Adverse Event Transparency
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MedHawk App Available on Apple App Store!

This is "medhawk" by Uptempo Group on Vimeo, the home for high quality videos and the people who love them.
MedHawk's insight:

Available today, the app MedHawk offers a groundbreaking way to report medical side effects on Twitter through an iPhone. It allows patient advocates, as well as patient revolutionaries, to tweet and discuss the many adverse drug effects that are prevalent in today’s popular pharmaceutical medications. The MedHawk mobile application serves as an online platform to promote more transparency in modern day medicine.


Patients are now able to report and share their personal side effects on Twitter with MedHawk. If a patient is not able to find a certain side effect that they are experiencing, MedHawk allows users to create their own side effect that will be added to Medhawk’s side effect database. Thanks to the suggested tag column, patients can also directly tag the FDA and the pharmaceutical company about their side effects.

 

MedHawk is now available on the Apple App Store for free. Take the time to download this mobile application and let your voice be heard about adverse drug events in today’s society. Join the patient revolution!

 


MedHawk App LLC©

 Download: https://itunes.apple.com/us/app/id897448152?mt=8

Website: http://www.medhawk.net/

Twitter: https://twitter.com/MedHawkapp

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Launch Of OpenFDA Increases Accessibility To Adverse Drug Event Reports - Mondaq News Alerts (registration)

Launch Of OpenFDA Increases Accessibility To Adverse Drug Event Reports - Mondaq News Alerts (registration) | Adverse Event Transparency | Scoop.it

"Launch Of OpenFDA Increases Accessibility To Adverse Drug Event Reports Mondaq News Alerts (registration) On June 2, 2014, the Food and Drug Administration launched openFDA (https://open.fda.gov ), a program designed to improve access to publicly...

MedHawk's insight:

On June 2, 2014, the FDA launched a new website openFDA (https://open.fda.gov), a database intended to expand access to openly obtainable statistics on adverse drug event reports. While greater availability to adverse event reports has manufacturing returns, it may also put pharmaceutical industrialists at greater lawsuit risk. Here is a description on  how OpenFDA works and its impact on litigation:


How OpenFDA Works: OpenFDA is a search-based application programming interface. OpenFDA users may propose a query to the API using catagories that include brand name, generic name, route of administration, active ingredients, and pharmacologic class. The data from openFDA are undoubtedly useful; however, API forces users to write code to attain search results. Amplified access to this data will be valuable to academic scientists and medicinal businesses. The power to evade submitting Freedom of Information Act requests or analyzing difficult-to-use reports will save researchers and pharmaceutical companies time and money. Having the data in one place in a simplified form will allow these groups to analyze adverse event reports and statistics in order to better understand the limitations and benefits of various drugs.

 

OpenFDA's Impact on Litigation: OpenFDA could potentially increase litigation risk for pharmaceutical companies. Simple access to a decade's worth of adverse event reports will allow the plaintiffs' bar to mine adverse drug event data for potential claims and may lead to increased litigation filings. For pending litigation, openFDA will provide plaintiffs with access to more adverse event reports than they would be able to obtain in discovery, creating larger sample sizes on which experts can base their opinions.

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Unintended Danger from Antidepressant Warnings | HMS

Unintended Danger from Antidepressant Warnings | HMS | Adverse Event Transparency | Scoop.it
FDA warnings INCREASE teen suicides, an example of the biomedicrat syndrome: Regulate any risk, ignore all benefits. http://t.co/oGClcFyzJz
MedHawk's insight:

Researchers have found that U.S. Food and Drug Administration warnings about a potential danger for young people taking antidepressants may have backfired, causing an increase in suicide attempts by teens and young adults.


Following a decline of more than 28 percent, the suicide rate for 10- to-24-year-olds increased by 8 percent, the largest single-year rise in 15 years, according to a report just released in the Centers for Disease Control and Prevention's (CDC) Morbidity and Mortality Weekly Report (MMWR).


The risks cited by the FDA were about 1 percent of those treated, but antidepressant use dropped suddenly by about a relative 20 percent, unintentionally leaving many depressed young people without appropriate treatment, which likely drove the accompanying hospital and emergency department admissions for suicide attempts, he said.


The researchers noted that suicide attempts with drug overdose are very serious, resulting in long-term hospitalization and significant disruption to the lives of patients and their families.

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FDA Looks to Twitter to Raise Drug Awareness - Huffington Post

FDA Looks to Twitter to Raise Drug Awareness - Huffington Post | Adverse Event Transparency | Scoop.it
FDA Looks to Twitter to Raise Drug Awareness Huffington Post Any which way you look at it, the FDA is utilizing one of the most popular forms of social media to raise awareness about the dangers that come with prescription drugs, and I think it's...
MedHawk's insight:

The FDA continues to make strong moves to provide consumers the information they need about prescription drugs. This insightful article talks about how the FDA is taking an innovative step to raising awareness for adverse drug events. 


According to new FDA guidelines, companies that create and manufacture prescription drugs may be required to utilize their 140 characters on Twitter to warn consumers about the dangers of their prescription drug. Side effects are one of the top reasons for adverse drug effects and the FDA is trying to find ways to stop it.


"If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message.” - The FDA


The FDA's proposal makes it so the most dangerous side effects must be tweeted, as well as any and all dangers that come printed on the actual prescription bottle. Using social media platforms like Twitter, consumers of these drug companies are exposed to dangerous reports prescription drugs online. 

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Tips for Beating Anxiety Without Medication

Tips for Beating Anxiety Without Medication | Adverse Event Transparency | Scoop.it
If you struggle with any level of anxiety, you know that it's one of the most frightening feelings you can have. Once you are set off... (11 tips for beating anxiety!
MedHawk's insight:

For individuals who are dealing with anxiety problems, prescription drugs are accessible to fight off the symptoms. As beneficial as these drugs can be, many people look for different alternatives than resorting to medications on a daily basis.

 

Here are some tips to deal with anxiety without medication:

 

1. Focus Your Energy

 

If an individual continues to focus their energy on their symptoms, anxiety only builds in a person. Instead, exert your energy on something productive or healthy that will benefit your life.


2. Be Around People


Being around people will help distract the mind from anxiety. Being able to relate with someone will help decrease anxiety and stress levels.


3. Turn on a Light


Occasionally, darkness can add to the tension that heightens an anxiety attack. Nighttime is often the worst time of day for someone who is prone to feeling anxious, and just being in the dark can worsen the symptoms.


4. Visit a Doctor


If your anxiety symptoms are unbearable, visit a doctor for advice. Finding out for sure that you don't have a heart problem or another serious health issue can go a long way to put your mind at ease.

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Prevention of adverse drug events in hospitals

Prevention of adverse drug events in hospitals | Adverse Event Transparency | Scoop.it
Adverse drug events (ADEs) comprise the largest single category of adverse events experienced by hospitalized patients, accounting for about 19 percent of all injuries. The occurrence of ADEs is associated with increased morbidity and mortality, prol
MedHawk's insight:

Every year, adverse drug events send more adult patients to American physician offices and emergency departments than do pneumonia or strep throat. The trips add up to an estimated 4.5 million annual outpatient visits related to medication problems, with seniors and patients taking more than six medications the most likely to show up in doctors' offices.

 

Nearly three-quarters of the 4.5 million adverse drug event-related visits were to physician offices, said the study, published online May 10 in Health Services Research. About 400,000 of these 4.5 million patients are subsequently hospitalized.

 

"It's scary, just to think about the number of patients who are coming in with adverse drug events -- and it could be the tip of the iceberg because there is a whole group of patients with problems who are not coming in," said Lee A. Lindquist, MD, MPH, a geriatrician at Northwestern Memorial Hospital in Chicago. 


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US Pharma Firm Abbott to Buy Drugmaker Veropharm for up to $495 Million - The Moscow Times

US Pharma Firm Abbott to Buy Drugmaker Veropharm for up to $495 Million - The Moscow Times | Adverse Event Transparency | Scoop.it
The Moscow Times
US Pharma Firm Abbott to Buy Drugmaker Veropharm for up to $495 Million
The Moscow Times
"There is an aging population and it is a country that really needs good pharma.
MedHawk's insight:

U.S. healthcare company Abbott Laboratories will purchase the Russian drugmaker Veropharm for $495 million. This gives the United States more healthcare manufacturing power, said Abbott on June 24th, 2014.

 

Abbott's acquisition is the biggest purchase by a U.S. company in Russia since Philip Morris International publicized plans to acquire stakes in cigarette distributor Megapolis for $750 million in December.

 

"Russia's middle class is growing and when the middle class grows the sector that grows is healthcare," said one trader. "There is an aging population and it is a country that really needs good pharma. If you want to get a part of that market, you have got to be a local producer and this is a way for Abbott to be locally producing."

 

The Illinois-based company, which has been operating in Russia since 1978, said the deal would allow it to establish a manufacturing presence in the country. America will continue to improve its heathcare presence in society.

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The Ostrich Syndrome - Pharma's Response to Side Effects on Twitter

The Ostrich Syndrome - Pharma's Response to Side Effects on Twitter | Adverse Event Transparency | Scoop.it
MedHawk's insight:

Twitter is becoming a popular social healthcare platform where patients report adverse drug events online.

 

A recent study published by Boston University and Harvard Medical School revealed thousands of adverse drug reports on Twitter. Within a six-month time frame, researchers collected 6.9 million tweets by filtering Twitter for buzzwords relating to medication; they randomly chose 61,000 of the tweets to investigate. As a result of the tweets analyzed, 4,400 were categorized as adverse events. Within the same timespan, there were only 1,400 events reported about the same drug to the FDA. Intriguingly, researchers also mentioned that Twitter users who tweeted about their adverse event plan to also report their problem to the FDA.

 

“For an industry that is used to having a clear framework from regulators, this is a disconcertingly vague environment and has made social media strategies challenging for the pharmaceutical industry,” – Researcher at Harvard

 

Pharmaceutical companies have been criticized for their lack of communication with social media. It was not until the FDA enforced stricter guidelines where large pharmaceutical companies began becoming active online. However, social media engagement continues to be a big problem for these companies, partly because of adverse event reporting. Although they maintain an active Twitter account, the drug companies may be responsible for reporting any adverse reaction a user tweets at them.

 

 This brings into question, the role that Pharma should play in monitoring social media for adverse events and providing patients with a process for reporting them.  It seems that many pharma companies have taken on the “Ostrich in the sand” philosophy toward social media adverse events.  Despite the fact that many of these pharma companies have extensive social media monitoring via their agencies, or significant Twitter presence during major conferences, many of these companies seem to ignore legitimate adverse events reported on Twitter. 

 

 

AZhelps is an interesting step forward by Astra Zeneca, replying to Adverse events on Twitter and directing patients to the appropriate channels.  AZHelps has been actively doing this for years, yet very few pharma companies have followed suit.  This is a very interesting development.  For any company to avoid comments about their products online is awkward in today’s social media environment.  Pharma companies seem to forget that their customer is the patient.  While they spend thousands on booths at Medical Conventions to reach doctors, along with high dollar expense accounts for daily lunches with their reps, it seems odd that they can’t afford to monitor adverse events reporting and help patients on Twitter in need.

 

 

MedHawk will be developing a weekly Ostrich award for the brands that ignore these reported adverse events on Twitter. 

 

The MedHawk app will be a simple app for crowdsourcing side effect information via Twitter to better communicate these side effects to the patient community.

 

 

The MedHawk App is coming soon…Join the patient revolution!

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Nuviun Digital Health Landscape & Interactive Venn Diagram

Nuviun Digital Health Landscape & Interactive Venn Diagram | Adverse Event Transparency | Scoop.it
MedHawk's insight:

Nuviun's interactive digital venn diagram explores the current news on digital health in our modern world. It utilizes technology to capture the entire umbrella of consumers, healthcare providers, and researchers to delivery cutting-edge information that is understandable, appropriate, efficient, and individualized to the patient and family.


Digital Health is a health term that includes all healthcare-related apps and technology that stem from  the influence  of medicine  that consist in the digital space. Digital Health is an encompassing field which includes sub-specialties such as telemedicine, e-health, m-health, EMR/EHR, genomics, Big Data, and Health IT - to name a few. Through Nuviun's interactive venn diagram, they keep their users updated with the  latest news and practices within the digital health world, allowing health care advocates to stay updated and informed about the Digital Health care revolution.


If you would like to try out their venn diagram, click on the link above. You will learn about the different sectors in digital health care and read relevant articles about each subject in today's world.  


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Social media continues to challenge medical professionalism

Social media continues to challenge medical professionalism | Adverse Event Transparency | Scoop.it
MedHawk's insight:

As medical doctors and physicians begin to integrate social media into their profession and businesses, patients and medical students attempt to find a balance between utilizing social media while maintaining professionalism.


A literature review by medical student Brittany Harrison and Dr. Ali Jalali from the University of Ottawa concluded that while social media networks are becoming “a ubiquitous source of information sharing in medicine,” medical students need to be aware that their conduct on social media platforms can impact future employment.


The small study based on online survey feedback showed medical students were aware content they posted on social media could be viewed as unprofessional. Following completion of learning module in bioethics on this topic, the majority of students said they would modify or hide their social media use to avoid potential future conflicts with their professional career.

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New Emoji | Social Media Today

New Emoji | Social Media Today | Adverse Event Transparency | Scoop.it
There's been a craze in the last couple of days as the Version 7.0 of the Unicode Standard is now available. Among the new 2,834 new characters, approximately 250 emoji (pictographic symbols) have been added. This means users will have a chance to add more meaningful signs to our keyboard-based communications.
MedHawk's insight:

Emojis are slowly taking over the social media world. With nearly 250 recognizable emojis, people on websites such as Twitter and Facebook are using emojis as a method of communication. The demand and pressure for emojis continue to rise; it is no surprise that users want Emojis to display more representative ethnicities.

 

The way people interact with each other on the Internet has changed since the emergence of Emojis. Rather than conversations being text-based, many users are expressing their emotions through emoticons. Chats can become more personal and personal emotions can be shown visually on text.

 

The rise of Emojis create an opportunity for users to carefully listen and express their inner feelings through social media. MedHawk plans to take advantage of Emojis for patient advocates to express their feelings on certain medical side effects in certain drugs. We hope that this will push for more transparency in modern-medicine and change healthcare for the better.

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More transparency from Big Pharma - Cyprus Mail

More transparency from Big Pharma - Cyprus Mail | Adverse Event Transparency | Scoop.it
More transparency from Big Pharma Cyprus Mail Pharmaceutical companies are to disclose their dealings with healthcare professionals as part of a Europe-level initiative to apply a stricter self-regulatory framework in the sector and increase...
MedHawk's insight:

Medical companies are reporting their negotiations and sales with healthcare to advocate more transparency in modern medicine and create a more self-regulatory system.

 

A proposal for a new code of conduct will establish stricter provisions between the interaction between medical representatives and healthcare professionals. This would certify that the transaction of medicines to healthcare professionals would be delivered in a clear and trustworthy way.

 

“This is a Europe-level initiative, aimed at increasing the transparency of practices applied in the pharmaceutical industry.” -  Kyriakos Mikellis, a member of the Cyprus Association of Research and Development Pharmaceutical Companies (KEFEA).

 

Transparency in modern day medicine will help consumers trust and believe in pharmaceutical companies and their drugs. 

 

 

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Tweet This: FDA Finally Proposes Social Media Guidelines - Pharmalot - WSJ

Tweet This: FDA Finally Proposes Social Media Guidelines - Pharmalot - WSJ | Adverse Event Transparency | Scoop.it
After several years of anticipation, the FDA has finally proposed a pair of guidelines for how drug and device makers should cope with some of the challenges and pitfalls posed by social media.
MedHawk's insight:

After years of speculation, the FDA has proposed a guide for how pharmaceutical drug companies should react with some of the feedback and reactions found on social media. According to the article, companies should contact bloggers to make changes of misinformation on their websites and products.


“The information should not be promotional and should be factually correct. This is not an opportunity for a company to tout its drugs,” he says. “The information [being added or revised] should be consistent with the FDA-approved [product] labeling and for it to be effective, you want it posted right by the misinformation.” - Tom Abrams, head of FDA Office of Prescription Drug Promotion.


Among the 50 bigggest pharmaceutical companies, almost half are not utilizing social media to communicate with consumers or patients, according to a recent survey by IMS Institute for Health Informatics. The reasoning may actually be simple – drug companies are worried that any communication between the company and consumer may influence the FDA to falsly accuse the company of explicitly promoting a product. Luckily, the FDA is continuing to fix the problem on healthcare social media and giving the consumers more power to speak with these drug companies.

 

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Summary of Vyvanse side effects reported on Twitter

Summary of Vyvanse side effects reported on Twitter | Adverse Event Transparency | Scoop.it
MedHawk's insight:

Most Americans take medical drugs sometime in their lives. In most cases, the drug cures a human’s sickness. Stimulants are measured for people with reasonable to severe attention deficit hyperactivity disorder (ADHD) who have difficulty in recreational settings such as school and home. Stimulants may be the most effective treatment for the symptoms of ADHD. These medicines can suddenly and dramatically improve behavior. If treatment with a stimulant is successful, it usually helps control symptoms over time without increasing the dosage. But like any pharmaceutical drug, stimulants are capable of possessing harmful side effects. For Vyvanse, the most common side effects are loss of appetite, difficulty sleeping, stomachache, headache, and increased blood pressure. Many Twitter users report these side effects online, but there are some adverse reports such as laziness and mood swings that are not typical side effects for Vyvanse. Below is a link that reveal some of side effects posted by Twitter users on Vyvanse. 


https://storify.com/MedHawkapp/vyvanse-side-effects

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Common Side Effects of Popular Pharmaceutical Drugs

Common Side Effects of Popular Pharmaceutical Drugs | Adverse Event Transparency | Scoop.it
MedHawk's insight:

Most Americans take medical drugs sometime in their lives. In most cases, the drug cures a human’s sickness. However, there are many cases where people experience unpleasant side effects. A side effect is an inadvertent incidence that results from taking a drug. For example, antihistamines, used to help with allergy symptoms like itchy eyes and sneezing, have the side effect of making you feel very sleepy. The three popular prescription drugs with the most reported side effects are antipsychotic, ADHD stimulants, and rheumatoid arthritis. Here is a list of description and side effects of each medication.

 

1. Antipsychotic Medication

Psychiatric medications treat mental disorders. Known as psychotropic or psychotherapeutic medications, these prescription drugs have the ability to calm those who have been diagnosed with depression. People with mental disorders are able to live fulfilling lives with the help of these medications. Without them, people with mental disorders might suffer serious and disabling symptoms. However, popular drugs such as Abilify and Seroquel have been proven to have serious side effects. Some of these side effects include drowsiness, dizziness, blurred vision, rapid heartbeat, skin rashes, and menstrual problems for women. Although these medications are meant to cope with depression, they are capable of causing more trouble for patients.


2. ADHD Stimulants

Stimulants are measured for people with reasonable to severe attention deficit hyperactivity disorder (ADHD) who have difficulty in recreational settings such as school and home. Stimulants may be the most effective treatment for the symptoms of ADHD. These medicines can suddenly and dramatically improve behavior. If treatment with a stimulant is successful, it usually helps control symptoms over time without increasing the dosage. But like any pharmaceutical drug, stimulants are capable of possessing harmful side effects. The most common side effects are loss of appetite, difficulty sleeping, stomachache, headache, and increased blood pressure. Popular stimulant drugs are Adderall, Vyvyanse, Ritalin, and Concerta.

 

3. Rheumatoid Arthritis Medication

Rheumatoid arthritis (RA) is an inflammatory disease that distresses the joints in our bodies. It gets worse over time unless the inflammation is stopped or slowed. People are encouraged to take medication to slow down the inflammation. There are only a few cases where rheumatoid arthritis is slowed without medication. Arthritis medications play an essential role in controlling the progression and symptoms of rheumatoid arthritis. Some of the most popular rumitoid arthritis medications are Methotrexate, Arava, and Plaquenil. Common side effects are nausea, vomiting, abnormal liver function, and diarrhea.

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5 Ways to LowerBlood Pressure without Medication

5 Ways to LowerBlood Pressure without Medication | Adverse Event Transparency | Scoop.it
High blood pressure, also known as hypertension, is a condition wherein a person’s blood pressure is above 140/90.

Via 27BloodPressure
MedHawk's insight:

High blood pressure is a medical condition where an individual’s blood pressure is above 140/90. Hypertension puts pressure on a person’s heart and blood vessels, making a person vulnerable to conditions such as heart attacks and even strokes. There are several prescription drugs to deal with high blood pressure, but many are skeptical to take it because of medical side effects. Luckily, there are methods to reduce blood pressure without medications.

 

1. Breathe properly
Taking gentle, controlled breaths decrease the amount of stress hormones that produce renin. Renin is an enzyme produced by the kidney that raises blood pressure. When you’re feeling stressed, take a break and have a few deep breaths.

 

2. Have some sunlight
Relaxing in the sun allows blood to flow more freely and reducing blood pressure in the process. Enjoying the sun for an appropriate amount of time will reduce the risk of having a heart attack. However, spending too much time in the sun will cause the body to overheat, leading to hypertension.

 

3. Have a walk
Walking around the block or at a park for at least 30 minutes daily can decrease your blood pressure evaluations by 10 points or more. Improving your cardiovascular health will strengthen your heart.

 

4. Drink tea
Recent studies have shown that tea consumption is directly linked to the reduction of blood pressure and heart rate. Probable mechanisms for this unique ability include tea’s ability to relax the senses and its superior antioxidant content. It is recommended that you drink 1 to 4 cups of tea daily.

 

5. Listen to music
A study published in the Netherland Heart Journal states that those who regularly play or listen to music have lower blood pressure than those who don’t. The main reason behind these results is that the somatosensory region of the brain is stimulated, leading to improved autonomic nervous system function.

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More Patients Ignoring Medication Dosage - Big Country Homepage

More Patients Ignoring Medication Dosage - Big Country Homepage | Adverse Event Transparency | Scoop.it
Big Country Homepage More Patients Ignoring Medication Dosage Big Country Homepage "About 10% of hospital admissions can be linked to poor medication adherence, or not taking your medications," says Greg Young, pharmacy manager at Hendrick Medical...
MedHawk's insight:

People who suffer medical illnesses tend to stop taking medication after a certain period of time. However, a doctor must monitor medication withdrawal to ensure safety for the patient. So why do people stop taking their medications when they know a doctor’s advice is so crucial?

 

Not surprisingly, the number one reason people stop medications is due to side effects. Any one of these side effects might make you consider stopping your medication, some side effects being more persuasive than others. It makes them feel bad about themselves, which is pretty much exactly the opposite effect we wish the drugs to have.

 

"About 10% of hospital admissions can be linked to poor medication adherence, or not taking your medications. Take your medication in the way your doctor has written it. We want you to control this condition that you have, and not let it control you,” says Greg Young, pharmacy manager at Hendrick Medical Center.

 

Stopping medication can cause very unpleasant and sometimes dangerous withdrawal effects or a re-emergence of the underlying illness—possibly making the person harder to treat. Doctors do work to prevent these things as best they can. For best results, be sure to talk with your physician if it is safe to stop taking medication. 

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Scoring system could help reduce adverse drug events in hospital patients » News » University of Florida

Scoring system could help reduce adverse drug events in hospital patients » News » University of Florida | Adverse Event Transparency | Scoop.it
GAINESVILLE, Fla. � University of Florida College of Pharmacy researchers are working closely with colleagues at UF Health to identify hospital patients at greatest risk for preventable adverse drug events.
MedHawk's insight:

Health care improvement brings attention towards an improved health care system at affordable rates. To improve the healthcare sector, the American Society of Health-System Pharmacists, also knows as ASHP, has planned a pharmacy practice model that stresses pharmacists’ key role in medication therapy management.

 

The American Society of Health-System Pharmacists Foundation has awarded a two-year, $499,000 grant to College of Pharmacy researcher Almut Winterstein, to lead a UF Health research team that will develop and validate a complexity score to help hospitals determine the best pharmacist staffing to prevent adverse drug events and improve patient safety.

 

“Adverse events in health care have received increasing attention over the past two decades because many are preventable,” said Winterstein, a professor of pharmaceutical outcomes and policy at the UF College of Pharmacy. “Errors surrounding the selection or dosing of medications have been described as one of the most prominent areas in health care that result in preventable adverse events.”

 

Winterstein’s research team foresees an everyday report for pharmacists of the patients who have the highest scores based on their medical history and current health conditions. This gives consumers an idea of the severity of every patient’s adverse drug event.

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ARIAD Pharmaceuticals' Public Twitter Policy

ARIAD Pharmaceuticals' Public Twitter Policy | Adverse Event Transparency | Scoop.it

ARIAD, like many biopharmaceutical companies, is in the process of engaging in conversations via new social media channels like Twitter.

About @ARIADPharm:



Via Pharma Guy
MedHawk's insight:

Social media is changing the nature and atmosphere of health care interface between customers and pharmaceutical companies. The transformation of information gathering and the emergence of the engaged patient has demonstrated the increased importance of social media in the broader healthcare context. ARIAD, like many biopharmaceutical companies, is currently in the process of establishing conversations via Twitter.

 

It is apparent that a growing percentage of today’s patients are increasingly using digital tools as part of their overall health maintenance. In a recent survey, 51% of patients say they’d feel more valued as a patient via digital health communications, and another survey indicates that 41% of people said social media would affect their choice of healthcare provider.

 

These communications are important for pharmaceutical companies to have more understanding and awareness of what is important to the patients and those whose lives are affected by cancer. For ARIAD, social media allows customers to ask questions anonymously without feeling embarrassed to ask. This is a key technique to establish consumer trust for the company.

 

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Pharma Guy's curator insight, June 24, 2014 7:18 AM

Back in June, 2014, I praised Aruad: "It's refreshing to see a social media policy published by a pharma company. I recently praised Boehringer Ingelheim's video social media policy (see Gefällt Mir! Boehringer Ingelheim Invites Two-Way Communication Via Social Media). Most large pharma companies (e.g., Pfizer) do not do this although they boast of having policies that the public cannot access (read Pfizer, Show Us Your Social Media "Playbook")."

 

But since the company raised the price of its leukemia treatment 4 or more times in a year to meet investor expectations (read Wall Street is Fueling Drug Price Hikes, Not "Benefit to Patients" as Claimed by Ariad & Other #pharma Companies; http://sco.lt/8FBHg9), I have to reconsider how I rate the social media savviness of pharma companies and bring into it their general attitude towards patients as well. 

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FDA Does Not Plan To Regulate Medical Device Data Systems - iHealthBeat

FDA Does Not Plan To Regulate Medical Device Data Systems - iHealthBeat | Adverse Event Transparency | Scoop.it
FDA last week released draft guidance indicating that it does not intend to regulate medical device data systems. The draft guidance marks a shift in FDA policy, but an agency official says FDA's new position is consistent with the federal government's recently released health IT risk-based framework. FierceHealthIT, Modern Healthcare.
MedHawk's insight:

On June 20 2014, FDA issued draft guidance mentioning that it believes medical device applications and data systems are safe and do not require extensive regulation. The draft guideline is a different approach from previous FDA guidelines, as the agency in January 2011 had mentioned that medical device data systems are the highest-risk technology in modern healthcare.

 

According to the draft guidance, medical device data systems do not aim to control or "alter the functions ... of any connected medical devices," but instead: 


1. Facilitate electronic transfer or exchange of medical device data

2.Store and retrieve medical device information, such as blood pressure data

3. Convert medical device data from one format to another

4. Display medical device information (FierceHealthIT, 6/20).


As a result of FDA's draft guidance, medical device data systems -- such as software that collects data from a glucometer or a weight scale -- no longer will have to follow with FDA rules.

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Docetaxel May Cause Intoxication, FDA Warns - OncLive

Docetaxel May Cause Intoxication, FDA Warns - OncLive | Adverse Event Transparency | Scoop.it
Medscape
Docetaxel May Cause Intoxication, FDA Warns
OncLive
FDA Logo The FDA has issued a drug safety communication regarding the risk of intoxication with the intravenous ethanol-containing chemotherapy docetaxel.
MedHawk's insight:

The FDA has issued a warning to health care professionals that docetaxel contains ethanol; this may cause consumers to experience intoxication during and after taking the medication. Health care industrialists should monitor the alcohol level of docetaxel when suggesting or prescribing the drug to patients, particularly to those who are sensitive to alcohol in medication.

 

The notice was delivered based on a review of the FDA Adverse Event Reporting System database that exposed three different scenarios of alcohol intoxication related with docetaxel. Additionally, the FDA noted that certain medications, such as pain relievers and sleep aids, could adversely interact with the alcohol within docetaxel during infusion worsening the effects. Patients should be informed that docetaxel could potentially cause intoxication from the alcohol it contains, and should avoid driving or any other activities that are dangerous for one to two hours after the infusion of docetaxel. 

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FDA's Suicide Warnings Backfire - Daily Beast

FDA's Suicide Warnings Backfire - Daily Beast | Adverse Event Transparency | Scoop.it
Forbes
FDA's Suicide Warnings Backfire
Daily Beast
They believe that the FDA's warnings spooked practitioners from offering the drugs, which began coming with warnings for adolescents in 2004, and expanded to reach young people in 2007.
MedHawk's insight:

When the federal government labeled suicide warnings on antidepressant prescription in 2004, Congress had strong feelings that it would reduce the number of young people from taking the drug without purpose. However, The FDA’s “black box” suicide warnings on antidepressants may have caused adverse drug effects over the last ten years. Although usage of antidepressants have gone down, suicide rates have increased.


According to studies from Harvard University, the use of antidepressants have decreased by 31 percent within teens. However, the number of young adolescents looking for medical aid for overdosing on antidepressants rose by 22 percent for teenagers and 3 percent for young adults. Attempted suicides between 18-29 year olds went up by 37 percent across this period.


The federal government's act to begin labeling suicidal warnings on packages has always been controversial; young people are five times more likely to commit suicide than older adults. “The warning covered the necessary information for clinicians and patients and the public,” the study’s lead author, Christine Yu, said. “In news reports the emphasis was on the risk of completed suicide. I think that’s alarming for parents and patients and clinicians to see.”

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Do You Trust Your Doctor’s Prescriptions?

Do You Trust Your Doctor’s Prescriptions? | Adverse Event Transparency | Scoop.it
When it comes to medications, Americans are skeptical. Many assume their doctors — and expert bloggers on health sites — prescribe or promote certain drugs
MedHawk's insight:

Congress took the initiative of promoting transparency in modern medicine with the Physician Payments Sunshine Act, which went into effect Aug. 1, 2013. Pharmaceutical companies are obligated to report any expenditure they make with physicians that are worth $10 or more. This information is will be available to the public on September 30, 2014.

 

Various hospitals around the country have also taken the initiative to disclose information to the public. For example, Cleveland Clinic obliges doctors to release any business relationships or funding that it receives. Consumers are able to learn every doctor’s transactions through the staff directory listing.

 

In today’s world, patients need transparency in medicine to ensure they are taking the right medications for their illness. Patients also need trust and honesty from their doctors.. With the right safeguards in place, patients can have both.

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8 takeaways from the FDA's draft guidance on social media - mobihealthnews

8 takeaways from the FDA's draft guidance on social media - mobihealthnews | Adverse Event Transparency | Scoop.it
mobihealthnews 8 takeaways from the FDA's draft guidance on social media mobihealthnews The guidelines do clear up some very specific social media concerns, but don't really address others, such as whether having a public Twitter opens up pharma...
MedHawk's insight:

The FDA has announced a guideline on how pharmaceutical companies should act on social media websites like Twitter and Facebook when modifying misinformation on third-party websites. The FDA ensures that pharmaceutical companies always disclose its side effects when mentioning its benefits for a drug and that advertisement are only for use for which they have been approved.

 

The new guideline, which can be found on two documents displayed on the FDA website, attempts to address these concerns addressed by society.

 

Here are 8 quick guidelines on the FDA’s new regulation:

 

1. Each Tweet will include both the benefits and the side effects for a certain drug

- This will ensure the consumers are well-educated on the drug they are prescribed.

 

2. Every Tweet posted by a pharmaceutical company is accurate and complete

            - There will be trust between the company and its consumers.

 

3. Each tweet should include a hyperlink to a more comprehensive list of risks and side effects

            - Consumers can do more research on a particular drug if needed.

 

4. If it doesn’t fit, don’t tweet it

            - FDA encourages pharmaceutical companies to only tweet what is relevant for consumers.

 

5. Companies don’t have to correct misinformation about them, but they can

            - As long as the information on their website is legitimate.

 

6. Companies must correct the good along with the bad

            - Any correction a pharma company posts has to correct all information on their website.

 

7. Corrections must be limited in scope

            - The FDA recommends that those corrections be “limited and tailored to the misinformation” and “non-promotional in nature, tone, and presentation.”

 

8. Keep records of corrective interactions

            - Pharma companies won’t be held responsible if they reach out to an online content poster and ask for a correction if they are ignored.

 

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Popular blood pressure drug could lead to serious adverse events in older adults - TheHealthSite

Popular blood pressure drug could lead to serious adverse events in older adults - TheHealthSite | Adverse Event Transparency | Scoop.it
TheHealthSite Popular blood pressure drug could lead to serious adverse events in older adults TheHealthSite low-blood-pressure Researchers at UT Southwestern Medical Center have found that adults over 65 who have recently begun thiazide diuretics...
MedHawk's insight:

Nearly sixty-six percent of older adults in the United States have high blood pressure. Doctors often suggest thiazide diuretics, a medicine to treat hypertension, as the primary medication for these hypertensive patients. However, researchers at UT Southwestern Medical Center recently discovered that thiazide diuretics increase the risk for developing metabolic-related adverse events.

 

The researchers executed a nine month long experiment and discovered that fourteen percent of older adults prescribed a thiazide diuretic had a metabolic adverse event, while only six percent of adults did when not prescribed a thiazide diuretic. For every 12 adults who were newly prescribed a thiazide diuretic, one developed a metabolic adverse event that he or she would not otherwise have had. 

 

“Our research quantifies the risks of metabolic adverse events in older adults in real-world, clinical practice shortly after initiating thiazide diuretics,” Dr. Anil Makam, assistant professor of Internal Medicine at UT Southwestern.

 

Here are some health consequences that occur with High Blood Pressure:

 

1. Vision Loss

2. Memory Loss

3. Kidney Damage

4. Stroke

5. Damage to the heart and arteries

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