Pharmacovigilance is science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
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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.
Defined daily dose-DDD
B Pharm, Pharm D and medicine syllabus
Useful for examination and regulatory function information
Useful for Pharmacovigilance interview and medical coding also.
Good Luck and all the best!!!
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
A concise overview of pharmacoeconomics, health economics, various costs, various pharmacoeconomic study designs and its application in the field of medicine and drug development
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
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.
Defined daily dose-DDD
B Pharm, Pharm D and medicine syllabus
Useful for examination and regulatory function information
Useful for Pharmacovigilance interview and medical coding also.
Good Luck and all the best!!!
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
A concise overview of pharmacoeconomics, health economics, various costs, various pharmacoeconomic study designs and its application in the field of medicine and drug development
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
pharmacovigilance from pharmaceutical administration topic presented by konatham kumar reddy from chilkur balaaji college of pharmacy hyderabad telangana
Pharmaceutical care concepts - clinical pharmacy ShaistaSumayya
The pharmaceutical care is defined as “the direct, responsible provision of medication-related care for the purpose of achieving definite outcomes that improve a patient’s quality of life.”
Pharmaceutical care involves the process through which a pharmacist cooperates with a patient and other professional in designing , implementation, and monitoring a therapeutic plan that will produce specific therapeutic outcomes for the patient
Fixed dose combination products – rationality, status in india, development i...Dr Sukanta sen
The development of FDCs is becoming increasingly
important from a public health perspective.
•They are being used in the treatment of a wide range of
conditions and are particularly useful in the management of
human immunodeficiency virus/acquired immunodeficiency
syndrome (HIV/AIDS), malaria and tuberculosis, which are
considered to be the foremost infectious disease threats in the world today.
Prospects of incretin mimetics in therapeuticsDr Sukanta sen
Comparative trials show that there are important differences between
and among the GLP-1 receptor agonists and DPP-4 inhibitors with
respect to glycemic lowering, weight effects, and effects on systolic
blood pressure and the lipid profile.
•Nausea, diarrhea, headaches, and dizziness are common with the
available GLP-1 receptor agonists.
•Upper respiratory tract infections, nasopharyngitis, and headaches
are common with the DPP-4 inhibitors.
•Ongoing safety evaluations should provide a clear picture regarding
long-term safety.
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
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
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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.
2. 1. WHY PHARMACOVIGILANCE?
The information collected during the pre-marketing phase of a
medical drug is inevitably incomplete with regard to possible
adverse reactions:
tests in animals are insufficiently predictive of human
safety
in clinical trials patients are selected and limited in number,
the conditions of use differ from those in clinical practice and the
duration of trials is limited
information about rare but serious adverse reactions,
chronic toxicity, use in special groups (such as children, the
elderly or pregnant women) or drug interactions is often incomplete
or not available.
2
3. Pharmacovigilance is needed in every country, because
there are differences between countries (and even regions
within countries) in the occurrence of adverse drug reactions
and other drug-related problems.
This may be because of differences in:
drug production
distribution and use (e.g. indications, dose,
availability)
genetics, diet, traditions of the people
pharmaceutical quality and composition (excipients)
of locally produced pharmaceutical products
the use of non-orthodox drugs (e.g. herbal remedies)
which may pose special toxicological problems, when
used alone or in combination with other drugs.
3
4. Data derived from within the country or region may
have greater relevance and educational value and
may encourage national regulatory decision-
making.
When information from a region itself is not available,
it may take longer before a problem becomes known to
drug regulatory authorities, physicians, pharmacists,
patients and pharmaceutical companies.
4
5. 2. DEFINITION AND AIMS
Pharmacovigilance is science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
5
6. The ultimate goals of pharmacovigilance are:
the rational and safe use of medical drugs
the assessment and communication of the risks
and benefits of drugs on the market
educating and informing of patients/ consumers
6
7. 3. BASIC STEPS IN SETTING UP A
PHARMACOVIGILANCE CENTRE
1. Make contacts with the health authorities and with
local, regional or national institutions and groups,
working in clinical medicine, pharmacology and toxicology
outlining the importance of the project and its purposes.
2. Design a reporting form and start collecting data by
distributing it to hospital departments, family
practitioners, etc.
3. Produce printed material to inform health
professionals about definitions, aims and methods of
the pharmacovigilance system.
4. Create the centre: staff, accommodation, phone,
word processor, database management capability,
bibliography etc.
7
8. 5. Take care of the education of pharmacovigilance
staff with regard, for example, to:
data collection and verification
interpreting and coding of adverse reaction descriptions
coding of drugs
case causality assessment
signal detection
risk management
6. Establish a database (administrative system for the
storage and retrieval of data)
8
9. 7. Organise meetings in hospitals, academia and
professional associations, explaining the principles
and demands of pharmacovigilance and the importance of
reporting.
8. Promote the importance of reporting adverse drug
reactions through medical journals, other professional
publications, and communications activities.
9. Maintain contacts with international institutions
working in pharmacovigilance, e.g. the WHO
Department of Essential Drugs and Medicines Policy
(Geneva) and the Uppsala Monitoring Centre, Sweden.
9
10. 4. REPORTING OF ADVERSE DRUG REACTIONS
Spontaneous reporting:
a regional or country-wide system for the
reporting of suspected adverse drug reactions
is currently the major source of information in
pharmacovigilance.
10
11. 5. REPORTING FORM
Case report: A notification relating to a patient with an adverse
medical event (or laboratory test abnormality) suspected to be
induced by a medicine.
A case report should (as a minimum to aim at) contain information on
the following elements:
1. The patient: age, sex and brief medical history (when relevant). In
some countries ethnic origin may need to be specified.
2. Adverse event: description (nature, localisation, severity,
characteristics), results of investigations and tests, start date,
course and outcome.
3. Suspected drug(s): name (brand or ingredient name +
manufacturer), dose, route, start/stop dates, indication for use (with
particular drugs, e.g. vaccines, a batch number is important).
11
12. 4. All other drugs used (including self-medication):
names, doses, routes, start/stop dates.
5. Risk factors (e.g. impaired renal function,
previous exposure to suspected drug, previous
allergies, social drug use).
6. Name and address of reporter (to be considered
confidential and to be used only for data
verification, completion and case follow-up).
Reporting should be as easy and cheap as possible.
12
15. A. Patient Information
1. Patient initials: A reporter should only mention the
initials of a patient instead of the full name. For e.g.:
Madhu Gupta should be written as MG.
2. Age at time of event or date of birth: A reporter must
report either the date of birth or age of the patient at the
time the event or reaction occurred.
3. Sex: A reporter must mention the gender of the patient.
4. Weight: The weight of the patient should be in kilograms.
15
16. B. Suspected Adverse Reaction
5. Date of reaction started: A reporter must report the
date on which the reaction was first observed.
6. Date of recovery: If the reaction recovered, the date
on which the reaction recovered should be reported.
7. Describe reaction: A reporter must briefly describe
the event in terms of nature, localization etc. For
example patient developed erythematous
maculopapular rash over upper and lower limbs.
16
17. C. Suspected Medications
8. The details of suspected medication(s) such as the drug name
(brand or generic name), manufacturer, batch no/lot no, expiry
date, dose used, route used, frequency, dates of therapy started and
stopped, and indication of use must be provided by the reporter.
9. De-challenge details:
A reporter must report the status of de-challenge as:
‘Yes’- if reaction abated or reduced after de-challenge
‘No’- if reaction did not abated after de-challenge
‘Unknown’- if information on de-challenge is not confirmed or
not known
‘Not Applicable’ or ‘NA’- if de-challenge is not possible as in
case of anaphylaxis, life threatening events, anaesthetic drugs or
where a single dose is given.
‘Reduced dose’- If dose at which the reaction occurred is reduced
Note: Also mention the reduced dose
17
18. 10. Re-challenge details:
A reporter must report the status of re-challenge as:
• ‘Yes’- if reaction reappeared after re-challenge
• ‘No’- if reaction did not reappear after re-challenge
• ‘Unknown’- if information on re-challenge is not confirmed or not
known
• ‘Not Applicable’ or ‘NA’- if re-challenge is not applicable as in the
case of injections.
• ‘Re-introduced dose’- If the drug is reintroduced is it a reduced
dose or is it the same dose at which adverse event occurred initially.
11. Concomitant drugs: A reporter should include all the details of
concomitant drugs including self medication, OTC medication, herbal
remedies with therapy dates (start and stop date.)
18
19. 12. Relevant tests/ laboratory data:
A reporter must mention any laboratory data (if available)
relevant to the adverse event that occurred.
13. Other relevant history:
A reporter must mention any relevant history pertaining to the
patient including pre-existing medical conditions (e.g. allergies,
pregnancy, smoking, alcohol use, hepatic/renal dysfunction).
14. Seriousness of the reaction:
If any event is serious in nature, a reporter must select the
appropriate reason for seriousness :
• ‘Death’- if the patient died due to the adverse event
• ‘Life-threatening’- if patient was at substantial risk of dying
because of the adverse event
19
20. ‘Hospitalisation/prolonged’- if the adverse event led to
hospitalization or increased the hospital stay of the patient
‘Disability’- if the adverse event resulted in a substantial
disruption of a person's ability to conduct normal life functions
‘Congenital anomaly’- if exposure of drug prior to conception or
during pregnancy may have resulted in an adverse outcome in the
child.
‘Required intervention to prevent permanent
impairment/damage’- if medical or surgical intervention was
necessary to preclude permanent impairment of a body function, or
prevent permanent damage to a body structure
‘Other’ -when the event does not fit the other outcomes, but the
event may put the patient at risk and may require medical or
surgical intervention to prevent one of the other outcomes.
Examples include serious blood dyscrasias (blood disorders) or
seizures/convulsions that do not result in hospitalization,
development of drug dependence or drug abuse 20
21. 15. Outcomes: The reporter must tick the outcome of the
event as:
• ‘Fatal’- if the patient dies due to the adverse event
• ‘Continuing’- if the patient is continuing to have the
symptoms of the adverse event which occurred
• ‘Recovering’- if the patient is recovering from the existing
adverse event
• ‘Recovered’- if the patient has recovered from the event
• ‘Unknown’- if the outcome is not known
16. Reporter
• 16. Name and Professional address: A reporter must
mention his/her name and professional address on the form.
The identity of the reporter will be maintained confidential
17. Causality assessment: The reporter (if trained) must
perform the causality assessment.
18. Date of report: Mention the date on which he/she
reported the adverse event.
21
22. Who can report:
Any health care professional (Doctors including
Dentists, Nurses, Pharmacists & Recently Consumers
also)
Where to report:
Please return the completed form to the nearest
Adverse drug reaction Monitoring Centre (AMC)
or to National Coordinating Centre
A list of nationwide AMCs is available at:
http://cdsco.nic.in/pharmacovigilance.htm
22
23. What happens to the submitted information:
Information provided in this form is handled in strict
confidence. The causality assessment is carried out at Adverse
Drug Reaction Monitoring Centres (AMCs) by using WHO-UMC
scale.
The analyzed forms are forwarded to the National
Coordinating Centre through the ADR database.
Finally the data is analyzed and forwarded to the Global
Pharmacovigilance Database managed by WHO Uppsala
Monitoring Center in Sweden.
The reports are periodically reviewed by the National
Coordinating Centre (PvPI). The information generated on the
basis of these reports helps in continuous assessment of the
benefit-risk ratio of medicines.
The information is submitted to the Steering Committee of
PvPI constituted by the Ministry of Health and Family Welfare.
The Committee is entrusted with the responsibility to review the
data and suggest any interventions that may be required.
23
24. ASSESSMENT OF CASE REPORTS
1. Quality of documentation (e.g. completeness and integrity of data,
quality of diagnosis, follow-up).
2. Coding. Drug names should be registered in a systematic way, for example
by using the WHO Drug Dictionary (which is based on the INN
nomenclature and the ATC classification).
For the coding of the adverse events the WHO Adverse Reaction
Terminology (WHOART), or another internationally recognised
terminology (e.g. MedDRA) should be used.
3. Relevance with regard to the detection of new reactions, drug regulation, or
scientific or educational value.
The following questions especially may be asked:
. New drug? Products on the market less than five years are usually
considered new drugs
. Unknown reaction? (i.e. not included in the approved Summary of Product
Characteristics or Unlabelled). Also important is whether the reaction is
described in the literature, e.g. national drug formulary, Martindale, Meylers
Side Effects of Drugs. (Ask the Uppsala Monitoring Centre for books and
other information sources)
. Serious reaction?
24
25. 4. Identification of duplicate reports
Certain characteristics of a case (sex, age or date of birth, dates of
drug exposure, etc.) may be used to identify duplicate reporting.
5. Causality assessment
With few exceptions, case reports describe suspected
adverse drug reactions. Various approaches have been
developed for the structured determination of the likelihood of a
causal relationship between drug exposure and adverse events, for
example by the WHO Drug Monitoring Programme, the European
Commission, and the French national pharmacovigilance
programme.
These systems are largely based on four considerations:
. the association in time (or place) between drug
administration and event
. pharmacology (including current knowledge of nature and
frequency of adverse reactions)
. medical or pharmacological plausibility (signs and symptoms,
laboratory tests, pathological findings, mechanism)
likelihood or exclusion of other causes.
25
26. ADVICE ABOUT REPORTING
• Report adverse experiences with medications
• Report serious adverse reactions. A reaction is serious
when the patient outcome is:
• death
• life-threatening (real risk of dying)
• hospitalization (initial or prolonged)
• disability (significant, persistent or permanent
• congenital anomaly
• required intervention to prevent permanent
• impairment or damage
Report even if:
• You’re not certain the product caused adverse reaction
• you don’t have all the details, however, point nos. 1, 5, 7, 8, 11,
15, 16 & 18 are essentially required.
26
27. CAUSALITY CATEGORIES
The causality categories described by the Uppsala Monitoring Centre
are as follows:
1. Certain:
a clinical event, including laboratory test abnormality,
occurring in a plausible time relationship to drug administration,
and which cannot be explained by concurrent disease or other drugs
or chemicals. The response to withdrawal of the drug (dechallenge)
should be clinically plausible. The event must be definitive
pharmacologically or phenomenologically, using a
satisfactory rechallenge procedure if necessary.
2. Probable/Likely:
a clinical event, including laboratory test abnormality, with
a reasonable time sequence to administration of the drug, unlikely to
be attributed to concurrent disease or other drugs or chemicals, and
which follows a clinically reasonable response on withdrawal
(dechallenge).
Rechallenge information is not required to fulfil this definition.
27
28. 3. Possible:
a clinical event, including laboratory test abnormality, with
a reasonable time sequence to administrations of the drug, but
which could also be explained by concurrent disease or other drugs or
chemicals. Information on drug withdrawal may be lacking or
unclear.
4. Unlikely:
a clinical event, including laboratory test abnormality, with a
temporal relationship to drug administration which makes a causal
relationship improbable, and in which other drugs, chemicals or
underlying disease provide plausible explanations.
5. Conditional/Unclassified:
a clinical event, including laboratory test abnormality,
reported as an adverse reaction, about which more data is essential
for a proper assessment, or the additional data is under examination.
6. Unassessable/Unclassifiable: a report suggesting an adverse
reaction which cannot be judged because information is
insufficient or contradictory, and which cannot be supplemented or
verified.
28
29. As a step towards harmonisation in drug regulation in the countries
of the European Union, the EU pharmacovigilance working
parties proposed the following three causality categories: .
Category A:
Reports including good reasons and sufficient
documentation to assume a causal relationship, in the sense of
plausible, conceivable, likely, but not necessarily highly probable.
Category B:
Reports containing sufficient information to accept the
possibility of a causal relationship, in the sense of not
impossible and not unlikely, although the connection is uncertain
and may be even doubtful, e.g. because of missing data,
insufficient evidence or the possibility of another explanation.
Category O:
Reports where causality is, for one or another reason, not
assessable, e.g. because of missing or conflicting data.
29