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Panelists discuss how pharmacists can systematically identify eligible patients through team-based approaches involving technicians and student pharmacists who can query databases by age (50+) and high-risk conditions or medications, while addressing common barriers identified in research including insurance coverage, patient willingness, eligibility (..)
Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.
In response to this, the Leeds Teaching Hospitals NHS Trust (LTHT) pharmacy team has recently launched its ‘Digital Induction’ document. Initial feedback has been overwhelmingly positive, leading to the creation of additional documents tailored for line managers and pharmacy students with specific digital needs.
By John W.M. Claud & Michelle L. Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. One area drawing increasing attention is how these changes will affect the drug development and review process.
Regular performance reviews, goal-setting, and clear documentation aren't just administrative tasks—they're critical shields against potential workplace conflicts and legal challenges. Equally important is her emphasis on structured human resources practices.
In an unusual move, an audit of commercial health plans by Tennessee officials found that Express Scripts, one of the largest pharmacy benefit managers in the United States, violated state laws in its dealings with pharmacies, according to newly released documents.
Here, the FDA investigators documented several instances in which the Quality Manager appeared directly responsible for preventing company employees from talking with FDA about their responsibilities or responding to direct questions from FDA about areas in which FDA has authority to inspect. FDA Guidance , at 8 (emphasis added).
UnitedHealth acquired full or partial ownership stakes in more than 100 surgery centers in 2024, according to a STAT review of UnitedHealth’s newest annual financial documents.
The document identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. Inadequate validation of test methods : KVK-Tech failed to establish and document the accuracy, sensitivity, specificity and reproducibility of test methods.
Considering its numerous benefits, such as the above, regulators therefore encourage drug manufacturers to use mass spectrometry together with ELISA analysis, or mass spectrometry analysis by itself, for control and documentation of product impurities, explained Alphalyse.
The advent of the first generic GLP-1 drugs could help Medicare negotiate a lower price for the highly sought after diabetes and obesity medication semaglutide , according to experts familiar with the price-negotiation program and STAT’s review of documents from the first round of negotiations.
The brief, 20-page document, instead, focuses on AI models used to produce data that supports regulatory decision-making about the safety, effectiveness, or quality of drugs. The guidance does not, however, capture how AI is being used in drug discovery, the process of identifying and designing molecules, or in operational efficiency.
Document 9286/25. The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. Brussels: Council of the European Union; 2 June 2025. Interinstitutional File: 2023/0131 (COD).
Without documented patient consent: Claims can be denied Medicare reimbursement is forfeited Practices face potential audits, penalties, or disqualification from CMS programs Trust between providers and patients erodes These consequences are what no executive or practice manager can afford to ignore.
Per FDA’s update, non-application products without annual report requirements should prepare similar documentation and retain it for FDA inspection requests.
While clinical services represent the future, the practical challenge of documenting these encounters threatens to impede progress. This documentation burden isn't just inefficient; it's a barrier to success. They want to understand the what and the how of the interventions that close gaps in care.
The study cohort included 670 patients who were diagnosed with PsA of at least a 3 month duration and have active plaque psoriatic skin lesions or a documented medical history of plaque psoriasis. READ MORE: Significant Knowledge Gap Exists in Patient Awareness of Psoriatic Disease The study found that 54.2%
Low uptake of vaccination to protect against invasive pneumococcal disease (IPD) was observed both before and after a pneumococcal-related hospitalization, with countless missed vaccination opportunities documented.
The authors found references to skin tone, pigmentation, or race in 4% of the documents submitted before the FDA made its suggestion to diversify skin tone testing in 2013.
Smarter MLR Workflows Review cycles that once took weeks can now be accelerated by AI-based content tagging and document comparison tools. AI tools assist in document comparison, regulatory tagging, and claim validation to speed up MLR processes while reducing compliance risks. How does AI help with compliance in pharma marketing?
Effortless document copying with “Edit in eWizard” Our team ensured version accuracy for the localization copy with the MLR-approved content item. Content creators can now be 100% sure that they are working on an approved version of the document without worrying about creating duplicates and accidentally working on an old version.
Right documentation. CLMM ensures that, across all stages of the process from prescription to bedside administration, including medication preparation, dispensing and distribution the six rights of medication administration are met: 1. Right patient 2. Right medication 3. Right dose 4. Right time 5. Right route 6.
The data challenge The research reveals a stark reality: 80 percent of pharmaceutical organisations surveyed report serious problems with either the availability or quality of data and documentation. “There was definitely a perceived risk of changing the ways of working practices.
Within the UK, pharmacists generally lead on SACT protocol development and are the authors of these important medicines information documents – with the MDT, clinicians and nurses reviewing the content.’
Ask for EIN, 501(c)(3) documentation, and referencesbut know that these can even be faked. Vague mission or unverifiable charity status. Pressure to ship immediately. Payment by credit card only. Here’s How To Protect Yourself If it smells fishy, trust your gut and say no. Never ship before verifying that the payment is legitimate.
Alcohols negative effects on the liver are well-documented. In rare cases, clonidine can cause liver problems, such as hepatitis and increased liver enzymes, according to its prescribing information. Alcoholic liver disease may occur in people who drink excessively over a long period or those who binge drink.
This, in turn, requires structured documentation, such as dedicated fields in electronic prescribing systems, where prescribers can specify critical preferences like flavour, texture or excipient restrictions, to ensure that each patient receives a safe and personalised formulation.
Data traceability and immutability : meticulously documenting metadata pertaining to data sources, quality and context, to provide AI applications with the necessary contextual information during data processing. Also, this aspect is crucial for interpretable results.
Pharmacists can get trained credentials, get up to speed and enrolled to generate $20, $30, $50 a month per patient in managing their medications a little better and documenting it.
1-2 years) Increase standardized HIT for documentation of MTM services Re-establish consensus on standards for clinical documentation for MTM services (e.g.,
Having a written pharmacy drug recall policy and procedure document in place for all staff members can help ensure a smooth process, especially if an FDA inspector decides to verify any recalled drugs at your pharmacy. However, in many cases, the FDA requests or mandates that a drug is recalled.
Frances Abanonu Abanonu started a blog to document her experiences as a mom attending school, to both encourage herself and other mothers. After I had my kids, I told my husband I want to go to pharmacy school this is what I've always wanted to do I'm still thankful for the routes that I took because every experience is valuable.
The insurance company may require additional documentation from your healthcare provider, and pharmacies often have to verify with the provider that it is okay to fill early. They’ll know exactly what documentation is needed.” Examples of common controlled prescriptions include ADHD medications, such as Adderall and Ritalin.
Documenting this trial may be required for certain prior authorizations. While Bonjesta is not currently available as a generic medication, there are other steps that can be taken to help get this medication covered by insurance. The OB or OB-GYN will likely first try diet and lifestyle adjustments to help manage nausea and vomiting.
You can consider the following when verifying your insurance coverage for Mounjaro: Review your benefits plan document: Read through your evidence of coverage documents carefully to see if Mounjaro is listed as a covered medication. Pay attention to details about coverage levels and any specific requirements or restrictions.
While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals.
27 of this year to meet the requirements, as long as they are making documented efforts to finalize data connections, of course. In fact, wholesalers and repackagers had until May 27, 2025 (following this day, full-unit traceability would be mandatory), a date that has officially passed.
Pulmonary function tests and provider documentation were manually reviewed to confirm asthma diagnoses, while individuals with other pulmonary diseases were excluded. 1 The study also observed that 65% of patients had a documented visit with an asthma specialist during the follow-up period.
Other documented causes of secondary dysmenorrhea include fibroids, adenomyosis, infection, myomas, obstructive reproductive tract anomalies, and ovarian cysts About the Author Yvette C. Dysmenorrhea, also known as painful menstruation, is the most commonly reported menstrual symptom among females during the reproductive years.
This is called prior authorization , and depending on the plan, the prescribing healthcare provider may need to provide some documentation of the patients symptoms or other treatments theyve tried. You may also have to complete step therapy, which means trying other medications before Aimovig.
Formulary Every insurance plan has a long document that shows how it covers each prescription medicine, called a formulary. Aetna’s many formulary documents show that Contrave (when it’s listed) often falls under non-preferred brands. Some plans will, in fact, provide coverage. It’s all based on a few different variables.
The long-term side effects of Mounjaro haven’t been well documented but may include an increased risk of gallstones. It’s injected under the skin once per week to help control blood sugar levels. The most common side effects of Mounjaro typically go away after several weeks. What are common Mounjaro side effects?
Enhanced Compliance and Transparency With robust data systems, pharma marketers can track and document how audiences are targetedan essential capability in an environment governed by HIPAA, GDPR, and other privacy regulations. This precision translates to better ROI and lower cost-per-engagement.
billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment. Annual health-related costs related to PFAS across Europe are estimated at up to 4.6
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