This document discusses adverse drug reactions (ADRs). It begins by defining ADRs according to the WHO as any unintended and noxious response to a drug. It then provides a brief history of notable ADR events. The document goes on to classify ADRs based on factors like onset, type of reaction, and severity. It describes each type of reaction with examples. Finally, it discusses other drug-related concepts like side effects, toxicity, dependence, and teratogenicity.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
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.
Introduction to daily activities of clinical pharmacist.
Drug therapy monitoring,
Medication chart review
Clinical Progress
Pharmacist intervention
Detection and management of ADRs
DRUG INTERACTIONS (MECHANISMS OF DRUG-DRUG INTERACTIONS)N Anusha
A Drug interaction is an interaction between a drug and some other substance, such as another drug or a certain type of food, which leads to interaction that could manifest as an increase or decrease in the effectiveness or an adverse reaction or a totally new side effect that is not seen with either drug alone that can be severe enough to alter the clinical outcome.
Every time a drug is administered with any other prescription medicine, OTC products, herbs or even food we expose ourselves to the risk of a potentially dangerous interaction.
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
Therapeutic Drug Monitoring (TDM) is important tool to identify the drug concentration for their therapeutic range to minimize unwanted effects of particular drugs
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
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.
Introduction to daily activities of clinical pharmacist.
Drug therapy monitoring,
Medication chart review
Clinical Progress
Pharmacist intervention
Detection and management of ADRs
DRUG INTERACTIONS (MECHANISMS OF DRUG-DRUG INTERACTIONS)N Anusha
A Drug interaction is an interaction between a drug and some other substance, such as another drug or a certain type of food, which leads to interaction that could manifest as an increase or decrease in the effectiveness or an adverse reaction or a totally new side effect that is not seen with either drug alone that can be severe enough to alter the clinical outcome.
Every time a drug is administered with any other prescription medicine, OTC products, herbs or even food we expose ourselves to the risk of a potentially dangerous interaction.
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
Therapeutic Drug Monitoring (TDM) is important tool to identify the drug concentration for their therapeutic range to minimize unwanted effects of particular drugs
adverse drug reactions and adrs monitoringRaj Kumar
adverse drug reaction includes ..typeA to type F..very useful to undergraduates..including post graduates..various types of reactions like side effect,toxicity,teratogenecity,allergic reactions..carcinogenicity and mutagenecity
Adverse Drug Reactions (ADR)- Ravinandan A PRavinandan A P
The World Health Organization (WHO) defines an adverse drug reaction (ADR) as “any response to a drug which is noxious (harmful/toxic), unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of a disease, or for the modification of physiological function ".
An adverse drug effect (ADE) is any harmful or unintended response to a medication or drug therapy. These effects can range from mild symptoms, such as nausea or headache, to severe or life-threatening reactions, such as anaphylaxis or organ damage. ADEs can occur due to various reasons, such as allergic reactions, drug interactions, dosage errors, or individual variations in drug metabolism or tolerance. Monitoring and managing ADEs are essential in ensuring the safety and efficacy of drug therapies. Healthcare professionals can take measures to prevent or minimize ADEs, such as proper patient screening, careful medication selection and dosing, and close monitoring of drug effects and side effects. Patients can also play a role in reducing ADEs by following medication instructions, reporting any symptoms or concerns to their healthcare provider, and informing their provider of any other medications or supplements they are taking.An adverse drug reaction (ADR) is a type of adverse drug event (ADE) that involves an unexpected, harmful, or unwanted response to a medication or drug therapy. ADRs can occur at any dose and can range from mild to severe or life-threatening. These reactions may be caused by various factors, such as drug interactions, allergic reactions, dosage errors, or individual variations in drug metabolism or tolerance.
ADR can be classified into two types: type A and type B. Type A ADRs are predictable and occur at a relatively high frequency, such as gastrointestinal upset or drowsiness. Type B ADRs, on the other hand, are less predictable and occur at a low frequency, such as allergic reactions, drug-induced liver injury, or blood disorders.
Monitoring and managing ADRs are crucial in ensuring the safety and efficacy of drug therapies. Healthcare professionals can take measures to prevent or minimize ADRs, such as proper patient screening, careful medication selection and dosing, and close monitoring of drug effects and side effects. Patients can also play a role in reducing ADRs by following medication instructions, reporting any symptoms or concerns to their healthcare provider, and informing their provider of any other medications or supplements they are taking.
Toxicity refers to the degree to which a substance or agent can harm or damage living organisms, such as humans, animals, or plants. It can be caused by various factors, such as chemical composition, dosage, duration of exposure, and individual susceptibility.
Toxicity can be classified into acute or chronic. Acute toxicity occurs when a substance or agent causes harmful effects rapidly after a single exposure or within a short period. Symptoms of acute toxicity may include nausea, vomiting, headache, dizziness, seizures, or coma, depending on the type and dose of the toxic substance.
Chronic toxicity occurs when a substance or agent causes harmful effects after repeated or long-term exposure. Chronic toxicity may lead to gradual or cumulative damage to organs
According to Syllabus of Gujarat Technological University
Pharmacy Practice
Topic :
Classifications of Adverse Drug Reaction
1. Excessive Pharmacological effects
2. Secondary Pharmacological effects
3. Idiosyncrasy
4. Allergic reactions
5. Genetic make up of the patients
6. Sudden drug withdrawal
7. Drug interactions
https://youtu.be/OHwPDeD-xyc
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
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
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
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
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NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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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.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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.
2. Lesson plan
• Definition of terms associated with Adverse Drug
Reactions (ADRs)
• Classification of ADRs
• Discussion on each type of ADR with examples
3. What is ADRs?
WHO Definition
Any response to a drug
which is noxious &
unintended & which occurs
at doses in man for
prophylaxis, diagnosis or
treatmant.
4. History about ADRs
1922 : JAUNDICE associated with the use of SALVARSAN,
an organic arsenical used in the treatment of Syphillis.
In 1937: In USA, 107 people died from taking an ELIXIR
OF SULFANILAMIDE that contained the SOLVENT
DIETHYLENE GLYCOL
Establishment of the FOOD AND DRUG ADMINISTRATION
(FDA), which was given the task of enquiring into the
safety of new drugs before allowing them to be marketed.
.
5. • 1958: Thalidomide markated in
West Germany as a non
barbiturate hypnotic & for morning
sickness during pregnancy
based on animal toxicity report.
1959-61 thalidomide disaster
(4000-100000 case)
• In 1959 - 1961, it was reported in that there was an
outbreak of PHOCOMELIA (hypoplastic and
aplastic limb deformities) in the new born babies.
6. • The THALIDOMIDE INCIDENT led to a public outcry,
to the institution all round the world of DRUG
REGULATORY AUTHORITIES, to the development of
a much more sophisticated approach to the preclinical
testing and clinical evaluation of drugs before marketing,
and to a greatly increased awareness of adverse
effect of drugs and methods of detecting them…
7. Classification of ADRs
• Depending on….
• Onset of event: Acute (<60 minutes), Sub-acute (1-
24 hrs) and Latent (>2 days)
• Type of reaction: (Wills and brown)
Type A (Augmented), B (Bizarre), C (Chronic),
D (Delayed), E (End of treatment)
• Severity: Minor, Moderate, Severe, Lethal ADRs
• Others: Side effects, Secondary effects, Toxic effects,
Intolerance, Idiosyncrasy, Drug allergy, Mutagenicity,
Photosensitivity, Drug Dependence, Drug Withdrawal
Reactions, Teratogenicity, Carcinogenicity, Drug
induced disease (Iatrogenic).
8. Reactions which can be predicted from the
known pharmacology of the drug
Dose dependent
Can be alleviated by a dose reduction
common
Skilled management reduces their incidence.
E.g.
• Anticoagulants Bleeding
• Beta blockers Bradycardia
• Nitrates Headache
• Prazosin Postural hypotension
Type A (Augmented) reactions
9. Type B (Bizarre) reactions
• Predictable where the mechanism is known, otherwise
unpredictable for the individual, although the incidence
may be known.
• Dose independent, rare
• Host dependent factors important in predisposition
• unwanted effects due to inherited abnormalities
(idiosyncrasy) and immunological processes(drug allergy).
• These account for most drug fatalities.
E.g. Penicillin Anaphylaxis,
Anticonvulsant Hypersensitivity
10. • Reactions due to long time exposure.
• e.g. Analgesic neuropathy
Dyskinesia with levodopa
Type C ( Chronic)
11. Type D (Delayed) reactions
• Occur due to prolonged exposure.
• Can be due to accumulation.
E.g.
Carcinogenesis, or short term exposure at
a critical time e.g.teratogenesis.
12. Type E (End of use) reactions
• Occur on withdrawal especially when drug
is stopped abruptly
E.g.
• Phenytoin withdrawal Seizures
• Steroid withdrawal Adrenocortical
insufficiency.
• opioid causing the withdrawal syndrome.
13. Types of ADRs……..
Type Type of
effect
characteristics example
A Augmented Dose dependent
predicted from the
known
pharmacology of the
drug
Hypoglycaemia-
insulin
B Bizarre Unpredictable
Dose independent
Rare,fatal
Anaphylaxis to
penicillin
C Chronic Prolong treatment Analgesic neuropathy
D Delayed After years of
treatment
Antipsycotic –turdive
dyskinesia
E End of use Withdrawal effect GC withdrawal
14. Classification of ADRs :Depending on Severity
• Minor ADRs: No therapy, antidote or prolongation
of hospitalization is required.
• Moderate ADRs: Requires change in drug therapy,
specific treatment or prolongs hospital stay by
atleast 1 day.
• Severe ADRs: Potentially life threatening, causes
permanent damage or requires intensive medical
treatment.
• Lethal: Directly or indirectly contributes to death of
the patient.
15. Side effects
• Unwanted but often unavoidable, occur at
therapeutic doses
• Predicted from the pharmacological profile
of a drug
• Known to occur in a given percentage of
drug recipients
• E.g.
Atropine dryness of mouth
Promethazine (anti-allergic) sedation
Codeine(anti-tussive)constipation Used
in Traveller’s diarrhoea
16. Side effects….(Drug discovery)
• Occasionally, “adverse” effects may be exploited to
develop an entirely new indication for a drug.
• E.g:
• Unwanted hair growth during Minoxidil treatment
of severely hypertensive patients development
of the drug for hair growth.
• Sulfonamides used as antibacterials were found to
produce hypoglycemia and acidosis as side effects
development of Hypoglycemic Sulfonylureas…
17. Untoward effect –
Slight more serious effect than side effect
produced with therapeutic dose.
Seriously unpleasant.
Harmful.
e.g. Superinfection produced by broad
spectrum antibiotic, vomiting by morphine
in postoperative patients, hypokalamia by
thiazide diuretics.
18. »Toxic effects
• Predictable Unpredictable
• Dose dependent Allergy
• Rebound response Idiosyncrasy
• Excess pharmacological Not found in clinical
effect in high dose. trial.
• These are known. Pharmacologist may
Detected by not be able to
pharmacologist detect
this during study
of drug development
19. Predictable toxic effects
Dose dependent adverse effect may be –
Direct damaging effect to tissue e.g.
Paracetamol overdose leads to hepatotoxicity,
Aminoglycoside (Gentamicin) causes
nephrotoxicity.
Rebound response – ( due to R-upregulation)
abrupt withdrawl after chronic use.
e.g.propranolol stoppage leads to precipitation of
MI, Glucocorticoid withdrawal leads to acute
adrenal insufficiency.morphine – due to R
supersensitivity.
20.
21. • Excess pharmacological effect: Result of
excessive pharmacological action of the drug due to
over dosage or prolonged use.
• e.g. Excess insulin-hypoglycemia even death from
hypoglycemic shock
Antihypertensive - hypotension
Anticoagulant-
severe bleeding.
23. Idiosyncrasy –
• unusual response to a drug due to genetic
abnormality.
• Drug interacts with some unique feature of the
individual, not found in majority subjects, and
produces the uncharacteristic reaction.
• E.g.
Isoniazid: N-Acetylation affects the metabolism
of isoniazid
• Slow N-Acetylation: Isoniazid is more likely to
cause peripheral neuritis.
• Fast N-Acetylation:cause hepatotoxicity in this
group.
24. Succinylcholine can produce apnea in people
with abnormal serum cholinesterase. Their
cholinesterase is incapable of degrading the
succinylcholine, thus it builds up and
depolarization blockade results.
Primaquine, Sulfonamides induce acute
hemolytic anemia in patients with Glucose-6-
Phosphate Dehydrogenase deficiency.
--They have an inability to regenerate NADPH in
RBC.G-6-p deficiency is most prevalent in blacks &
Semitics. It is rare in Caucasians & Asians.
25. Drug allergy
– Acquired, altered reaction of the body to
drug.
– Immunologically mediated reaction.
– occur even with much smaller doses
– Also called Drug hypersensitivity
– Not genetic,not occurred in all
– Occurs on reexposure
– E.g. penicillin→1st time →stimulate antibody
→Ag-Ab reaction →allergy
– Chief organ: Skin, respiratory tract,GIT,Blood
& blood vessels
26. Type of reaction Time
before
clinical
sign
Characteristics Example
Anaphylactic
(Immediate IgE-
mediated
anaphylaxis)
< 30 min
IgE binds to must cell or
basophil,causes degranulation of must
cell & basophil& release of reactive subs.
histamine
Penicillin
anaphylaxis
Cytotoxic
(Antibody-
Dependent Cellular
Cytotoxicity
5 –
12 hr
Antigen cause formation of IgG or IgM
antibodies to bind that .
Drug forms an antigenic complex with
the surface of the cell and combination
with antibody activate complement
system causing cell destruction.
Hemolytic anemia:
Penicillin or
Methyldopa
Thrombocytopenia
: Quinidine
SLE:Hydralazine or
Procainamide.
Immune complex
mediated
8-10 antigen antibody form complexes that
causes inflammation
Steven-Johnson
Syn
Serum
Sicknessdrome
Cell mediated
allergy(delayed
type)
24 to
48 hrs
Antigen specific receptors develop on T-
lymphocytes. Subsequent administration
leads to local or tissue allergy.
Contact dermatitis
Rejection of
transplanted tissue
27. Certain tissues which are vulnerable
Hemopoietic system & bone marrow –
Quinine, Rifampicin, Sulfonamide, Thiazide – drug
allergy (type II reaction) – Throimbocytopenia.
Carbamazepine, Sulfonamide, carbimazole,
clozapine (fatalneutropenia) - drug allergy (type II
reaction) – Granulocytopenia.
Chloramphenicol (idiosyncracy) -Aplastic anemia.
Anti cancer, cytotoxic drugs -direct bone marrow
depression
primaquine, quinine, chloroquine, dapsone,
sulfonamide(due to idiosyncracy) Methyldopa used
in pregnancy – Hemolytic anemia.
28. Liver damage/ Hepatic injury –
Chloroform, Halothane, Enflurane – when given
in repeated dose – hepatotoxicity – jaundice
(so, before anesthesia H/O jaundice taken).
Chlorpromazine, Flucloxacillin, OCP –(type II)
cholestatic jaundice( causes edematous bile
canaliculi-stasis of bile)
INH, Rifampicin, Methyldopa – hepatocellular
necrosis – jaundice (cause is unknown).
Methotrexate, Alcohol – cirrhosis of liver.
Paracetamol overdose (8 – 10 gm of
paracetamol in 10 – 24 hours if taken) – toxic
metabolite (Epoxide) – Hepatocellular necrosis.
Minocycline (newer tetracycline) – Chronic
Active Hepatitis.
29. Renal damage –
Phenylbutazone, Sulfonamide, Hydralazine –
damage to glomerular membrane –
Glomerulonephritis.
Aminoglycoside (Gentamicin), Amphotericin
(antifungal), High dose paracetamol,
Cefalothin –Acute tubular necrosis.
NSAID, Lithium, Penicillamine – long term
use in rheumatoid arthritis – Acute interstitial
nephritis.
ACEI – Renal vascular damage.
30. Intolerance
• Appearance of characteristic toxic effects of a
drug in an individual at therapeutic doses
• Converse of tolerance
• Indicates a low threshold of the individual
• E.g.
• Triflupromazine (single dose) Muscular
dystonias in some individuals
• Carbamazepine (few doses) Ataxia in some
individuals
• Chloroquine (single tablet) Vomiting and
abdominal pain in some individuals
31. Tolerance –
↓ pharmacological effect on repeated
administration of the drug.
Pharmacokinetic Tolerance: ↑ the
enzymes responsible for metabolizing the
drug.
e.g.Phenobarbitone induces metabolism of its
own by increasing its own metabolic enzyme.
Pharmacodynamic Tolerance: Cellular
tolerance, due to down-regulation of
receptors.
Depletion of stores e.g.Amphetamine
32. Tachyphylaxis:
When responsiveness diminishes rapidly after
administration of a drug, the response is said
to be subject to tachyphylaxis.
Tyramine can cause depletion of all NE
stores if you use it long enough, resulting in
tachyphylaxis.
33. Photosensitivity
• Cutaneous reaction resulting from drug induced sensitization
of the skin to UV radiation. The reactions are of two types
• Phototoxic: Drug or its metabolite accumulates in the skin,
absorbs light and undergoes a photochemical reaction
resulting in local tissue damage (sunburn-like, i.e.,
erythema, edema, blistering, hyper pigmentation)
E.g. Tetracyclines (esp. Demeclocycline), and Tar
products, Nalidixic acid, Fluoroquinolones, Sulfones etc
• Photoallergic: Drug or its metabolite induces a cell
mediated immune response which on exposure to light
(longer wave length) produces a papular or eczematous
contact dermatitis like picture.
E.g. Sulfonamides, Sulfonylureas, Griseofulvin,
Chloroquine, Chlorpromazine
34. Drug dependence
• Drugs capable of altering mood and feelings are liable
to repetitive use to derive euphoria, withdrawal from
reality, social adjustment, etc.
• Psychological dependence: Individual believes that
optimal state of well being is achieved only through
the actions of the drug.
• E.g. Opioids, Cocaine.
• Physical dependence: Altered physiological state
produced by repeated administration of a drug which
necessitates the continued presence of the drug to
maintain physiological equilibrium. Discontinuation of
the drug results in a characteristic withdrawal
(abstinence) syndrome.
• E.g. Opioids, Barbiturates, Alcohol, Benzodiazepines
35. Drug dependence….
• Drug abuse: Use of a drug by self medication in a
manner and amount, that deviates from the approved
medical and social patterns in a given culture at a given
time.
Drug abuse refers to any use of an illicit drug.
• Drug addiction: Compulsive drug use characterized by
overwhelming involvement with the use of a drug.
• Drug habituation: Less intensive involvement with the
drug, withdrawal produces only mild discomfort.
• Habituation and addiction imply different degrees of
psychological dependence.
36. Mutagenecity and Carcinogenicity
• Capacity of a drug to cause genetic defects and
cancer respectively.
• Chemical carcinogenesis generally takes several
(10-40) years to develop.
• Unpredictable
e.g.
Estrogen- Endometrial carcinoma.
OCP- Ca cervix, breast Ca
Iron S/C or I/M – blackening of area –
increase incidence of sarcoma (cause is
unknown).
Anticancer drug.
38. Teratogenicity
• Capacity of a drug to cause foetal abnormalities when
administered to the pregnant mother.
• Drugs can affect the foetus at 3 stages:
1. Fertilization and implantation (Conception to 17
days): failure of pregnancy which often goes
unnoticed.
2. Organogenesis(18 days to 55 days): most
vulnerable period, deformities are produced.
3. Growth and development (> 56 days):
developmental and functional abnormalities can
occur. E.g:
• Thalidomide Phocomelia, multiple defects
• Anticancer drugs Cleft palate, hydrocephalus,
multiple defects
41. Cont’d
Trimethoprim – cleft palate.
Phenytoin, carbamazepine, valproate -
Malformation of fingers,cleft palate,neural tube
defect(spina bifida)
Diethylstilbestrol - Oral contraceptive is no longer
used because it causes reproductive cancers in
daughters born to mothers taking the drug.
Androgen- virulization of female fetus
Aminoglycosides, Chloroquine – Deafness.
42. Teratogens in first trimester
• Phenytoin, carbamazepine, valproate - neura tube
defects (spina bifida)
• lithium – cardiac malformations
• Warfarin - bone deformation, chondrodysplasy,
CNS defects
• Heparin (demineralization of bone in mother –
switch to LMW)
• Retinoids-def. CNS, heart, limbs, liver
• oncologic drugs (fluorouracil, metotrexate,
cyclofosfamid, busulfan)
43. Drugs cannot be given in last trimester
• Antithyroid drugs: Hypothyroidism in
neonates
• Streptomycin - Ototoxicity
• Morphine: Respiratory depression
• Chloroquine: Retinopathy of fetus
• Aspirin: delay labour pain.
44. Individual variation in response to drug
Variation due to age, sex, body weight, surface
area, nutrition, alcoholic, cigarette smoking,
pregnancy, genetic factor, environment, and
pathological condition.
4 general mechanism:
A) Alteration in concentration of drug that
reaches the receptors –
rate of absorption of a drug
distributing it through body compartments
clearing the drug from the blood.
45. B) Variation in concentration of an
endogenous receptor ligand –
variability in responses to pharmacological
antagonist.
propranolol will markedly slow the HR of a
patient whose endogenous catecholamine are
elevated (as in pheochromocytoma), but will not
affect the resting HR of a well trained marathon
runner.
C) Alteration in number or function of
receptor – ↑ or ↓ in number or alteration in
efficiency of coupling of receptor to distal
effector mechanism – change in responsiveness.
46. e.g.Thyroid hormone increase number of β
receptor in heart and increase sensitivity of
cardiac muscle to catecholamine – tachycardia
of thyrotoxicosis.
D) Changes in components of response
distal to the receptor – Response depend
on the functional integrity of biochemical
process in the responding cell and
physiological regulation by interacting organ
system.
47. Cont’d…
Medicines are supposed to save lives
Dying from a disease is sometimes unavoidable;
dying from a medicine is unacceptable. Lepakhin
V. Geneva 2005
49. Cont’d…
ADRs are expensive !!
Cost of ADRs in the US:
Cost of drug related morbidity and mortality
exceeded $177.4 billion in 2000 (Ernst FR & Grizzle
AJ, 2001: J American Pharm. Assoc)
ADR related cost to the country exceeds the cost
of the medications themselves.
50. Cont’d…
Ethics:
To know of something that is harmful to another
person who does not know, and not telling, is unethical.
No medicine is risk free,
Vigilant assessment of the
risks and benefits of medicine
promote safety.
51. Aims of knowing ADRs
To improve patient care and safety
To improve public health and safety
To contribute to the assessment of benefit,
harm, effectiveness and risk of medicine.
52. Adverse drug reactions[ADRs] monitoring
Monitoring centre:
- WHO collaborating centre for international
drug monitoring , Uppsala Monitoring Centre,
Sweden.
- Established in1968.
In Bangladesh:
- Directorate General of Drug Administration.
105-106, Motijheel Commercial Area, Dhaka-1000,
Bangladesh.
54. ADRs reporting:
Who to report:
- All health care professionals.
What to report:
-Apparent ADRs previously
unknown to the reporters
-Serious ADRs
-All suspected ADRs to new drugs
Cases of suspected dependence
55. Cont’d…
How to report:
- ADRs form
- Assessment tool: Naranjo
scale
Where to report:
- National body (Directorate
General of Drug Administration.
105-106, Motijheel Commercial
Area Dhaka-1000, Bangladesh