The document discusses adverse drug reactions (ADRs), including definitions, types, monitoring and reporting. It defines an ADR as an unwanted effect of a medication that is harmful and unintended. ADRs are classified into types A-G based on mechanism and timing. Type A reactions are augmented pharmacological effects, type B are bizarre reactions unrelated to a drug's known effects, type C occur with long-term use, and type D have delayed onset. Pharmacovigilance aims to detect, assess and prevent ADRs through monitoring and signal generation. However, ADR reporting is still limited in India due to lack of awareness and appreciation of pharmacists' role in reporting. Improving education and infrastructure could help strengthen pharmac
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
complete description of causality assessment with the definition of basic terminologies.& relation with an adverse event and adverse drug reaction, causality terms & assessment criteria.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
complete description of causality assessment with the definition of basic terminologies.& relation with an adverse event and adverse drug reaction, causality terms & assessment criteria.
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.
History and Progress of Pharmacovigilance, Significance of Safety Monitoring, Pharmacovigilance in India And International Aspects, WHO International Drug Monitoring Programme, WHO and Regulatory Terminologies of ADR, Evaluation of Medication Safety, Establishing Pharmacovigilance Centres in Hospitals, Industry and National Programmes Related to Pharmacovigilance, Roles and Responsibilities in Pharmacovigilance, International Non-Proprietary Names for Drugs, International Classification of Diseases, Passive and Active Surveillance, Comparative Observational Studies, Targeted Clinical Investigations and Vaccine Safety Surveillance, Aris G Pharmacovigilance, VigiFlow, Statistical Methods for Evaluating Medication Safety Data
A concise overview of pharmacoeconomics, health economics, various costs, various pharmacoeconomic study designs and its application in the field of medicine and drug development
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology. I highlight some bioinformatic roles in the drug discovery process, and discuss the use of semantic web technologies for data integration and knowledge discovery..
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.
History and Progress of Pharmacovigilance, Significance of Safety Monitoring, Pharmacovigilance in India And International Aspects, WHO International Drug Monitoring Programme, WHO and Regulatory Terminologies of ADR, Evaluation of Medication Safety, Establishing Pharmacovigilance Centres in Hospitals, Industry and National Programmes Related to Pharmacovigilance, Roles and Responsibilities in Pharmacovigilance, International Non-Proprietary Names for Drugs, International Classification of Diseases, Passive and Active Surveillance, Comparative Observational Studies, Targeted Clinical Investigations and Vaccine Safety Surveillance, Aris G Pharmacovigilance, VigiFlow, Statistical Methods for Evaluating Medication Safety Data
A concise overview of pharmacoeconomics, health economics, various costs, various pharmacoeconomic study designs and its application in the field of medicine and drug development
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology. I highlight some bioinformatic roles in the drug discovery process, and discuss the use of semantic web technologies for data integration and knowledge discovery..
Polypharmacy and Rational Prescribing in Elderly Patients.pptxAhmed Mshari
Polypharmacy is typically defined as the prescription of five or more medications.
It also refers to the prescription of medications that do not have a specific current indication, that duplicate other medications, or that are known to be ineffective for the condition being treated.
In other words, polypharmacy is the use of multiple medications that are unnecessary and have the potential to do more harm than good.
POINTS TO BE INCLUDED
Definition, scope,
Technical definitions, common terminologies used in clinical
settings
Daily activities of clinical pharmacists
Ward round participation
Treatment Chart Review
Adverse drug reaction monitoring
Interprofessional collaboration
PHARMACOVIGILANCE TERMINOLOGIES ASKED IN INTERVIEWS-
For more information regarding PHARMACOVIGILANCE, CLINICAL RESEARCH, CLINICAL DATA MANAGEMENT & DRUG REGULATORY AFFAIRS kindly contact us on 9028839789
Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines.
Similar to Adverse Drug Reactions - Basics and Classification (20)
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
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
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
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
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
3. INTRODUCTION
ADVERSE REACTION:
“ One which is noxious and unintended, and
which occurs at doses normally used in
man for the prophylaxis, diagnosis, or
therapy of disease, or for the modification
of physiological function ”of physiological function ”
The terms “adverse reaction” and “adverse
effect” are interchangeable, except that an
adverse effect is seen from the point of
view of the drug, whereas an adverse
reaction is seen from the point of view of
the patient.
4. The term “adverse effect” encompasses all
unwanted effects; it makes no
assumptions about mechanism, evokes no
ambiguity, and avoids the risk of
misclassification.
The term “adverse effect” is preferable to
other terms such as “toxic effect” or
“side effect”.“side effect”.
6. ADVERSE DRUG EVENT (AE)
Any occurrence or worsening of an
undesirable or unintended sign, symptom
(including an abnormal laboratory
finding), or disease temporally associatedfinding), or disease temporally associated
with the use of a medicinal
product/procedure.
which does not necessarily have a causal
relationship with this treatment
7. • Following scale will be used to estimate
Adverse drug Event grade:
• Grade 1, Mild: Transient or mild
discomfort; no limitation in activity; no
medical intervention/therapy required
• Grade 2, Moderate: Mild to moderate
limitation in activity –some assistance
may be needed; no or minimal medical
intervention/therapy required
8. • Grade 3, Severe: Marked limitation in
activity, some assistance usually
required; medical intervention/therapy
required and hospitalization possible
• Grade 4, Life-Threatening: Extreme
limitation in activity, significant
assistance required; significant medical
intervention/therapy required;
hospitalization or hospice care
9. SIGNAL
• Reported information on a possible causal
relation between an adverse event and a drug,
the relation being previously unknown or
incompletely documented.incompletely documented.
Usually more than a single report is required to
generate a signal,depending on the seriousness
of the event and the quality of the information.
10. PHARMACOVIGILANCE
• Pharmacovigilance (PV) is defined as
the science and activities relating to
the detection, assessment,the detection, assessment,
understanding and prevention of
adverse effects or any other drug-
related problem.
11. HAEMOVIGILANCE
• Monitoring, identification, reporting,
investigation and analysis of adverse events
near-misses and reactions related to blood
transfusion.transfusion.
• Adverse events following immunization (AEFI)
12. PHARMACOVIGILANCE-BENEFITS
Pharmacovigilance plays an important role
in the rational use of medicines by
providing information about ADRs in the
general population.
Knowledge of the adverse effects of drugs Knowledge of the adverse effects of drugs
is important for effective treatment.
Communicating the potential harm of drug-
use to patients is a matter of high priority
and should be carried out by every
prescriber.
14. • Drug use in special situations not studied
in clinical trials (Renal and hepatic failure
patients).
Need of ADR Monitoring
• Most trials assess relatively healthy
patients with only one disease and mostly
exclude specific groups such as pregnant
women, children, and elderly people.
15. • As most drugs are developed in the West,
most of the efficacy data are based on the
Caucasians, with little or no information
available on the Asians.
• Drug interactions may not be studied in• Drug interactions may not be studied in
clinical trials. There is no data on ADRs
that may occur due to the interaction
between the established medicines and
traditional, herbal medicines and vaccines
used locally.
16. Prevalence of ADR
The median proportions of Prevalence of ADR-
related hospitalization in developed and
developing countries was 6.3 % (3.3–11.0) and
5.5 % (1.1–16.9), respectively.
The median proportions of preventable ADRs in The median proportions of preventable ADRs in
developed and developing countries were 71.7 %
(62.3–80.0) and 59.6 % (51.5–79.6), respectively.
Similarly, the median proportions of ADRs
resulting in mortality in developed and
developing countries were 1.7 % (0.7–4.8) and
1.8 % (0.8–8.0), respectively.
18. 27 studies on antipsychotics causing diabetes or other metabolic problems
26 studies on antipsychotics causing heart problems
23 studies on antipsychotics causing weight gain or obesity
22 studies on antipsychotics causing death
8 studies on antipsychotics causing stroke
8 studies on antipsychotics causing involuntary movements
5 studies on antipsychotics causing brain shrinkage and/or structural changes
4 studies on antipsychotics causing cognitive decline or impairment
ANTIPSYCHOTIC DRUG STUDIES:
There are 160 studies from 25 countries
4 studies on antipsychotics causing cognitive decline or impairment
3 studies on antipsychotics causing Parkinson’s Disease
3 studies on antipsychotics having lack of efficacy
3 studies on antipsychotics causing lowered bone mass
3 studies on antipsychotics causing sexual dysfunction
2 studies on antipsychotics causing birth defects
1 study on antipsychotics causing violence and homicidal ideation
1 study on antipsychotics causing psychosis
1 study on antipsychotics causing tumors
1 study on antipsychotics causing coma
19. • 41,000 hospitalizations per year for NSAID-
induced ulcers.
• 16,000 car crashes per year from anti-
psychotics.
Some examples of studies pointing out the results of
adverse drug events
psychotics.
• 32,000 hip fractures per year leading to 1,500
deaths.
• Drug-induced Parkinson’s has developed in
63,000 patients.
20. • 21.3% of the 548 most recently FDA
approved medications were subsequently
withdrawn from the market or given a black
box warning.
• In the recent reports, 51% of new drugs
have serious, undetected adverse effects athave serious, undetected adverse effects at
the time of approval.
• Of the best selling prescription drugs, 148
can cause depression, 133 hallucinations or
psychoses, 105 constipation, 76 dementia,
27 insomnia and 36 parkinsonism.
27. TYPE OF ADVERSE REACTIONS
♠ Type A (Augmented)
♠ Type B (Bizarre)
♠ Type C (Chronic)
♠ Type D (Delayed)
♠ Type E (End of use)
♠ Type F (Therapeutic failure)
♠ Type G (Genetic/genomic)
28. CAN YOU DEFINE THE
VARIATIONS BETWEEN THIS
TYPES OF ADRs?....
29. 11) Type A ADRs) Type A ADRs
Type A (augmented) ADRs are expected
but exaggerated pharmacological or toxic
responses to a drug.
This may be an exaggeration of the This may be an exaggeration of the
intended response to the drug, a
secondary response affecting an organ
other than the target organ but
predictable based on the pharmacology of
the drug, or a toxic response.
30. TypeType AA ADRsADRs contdcontd……......
Most ADRs of this type is due to higher
plasma free drug concentrations
They are usually dose dependent and
avoidable if sufficient drug and patient
information is available.
33. Type A reactions (classes)Type A reactions (classes)
An adverse drug reaction caused by excessive
dosing
I) Toxicity of Overdose (Drug Overdose) :
e.g., Hepatic failure with dose of
paracetamol
Headache with antihypertensives
Hypoglycemia with sulfonylurea;
34. The causes of these types of abnormalities
can be categorized as pharmaceutical,
pharmacokinetic or pharmacodynamic.
35. PharmaceuticalPharmaceutical (dosage(dosage formulationformulation -- related)related):: These
problems cause increased availability of the drug at
the site of delivery due to:
Increased drug quantity - Noncompliance with
pharmacopoeia requirements (BP or USP) during drug
manufacture might increase the amount of activemanufacture might increase the amount of active
agent in the dosage formulation,
Enhanced drug release—Improper formulation can
result in sudden or enhanced release of irritant agents
(eg, potassium chloride and indomethacin) from the
dosage formulation.
36. PharmacokineticPharmacokinetic::
This comprises quantitative alterations in
pharmacokinetic parameters resulting in
abnormally high concentrations of the drug at the
site of action with consequent enhancement of
biological effects. These parameters include ADME.
This is exemplified by the individual variation in
rates of microsomal oxidation due to genetic(eg,
debrisoquine hydroxylation), biological(eg, age and
disease state), or environmental (eg, dietary,
pollutants, alcohol & other interacting drugs)
factors.
37. PharmacodynamicPharmacodynamic::
The organ or tissue responsiveness to toxic actions
might be elevated in some patients leading to ADRs.
This increased sensitivity might reflect:
♠ Enhanced activity or increased number of drug
receptors,
♠ Imbalances of individual homeostatic mechanisms,
for example, the development of severe tachycardia
in some individuals after atropine injection,
♠ Disease states such as the development of
obstructive airway disease precipitated by
propranolol in asthmatic patients.
38. II) Side Effects
Nearly unavoidable secondary drug effect
produced by therapeutic doses
intensity is dose dependent intensity is dose dependent
Occur immediately after initially taking drug or
may not appear until weeks after initiation of
drug use
E.g., sedation with antihistamines
39. III) Drug Interactions
When two drugs taken together & they effect
each other’s response alter
pharmacologically or kinetically
E.g., one drug slow metabolism of 2nd drug
plasma drug conc. toxicity
Theophylline toxicity in presence of
erythromycin
40. 2) Type B reactions or2) Type B reactions or BizzareBizzare
• Type B reactions or Bizzare
– refers to totally abnormal effects,
unrelated from the drug’s known
pharmacological actions.
41. CHARACTERISTICS OF BIZZARE
REACTION
♦ illness is often recognizable as an
immunological reaction.
♦ undetectable during conventional testing.
♦ little or no relation to the usual
pharmacological effects of the drug.
♦ delay between first exposure to the drug
and the occurrence of the subsequent
adverse reaction.
42. Type B Reactions (classes)
I) Hypersensitivity (immunological reaction)
HYPERSENSITIVITY REACTION
I) Hypersensitivity (immunological reaction)
Immune mediated response to a drug agent
in sensitized patient
e.g., anaphylaxis with penicillin
43. Mechanism and types of allergic reactions
A. Humoral
Type-I (anaphylactic) reactions
Reaginic antibodies (IgE) are produced which get
fixed to the mast cells.
Hypersensitivity - I
On exposure to the drug, AG: AB reaction takes
place on the mast cell surface releasing mediators
like histamine, 5-HT, leukotrienes (especially LT-
C4 and D4) prostaglandins, PAF, etc. resulting in
urticaria, itching, angioedema, bronchospasm,
rhinitis or anaphylactic shock.
44. Hypersensitivity -
Mast Cell
Degranulation
Anaphylaxis is usually heralded by paresthesia,
flushing, swelling of lips, generalized itching,
wheezing, palpitation followed by syncope. The
manifestations occur quickly after challenge and
are called immediate hypersensitivity.
Hypersensitivity -
Gell & Coombs Type I
Degranulation
45. Type-II (cytolytic) reactions
Drug + component of a specific tissue cell act as
AG.
The resulting antibodies (IgG, IgM) bind to the
Hypersensitivity - II
target cells; on reexposure AG: AB reaction takes
place on the surface of these cells, complement
is activated and cytolysis occurs, e.g.
thrombocytopenia, agranulocytosis, aplastic
anaemia, haemolysis, organ damage (liver,
kidney, muscle), systemic lupus erythematosus.
46. Hypersensitivity -
Gell & Coombs Type II
NK Cell
Phagocyte
Complement
Removed by
Reticuloendothelial
System
47. Hypersensitivity - III
Type-III (retarded, Arthus) reactions
These are mediated by circulating antibodies
(predominantly IgG, mopping AB). AG: AB complexes
bind complement and precipitate on vascular
endothelium giving rise to a destructiveendothelium giving rise to a destructive
inflammatory response. Manifestations are rashes,
serum sickness (fever, arthralgia, lymph
adenopathy), polyarteritis nodosa, Steven Johnson
syndrome (erythema multiforme, arthritis,
nephritis, mental symptoms). The reaction usually
subsides in 1–2 weeks.
48. Hypersensitivity - IV
B. Cell mediated
Type-IV (delayed hypersensitivity) reactions
These are mediated through production of
sensitized T-lymphocytes carrying receptors for
the AG. On contact with the AG these T cellsthe AG. On contact with the AG these T cells
produce lymphokines which attract granulocytes
and generate an inflammatory response, e.g.
contact dermatitis, some rashes, fever,
photosensitization. The reaction generally takes
> 12 hours to develop.
49. IDIOSYNCRATIC REACTIONS
• An uncommon & abnormal response to drug
• Usually due to genetic abnormality
• Affect drug metabolism & receptor
sensitivity
• Harmful even fatal, appear in low doses
E.g., Anemia (hemolysis) by antioxidant drugs
(G6PD deficiency)
Paralysis due to succinylcholine
(enzyme deficiency)
51. 3) Type C (chronic) Reactions3) Type C (chronic) Reactions
Associated with long-term drug
therapy
Well known and can be anticipated
E.g. opoids, alcohol, barbiturates
52. 4) Type D (delayed) Reactions4) Type D (delayed) Reactions
♦ Carcinogenic & teratogenic effects
♦ Delayed in onset
♦ Very rare
Carcinogenic EffectCarcinogenic Effect
Medication lead to cancer; take >20 y to
develop
Teratogenic Effect
Drug- induced birth defects
53. CURRENT STATUS OFCURRENT STATUS OF
PHARMACOVIGILANCE IN INDIAPHARMACOVIGILANCE IN INDIA
♠ Pharmacovigilance is an integral part of drug therapy.
♠ Still, it is not widely practiced in Indian hospitals. In
various studies, adverse drug reactions have beenvarious studies, adverse drug reactions have been
implicated as a leading cause of considerable
morbidity and mortality
♠ Currently the role of the pharmacist in the reporting
of ADRs is not appreciated everywhere.