Safety Data Exchange Agreements (Brief)
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• Understand when to start and where to look for emerging safety information.
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• Discuss current methods that can increase the likelihood of early detection of a safety issue and minimize the issues surrounding.
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Please join Elizabeth E. Garrard, PharmD, founder and CEO of Garrard Safety Solutions, as she reviews key issues in literature surveillance for Pharmacovigilance.
Objectives:
• Understand the regulatory obligations, best sources and procedures for conducting literature surveillance.
• Appreciate some examples of when a safety signal was detected in the literature and its impact on the lifecycle of a drug.
• Understand when to start and where to look for emerging safety information.
• Setting up your search strategy, how to ensure your search strings are well balanced, recognizing the challenges between precision and sensitivity.
• What is the impact of the new literature monitoring by EMA of a number of substances in selected medical literature to identify suspected adverse reactions with medicines authorized in the European Union. Early insights into successes and issues.
• Discuss current methods that can increase the likelihood of early detection of a safety issue and minimize the issues surrounding.
• Realize the challenges we face including wide differences in quality, accuracy, and completeness in the scientific literature and how best to navigate these differences and maintain proper vigilance.
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The European Medicines Agency has observed several challenges in the first year of implementing the Medical Device Regulation for drug-device combination products. Issues include inconsistent device classification, clarifying economic operator roles, and determining what constitutes a substantial device change requiring a new notified body opinion. The EMA is working to address these challenges through ongoing dialogue and plans to update guidance on the regulation.
Fda postmarket surveillance-report-september-remediated
This document proposes strengthening the US national system for medical device postmarket surveillance. It outlines 4 key actions: 1) Establish a unique device identification system. 2) Promote national/international device registries. 3) Modernize adverse event reporting and analysis. 4) Develop new methods for evidence generation, synthesis, and appraisal. The goal is a near real-time surveillance system using electronic health data to quickly identify safety issues and characterize device risks and benefits.
PMS and Outsourcing - Copy.pptx
Post-marketing surveillance involves monitoring drug safety after market release. It identifies rare or long-term adverse effects not seen in clinical trials. Manufacturers must report serious adverse events to regulatory agencies. Outsourcing bioavailability and bioequivalence studies to contract research organizations allows companies to access expertise and resources while reducing costs and time to market. CROs conduct clinical trials, data analysis, and reporting according to Good Clinical Practice standards. Qualification of appropriate CROs involves assessing capabilities, infrastructure, compliance history, and collaboration effectiveness.
OF_Simposio_Cientifico_20160921
"Pharmaceutical sciences
and the challenge for a healthcare focused agenda for pharmacists training"
(A interface ensino-profissão no desenvolvimento das Ciências Farmacêuticas)
Rogério Gaspar
(Presidente da SPCF)
21.SET.2016
Pharmacovigilance systems & methodologies across the globe
The document discusses various pharmacovigilance systems and methodologies used around the world to monitor the safety of medicines. It describes the WHO global database VigiBase which contains reports of adverse drug reactions. It also outlines other pharmacovigilance systems like EudraVigilance in Europe, FAERS in the US, Canada Vigilance in Canada, and the Yellow Card Scheme in the UK. The document then discusses data mining and analysis techniques used for pharmacovigilance, including those for pre-marketing surveillance using computational approaches as well as those for post-marketing surveillance using spontaneous reporting systems, electronic health records, and non-traditional data sources.
International Regulatory Overview 2009 Rev Linkedln
Roger Leclerc presented on international medical device regulatory challenges and overviews. He discussed regulatory bodies and their challenges in Canada, the US, Europe, Australia and Asia. For Health Canada, he outlined strategic objectives like modernization, adequate funding, and improved governance. Key regulatory issues from 2008-2009 included standards recognition, special access programs, significant changes, and sale of unlicensed devices.
cmc [ chemistry manufacturing control ]
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
Medical device management in china and latest regulatory updates_Edwin
Currently, China is one of the world's most promising markets for medical devices, which on the back of its vast market size, offers huge potential to medical device companies. All medical devices marketed or sold for use in China must be registered with China Food and Drug Administration (CFDA).
German hospital network, AVS. Birgitta Schweicker (Germany)
German hospital network, AVS. Birgitta Schweicker (Germany)European Centre for Disease Prevention and Control (ECDC)
Presentation from the 3rd Joint Meeting of the Antimicrobial Resistance and Healthcare-Associated Infections (ARHAI) Networks, organised by the European Centre of Disease Prevention and Control - Stockholm, 11-13 February 2015European Medicines Agency policy on publication of clinical data for medicina...
European Medicines Agency policy on publication of clinical data for medicinal products for human use
Similar to Safety Data Exchange Agreements (Brief) (20)
International Overview & Future Medical Devices Regulations
International Overview & Future Medical Devices Regulations
Clinical evaluation report cer in a more stringent regulatory- Pepgra Healthcare
Clinical evaluation report cer in a more stringent regulatory- Pepgra Healthcare
IPI - Developing Global Solutions for Product Safety
IPI - Developing Global Solutions for Product Safety
presentation-ema-experience-mdr-implementation_en.pdf
presentation-ema-experience-mdr-implementation_en.pdf
Fda postmarket surveillance-report-september-remediated
Fda postmarket surveillance-report-september-remediated
Pharmacovigilance systems & methodologies across the globe
Pharmacovigilance systems & methodologies across the globe
International Regulatory Overview 2009 Rev Linkedln
International Regulatory Overview 2009 Rev Linkedln
Medical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_Edwin
German hospital network, AVS. Birgitta Schweicker (Germany)
German hospital network, AVS. Birgitta Schweicker (Germany)
European Medicines Agency policy on publication of clinical data for medicina...
European Medicines Agency policy on publication of clinical data for medicina...
More from Arete-Zoe, LLC
Availability of essential medicines in the Czech Republic (2017)
This report analyzes availability of essential medicines as defined in the World Health Organization (WHO) Essential List Medicines (Report of the WHO Expert Committee) in the Czech Republic. The WHO list of essential medicines contains most effective and safe medicines needed to meet the most important needs in health systems, and is frequently used by countries to create their own national lists. Without these drugs, some conditions will not be able to receive optimal therapy. Availability gap represents serious public health concern.
Expert Committee of the World Health Organization selects Essential Medicines Lists in accordance with approved procedures. The Committee evaluates the scientific evidence on the basis of the comparative effectiveness, safety and cost–effectiveness of the medicines. Both lists (adult and pediatric) went through major revisions in 2015, as the Committee considered 77 applications, including 29 treatment regimens for cancer, hepatitis C and tuberculosis (The Selection And Use Of Essential Medicines. Report Of The WHO Expert Committee, 2015).
Local availability is expressed as registration, in the form of total number of licensed products, and number of marketed products, i.e. products that were on the market in Q3 2016. Of the total number of 13,256 individual registrations for essential medicines, only 2,110 (14%) were actively marketed in Q3 2016. Total number of licensed and marketed product equals all strengths, formulations and dosage forms counted separately. The dataset is current as of December 30, 2016. Any revisions to the database made in the period between data download and publication of this report are not considered. Locally available products were compared to the WHO list of essential medicines. The material is presented in graphs and summary tabulations as listed in the table of contents.
Of the 427 essential drugs, 311 are registered in the Czech Republic, 292 were registered and marketed in Q3 2016, 19 were registered but not marketed, and 135 (32%) were unavailable. Most affected classes are antibacterials, antituberculars, antiretrovirals, antiparasitics, and dermatologicals. Essential medicines availability gap overlaps significantly with drugs that are in shortage globally.
The report provides overview of the situation in the Czech Republic. Essential medicines availability gap represents both public health concern and risk of harm to individual patients. Substitute and second line therapies are often less effective, more toxic, or more expensive. Improvisation and the use of less familiar medicines are more likely to lead to medication errors. Mitigation of shortages and creation of shared contingency supplies puts additional strain on understaffed hospitals, in addition to human toll inflicted by social stress. Drug shortages make it impossible to follow evidence-based practice guidelines, and force decisions to prioritize certain group of people over another.
Post-marketing safety surveillance of medical devices and drug-device combina...
ISoP Medical Device SIG Webinar on Post-marketing safety surveillance of medical devices and drug-device combination products
https://isoponline.org/special-interest-groups/medical-devices-group/
PMS is an integral part of a quality management system described in ISO 13485. ISO 13485 references inclusion of applicable regulatory requirements on post market surveillance into the quality management system.
Regulatory requirements are country specific and are continuously evolving. The regulatory processes for devices are significantly different than for drugs. Moreover, the requirements for drug-device combination products are not always clearly articulated.
• In Europe, according to the EU MDR, post-market surveillance shall also allow a comparison to be made between the device and similar products available on the market.
• The first challenge is identifying similar products on the market, that is out of the scope of this webinar. The second challenge is finding relevant information on equivalent and similar products.
• Since EUDAMED does not currently have a post-marketing module, manufacturers have to rely on a large number of national databases. The focus of this webinar is on regulatory requirements in major jurisdictions. There will be another webinar coming soon that will focus on how to obtain the information required to comply with all these requirements.
• With some effort, it is possible to locate information on advisory notices.
• However, adverse events or incidents are not publicly available. This is a major difference from medicinal products.
• In addition, certain AEs are subject to the National Competent Authority Report (NCAR) Exchange. These reports are shared between agencies and can potentially result in FSCA. So even when unable to monitor competitor product adverse event profile, it is important to know about their FSCAs.
Sexual assault (2017)
Sexual assault cases regularly make headlines and can potentially cause serious reputational harm to law enforcement agencies and police departments for mishandling the cases or not pursuing them vigorously enough.
The picture on the left shows the latest developments in a long-term problem of sexual assault on college campuses. In June, Candice Johnson, OCR Acting Assistant Secretary for Civil Rights issued a memo that effectively stalled investigation of civil rights violations including sexual assault on campuses. A month later, Democratic Senators Kirsten Gillibrand from New York State and Claire McCaskill from Missouri urged Secretary of Education Betsy Devos to reverse this decision as unlawful because of failure to protect students under Title IX. Full text of the memo and Title IX, Sec. 1681 Sex are part of your lesson handout.
Similar problem with widespread sexual assault, and especially against minors, is a long-term problem at cruise ships. Because of the nature of cruise ships, there is no immediate response by law enforcement and the ship guards that investigate the matter are the cruise company’s employees therefore often unlikely to be of meaningful help to the victims. Jurisdiction can be federal, state or foreign, depending on the ship’s flag.
Finally, sexual violence in a workplace can be difficult to address because of the unequal relationship between parties and under-reporting. Recently, car company Tesla appeared in the news as a hostile workplace to women.
Mitigating consequences of a drug-facilitated sexual assault .pdf
Mitigating consequences of a drug-facilitated sexual assault
First published: 27 Jan 2017
Revised: 19 Jan 2020
Drug-facilitated sexual assault (DFSA) is not just bad sex. It occurs either without the victim’s consent or with consent that cannot be considered valid due to incapacitation of the victim by alcohol or drugs. While opportunistic DFSA is carried out once the victim has been rendered unconscious by own actions, pro-active DFSA describes situations when the perpetrator spikes the victim’s drinks covertly.
The most frequently used drug in DFSA is alcohol. Other drugs often involved include flunitrazepam (Rohypnol), gamma-hydroxybutyrate (GHB), gamma-butyrolactone (GBL), carisoprodol (Soma) and ketamine. Ecstasy (MDMA) and other benzodiazepines are occasionally used also. These drugs rapidly induce drowsiness, sedation and muscle relaxation. Typical symptom is decreased inhibition. Most of the drugs used for DFSA are odorless and tasteless, with the exception of GBL that has a bitter taste. Memoryy loss is common, most victims have little to no recollection of the previous night.
The most common way of obtaining these drugs is through the darknet. Benzodiazepines, GHB (Xyrem), and ketamine (an anesthetic used in human and veterinary medicine) are often diverted from legitimate medical use for illicit purposes.
In 2012, in U.S. v. Caronia became one of the landmark cases in the promotion of prescription drugs for unapproved (off-label) indications. Physicians who prescribe Xyrem (GHB) have to pass special certification to ensure safe prescription, handling, and storage of the drug (REMS).
Sedative or tranquilizer Flunitrazepam is still legally manufactured in Europe and some countries in Latin America. The drug has been reformulated, so it imparts an easily identifiable blue color to clear beverages and haziness to colored drinks. Drugs obtained from illegal manufacturing sources naturally do not display this effect.
DFSAs are increasingly popular in bars, clubs, and raves, but also fraternities and at college campuses. Mishandling of cases of sexual assault at college campuses has been subject to much criticism.
It is very difficult to estimate the total number of DFSAs. The main reason for failure to report sexual assault is the reluctance of the victims to go to the police. Indications exist that the numbers are on the increase. Because of memory loss associated with these drugs, victims often feel embarrassed or guilty. Additional reasons for not reporting sexual assault include need to avoid further stigmatization, especially when the evidence does not seem to be sufficient to support the claim confidently. Forensic evidence is difficult to obtain and often lost after first urination the morning after. All drugs used for DFSA are metabolized rapidly by the body, rendering them undetectable within 24 to 48 hours after ingestion.
Approach to preparing for a biological attack (2017)
Approach to preparing for a biological attack
June 2017
Hospital risk management series
The debate on critical issues in science, health, and security encompasses many controversies and ethical challenges. The difference between a naturally occurring outbreak and criminal act of bioterrorism is often challenging to establish, and emergencies have to be handled as they come, regardless of the origin of the incident. The post-incident forensic analysis may or may not offer satisfactory answers in regards to attribution, liability, and the responsibility for compensation. The underlying issue for all ethical concerns examined in this work is the balance between individual rights and the needs of public health systems to protect others.
Improving the resilience of vulnerable populations
Vulnerable populations in terms of health care disparities include the economically disadvantaged and uninsured, the elderly, and people with chronic health conditions. Low-education status compounds the problem and leads to poorer outcomes than in people with the same disease but higher educational status. Significant disparities include namely risk factors relating to morbidity and mortality and access to healthcare. In the domain of physical health, the worst affected are people with chronic health conditions such as respiratory diseases and metabolic syndrome, including hyperlipidemia and diabetes, and resulting in heart diseases and hypertension. Vulnerable populations often experience accumulation of problems that are multiplied by poor health, yet the medical and non-medical needs of these populations are still underestimated. A significant number of vulnerable people with at least one chronic condition skip purchasing prescription drugs because of the costs involved. The most relevant risk factors that result in poor access to health care include low income and uninsured status, in combination with a lack of regular care. Chronic conditions such as dyslipidemia may not be particularly apparent now, yet represent a high risk of future disability (“Vulnerable Populations: Who Are They?”, 2006).
Pricing transparency at point of care
Medical innovation, increasing the complexity of care, and the relationships between stakeholders gradually lead to the increase in prices of healthcare for consumers. Lack of transparency affects the cost of premiums as well as out-of-pocket expenses. Policymakers in their considerations need to include more indicators than just insurance coverage that, without other measures, will not curb soaring healthcare expenses. Delayed care is a public health concern because of the risk of disability and under-treatment of otherwise treatable conditions. The presentation of data to non-technical audiences, including decision-makers, has to be understandable to convey the information reliably. Systems modeling techniques should be considered to estimate stakeholder behavior in a dynamic system accurately. Currently, many instances of abuse exist within the system. As an example, chargemaster fees apply to uninsured or out-of-network patients. Hospital fees are, however, tackled by state laws rather than at the federal level. Consumers in health care tend to behave differently than in other industries and often think less about the costs involved. Physicians’ education should include the delivery of cost-conscious care to prevent financial harm to their patients. Transparency of cost is one of the most effective mechanisms that enable patients and providers to make informed choices.
Handling a high-risk HIPAA Breach
Handling a high-risk HIPAA Breach Published April 2017 Part of scenarios for patient privacy crisis management Every hospital encounters patients, who for the reason of their social circumstances, dependent status, personal characteristics, or the nature of their condition, are more vulnerable than the general population. While compliance with HIPAA is indeed important, because of the potential to inflict significant liability on the hospital resulting from compliance failure, it should not be the only consideration when caring for vulnerable patients. Mere compliance with the minimum requirements of HIPAA does not guarantee the safety of vulnerable patients. In the case study scenario, the hospital emergency department in a small town admitted a 15-year-old female with emergency labor. After delivery in the emergency room, the mother and the baby were moved to Obstetrics and Neonate. Despite appropriate care, the infant presented with multiple medical problems, which may or may not be resolved in the future. A nurse, who took care of the young mother, accidentally disclosed the patient’s identity and condition to her young daughter, who spread the news in all high schools in the area by the following day. The 15-year-old managed to hide her pregnancy from her family. To complicate matters, the young mother’s mother and aunt work in the same hospital.
Addressing pediatric medication errors in ED setting utilizing Computerized P...
Pediatric patients who are treated in general acute care hospitals are at increased risk of medication errors. The main reasons are the lack of experience with the special needs of pediatric patients, their lower ability to tolerate medication errors, medication-related problems such as forms and packaging designed primarily for adults and labeling with insufficient information on the dosing of pediatric patients. Medication errors can be reduced significantly by appropriate medication management systems. Computerized Provider Order Entry (CPOE) systems reduce the frequency of medication errors in all stages of the process. IT technology introduces an additional vulnerability in the form of IT-related medication errors. Nurses are the last individuals in the medication management process who can detect and intercept a medication error and prevent incorrect medication orders from reaching and harming their patients. To be able to do so, nurses have to be familiar with the medication management system in their hospital and escalate incorrect orders as appropriate and relevant.
Let's talk causality attribution: Current practices and path forward
Consistent and reliable causality attribution at the case level is the cornerstone of confident signal detection.
The current practice relies on study investigators to establish causal relationships based on their observations. The Sponsor (Company) can add their assessment based on additional information about the drug. The current industry standard, E2B (R3), accounts for multiple assessment methods and presents the data elements for each drug-event pair evaluated by multiple sources in a matrix.
There are many causality assessment methods used within the industry, some universal, others more specialized. Most commonly used methods include WHO-UMC, Naranjo, Roussel-Uclaf (RUCAM) - to detect drug-associated liver injury, Karch and Lasagna, the French PV Algorithm, Bayesian Adverse Reactions Diagnostic Instrument (BARDI), MacBARDI, and Updated Logistic method. Expert judgment remains the most common method used.
Serious challenges prevent the practical implementation of existing algorithms by the industry. Many of the algorithms cannot be applied rigorously because of missing data. Additionally, an accurate definition of clinical harm is often lacking (e.g., peripheral neuropathy, vasculitis). Brighton Collaboration Case Definitions partly address this component.
Algorithms do not consider medication errors and are not easy to use with interactions, contributory causation, or secondary harms. Information obtained from the reporter is usually insufficient to establish a causal relationship, and follow-up requests for information must be sent, often repeatedly. The result is a very high share of unassessable reports and poor internal consistency of existing assessments.
I suggest modifying the ADE reporting to incorporate components enabling structured causality assessment directly by the reporting physician (postmarket) or investigator (clinical trials). Guiding questions would assist the reporting physician in determining causal relationships and facilitate algorithmic attribution upon submission:
Temporal relationship is a key component of causality assessment. Safety databases routinely calculate latency and last dose latency that feed the algorithm.
Dechallenge and Rechallenge represent key concepts in pharmacovigilance. This information is typically missing from reports. A series of questions regarding Outcome and Response (Action taken with drug) guide the reporting physician through a checklist for all suspect and interacting drugs, reliably and consistently calculating dechallenge/rechallenge for each drug-event pair.
Biological plausibility is a complex component requiring knowledge of the drug and the patient's medical condition.
Finally, it is important to ask the reporting physician about any underlying diseases that could have contributed to the event. A clear answer to this question is an essential component of the causality assessment algorithms.
Clinical evaluation: Supporting medical device product life-cycle. Applicable...
Clinical Evaluation: Applicable Standards
MDR 2017/745 – Article 61
MDR 2017/745 - Annex XIV
MDR 2017/745 - Annex I
MDCG 2020-5, MDCG 2020-6, MDCG 2020-13
MDCG 2020-7, MDCG 2020-8, MDCG 2020-9
MEDDEV 2.7/1 Rev4, MEDDEV 2.12/2 rev2, MEDDEV 2.7/4 Rev. 4
IMDRF MDCE WG/N56 FINAL:2019
IMDRF MDCE WG/N55 FINAL:2019
Biological evaluation – ISO 10993-1, ISO 10993-18
Clinical Investigations – ISO 14155
Information supplied - ISO 15223-1:5/2017
Risk management – ISO 14971:6/2020, ISO/TR 24971:2020
Quality Management System – ISO 13485:ed2:12/2016
Clinical documentation for medical devices
Clinical documentation for medical devices
Medical Devices Regulation (EU) 2017/745
We prepare EU MDR-compliant clinical documentation for medical device manufacturers for submission to notified bodies and national regulatory authorities.
EU MDR-compliant clinical documentation (English, Czech):
- Clinical evaluation (plan, report)
- Post-Market Clinical Follow-Up, -
- PMCF (plan, report, study design)
- Post-Market Surveillance System (plan, report)
- Clinical investigation design to complement existing evidence
- Biological Evaluation
- Literature review
Consulting
- Strategy how to generate clinical evidence
- Design of PMCF studies and clinical investigations
Additional support:
- Clinical expert for multiple medical specialties
- Risk management specialist
- Technical documentation
Zpracování klinické dokumentace dle EU MDR 2017/745
Zpracování klinické dokumentace dle EU MDR 2017/745
- Strategie generování klinického důkazu
- Zpracování klinické dokumentace
- Design PMCF studií a zkoušek
- Návrhy aktualizací existující dokumentace
Služby
Poradenství
Strategie generování klinického důkazu
Design PMCF studií a zkoušek
Zpracování klinické dokumentace (ČJ, AJ)
Klinické hodnocení (plán/zpráva)
PMCF, PMS (plán/zpráva), PSUR
Biologické hodnocení
Návrh aktualizace související dokumentace
Stavba týmu dle potřeb zákazníka:
Klinický expert relevantní pro daný lékařský obor
Specialista na management rizika
Laboratoř na testování software, včetně AI/ML
Zpracování ostatních částí technické dokumentace
Klinické hodnocení (Plán, Zpráva)
Protokol literární rešerše
Biologické hodnocení
Post-Market Clinical Follow-Up (PMCF) (Plán, Zpráva)
Post-Market Surveillance (PMS) (Plán, Zpráva)
Periodic Safety Update Report (PSUR)
COVID-19 Vaccines (Pfizer/BioNTech)
VAERS Explorer: Resource gateway
The Pfizer-BioNTech COVID-19 Vaccine (Tozinameran)
COMIRNATY- covid-19 vaccine, mRNA injection, suspension
Disease summary
Product approval
Vaccine description
Mechanism of action
Indications and usage
Contraindications
Warnings and precautions
Adverse reactions - experience
from clinical trials
Adverse reactions - postmarketing experience
Mandatory reporting
Adverse events of special interest (AESI)
Pregnancy and breastfeeding
Usage in other populations
Completed clinical trials
Ongoing clinical trials
Resources
VAERS Explorer https://www.aretezoe.com/vaers-explorer
Vaccine labels
https://www.aretezoe.com/vaccine-labels
Anthrax vaccine
Anthrax is a serious infectious disease caused by the bacteria Bacillus anthracis. People or animals can contract anthrax from contact with infected animals or contaminated animal products. Bacillus anthracis forms spores than can survive in the environment, especially soil or animal products (e.g., rawhide) for decades. The most common route of exposure is via skin scrapes when working with infected animals resulting in cutaneous anthrax. Gastrointestinal infection occurs following eating raw or undercooked infected or contaminated meat. The most dangerous form of anthrax follows after inhalation of aerosolized anthrax spores, typically during industrial processing of infected animal products (e.g., rawhide, wool). In the United States, anthrax is very rare. Vaccination of livestock is recommended in areas with historical occurrences of anthrax. Moreover, all food animals are examined before slaughter (Mayo Clinic, Guide to Understanding Anthrax, ACIP).
Anthrax spores had been mass-produced as a bioweapon by the Soviet Union (STAT News). In 2001, anthrax was also used as a bioweapon when letters laced with anthrax were mailed to several news media offices and Democratic Senators Tom Daschle and Patrick Leahy, killing five and sickening 17 (Amerithrax investigation). Anthrax vaccine BioThrax is given to adults at increased risk of exposure in five doses, with a booster dose each year. It is also used as post-exposure prophylaxis in combination with antibiotics.
VAERS Explorer https://www.aretezoe.com/vaers-explorer
You can follow VAERS Explorer on social media:
Facebook: https://www.facebook.com/VAERSExplorer/
LinkedIn: https://www.linkedin.com/showcase/vaers-explorer/
Twitter: https://twitter.com/AreteZoe
MeWe: https://mewe.com/i/veronikavaldova1
Gab: https://gab.com/VAERSExplorer
TruthSocial: https://truthsocial.com/@vaersexplorer
Parler: https://parler.com/VAERSExplorer
YouTube: https://www.youtube.com/playlist?list=PLB6cShh65rNpo1dHiAQJ3-QEHyyM9zSJ1
Rumble: https://rumble.com/user/VAERSExplorer
Adenovirus vaccine
Adenoviruses commonly cause respiratory illnesses ranging from the common cold to pneumonia, croup, and bronchitis, but also gastroenteritis, conjunctivitis, cystitis, or neurological disease. Adenoviruses have been a common cause of acute respiratory illness in military recruits. As non-enveloped viruses, adenoviruses are relatively resistant to common disinfectants. There are more than 50 types of immunologically distinct adenoviruses. People with weakened immune systems are at high risk of developing a severe disease caused by adenovirus infection (CDC, Health.mil). The vaccine is mandatory for all enlisted military recruits (Army Regulation 40-562).
Vaccine: Adenovirus Type 4 and Type 7 Vaccine, Live, Oral (US)
Pharmacovigilance Workshop: Case Studies
Pharmacovigilance Workshop
The workshop is designed to introduce pharmacovigilance to graduate students and working professionals interested in drug safety as a career field. After a brief introduction of publicly available data sources, each team received a case study that detailed a specific safety concern that resulted in a significant safety update of product labeling or product withdrawal.
Medicines may be withdrawn from markets because of risks to patients or business reasons. Change of benefit: risk profile is usually prompted by adverse effects that were either not previously detected, are more frequent, or more severe than anticipated based on the results of Phase III clinical trials. Market withdrawals are triggered by adverse events that were only made apparent from postmarketing surveillance data collected from population-wide use over more extended periods of time. The sources of information the regulatory agencies use when deciding on market withdrawal include meta-analyses and pooled analyses of data from clinical trials, clinical trials, spontaneous case reports, laboratory studies, observational studies, animal studies, and reviews of existing safety data.
In the U.S., individual case safety reports are collected in the FDA Adverse Event Reporting System (FAERS). In Europe, medication side effects are sent to national regulatory authorities and in the EU pharmacovigilance database EudraVigilance. The participants learned where to find clinical trials, market authorizations, and product labeling.
After the introductory presentation, each team received a case study that detailed a specific safety issue that resulted in a significant safety update of product labeling or product withdrawal. Each case study received product labeling and several scientific publications that discussed the safety concern in depth. Each team prepared a presentation with detailed overview of their assigned case study.
Are you interested in drug safety?
Try this for yourself!
Case studies:
Mylotarg (Gemtuzumab ozogamicin): no benefit, risk of death
Roaccutane (isotretinoin): teratogenic effect
Lariam (mefloquine): neuropsychiatric side effects
Zyprexa (olanzapine): stroke in patients with dementia
Avandia (rosiglitazone): myocardial infarction, death due to cardiovascular causes
Seroxat (paroxetine): suicidality
Xyrem (sodium oxybate): diversion, abuse
Coumadin (warfarin): bleeding
https://www.aretezoe.com/pharmacovigilance-workshop
Pharmacovigilance workshop
The workshop is designed to introduce pharmacovigilance to graduate students and working professionals interested in drug safety as a career field. After a brief introduction of publicly available data sources, each team received a case study that detailed a specific safety concern that resulted in a significant safety update of product labeling or product withdrawal.
Medicines may be withdrawn from markets because of risks to patients or business reasons. Change of benefit: risk profile is usually prompted by adverse effects that were either not previously detected, are more frequent, or more severe than anticipated based on the results of Phase III clinical trials. Market withdrawals are triggered by adverse events that were only made apparent from postmarketing surveillance data collected from population-wide use over more extended periods of time. The sources of information the regulatory agencies use when deciding on market withdrawal include meta-analyses and pooled analyses of data from clinical trials, clinical trials, spontaneous case reports, laboratory studies, observational studies, animal studies, and reviews of existing safety data.
In the U.S., individual case safety reports are collected in the FDA Adverse Event Reporting System (FAERS). In Europe, medication side effects are sent to national regulatory authorities and in the EU pharmacovigilance database EudraVigilance. The participants learned where to find clinical trials, market authorizations, and product labeling.
After the introductory presentation, each team received a case study that detailed a specific safety issue that resulted in a significant safety update of product labeling or product withdrawal. Each case study received product labeling and several scientific publications that discussed the safety concern in depth. Each team prepared a presentation with detailed overview of their assigned case study.
Are you interested in drug safety?
Try this for yourself!
https://www.aretezoe.com/pharmacovigilance-workshop
Ethical Dilemmas in Gerontology (2017)
Published April 2017
Part of hospital test scenarios, escalation to ethics committee
Patients with a terminal illness who communicate their wish to die to a nurse shall receive appropriate care that is in line with institutional procedures, local laws, and their personal preferences. A nurse should be able to rely on the support of the institution he or she works for in terms of training, clear line of responsibility for such decisions, and unambiguously communicated expectations defined in organizational procedures. Assisted suicide is legal in Switzerland and several other European countries, in several states in the U.S., and in Canada. The mental capacity of the patient has to be considered in addition to locally applicable laws. Medical Power of Attorney is helpful if the patient previously described his or her wishes regarding end-of-life decisions and became incapacitated in the meantime. Financial toxicity, in addition to dubious effectiveness, contributes to the reluctance of some patients to undergo aggressive and invasive therapies. German physician Albert Moll in his book Medical Ethics (1902), argues that aggressive care in incurably ill patients is unethical. Healthcare staff, including nurses, can conscientiously object to assisting with suicide.
Deteriorating Patient with Sepsis: Early Diagnosis and Intervention (2017)
JB, a 23-year-old female, presented to the emergency department with fever, chills, nausea and abdominal pain. She was diagnosed with sepsis and treated initially with antibiotics and IV fluids. Her condition deteriorated after being transferred to a non-emergency ward, as key safety parameters like hypotension and elevated lactate were missed during handover. By Sunday, her symptoms met the criteria for septic shock, including low blood pressure, increased heart rate, and elevated lactate levels, indicating critical organ dysfunction from sepsis.
More from Arete-Zoe, LLC (20)
Availability of essential medicines in the Czech Republic (2017)
Availability of essential medicines in the Czech Republic (2017)
Post-marketing safety surveillance of medical devices and drug-device combina...
Post-marketing safety surveillance of medical devices and drug-device combina...
Mitigating consequences of a drug-facilitated sexual assault .pdf
Mitigating consequences of a drug-facilitated sexual assault .pdf
Approach to preparing for a biological attack (2017)
Approach to preparing for a biological attack (2017)
Improving the resilience of vulnerable populations
Improving the resilience of vulnerable populations
Addressing pediatric medication errors in ED setting utilizing Computerized P...
Addressing pediatric medication errors in ED setting utilizing Computerized P...
Let's talk causality attribution: Current practices and path forward
Let's talk causality attribution: Current practices and path forward
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Safety Data Exchange Agreements (Brief)
- 1. SDEAs Integral part of enterprise risk management 11/10/2016©Arete-Zoe, LLC
- 2. 11/10/2016©Arete-Zoe, LLC Compliance management Article 11(1) of the Commission Implementing Regulation (EU) No 520/2012 Specific quality system procedures and processes shall be in place in order to ensure: (a) Continuous monitoring of PV data, options for risk minimization and prevention and appropriate measures by MAH (b) Scientific evaluation of all information on the risks of medicinal products by MAH (c) Submission of accurate and verifiable data on serious and non-serious adverse reactions to the EudraVigilance (d) Quality, integrity and completeness of the information submitted on the risks of medicinal products, including processes to avoid duplicate submissions and to validate signals (e) Effective communication by the MAH with the national competent authorities and the Agency: - Communication on new risks or changed risks - Pharmacovigilance system master file - Risk management systems, risk minimization measures - PSURs, CAPAs, and PASS (f) Update of product information in the light of scientific knowledge, EMA portal assessments and recommendations (g) Appropriate of relevant safety information to healthcare professionals and patients.
- 3. 11/10/2016©Arete-Zoe, LLC Safety Data Exchange -USA The FD&C Act and applicable regulations cover post-marketing adverse event reporting for • Rx and non-Rx drugs with approved NDAs (21 CFR 314.80 and 314.81) • Prescription drugs and nonprescription drugs that have approved abbreviated new drug applications (21 CFR 314.98 and 314.81) • “Subpart H” drugs approved under accelerated approval (21 CFR 314.540) • “Subpart I” drugs approved when human efficacy studies are not possible (21 CFR 314.630) • Non-application nonprescription drug products (FD&C Act Chapter VII, Subchapter H, Section 760) (Over-the Counter (OTC) Monograph) • Licensed therapeutic biological products (21 CFR 600.80, 601.28, and 601.70) • Biological products approved under accelerated approval (21 CFR 601.44) • Biological products approved when human efficacy studies are not possible (21 CFR 601.93) Marketed prescription drugs not the subject of approved applications (21 CFR 310.305)1
- 4. 11/10/2016©Arete-Zoe, LLC Safety Data Exchange - EU Europe Regulation (EC) No 726/2004 with respect to centrally authorized medicinal products Directive 2001/83/EC with respect to nationally authorised medicinal products (including MRP and DCP) Commission Implementing Regulation (EU) No 520/2012 includes details on certain aspects of pharmacovigilance Good pharmacovigilance practice guidelines (GVP)
- 5. Strategic management framework 11/10/2016©Arete-Zoe, LLC Complexity scales up with size of the enterprise External Material Labor Information Material Labor Information Internal Production Facilities Relations Jurisdictional boundaries
- 6. 11/10/2016©Arete-Zoe, LLC Governance model Change Acquisition Strategic partnership Legacy product New vendor Outsourcing Reorganization
- 7. 11/10/2016©Arete-Zoe, LLC Roles and responsibilities Change Acquisition Strategic partnership Legacy product New vendor Outsourcing Reorganization Functional charts and diagrams
- 8. 11/10/2016©Arete-Zoe, LLC Roles and responsibilities Functional charts and diagrams by jurisdiction Version control Change control Legislation Industry regulations Guidelines, non-binding recommendations, policies
- 9. 11/10/2016©Arete-Zoe, LLC Supply & Distribution Channels PV, QA/RA HQ Manufacturing Distributors High-volume products with predictable demand Cold-chain Specialty pharmacies, niche SDEAs ensure multidirectional exchange of information across multiple jurisdictions Packaging
- 10. MORT Analysis Management Oversight & Risk Tree 11/10/2016©Arete-Zoe, LLC • . A safety system/program is a formal approach to eliminate/control hazardous events through engineering, design, education, management policy, and supervisory control of conditions (environment) and practices. DESIGN TRAINING MANAGEMENT SUPERVISION CONTROLS
- 11. Procedural documents SDEA templates • Change control • Version control • Document management system • Process review 11/10/2016©Arete-Zoe, LLC Co-marketing Distribution Co-Promotion Vendors Service providers Others
- 12. CAPA management processes 11/10/2016©Arete-Zoe, LLC Data Collection Assessment CAPA Inform Follow-up Root cause methods - Events and causal factor analysis - Change analysis - Barrier analysis - Management Oversight and Risk Tree (MORT) - Human performance evaluation - Kepner-Tregoe model
- 13. Supporting systems 11/10/2016©Arete-Zoe, LLC Data Breach Scenarios • The Human Element: • Insider threat • Victim of exploitation • Conduit devices misuse and tampering • Exploitation of interface settings • Misconfiguration by user • Reconfiguration by intruder • Sophisticated/special purpose illicit software
- 14. Document repositories 11/10/2016©Arete-Zoe, LLC Source documents Other relevant information SDEAs Confidentiality agreements Contracts CIOMS forms SOPs Organizational hierarchies Evaluation and validation documents CAPA plans RMPs
- 15. Strategic management framework Penalty for non- compliance Loss of IP Litigation Liability Denial of market access Consumer rejection 11/10/2016©Arete-Zoe, LLC Internal and external inter- dependencies Sole-source supply chain Overspecialization Lean operations Personnel turbulence Compliance failure Incompetence Corruption Accident Civil disruption Crime Organized crime Business sector competitors Severe weather Natural disaster