detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
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.
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
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.
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
pharmacovigilance from pharmaceutical administration topic presented by konatham kumar reddy from chilkur balaaji college of pharmacy hyderabad telangana
Managing an end to end Pharmacovigilance system from affiliates to regulatory...MyMeds&Me
MyMeds&Me CEO Dr. Andrew Rut explores how technology can help address the challenges facing Pharmacovigilance teams.
He reviews how the latest intake technology can influence end-user experience and effectiveness, as well as internal value & efficiency.
He concludes that a focus on simplifying case intake re-shapes the traditional PV system, enabling Pharma companies to reap significant process and efficiency benefits.
Ayurveda technology ETG AyurvedaScan which is the only hi-technology approved by the Government of India, comes under Right to information, is elaborating by Dr DBBajpai the inventor of the technology and Chief ETG AyurvedaScan Investigator.
आयुर्वेद सिध्धान्तों का आधुनिक हाई टेक्नोलाजी इलेक्ट्रि त्रिदोष ग्राफ ई०टी०जी...Dr. Desh Bandhu Bajpai
आयुर्वेद के नाड़ी परीक्षण के मूल सिध्धान्तों को एक तरफ आधार मानकर तथा दूसरी तरफ आधुनिक वैग्यानिक दृष्टिकोण को स्वीकार करते हुये और इसके साथ साथ आधुनिक वैग्यानिक खोजों तथा प्राचीन ग्यान के बीच मे अन्त: सम्बन्ध यानी को-रिलेशन को केन्द्रीय विचार मानते हुये आयुर्वेद के अन्य तमाम मौलिक सिध्धन्तो को वैग्यानिक सामन्जस्य को साथ लेते हुये और तारतम्य और एकरूपता को एक सूत्रीय बनाये रखते हुये ऐसे विचार को लेकर प्रस्तुत पुस्तक की रचना की गयी है /
आयुर्वेद के आदि रचित शास्त्रीय ग्रन्थो मे आयुर्वेद के मौलिक सिध्धन्तो का प्रतिपादन किया गया है / इन सिध्धान्तो और नियमो को लेखको और व्याख्याकारों द्वारा कई तरह से समझाने की कोशिश की गयी है / आयुर्वेद के सिध्धान्त यथा दोष, त्रिदोष, त्रिदोष भेद, सप्त धातुयें, मल, उप-धातुयें और कार्य विकृति और दोष विकृति और स्थापित दोषो के शरीर मे स्थान आदि की व्याख्या चरक, सुश्रुत, वाग्भठ्ठ, भाव मिश्र , शारन्गधर आदि के द्वारा की गयी है /
नाड़ी परीक्षण के द्वारा त्रिदोषो का ग्यान करने का परिचय भाव प्रकाश ग्रन्थ मे मिलता है / वैग्यानिक दृष्टिकोण से देखा जाय तो यही एक आयुर्वेद मे परीक्षण विधि है जिसके द्वारा शरीर के त्रिदोषो का अन्कलन किया जा सकता है / आयुर्वेद के ग्रन्थों में पन्च विधि और अष्ट विधि और दश विधि परीक्षण के अलावा आकृति परीक्षा और मल तथा मूत्र और स्वेद परीक्षा का भी वर्णन ग्रन्थों में मिलता है , जिनके द्वारा भी त्रिदोष का अन्कलन किया जा सकता है , ऐसा आयुर्वेद के महर्षियो ने बताया है /
यद्यपि वैग्यानिक दृष्टिकोण से और आधुनिक प्रत्यक्ष और प्रमाण की दृष्टि से साक्ष्य आधारित विधि का नूतन आविष्कार, जिसको ” इलेक्ट्रो त्रिदोष ग्राफ ; ई०टी०जी० आयुर्वेदास्कैन ” का नाम करण लेखक द्वारा किया गया है, इस विधि द्वारा आयुर्वेद के लगभग समस्त मुख्य मौलिक सिध्धन्तो का मूल्यान्कन किया जा सकता है, जिन्हे आयुर्वेद मे बताया गया है / यह परीक्षण आधुनिक डिजिटल कम्प्यूटेराइज़्ड मशीनो द्वारा किया जाता है, इसलिये अब आयुर्वेद साक्ष्य आधारित चिकित्सा विग्यान यानी इवीडेन्स बेस्ड मेडिकल साइन्स हो गयी है /
ई०टी०जी० आयुर्वेदास्कैन सिस्टम को भारत सरकार द्वारा परीक्षित किया जा चुका है / प्राचीन विग्यान और अर्वाचीन विग्यान दोनों के समन्वयन के द्वारा आयुर्वेद को आधुनिक वैग्यानिक स्वरूप देने का प्रयास लेखक और सम्पादक द्वारा किया गया है /
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.
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
a presentation in CME activities by Saad Specialist Hospital, KSA
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 is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.
Pharmacovigilance - Defination, Aim, Need ,Importance ,history, workflow, co...MADHAV JAJNURE
pharmacovigilance(PV)
Defination of pharmacovigilance
Aims of pharmacovigilance
Origin of pharmacovigilance
History of pharmacovigilance
Importance of pharmacovigilance
Work flow of Pharmacovigilance
Conclusion
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.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
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.
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.
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
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
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
We understand the unique challenges pickleball players face and are committed to helping you stay healthy and active. In this presentation, we’ll explore the three most common pickleball injuries and provide strategies for prevention and treatment.
2. ADVERSE DRUG REACTION
•
We define an adverse drug reaction as "an
appreciably harmful or unpleasant reaction,
resulting from an intervention related to the use
of a medicinal product, which predicts hazard
from future administration and warrants
prevention or specific treatment, or alteration of
the dosage regimen, or withdrawal of the
product."
3. 3Pharmacovigilance
•
The science and activities relating to the detection,
evaluation, understanding and prevention of
adverse drug reactions or any other drug-related
problems
4. 4
Aims of
Pharmacovigilance
•
To improve patient care and safety
•
To improve public health and safety
•
To contribute to the assessment of benefit, harm,
effectiveness and risk of medicines
•
To promote understanding, education and clinical
training
5. 5Who are the partners?
•
Government
•
Industry
•
Hospitals and academia
•
Medical and pharmaceutical associations
•
Poisons information centres
•
Health professionals
•
Patients
•
Consumers
•
Media
•
WHO
6. 6History
•
1986 - a formal adverse drug reaction (ADR)
monitoring system consisting of 12 regional
centers, each covering a population of 50 million,
was proposed for India.
•
In 1989, under the aegis of the Drug Controller of
India, six regional centres were set up in
Mumbai, New Delhi, Calcutta, Lucknow,
Pondicherry and Chandigarh.
7.
8. 8
•
In 1997, India joined the WHO Programme for
International Drug Monitoring managed by the
Uppsala Monitoring Centre, Sweden.
•
Of the six centres, only the centres in Mumbai
and New Delhi were active, yet spontaneous
reporting of ADRs was poor.
9. 9History
•
Recognising the need for improved ADR
monitoring in India, the Government of India
sent a proposal to the World Bank for funding.
•
The World Bank approved the proposal with an
annual grant of $US 0.1 million for 5 years and
the National Pharmacovigilance programme was
launched in November 2004.
11. 11
1959 / 61– Epidemia de focomelia por
Talidomida (4.000 – 10.000 casos no mundo,
com 15% de mortos)
12. 12
Reason 1:
•
Humanitarian concern –
•
Insufficient evidence of safety from clinical trials
•
Animal experiments
•
Phase 1 – 3 studies prior to marketing authorization
13. 13
Examples of product recalls due to toxicity
MEDICINE YEAR Examples of serious and
unexpected adverse
events leading to
withdrawal of medicine
Thalidomide 1965 Phocomelia
Practolol 1975 Sclerosing peritonitis
Terfenadine 1997 Torsade de pointes
Rofecoxib 2004 Cardiovascular effects
Veralipride 2007 Anxiety, depression,
movement disorders
Rosiglitazone 2010 Cardiovascular effects
Nimesulide 2011 Hepatotoxicity
14. 14Reason 2
•
Medicines are supposed to save lives
•
Dying from a disease is sometimes unavoidable;
dying from a medicine is unacceptable.
Lepakhin V. Geneva
2005
15. 15
•
More than 3% of all
deaths seem to be
caused by adverse
reactions to medical
drugs, according to
new research.
18. 18Cost of ADRs in the US?
•
Cost of drug related morbidity and mortality
exceeded $177.4 billion in 2000 (Ernst FR &
Grizzle AJ, 2001: J American Pharm. Assoc)
•
ADR related cost to the country exceeds the cost
of the medications themselves
25. 25
•
According to a fact sheet by WHO(May-2010) about the rational use of medicines ,more than 50
percent of all medicines are not correctly prescribed ,dispensed, and sold: and more than 50
percent patients take their drugs incorrectly.
26. 26Reason 6
•
Ethics
•
To know of something that is harmful to another
person who does not know, and not telling, is
unethical
27. 27
•
Not reporting a serious unknown reaction is
unethical
valid for everyone
patient
health professional
manufacturer
authorities
30. 30What to report?
•
The programme particularly solicits reports of:
•
• All adverse events suspected to have been
caused by new drugs and •drugs of current
interest'
•
(List published by CDSCO {Central Drugs
Standard Control Organization} from time to time)
31. 31
•
• Reactions to any other drugs which are
suspected of significantly affecting a patient's
management, including reactions suspected of
causing:
•
• 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.
38. 38HOW?
•
Monitor clinical status of patients
•
Identify the correct ADRs not side effects
•
Get more information
•
Investigate at hospital level
•
Help practitioners to fill-up the forms
•
Keep patient’s record if more information needed
39. 39CONCLUSION
•
Pharmacovigilance looks at all available
information to assess the safety profile of a drug.
•
Pharmacovigilance should also take the benefit of
the drug in account.
•
Pharmacovigilance is required for systematically
identifying and correlating drugs and side-effects
and taking corrective actions, especially for the
product launching first time in India.
41. 41
•
Tegaserod is reported to
increase the risk of heart
attacks by 10 times, while
the use of gatifloxacin in
elderly patients may
increase risk of
developing serious
hyperglycemia 17 times
compared with other anti-
biotics