This document provides information on adverse drug reactions (ADRs), including:
1. It defines ADRs and differentiates them from adverse drug events, and outlines some common causes of events that are excluded from being considered ADRs.
2. It describes various types and classifications of ADRs, including by intensity/severity, outcome, mechanism of production, and pharmacoepidemiological criteria.
3. It discusses methods of pharmacovigilance for detecting ADRs and standards for determining the imputability or likelihood that a reaction was caused by a drug.
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
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
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
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
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How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
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http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
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Palestine last event orientationfvgnh .pptxRaedMohamed3
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4. Any response to a drug which is noxious and unintended, and which occurs at
doses normally used in man, for: prophylaxis, diagnosis, or therapy of disease,
or for the modification of physiological functions.
ADVERSE DRUGS REACTIONS (ADRs)
EXCLUDING……….
Therapeutic failures
Intentional and accidental overdose
Drug abuse
Errors in drug administration
Taken of: International Drug Monitoring Programme, September, 1991.
http://www.who-umc.org/umc.html
5. RELATIVE OVERDOSE:
Administered drugs to habitual dose, but due, to
characteristic special pharmacokinetics, their systemic
circulating concentrations are higher.
Eg: Patient with renal failure, they have bigger incidence
of deafness, when they are treated with antimicrobials
aminoglycosides. Eg: Streptomycin. There is necessary
and dose adjustment or change the therapy.
6. SECONDARY EFFECT:
Undesirable effect, that It is not due to the main pharmacological
action mechanism, but, It is consequence of the looked for effect.
Ex: bacteriostatic action of the Tetracycline, Ciprofloxacin, or
Chloramphenicol, can alter the intestinal bacterial flora, the square
of Disbacteriosis it would be the secondary action
7. All Drugs are Dangerous No Drugs are Dangerous
if used properly
How dangerous a drug is, depends on the skill
of the prescriber
Some drugs have a low
therapeutic ratio
Some drugs have a low
incidence of horrendous effects
Some adverse effects can be
predicted if you know the
pharmacology (Type A); some
are not predicted (Type B)
Some adverse effects
occur after a delay or after
stopping
BAD
GOOD
ASPECTS TO KEEP IN MIND
8. CLASIFICATION OF ADRs ACORDING TO THEIR
INTENSIVITY OR SEVERITY
MILD : They don't put in risk the patient's life and they are passable
MODERATE: They put in risk the patient's life and the patient needs to
be treated or to suspend the treatment
SERIOUS: They put in risk the patient's life and he/she needs to be
hospitalized, and usually they leaves sequels.
LETAL OR MORTAL: They cause the death
9. CLASIFICATION OF ADRs ACORDING TO
OUTCOME
RECOVERY WITHOUT SEQUELE
RECOVERY WITH SEQUELE
NO RECOVERY
DEATH
10. CLASSIFICATION OF THE ADRs, ACCORDING TO MECHANISM OF
PRODUCTION
1. COLATERAL EFFECT
2. PARADOXICAL EFFECT
3. TOXIC EFFECT
4. HYPERSENSITIVITY
5. IDIOSYNCRASY
6. EFFECT TERATOGENICO
7. PHENOMENON OF IT BOUNCES
8. TOLERANCE
9. TAQUIFILAXIA
10. DEPENDENCE
11. RESISTANCE OR DRUG IMMUNITY.
12. INTOLERANCE OR HIPERSUCEPTIBILITY
13. HERXHEIMER REACTION
14. VIRAL DRUG-INFECTION INTERACTION
INDEPENDIENT STUDY: Bibliography: Pharmacology General textbook
11. 1 - HYPERSENSITIVITY OR ALLERGIC REACTION:
It is the appearance of an unusual answer after the administration of a medication after the
patient has contacted normal concentrations of this in a more previous occasions
(contact sensitizing and trigger).
It has an immunologic base (Reaction antigen - antibody)
Example: (Fever, angioneurotic edems, Rash, shock anaphylactic). (Penicillins,
Sulphonamides, Aspirin , etc.)
Study Independent:
Types of hypersensitivity reactions :1- Anaphylactic or immediate, 2- cytotoxic, 3- by
immune complex formation and 4- Dilayed ) and examples. General pharmacology
textbook
12. 2 - IDIOSYNCRASY.
Atypical answer to a drug, used in appropriate dose, very tolerated for most of
those that receive it. It happens when the medication is administered for the
first time.
It is genetically certain and very related with enzymatic deficiencies.
Example: Hemolytic crisis for oxidant drugs, in patient with deficit of G-6-P -
Dehydrogenase . EX: Primaquine, ASA, Chloramphenicol, etc.
13. 3 - COLLATERAL EFFECT (DIFFERENT FROM
SECONDARY ACTION)
It depends on the mechanism of action of the
medication, It almost always appears when it is
administered and the intensity is dependent of the dose,
in general they are not dangerous for the patient's life.
Example: Nitroglycerine: Intense migraine for effect
vasodilator on the arteries meninges.
14. 4 - TOXIC EFFECT OR ON RELATIVE DOSE.
It can appear in all the fellows if the dose is sufficiently high, for direct toxic
effect of the drug or its metabolites. It depends on the dosage, time of exhibition,
of certain pathological states and of the sick person's susceptibility, and the
possibility exists of committing the patient's life.
Example: Ototoxicity and nephrotoxicity for aminoglycosides (Amikacin,
kanamycin, Streptomycin).
15. 5 - Paradoxical effect.
It is an opposed effect to the prospective or habitual that
clinically is same or resemblance to the pathological square for
which the own medication was used.
Example: Bronchodilator in aerosol (Salbutamol), can cause
bronchospasm.
16. 6 - TERATOGENIC EFFECT.
They are the malformations or anomalies of anatomical or functional character
caused in the fetus by the administration of medications to the mother during the
gestation.
Independent study:
Categories of drug risk during the pregnancy according to the FDA.
(A,B,C,D,E and X)
General pharmacology tesbook
17. 7 – PHENOMENON BOUNCE OR WITHDRAWAL SYNDROME.
It happens for the abrupt suppression of the medication, and it shows a quick
investment and notable of the effect therapeutic initial.
Example: Cimetidine appears multiple peptic ulcers and bleeding., B- blockers
(Hypertension), Steroids (allergic crisis)
8 - TOLERANCE.
Gradual decrease of the answer to a drug when one administers during a lingering time.
Example: Diazepam
18. 9 - TAQUIFILAXIA.
It is the quick decrease of the answer to a drug, when it is administers repeatedly. It is a
short term tolerance.
Example: Ephedrine like bronchodilator.
10-DRUG DEPENDENCE: The patient can not stop the consumption of drug
Independent work. Dependence the nicotine, alcohol, cannabis (marijuana) cocaine and
others drugs.
11- RESISTANCE.
Total loss, of the primary therapeutic answer, the very high doses are even tolerated
without toxicity manifestations. It can be congenital or acquired.
Example: The Cytostatic, Morphine
19. 12-INTOLERANCE.
Very exaggerated undesirable answer that happens with very small dose of the drug. It has genetic origin.
Example: Intolerance to the iodine.
13 - REACTION OF HERXHEIMER.
When using antimicrobial that cause the death of great quantity of microorganism, these microorganism can
liberate toxins that cause toxic effects.
Example: Treatment of the Typhoid fever with Chloramphenicol.
14 - REACTION CAUSED BY THE INTERACTION VIRAL DRUG-INFECTION.
Example: Syndrome of Reye (Encephalopathy with serious Hepatotoxicity). Children with infections for virus
chicken pox zoster or influenza type B, tried with acetylsalicylic acid.
20. A B C
D E F
CLASSIFICATION OF THE ADVERSE DRUG REACTIONS ACCORDING TO
PHARMACOEPIDEMIOLOGICAL CRITERIA OF RAWLINS AND THOMPSON
On this classification are grouped the previous
classifications
INDEPENDIENT STUDY:
GENERAL PHARMACOLOGY TEXTBOOK. CLASSIFICATION OF THE ADVERSE DRUG
REACTIONS ACCORDING TO PHARMACOEPIDEMIOLOGICAL CRITERIA
21. (Augmented/predictable) reactions
- They are originates for exaggeration of the drug effect
- They are predictable, or at least, expected.
- Their intensity depends on the administered dose.
- Their treatment requires dose adjustment.
- It can be due to the pharmaceutical form of the medication, drug interaction, or other pathologys
asociate.
- They depend the mechanism of action of the medication
TYPE A:
22. Examples of Type A
• Collateral effects: (e.g sedation with antihistamines)
• Secondary effects: (e.g. development of diarrhea With antibiotic therapy
due to altered gastrointestinal bacterial flora) Ciprofloxacin in high dose
• Drug interaction: (e.g. Theophylline toxicity in the presence of
Erythromycin therapy. By Methabolical Inhibition )
23. Factors predisposing to pharmacological adverse drug reactions
Factor Example Toxicity Mechanism
Pharmaceutical Osmosin Gastrointestinal Release of high
(slow release bleeding concentrations of
indomethacin) active drug locally
in GI
Pharmacokinetic* Digoxin Digoxin toxicity Decreased elimination
(nausea, arrhythmias) if renal function is
impaired
Pharmacodynamic Indomethacin Left ventricular Water and sodium
failure retention
Drug-drug TerfenadineTM Prolonged QT Inhibition of
interaction* Erythromycin interval and metabolism of
torsades de terfenadine by
pointes erythromycin
*Can affect absorption, distribution, metabolism, or excretion.
24. Ways to minimize both pharmacokinetically- and
pharmacodynamically-derived ADRs include
Understanding the pharmacology of the drug being prescribed
Monitoring drugs with a narrow therapeutic window
Avoiding polypharmacy whenever possible
25. Type B (bizarre/unpredictable) reactions
• Cannot be predicted from the pharmacology of the drug
• Type B reactions include idiosyncratic reactions, Hypersensitivity
immunologic or allergic reactions (e.g.anaphylaxis by Penicillins),
• While uncommon, are often among the most serious and potentially life-
threatening of all ADRs, and are a major cause of important drug-induced
disease.
• Not dose dependent, host dependent factors important in genetical
pre-disposition
26. Type B (bizarre/unpredictable) reactions
Reactions Example
Intolerance tinnitus with use of Aspirin)
Hypersensitivity Immunological reaction (e.g.
Anaphylaxis with penicillin
administration.
Pseudoallergic (Non-Immunological) reaction ( radio
contrast dye reaction).
Idiosyncratic reaction (e.g. development of haemolytic
anemia with the use of anti-malarial
drugs in the presence of glucose-6
phosphate dehydrogenase deficiency).
28. Variable A B
Dose Dependent Dose Independent
Nature or adnormality quantitative qualitative
Predictable yes No
Liver or renal
dysfunction
Increase the Toxicity,
depending of the revoval way
No affected
Prevention Dose Adjustment To avoid the use
Treatment lower Dosis Discontinue the
administration
Mortality Usually low Usually high
29. Type “C” (chronic) reactions
These reactions are associated with long-term drug therapy
e.g. Benzodiazepine – tolerance and dependence
Paracetamol- hepatotoxicity.
Aspirin - nephropathy .
They are well known and can be anticipated.
Type “D” (Delayed) reactions
These reactions refer to carcinogenic and teratogenic effects. These reactions are
delayed in onset and are very rare since extensive mutagenicity and carcinogenicity
studies are done before drug is licensed.
E.g. Secondary tumours after treatment with chemotherapy,
Teratogenic effects of phenytoin taken during pregnancy,
30. Type E ( End of treatment) reactions
Bounce phenomenon or withdrawal effect
• The illness for which the medication was indicated
becomes worse
• Occur on withdrawal especially when drug is stopped
abruptly
E.g.
withdrawal seizures on stopping Phenytoin,
Adrenocortical insufficiency on withdrawal of steroids
Prednisone
31. As type F is concidered (Failure of Therapy ~ Fail unexpected of the therapy; also
Foreing or strange )
• They often happen for interactions and they are dependent dose.
Example: Fail of the effect of the oral contraceptives, when they are used
with drug enzymatic inductor (Ampicillin).
Although it is a proposed category in a recent way, other authors use it to refer to the
unwanted effects caused at the beginning by other components of the medication,
including exicipients, contaminants or impuritis, (assuming the F to foreign or
stranger).
Type F ADRs
32. PREDISPOSING FACTORS FOR ADRS
THE MAIN CLINICAL FACTORS WHICH INCREASE THE CHANCE THAT PATIENTS
WILL EXPERIENCE AN ADVERSE REACTION ARE LISTED BELOW:
•Age
- The elderly and neonates are at greatest risk
•Gender
- Women are generally at greater risk
•Race
- Ethnic origin may affect drug metabolism
•Impaired excretory mechanisms
- Reduced hepatic and/or renal function
•Specific diseases
- e.g. Asthma and beta-blockers
•Polypharmacy
- Drug interactions (see below)
•Any previous history of an adverse drug reaction.
33. METHODS OF PHARMACOVIGILANCE
METHODS SOURCES OF OBTAINING ADRMS DETECTEDS
Statistical analysis Records of mortality
and morbility
Acute and sub-acute
reactions
Intensive
Monitoring inpatient
Clinical record of
patient
Interviews
Acute and sub-acute
reactions
Voluntary
Notification
Yellow card or
expontaneus report
Unknown ADR
ADR of low-intensity
Pharmacoepidemiol
ogycal studies
Ex. Case control studies, Cohorte studies,
studies of drug utilización, clinical estudies,
Case study, studies of series of cases. traverse
Research results
Publications
Early detection of ADR
New drugs ADR
34. SPONTANEOUS REPORT OF ADRs SUSPICION.
Model through which the suspicion is notified that relationship
exists between the administration of a medication and the
appearance of the ADR
The same one picks up the referred basic data of the patient, to
the drug and the possible ADR
The information is sent to the Pharmacovigilance centers where
it is controlled, it analyzes and they are defined stocks in this
respect.
35.
36.
37. STANDARDIZED METHODS TO DETERMINE IMPUTABILITY OF THE ADRs
1- Karch F.E., Lassagna 1977
2- Dangouman J. et al. 1978
3- Blanc S.P. et al. 1979
4- Kramer M.S. et al. 1979
5- Venulet J.A. et al. 1980
6-Emanueli A. et al. 1980
7- Naranjo C.A. et al. 1981
8- Jones J. 1982
9- Lagier G. et al. 1983
10-Stephens H. 1984
These methods allow to know if the adverse event is an ADR or not
38. CLASIFICATION OF ADRs ACORDING IMPUTABILITY
PROVED OR ULTIMATELY
PROBABLE
POSSIBLE
QUESTIONABLE OR CONDITIONAL
39. ASPECTS THAT DEFINE THE ADR IMPUTABILITY
PROVED PROBABLE POSIBLE QUESTONABLE
1 - it shows a reasonable
temporary relationship after the
administration of the medication,
or it has been determined the
plasmatic levels of the drug in
liquids or fabrics.
YES YES YES YES
2 - well-known answer pattern
shows with the suspicious
medication.
YES YES YES OR NO NO
3 - you confirms by means of
improvement when suspending
the treatment, and
it reappears when Its
administers again.
YES
YES
YES
YOU DON’T
NOW
NO
NO
NO
NO
4 - It cannot explain to himself
for the characteristics of the
YES YES YNO NO
40. PHARMACOVIGILANCE
What ADRs should be reported?
Unknown ( are not reported in the bibliography)
Unexpected
All that appear with new drugs
Serious (also when it is known)
Fatal or life-threatening
Malformations
Unexpected beneficial effects
Unexpected ineffectiveness
41. SOME ADRs OF SPECIAL
MONITORING BY
PHARMACOVIGILANCE