Hospital Pharmacy Europe

SEPTEMBER 24, 2024

The European Society of Cardiology Congress 2024 showcased the very latest in cardiovascular medicine and science with presentations and discussions about recent findings and new guidelines, as well as in-depth clinical teaching and education. Research highlights Over the four days, a host of late-breaking science sessions were held.

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Documentation Hospitals Clinic Management Patient Care 52

Pharmaceutical Technology

MARCH 28, 2024

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.

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Documentation Vaccines 113

OctariusRx

FEBRUARY 20, 2024

The 2024 controlled substance assessment quiz is about to be released! you know that not following proper processes and poor documentation can lead to patient harm and/or large fines from regulatory agencies, such as the United States Drug Enforcement Administration (DEA). How are you assessing your staff? Contact us for assistance.

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Controlled Substances Documentation 73

STAT

APRIL 11, 2024

Medicare for the first time has estimated that a new Alzheimer’s treatment could cost the program billions of dollars by next year — well beyond what Wall Street or even the drug’s manufacturer have projected — according to a document obtained by STAT.

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Documentation 145

OctariusRx

MAY 13, 2024

Our 2024 nursing calculations quiz is now available. Since medications are usually dosed milligrams per kilogram, learn to consistently convert and document the patient’s weight in kilograms. If you’re already part of our team, you can expect to see the 2024 Nursing Medication Calculations Quiz during our upcoming facility visit.

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Long-Term Care Facilities Labelling Medication Labelling Documentation 70

STAT

AUGUST 5, 2024

As documented in a recent commentary that I and several colleague published in the journal Frontiers in Research Metrics and Analytics, considerations of diversity, equity, and inclusion (DEI) have been introduced into federal science funding decisions. Each of the major U.S. Read the rest…

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Documentation 143

STAT

JULY 23, 2024

CVS Caremark, one of the largest pharmacy benefit managers in the country, agreed to pay at least $45 million to the state of Illinois to settle allegations that rebates were not passed through during a recent four-year period, according to a document obtained by STAT.

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Documentation 138

STAT

MARCH 18, 2024

CVS Caremark, the PBM owned by CVS Health that oversees the prescription drug benefits of 103 million people, told its employer clients that it anticipated “more lower-cost products (including specialty biosimilars) may become preferred products” on its lists of approved drugs for 2024, according to documents obtained by STAT.

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Documentation Pharmaceutical Companies Pharmaceutical Companies Insurance 145

The Happy PharmD

SEPTEMBER 15, 2024

The stress experienced by community pharmacists compared to those in other settings is well-documented and has been a longstanding issue. The post State of Well-Being 2023-2024 appeared first on The Happy PharmD. A survey conducted in 2021 highlighted this concern, indicating that workforce issues are a common challenge.

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Documentation Dosage Communication Insurance 52

STAT

OCTOBER 23, 2023

Starting in the first quarter of 2024, Optum’s post-acute-care companies will be called Home & Community Care, according to internal documents obtained by STAT. However, Optum advised employees that “Home & Community Care should not be directly next to the Optum logo” in marketing materials.

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Documentation Patient Care Hospitals Insurance 145

STAT

MAY 20, 2024

A huge amount of those documents were released last week, and the numbers mirror what  we’ve been seeing over the past several months : Not all hospitals are in dire straits, and in fact, many continue to do quite well. Sign up to get it in your inbox every Monday. Continue to STAT+ to read the full story…

Hospitals 101

Hospitals Documentation 101

The FDA Law Blog

SEPTEMBER 24, 2024

Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. By Deborah L. 89 FR 74966 at 74968 (Sept.

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Documentation FDA Packaging 57

European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co. Internet} US FDA.

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FDA Documentation 98

European Pharmaceutical Review

JANUARY 25, 2024

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

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FDA Documentation Method Validation Packaging 98

Hospital Pharmacy Europe

OCTOBER 3, 2024

The crucial role of hospital pharmacists in addressing challenges and improving access to safe, quality medicines and medical devices has been highlighted in a new reference document from the International Pharmaceutical Federation (FIP). This document highlights the importance of access to essential medicines.

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Hospitals Documentation 52

Birth Control Pharmacist

AUGUST 7, 2024

On August 6, 2024, the CDC released the 2024 U.S. MEC) and the 2024 U.S. These documents provide current evidence-based contraception recommendations for health care providers. The 2024 U.S. The 2024 U.S. Get the 2024 Chart Download the updated app including updated recommendations from the 2024 U.S.

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Documentation 52

European Pharmaceutical Review

AUGUST 25, 2023

According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments. The document highlights that the revision should also consider related changes in other GMP chapters and annexes as well as in other regulatory documents. What is included in the new revision?

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Documentation 98

IDStewardship

OCTOBER 14, 2024

BCPS, BCIDP Article Posted October 2024, First Released in the June 2024 IDstewardship Newsletter Tip 1: Start by picking an article type and journal The article type (e.g., In this article a pharmacist with experience in writing and publishing provides 5 quick tips for pharmacy residents preparing manuscripts Authored By: Timothy P.

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Documentation Communication 130

The FDA Law Blog

OCTOBER 13, 2024

Although the program has not been without its critics (including as documented in two GAO reports from 2016 and 2020 ), there is ample evidence that the program has been successful at accomplishing its goals, which has become more evident with time. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024).

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Documentation FDA 62

STAT

FEBRUARY 28, 2024

antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022 , STAT writes. The … A much-anticipated inquiry by U.S.

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FDA Documentation Insurance 107

DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. Not All Pharmacies Can Exempt from The 11/27/2024 DSCSA Requirements. The original article can be found HERE. The DSCSA Adventure continues. The DSCSA Adventure continues.

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Independent Pharmacies FDA Documentation CPhT 52

Hospital Pharmacy Europe

MAY 17, 2023

from April 2024, and has invited feedback via an online consultation survey. The increases would affect fees for the 2024 registration assessment – for which bookings open in February 2024 – as well as registration renewal fees from April 2024. Fees have been frozen for the last two years in 2022 and 2023.

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Documentation Hospitals 97

European Pharmaceutical Review

MARCH 19, 2024

percent between 2024-2031. the global continuous bioprocessing market is expected to value $1,067.8 million by 2031. While the market was valued at $255.9 million in 2023, the report predicted it will witness a CAGR of 19.72

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Documentation 94

European Pharmaceutical Review

DECEMBER 19, 2023

The document was adopted by EMA’s Management Board at its December meeting. Preparations to support the implementation of the EU AI Act will start in 2024. The plan was prepared by the Big Data Steering Group (BDSG), a joint initiative between HMA and EMA.

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Packaging Documentation 105

European Pharmaceutical Review

AUGUST 5, 2022

Clinigen Healthcare is recalling three batches of Mexiletine hydrochloride hard capsules, indicated for the treatment of documented arrhythmias, due to a potential risk of under- or overdose, which could have consequences for the safety of patients. First distributed. 84 capsules. 10/02/2022. Batch number. Expiry date. First distributed.

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Documentation 98

The FDA Law Blog

OCTOBER 16, 2023

Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

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Documentation FDA 117

PQA

APRIL 26, 2023

PQA has a new frequently asked questions (FAQ) document that addresses background and basics of SDS risk adjustment and PQA’s risk adjustment recommendations for the three adherence measures in Medicare Part D (PDC-Diabetes All Class, PDC-Renin Angiotensin System Antagonists, and PDC-Statins).

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Documentation 40

The FDA Law Blog

AUGUST 7, 2023

Submit proposal documents by email to ELP Proposal Submissions by September 5, 2023 at 12 PM ET. Complete a Site Visit Agenda ( Sample Site Visit Agenda ). Identify the site visit duration. Most common are one- or two-day site visits.) Indicate ability to host a virtual site visit.

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Documentation Insurance FDA 40

PQA

DECEMBER 14, 2023

Strengthen requirements for standardized documentation and reporting related to the quality of MTM services. Increase stakeholder education about the use of the Medication Therapy Problem Categories Framework to assist with standardizing documentation. You can read more about each of these in the draft call to action document.

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Documentation 45

The FDA Law Blog

AUGUST 18, 2024

In effect, these documents serve as road signs helping to direct new market entrants. The agency has done far better in posting 510(k) summaries, which are similar types of documents. The same cannot be said for De Novos from January or February.

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FDA Documentation Hospitals 67

Viseven

JULY 10, 2024

As a specialized field, medical writing encompasses the creation of various documents, from regulatory submission documents to medical journal articles, that convey critical medical knowledge to diverse audiences. This crucial role explains why the market is projected to grow at a CAGR of 10% from 2024 to 2032, potentially reaching $2.57

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Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

The FDA Law Blog

FEBRUARY 28, 2024

FDA has not yet published draft guidance; however, the statutory deadline to do so is June 2024. The next document in the docket is a letter from Dr. Marks referring to an upcoming October 2, 2023, joint (virtual) meeting with CDER and Oncopeptides. Tobolowsky & Michelle L. On August 4, 2023, Oncopeptides submitted its appeal.

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FDA Documentation Labelling 57

Blog: Ask a Student Pharmacist

AUGUST 22, 2024

Despite video documentation of George Floyd’s murder, these longstanding generational injustices still caused many to doubt how just the trial’s outcome might be. This tragedy sparked a new awareness for many people of the disparities and injustices that have plagued people of color every day for generations.

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Documentation 52

The FDA Law Blog

NOVEMBER 11, 2024

Livornese & JP Ellison — On November 8, 2024, FDA issued a proposed order to remove the oral decongestant ingredient phenylephrine (including both phenylephrine hydrochloride and phenylephrine bitartrate) (collectively, PE) from the OTC monograph on the basis of a lack of effectiveness. By Deborah L.

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FDA Documentation Dosage 108

Blog: Ask a Student Pharmacist

AUGUST 9, 2024

Despite video documentation of George Floyd’s murder, these longstanding generational injustices caused many, especially people of color, to doubt the outcome of the trial. This tragedy sparked a new awareness for many people of the disparities and injustices that have plagued people of color every day for generations.

Documentation 52

Documentation 52

The Checkup by Singlecare

AUGUST 20, 2024

In Ohio, this process was expected to conclude in early 2024, but a federal audit by the Office of the Inspector General found that up to 78,486 people were incorrectly classified , some of whom may have had their coverage incorrectly terminated. Make sure you take all the required documents with you.

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Documentation Insurance 52

PQA

MARCH 8, 2024

Offering Resources to Implement Point-of-Care Testing The National Community Pharmacists Association and National Alliance of State Pharmacy Associations have developed a new guidance document to help community pharmacy teams with their point-of-care testing services. "A prior to the PQA Leadership Summit. Register today!

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Community Pharmacies Specialty Pharmacies Independent Pharmacies Documentation 52