PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug 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 modifications of physiological function.”
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
GVP stands for Good Pharmacovigilance Practices, which are a set of guidelines and regulatory requirements that provide a framework for the conduct of pharmacovigilance activities. The GVP modules outline specific areas of pharmacovigilance and provide detailed guidance on various aspects. Here are the main GVP modules
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
GVP stands for Good Pharmacovigilance Practices, which are a set of guidelines and regulatory requirements that provide a framework for the conduct of pharmacovigilance activities. The GVP modules outline specific areas of pharmacovigilance and provide detailed guidance on various aspects. Here are the main GVP modules
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
A brief description about Pharmacovigilance, aims and scope, need of pharmacovigilance, programs by WHO for international drug safety monitoring, UMC, VIGIBASE, WHO causality assessment scale and specific regulatory bodies of various countries
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
The World Health Organization defines pharmacovigilance as the science and actions connected to the detection, evaluation, understanding, and prevention of adverse effects or any other drug related problem. Pharmacovigilance is critical in ensuring that patients receive safe pharmaceuticals. We can learn more about a drugs side effects through a variety of methods, including spontaneous reporting, diligent monitoring, and database research. Novel mechanisms are being established at both the regulatory and scientific levels to increase pharmacovigilance. They include conditional approval and risk management strategies on a regulatory level, and openness and increasing patient engagement on a scientific one. OBJECTIVE To review and discuss various aspects of pharmacovigilance, including new methodological developments. V Sai Kruthika | Sarvani Ekathmika | Prathamesh Golapkar "Advanced Methodologies in Pharmacovigilance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-2 , April 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd55052.pdf Paper URL: https://www.ijtsrd.com.com/other-scientific-research-area/other/55052/advanced-methodologies-in-pharmacovigilance/v-sai-kruthika
A brief description about Pharmacovigilance, aims and scope, need of pharmacovigilance, programs by WHO for international drug safety monitoring, UMC, VIGIBASE, WHO causality assessment scale and specific regulatory bodies of various countries
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
The World Health Organization defines pharmacovigilance as the science and actions connected to the detection, evaluation, understanding, and prevention of adverse effects or any other drug related problem. Pharmacovigilance is critical in ensuring that patients receive safe pharmaceuticals. We can learn more about a drugs side effects through a variety of methods, including spontaneous reporting, diligent monitoring, and database research. Novel mechanisms are being established at both the regulatory and scientific levels to increase pharmacovigilance. They include conditional approval and risk management strategies on a regulatory level, and openness and increasing patient engagement on a scientific one. OBJECTIVE To review and discuss various aspects of pharmacovigilance, including new methodological developments. V Sai Kruthika | Sarvani Ekathmika | Prathamesh Golapkar "Advanced Methodologies in Pharmacovigilance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-2 , April 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd55052.pdf Paper URL: https://www.ijtsrd.com.com/other-scientific-research-area/other/55052/advanced-methodologies-in-pharmacovigilance/v-sai-kruthika
Medicines is the applied science or practice of the diagnosis, treatment, and prevention of disease.
Bad effects called Adverse Drug Reactions (ADRs) , it differs from side effects.
Pharmacovigilance (PhV) is the science that concerns with the detection, assessment, understanding and prevention of ADRs
Medicines: is the applied science or practice of the diagnosis, treatment, and prevention of disease.
Bad effects called Adverse Drug Reactions (ADRs) , it differs from side effects.
PHARMACOVIGILANCE_SLIDE. Insight to pharmacovigilance, covering basics and va...ssharmapharmacy005
Insight to pharmacovigilance,
covering basics and various aspects, case processing types of ADR, basic terminologies
adr reporting dverse vent, types of adr, meddra
IFPMA Geneva Pharma Forum on Pharmacovigilance: Partnering
for Patient Safety (Geneva, 20 November 2012)
Dr Shanthi Pal, Programme Manager for Pharmacovigilance
Quality Assurance and Safety of Medicines,
World Health Organization
HERE I INCLUDED HISTORY, RESPONSIBILITIES, TERMINOLOGY AND METHODS INVOLVED .
HOPE IT WILL BE USEFUL FOR YOU TO UNDERSTAND THE BASICS OF PHARMACOVIGILANCE.
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“WHO Medicines Safety Programme: Pharmacovigilance and risk minimization programs for biological products”
Illustrates the WHO work program on pharmacovigilance, with a focus on both small molecule chemically-synthesized medicines and biotherapeutics
An evaluation of community pharmacists’ readiness to implement the Falsified ...RavinaBarrett
Pharmacies are not FMD compliant and limited practical help and support seems available. A lack of resources, knowledge, competency, training and confidence makes this a difficult directive to implement successfully. Improved patient safety is anticipated, but difficult to quantify.
Herbal drugs / herbal medicines include
herbs, herbal materials, herbal preparations and
finished herbal products, that contain as active ingredients, part of plants, or other plant materials, or combinations.
Herbal medicines comprise of therapies employing plant based products.
It is an integral part of Ayurveda and some indigenous medical systems.
Herbal drugs are becoming more popular in the modern world for their application to cure variety of diseases with less toxic effects and better therapeutic effects
OSI Reference Model - internationally standardised network architecture.
OSI = Open Systems Interconnection: deals with open systems, i.e.systems open for communications with other systems.
Specified in ISO 7498.
Model has 7 layers.
Supercomputers...are used to process very large amounts of information including processing information to predict hurricanes, satellite images and navigation, and process military war scenarios
Mainframes...are used by government and businesses to process very large amounts of information.
Mini-Computers...are similar to mainframes...they are used by business and government to process large amounts of information.
Personal Computers (PC
The first computers used vacuum tubes for circuitry and magnetic drums for memory.
They were often enormous and taking up entire room.
First generation computers relied on machine language.
They were very expensive to operate and in addition to using a great deal of electricity, generated a lot of heat, which was often the cause of malfunctions.
The UNIVAC and ENIAC computers are examples of first-generation computing devices.
Chromatography is an analytical method in which compounds are physically separated and measured.
The main purpose of chromatography is to separate and quantify the target sample.
The Chromatography technique used to separate a mixture of compounds in pharmaceutical sciences , analytical analytical Chemistry with the purpose of identifying, quantifying and purifying the individual components of the mixture.
The Hedgehog pathway was discovered in fruit fly (Drosophila) and is conserved in vertebrates (including humans)
The Hedgehog pathway is involved in cell growth and differentiation to control organ formation during embryonic development.
Hedgehog signalling regulates embryonic development, ensuring that tissues reach their correct size and location, maintaining tissue polarity and cellular content.
In the skin, the Hedgehog pathway is critical for regulating hair follicle and sebaceous gland development.
Germline mutations in components of the Hedgehog signalling pathway results in a number of developmental abnormalities.
Hedgehog signalling normally remains inactive in most adult tissues
Oxygen is highly reactive atom that is capable of becoming part
of potentially damaging molecule commonly called “free radical.”
Free radicals are capable of attacking cells of the body, causing
them to lose their structure and function.
Free radicals have been implicated in the pathogenesis of at
least 50 diseases.
Free radial formation is controlled naturally by various compounds
known as antioxidants.
It is when the ability of antioxidant is limited that this damage can
become cumulative and debilitating.
Following criteria should be considered while selecting an antioxidant.
It should be able to produce desire redox reaction.
It should be physiologically and chemically compatible.
It should be physiologically inert.
It should be non-toxic both in the reduced and oxidized forms.
It should be effective in low concentration.
It should provide prolonged stability to the formulation.
These are the substances which are added in the formulation along the therapeutic agent so as to impart specific qualities in the formulation.
These are have very little or no therapeutic value but are necessary in the manufacture of various dosage forms.
Purposes served by Additives:
Provide bulk to the formulation.
Facilitate drug absorption or solubility and other pharmacokinetic considerations.
Aid in handling of “API” during manufacturing .
Provide stability and prevent from denaturation etc
Exists without actions of humankind in the form of matter/energy which is available in the earth and get used by living thing.
Or exist as a separate entity such as fresh water, air and as well as a living organism such as a fish.
Or it may exist in an alternate form that must be processed to obtain the resource such as metal ores, petroleum, and most forms of energy.
Extraction is a process of separation or isolation of pharmaceutical active ingredients
from plant or animal drugs with the help of solvent.
On the basis of the physical nature of crude drug to be extracted i.e. liquid or solid ,the extraction process may be:
Liquid –Liquid Extraction Or
Solid –Liquid Extraction.
The solvent used for extraction is called as ‘Menstruum’ and the residue left after extracting desired constituents is called ‘Marc’.
Required Ideal Properties of Menstruum :
Should be inert and non –toxic
Should extract only the desirable constituent of the crude drug .
Should be cheap and easily available
Parkinson’s disease (PD) is the second most chronic, slowly progressive age associated
neurodegenerative disorder characterized by selective loss of dopaminergic neurons in the substantia nigra (SN) pars compacta, leads to deficiency or depletion dopamine (DA) in the striatum.
Idiopathic - (unknown cause)
Genetic - (clustering of early-onset pd in some families)
Drug induced (Anti-depressant, calcium channel blockers)
Toxins – (Environmental and Neurotoxins)
Head Trauma – (During accidental conditions)
Cerebral Anoxia
Histamine is an endogenous substance that is amine synthesized, stored and released by the various cells of the body: (a) Mast cells, which are abundant in the skin, GI, and the respiratory tract,
(b) Basophils in the blood, and (c) Some neurons in the CNS and peripheral NS.
It is an “Autocoid” that is secreted locally and regulate the activity of various near lying cells and neurons.
Huntington's disease is slowly progressive, rapidly growing hereditary brain disease that causes abnormal motor coordination, thinking, behavior and ultimately leads to dementia.
Its necessary to diagnosis earlier i.e. onset of movement disorder, particularly
with chorea and impaired voluntary movement.
Autosomal dominant inheritance with 2000 people are diagnosed each year.
No drug therapy is available
The worldwide prevalence of Huntington’s Disease is 5-10 cases per 10000 which affects men and women equally
SPECTROSCOPY is defined as the study of the interactions between radiations and matter as function of wavelength λ .
Interactions with particle radiation or a response of a material to an altering field
or varying frequency.
SPECTRUM : A plot of the response as a function of wavelength or more commonly frequency is referred to as spectrum.
SPECTROMETRY : It is measurement of these responses and an instrument which performs such measurements is a spectrophotometer or spectrograph, although
these terms are more limited in use to original field of optics from which the
concept sprang.
HPTLC is the improved method of TLC which utilizes the conventional technique of TLC in more optimized way.
It is also known as planar chromatography or Flat-bed chromatography.
Chromatography is a physical process of separation in which the components to be separated are distributed between 2 immiscible phases-a stationary phase which has a large surface area and mobile phase which is in constant motion through the stationary phase.
These are the organic products of natural or synthetic origin which are basic in
nature & contain one or more than one nitrogen atoms, normally of heterocyclic nature &
possess specific physiological actions on human or animal body, when used in small quantites.
The term is derived from the word ‘alkali-like’ & hence they resemble some of characters
of naturally occuring amines.
The term is derived from the word ‘alkali-like’ & hence they resemble some of
characters of naturally occuring amines.
A Ward round is a visit made by a medical practitioner, alone or with a team of health care professionals and medical students to hospital in-patients at their bedside to review and follow-up the progress in their health.
Usually at least one ward round is conducted
everyday to review the progress of each
patient outcome.
Pharmacist’s participating in medical ward
rounds promotes health care
Participation of the Pharmacists in ward
rounds in various practice settings helps to
provide rational drug use.
Have full fleged clinical trial data management systems which bring them a good amount of business and revenue.
CDM is a fundamental process which controls data accuracy of each trial besides helping the timelessness to be achieved.
It helps in linking clinical research co-ordinator = who monitor all the sites & collects the data.
it Links with biostatisticians = who analyze, interpret and report data in clinically meaningful way.
Pyrogens include any substance capable of eliciting a febrile (or fever) response upon injection or infection
Endotoxin is a subset of pyrogens that are strictly of gram- negative bacterial origin; they occur (virtually) nowhere else in nature.
Lipopolysaccharide (LPS)is a part of endotoxin, or, endotoxin is the natural complex of LPS occurring in the outer layer of the bilayered gram-negative bacterial cell
The efficacy of antimicrobial preservation of a pharmaceutical preparation on its own or, if necessary, with the addition of a suitable preservative has to be ascertained during the development of the product.
The primary purpose of adding antimicrobial preservatives to dosage forms is to prevent adverse effects arising from contamination by micro-organisms that may be introduced inadvertently during or subsequent
to the manufacturing process.
However, antimicrobial agents should not be used solely to reduce the viable microbial count as a substitute for good manufacturing procedures.
There may be situations where a preservative system may have to be used to minimise proliferation of micro-organisms in preparations that are not required to be sterile.
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micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
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
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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
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
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.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
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
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GOOD PHARMACOVIGILANCE PRACTICES
1. GOOD PHARMACOVIGILANCE
PRACTICES
SOURABH KOSEY
ASSOCIATE PROFESSOR
DEPT. OF PHARMACY PRACTICE
ISF COLLEGE OF PHARMACY
WEBSITE: - WWW.ISFCP.ORG
EMAIL: SOURABHKOSEY@GMAIL.COM
ISF College of Pharmacy, Moga
Ghal Kalan,nGT Road, Moga- 142001, Punjab, INDIA
Internal Quality Assurance Cell - (IQAC)
3. PHARMACOVIGILANCE
The
World Health Organization (WHO)
defines Pharmacovigilance as
“the science and activities
relating to the detection,
assessment, understanding and
prevention of adverse effects or
any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a
response to a drug which is
noxious and unintended, and
which occurs at doses normally
3
4. HISTORY OF
PHARMACOVIGILANCE
1848
The Lancet started collecting notifications of side
effects caused by use of anaesthesia.
1906
US Federal and Food Act was implemented stating
that pharmaceuticals should be ‘pure’ & free from
‘contamination’.
1937
In USA 107 lethal cases were reported after
diethylene glycol was mistakenly used as solvent for
sulphanilamides.
4
5. 1959-61
Reports of foetal abnormalities after the use of drug
thalidomide.
1962
USA revised law requiring to prove safety and
efficacy of drug before issuing marketing
authorization.
1967
WHO’s International Drug Monitoring programme
was launched.
5
7. WHAT IS GPV (Good
Pharmacovigilance
Practices) Good Pharmacovigilance practices (GVP)
are a set of measures drawn up to facilitate
the performance of pharmacovigilance in
the European Union (EU). GVP apply to
marketing-authorisation holders, the
European Medicines Agency and medicines
regulatory authorities in EU Member States.
Our knowledge of a drug’s adverse
reactions can be increased by various
means, including spontaneous reporting,
intensive monitoring and database studies.
7
8. METHODS
1) CLINICAL TRIAL DATA
COLLECTION
Main method currently used to gather information
on a drug in the pre-marketing phase.
Pre-marketing clinical trials can be divided into
three phases.
These are considered to be the most rigorous
approach to determining whether a cause-effect
relationship exists between a treatment and an
outcome.
8
9. This study design is not optimal due to the limited
number of patients participating, it is generally not
possible to identify ADRs that occur only rarely.
Moreover short duration of clinical trials makes it
difficult to detect ADRs with a long latency.
Another limitation of clinical trials is the population in
which a drug is tested i.e characteristics of the
participants do not always correspond to the
characteristics of the population in which it will later
be used; consequently, it may be difficult to
extrapolate the results obtained from clinical trials to
the population at a larger scale.
9
10. 2)SPOTANEOUS REPORTING
In 1961, a letter from the Australian physician WG
McBride was published in Lancet. In this letter, he
shared his observation that babies whose mothers
had used thalidomide during pregnancy were born
with congenital abnormalities more often than
babies who had not been exposed to thalidomide in
utero.
In the years to come it became evident that
thousands of babies had been born with limb
malformations due to the maternal use of
thalidomide.
10
11. In order to prevent a similar disaster from
occurring, systems were set up all over the world
with the aim of regulating and monitoring the safety
of drugs.
Thus, Spontaneous reporting systems (SRS)
were
created and these have become the primary
method of collecting post-marketing information
on the safety of drugs.
11
12. This system enables physicians and, increasingly more
often, pharmacists and patients to report suspected
ADRs to a pharmacovigilance centre.
The task of the pharmacovigilance centre is to collect
and analyse the reports and to inform stakeholders of
the potential risk when signals of new ADRs arise.
Also used by various industries for reporting of their
drugs.
Possible to monitor all drugs on the market throughout
their entire life cycle at a relatively low cost.
The main criticism of this approach is the potential for
selective reporting and underreporting
12
13. 3 DATA MINING IN SPONTANEOUS
REPORTING
The term ‘data mining’ refers to the principle of
analysing data from different perspectives and
extracting the relevant information.
Approaches of data mining are currently in use are
Proportional reporting ratios (PPRs), compare the
proportion of reports for a specific ADR reported for a
drug with the proportion for that ADR in all other
drugs.
The Bayesian confidence propagation neural network
(BCPNN) method is used to highlight dependencies in
a data set. This approach uses Bayesian statistics
implemented in a neural network architecture to
13
14. WHO Collaborating Centre for International Drug
Monitoring uses this method for data mining.
A related approach is the Multi-Item Gamma
Poisson Shrinker (MGPS) used by the FDA for data
mining of their spontaneous report’s database. The
MGPS algorithm computes signal scores for pairs,
and for higher-order (e.g. triplet, quadruplet)
combinations of drugs and events that are
significantly more frequent than their pair-wise
associations would predict
14
15. 4)INTENSIVE MONITORING
In the late 1970s and early 1980s a new form of
active surveillance was developed in New Zealand
(Intensive Medicines Monitoring Programme) and
the UK (Prescription Event Monitoring).
These intensive monitoring systems use
prescription data to identify users of a certain drug.
The prescriber of the drug is asked about any
adverse event occurring during the use of the drug
being monitored. These data are collected and
analysed for new signals.
15
16. It is unaffected by the kind of selection and
exclusion criteria that characterise clinical trials,
thereby eliminating selection bias.
Another strength of this methodology is that it is
based upon event monitoring and is therefore
capable of identifying signals for events that were
not necessarily suspected as being ADRs of the
drug being studied.
16
17. This approach, however, also hasThis approach, however, also has
recognised limitations :-recognised limitations :-
a)a) The proportion of adverse effects thatThe proportion of adverse effects that
go unreported is unknown.go unreported is unknown.
b)b) It produces reported event ratesIt produces reported event rates
rather than true incident ratesrather than true incident rates
c)c) The true background incidence forThe true background incidence for
events is not known.events is not known.
In European commission consultationIn European commission consultation
‘Strategy to better protect public‘Strategy to better protect public
health by strengthening andhealth by strengthening and
rationalising EU pharmacovigilance’rationalising EU pharmacovigilance’
intensive monitoring is mentioned asintensive monitoring is mentioned as
17
18. 5)DATABASE STUDIES
The General Practice Research Database (GPRD) and
the PHARMO Record Linkage System are two major
European database used for ADR reporting.
GPRD
Virtually all patient care in the UK is coordinated by the
general practitioner (GP), and data from this source
provide an almost complete picture of a patient, his
illnesses and treatment.
In any given year, GPs, who are members of the GPRD,
collect data from about 3 million patients and ADR
reporting is done.
There have been over 250 publications in peer-reviewed
journals using the GPRD.
18
19. PHARMO
In the early 1990s, the PHARMO system of record linkage
was developed in The Netherlands.
PHARMO links community pharmacy and hospital data
within a specific region on the basis of patient birth date,
gender and GP code.
The system now includes drug-dispensing records from
community pharmacies and hospital discharge records of
about 2 million people in the Netherlands.
19
20. The data collection is longitudinal and goes back to
1987.
The system has well-defined denominator
information that allows incidence and prevalence
estimates and is relatively cheap because existing
databases are used and linked.
The PHARMO database is used for follow-up
studies, case-control studies and other analytical
epidemiological studies for evaluating drug-induced
effects.
20
21. 6.PERIODIC SAFETY UPDATE REPORTS(PSUR)
Pre marketing clinical trials may not be sufficient to reflect
the product safety profile.
Therefore medically advanced countries impose the
“post marketing drug safety monitoring period ” on new
drugs.
License holders shall proactively collect post marketing
safety data, prepare PSUR and submit them to the health
authority.
21
22. According to the “regulation of medical products
under safety monitoring” ,if pharmaceutical companies
fail to submit PSUR as required , then the health
authority may reassess the safety of the concerned
product.
The last PSUR should be submitted before the
expiration of the drug safety monitoring period.
The “summary bridging report” provides summarized
information of the PSURs.
22
25. Hartwig and Seigels scale
For assessing the severity-
1.Mild ADRs-are self limiting and do not
contribute
to prolongation of length of hospital stay.
2.Moderate ADRs- require therapeutic
intervention or hospital admission or prolonged
hospital stay by at least one day .
3.Severe ADRs- life threatening, requiring
intensive medical care or produce disability or lead
to death.
25
27. DEVELOPMENTS IN PV
USA
In February 2007, on the basis of the IOM report, the
FDA announced several initiatives designed to
improve the safety of prescription. These initiatives
fall into four main categories. These are :-
i. Increasing the resources for drug safety activities &
perceiving the agency as being overly dependent on
industry funding.
ii. Reform new authority for the FDA.
iii. Improvement of post-marketing surveillance.
iv. changes in the FDA management practices and
safety supervision are necessary
27
28. In May 2007, the U.S. senate passed its version of
reform for the FDA. The senate proposed that the
Prescription Drug User Fee Act, which allows the
pharmaceutical industry to pay money directly to the
FDA, should increase their payments to the FDA by
close to U.S. 400 million dollars.
EUROPE
In 2005, a document was drafted by the Heads of the
Medicines Agencies called ‘Implementation of the
Action Plan to Further Progress the European Risk
Management Strategy’.
28
29. The Yellow Card Scheme is the UK system for
collecting information on suspected adverse drug reactions
(ADRs) to medicines. The scheme allows the safety of the
medicines and vaccines that are on the market to be
monitored.
Founded in 1964 after the thalidomide disaster, and was
developed by Bill Inman.
It is run by the Medicines and Healthcare Products
Regulatory Agency (MHRA) and the Commission on
Human Medicines (CHM). Suspected ADRs are collected
on all licensed medicines and vaccines, from those issued
on prescription to medicines bought over the counter from a
pharmacist or supermarket.
The Scheme also includes all herbal preparations and
unlicensed medicines. ADRs can be reported by any
29
30. The sort of ADRs that should be reported are:
i. ADRs that have caused death or a serious illness
ii. Any ADR, however minor, if associated with a new medicine
or one that is under continued monitoring (highlighted in the
British National Formulary (BNF) with a ▼ black triangle)
iii. Any ADR, however minor, if associated with a child (under 18
years of age) or in pregnancy
Yellow Cards are available from pharmacies and a few are
presented near the back of the BNF as tear-off pages, copies
may also be obtained by telephoning +44 (0) 808 100
3352.The scheme provides forms that allow members of the
public to report suspected side effects, as well as health
professionals.
30
31. Officially started on 23 November 2004 at new Delhi.
Pharmaceutical industry in India is valued at 90,000crore
and is growing at the rate of 12-14% per annum.
Total export of Pharmacy products is to the extent of
40,000crore.
India is now being recognized as the “global pharmacy of
generic drugs”
31
32. India is also emerging rapidly as a hub of global clinical
trials & destination for drug discovery and development.
In a vast country like India with a population of over1.2
billion with vast ethnic variability ,different disease
prevalence patterns , practice of different systems of
medicines, different SES , it is important to have robust
Pharmacovigilance and drug safety monitoring
programmes.
32
33. PVPI is under control of-
1.CDSCO(Central Drugs Standard
Control Organization)
2.directorate general of health
services
3.Indian Pharmacopeia
Commission (Ghaziabad)
The programme is conducting by NCC(National
Coordinating Centre) .
33
34. Goals and objectives-
Goal- to ensure that the benefits of use of medicine
outweighs the risks.
Objectives-
1. To monitor ADRs .
2.To create awareness among health care professionals
about ADRs.
3. To monitor benefit-risk profile of medicines.
34
35. 4. Generate independent ,evidence based
recommendations.
5. Support the CDSCO.
6. Communicate findings with all stake holders.
7. Create a national centre.
35
36. PvPI is administered and monitored by the following committees:-
1.Steering Committee
2.Strategic Advisory Committee
36