Pharmacovigilance supports safe and appropriate use of drugs. Spontaneous reporting of adverse drug reactions (ADRs) is an essential component of pharmacovigilance. However, there is significant underreporting of ADRs. Adverse drug reactions have become a major problem in developing countries. Knowledge of pharmacovigilance could form the basis for interventions aimed at improving reporting rates and decreasing ADRs.
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Establishment of Pharmacovigilance ProgrammeNipun Gupta
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
complete description of causality assessment with the definition of basic terminologies.& relation with an adverse event and adverse drug reaction, causality terms & assessment criteria.
Slides includes ADR monitoring process, Safety reporting, what is pharmacovigilance, types of ADR, basic terms in ADR monitoring, what is PvPI in India, role. stakeholders, ADR reporting form, Apps, Role of community Pharmacist in ADR monitoring, Importance of ADR monitoring, etc.
Causality Assessment in PharmacovigilanceClinosolIndia
Causality assessment is the process of determining whether a particular drug or medical intervention is the cause of an adverse event or reaction that has occurred in a patient. The following are some key principles and factors that are considered in causality assessment:
Temporal relationship: The timing of the adverse event in relation to the drug or intervention is a key factor in causality assessment. If the adverse event occurs shortly after the drug is administered or the intervention is performed, this may suggest a causal relationship.
Biological plausibility: The biological mechanisms by which the drug or intervention could cause the adverse event should be considered. If there is a plausible biological mechanism for the adverse event, this may support a causal relationship.
Alternative explanations: Other factors that could have caused the adverse event, such as pre-existing medical conditions, should be considered and ruled out before attributing the event to the drug or intervention.
Dose-response relationship: If there is a clear dose-response relationship between the drug or intervention and the adverse event, this may suggest a causal relationship.
Rechallenge: If the adverse event reoccurs when the drug or intervention is readministered, this may provide further evidence for a causal relationship.
There are several methods for conducting causality assessment, including the Naranjo algorithm, the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system, and the Liverpool Causality Assessment Tool (LCAT). These methods use different criteria and scoring systems to evaluate the likelihood of a causal relationship between the drug or intervention and the adverse event.
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
Presentation: Global pharmacovigilance networks - A regulator'sTGA Australia
Global pharmaceutical companies manufacture and distribute a broad portfolio of drug products in multiples regions and countries. The pharmacovigilance system must ensure safety data collection in compliance with local regulations, and consolidate all sources to ensure an ongoing monitoring of potential changes in benefit-risk profiles. It must also guarantee a timely communication to patients, prescribers and regulatory authorities. The complexity resides in the need for a dense network of local safety departments, a strong global organisation processing and analysing cases, and a reporting system ensuring compliance to heterogeneous regulatory requirements. Pfizer has one of the largest pharmacovigilance department among all global companies, and has established patient safety as a core priority. We will describe how pharmacovigilance is organised at Pfizer, global compliance and individual patient safety.
History and Progress of Pharmacovigilance, Significance of Safety Monitoring, Pharmacovigilance in India And International Aspects, WHO International Drug Monitoring Programme, WHO and Regulatory Terminologies of ADR, Evaluation of Medication Safety, Establishing Pharmacovigilance Centres in Hospitals, Industry and National Programmes Related to Pharmacovigilance, Roles and Responsibilities in Pharmacovigilance, International Non-Proprietary Names for Drugs, International Classification of Diseases, Passive and Active Surveillance, Comparative Observational Studies, Targeted Clinical Investigations and Vaccine Safety Surveillance, Aris G Pharmacovigilance, VigiFlow, Statistical Methods for Evaluating Medication Safety Data
Establishment of Pharmacovigilance ProgrammeNipun Gupta
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
complete description of causality assessment with the definition of basic terminologies.& relation with an adverse event and adverse drug reaction, causality terms & assessment criteria.
Slides includes ADR monitoring process, Safety reporting, what is pharmacovigilance, types of ADR, basic terms in ADR monitoring, what is PvPI in India, role. stakeholders, ADR reporting form, Apps, Role of community Pharmacist in ADR monitoring, Importance of ADR monitoring, etc.
Causality Assessment in PharmacovigilanceClinosolIndia
Causality assessment is the process of determining whether a particular drug or medical intervention is the cause of an adverse event or reaction that has occurred in a patient. The following are some key principles and factors that are considered in causality assessment:
Temporal relationship: The timing of the adverse event in relation to the drug or intervention is a key factor in causality assessment. If the adverse event occurs shortly after the drug is administered or the intervention is performed, this may suggest a causal relationship.
Biological plausibility: The biological mechanisms by which the drug or intervention could cause the adverse event should be considered. If there is a plausible biological mechanism for the adverse event, this may support a causal relationship.
Alternative explanations: Other factors that could have caused the adverse event, such as pre-existing medical conditions, should be considered and ruled out before attributing the event to the drug or intervention.
Dose-response relationship: If there is a clear dose-response relationship between the drug or intervention and the adverse event, this may suggest a causal relationship.
Rechallenge: If the adverse event reoccurs when the drug or intervention is readministered, this may provide further evidence for a causal relationship.
There are several methods for conducting causality assessment, including the Naranjo algorithm, the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system, and the Liverpool Causality Assessment Tool (LCAT). These methods use different criteria and scoring systems to evaluate the likelihood of a causal relationship between the drug or intervention and the adverse event.
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
Presentation: Global pharmacovigilance networks - A regulator'sTGA Australia
Global pharmaceutical companies manufacture and distribute a broad portfolio of drug products in multiples regions and countries. The pharmacovigilance system must ensure safety data collection in compliance with local regulations, and consolidate all sources to ensure an ongoing monitoring of potential changes in benefit-risk profiles. It must also guarantee a timely communication to patients, prescribers and regulatory authorities. The complexity resides in the need for a dense network of local safety departments, a strong global organisation processing and analysing cases, and a reporting system ensuring compliance to heterogeneous regulatory requirements. Pfizer has one of the largest pharmacovigilance department among all global companies, and has established patient safety as a core priority. We will describe how pharmacovigilance is organised at Pfizer, global compliance and individual patient safety.
History and Progress of Pharmacovigilance, Significance of Safety Monitoring, Pharmacovigilance in India And International Aspects, WHO International Drug Monitoring Programme, WHO and Regulatory Terminologies of ADR, Evaluation of Medication Safety, Establishing Pharmacovigilance Centres in Hospitals, Industry and National Programmes Related to Pharmacovigilance, Roles and Responsibilities in Pharmacovigilance, International Non-Proprietary Names for Drugs, International Classification of Diseases, Passive and Active Surveillance, Comparative Observational Studies, Targeted Clinical Investigations and Vaccine Safety Surveillance, Aris G Pharmacovigilance, VigiFlow, Statistical Methods for Evaluating Medication Safety Data
Pharmacovigilance is defined as, The pharmacological science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines or Pharmacovigilance is the name given to the mechanisms and controls that together map and ensure the safety of a medicine throughout its life span – from test tube to patient.
PHARMACOVIGILANCE - A Worldwide masterkey for Drug MonitoringVenugopal N
Pharmacovigilance is the pharmacological science that aims at the detection, assessment, monitoring, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines to ensure drug safety.
The safe use of medicines is perhaps the single most important criteria that any regulatory authority within a given country has to ensure in order both to protect the public health and the integrity of its health care system. For the same purpose pharmacovigilance was established. According to WHO, Pharmacovigilance is the science and activities related to the collection, detection, and assessment of ADR’s. It promotes the systematic, rational use and assures the confidence for the safety of drugs. It improves patient care and safety. Significance of pharmacovigilance is growing as the patients or consumers have become more responsive about the advantage and hazard of medicines. Pharmacovigilance is a complex process and a robust system is essential to undertake the activity. A good pharmacovigilance system will identify the hazard aspects in the short period of time. This review article tries to explain the some basic principles, history and developments, methods and some scope of this developing field i.e. Pharmacovigilance in India.
This ppt is about pharmacovigilance in India & spontaneous reporting of adverse drug effect and there regulation by WHO or uppsala. It also include drug interaction in herbal medicine.
Implants- B.Pharm SEM 7- Novel Drug Delivery Systemvedanshu malviya
Implantable drug delivery device classification is not a straightforward task as there are a number of complex implants that will fall into hybrid categories. Nevertheless, implantable drug delivery devices can be broadly classified in two main groups: passive implants and active implants. The first group includes two main types of implants: biodegradable and non-biodegradable implants. On the other hand, active systems rely on energy dependent methods that provide the driving force to control drug release. The second group includes devices such as osmotic pressure gradients and electromechanical drives.
Enzyme Immobilization- Biotechnology- B.Pharm SEM 5vedanshu malviya
Immobilization is a technical process in which enzymes are fixed to or within solid supports, creating a heterogeneous immobilized enzyme system. Immobilized form of enzymes mimic their natural mode in living cells, where most of them are attached to cellular cytoskeleton, membrane, and organelle structures.
Concept of Health and Diseases- B.Pharm Semester 7vedanshu malviya
health is a state of bodily equilibrium while disease is a state of homeostatic failure. But the process of human growth as Boorse observed is itself leading to homeostatic disequilibrium . Value: disease is undesirable while health is desirable. Health is thus a social value in human society.
Microencapsulation in Novel Drug Delivery Systemvedanshu malviya
Microencapsulation is a process in which tiny particles or droplets are surrounded by a coating to give small capsules, with useful properties. In general, it is used to incorporate food ingredients, enzymes, cells or other materials on a micro metric scale.
Pharmaceutical film coating is considered a key part in the production of solid pharmaceutical dosage forms since it gives superior organoleptic properties products. In addition, it can improve the physical and chemical stability of dosage forms, and modify the release characteristics of the drug. Several troubleshooting problems such as twinning mottling, chipping, etc., may arise during or after or even during the shelf life of the film coated dosage forms. These troubleshooting problems may be due to tablet core faults, coating formulation faults and/or coating process faults. These problems must be overcome to avoid unnecessary product problems. Film coating as well as other parts of the pharmaceutical technology is subjecting to continuous innovation. The innovation may be at different levels including pharmaceutical excipients, processes, software, guidelines and equipment. In fact, of particular note is the growing interest in process analytical technology, quality by design, continuous coating processing and the inclusion of new ready for use coating formulations. In this review, we tried to explore and discuss the status of pharmaceutical film coating, the challenges that face this manufacturing process and the latest technological advances in this important manufacturing process.
The most common tablet manufacturing process techniques are wet granulation, dry granulation, and direct compression.
Your active pharmaceutical ingredients’ (APIs) physical and chemical stability influences manufacturing.
For successful tablet manufacturing, you need granulators, mixing equipment, drying machinery, and coating systems.
Even if you’re using the right equipment to manufacture your product, there is a wide range of common tablet defects that can occur that affect quality.
There are several goals to aim for during the tablet manufacturing process:
Develop tablets that are strong and hard enough to hold up against mechanical shock during manufacturing, packaging, shipping, and dispensing
Formulate tablets that are uniform in weight and drug content
Manufacture bioavailable products according to indication requirements
Create chemically and physically stable tablets that last over long periods
Formulate products that are free of defects and have an elegant finish
Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption.
Ayurveda, the knowledge of life, immortalized in the form of elegant Sanskrit stanzas in the samhitas describe diagnosis and therapy of disease as well as ways to maintain positive health. Although the technical term “Pharmacovigilance” does not feature in ayurvedic texts, the spirit of pharmacovigilance is vibrant and is emphasized repeatedly in all major texts. The major goals of pharmacovigilance, namely to improve patient care and safety in relation to drug use, and thus promote rational drug use are recurrent themes of ayurvedic pharmacology (dravyaguna vigyan) and therapeutics (chikitsa).
Pharmacokinetics (PK) is the study of how the body interacts with administered substances for the entire duration of exposure (medications for the sake of this article). This is closely related to but distinctly different from pharmacodynamics, which examines the drug’s effect on the body more closely. The four main parameters generally examined by this field include absorption, distribution, metabolism, and excretion (ADME). Wielding an understanding of these processes allows practitioners the flexibility to prescribe and administer medications that will provide the greatest benefit at the lowest risk and allow them to make adjustments as necessary, given the varied physiology and lifestyles of patients.
When a provider prescribes medication, it is with the ultimate goal of a therapeutic outcome while minimizing adverse reactions. A thorough understanding of pharmacokinetics is essential in building treatment plans involving medications. Pharmacokinetics, as a field, attempts to summarize the movement of drugs throughout the body and the actions of the body on the drug. By using the above terms, theories, and equations, practitioners can better estimate the locations and concentrations of a drug in different areas of the body.
The appropriate concentration needed to obtain the desired effect and the amount needed for a higher chance of adverse reactions is determined through laboratory testing. Using the equations given above, a clinician can easily estimate safe medication dosing over a period of time and how long it will take for a medication to leave a patient’s system. These are, however, statistically-based estimations, influenced by differences in the drug dosage form and patient pathophysiology. This is why a deep understanding of these concepts is essential in medical practice so that improvisation is possible when the clinical situation requires it.
Mixing is a general term that includes stirring, beating, blending, binding, creaming, whipping, and folding. In mixing, two or more ingredients are evenly dispersed in one another until they become one product.
The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United States.
What is ICH Q8 guidelines?
Image result for ICH Pharmaceutical development guideline-Q8
The ICH Q8 guideline is intended to provide guidance on the contents of Section 3.2. P. 2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4).
ICH Q7A means the good manufacturing practice guidance for active pharmaceutical ingredients developed under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
Tablet defects can come from any of the unit operations upstream and from the tablet press. The raw materials may be of poor quality or do not meet specifications, causing excessive fines that lead to a host of defects. The formulation may be the source of defects if the material does not compress well or the processing step specified within the formulation fail to produce a powder with a good flow, compressibility, and ejection properties. The processing and granulation of powder are often the sources of the defect.
Every product behaves differently on a tablet press, even if it‘s the same product run on a different day. The variation often
stems from changes in the properties of the raw materials—active ingredients and excipients- from batch to batch. Naturally,
the goal is to minimize these changes. Tablet press operators, however, don‘t have any control over formulation and
granulation. Tablet specifications are tight, and the list of possible defects is long: Variable weight, sticking, picking, capping, lamination, variable hardness, among others. This article focuses on these variations. It pinpoints the possible causes of these defects and offers advice on preventing and fixing the source of the problems.
The main principle involved in the FBP is the air suspension in which the material to be coated is suspended in the coating material with the help of an air stream. A fluid bed processor (fbp) is a popular material processing technique in different field industries.
The suspension dosage form has long been used for poorly soluble active ingredients for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts.
Distillation, or classical distillation, is the process of separating the components or substances from a liquid mixture by using selective boiling and condensation. Dry distillation is the heating of solid materials to produce gaseous products. Early evidence of distillation was found on Akkadian tablets dated c. 1200 BCE describing perfumery operations. The tablets provided textual evidence that an early primitive form of distillation was known to the Babylonians of ancient Mesopotamia.[8] Early evidence of distillation was also found related to alchemists working in Alexandria in Roman Egypt in the 1st century CE.
Polymorphism is the ability of solid materials to exist in two or more crystalline forms with different arrangements or conformations of the constituents in the crystal lattice. ... More than 50% of active pharmaceutical ingredients (APIs) are estimated to have more than one polymorphic form
Conductometry is a measurement of electrolytic conductivity to monitor the progress of the chemical reactions. Conductometry has notable application in analytical chemistry, where conductometric titration is a standard technique.
Navigating the Health Insurance Market_ Understanding Trends and Options.pdfEnterprise Wired
From navigating policy options to staying informed about industry trends, this comprehensive guide explores everything you need to know about the health insurance market.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
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CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
the IUA Administrative Board and General Assembly meeting
Introduction on Pharmacovigilance.pptx
1.
2. • Introduction of pharmacovigilance
• Drug safety in practice
• Need for monitoring the safety of drugs
• Organisation of pharmacovigilance
3. • Have knowledge of the definition of
pharmacovigilance
• What is a “serious” side effect, according to
the formal definition.
• Peruse the history of pharmacovigilance and
a number of side effects that have played a
role.
• Knowledge on how safety of medicines in the
Netherlands and Europe are organised
4. The science and activities relating to the
detection, assessment, understanding and
prevention of adverse drug effects or any
other drug related problem
5. A response to a drug which is noxious and
unintended, and which occurs at doses
normally used in man for prophylaxis,
diagnosis, therapy or for the modifications of
physiological function
6.
7. ADE: Adverse Drug Event
› Medical occurrence temporally associated with the use of a medicinal
product, but not necessarily causally related
› Not consistent with applicable product information or characteristics of
drug
AE: Adverse Event
› Medical occurence which is not necessarily causally related to the use of a
drug, and might rely on coincidence
Definition WHO
› Response of drug action in a person, resulting in experienced harm
8. A medical event that gives rise to one or more of the
following
› Death
› Life-threatening situations
› Hospitalization or prolongation thereof
› Permanent incapacity or disability
› Birth defects
› Other medically important conditions
9.
10.
11. Five years between first victim and the
withdrawal of thalidomide from the market
Establishment of Medicines Evaluation Boards
worldwide
Establishment of spontaneous reporting
centers to identify potential adverse drug
reaction in an early stage
12. Drug is back on the market and is now used
for the treatment of, for example
- Leprosy
- HIV / AIDS complications
- Multiple myeloma (multiple myeloma)
New cases of congenital malformations,
despite precautionary measures
13. Synthetic oestrogen for the prevention of
miscarriages
- On the Dutch market from 1947-1976
- Warning NTvG 1972
- Ministry of Health issued warning not to use
DES anymore in 1974
In children of mothers who used DES there
is an increasred risk of
- cervical cancer (Clear Cell Adenocarcinoma)
- deviations in the shape of the uterus
14.
15.
16. No children
No elderly
Not pregnant
Little or no comorbidity
Little or no use concomitant medications
Limited numbers
ADRs with long time onset hard to detect
17.
18. Extensive research before drug reaches the
market
At the time of market authorization has
balance safety / efficacy good
In post-marketing (Phase IV) more knowledge
open approach: spontaneous reporting
when needed additional studies
Combination of knowledge is used to monitor
balance safety / efficacy
19. Medicines Evaluation Board
Netherlands Pharmacovigilance centre
Healthcare professionals and patients
Marketing Authorization Holders
Inspectorate of health
EMA
WHO
20. Healthcare professionals should immediately
report any suspected serious adverse
reactions to a body of professionals and
patient organizations as referred to in Article
76, paragraph three, and any suspected
transmission via a medicinal product of
infectious agents
21. Signalling and Analysing as yet unknown
adverse events
- Identifying adverse events (partially from
Lareb)
- Evaluation of PSURs
Final risk/benefit assessment
Determine actions to be taken i.e. by
- Amendment of SmPC
- Dear Health Care Professional letter
- Suspension of withdrawal of drug
22. Amendment Summary of product characteristics
- New update
- Warning
- Contraindication
- Mitigate indication of use
Temporary suspension of drug
Withdraw drug from market
Informing medical professionals by a “Dear
Healthcare Professional Communication” (DHPC)
Initiate additional reasearch into the safety of a
drug
23. Monitoring safety of own products on a
continuous basis
- Spontaneous reports
- Evaluation of studies
- Literature
Periodic Safety Update Reports
If applicable, apply for an update in the
product information in between
24. Overview of serious and non-serious adverse reactions
worldwide
Frequency
- a PSUR every six months for the first two years after
being placed on the market
- during the following two years a PSUR every year
- thereafter at three-yearly intervals
- If needed more often…
Is change in SmPC needed?
25. Reports are forwarded to the Eudravigilance
database of the European Medicines Agency
Registration
- National (National Authorised products)
- Central (Central Authorised products)
Signal Detection via member states
- National level
- Central level
26. Provide advise on safety medicinal products
authorised in the EU
Investigation of ADRs to enable effective
assessment and management of risk during
any phase in product life cycle
27. • Evaluation of potential signals
• Provision of advice on confirmation and
quantification of risk and on regulatory
options;
• Risk management
• Monitoring regulatory action and the
outcomes
• Setting standards for procedures and
methodologies
28.
29. Receipt, analysis and recording of worldwide
adverse event data
Maintenance and screening of the
international database
Studies on WHO database
Training courses and meetings on
pharmacovigilance
30. 1. Website EMA: central registered products
2. Website national MEB (CBG): all other products
3. KNMP - Informatorium Medicamentorum (for
pharmacists)
4. Farmacotherapeutisch Kompas (free access)
5. Website Netherlands PV centre Lareb: spontaneous
reports; not always a causal relationship!
1 and 2 official information
Other sources additional and interpreted information