors
Gastritis
Nausea
No ADR
No ADRs
33
Summary
  • Doxofylline was more therapeutically effective
    than theophylline in COPD
  • ADR profiles of theophylline and doxofylline
    included dyspepsia, anxiety, muscle spasm,
    tremors, dizziness, and headache
  • Doxofylline treated group was associated with
    lesser frequency of ADRs as compared to the
    theophylline group
  • Such focussed studies will be helpful in
    rationalizing drug therapy in OAD

34
Acknowledgements
  • Dr. V K Vijayan
  • Prof. A Ray
  • Dr. Neeraj Tyagi
  • Dr. Gaurav Vishnoi
  • Dr. Dushyant Lal
About PowerShow.com