http://stopadr.org/blogBLOG RSSFri, 18 Jul 2025 17:36:45 GMTFri, 18 Jul 2025 17:36:45 GMThttp://stopadr.org/blog/from-challenge-to-consensus-proposed-statements-for-advancing-pharmacogenomics-standardsThe STRIPE Collaborative Community invites all registered participants to review and vote on the proposed consensus statements that emerged from a year-long, multi-stakeholder effort to address key challenges in pharmacogenomics testing and implementation. These statements, developed through extensive discussion across six focus areas, represent a significant step toward establishing shared standards that advance the safety, reliability, and equitable use of pharmacogenomic information inSun, 16 Nov 2025 22:26:41http://stopadr.org/blog/from-challenge-to-consensus-proposed-statements-for-advancing-pharmacogenomics-standardshttp://stopadr.org/blog/a-milestone-for-patient-safety-fda-adds-dpyd-testing-requirement-to-xeloda-labelThe U.S. Food and Drug Administration (FDA) has taken a landmark step for patient safety and personalized medicine. In October 2025, the agency approved major updates to the U.S. Prescribing Information (USPI) for Xeloda® (capecitabine) that add a boxed warning calling for DPYD genotyping before initiating therapy unless immediate treatment is necessary.The revised warning explicitly states:“Test patients for genetic variants of DPYD prior to initiating XELODA unless immediate treatment isWed, 22 Oct 2025 15:51:09http://stopadr.org/blog/a-milestone-for-patient-safety-fda-adds-dpyd-testing-requirement-to-xeloda-labelhttp://stopadr.org/blog/stripe-invites-public-comment-on-pharmacogenomics-consensus-statementsThe STRIPE Collaborative Community is excited to announce that the draft consensus statements developed during our October 2024 Consensus Development Conference at the U.S. Pharmacopeia (USP) Campus are now available for public review and input.Held in Rockville, Maryland, the STRIPE Consensus Development Conference brought together leading experts, stakeholders, and patient advocates across the pharmacogenomics (PGx) landscape. The collaborative dialogue and robust discussions during theThu, 24 Jul 2025 14:18:29http://stopadr.org/blog/stripe-invites-public-comment-on-pharmacogenomics-consensus-statementshttp://stopadr.org/blog/take-action-tell-congress-to-support-the-right-drug-dose-now-actEvery 90 seconds, an American dies from an adverse drug event (ADE). That’s more than 380,000 preventable deaths a year—many of them due to outdated systems, lack of education, and missed opportunities to personalize treatment. The time to act is now.A bipartisan bill—the Right Drug Dose Now Act—has been reintroduced by Reps. Swalwell (CA-14) and Crenshaw (TX-02) to address this national crisis. This legislation would modernize how we prevent medication-related harm by expanding access toSun, 23 Mar 2025 23:42:33http://stopadr.org/blog/take-action-tell-congress-to-support-the-right-drug-dose-now-acthttp://stopadr.org/blog/predicting-adverse-drug-event-prevalence-a-data-driven-approachAdverse drug events (ADEs)—including medication errors, overdoses, allergic reactions, and side effects from drugs taken as prescribed—are a major but often underrecognized threat to public health. While many assume such events are rare or well-documented, the reality is that the current systems for detecting and reporting drug-related harm dramatically underestimate the true toll. Recent analyses, drawing from a wide range of data sources and adjusting for known reporting limitations, suggestMon, 24 Mar 2025 00:21:05http://stopadr.org/blog/predicting-adverse-drug-event-prevalence-a-data-driven-approachhttp://stopadr.org/blog/preparing-for-the-stripe-annual-meeting-pre-meeting-surveys-now-availableAs we gear up for the upcoming STRIPE Annual Meeting, we are excited to share an essential step in the preparation process: our Pre-Meeting Surveys. These surveys are designed to gather your insights on draft consensus statements that will serve as the foundation for our workshop discussions. Your feedback will be instrumental in shaping the direction of each workshop and ensuring our sessions are as impactful as possible.Whether you're participating in the Health Equity, LaboratoryTue, 15 Oct 2024 13:43:44http://stopadr.org/blog/preparing-for-the-stripe-annual-meeting-pre-meeting-surveys-now-availablehttp://stopadr.org/blog/supporters-of-the-right-actThe following organizations, representing a diverse set of stakeholders interested in improving medication management for patients, stand together united in our support for the Right Drug Dose Now (Right) Act, which will support the incorporation of evidence-based pharmacogenomic (PGx) information in clinical practice, advance precision medicine, and improve the quality of care for Americans by optimizing medication use and reducing rates of adverse drug events. To sign-on to support the RightFri, 26 Apr 2024 04:11:52http://stopadr.org/blog/supporters-of-the-right-acthttp://stopadr.org/blog/national-adverse-drug-event-ade-awareness-day-a-united-front-in-the-fight-against-adesMarch 24th is observed annually as National Adverse Drug Event (ADE) Awareness Day, a crucial initiative spotlighting the imperative of minimizing the risks associated with medication use through vigilant reporting and proactive prevention. This day unites healthcare professionals, patients, and the wider community in a concerted effort to diminish the incidence of ADEs, a predominant cause of harm in healthcare environments.Integral to the observance of this day are the organizations thatTue, 19 Mar 2024 16:26:33http://stopadr.org/blog/national-adverse-drug-event-ade-awareness-day-a-united-front-in-the-fight-against-adeshttp://stopadr.org/blog/inside-fda-s-proposed-rule-to-regulate-laboratory-developed-tests-ldts-key-takeawaysThe FDA is introducing a rulemaking proposal related to in vitro diagnostic products (IVDs or LDTs). The proposal seeks to clarify that IVDs are considered devices under the Federal Food, Drug, and Cosmetic Act. This classification holds even when the IVD is manufactured by a laboratory. The FDA plans to phase out its general enforcement discretion approach to Laboratory Developed Tests (LDTs). This indicates a shift in the FDA's stance towards LDTs and might imply stricter regulations in theTue, 31 Oct 2023 21:22:02http://stopadr.org/blog/inside-fda-s-proposed-rule-to-regulate-laboratory-developed-tests-ldts-key-takeawayshttp://stopadr.org/blog/anxiety-disorders-what-are-they-and-why-it-is-important-to-be-screenedMay 3 is National Anxiety Disorders Screening Day.I have suffered from anxiety my whole life. Until I was evaluated and treated for it, I did not have the language or understanding to know why I was like that. Now I can use the coping skills I have learned to help manage it.Anxiety affects millions of people. If you or someone close to you suspects that you suffer from one or more anxiety disorders, it is important to be screened by a professional to determine the best course of treatment.Tue, 12 Mar 2024 02:06:40http://stopadr.org/blog/anxiety-disorders-what-are-they-and-why-it-is-important-to-be-screenedhttp://stopadr.org/blog/adverse-drug-events-allergies-side-effects-and-adverse-reactions-what-are-the-differencesAn Adverse drug event is when someone is harmed by a medicine.Can be caused by medication errors, adverse reactions, allergic reactions, and overdoses.Annually account for more than 1 million emergency department visits, 2.2 million hospital admissions, 3.5 million physician office visits, and $136 billion in U.S. health care costs.While being the #1 most costly hospital-acquired conditions, they are also the #1 most preventable.If you take a medication and have an undesirable result, itFri, 24 Mar 2023 17:25:50http://stopadr.org/blog/adverse-drug-events-allergies-side-effects-and-adverse-reactions-what-are-the-differenceshttp://stopadr.org/blog/tips-on-how-to-get-back-on-track-after-overcoming-addictionThe road to recovery after experiencing addiction is not always a simple and easy fix. Instead, it's often about taking those conscious steps forward so you can embrace a healthier lifestyle, not just for now but for the foreseeable future. Here are a few tips you should employ to ensure your recovery stays on the right track.Consume the Proper DietFood plays a critical role in how we feel about ourselves. Our diet often influences our mental health as well as the physical shape we findMon, 31 Oct 2022 01:48:23http://stopadr.org/blog/tips-on-how-to-get-back-on-track-after-overcoming-addictionhttp://stopadr.org/blog/patient-stories-the-right-actGrace, secondary school student*After going through a series of tests to confirm her ADHD diagnosis, Grace and her parents shared some concerns they had with her current medications. Grace had been struggling in classroom settings even before lunchtime started and she was experiencing body tics, including repetitive arm motions and some facial twitches. What caused these conditions was unknown but Grace was embarrassed around friends and frustrated to not know what was happening with herWed, 06 Apr 2022 13:36:23http://stopadr.org/blog/patient-stories-the-right-acthttp://stopadr.org/blog/stripe-year-in-review2021 was a busy year for the Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community. Whether it was launching a podcast, hosting a webinar series with industry leaders, or coming together during All Members Meetings, it was a year full of growth and success.Get involved: 1. Subscribe to our podcast 2. Create awareness with the #fourthcause campaign 3. Tune in for the Partners in Precision Medicine webinar series 4. Join the network Everything we do pushesSun, 12 Dec 2021 05:25:55http://stopadr.org/blog/stripe-year-in-reviewhttp://stopadr.org/blog/have-you-ever-wondered-about-the-difference-between-the-terms-pharmacovigilance-and-drug-safetyAs I predicted in a previous article1, there is no doubt that the field of pharmacovigilance and drug safety is entering a new era in the current decade, with the management transformation of massive safety data related to pharmaceutical products by integrating artificial intelligence solutions.This has given a new dynamic to the outsourcing and job markets with the need for more qualified professionals in the field2, a market with a Compound Annual Growth Rate of 11.5% and expected to reachThu, 09 Dec 2021 03:49:42http://stopadr.org/blog/have-you-ever-wondered-about-the-difference-between-the-terms-pharmacovigilance-and-drug-safetyhttp://stopadr.org/blog/pharmacogenomics-what-does-it-mean-for-your-health-and-how-can-it-prevent-adverse-drug-reactionsAnnually, adverse drug events account for one million emergency room visits, 2.2 million hospitalizations, 3.5 million physician visits, and a staggering 136 billion dollars in healthcare costs. Adverse drug reactions are also the fourth leading cause of death in the United States.Pharmacogenomics is an emerging field which studies how your DNA affects the way you respond to medications. In some cases, your DNA can affect whether you have a bad reaction to a drug or whether a drug helps youFri, 18 Jun 2021 13:28:32http://stopadr.org/blog/pharmacogenomics-what-does-it-mean-for-your-health-and-how-can-it-prevent-adverse-drug-reactionshttp://stopadr.org/blog/asp-establishes-march-24-as-national-adverse-drug-event-awareness-day-launches-awareness-campaignHOUSTON, TX, March 24, 2021 – The American Society of Pharmacovigilance officially announced the establishment of March 24th as National Adverse Drug Event Awareness Day, in a coordinated effort to help spark a national discussion over the ongoing tragedy and staggering healthcare costs directly related to adverse drug events (ADE). As part of its ongoing mission, ASP also launched a national awareness campaign to encourage victims of ADEs to share their stories and begin building communityWed, 24 Mar 2021 06:35:50http://stopadr.org/blog/asp-establishes-march-24-as-national-adverse-drug-event-awareness-day-launches-awareness-campaignhttp://stopadr.org/blog/the-reality-of-childhood-cancer-and-long-term-thrivingBrady Lucas, childhood cancer thriver, shares his two-time childhood cancer experience with short and long-term medication side-effects from the lens of a young adult.“I’ll probably never be able to have children in my life,” is not a typical statement that would come up after just a few months of dating someone as a young adult. After second guessing myself multiple times, I knew I had to address the topic. Why would a 20-year-old have to address children with his 21-year-old girlfriend aMon, 31 Aug 2020 14:30:46http://stopadr.org/blog/the-reality-of-childhood-cancer-and-long-term-thrivinghttp://stopadr.org/blog/fda-becomes-a-member-of-the-stripe-collaborative-communityHOUSTON, Aug. 25, 2020  -- The American Society of Pharmacovigilance (ASP) today announced that the Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Initiative has developed a collaborative community with participation by the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). ASP is convening the STRIPE community to accelerate the development of personalized medicine practices as the standard of care by building a platform for stakeholdersTue, 25 Aug 2020 13:07:04http://stopadr.org/blog/fda-becomes-a-member-of-the-stripe-collaborative-communityhttp://stopadr.org/blog/parc-report-a-perspective-on-the-state-of-clinical-pharmacogenomics-testingThe Pharmacogenomics Access Reimbursement Coalition (PARC) recently announced the release of PARC Report: A Perspective on the State of Clinical Pharmacogenomics Testing. This article is part one of a three-part series to define challenges and opportunities in expanding patient access to personalized medicine. The report discusses the state of pharmacogenomics testing addressing a number of advances, challenges and barriers, including legal ramifications, changes to the regulatory landscape,Mon, 13 Jul 2020 22:59:02http://stopadr.org/blog/parc-report-a-perspective-on-the-state-of-clinical-pharmacogenomics-testing