#Sartans Market

[soumyafwr]

https://carbonfacesocial.org/blogs/81472/Fatty-Liver-Treatment-Market-Analysis-Size-Share-and-Forecast-2031

Sartans Market Size, Overview, Share and Forecast 2031

[sudheervanguri]

Titan Laboratories Hiring for Regulatory Affairs API in Navi Mumbai Join Titan Laboratories Pvt Ltd as a Regulatory Affairs API Professional Titan Laboratories Pvt Ltd, a leader in pharmaceutical manufacturing, is seeking experienced professionals for the position of Regulatory Affairs API at their Navi Mumbai (Turbhe) Head Office. If you have 9+ years of experience in regulatory submissions and lifecycle management, this is an excellent opportunity to advance your career. Job Responsibilities As an Officer/Sr. Officer/Executive/Sr. Executive/Asst. Manager in Regulatory Affairs API, you will be responsible for: Responsible for submissions and Lifecycle Management - Europe/UK/US/Canada/WHO and ROW market. Preparing Nitrosamine Risk Assessment Report for Sartans and other drug substances. Submissions of USDMF, EU-ASMF, CEP, WHO and Health Canada query responses to the respective regulatory authorities through electronic submissions. (ESG, CESP submissions) Submission of US-Amendments/ASMF Updates/CEP Revisions adequately based on changes proposed for the drug Substances. Notifications of US-Amendment/ASMF Update/CEP Revision to relevant customers.  Preparing and compiling DMF/Technical Packages & Dossiers for submission to the Regulatory Agencies of the various countries (US, Europe, WHO, Canada & ROW). Knowledge and experience in preparation & reviewing of Module 1 to Module 3 CMC Documentation. Compiling eCTD sequences through Pharmaready. Review of Validation reports, Stability studies, Specifications/ Method of Analysis, Batch Manufacturing Records (BMR’s/MFR’s), Pharmaceutical Development Reports (PDR). Interact with various departments/teams for regulatory documents and compilation on time as per regulatory requirements. Maintenance of the complete history of each drug substance (Filing history with agencies/customers, deficiency responses, amendments, annual reports)  Issue Letter of Access and other relevant regulatory documents and their submission to regulatory authorities.  Review of all documents from QA, R&D, AR&D, Production and other department with respect to correctness and compliance for regulatory submission. Audit Faced: WHO-GENEVA, USFDA, EDQM and Customer audits. Qualifications Experience: 9+ years in Regulatory Affairs API. Educational Background: M. Pharma or B. Pharma. Location: Navi Mumbai (Turbhe) Head Office. How to Apply Interested candidates can share their resumes with Shweta M at shweta.m@titanpharma.com. [caption id="attachment_79912" align="aligncenter" width="930"] Titan Laboratories Pvt Ltd Recruitment - Job vacancies[/caption]

[xtruss]

Do Drug Trials Underestimate Side Effects?

"Drug companies... will studiously avoid mentioning the fact that large segments of the population were excluded from the trials"

— By Sebastian Rushworth, MD | Anti-Empire | July 19, 2021

“The easiest solution, if you want to avoid finding nasty side effects, is to not report them, regardless of which treatment group the participant is in. That will cut down on total adverse events in both groups”

One commonly used trick in drug trials is to exclude any group that might make the drug look worse, such as those that are more likely to experience side effects. A good recent example of this is the covid vaccine trials, which largely excluded people with auto-immune diseases (more likely to develop an auto-immune disease after vaccination), people with allergies (more likely to have an allergic reaction to the vaccine), and, of course, the elderly (less likely to develop immunity after getting the vaccine, and more likely to become seriously sick from it).

These three groups are all frequently excluded from trials, and the exclusion is particularly galling when it comes to the elderly, because they are a big segment of the population, and they are also usually the most likely to end up actually using the drugs being tested.

When drug companies have gotten a drug approved, and move on to market the drug, they will studiously avoid mentioning the fact that large segments of the population were excluded from the trials. When drug reps show their flashy powerpoints to gatherings of doctors, say for a new drug to lower blood pressure, they will always present impressive looking graphs of benefit, and they will of course point out how safe their drug was shown to be in the trials. Not once will they mention that the groups of patients the doctors will primarily be prescribing the drug to weren’t even included in the trials.

The doctors will then happily go off and prescribe the drug to multi-morbid 90 year olds, which might explain why prescription drugs are now the third leading cause of death in the western world.

The manipulation of who is included in trials is probably one of the main reasons why findings of side effects always end up being much higher in reality than in clinical trials. It might explain, for example, why muscle pain is a massively common side effect of statins in the real world, while being vanishingly rare in the statin trials (as Dr. Malcolm Kendrick has written about in detail).

A study recently published in the Lancet Healthy Longevity sought to estimate the extent to which drug trials underestimate side effects. It was funded by the UK Medical Research Council and the Wellcome Trust. The study chose as its particular focus people being treated for high blood pressure with a certain class of blood pressure lowering drugs known as RAAS blockers (which includes all drugs with names ending in -pril and all drugs with names ending in -sartan). The advantage with looking at this particular class of drugs is that there are a ton of trials. Every major pharmaceutical company has its own RAAS-blocker. It should therefore be possible to draw relatively broad conclusions about the results – whatever they show, they apply to the entire pharmaceutical industry, not just to a few specific companies. It’s also reasonable to think that the results apply to other classes of drugs too – there’s no reason to think trials of RAAS-blockers have been done differently than trials of other drug classes.

What the study sought to do more specifically was compare the rate of serious adverse events in clinical trials of RAAS-blockers with the rate observed in the real world. A serious adverse event is any event that is potentially life threatening or that results in death, hospitalization or lasting disability. If a trial has been designed in such a way that it is representative of reality, then the rate of serious adverse events in the trial should largely mirror that seen in the real world.

110 trials of RAAS-blockers were identified by the researchers. Of these, 11 were specifically designed to look at older people (i.e. didn’t recruit anyone under the age of 60). The data on serious adverse events from these 110 trials was extracted and compared to real world data on deaths and hospitalizations taken from a UK government funded database of 55,000 people living in Wales, who were being treated with RAAS-blockers. Deaths and hospitalizations are not exactly the same thing as serious adverse events (which as mentioned above also include “life threatening events”, and could for example include someone who is treated in an emergency department after a fall but not admitted to the hospital), but they’re close enough to allow a reasonable comparison.

So, what were the results?

Let’s begin with comparing the trials of older people with the “standard” trials. The relative rate of serious adverse events in the trials of older people was 76% higher than the rate in the standard trials. This shows the importance of including elderly people in drug trials – they are much more likely to experience adverse events of all kinds (including those actually caused by the drug being tested), and excluding them will therefore likely underestimate side effects.

Considering that many of the drugs in common use show marginal benefits at best (statins have, for example, only been shown to prolong life by a few days on average), this is important information. Why? Because a drug that is beneficial, on balance, to a fifty year old, who has a fully functioning kidney and liver, and is therefore unlikely to suffer side effects, could easily be harmful, on balance, to an 80 year old.

That’s why drug studies done on younger people should not be used to guide treatment of older people. No shock there. Everyone already knows that we shouldn’t be extrapolating results from one group to another (even though it happens all the time, as we’ve seen most recently with the covid vaccine trials).

Next we come to the more important, and perhaps more shocking finding.

The real world patients were between 300% and 400% more likely to experience a serious event than the participants in the trials! That is in spite of the fact that the trials, as mentioned above, were using a broader definition of what constituted a serious event. If the trials were representative of reality, then they should have a higher rate of events than is seen in the real world data. Instead they have a rate that is several times lower!

Interestingly, the trials of older people were just as far from the real world results as the trials of younger people. Clearly, doing trials on the elderly is not enough on its own to produce trials that are representative of reality. What’s happening here exactly?

There are three possible explanations, as far as I can see. The first explanation is that the trials are representative of reality, but that the Welsh die and are hospitalized at a rate that is several times higher than people in the countries where the studies were conducted. Many of the trials were conducted in the US, not in Wales. But Wales has a higher life expectancy than the United States, so that seems unlikely. I think we can discount that explanation.

The second explanation is that the trials are unrepresentative in so many different ways that just correcting the age issue doesn’t make a noticeable difference. That’s probably part of the explanation. The average age even in the trials of “older people” was 73, which isn’t very old from my perspective. And those 73 year olds included in the trials were probably at the healthier end of the spectrum.

The third, more sinister explanation, is that the pharmaceutical companies are hiding serious adverse events… But wait a minute, the trials are randomized and blinded, so the people running the drug trials have no way of knowing if someone experiencing a possible side effect is in the treatment group or the placebo group, right?

Yes, that’s right, so the easiest solution, if you want to avoid finding nasty side effects, is to not report them, regardless of which treatment group the participant is in. That will cut down on total adverse events in both groups, which will make any difference between the groups that does exist smaller in absolute terms, and also less likely to reach the level of statistical significance. Voila – the treatment group and the placebo group end up having similar rates of side effects, and the drug company can conclude that the drug is completely safe.

Is that what’s happened here? Are the pharmaceutical companies hiding adverse events? Well, it’s very strange that the real world data shows a rate of serious adverse events that is several times higher than is found in the trials. It’s hard to see how that massive difference could be explained in any other way.

So, how big a problem is this?

Big. Very big. It should shake the very foundations of evidence based medicine. If the drug trials and the real world data show such wildly different rates of adverse events, then it really begs the question how much we can trust the trials at all. It would be perfectly reasonable in this situation to say that all “evidence” produced by pharmaceutical companies is so suspect that it should be dismissed out of hand, and that only independently funded trials should be used as a basis for medical treatment decisions.

The problem with that is that it would mean saying goodbye to most of the trials that form the basis of modern medical treatment, and there is not much to replace them with. This issue could be solved over the longer term through large tax payer funded investments in new independent trials. But there’s no quick fix.

The problem is most acute when it comes to the many drugs in common use that only show marginal benefits, such as statins. If the rate of side effects is actually 300% to 400% higher than seen in the trials, then the harms of these drugs could easily outweigh the benefits. In other words, the cost-benefit calculation could shift entirely for many of the most commonly used drugs.

Ok, let’s wrap this up. What can we conclude?

Drug trials do no accurately represent rates of adverse events. It is likely that the true rate of side effects is often many times higher than that seen in drug trials.

— Source: Sebastien Rushworth MD | sebastienrushworth.com

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Cardiovascular Diseases Industry in India Share, Trends & Forecast to 2026

Cardiovascular diseases (CVDs) are amongst the fatal diseases across the globe, accounting for over 25% of the total mortalities in India every year. The Harvard School of Public Health (HSPH) and the World Economic Forum (WEF) revealed that between 2012 and 2030, the total economic burden of non-communicable diseases in India is estimated to reach $1.7 trillion (INR 126 lakh crore). CVD includes high blood pressure, coronary artery disease, cardiac arrest, stroke, arrhythmia, congestive heart failure, peripheral artery disease, and congenital heart disease. The high blood pressure is the most prevalent in India. Therefore, there is a significant demand for anti-hypertensive drugs in the Indian CVD market. In conjunction with the management of high blood pressure, the chances reduces for the occurrence of other chronic health conditions, such as stroke, heart attack, or other complications.

Get Free Sample Copy @ https://marketinsight.in/request-sample/indian-cardiovascular-diseases-industry-outlook

As per the Institute for Health Metrics and Evaluation (IHME), CVD's risk factors have increased across all states in India between 1990 and 2017. In less developed Indian states, such as Bihar, Rajasthan, Meghalaya, Jharkhand, Uttar Pradesh, Assam, Madhya Pradesh, Chhattisgarh, and Odisha, the prevalence of the CVD is comparatively less, with the prevalence of the disease varied between 3,000 and 4,000 per one million population in 2017.

A Full Report of Indian Cardiovascular Diseases Industry is Available at: https://marketinsight.in/industry-reports/indian-cardiovascular-diseases-industry-outlook

MAJOR CATEGORIES IN THE CVD THERAPY

i)          Lipid Medications (Statins)

ii)         Angiotensin Receptor Blockers (Sartans)

iii)        Beta-Blockers

iv)        Anticoagulants

Whereas beta-blockers are used to treat various conditions such as hypertension, arrhythmia, chest pain, and migraine, among others. This CVD drug therapy accounts for nearly 20% of the Indian CVD drug market, as per OMR analysis. The major key players active in the Indian CVD drug market include Sun Pharmaceutical Industries Ltd., Torrent Pharmaceuticals, Ltd., Lupin, Ltd., USV Pvt., Ltd., and Glenmark Pharmaceuticals, Ltd. Company-wise, Sun Pharmaceutical Industries Ltd. is the largest player in CVD drugs with around 15% market share in the Indian CVD drug market in 2020.

For More Customized Data, Request for Report Customization @ https://marketinsight.in/report-customization/indian-cardiovascular-diseases-industry-outlook

About Market Insight

Marketinsight.in, a sub-division of Orion Market Research (OMR), is a determined market research firm that simply aims at providing services such as consulting, customize research, field research and a growth strategy plan to the Indian enterprises. It provides a complete suite of customized services focused on to bringing process efficiency and market effectiveness in its services.

Media Contact: Company Name: Market Insight Contact Person: Mr. Anurag Tiwari Email: info@marketinsight.in Contact no: +91 780-304-0404

[soumyafwr]

https://zekond.com/read-blog/60858_sartans-market-size-overview-share-and-forecast-2031.html

Sartans Market Size, Overview, Share and Forecast 2031

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FDA says all ranitidine drugs should be recalled on safety concerns

The FDA has asked drugmakers to pull all prescription and over-the-counter products based on ranitidine off the market immediately, after a review failed to alleviate concerns about a cancer risk.

The move extends voluntary recalls last year by several drugmakers – including Sanofi, Sandoz and the drug’s original developer GlaxoSmithKline – which were implemented after preliminary investigations last summer suggested a carcinogenic impurity was present in a range of ranitidine products.

Now, the US regulator says new evidence from its probe into the nitrosamine contaminant known as N-nitrosodimethylamine (NDMA) shows that the level increases in some ranitidine products over time when stored at room temperature.

That “may result in consumer exposure to unacceptable levels of this impurity,” it said, as it implemented a ban on new and existing prescriptions for the gastrointestinal drug, commonly known as Zantac and used to treat conditions like heartburn.

Low levels of NDMA are ingested in the diet as the substance is found in food and water, but not at levels expected to cause an increase in cancer risk.

“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” said Janet Woodcock, who leads the FDA’s Centre for Drug Evaluation and Research (CDER),

“However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” she added.

Testing found that NDMA increased during normal storage conditions, and that there was a bigger rise if samples were exposed to higher temperatures during distribution and handling by patients.

Put simply, “the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA,” according to the FDA.

The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called angiotensin II receptor blockers or ‘sartans’ since last year, and is also looking into levels in diabetes drug metformin.

Meanwhile, in Europe the CHMP has also asked manufacturers of all drugs considered at risk of NDMA impurities to review their products and report the outcome by 1 October this year.

The FDA is advising consumers to stop taking any OTC ranitidine products they may have and dispose of them at home.

They should also consider using other approved OTC products that have similar uses. So far, NDMA hasn’t been found in in famotidine, cimetidine, esomeprazole, lansoprazole or omeprazole, which are all alternative treatments for heartburn.

People prescribed ranitidine should seek medical advice before stopping treatment, it adds.

The post FDA says all ranitidine drugs should be recalled on safety concerns appeared first on .

from https://pharmaphorum.com/news/fda-says-all-ranitidine-drugs-should-be-recalled-on-safety-concerns/

[psychic-readingonline]

Astrology Podcast Houses

Contents

Personalized daily horoscope

Vedic astrology horoscope

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2019 rashifal (horoscope)

… 12 reasons

Jun 10, 2014 … Some traditional astrologers think that the two approaches should not be … In modern astrology the significations of the houses are largely derived from … You can either download this episode of the podcast as an MP3 or you …

Moon Sign Astrology November 2017 Astrology Birth Chart In Urdu Cancer Get free horoscope 2019 & free Astrology 2019. Your personalized daily horoscope, 2019 horoscope, moon sign horoscopes, horoscope matching & kundli software online based on vedic astrology. We are Vedic horoscope & vedic astrology market leaders. cancer Women, Girl, Boy, Men, Parents And Kids. All Details About Burj Sartan Astrology Today Rohini Jyotisha or Jyotishya (from Sanskrit jyotiṣa, from jyóti-"light, heavenly body") is the traditional Hindu system of astrology, also known as Hindu astrology, and more recently Vedic astrology.The term Hindu astrology has been in use as the English equivalent of Jyotiṣa since the early 19th century, whereas Vedic astrology is a relatively recent term, entering common

Jul 18, 2013 … In this episode Chris and Kelly talk about the issue of house division in astrology, and the wide range of different house systems that …

Astrology App Price You can find the vedic astrology horoscope (Daily, Monthly, Yearly, Major Transits) by KT Astrologer.You will come to know about your health, love, relationship … price: free audience: beginners and intermediate astrologers. The Daily Horoscope is the most popular horoscope app currently on smartphones. In addition to … Astrology Today Rohini Jyotisha or Jyotishya (from Sanskrit

If you know nothing about astrology begin with the idea that you are not one sign – you are several in one body! Here is how to find your main signs and find …

Astrology Kundali Astrology Today New Moon astrology birth chart In Urdu Cancer Get free horoscope 2019 & free Astrology 2019. Your personalized daily horoscope, 2019 horoscope, moon sign horoscopes, horoscope matching & kundli software online based on vedic astrology. We are Vedic horoscope & vedic astrology market leaders. cancer Women, Girl, Boy, Men, Parents And Kids. All Astrology 2019 Bengali The 2019 rashifal (horoscope) has been prepared on the basis of your moon sign. It consists of different Rashifal (Horoscope)s for 2018 such as love Rashifal (Horoscope) 2019, finance Rashifal (Horoscope) 2019, family astrology 2019, sex Rashifal (Horoscope) 2019, Lal Kitab 2019 Rashifal (Horoscope) and Chinese Rashifal (Horoscope) 2019 etc. We, at AstroSage, are back Astrology Aspects Of Healers Astrology is the study of the movements and relative positions of celestial objects as a means for divining information about human affairs and terrestrial events. The position of the stars, planets, sun and moon when one is born are believed to have affect one’s personality, shape how relationships work in one’s life and predict future

May 14, 2018 … Discussing the assignment of sex to the houses in western astrology over the past 2000 years, and the shift between the 7th, 5th, and 8th …

Nov 21, 2015 … This episode of the podcast is a recording of a lecture I presented recently … 12 reasons Why Whole Sign Houses Is The Best House System … It solves a long- standing dispute that astrologers have had for the past 1000 …

astrology news. News and information about what is going on in the astrological community, and in the world in general from an astrological perspective.

May 14, 2016 … A transcript of a podcast that talks about the origins of the significations of the 12 houses in western astrology, and where they come from.

Our mission is to facilitate the best astrology education with quality instructors who can teach as well as they inspire you.We present a diverse menu of astrological styles and teachings so that you can benefit from a well-rounded education.

Nov 19, 2018 … Tagged With: Ascendant, benefics & malefics, birth certificate, birth data collection, birth times, house rulers, rectification, rising sign, ruler of the …

The purpose of this article is to give an overview of a form of house division used in western astrology called whole sign houses. Whole sign houses is the oldest form of house division, originating sometime around the 1st century BCE as a part of the Greco-Roman tradition of astrology known as Hellenistic astrology.

[pavanghage]

Sartans Market Future Scope by 2021-2027: Business Size and Global Opportunity by Top Players, End User, Demand and Consumption Scenario

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Sartans Market is analyzed with industry experts in mind to maximize return on investment by providing clear information needed for informed business decisions. This research will help both established and new entrants to identify and analyze market needs, market size and competition. It explains the supply and demand situation, the competitive scenario, and the challenges for market growth, market opportunities and the threats faced by key players.

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A 360 degree outline of the competitive scenario of the Global Sartans Market is presented by Axel Reports Market Insights. It has a massive data allied to the recent product and technological developments in the markets.

It has a wide-ranging analysis of the impact of these advancements on the market’s future growth, wide-ranging analysis of these extensions on the market’s future growth. The research report studies the market in a detailed manner by explaining the key facets of the market that are foreseeable to have a countable stimulus on its developing extrapolations over the forecast period.

Reasons for buying this report:

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It offers seven-year assessment of Global Sartans

It helps in understanding the major key product segments.

Researchers throw light on the dynamics of the market such as drivers, restraints, trends, and opportunities.

It offers regional analysis of Global Sartans Market along with business profiles of several stakeholders.

It offers massive data about trending factors that will influence the progress of the Global Sartans

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By Market Players: Pfizer Bristol-Myers Squibb Astra Zeneca Novartis Sanofi Merck GSK Eli Lilly Jhonson and Johnson Bayer Teva Pharmaceutical By Type Valsartan Telmisartan Losartan Irbesartan Azilsartan Olmesartan By Application Hypertension Cardiovascular Diseases Kidney Diseases Other

A detailed outline of the Global Sartans Market includes a comprehensive analysis of different verticals of businesses. North America, Latin America, Asia-Pacific, Africa, and Europe have been considered for the studies on the basis of several terminologies.

This is anticipated to drive the Global Sartans Market over the forecast period. This research report covers the market landscape and its progress prospects in the near future. After studying key companies, the report focuses on the new entrants contributing to the growth of the market. Most companies in the Global Sartans Market are currently adopting new technological trends in the market.

Finally, the researchers throw light on different ways to discover the strengths, weaknesses, opportunities, and threats affecting the growth of the Global Sartans Market. The feasibility of the new report is also measured in this research report.

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Table of Contents:

Global Sartans Market Overview

Economic Impact on Industry

Market Competition by Manufacturers

Production, Revenue (Value) by Region

Production, Revenue (Value), Price Trend by Type

Market Analysis by Application

Cost Analysis

Industrial Chain, Sourcing Strategy and Downstream Buyers

Marketing Strategy Analysis, Distributors/Traders

Market Effect Factors Analysis

Global Sartans Market Forecast

ABOUT US:

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[manostaxx]

Nitrosamine Impurities In Medicines: What Have We Learned?

Nitrosamine Impurities In Medicines: What Have We Learned?

[text-blocks id=”20539″ slug=”tradelabor”]

Nitrosamine impurities, potential carcinogens, were identified in human blood pressure medications known as “sartans” in 2018. The risk that these compounds cause cancer in humans is reported to be very low. However, in an abundance of caution, the European Medicines Agency (EMA) requested that marketing authorization holders perform analyses to…

[compare-wp10]

EU MONITOR - Learn about the COVID-19 initiatives of your colleagues! | European Association of Hospital Pharmacists

See on Scoop.it - COMPARE RISK COMMUNICATION

The EAHP EU Monitor is a regular round up of news relevant to hospital pharmacy in Europe. You can subscribe to receive the EAHP EU Monitor by email HERE.  EAHP-ESCP video initiative goes live  Over the last couple of weeks the video initiative of the European Association of Hospital Pharmacists (EAHP) and the European Society of Clinical Pharmacy (ESCP) collected best practice examples of clinical and hospital pharmacy services that made a difference for patients during the COVID-19 pandemic.  Short 2 to 3-minute videos have been made available on the initiatives YouTube channel to demonstrate how clinical and hospital pharmacists coped with the challenges posed by the novel coronavirus. Contributions were submitted from all across Europe touching for example on the preparation of disinfectants, the creation of new workflows and the r esolution of medicines shortage problems.  As outlined in the call to action, clinical and hospital pharmacists can still submit their videos to EAHP and ESCP, despite the fact that the deadline has passed. There are no limitations apart from the fact that the video should fulfil minimum graphical quality standards and that is should be non-commercial and respect ethical and privacy standards. Thus, in case you have just finished your video contribution, please email it via we-transfer (https://wetransfer.com/) to covid19[at]eahp[dot]eu  and international.office[at]escpweb[dot]org. Watch the submitted videos HERE  More information about the video initiative is available HERE   Don’t miss today’s webinar on “International Hospital Pharmacy against COVID” Today, the Spanish Association of Hospital Pharmacists (SEFH) will be organising a webinar showcasing international hospital pharmacy contributions against COVID-19. EAHP’s Director of Finance, Dr András Süle, will participate on behalf of the Association.  Together with the Senior Vice President of the American Society of Health-System Pharmacists (ASHP), Dr Douglas J. Scheckelhoff, the President of the International Pharmaceutical Federation (FIP), Dr Dominique Jordan, the Innovation Director of SEFH, Dr José Manuel Martínez Sesmero and the Vice President of SEFH, Dr Jordi Nicolás Picó, Dr Süle will be sharing how hospital pharmacists addressed the challenges posed by the COVID-19 pandemic.  The webinar will start at 6 PM CEST. Registrations are still possible via the following  LINK      Council Conclusions on Shaping Europe's Digital Future Under the Croatian Presidency the Council adopted conclusions in June addressing a variety of issues linked to the EU’s digital strategy. Titled ‘Shaping Europe's Digital Future’, the document touches, among other things, on cybersecurity, artificial intelligence, digital health and education.  In the field of health, the council conclusions address the digital transformation of health and care and its value in strengthening the resilience of health systems. In particular due to the COVID-19 pandemic they highlight the importance of a European Health Data Space and mobile applications to support contact tracing. Other points interlink with the importance of interoperability of for example electronic health records and the future contributions of artificial intelligence for the health sector. Croatia will conclude its presidency today. For the coming six months, Germany will hold the EU’s Council presidency. It’s work programme is built around to the slogan "Together for Europe's recovery". The COVID-19 pandemic will be a key focus.  Access the council conclusions HERE Public consultation for the EU pharmaceutical strategy   In addition to the roadmap consultation – which EAHP featured in its EU Monitor of 9 June 2020 – the European Commission opened a public consultation for its new EU Strategy on safe and affordable medicines. Until 15 of September, members of the public, stakeholders and organisations are encouraged to contribute to this consultation. The pharmaceutical strategy for Europe aims to address issues linked to the availability and the affordability of medicines by creating a future proof regulatory framework. In addition, its seeks to support industry in promoting research and technologies that actually reach patients and fulfil their therapeutic needs while addressing market failures.  The consultation consists of questions, which will focus on key themes: strategic autonomy and manufacturing of medicines, access to affordable medicines, innovation, and environmental sustainability and health challenges. The aim of the consultation is to allow the public, experts and stakeholders to contribute and voice their opinion on the best ways to address pharmaceutical related issues in the EU. The results of the public consultation will contribute to the preparation, in the autumn, of the EU pharmaceutical strategy, which is expected to be adopted by the end of the year. Access the public consultation HERE   Lessons learnt from presence of N-nitrosamine impurities in sartan medicines The European Medicines Agency (EMA) together with the Head of Medicines Agencies (HMA) published the outcomes of its lessons learned exercise on the presence of nitrosamines in sartan medicines. Started in May 2019, the exercise consider ways to prevent unexpected impurities such as N-nitrosamines from being present in human medicines and to better manage such cases should they occur in the future. The recommendations outlined in the report call for the development of additional guidance on the roles and responsibilities of companies involved in the manufacture of medicines, controlling impurities, good manufacturing practice (GMP) as well as sampling and testing. In addition, the report suggests: improving communication with patients and healthcare professionals; expanding cooperation with international partners; and, further developing information technology systems. The forty recommendations will now feed into concrete measures that aim at protecting the quality of EU medicines with respect to N-nitrosamines and other impurities. Read the report HERE   Provision of clinical pharmacy services during the COVID-19 pandemic: a qualitative study of clinical pharmacists’ views and experiences The Research Committee of the European Society of Clinical Pharmacy (ESCP) and the University of Birmingham are looking for clinical pharmacists that are interested to take part in a research study that aims to explore the views, experiences provision of clinical pharmacy services during the COVID-19 pandemic.  Clinical pharmacists practicing in diverse healthcare settings in Europe who are involved in clinical roles are encouraged to join. For more information please contact Dr Vibhu Paudyal, University of Birmingham, Chair of the Research Committee, via email: v.paudyal[at]bham.ac[dot]uk. Consult the participants information sheet HERE       Updates from the European Medicines Agency  The European Medicines Agency (EMA) published new communications linked to the ICMRA vaccine confidence statements and the recommendation of a first COVID-19 treatment for EU authorisation. ICMRA vaccine confidence statements EMA has endorsed two statements for healthcare professionals and the general public about the importance, safety and effectiveness of vaccines published by the International Coalition of Medicines Regulatory Authorities (ICMRA).  International regulators from different countries and regions have come together and jointly developed these statements to reassure healthcare professionals and the public around the globe that medicines regulatory authorities only allow vaccines onto the market that fulfil the highest standards for safety, efficacy and quality. In these statements, they also reiterate that it is everyone’s responsibility to get vaccinated in order to protect not only themselves but also their families, friends, communities, vulnerable populations who cannot get immunised as well as the generations to come. Access the ICMRA statement about confidence in vaccine safety and effectiveness for healthcare professionals HERE Access the ICMRA statement about confidence in vaccines for the general public HERE First COVID-19 treatment recommended for EU authorisation  EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU. Data on remdesivir were assessed in an exceptionally short timeframe through a rolling review procedure, an approach used by EMA during public health emergencies to assess data as they become available. The European Commission, which was kept informed by EMA throughout the evaluation, will fast-track the decision-making process and aims to grant a decision on the conditional marketing authorisation for remdesivir in the coming week, allowing the product to be marketed in the EU. More information is available HERE Please check EMA’s dedicated webpage on COVID-19 for the latest updates. EJHP: Read the July issue The July issue of the European Journal of Hospital Pharmacy (EJHP) is now available. Besides sharing insights on EAHP’s 2019 Medicines Shortages Survey it also touches on the power of cooperation. Its original articles inform about the management and challenges of emergency drug kits at the Danish hospital pharmacies, the Council of Europe Resolution CM/Res(2016)2 and interventions for improving surgical antibiotic prophylaxis adherence and reducing hospital readmissions Read the July issue HERE       [COVID-19 Updates]   EAHP’s COVID-19 Resource Centre To assist its member associations and individual hospital pharmacists in this critical time with the provision of the best possible care for patients, EAHP has decided to gather and make available information on COVID-19 relevant for the hospital pharmacy profession. Access the Resource Centre HERE Alzheimer Europe - Resource Hub Alzheimer Europe has put together a range of valuable online resources with helpful information, tips and guidelines. Learn more HERE  French Society of Anaesthesia & Intensive Care Medicine (SFAR) - Prevention of medication errors in anaesthesia and resuscitation SFAR and the SFPC have developed joint recommendations for the prevention of medication errors in anaesthesia and resuscitation in times of acute health crisis, based on initial feedback from the COVID-19 period. Learn more HERE   Do you know about the Statement Resources? Since 2016 EAHP has been working on the implementation of the European Statement of Hospital Pharmacy. To help hospital pharmacists with the putting in practice of the Statements in their pharmacy, EAHP has published resources for each of the 6 Sections. These include for instance case studies and best practice examples.  Access the Statement Resources HERE ___________________________________________________________________________________________________________________ Consultations    Commission – Roadmap: new EU pharmaceutical strategy The European Commission is seeking input on its roadmap for the new EU pharmaceutical strategy. Deadline – 7th July 2020 Access consultation HERE

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Merck and the machine: German pharma tests real-time platform to forestall drug shortages

With hundreds of drug shortages hitting the pharmaceutical industry each quarter, drugmakers are looking for novel ways to accurately forecast demand and control costs at the same time. For Merck KGaA, that search led to an experiment in machine learning.

The German pharma plans to launch a pilot project with TraceLink, using real-time data points in the company’s supply chain to more accurately predict future demand for its drugs.

Merck told the Wall Street Journal its current forecasts for global demand are about 85% accurate. Those predictions matter because drugmakers are forced to stockpile inventory that may expire or run out depending on rapid shifts in the supply chain, sometimes causing a big hit to the company’s financials.

TraceLink is developing the pilot platform specifically for Merck KGaA’s immuno-oncology business, Alessandro DeLuca, chief information officer for Merck’s health-care division, told the Journal.

“The value is going to be that every single patient will receive the drug that he or she needs at the right moment,” DeLuca said.

Drug shortages are no laughing matter for pharma: So far in the third quarter, there have been 212 FDA-reported drug shortages, according to the American Society of Health System Pharmacists. That figure is roughly in line with 150 to 300 U.S. shortages reported each quarter between 2014 and 2019, the Journal said.

On average, pharmas carry 156 days of inventory on average, with retailers typically holding around 78 days of inventory, the Journal said.

Merck KGaA hopes that the pilot platform will not only help it save in established supply chains like the U.S. but also allow it to expand into regions with less-reliable distribution, such as Africa and Southeast Asia.

A platform that significantly improves supply chain forecasts could be a game-changer in an industry regularly plagued by shortages. Sometimes those shortages are tied to forecasting, but other issues are sometimes in play.

For example, on Monday, AstraZeneca said manufacturing problems would hinder U.S. supply of the drugmaker’s inhaled flu vaccine FluMist. The company said it would only ship three lots of the vaccine—or around 758,000 doses—to the U.S. in anticipation of the coming flu season. That’s about one-third the amount available during the last flu season and a small fraction of what AZ has shipped in years past.

Meanwhile, “sartan”-based blood pressure drugs are still running short, after possible carcinogens in Indian and Chinese active ingredients triggered recalls last year. The FDA has allowed limited amounts of the drugs, including valsartan and losartan, on the market specifically to address the continued shortages.

Other shortages are simply outside a drugmaker’s control. Back in September, Germany’s Fresenius Kabi said it was limiting allocations of the blood thinner heparin, derived from pig intestines, after a swine fever outbreak in China. Earlier this summer, reports pegged China’s loss of pigs due to swine fever at 150 million of an estimated 440 million swine nationwide.