The availability of Essential Medicines in Hungary shows summary tables that compare the World Health Organization Essential Medicines List (WHO EML) with the National Substitution List (NL) by system organ class. The graphs are color-coded for more natural orientation: WHO EML products are marked blue, NL products are green, and products included in both lists are yellow. Many registrations include the number of individual drug forms, including package sizes and dosage forms, rather than a single registration number. This is because different dosage forms may have different indications. Drugs are categorized by ATC Code; that means some active ingredients are listed in all relevant forms and system organ classes. The dataset is presented as a summary and then in detail by organ class and ATC subclass as relevant/appropriate. The focus of the following analysis is on essential medicines that are not available in Hungary, and evaluation of the situation in the context of public health needs and global drug shortages. To this end, the Essential List of Medicines defined by the World Health Organization (WHO) is compared to the Substitution List, which can be found on the website of The National Institute of Pharmacy and Nutrition.
Country study: Availability of essential medicines Arete-Zoe, LLC
The document analyzes the availability of essential medicines in the Czech Republic as compared to the WHO Model List of Essential Medicines. It finds that while many essential medicines are available locally, some important ones are still unavailable. It provides breakdowns by organ class of medicines available and unavailable. Key medicines reported as unavailable include hyoscine hydrobromide, oral rehydration salts, and magnesium sulfate.
Toxic Chemicals in Air Fresheners & Health Effectsv2zq
This document analyzes chemicals identified in air fresheners and their associated health effects. Gas chromatography/mass spectrometry was used to identify chemicals in air fresheners. Many chemicals found are recognized as toxic or hazardous but are not listed on product labels. These include acetaldehyde, a recognized carcinogen, and acetone, isopropyl alcohol, limonene, and others which are suspected of causing negative health effects affecting multiple body systems. Many chemicals are regulated as toxic or hazardous by laws governing air quality and toxic substances.
Reimbursement of Bleeding Disorders' Treatment in Latvia 2005-2015Baiba M. Ziemele
Brief analysis of reimbursement of bleeding disorders' treatment in Latvia in past decade (2005-2015): hemophilia A and B factor consumption and spending, number of served patients.
An in-depth study on the patent litigation in Pharma & Biotech industry in 2014.
See who were the top defendants and the top plaintiffs. Patent litigation suits filed by year, by court, by law-firms, by region, etc.
Granted Pharmaceutical Patent Applications in India by Indian Patent Office. 1001 drug patents granted by Patent Office in India between April 2010 and March 2013, of which 771 were granted to foreign drug makers.
Magellan Health Services_ModularAmbulatory Compliance Certificate 2014 Editio...Brent Senesac
This certificate certifies that Magellan Health Services' CLINICAL ADVISOR powered by ClaimTrak 2.0 modular electronic health record (EHR) was tested and certified as being compliant with the 2014 Edition certification criteria. The EHR was tested on modules for ambulatory care including sections 170.314 (a)(3-5, 8, 11, 14); (b)(1, 2, 4, 5, 7); (c)(1-3); (d)(1-8); (e)(1, 2); (g)(2-4) and various clinical quality measures. The certification was issued by Drummond Group, who is approved by ONC to certify EHR technology.
This document summarizes new sanctions imposed by the US against Russian entities. Specifically, it adds 10 entities to the Entity List, restricting exports to them. Five entities from Russia's defense sector are added under Executive Order 13661 due to their role in Ukraine. Five energy companies, including Gazprom and Lukoil, are added under Executive Order 13662 due to operating in Russia's energy sector. The additions impose a license requirement on all exports to these entities from the US.
The document summarizes trade statistics for Slovakia from 2006-2010. It shows that Slovakia's total imports increased from 38.8 billion Euros in 2009 to 48.7 billion Euros in 2010. Exports also increased, from 39.7 billion Euros in 2009 to 48.8 billion Euros in 2010. The top export commodities for Slovakia are vehicles, machinery/electrical equipment, and base metals. Germany and the Czech Republic are Slovakia's largest import and export partners.
Country study: Availability of essential medicines Arete-Zoe, LLC
The document analyzes the availability of essential medicines in the Czech Republic as compared to the WHO Model List of Essential Medicines. It finds that while many essential medicines are available locally, some important ones are still unavailable. It provides breakdowns by organ class of medicines available and unavailable. Key medicines reported as unavailable include hyoscine hydrobromide, oral rehydration salts, and magnesium sulfate.
Toxic Chemicals in Air Fresheners & Health Effectsv2zq
This document analyzes chemicals identified in air fresheners and their associated health effects. Gas chromatography/mass spectrometry was used to identify chemicals in air fresheners. Many chemicals found are recognized as toxic or hazardous but are not listed on product labels. These include acetaldehyde, a recognized carcinogen, and acetone, isopropyl alcohol, limonene, and others which are suspected of causing negative health effects affecting multiple body systems. Many chemicals are regulated as toxic or hazardous by laws governing air quality and toxic substances.
Reimbursement of Bleeding Disorders' Treatment in Latvia 2005-2015Baiba M. Ziemele
Brief analysis of reimbursement of bleeding disorders' treatment in Latvia in past decade (2005-2015): hemophilia A and B factor consumption and spending, number of served patients.
An in-depth study on the patent litigation in Pharma & Biotech industry in 2014.
See who were the top defendants and the top plaintiffs. Patent litigation suits filed by year, by court, by law-firms, by region, etc.
Granted Pharmaceutical Patent Applications in India by Indian Patent Office. 1001 drug patents granted by Patent Office in India between April 2010 and March 2013, of which 771 were granted to foreign drug makers.
Magellan Health Services_ModularAmbulatory Compliance Certificate 2014 Editio...Brent Senesac
This certificate certifies that Magellan Health Services' CLINICAL ADVISOR powered by ClaimTrak 2.0 modular electronic health record (EHR) was tested and certified as being compliant with the 2014 Edition certification criteria. The EHR was tested on modules for ambulatory care including sections 170.314 (a)(3-5, 8, 11, 14); (b)(1, 2, 4, 5, 7); (c)(1-3); (d)(1-8); (e)(1, 2); (g)(2-4) and various clinical quality measures. The certification was issued by Drummond Group, who is approved by ONC to certify EHR technology.
This document summarizes new sanctions imposed by the US against Russian entities. Specifically, it adds 10 entities to the Entity List, restricting exports to them. Five entities from Russia's defense sector are added under Executive Order 13661 due to their role in Ukraine. Five energy companies, including Gazprom and Lukoil, are added under Executive Order 13662 due to operating in Russia's energy sector. The additions impose a license requirement on all exports to these entities from the US.
The document summarizes trade statistics for Slovakia from 2006-2010. It shows that Slovakia's total imports increased from 38.8 billion Euros in 2009 to 48.7 billion Euros in 2010. Exports also increased, from 39.7 billion Euros in 2009 to 48.8 billion Euros in 2010. The top export commodities for Slovakia are vehicles, machinery/electrical equipment, and base metals. Germany and the Czech Republic are Slovakia's largest import and export partners.
This document discusses three web tools - ChemMaps, Tox21BodyMap, and InterPred - for exploring toxicity data from the Tox21 program. Tox21 uses in vitro assays on over 10,000 chemicals to screen for toxicity, identify mechanisms of action, and develop predictive models. InterPred specifically predicts assay interference, where chemicals may interfere with assay readouts without biological activity. The document describes developing InterPred models using Tox21 interference assay data and molecular descriptors to classify chemicals as interferents or non-interferents with over 80% accuracy.
Anatomical, therapeutic and chemical classification of drugs.pptxReshmaManeDeshmukh
This document discusses the Anatomical Therapeutic Chemical (ATC) classification system for drugs. It provides details on the different levels of the classification system and examples to illustrate how a drug is classified. The ATC system divides active substances into 14 main anatomical groups according to the organ or system they act on. Drugs are further classified into subgroups at five different levels including the chemical substance. The document also outlines the inclusion and exclusion criteria for classifying drugs in the ATC system, which is established and maintained by the WHO collaborating centre in Oslo.
This document lists various countries and their respective regulatory authorities for drugs and medical devices. It includes over 50 countries from regions like Europe, Asia, Africa, North America, South America, and Oceania. For each country, it provides the name of the regulatory agency or government ministry responsible for oversight of pharmaceuticals and medical products in that jurisdiction. The regulatory authorities range from specialized drug agencies to broader health ministries.
This study investigates the possibility of a harmonized EU approach to assessing the added therapeutic value (ATV) of medicines. It finds that while ATV is not systematically assessed for marketing authorization, most EU countries do consider it as part of pricing and reimbursement decisions. The study reviews the EU legal framework, explores ATV practices across the EU-28, and provides an in-depth analysis of ATV in six countries. It closes by outlining recommendations for a possible European harmonization of ATV assessment within the current legal framework.
The document provides an overview of the marketing authorisation procedures for medicines in the European Union, with a focus on the centralised procedure. It discusses the historical development of regulation, the roles of the European Medicines Agency and other EU institutions. The centralised procedure is mandatory for certain drug classes and allows for a single marketing authorisation valid across all EU member states. The process involves evaluation of documentation like the common technical document by committees like CHMP and ultimately decisions made by the European Commission.
The document provides an overview of the marketing authorisation procedures for medicines in the European Union, with a focus on the centralised procedure. It discusses the historical development of regulation, the roles of the European Medicines Agency and other EU institutions. The centralised procedure is mandatory for certain drug classes and allows for a single marketing authorisation valid across all EU member states. The process involves evaluation of dossier submissions by scientific committees like CHMP and a decision on authorisation by the European Commission. Post-approval obligations include pharmacovigilance and risk management activities.
Piacenza, October 14, 2011
"Innovating Food, Innovating the Law"
Conference
ALDO PRANDINI (Università Cattolica del Sacro Cuore, Italy)
The identification of potentially emerging food safety issues: an analysis of reports published by the European Community’s Rapid Alert System for Food and Feed (RASFF)
Video: http://vimeo.com/31452234
In 2014, RASFF celebrated its 35th anniversary and saw improvements to its systems and procedures. There were 3,157 original notifications, of which 751 were alerts, and these resulted in 5,910 follow-ups. Notifications focused more on cases presenting significant health risks to consumers, with alert notifications increasing over 25% from 2013. RASFF also concluded initiatives like new standard operating procedures and an online notification platform, while beginning new work that will shape its future.
Statistics of Scientific Procedures | on Living Animals | Great Britain 2011All Animal Rights
1. Over 3.79 million scientific procedures were started in Great Britain in 2011, a 2% increase from 2010. Breeding of genetically modified and harmful mutant animals, mainly mice, remained stable and accounted for 1.62 million procedures.
2. Excluding breeding, the total number of procedures increased 3% to 2.18 million. Procedures increased for cats, pigs, birds, and fish but decreased for rats, guinea pigs, dogs, and non-human primates.
3. Toxicology procedures increased 2% to 399,000 due to more fish used in regulatory testing. Most toxicology is done commercially where procedures also rose 1%.
China blood products industry report, 2010 2011ResearchInChina
This document analyzes the Chinese blood products market and focuses on key manufacturers. It highlights that China's blood products market has grown rapidly but domestic supply is constrained by limited plasma sources. The largest manufacturers, including Hualan Biological Engineering and Shanghai RAAS Blood Products, operate numerous plasma stations but supply remains tight. The document provides an overview of the market size, segments, manufacturers and competitive landscape of China's blood products industry.
Essential medicines, as defined by the World Health Organization (WHO) are "those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford
Antihypertensive Peptides; Synthesis, Properties and Application in FoodsAkshay Ramani
1) Hypertension affects over 1 billion people worldwide and is a major cause of death and disability. Oxidative stress and inflammation contribute to hypertension and related conditions like cardiovascular disease.
2) Bioactive peptides derived from food proteins can regulate blood pressure by inhibiting the angiotensin converting enzyme (ACE). ACE is involved in blood pressure regulation and peptide inhibitors of ACE have potential for treating hypertension.
3) Bioactive peptides are released from proteins through enzymatic digestion and fermentation and have been shown to lower blood pressure in animal and human studies by inhibiting ACE.
This document provides guidelines for the use of antiretroviral agents in treating HIV-1 infection in adults and adolescents. It was developed by the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents. The guidelines have been updated since the last version, with key changes to the initial combination regimen recommendations and management of virologic failure. Additional new sections provide guidance on isolated CNS virologic failure, poor CD4 recovery despite viral suppression, and HIV-2 infection treatment. All drug interaction tables were also updated.
The document is the 2011 annual report of the Rapid Alert System for Food and Feed (RASFF). RASFF is a system managed by the European Commission that facilitates the rapid exchange of information between EU Member States about serious risks detected in food and feed. In 2011, RASFF received 9,157 notifications from inspectors reporting non-compliances with EU food and feed legislation. The report describes the RASFF system and provides an overview of the notifications handled by RASFF in 2011, including notifications related to pesticide residues.
Global clinical research opportunities and challenges. Example of Hungary- clinical trials growth, data quality, ethics approvals, investigator landscape
Availability of essential medicines in the Czech Republic (2017)Arete-Zoe, LLC
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...Arete-Zoe, LLC
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 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 .pdfArete-Zoe, LLC
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)Arete-Zoe, LLC
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 populationsArete-Zoe, LLC
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).
This document discusses three web tools - ChemMaps, Tox21BodyMap, and InterPred - for exploring toxicity data from the Tox21 program. Tox21 uses in vitro assays on over 10,000 chemicals to screen for toxicity, identify mechanisms of action, and develop predictive models. InterPred specifically predicts assay interference, where chemicals may interfere with assay readouts without biological activity. The document describes developing InterPred models using Tox21 interference assay data and molecular descriptors to classify chemicals as interferents or non-interferents with over 80% accuracy.
Anatomical, therapeutic and chemical classification of drugs.pptxReshmaManeDeshmukh
This document discusses the Anatomical Therapeutic Chemical (ATC) classification system for drugs. It provides details on the different levels of the classification system and examples to illustrate how a drug is classified. The ATC system divides active substances into 14 main anatomical groups according to the organ or system they act on. Drugs are further classified into subgroups at five different levels including the chemical substance. The document also outlines the inclusion and exclusion criteria for classifying drugs in the ATC system, which is established and maintained by the WHO collaborating centre in Oslo.
This document lists various countries and their respective regulatory authorities for drugs and medical devices. It includes over 50 countries from regions like Europe, Asia, Africa, North America, South America, and Oceania. For each country, it provides the name of the regulatory agency or government ministry responsible for oversight of pharmaceuticals and medical products in that jurisdiction. The regulatory authorities range from specialized drug agencies to broader health ministries.
This study investigates the possibility of a harmonized EU approach to assessing the added therapeutic value (ATV) of medicines. It finds that while ATV is not systematically assessed for marketing authorization, most EU countries do consider it as part of pricing and reimbursement decisions. The study reviews the EU legal framework, explores ATV practices across the EU-28, and provides an in-depth analysis of ATV in six countries. It closes by outlining recommendations for a possible European harmonization of ATV assessment within the current legal framework.
The document provides an overview of the marketing authorisation procedures for medicines in the European Union, with a focus on the centralised procedure. It discusses the historical development of regulation, the roles of the European Medicines Agency and other EU institutions. The centralised procedure is mandatory for certain drug classes and allows for a single marketing authorisation valid across all EU member states. The process involves evaluation of documentation like the common technical document by committees like CHMP and ultimately decisions made by the European Commission.
The document provides an overview of the marketing authorisation procedures for medicines in the European Union, with a focus on the centralised procedure. It discusses the historical development of regulation, the roles of the European Medicines Agency and other EU institutions. The centralised procedure is mandatory for certain drug classes and allows for a single marketing authorisation valid across all EU member states. The process involves evaluation of dossier submissions by scientific committees like CHMP and a decision on authorisation by the European Commission. Post-approval obligations include pharmacovigilance and risk management activities.
Piacenza, October 14, 2011
"Innovating Food, Innovating the Law"
Conference
ALDO PRANDINI (Università Cattolica del Sacro Cuore, Italy)
The identification of potentially emerging food safety issues: an analysis of reports published by the European Community’s Rapid Alert System for Food and Feed (RASFF)
Video: http://vimeo.com/31452234
In 2014, RASFF celebrated its 35th anniversary and saw improvements to its systems and procedures. There were 3,157 original notifications, of which 751 were alerts, and these resulted in 5,910 follow-ups. Notifications focused more on cases presenting significant health risks to consumers, with alert notifications increasing over 25% from 2013. RASFF also concluded initiatives like new standard operating procedures and an online notification platform, while beginning new work that will shape its future.
Statistics of Scientific Procedures | on Living Animals | Great Britain 2011All Animal Rights
1. Over 3.79 million scientific procedures were started in Great Britain in 2011, a 2% increase from 2010. Breeding of genetically modified and harmful mutant animals, mainly mice, remained stable and accounted for 1.62 million procedures.
2. Excluding breeding, the total number of procedures increased 3% to 2.18 million. Procedures increased for cats, pigs, birds, and fish but decreased for rats, guinea pigs, dogs, and non-human primates.
3. Toxicology procedures increased 2% to 399,000 due to more fish used in regulatory testing. Most toxicology is done commercially where procedures also rose 1%.
China blood products industry report, 2010 2011ResearchInChina
This document analyzes the Chinese blood products market and focuses on key manufacturers. It highlights that China's blood products market has grown rapidly but domestic supply is constrained by limited plasma sources. The largest manufacturers, including Hualan Biological Engineering and Shanghai RAAS Blood Products, operate numerous plasma stations but supply remains tight. The document provides an overview of the market size, segments, manufacturers and competitive landscape of China's blood products industry.
Essential medicines, as defined by the World Health Organization (WHO) are "those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford
Antihypertensive Peptides; Synthesis, Properties and Application in FoodsAkshay Ramani
1) Hypertension affects over 1 billion people worldwide and is a major cause of death and disability. Oxidative stress and inflammation contribute to hypertension and related conditions like cardiovascular disease.
2) Bioactive peptides derived from food proteins can regulate blood pressure by inhibiting the angiotensin converting enzyme (ACE). ACE is involved in blood pressure regulation and peptide inhibitors of ACE have potential for treating hypertension.
3) Bioactive peptides are released from proteins through enzymatic digestion and fermentation and have been shown to lower blood pressure in animal and human studies by inhibiting ACE.
This document provides guidelines for the use of antiretroviral agents in treating HIV-1 infection in adults and adolescents. It was developed by the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents. The guidelines have been updated since the last version, with key changes to the initial combination regimen recommendations and management of virologic failure. Additional new sections provide guidance on isolated CNS virologic failure, poor CD4 recovery despite viral suppression, and HIV-2 infection treatment. All drug interaction tables were also updated.
The document is the 2011 annual report of the Rapid Alert System for Food and Feed (RASFF). RASFF is a system managed by the European Commission that facilitates the rapid exchange of information between EU Member States about serious risks detected in food and feed. In 2011, RASFF received 9,157 notifications from inspectors reporting non-compliances with EU food and feed legislation. The report describes the RASFF system and provides an overview of the notifications handled by RASFF in 2011, including notifications related to pesticide residues.
Global clinical research opportunities and challenges. Example of Hungary- clinical trials growth, data quality, ethics approvals, investigator landscape
Availability of essential medicines in the Czech Republic (2017)Arete-Zoe, LLC
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...Arete-Zoe, LLC
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 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 .pdfArete-Zoe, LLC
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)Arete-Zoe, LLC
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 populationsArete-Zoe, LLC
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).
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 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...Arete-Zoe, LLC
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 Arete-Zoe, LLC
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 documentation for medical devices Arete-Zoe, LLC
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 Arete-Zoe, LLC
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)
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
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Rumble: https://rumble.com/user/VAERSExplorer
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
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
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
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)Arete-Zoe, LLC
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.
Research, Monitoring and Evaluation, in Public Healthaghedogodday
This is a presentation on the overview of the role of monitoring and evaluation in public health. It describes the various components and how a robust M&E system can possitively impact the results or effectiveness of a public health intervention.
Basics of Electrocardiogram
CONTENTS
●Conduction System of the Heart
●What is ECG or EKG?
●ECG Leads
●Normal waves of ECG.
●Dimensions of ECG.
● Abnormalities of ECG
CONDUCTION SYSTEM OF THE HEART
ECG:
●ECG is a graphic record of the electrical activity of the heart.
●Electrical activity precedes the mechanical activity of the heart.
●Electrical activity has two phases:
Depolarization- contraction of muscle
Repolarization- relaxation of muscle
ECG Leads:
●6 Chest leads
●6 Limb leads
1. Bipolar Limb Leads:
Lead 1- Between right arm(-ve) and left arm(+ve)
Lead 2- Between right arm(-ve) and left leg(+ve)
Lead 3- Between left arm(-ve)
and left leg(+ve)
2. Augmented unipolar Limb Leads:
AvR- Right arm
AvL- Left arm
AvF- Left leg
3.Chest Leads:
V1 : Over 4th intercostal
space near right sternal margin
V2: Over 4th intercostal space near left sternal margin
V3:In between V2 and V4
V4:Over left 5th intercostal space on the mid
clavicular line
V5:Over left 5th intercostal space on the anterior
axillary line
V6:Over left 5th intercostal space on the mid
axillary line.
Normal ECG:
Waves of ECG:
P Wave
•P Wave is a positive wave and the first wave in ECG.
•It is also called as atrial complex.
Cause: Atrial depolarisation
Duration: 0.1 sec
QRS Complex:
•QRS’ complex is also called the initial ventricular complex.
•‘Q’ wave is a small negative wave. It is continued as the tall ‘R’ wave, which is a positive wave.
‘R’ wave is followed by a small negative wave, the ‘S’ wave.
Cause:Ventricular depolarization and atrial repolarization
Duration: 0.08- 0.10 sec
T Wave:
•‘T’ wave is the final ventricular complex and is a positive wave.
Cause:Ventricular repolarization Duration: 0.2 sec
Intervals and Segments of ECG:
P-R Interval:
•‘P-R’ interval is the interval
between the onset of ‘P’wave and onset of ‘Q’ wave.
•‘P-R’ interval cause atrial depolarization and conduction of impulses through AV node.
Duration:0.18 (0.12 to 0.2) sec
Q-T Interval:
•‘Q-T’ interval is the interval between the onset of ‘Q’
wave and the end of ‘T’ wave.
•‘Q-T’ interval indicates the ventricular depolarization
and ventricular repolarization,
i.e. it signifies the
electrical activity in ventricles.
Duration:0.4-0.42sec
S-T Segment:
•‘S-T’ segment is the time interval between the end of ‘S’ wave and the onset of ‘T’ wave.
Duration: 0.08 sec
R-R Interval:
•‘R-R’ interval is the time interval between two consecutive ‘R’ waves.
•It signifies the duration of one cardiac cycle.
Duration: 0.8 sec
Dimension of ECG:
How to find heart rhytm of the heart?
Regular rhytm:
Irregular rhytm:
More than or less than 4
How to find heart rate using ECG?
If heart Rhytm is Regular :
Heart rate =
300/No.of large b/w 2 QRS complex
= 300/4
=75 beats/mins
How to find heart rate using ECG?
If heart Rhytm is irregular:
Heart rate = 10×No.of QRS complex in 6 sec 5large box = 1sec
5×6=30
10×7 = 70 Beats/min
Abnormalities of ECG:
Cardiac Arrythmias:
1.Tachycardia
Heart Rate more than 100 beats/min
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As Mumbai's premier kidney transplant and donation center, L H Hiranandani Hospital Powai is not just a medical facility; it's a beacon of hope where cutting-edge science meets compassionate care, transforming lives and redefining the standards of kidney health in India.
The story of Dr. Ranjit Jagtap's daughters is more than a tale of inherited responsibility; it's a narrative of passion, innovation, and unwavering commitment to a cause greater than oneself. In Poulami and Aditi Jagtap, we see the beautiful continuum of a father's dream and the limitless potential of compassion-driven healthcare.
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The Ultimate Guide in Setting Up Market Research System in Health-TechGokul Rangarajan
How to effectively start market research in the health tech industry by defining objectives, crafting problem statements, selecting methods, identifying data collection sources, and setting clear timelines. This guide covers all the preliminary steps needed to lay a strong foundation for your research.
"Market Research it too text-booky, I am in the market for a decade, I am living research book" this is what the founder I met on the event claimed, few of my colleagues rolled their eyes. Its true that one cannot over look the real life experience, but one cannot out beat structured gold mine of market research.
Many 0 to 1 startup founders often overlook market research, but this critical step can make or break a venture, especially in health tech.
But Why do they skip it?
Limited resources—time, money, and manpower—are common culprits.
"In fact, a survey by CB Insights found that 42% of startups fail due to no market need, which is like building a spaceship to Mars only to realise you forgot the fuel."
Sudharsan Srinivasan
Operational Partner Pitchworks VC Studio
Overconfidence in their product’s success leads founders to assume it will naturally find its market, especially in health tech where patient needs, entire system issues and regulatory requirements are as complex as trying to perform brain surgery with a butter knife. Additionally, the pressure to launch quickly and the belief in their own intuition further contribute to this oversight. Yet, thorough market research in health tech could be the key to transforming a startup's vision into a life-saving reality, instead of a medical mishap waiting to happen.
Example of Market Research working
Innovaccer, founded by Abhinav Shashank in 2014, focuses on improving healthcare delivery through data-driven insights and interoperability solutions. Before launching their platform, Innovaccer conducted extensive market research to understand the challenges faced by healthcare organizations and the potential for innovation in healthcare IT.
Identifying Pain Points: Innovaccer surveyed healthcare providers to understand their difficulties with data integration, care coordination, and patient engagement. They found widespread frustration with siloed systems and inefficient workflows.
Competitive Analysis: Analyzed competitors offering similar solutions in healthcare analytics and interoperability. Identified gaps in comprehensive data aggregation, real-time analytics, and actionable insights.
Regulatory Compliance: Ensured their platform complied with HIPAA and other healthcare data privacy regulations. This compliance was crucial to gaining trust from healthcare providers wary of data security issues.
Customer Validation: Conducted pilot programs with several healthcare organizations to validate the platform's effectiveness in improving care outcomes and operational efficiency. Gathered feedback to refine features and user interface.
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2024 Media Preferences of Older Adults: Consumer Survey and Marketing Implica...Media Logic
When it comes to creating marketing strategies that target older adults, it is crucial to have insight into their media habits and preferences. Understanding how older adults consume and use media is key to creating acquisition and retention strategies. We recently conducted our seventh annual survey to gain insight into the media preferences of older adults in 2024. Here are the survey responses and marketing implications that stood out to us.
Test bank clinical nursing skills a concept based approach 4e pearson educati...rightmanforbloodline
Test bank clinical nursing skills a concept based approach 4e pearson education
Test bank clinical nursing skills a concept based approach 4e pearson education
Test bank clinical nursing skills a concept based approach 4e pearson education
Simple Steps to Make Her Choose You Every DayLucas Smith
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2. "We have essentially been avoiding this elephant in the
room for the past twenty years, never daring to state
what we know: namely that the use of public healthcare
services does not reflect the needs of society, but
rather the interests of the institutional system."
Dr. Zoltán Ónodi-Szűcs,
Hungarian Secretary of State for Health (Haynes, 2017)
https://www.aretezoe.com/
3. System organ class WHO EML
WHO EML
Available
WHO EML
Unavailable
WHO EML
Unavailable
%
NL EML
Both EM Lists
(overlap)
A – Alimentary tract and metabolic diseases 34 26 8 24% 38 13
B – Blood and blood-forming organs 30 27 3 10% 5 2
C – Cardiovascular system 25 20 5 20% 81 13
D – Dermatologicals 21 11 10 48% 14 3
G - Genito-urinary system, sex hormones 19 11 8 42% 32 4
H – Hormones, excl. sex hormones and
insulins
11 11 0 0% 6 3
J – Systemic anti-infectives 119 83 36 30% 29 19
L – Anti-neoplastic agents, immunomodulants 45 39 6 13% 17 7
M – Musculoskeletal system 6 4 2 33% 18 1
N – Nervous system 37 35 2 5% 62 11
P – Anti-parasitics, insecticides, repellents 36 7 29 81% 0 0
R – Respiratory system 10 7 3 30% 24 4
S – Sensory organs 13 7 6 46% 18 2
V - Various 21 12 9 43% 2 1
TOTAL 427 301 121 30% 346 83
https://www.aretezoe.com/
FIG. 1 - Summary (table): Availability of essential medicines by organ class
4. https://www.aretezoe.com/
FIG. 2 – Summary (graph): Essential medicines lists by organ class
34
30
25
21 19
11
119
45
6
37 36
10
13
21
38
5
81
14
32
6
29
17 18
62
0
24
18
2
13
2
13
3 4 3
19
7
1
11
0
4 2 1
0
20
40
60
80
100
120
140
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
5. https://www.aretezoe.com/
FIG. 3 – Summary (graph): Availability of essential medicines lists by organ class
0
20
40
60
80
100
120
140
WHO List of EM Unavailable
WHO List of EM Available
10. https://www.aretezoe.com/
FIG 7 – Stomatologicals (A01) and Acid related disorders (A02)
12
15
10
16
10
42
76
23
50 51
4
0
10
20
30
40
50
60
70
80
benzydamine
Al3+,Mg2+,Ca2+combinations
ordinarysalts
ranitidine
famotidine
omeprazole
pantoprazole
lansoprazole
rabeprazole
esomeprazole
sucralfate
NL NL NL WHO, NL NL WHO, NL NL NL NL NL NL
A01AD02 A02AD A02AD01 A02BA02 A02BA03 A02BC01 A02BC02 A02BC03 A02BC04 A02BC05 A02BX02
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
11. https://www.aretezoe.com/
FIG. 8 – Drugs for functional GIT disorders (A03),
antiemetics and antinauseants (A04)
11
1
4
2
3
29
14
0
0
5
10
15
20
25
30
35
drotaverine atropin hyoscine
butylbromide
metoclopramide domperidone ondansetron granisetron hyoscine hydrobr
NL WHO WHO WHO NL WHO, NL NL WHO
A03AD02 A03BA01 A03BB01 A03FA01 A03FA03 A04AA01 A04AA02 A04AD01
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
12. https://www.aretezoe.com/
FIG. 9 – Bile and liver therapy (A05),
drugs for constipation (A06), anti-diarrheals (A07)
7
0
5
4
0
3
1
10
0
1
0
2
4
6
8
10
12
silymarin
docusatesodium
sennaglycosides
lactulose
paromomycin
medicinalcharcoal
Oralrehydrationsalts
loperamide
hydrocortisone
sulfasalazine
NL WHO WHO WHO, NL WHO WHO, NL WHO WHO, NL WHO WHO
A05BA03 A06AA02 A06AB06 A06AD11 A07AA6 A07BA01 A07CA A07DA03 A07EA02 A07EC01
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
13. https://www.aretezoe.com/
FIG. 10 – Anti-obesity drugs (A08) and digestives incl. enzymes (A09)
4
9
12
0
2
4
6
8
10
12
14
sibutramine orlistat multienzymes
NL NL WHO, NL
A08AA10 A08AB01 A09AA02
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
14. https://www.aretezoe.com/
FIG. 11 – Drugs used in diabetes (A10)
70
32
50
4
35
72
8
35
17
31
0
10
20
30
40
50
60
70
80
insulin, fast-
acting
insulin,
intermediate
metformin glibenclamide gliclazide glimepiride acarbose pioglitazone sitagliptin repaglinide
WHO WHO WHO, NL WHO WHO, NL NL NL NL NL NL
A10AB A10AC A10BA02 A10BB01 A10BB09 A10BB12 A10BF01 A10BG03 A10BH01 A10BX02
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
15. https://www.aretezoe.com/
FIG. 12 - Vitamins (A11)
16
4
0
6
13
5
19
0
3
0
0
2
4
6
8
10
12
14
16
18
20
multivitaminsandminerals
retinol
ergocalciferol
alfacalcidol
cholecalciferol
thiamine
ascorbicacid
nicotinamide
pyridoxine
riboflavin
NL WHO, NL WHO NL WHO WHO, NL WHO, NL WHO WHO, NL WHO
A11AA03 A11CA01 A11CC01 A11CC03 A11CC05 A11DA01 A11GA01 A11HA01 A11HA02 A11HA04
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
16. https://www.aretezoe.com/
FIG. 13 - Mineral supplements (A12),
other alimentary tract & metabolism drugs (A16)
1
7
20
1
0
2 2
0
5
10
15
20
25
calcium gluconate calcium carbonate Calcium,
combinations
zinc sulfate sodium fluoride Other mineral
products
miglustat
WHO NL NL WHO WHO WHO NL
A12AA03 A12AA04 A12AX A12CB01 A12CD01 A12CX A16AX06
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
19. https://www.aretezoe.com/
FIG. 14 – Summary (graph): Availability of registered products (B) –
WHO EM List and National EM List combined
68
60
29
17
10 10
8 8 8 7
5 5 5 5 5 4 4 4 3 3 3 3 3 2 2 2 2 2 1 1 0 0 0
0
10
20
30
40
50
60
70
80
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
20. https://www.aretezoe.com/
FIG 15 - Anti-thrombotic agents (B01)
8
2
10
8
10
60
5
29
2
7
1
0
10
20
30
40
50
60
70
warfarin
heparin
dalteparin
enoxaparin
nadroparin
clopidogrel
ticlopidine
acetylsalicylicacid
triflusal
cilostazol
streptokinase
WHO, NL WHO WHO WHO WHO WHO, NL NL WHO NL NL WHO
B01AA03 B01AB01 B01AB04 B01AB05 B01AB06 B01AC04 B01AC05 B01AC06 B01AC18 B01AC23 B01AD01
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
21. https://www.aretezoe.com/
FIG 16 – Anti-hemorrhagics (B02)
3 2
5
68
0
10
20
30
40
50
60
70
80
trenexamic acid phytomenadione coagulation factors IX, II, VII
and X
coagulation factor VIII
WHO WHO WHO WHO
B02AA02 B02BA01 B02BD01 B02BD02
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
22. https://www.aretezoe.com/
FIG 17 – Anti-anemic preparations (B03)
4 4
5
1
3
0
1
2
3
4
5
6
Iron bivalent, oral Iron trivalent, oral Iron in combination
with folic acid
hydroxycobalamin folic acid
WHO WHO WHO WHO WHO
B03AA B03AB B03AD B03BA03 B03BB01
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
23. https://www.aretezoe.com/
FIG 18 – Blood substitutes and perfusion solutions (B05)
2
4
0 0
8
17
5
3
2
5
3 3
0
0
2
4
6
8
10
12
14
16
18
plateletconcentratesandwholeblood
dextran
redbloodcells
freshfrozenplasma
carbohydratesforparenteralnutrition
electrolytes
electrolyteswithcarbohydrates
mannitol
isotonicsolutions
potassiumchloride
sodiumbicarbonate
sodiumchloride
magnesiumsulfate
WHO WHO WHO WHO WHO WHO WHO WHO WHO WHO WHO WHO WHO
B05A B05AA05 B05AX01 B05AX03 B05BA03 B05BB01 B05BB02 B05BC01 B05DA B05XA01 B05XA02 B05XA03 B05XA05
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
24. Unavailable WHO EML
ATC Code Active ingredient
B05AX01 red blood cells
B05AX03 fresh frozen plasma
B05XA05 magnesium sulfate
26. https://www.aretezoe.com/
FIG. 20A – Summary (graph): Availability of registered products (C) – National EML
146
105
93 93
75 74
67 66
58 58 57
53 51
45 44 44 44
40
0
20
40
60
80
100
120
140
160
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
27. https://www.aretezoe.com/
FIG. 20B – Summary (graph): Availability of registered products (C) – National EML
39
37 37
35
31
25
23 23 22 21 20 19 18 18 17 17 16 15 15
13 13
0
5
10
15
20
25
30
35
40
45
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
28. https://www.aretezoe.com/
FIG 19 – Summary (graph): Availability of registered products (C) – WHO EML
58
53
44
39
37
31
18
12
10 9 8 8
6
3 3 2 2 2 2 1 0 0 0 0 0
0
10
20
30
40
50
60
70
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
29. https://www.aretezoe.com/
FIG. 20C – Summary (graph): Availability of registered products (C) – National EML
12 12 12 12 12 12 12
11
10 10 10 10 10 10
9 9 9
0
2
4
6
8
10
12
14
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
30. https://www.aretezoe.com/
FIG. 20D – Summary (graph): Availability of registered products (C) – National EML
8 8 8 8 8 8 8
7 7 7 7
6 6 6 6 6
4
3 3 3 3 3
2 2 2
0
1
2
3
4
5
6
7
8
9
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
31. https://www.aretezoe.com/
FIG. 21A – Summary (graph): Availability of registered products (C) –
WHO EML and National EML combined
146
105
93 93
75 74
67 66
58 58 57
53 51
45 44 44 44
40 39 37 37 35
31
25 23 23 22 21 20 19 18 18 17 17 16
0
20
40
60
80
100
120
140
160
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
32. https://www.aretezoe.com/
FIG. 21B – Summary (graph): Availability of registered products (C) –
WHO EML and National EML combined
15 15
13 13
12 12 12 12 12 12 12
11
10 10 10 10 10 10
9 9 9
8 8 8 8 8 8 8
7 7 7 7
0
2
4
6
8
10
12
14
16
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
33. https://www.aretezoe.com/
FIG. 21C – Summary (graph): Availability of registered products (C) –
WHO EML and National EML combined
6 6 6 6 6 6
4
3 3 3 3 3 3
2 2 2 2 2 2 2
1
0 0 0 0 0
0
1
2
3
4
5
6
7
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
34. https://www.aretezoe.com/
FIG. 22 - Cardiac therapy (C01)
2 2
10
2
1
6
0
18
0
7
15
20
0
5
10
15
20
25
digoxin
lidocaine
propafenone
amiodaron
dopamine
epinephrine(adrenaline)
ephedrine
glyceryltrinitrate
isosorbidedinitrate
isosorbidemononitrate
trimetazidine
ivabradine
WHO WHO NL WHO WHO WHO WHO WHO, NL WHO NL NL NL
C01AA05 C01BB01 C01BC03 C01BD01 C01CA04 C01CA24 C01CA26 C01DA02 C01DA08 C01DA14 C01EB15 C01EB17
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
35. https://www.aretezoe.com/
FIG. 23 - Antihypertensives (C02)
3
21
3
23
12
0 0
17
0
5
10
15
20
25
methyldopa
(levorotatory)
moxonidine rilmenidine doxazosin urapidil hydrazaline nitroprusside bosentan
WHO NL NL NL NL WHO WHO NL
C02AB01 C02AC05 C02AC06 C02CA04 C02CA06 C02DB02 C02DD01 C02KX01
Approvals (number of registrations) WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
36. https://www.aretezoe.com/
FIG. 24 – Diuretics (C03) and peripheral vasodilatators (C04)
2
15
8
10
22
0
2
8
0
5
10
15
20
25
hydrochlorothiazide
indapamide
furosemide
spironolactone
eplerenone
amiloride
hydrochlorothiazideandpotassium-
sparingagents
pentoxifylline
WHO NL WHO, NL WHO, NL NL WHO NL NL
C03AA03 C03BA11 C03CA01 C03DA01 C03DA04 C03DB01 C03EA01 C04AD03
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
37. https://www.aretezoe.com/
FIG. 25 – Vasoprotectives (C05) and beta-blocking agents (C07)
4
7
3 3
39
8
44
19
37
7
16
13
0
5
10
15
20
25
30
35
40
45
50
procaine calcium
dobesilate
propranolol sotalol metoprolol atenolol bisoprolol nebivolol carvedilol bisoprolol
and
thiazides
bisoprolol
and
amlodipine
metoprolol
and
ivabradine
NL NL WHO, NL NL WHO, NL WHO, NL WHO, NL NL WHO, NL NL NL NL
C05AD05 C05BX01 C07AA05 C07AA07 C07AB02 C07AB03 C07AB07 C07AB12 C07AG02 C07BB07 C07FB07 C07FX05
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
38. https://www.aretezoe.com/
FIG. 26 - Calcium-channel blockers (C08)
53
12
9
3
6
12
6 6
0
10
20
30
40
50
60
amlodipine felodipine nifedipine nitrendipine lercanidipine verapamil diltiazem amlodipine and
diuretics
WHO, NL NL WHO, NL NL NL WHO, NL NL NL
C08CA01 C08CA02 C08CA05 C08CA08 C08CA13 C08DA01 C08DB01 C08GA02
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
39. https://www.aretezoe.com/
FIG. 27 - Renin-angiotensin system: ACE inhibitors (C09A)
7
31
18
67 66
12
9 9
0
10
20
30
40
50
60
70
80
captopril enalapril lisinopril perindopril ramipril quinapril fosinopril trandolapril
NL WHO, NL NL NL NL NL NL NL
C09AA01 C09AA02 C09AA03 C09AA04 C09AA05 C09AA06 C09AA09 C09AA10
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
40. https://www.aretezoe.com/
FIG. 28 - Renin-angiotensin system: ACE inhibitors in combinations (C09B)
10
58
23
13
8
10
44
25
8
0
10
20
30
40
50
60
70
enalapril and
diuretics
perindopril and
diuretics
ramipril and
diuretics
quinapril and
diuretics
enalapril and
lercanidipine
lisinopril and
amlodipine
perindopril and
amlodipine
perindopril,
amlodipine
and
indapamide
perindopril and
bisoprolol
NL NL NL NL NL NL NL NL NL
C09BA02 C09BA04 C09BA05 C09BA06 C09BB02 C09BB03 C09BB04 C09BX01 C09BX02
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
41. FIG. 29 - Renin-angiotensin system: Angiotensin II antagonists (C09C)
57
105
93
37
51
12
0
20
40
60
80
100
120
losartan valsartan irbesartan candesartan telmisartan olmesartan
medoxomil
NL NL NL NL NL NL
C09CA01 C09CA03 C09CA04 C09CA06 C09CA07 C09CA08
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
42. FIG. 30 - Renin-angiotensin system: Angiotensin II antagonists
in combinations (C09D)
44
74 75
17
40
12
45
8 10
0
10
20
30
40
50
60
70
80
losartananddiuretics
valsartananddiuretics
irbesartananddiuretics
candesartananddiuretics
telmisartananddiuretics
olmesartanmedoxomilanddiuretics
valsartanandamlodipine
losartanandamlodipine
olmesartanmedoxomil,amlodipineand
hydrochlorothiazide
NL NL NL NL NL NL NL NL NL
C09DA01 C09DA03 C09DA04 C09DA06 C09DA07 C09DA08 C09DB01 C09DB06 C09DX03
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
43. FIG. 31 - Lipid modifying agents (C10)
58
6 11
146
93
3 6 2 2
10 8
35
12
0
20
40
60
80
100
120
140
160
simvastatin
pravastatin
fluvastatin
atorvastatin
rosuvastatin
gemfibrozil
fenofibrate
ciprofibrate
omega-3-triglyceridesincl.otherestersandacids
ezetimibe
simvastatinandezetimibe
atorvastatinandamlodipine
rosuvastatinandamlodipine
WHO, NL NL NL NL NL NL NL NL NL NL NL NL NL
C10AA01 C10AA03 C10AA04 C10AA05 C10AA07 C10AB04 C10AB05 C10AB08 C10AX06 C10AX09 C10BA02 C10BX03 C10BX09
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
44. Unavailable WHO EML
ATC Code Active ingredient
C01CA26 ephedrine
C01DA08 isosorbide dinitrate
C02DB02 hydrazaline
C02DD01 nitroprusside
C03DB01 amiloride
46. FIG. 32 – Summary (graph): Availability of registered products (D) – WHO EML
14
6
5
3 3 3
2 2
1 1 1
0 0 0 0 0 0 0 0 0 0
0
2
4
6
8
10
12
14
16
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
47. FIG. 33 – Summary (graph): Availability of registered products (D) – National EML
14
10 10
8
6 6 6
5 5
4 4
3 3 3
0
2
4
6
8
10
12
14
16
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
48. FIG. 34 – Summary (graph): Availability of registered products (D) –
WHO EML and National EML combined
14
10 10
8
6 6 6 6
5 5
4 4
3 3 3 3 3
2 2
1 1 1
0 0 0 0 0 0 0 0 0 0
0
2
4
6
8
10
12
14
16
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
49. FIG. 35 - Antifungals for dermatological use (D01)
0
5
0
3
0 0
6
4
0
14
0
2
4
6
8
10
12
14
16
nystatin clotrimazole miconazole ketoconazole salicylic acid selenium
sulfide
ciclopirox amorolfine griseofulvin terbinafine
WHO NL WHO NL WHO WHO NL NL WHO WHO, NL
D01AA01 D01AC01 D01AC02 D01AC08 D01AE12 D01AE13 D01AE14 D01AE16 D01BA01 D01BA02
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
50. FIG. 36 - Emollients and protectives (D02), antipsoriatics (D05) and antibiotics
and chemotherapeutics for dermatological use (D06)
2
1
6
2
1
3
0
1
2
3
4
5
6
7
Zinc products carbamide antipsoriatics for
topical use
mupirocin silver sulfadiazine podophyllotoxin
WHO WHO WHO WHO WHO WHO
D02AB D02AE01 D05A D06AX09 D06BA01 D06BB04
Approvals (number of registrations) WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
51. FIG. 37 – Corticosteroids for dermatological use (D07)
3
8
1
10
6
3
0
2
4
6
8
10
12
hydrocortisone hydrocortisone butyrate betamethasone mometasone clobetasol betamethasone
WHO NL WHO NL NL NL
D07AA02 D07AB02 D07AC01 D07AC13 D07AD01 D07XC01
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
52. FIG. 38 – Antiseptics and disinfectants (D08)
0 0
3
4
0 0 0
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
chlorhexidine chloroxylenol povidone-iodine octenidine,
combinations
isopropanol potassium
permanganate
ethanol
WHO WHO WHO, NL NL WHO WHO WHO
D08AC02 D08AE05 D08AG02 D08AJ57 D08AX05 D08AX06 D08AX08
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
53. FIG. 39 – Anti-acne preparations (D10)
5
6
10
0
2
4
6
8
10
12
benzoyl peroxide erythromycin isotretinoin
WHO, NL NL NL
D10AE01 D10AF02 D10BA01
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
56. FIG. 40 – Summary (graph): Availability of registered products (G) – WHO EML
10
9 9
8
7
5
3
2
1 1 1
0 0 0 0 0 0 0 0
0
2
4
6
8
10
12
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
57. FIG. 41 – Summary (graph): Availability of registered products (G) – National EML
97
83
32 31
28
18 16
11 11 10 10
7 6 6 6 6 5 5 5 5 5 5 4 3 3 3 2 2 2 2 2
0
20
40
60
80
100
120
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
58. FIG. 42 – Summary (graph): Availability of registered products (G) – WHO
EML and National EML combined
97
83
323128
1816
11111010 9 9 8 7 6 6 6 6 5 5 5 5 5 5 4 3 3 3 3 2 2 2 2 2 1 1 1 0 0 0 0 0 0 0 0
0
20
40
60
80
100
120
sildenafil
drospirenoneandethinylestradiol
gestodeneandethinylestradiol
tamsulosin
tadalafil
desogestrelandethinylestradiol
finasteride
estradiol
vardenafil
clotrimazole
terazosin
Intravaginalcontraceptives
progesteron
testosteron
levonorgestrelandethinylestradiol
desogestrel
norethisteroneandestrogen
raloxifene
tolterodine
levonorgestrel
dienogestandethinylestradiol
desogestrelandethinylestradiol
cyproterone
oxybutynin
solifenacin
cyproteroneandestrogen
medroxyprogesterone
tibolone
norethisteroneandestrogen
dutasteride
econazole
vaginalringwithprogestogenandestrogen
levonorgestrelandestrogen
chlormadinoneandethinylestradiol
gestodeneandethinylestradiol
misoprostol
clomifene
mifepristone
ergometrine
plasticIUDwithcopper
plasticIUDwithprogesteron
norethisteroneandethinylestradiol
medroxyprogesteroneandestrogen
norethisterone
levonorgestrel
etonorgestrel
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
59. FIG. 43 - Antiinfectives and antiseptics (G01), other gynecologicals (G02)
10
2
0
1
0 0
9
2
0
2
4
6
8
10
12
clotrimazole
econazole
ergometrine
misoprostol
plasticIUDwithcopper
plasticIUDwithprogesteron
Intravaginalcontraceptives
vaginalringwithprogestogenandestrogen
WHO, NL NL WHO WHO WHO WHO WHO NL
G01AF02 G01AF05 G02AB03 G02AD06 G02BA02 G02BA03 G02BB G02BB01
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
60. FIG. 44 – Hormonal contraceptives for systemic use: Progestogens and
estrogens, fixed combinations (G03AA)
0
7
0
18
32
83
2
5
0
10
20
30
40
50
60
70
80
90
norethisteroneandethinylestradiol
levonorgestrelandethinylestradiol
medroxyprogesteroneandestrogen
desogestrelandethinylestradiol
gestodeneandethinylestradiol
drospirenoneandethinylestradiol
chlormadinoneandethinylestradiol
dienogestandethinylestradiol
WHO WHO, NL WHO NL NL NL NL NL
G03AA05 G03AA07 G03AA08 G03AA09 G03AA10 G03AA12 G03AA15 G03AA16
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
61. FIG. 45 – Hormonal contraceptives for systemic use: Progestogens and
estrogens, sequential preparations (G03AB)
2
5
2
0
1
2
3
4
5
6
levonorgestrel and
estrogen
desogestrel and
ethinylestradiol
gestodene and
ethinylestradiol
WHO, NL NL NL
G03AB03 G03AB05 G03AB06
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
62. FIG. 46 –Progestogens (G03AC) and emergency contraceptives (G03AD)
0 0
3
0
6
5
0
1
2
3
4
5
6
7
norethisterone
levonorgestrel
medroxyprogesterone
etonorgestrel
desogestrel
levonorgestrel
WHO only WHO only WHO only WHO only NL only Both
G03AC01 G03AC03 G03AC06 G03AC08 G03AC09 G03AD01
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
63. FIG. 47 – Androgens (G03B), estrogens (G03C), progestogens (G03D)
androgens and female hormones comb. (G03E),
and progestogens and estrogens comb. (G03F)
8
11
3
9
6
3
0
2
4
6
8
10
12
testosteron
estradiol
tibolone
progesteron
norethisteroneandestrogen
norethisteroneandestrogen
WHO NL NL WHO NL NL
G03BA03 G03CA03 G03CX01 G03DA04 G03FA01 G03FB05
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
64. FIG. 48 – Gonadotropins and other ovulation stimulants (G03G), antiandrogens
(G03H) and other sex hormones and modulators of the genital system (G03X)
1
5
4
1
6
0
1
2
3
4
5
6
7
clomifene cyproterone cyproterone and
estrogen
mifepristone raloxifene
WHO NL NL WHO NL
G03GB02 G03HA01 G03HB01 G03XB01 G03XC01
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
65. FIG. 49 – Urologicals (G04)
5 6 5
97
28
11
31
10
16
3
0
20
40
60
80
100
120
oxybutynin tolterodine solifenacin sildenafil tadalafil vardenafil tamsulosin terazosin finasteride dutasteride
NL NL NL NL NL NL NL NL NL NL
G04BD04 G04BD07 G04BD08 G04BE03 G04BE08 G04BE09 G04CA02 G04CA03 G04CB01 G04CB02
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
66. Unavailable WHO EML
ATC Code Active ingredient
G02AB03 ergometrine
G02BA02 plastic IUD with copper
G02BA03 plastic IUD with progesteron
G03AA05 norethisterone and ethinylestradiol
G03AA08 medroxyprogesterone and estrogen
G03AC01 norethisterone
G03AC03 levonorgestrel
G03AC08 etonorgestrel
68. FIG. 50 – Summary (graph): Availability of registered products (H) –
WHO EML and National EML combined
25
19
18
15
13
10
9
6
3 3
2
1 1 1
0
5
10
15
20
25
30
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
69. FIG. 51 – Pituitary and hypothalamic hormones and analogues (H01),
corticosteroids for systemic use (H02)
19
3
1
6
18
2
9
0
2
4
6
8
10
12
14
16
18
20
desmopressin oxytocin fludrocortisone dexamethasone methylprednisolon prednisolone hydrocortisone
WHO, NL WHO WHO WHO WHO, NL WHO WHO
H01BA02 H01BB02 H02AA02 H02AB02 H02AB04 H02AB06 H02AB09
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
70. FIG. 52 – Thyroid therapy (H03), pancreatic hormones (H04),
calcium homeostasis (H05)
25
1
3
1
10
15
13
0
5
10
15
20
25
30
levothyroxine
sodium
propylthiouracil Iodine therapy Glucagon calcitonin (salmon
synthetic)
cinacalcet paricalcitol
WHO, NL WHO WHO WHO NL NL NL
H03AA01 H03BA02 H03CA H04AA01 H05BA01 H05BX01 H05BX02
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
72. FIG. 53 – Summary (graph): Availability of registered products (J) – WHO EML
(values <4 included in table 56C)
49
47 47
41
39
36
30
20
17
15 15 14 14 13 12 12 11 11
9 9 9 8 8 8 8 7 7 7 7 6 6 5 5 5 5 5 4 4 4 4 4
0
10
20
30
40
50
60
levofloxacin
amoxicillin&enzymeinhibitor
Bacterialandviralvaccines,combined
fluconazol
ciprofloxacin
azithromycin
clarithromycin
amoxicillin
immunoglobulins,normalhuman,IV
vancomycin
efavirenz(EFVorEFZ)
ceftriaxone
aciclovir
ribavirin
ceftazidime
lamivudine(3TC)
doxycycline
hepatitisBvaccine
ofloxacin
stavudine(d4T)
tenofovirdisoproxil
clindamycin
nevirapine(NVP)
oseltamivir
hepatitisAvaccine
cefixime
imipenemandenzymeinhibitor
linezolid
darunavir
cefotaxime
atazanavir
phenoxymethylpenicillin
valganciclovir
abacavir+lamivudine
emtricitabine+tenofovir
immunoglobulins,normalhuman,for…
amphotericinB
ritonavir(r)
encephalitis,tick-borne,inactivated,wholevirus
Rabiesvaccine
papillomavirus(humantypes6,11,16,18)
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
73. FIG. 54 – Summary (graph): Availability of registered products (J) – National EML
49
47
41
39
36
30
27
23
20
15
13 13 12 11
9 9 8 8 8 7 7 6 5 5
3 3 3 2 2
0
10
20
30
40
50
60
levofloxacin
amoxicillinandenzymeinhibitor
fluconazol
ciprofloxacin
azithromycin
clarithromycin
voriconazole
cefuroxime
amoxicillin
efavirenz(EFVorEFZ)
ribavirin
moxifloxacin
lamivudine(3TC)
doxycycline
ofloxacin
tenofovirdisoproxil
clindamycin
nevirapine(NVP)
itraconazole
linezolid
norfloxacin
valaciclovir
valganciclovir
famciclovir
lymecycline
sulfamethoxazole+trimethoprim
lamivudine+zidovudine(ZDVor…
fosfomycin
ketoconazole
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
74. FIG. 55A – Summary (graph): Availability of registered products (J) –
WHO EML and National EML combined
49
47 47
41
39
36
30
27
23
20
17
15 15 14 14 13 13 12 12 11 11
9 9 9
0
10
20
30
40
50
60
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
75. FIG. 55B – Summary (graph): Availability of registered products (J) –
WHO EML and National EML combined
8 8 8 8 8
7 7 7 7 7
6 6 6
5 5 5 5 5 5
4 4 4 4 4
0
1
2
3
4
5
6
7
8
9
Approvals (number of registrations) WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
77. FIG. 55D – Summary (table): Availability of registered products (J) – WHO EML
and National EML combined (Not available)
chloramphenicol clofazimine
benzathin benzylpenicilin dapsone
cloxacillin lopinavir + ritonavir (LPV/r)
cefalexin zidovudine (ZDV or AZT)
trimethoprim entecavir
sulfadiazine lamivudine + nevirapine + zidovudin
streptomycin lamivudine + nevirapine + stavudine
kanamycin ombitasvir + paritaprevir + ritonavir
spectinomycin diphtheria antitoxin
flucytosine snake venom antiserum
cycloserine rabies immunoglobulin
rifabutin diphtheria toxoid
rifapentine pertussis vaccine
capreomycin measles vaccine, live attenuated
protionamide mumps vaccine, live attenuated
ethionamide Rubella vaccines
terizidone
ethambutol and isoniazid
rifampicin, pyrazinamide and isoniazid
rifampicin, pyrazinamide, ethambutol and isoniazid
78. FIG. 56 - Antibacterials (J01): Tetracyclines (J01A) amphenicols (J01B)
11
3
0
0
2
4
6
8
10
12
doxycycline lymecycline chloramphenicol
WHO, NL NL WHO
J01AA02 J01AA04 J01BA01
Approvals (number of registrations)
WHO List of Essential Medicines
National List of Essential Medicines
Drug listed on both Lists
79. FIG. 57 - Antibacterials (J01): Beta-lactams – penicillins (J01C)
3
20
1
5
0 1 0
47
0
5
10
15
20
25
30
35
40
45
50
ampicillin
amoxicillin
benzylpenicillin
phenoxymethylpenicillin
benzathinbenzylpenicilin
procainbenzylpenicilin
cloxacillin
amoxicillinandenzymeinhibitor
WHO WHO, NL WHO WHO WHO WHO WHO WHO, NL
J01CA01 J01CA04 J01CE01 J01CE02 J01CE08 J01CE09 J01CF02 J01CR02
Approvals (number of registrations)
80. FIG. 58 - Antibacterials (J01): Beta-lactams – non-penicilline (J01D)
0
1
23
6
12
14
7 7
0
5
10
15
20
25
cefalexin cefazolin cefuroxime cefotaxime ceftazidime ceftriaxone cefixime imipenem and
enzyme inhibitor
WHO WHO NL WHO WHO WHO WHO WHO
J01DB01 J01DB04 J01DC02 J01DD01 J01DD02 J01DD04 J01DD08 J01DH51
Approvals (number of registrations)
81. FIG. 59 - Antibacterials (J01): Sulphonamides and trimethoprim (J01E) and
macrolides, linkosamides and streptogramins (J01F)
0 0
3
1
30
36
8
0
5
10
15
20
25
30
35
40
trimethoprim sulfadiazine sulfamethoxazole +
trimethoprim
erythromycin clarithromycin azithromycin clindamycin
WHO WHO WHO, NL WHO WHO, NL WHO, NL WHO, NL
J01EA01 J01EC02 J01EE01 J01FA01 J01FA09 J01FA10 J01FF01
Approvals (number of registrations)
82. FIG. 60 - Antibacterials (J01): Aminoglycosides (J01G)
0
3
0
3
0
0.5
1
1.5
2
2.5
3
3.5
streptomycin gentamicin kanamycin amikacin
WHO WHO WHO WHO
J01GA01 J01GB03 J01GB04 J01GB06
Approvals (number of registrations)
84. FIG. 62 - Antibacterials (J01): Other antibacterials (J01X)
15
3
1
2
0
7
0
2
4
6
8
10
12
14
16
vancomycin
metronidazole
nitrofurantoin
fosfomycin
spectinomycin
linezolid
WHO WHO WHO NL WHO WHO, NL
J01XA01 J01XD01 J01XE01 J01XX01 J01XX04 J01XX08
Approvals (number of registrations)
85. FIG. 63 – Antimycotics for systemic use (J02)
4
2
41
8
27
0
0
5
10
15
20
25
30
35
40
45
amphotericin
B
ketoconazole fluconazol itraconazole voriconazole flucytosine
WHO NL WHO, NL NL NL WHO
J02AA01 J02AB02 J02AC01 J02AC02 J02AC03 J02AX01
Approvals (number of registrations)
86. FIG. 64A – Antimycobacterials (J04): Tuberculosis (J04A)
2
0
2
0 0 0
1
0 0
0
0.5
1
1.5
2
2.5
p-aminosalicylic
acid
cycloserine rifampicin rifabutin rifapentine capreomycin isoniazid protionamide ethionamide
WHO WHO WHO WHO WHO WHO WHO WHO WHO
J04AA01 J04AB01 J04AB02 J04AB04 J04AB05 J04AB30 J04AC01 J04AD01 J04AD03
Approvals (number of registrations)
87. FIG. 64B – Antimycobacterials (J04) Tuberculosis (J04A) and leprosy (J04B)
2
1
0
1 1
2
0 0 0 0 0
0
0.5
1
1.5
2
2.5
pyrazinamid
ethambutol
terizidone
bedaquiline
delamanid
rifampicinandisoniazid
ethambutolandisoniazid
rifampicin,pyrazinamideandisoniazid
rifampicin,pyrazinamide,ethambutoland
isoniazid
clofazimine
dapsone
WHO WHO WHO WHO WHO WHO WHO WHO WHO WHO WHO
J04AK01 J04AK02 J04AK03 J04AK05 J04AK06 J04AM02 J04AM03 J04AM05 J04AM06 J04BA01 J04BA02
Approvals (number of registrations)
88. FIG. 65 – Antivirals for systemic use (J05): Nucleosides and nucleotides excl.
reverse transcriptase inhibitors (J05AB) and Protease inhibitors (J05AE)
14
13
5
6
5
3
4
6
7
1
0
0
2
4
6
8
10
12
14
16
aciclovir
ribavirin
famciclovir
valaciclovir
valganciclovir
saquinavir(SQV)
ritonavir(r)
atazanavir
darunavir
simeprevir
lopinavir+ritonavir(LPV/r)
WHO WHO, NL NL NL WHO, NL WHO WHO WHO WHO WHO WHO
J05AB01 J05AB04 J05AB09 J05AB11 J05AB14 J05AE01 J05AE03 J05AE08 J05AE10 J05AE14 J05AE30
Approvals (number of registrations)
89. FIG. 66 – Antivirals for systemic use (J05): Nucleoside and nucleotide reverse
transcriptase inhibitors (J05AF), Non-nucleoside reverse transcriptase
inhibitors (J05G) and Neuraminidase inhibitors (J05AH)
0
9
12
2
9
0
8
15
8
0
2
4
6
8
10
12
14
16
zidovudine
(ZDV or AZT)
stavudine
(d4T)
lamivudine
(3TC)
abacavir (ABC) tenofovir
disoproxil
entecavir nevirapine
(NVP)
efavirenz (EFV
or EFZ)
oseltamivir
WHO WHO WHO, NL WHO WHO, NL WHO WHO, NL WHO, NL WHO
J05AF01 J05AF04 J05AF05 J05AF06 J05AF07 J05AF10 J05AG01 J05AG03 J05AH02
Approvals (number of registrations)
90. FIG. 67 – Antivirals for systemic use (J05): Antivirals for treatment of HIV
infections, combinations (J05AR) and Other antivirals (J05AX)
3
5 5
0
1
0
2
1 1 1
0
0
1
2
3
4
5
6
lamivudine+zidovudine(ZDVorAZT)
abacavir+lamivudine
emtricitabine+tenofovir
lamivudine+nevirapine+zidovudin
efavirenz+emtricitabine+tenofovir
lamivudine+nevirapine+stavudine
daclatasvir
sofosbuvir
dasabuvir
ledipasvir+sofosbuvir
ombitasvir+paritaprevir+ritonavir
WHO, NL WHO WHO WHO WHO WHO WHO WHO WHO WHO WHO
J05AR01 J05AR02 J05AR03 J05AR05 J05AR06 J05AR07 J05AX14 J05AX15 J05AX16 J05AX65 J05AX66
Approvals (number of registrations)
91. FIG. 68 – Immune sera and immunoglobulins (J06)
0 0
5
17
2 2
0
0
2
4
6
8
10
12
14
16
18
diphtheria antitoxin snake venom
antiserum
immunoglobulins,
normal human, for
extravascular
administration
immunoglobulins,
normal human, for
intravascular
administration
anti-D
immunoglobulin
tetanus
immunoglobulin
rabies
immunoglobulin
WHO WHO WHO WHO WHO WHO WHO
J06AA01 J06AA03 J06BA01 J06BA02 J06BB01 J06BB02 J06BB05
Approvals (number of registrations)
168. FIG. 117 – Summary (graph): Availability of registered products (V) – WHO EM
List and National EM List combined
16
13 13
8
5
4
3 3
2
1 1 1 1
0 0 0 0 0 0 0 0 0
0
2
4
6
8
10
12
14
16
18
Approvals (number of registrations)
169. FIG. 118 – Various (V): All other therapeutic products (V03)
0 0 0 0
1
3
2
1
0 0
1
13
1
5
13
0
2
4
6
8
10
12
14
edetates
thiosulfate
sodiumnitrite
dimercaprol
protamine
naloxone
methylthioniniumchloride
(methyleneblue)
acetylcysteine
potassiumferric
hexacyanoferrate(II)·2H2O
(Prussianblue)
fomepizole
deferoxamine
sevelamer
mesna
calciumfolinate
oxygen
WHO WHO WHO WHO WHO WHO WHO WHO WHO WHO WHO NL WHO WHO WHO, NL
V03AB03V03AB06V03AB08V03AB09V03AB14V03AB15V03AB17V03AB23V03AB31V03AB34V03AC01V03AE02V03AF01V03AF03V03AN01
Approvals (number of registrations)
170. FIG. 119 – Various (V): Diagnostic agents (V04), all other non-therapeutic
products (V07) and contrast media (V08)
0
16
0
4
3
0
8
0
2
4
6
8
10
12
14
16
18
tuberculin, purified
protein derivative
(PPD) - BCG
Water for Injection Technical
disinfectants
diatrizoic acid iohexol iotroxic acid barium sulfate with
suspending
agents
WHO WHO WHO WHO WHO WHO WHO
V04CF01 V07AB V07AV V08AA01 V08AB02 V08AC02 V08BA01
Approvals (number of registrations)
172. ARETE-ZOE, as a consultancy, provides solutions to complex problems in the
high stakes and high consequence environment of Global Pharmaceuticals,
including clinical research, healthcare informatics, and public
health. We blend established, Pharma sector methodologies, innovation, and
adaptations/transfers from other sectors to identify and resolve consequential
practices that pose risk and often result in avoidable patient casualty. However,
we are specifically, not a patient advocacy group but believe in optimizing
organizational effectiveness and that smart business is agile, competitive and
profitable, while intrinsically safe, secure, and resilient. We work within a global
context because transnational interests influence national circumstances and
choices at point of prescription.
ARETE-ZOE, provides full spectrum organizational and operational risk
management consultancy. Our published materials provide a glimpse of some
aspects of our services to demonstrate both knowledge and ongoing participation
within the Pharmaceutical Industry. Our analysis and consultancy includes all
channels of misuse, diversion, counterfeiting and illicit exploitation of
pharmaceuticals, medical devices, and precursor chemicals. Our advisement is to
manufactures, jurisdictional entities, insurers, legislators, litigators, patients, and
health care providers.
This scope also frequently segues into the nexus of crime and terrorism as
significant influencers that undermine sector integrity differentiated from other
criminal activity. Obviously, vulnerability assessment, information collection
management and intelligence production supporting decision-making for risk
reduction and interventions are routinely within the scope of our services as well
as design and implementation of operational control measures.
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