This document discusses adverse drug reactions (ADRs), defined as any undesirable or unintended consequence of drug administration. ADRs are classified as either predictable (type A) or unpredictable (type B) reactions. Predictable reactions include excessive pharmacological effects, secondary pharmacological effects, and rebound effects on drug discontinuation. Unpredictable reactions include allergic drug reactions, idiosyncrasy, and genetically determined toxicity. The document also covers ADR detection methods like patient interviews, ADR reporting approaches, and ADR management based on reaction severity and importance of continued treatment.
Patient medication adherence, Medication adherence, Causes of medication non-adherence, Problems linked with Medication Non-adherence, Factors affecting medication adherence, Patient related factors, Social and Economic factor, Disease related factor, Health care provider related factors, Therapy related factors, pharmacist role in the medication adherence, role of pharmacist in the medication adherence, monitoring of patient medication adherence, Direct method, Indirect method
Patient medication adherence, Medication adherence, Causes of medication non-adherence, Problems linked with Medication Non-adherence, Factors affecting medication adherence, Patient related factors, Social and Economic factor, Disease related factor, Health care provider related factors, Therapy related factors, pharmacist role in the medication adherence, role of pharmacist in the medication adherence, monitoring of patient medication adherence, Direct method, Indirect method
Pharmacy and therapeutic committee, PTC, Organization of PTC, Functions of PTC, Automatic stop order, Emergency drug list, ADR and safety monitoring, Role of Pharmacy and therapeutic committee
Introduction to clinical pharmacy, Concept and Objectives of clinical pharmacy, Function and responsibilities of clinical pharmacist, Clinical Pharmacy services.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Function of community pharmacy, Organization and structure of retail and wholesale drug store, Legal requirement for establishment, Maintenance of records
Drug Information Services, Drug information Sources, Illegal DIC, Drug Information Bulletin, Classification of scientific literature, services offered bu drug information services
hospital formulary is developed under the guidance of pharmacy and therapeutic commitee of the hospital.pharmacist working in a hospital should play an important role in the preparation of the hospital formulary
Pharmacovigilance AND ADVERSE DRUG REACTIONS.
MONITORING REPORTING ROLE OF PHARMACIST.
CLASSIFICATION OF ADR. MECHANISM OF ADR
ROLE OF PHARMACIST IN MANAGING ADR. AUGMENTED, BIZZARE, CONTINOUS, DELAYED, END OF TREATMENT, ABCD, ABCDE.
ADE
INCIDENCE OF ADR
GREADING OF SEVERITY OF ADR
CLASSIFICATIONS
PHARMACOVIGILANCE
CATAGORIES
CAUSES OF ADR
DRUG INDUCED HEPATIC DYSFUNCTION
DRUG INDUCED ENDOCRINE DYSFUNCTION
DRUG INDUCED PHERIPHERAL NEUROPATHY
MANAGEMENT OF ADR
Pharmacy and therapeutic committee, PTC, Organization of PTC, Functions of PTC, Automatic stop order, Emergency drug list, ADR and safety monitoring, Role of Pharmacy and therapeutic committee
Introduction to clinical pharmacy, Concept and Objectives of clinical pharmacy, Function and responsibilities of clinical pharmacist, Clinical Pharmacy services.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Function of community pharmacy, Organization and structure of retail and wholesale drug store, Legal requirement for establishment, Maintenance of records
Drug Information Services, Drug information Sources, Illegal DIC, Drug Information Bulletin, Classification of scientific literature, services offered bu drug information services
hospital formulary is developed under the guidance of pharmacy and therapeutic commitee of the hospital.pharmacist working in a hospital should play an important role in the preparation of the hospital formulary
Pharmacovigilance AND ADVERSE DRUG REACTIONS.
MONITORING REPORTING ROLE OF PHARMACIST.
CLASSIFICATION OF ADR. MECHANISM OF ADR
ROLE OF PHARMACIST IN MANAGING ADR. AUGMENTED, BIZZARE, CONTINOUS, DELAYED, END OF TREATMENT, ABCD, ABCDE.
ADE
INCIDENCE OF ADR
GREADING OF SEVERITY OF ADR
CLASSIFICATIONS
PHARMACOVIGILANCE
CATAGORIES
CAUSES OF ADR
DRUG INDUCED HEPATIC DYSFUNCTION
DRUG INDUCED ENDOCRINE DYSFUNCTION
DRUG INDUCED PHERIPHERAL NEUROPATHY
MANAGEMENT OF ADR
Adverse Drug Reaction by Firoz Rosid.pptxFirozRosid1
Adverse reaction of any drug is a major concerning issue in many countries. A medicine may act as poison without proper dosing as well as management. Sometimes, adverse drug reaction is life threatening. About 10% of diseased people are dying due to adverse reaction of drug. They even don't know why medicine is not being effective them well. So, to get proper medication, knowledge about adverse drug reaction is a must.
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Pharmacology I pharmacokinetics (Biotransformation and Elimination of drug)Subhash Yende
Biotransformation- Phase I and Phase II reaction; Microsomal enzyme induction and inhibition; First pass metabolism;
Excretion - Kinetic; plasma half life
Pharmacology I- Pharmacokinetics (Absorption and Distribution)Subhash Yende
Transport of drug across cell membrane; Absorption- bioavailability, Bioequivalence; Distribution: Plasma protein binding, Physiological barrier, Apparent volume of distribution, redistribution
Definition, Types of drug distribution systems, Dispensing of drugs to ambulatory (outdoor) patients, Distribution of controlled drug, Novel drug distribution methods
Preclinical experimentation: An overviewSubhash Yende
Description of Preclinical pharmacology, laboratory animals, handling technique and route of administration, legal regulation, in vivo & in vitro experimentation
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Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
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- Link to NephroTube website: www.NephroTube.com
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Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
1. ADVERSE DRUG REACTION
Dr. Subhash R. Yende
Asst. Professor,
Gurunanak College of Pharmacy, Nagpur
1
Dr.SubhashR.Yende,GNCP,Nagpur
2. Definition
Any undesirable or unintended consequence of
drug administration
Any noxious change which is suspected to be due
to a drug, occurs at doses normally used in man,
for treatment, prophylaxis, diagnosis of disease.
Adverse effects are more common with multiple
drug therapy, after prolonged medication or even
after stoppage of the drug and in the elderly
patients
an incidence of 10–25% has been documented
2
Dr.SubhashR.Yende,GNCP,Nagpur
3. Reasons for adverse drug reaction
Dispensing and medication error
Failure to set therapeutic endpoint
Bioavailability differences
Patients factors
3
Dr.SubhashR.Yende,GNCP,Nagpur
4. Classification
Predictable (Type A or Augmented) reactions
Excessive pharmacological effects
Secondary pharmacological effects
Rebound effect on discontinuation
Unpredictable (Type B or Bizarre) reactions
Allergic drug reactions
Idiosyncrasy
Genetically determined toxicity
4
Dr.SubhashR.Yende,GNCP,Nagpur
5. Excessive pharmacological Effects (Toxic effects)
Due to overdosage or prolonged use
Overdosage may be absolute (accidental, homicidal,
suicidal) or relative (i.e. usual dose in presence of renal
failure, age range, lower albumin level etc)
Examples-
Coma by barbiturates
Complete A-V block by digoxin
Bleeding due to heparin
Morphine (analgesic) causes respiratory failure in overdosage
Phenytoin (anticonvulsant) cause memory impairment after
prolong used
5
Predictable reactions
Dr.SubhashR.Yende,GNCP,Nagpur
6. Secondary pharmacological effects (Side effects)
Unwanted but often unavoidable pharmacodynamic
effects that occur at therapeutic doses
can be predicted from the pharmacological profile of a
drug
Reduction in dose, usually ameliorates the symptoms
Examples- postural hypotension caused by prazosin;
promethazine produces sedation
Sometime side effect may be based on the same action
as the therapeutic effect, e.g. atropine is used in
preanaesthetic medication for its antisecretory action;
codeine used for cough produces constipation as a side
effect, but the latter is its therapeutic effect in traveller’s
diarrhoea 6
Predictable reactions
Dr.SubhashR.Yende,GNCP,Nagpur
7. Rebound effect on discontinuation
Chronic use of certain drugs produces drug dependence
and addiction
Drugs producing dependence are-opioids, barbiturates
and other depressants including alcohol and
benzodiazepines
Amphetamines, cocaine, cannabis are drugs which
produce addiction
Sudden interruption of therapy with certain other drugs
also results in adverse consequences (Withdrawal
effects)
Severe hypertension, restlessness and sympathetic over
activity may occur shortly after discontinuing clonidine ;
Frequency of seizures may increase on sudden
withdrawal of an antiepileptic
7
Predictable reactions
Dr.SubhashR.Yende,GNCP,Nagpur
8. Allergic drug reactions
An immunologically mediated reaction producing
stereotype symptoms which are unrelated to the
pharmacodynamic profile of the drug
occur only in a small proportion of the population exposed
to the drug
The drug or its metabolite acts as an antigen (AG), or
more commonly a hapten (incomplete antigen: drugs
have small molecules which become antigenic only after
binding with an endogenous protein) and induce
production of antibody (AB)/sensitized lymphocytes
Eg. Drugs like Penicillins , Aspirin, Sulfonamides – urticaria,
itching, rashes on skin
Tetracyclin cause dermatitis
Penicillins, LA causes respiratory difficulties
Methyldopa, quinidine cause anemia 8
Unpredictable reactions
Dr.SubhashR.Yende,GNCP,Nagpur
9. Idiosyncrasy
Genetically determined abnormal reactivity to a chemical
The drug interacts with some unique feature of the
individual, not found in majority of subjects, and produces
the uncharacteristic reaction
The type of reaction is restricted to individuals with a
particular genotype
e.g.:
Barbiturates cause excitement and mental confusion in
some individuals
Quinine/quinidine cause cramps, diarrhoea, asthma,
angioedema of face and hypotension in some patients
Analgesics may induced tumors of kidney in patients with
renal disease
9
Unpredictable reactions
Dr.SubhashR.Yende,GNCP,Nagpur
10. Genetically determined toxicity
In case of patients with special genotype or genetic make up,
there is risk of drug toxicity
Example –
Hereditary deficiency of pseudocholinestrase are unable to
metabolize the succinyl-choline and may develop prolonged
paralysis and apnoea following its use
Glucose 6 phosphate dehydrogenase is an enzyme which is
involved in the degradation of glucose. Such patients can
develop hemolytic anemia after use of primaquine, quinidine,
sulfonamide and nitrofurantoin
Isoniazid metabolised in the liver by the enzyme N-acetyl
transferase. In the population, some 1ndividuals are slow
acetylators and some fast acetylators. Slow acetylators of
isoniazide may suffer from peripheral neuropathy. 10
Unpredictable reactions
Dr.SubhashR.Yende,GNCP,Nagpur
11. ADR Reporting and Management
ADR detection:
Adverse effects resulting from excessive
pharmacological activity are well documented.
But unpredictable adverse effects are not identified, until
it has been subjected to much more widespread use.
Collection of Patients data either by-
Patient interview
Reviewing prescriptions containing drugs
Checking for abrupt cessation of any medications
Obtaining previous medical history
11
Dr.SubhashR.Yende,GNCP,Nagpur
12. Data to be collected includes-
Patient’s demographic data; presenting complaints; past
medication history; drug therapy details including
over‐the‐counter drugs, current medications and
medication on admission; and lab data such as
hematological, liver and renal function tests
Details of the suspected adverse drug reaction such as
time of onset and duration of reaction, nature and severity
of reaction;
Details of the suspected drug including dose, frequency,
time of administration, duration of treatment, plasma
concentration of drug;
Previous reports on reported reactions;
12
Dr.SubhashR.Yende,GNCP,Nagpur
13. ADR Reporting:
What to report ?
Serious and or life threatening reactions
Fatal reactions
Reactions resulted in disabilities/ permanent harm
Reactions resulted in increased healthcare costs
Severe reactions of any type
Any reactions to newer drugs
Newer reactions to any drugs in the market
Rare and uncommon adverse reactions
13
Dr.SubhashR.Yende,GNCP,Nagpur
14. Different approaches for ADR reporting are-
1. Cohort study: This study involve short term and long
term clinical trials and post marketing surveillance of
established and new drug.
2. Spontaneous reports of suspected adverse drug
reaction occurs when prescribers report suspected
reaction to investigator agency
3. Review of vital statistics: Regular review of national
and regional vital statistics
4. Case-control studies: patients with suspected drug
induced disease are compared with a reference
population
14
Dr.SubhashR.Yende,GNCP,Nagpur
15. Management of ADR:
Decisions are made by considering
Seriousness / severity of ADR
Seriousness of disease
Benefit / harm assessment
If the reaction is serious -
Withdraw suspected (all?) drugs
Treat urgently
15
Dr.SubhashR.Yende,GNCP,Nagpur
16. If the disease is serious -
Consider the effect of not having treatment
Continue treatment and treat symptoms of reaction if
necessary
Consider an alternative drug
Stop unnecessary drugs
If the reaction is mild –
Continue treatment if necessary
Stop unnecessary drugs
Consider dose reduction
Reassure and do nothing
Symptomatic treatment if warranted
16
Dr.SubhashR.Yende,GNCP,Nagpur