Geneva Pharma Forum on Pharmacovigilance: Partnering for
Patient Safety (Geneva, 20 November 2012), Jeremiah Mwangi, Director, Policy and External Affairs, IAPO
In the age of internet and social media, Dr. Carl Abelardo Antonio teaches us how to evaluate online health resources so we can tell which of them is gold and which of them is junk.
In the age of internet and social media, Dr. Carl Abelardo Antonio teaches us how to evaluate online health resources so we can tell which of them is gold and which of them is junk.
Dr. Julie Lyn Hall, WHO Country Representative for the Philippines, discusses the strategies of the WPRO in handling and preventing EIDs like Ebola and MERS-CoV in our region
Supporting agriculture and health ministries to implement a national food saf...ILRI
Poster by Hung Nguyen-Viet, Lucila Lapar, Seth de Vlieger, Nancy Johnson and Delia Grace at the 4th annual Leverhulme Centre for Integrative Research on Agriculture and Health (LCIRAH) conference, 3-4 June 2014, London, UK.
EUPATI Status Update at EMA PCWP Meeting, 26 Nov 2015jangeissler
Overview and Status Quo of the European Patients Academy (EUPATI) project, presented by EUPATI Director Jan Geissler at the EMA Patient and Consumer Working Party (PCWP) meeting in London on 26 Nov 2015
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
HCV HUB planning and implementation website introduction with a specific focus on the benefits provided to patient associations. http://hcvhub.deusto.es
HCV HUB planning and implementation website introduction with a specific focus on the benefits provided to health care professionals. http://hcvhub.deusto.es
“Biotherapy Drug Circulation Regulation in the Republic of Belarus. Current Status and Long-Term Prospects”
Illustrates the current norms in place in Belorussia for the marketing authorization of pharmaceutical products and the dossier requirements for biotherapeutics & biosimilars
Dr. Julie Lyn Hall, WHO Country Representative for the Philippines, discusses the strategies of the WPRO in handling and preventing EIDs like Ebola and MERS-CoV in our region
Supporting agriculture and health ministries to implement a national food saf...ILRI
Poster by Hung Nguyen-Viet, Lucila Lapar, Seth de Vlieger, Nancy Johnson and Delia Grace at the 4th annual Leverhulme Centre for Integrative Research on Agriculture and Health (LCIRAH) conference, 3-4 June 2014, London, UK.
EUPATI Status Update at EMA PCWP Meeting, 26 Nov 2015jangeissler
Overview and Status Quo of the European Patients Academy (EUPATI) project, presented by EUPATI Director Jan Geissler at the EMA Patient and Consumer Working Party (PCWP) meeting in London on 26 Nov 2015
Presentation in the framework of the International Conference "10th anniversary of the Spanish Network of Health Technology Assessment Agencies. Towads patient and public engagement in HTA" Zaragoza 27-28 April 2017
HCV HUB planning and implementation website introduction with a specific focus on the benefits provided to patient associations. http://hcvhub.deusto.es
HCV HUB planning and implementation website introduction with a specific focus on the benefits provided to health care professionals. http://hcvhub.deusto.es
“Biotherapy Drug Circulation Regulation in the Republic of Belarus. Current Status and Long-Term Prospects”
Illustrates the current norms in place in Belorussia for the marketing authorization of pharmaceutical products and the dossier requirements for biotherapeutics & biosimilars
“Regulatory experience with monoclonal antibody submissions in the EU”
Provides an overview of the current EU assessment of biotherapeutics, focusing specifically on monoclonal antibodies
“Immunogenicity testing of Biotechnology Products and the Impact to Biosimilars”
Illustrates procedures and potential outcomes of immunogenicity testing for biotherapeutics
“Pharmacovigilance in the Republic of Kazakhstan -Peculiarities. Biological medicinal products safety monitoring”
Shows the current pharmacovigilance system and practices in Kazakhstan, with a focus on biotherapeutic medicines
IFPMA Technical Briefing, Making Natural Product Research Work, Dr Bubpha Techapattaraporn, Research Assistant, Bioresource Technology Unit, BIOTEC National Center for
Genetic Engeneering and Biotechnology, Thailand (Geneva, 5 February 2013)
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. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
Jeremiah Mwangi of the International Association of Patients' Organizations talked about the role of patients and patient groups at the Partnership for Safe Medicines 2011 Interchange conference.
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
This session on safety was presented to the International Council of Nurses audience in Durban, South Africa. This is just a sample of the entire session; for more information on safety in the workplace, contact sharonw@corelimited.com
Antibiotic Guardian Birmingham Workshop4 All of Us
Antibiotic resistance is one of the biggest threats facing us today!
European Antibiotic Awareness Day (EAAD) is part of the UK 5 Year Antimicrobial Resistance Strategy 2013 to 2018, which focuses on antibiotics and sets out actions to slow the development and spread of antimicrobial resistance.
This year, to run in line with EAAD; Public Health England has established the Antibiotic Guardian pledge campaign. It calls on everyone in the UK, the public and healthcare community to become antibiotics guardian by choosing one simple pledge about how they will make better use of these vital medicines.
To ensure that the information and knowledge on Antibiotic Stewardship is disseminated to those practising healthcare across the nation, a series of awareness and educational events have been developed. These educational workshop events, to be held in Leeds, Birmingham and London, will provide guidance, resources and information for practitioners on topics associated with antibiotic awareness. The events will provide an opportunity to understand how you and your organisation can support combat the global challenge faced by antibiotic resistance whilst gaining advice, support and resources to inform patients and staff.
Rare Diseases SA has been actively improving the quality of life for those impacted by Rare Diseases over the last 5 years.
Our key focus areas have remained advocacy, patient navigation and community engagement, and through these strategic objectives we have successfully managed to see positive impact in our community.
From the development of over 80 patient connect points, to the implementation of a mobile app, RDSA has ensured patients remain supported and connected whilst the organization remains focused on our advocacy efforts.
The successful roll-out of our Rare Assist service has also seen a reduction in out of pocket costs for patients in the private sector.
We have attached our 5 year impact report which demonstrates some of the impact our work has had within our community. We have also included our programme overview of the Rare Assist Programme.
We would love to have your feedback on these reports, as well as feedback on the following questions:
1. What interest do you have with our organisation?
2. What is your current opinion on our work?
3. How would you like to stay informed about what we do?
4. What motivates you to stay connected with us?
Should you have any questions for us, we would love to hear from you.
Kind Regards
Kelly du Plessis
CEO -Rare Diseases South Africa
info@rarediseases.co.za
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatory Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines.
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatorz Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA Geneva Pharma Forum on 9 May 2014
Bringing Psoriasis into the Light
Presentation of Kim kjoeller, Senior Vice President
Global Development, Leo Pharma
IFPMA Geneva Pharma Forum on 9 May 2014
Bringing Psoriasis into the Light
Presentation of Professor Mahira Hamdy El Sayed
Dermatology and Venereology, Ain Shams University
David K. Robinson, Ph. D.Vice President, BiologicsHead and Executive Director, Biologics and Vaccines CMC RegulatoryMerck & Co, Inc.
Presenting on behalf of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)WCBP CASS, Washington DC, USAJanuary 2014
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
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
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.
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
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Hot Selling Organic intermediates
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...
Pharmacovigilance: Partnering for Patient Safety
1. Promoting patient-centred healthcare around the world
Pharmacovigilance: Partnering for
Patient Safety
Jeremiah Mwangi
Policy and External Affairs
Director
IFPMA Pharma Forum
November 20 2012
Genev, Switzerland
2. Promoting patient-centred healthcare around the world
Content of Presentation
• A short introduction to the International Alliance of
Patients’ Organizations (IAPO)
• Patient-Centred Healthcare
• The Patients Role in Patient Safety
• IAPO Toolkit on Patient Safety – Taking Medicines
Correctly
• IMI PROTECT – Innovative Methods for Reporting
• Conclusion
3. Promoting patient-centred healthcare around the world
About IAPO
• Unique global alliance of 215 national,
regional and international organizations Capacity Building
representing patients
• Crossing borders and diseases
• Vision: Patients throughout the world are at
the centre of healthcare
Advocacy
• Membership spans over 60 countries and
all world regions
• Representing an estimated 365 million
patients
Partnerships
4. Promoting patient-centred healthcare around the world
IAPO’s Mission
Our mission is to help build patient-centred healthcare
in every country by:
1. Realizing active partnerships with patients’
organizations, maximizing their impact through capacity
building
2. Advocating internationally with a strong patients’ voice on
relevant aspects of healthcare policy, with the aim of influencing
international, regional and national health agendas and policies
3. Building cross-sector alliances and working collaboratively
with like-minded medical and health professionals, policy
makers, academics, researchers and industry representatives
5. Promoting patient-centred healthcare around the world
An approach to healthcare is needed that focuses on the person
rather than the disease and involves people in their healthcare
aligning healthcare systems with patients’ needs:
→ Patient-Centred Healthcare
“The people have the right and
duty to participate individually
and collectively in the planning
and implementation of their
healthcare”
Alma Ata Declaration –
Principle IV (1978, WHO)
6. Promoting patient-centred healthcare around the world
What is patient-centred healthcare?
The IAPO Declaration on Patient-Centred Healthcare
outlines five principles:
• Respect and support for the individual patient, their wants, preferences, values,
needs and rights
• Choice and empowerment
• Patient engagement in health policy
(See www.patientsorganizations.org/involvement)
• Access and support
• Information that is accurate, relevant and comprehensive
(See www.patientsorganizations.org/information)
The essence of patient-centred healthcare is that the healthcare system is
designed and delivered so that it can answer the needs of patients
7. Promoting patient-centred healthcare around the world
What can patients and patient groups do?
Advocate – Advocate to raise political will to take action and
implement appropriate patient safety strategies and partner with
healthcare systems to develop solutions for patient safety
Educate – Educate and train patient groups to make an informed
contribution to patient safety initiatives and patients be informed and
empowered to make a personal contribution to safety
Raise awareness – Raise awareness of patient safety issues with
the public and the media
8. The Quality and Safety of Medicines
ACT NOW!
• Work with patients and health professionals to improve
communication of medicines information and the importance
of monitoring of adverse drug reactions
• Advocate for good quality information for patients
• Advocate for stronger political will and action to combat
substandard and counterfeit medicines, including appropriate
penalties for counterfeiters
• Raise awareness of the dangers of substandard and
counterfeit medicines.
9. The Quality and Safety of Medicines
Key information, facts and figures
• Medicines contain potent ingredients and therefore carry an
inherent risk that they may cause unexpected and sometimes
harmful reactions or side effects in some people. Because of this,
many countries have laws and regulations to ensure that medicines
are safe and meet certain quality criteria relating to their
development, manufacture, storage and distribution.
• Adverse Drug Reaction related hospital admissions represent
around 10% of total admissions in many developed countries.
• Counterfeit and substandard medicines are those whose
ingredients and/or composition do not meet required standards as
set by authorities and regulatory agencies.
• During a meningitis epidemic in Niger in 1995, 50,000 people
were inoculated with fake vaccines (a gift from another country that
thought they were safe) causing 2,500 deaths.
11. PROTECT Goal
To strengthen the monitoring of benefit-risk
of medicines in Europe by developing
innovative methods
to enhance early detection and
assessment of adverse drug
to enable the integration
reactions from different data
and presentation of data
sources (clinical trials,
on benefits and risks
spontaneous reporting and
observational studies)
These methods will be tested in real-life situations.
11
12. Work Package 4
Objectives:
• To assess the feasibility, efficiency and usefulness of modern
methods of data collection including using web-based data
collection and computerised, interactive voice responsive systems
(IVRS) by telephone
• To pilot approaches between data sources
• To measure the acceptability of these methods and assess the
transferability of data collection methods in different countries and
for other conditions
Prospective study in pregnant women in four countries is under
development:
• Denmark • United-Kingdom
• The Netherlands • Poland (tbc) 12
13. Work Package 5
Objectives:
• To assess and test methodologies for the benefit-risk
assessment of medicines
• To develop tools for the visualisation of benefits and
risks of medicinal products
Individual and population-based decision making
Perspectives of patients, healthcare prescribers, regulatory
agencies and drug manufacturers
From post-approval through lifecycle of products
13
14. Promoting patient-centred healthcare around the world
Conclusion
Patients need access to quality and safe medicines.
Pharmcovigilance is essential to medicines safety and patients are
key to its success.
Improve information on pharmacovigilance for patients:
• What is it?
• Why is it important?
• How should patients act?
Above all – Global commitment to improve regulation and
monitoring
15. Promoting patient-centred healthcare around the world
Contact us
Please visit our website to find out more:
www.patientsorganizations.org
If you would like to receive our free monthly email newsletter and
details of other publications, please send your details to us:
International Alliance of Patients’ Organizations
49-51 East Road
London N1 6AH
United Kingdom
Tel: +44 20 7250 8280
Fax: +44 20 7250 8285
Email: info@patientsorganizations.org
Website: www.patientsorganizations.org