Drug Safety
Aris Global - Drug Safety, Monitoring, Pharmacovigilance & Regulatory Software
For more than 20 years, Aris Global has pioneered the advancement of drug safety, drug safety monitoring, pharmacovigilance, regulatory compliance, medical information and clinical trials management software.
Our solutions are designed to help all life sciences organizations facilitate regulatory compliance, manage risk and improve operational efficiency.
Learn more about Aris Global’s drug safety offerings.
Relsys and Sentrix extend drug safety partnership
Pharma Marketletter
June 18, 2007
USA-based firms Relsys International and Sentrix are to extend their pharmacovigilance and risk management accord to include Relsys’ Argus Safety web-based compliance technology. The model is designed to …
Read more about this drug safety partnership.
Lilly’s CEO Calls for Reform of Nation’s Drug Safety System
FDA, health care industry, and the medical community collaboration would share data via a national health IT system
CLEVELAND, October 02, 2007 /PRNewswire-FirstCall/ — Sidney Taurel, chairman and chief executive officer, Eli Lilly and Company, in a speech today at the Cleveland Clinic, called on the health care industry, medical community and U.S. government to actively collaborate on a health information technology system that would provide more rapid and useful insights on the effectiveness of medicines while improving drug safety.
His proposal, along with other benefits that would flow from a true healthcare “Information Revolution,” was outlined for an audience of some of the nation’s medical thought-leaders attending Cleveland Clinic’s 2007 Medical Innovations Summit. Taurel was the keynote speaker.
“The use of prescription medicines always will be a matter of balancing benefits and risks,” Taurel said. “Fortunately, systems are now within our grasp to more quickly identify both the true benefits and the full extent of risks associated with medicines in widespread use.”
Read more about Taurel’s drug safety proposal.
Pharmaceutical Companies Expanding Post-Market Drug Safety Initiatives to Prevent Adverse Reactions, Finds PricewaterhouseCoopers Study
January 30, 2007
Pharmacovigilance Seen as Complementing Pre-Approval Testing
Heightened public awareness of drug safety, greater regulatory scrutiny and a number of recent drug withdrawals and black box warnings are causing pharmaceutical companies to rethink how they ensure the post-market safety of their products. Instead of relying solely on pre-approval clinical trials and the federal drug approval process, pharmaceutical companies are shifting to “pharmacovigilance” - continued, systematic monitoring of drug safety under real-world conditions, according to “Unlocking the Power of Pharmacovigilance,” a new PricewaterhouseCoopers report.
Read the rest of this article on drug safety initiatives.
Premera Announces Notable Results from Prescription Drug Safety Program
Tue Apr 28, 2009 5:21pm EDT
Polypharmacy Analysis Indicates Reduced ER Visits, Fewer Hospitalizations, and
Lower Healthcare Costs
MOUNTLAKE TERRACE, Wash.–(Business Wire)– Emergency room visits and hospitalizations fell among patients who received medication safety education, according to an analysis of Premera Blue Cross`s nationally recognized Polypharmacy Program.
In a recent two-year assessment of nearly 13,000 Premera members, Seattle-based health services researchers observed a 1.2 percentage point decrease in persons having ER visits and a 1 percentage point decrease in persons having hospitalizations after members were mailed a simple brown bag with a set of instructions.
PATIENT SAFETY IS THE GOAL
Patients were asked to fill the brown bag with all their prescriptions, over-the-counter medications, and supplements and to take the bag to their next doctor`s appointment for review. Premera had found many of its members not only were receiving multiple medications but also had multiple doctors. By putting all the drugs in one place, a provider could assess the appropriateness of the medications and change dosages if necessary.
The new analysis, whose key findings are now being released, noted that pharmacy utilization did increase after the program materials were mailed. A reduction in total healthcare costs was also observed by Premera based on a review of relevant claims data.
However, Ed Wong, Premera`s vice president of Pharmacy Services, points out that the Polypharmacy Program was never intended to save money on drug costs. “The goal of this program has always been patient safety,” says Wong. “Our intention with this brown bag review is for patients to get a better assortment of drugs and suffer fewer adverse reactions.”
Premera has mailed out approximately 150,000 bags since the program began in 2001. The bags are sent to members in Washington, Oregon and Alaska who are 19 and older and who are taking five or more drugs daily over a three-month period for chronic conditions, such as diabetes, hypertension or high cholesterol.
ANALYSIS INDICATES DECREASED HOSPITALIZATIONS
In one of the key observations, the researchers found that 22.8 percent of the patients had gone to the emergency room in the year before they had received their brown bags, while 21.6 percent went during the year after they had taken part in the program. Meanwhile, 12.9 percent had been hospitalized the year prior to the program, compared to 11.9 percent the year after.
The program has drawn national media coverage and has been highlighted in an advertising campaign by the Blue Cross Blue Shield Association. In annual surveys, an average 51 percent of respondents since 2001 have reported undergoing a medication review, while 51 percent said they found the informational brochures in the bags to be somewhat to very valuable.
Read more about Premera Blue Cross`s drug safety program.
Drug Safety Is Partly the Patient’s Responsibility
Updated June 12, 2008
Drug safety requires patient involvement. A patient should take certain measures to ensure drug safety. Patients need to fully understand their prescription after discussing it with their doctor and pharmacist. Patients should not be taking medications they have questions about — for example, “Why am I taking this,” or “How do I take it?” Don’t be shy about getting the answers you need and having the conversations you need to have.
10 Ways to Ensure Drug Safety
Review Prescription Medications With Your Doctor
Your medication regimen may seem arduous, but it becomes quite routine. It becomes almost too routine — second nature, habitual, done without thought. It is drilled into patients that being compliant with their treatment plan is important. Taking pills religiously, on time, everyday is expected. At each doctor appointment, have a conversation about your current pill regimen. Certain questions should be asked each time you see your doctor.
10 Things You Should Do When Given a New Prescription
When your doctor hands you a new prescription, it becomes your responsibility to know what the medication is for, how to take it, and what possible side effects might occur. Here are 10 tips for what you should do when given a new prescription that will help ensure your safety and understanding.
Review Prescription Label Directions
Prescription medication labels are confusing to some patients. Have your doctor read the instructions to you. Also ask your pharmacist to read the directions to you when you fill the prescription. Follow these other tips too.
How to Avoid Medication Errors
A few simple, common-sense tasks can help you avoid medication errors and ensure your safety. Here are 15 important tips which ensure drug safety.
How to Safely Dispose of Unused Medications
Proper drug disposal is an emerging environmental issue. As with any household waste, the disposal method chosen can directly effect the safety and health of the environment. Most strive to be responsible. What are your options?
How to Spot Pharmacy Errors
Pharmacy errors may have serious consequences. Many pharmacy errors go unreported because they remain undetected or cause no obvious harm. Potential problems make it imperative for people taking prescription drugs to always check the medication they receive. Though pharmacy errors are unlikely occurrences, they do happen.
Read more about drug safety.
Drug safety
Nature Reviews Drug Discovery 6, 937 (November 2007)
There is a pressing need to improve the understanding of safety issues during drug development and post-approval. Our interviewees this month explain their roles in efforts to enhance drug safety.
Julie Barnes, Ph.D. Chief Scientific Officer, BioWisdom Ltd., Cambridge, UK
Recent high-profile issues with drug safety have highlighted the need not only to improve post-marketing pharmacovigilance but also to identify drug candidates with good safety profiles earlier. To address these challenges, healthcare technology companies such as BioWisdom are providing intelligence to support decision-making about safety issues that arise during the development of new drugs. “Our approach is founded on the principles of ontology. This is a traditional science that applies a relationship-based approach to, for example, understand mechanisms of drug action as they pertain to adverse events,” explains CSO Julie Barnes.
Barnes’ career in drug development began when, following her Ph.D. in behavioural neuroscience, she took a postdoctoral position at GlaxoSmithKline (GSK) to develop a series of in vivo models and screens for evaluating new chemical entities for Alzheimer’s disease. Although initially very specialized in her discipline, over the next 15 years, she began to recognize the value of multidisciplinary research to bring different perspectives and technologies to a business problem.
“While at GSK, I saw projects come and go, clinical trials succeed and fail, and markets change,” she says. “Managing change and decision-making in such an environment is an experience that I am pleased to have had the opportunity to acquire.”
During this time, Barnes also experienced the rapid expansion in electronic information, which changed the behaviour of scientists from browsing current journals in company libraries to searching e-publications and other electronic data from their desktops. “Getting access to relevant information without being deluged with too much became an increasing challenge,” she explains.
Learn more about drug safety.
Consumer Medication Safety Resources
Patient Safety Awareness MOnth
Consumer Resources
Brochure - What You Need to Know About Your Medicine - Tips For Medication Safety
This resource is an 8 1/2″x 11″ tri-fold brochure with tips about medicine use -what consumers need to know at home, the hospital, the drug store and doctor’s office.
Available for download
For Consumers - My Medicine List
A form to help consumers keep track of medicines, including over-the-counter and herbal medicines, vitamins and allergies. This form will also help consumers talk with their doctor about their medicines.
Available for download
For Consumers - My Medicine List, Page 2
Additional pages for My Medicine List. This form can be downloaded if additional space is needed to document medications on “My Medicine List”.
Available for download
A 5-minute Video - Tips for Taking Medicines Safely from AHRQ
This 5-minute Web-accessible video of national patient safety experts providing tips for taking medicine safely. The video is from AHRQ based on their “Check Your Medicines: Tips for Taking Medicines Safely” resources.
Read the rest of this list and download these consumer medication safety resources.
Medication Safety Tools for Consumers
Everyone in the health care system is working hard to ensure that medicine errors do not happen. As a consumer, you can play a key role in ensuring your health and safety by actively helping to manage your own medicines.
You can expect to be asked these questions each time you visit a healthcare provider: “Do you have your medication list with you today? Is it up to date?”
Keeping a list of medicines is a simple step you can take. Update the list every time you start or stop taking medications. Carry your list with you in your wallet or purse.
To help keep track of all your prescription and non-prescription drugs, the Redwood Area Hospital recommends you use My Medicine List, a free form to keep you organized.
Click on the links below to download a free copy of My Medicine List:
Read the rest of this article on medication safety tools.
SOS Rx: National medication safety group organized - Eureka Alert
SOS Rx: National medication safety group organized
Washington DC–The nation’s oldest consumer advocacy organization today announced the launch of SOS Rx, a national healthcare coalition promoting the safe use of medications. The coalition, run by the National Consumers League, includes participation by more than 60 consumer and patient safety organizations, physician, pharmacist, caregiver, and employer groups, and government. The coalition’s purpose is to make the outpatient use of medications safer, especially for senior citizens. Today the coalition launched its online home, www.sosrx.org, which will provide information for consumers about upcoming educational campaigns on topics ranging from the safe use of anticoagulants to the advantages of e-prescribing and the benefits of maintaining a personal medication record.
“There is a safety gap in our healthcare system and in useful information for the consumer who may be taking several medications,” said Linda Golodner, NCL president. “Every consumer needs to be aware of risks, including prescribing errors and dangerous interactions, and how a lack of doctor-patient communication can adversely impact health or the health of your family. SOS Rx provides an extraordinary opportunity for an alliance of concerned partners to search for answers and positively affect both consumers and the system as a whole.” Members of SOS Rx include consumer and patient safety organizations, accrediting bodies, groups representing physicians, pharmacists, nurse practitioners, caregivers, and employers, and the government. (See below for full list of current members.) Dozens of other organizations, foundations, and private companies participate in workshops and meetings.
“Consumers face enormous challenges when they enter the health care arena as either patients or caregivers,” said Lucian Leape, Harvard School of Public Health. “The members of SOS Rx are committed to arming consumers with the information they need to successfully navigate the system and maintain and improve their own health.”
“AHRQ is proud to be a member of SOS Rx, a unique coalition that is bringing everyone to the table — patients, advocates, providers, and industry — to produce real changes in the health care system,” said Agency for Healthcare Research and Quality director Carolyn M. Clancy, MD. “AHRQ’s commitment to patient safety research, especially in the area of safe medication use, is intended to provide the kinds of tools needed to help make those changes a reality.”
SOS Rx is initially funded by an unrestricted educational grant from founding sponsor Express Scripts. “Express Scripts’ mission is to make the use of prescription drugs safer, as well as affordable, so we’re very pleased to collaborate with the National Consumers League in launching SOS Rx with the support of such a wide range of organizations committed to greater safety,” said Barrett Toan, chief executive officer of Express Scripts.
Read the rest of this press release on the launch of this medication safety group.