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.

Documentation 145

Documentation 145

Fierce Healthcare

MARCH 18, 2024

. | Following a single-hospital pilot, the nonprofit health system will roll out Regard’s tool in a phased approach to all 33 acute-care hospitals in its system across six states in 2024. The technology is an opportunity to increase facetime between providers and patients, the partners say.

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Documentation Hospitals 75

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…

Documentation 145

Documentation 145

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.

Documentation 145

Documentation Patient Care Hospitals Insurance 145

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.

Controlled Substances 72

Controlled Substances Documentation 72

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 108

Hospitals Documentation 108

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.

Long-Term Care Facilities 69

Long-Term Care Facilities Labelling Medication Labelling Documentation 69

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

PQA

SEPTEMBER 30, 2024

Today, we published the 2024 PQA Annual Report, which documents our progress towards our strategic goals. It is a collection of accomplishments from September 2023 to August 2024 and captures the efforts of our members and staff over the past year. 2024 PQA Leadership Summit, November 7-8 in Arlington, Va.

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Specialty Pharmacies Documentation Communication 52

STAT

DECEMBER 5, 2024

As we approach the end of 2024, First Opinion is publishing a series of essays on the state of AI in medicine and biopharma.

Documentation 108

Documentation 108

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?

Documentation 98

Documentation 98

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 123

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

PQA

NOVEMBER 14, 2024

November 7-8, 2024, for the 2024 PQA Leadership Summit. PQA also announced five students who completed the 2024 PQA Healthcare Quality IQ (HQIQ), sponsored by PQA by Innovaccer. PQA members gathered in Arlington, Va., The summit focused on PQA's recent and ongoing work to develop standard pharmacy quality measures.

Specialty Pharmacies 52

Specialty Pharmacies Documentation Patient Care Immunization 52

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.

Documentation 130

Documentation Communication 130

pharmaphorum

FEBRUARY 28, 2022

The government previously announced £150 million (around $200 million) to help drive digitisation in social care, and a target of 80% of social care providers to have digital social care records by March 2024.

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Documentation Communication 115

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.

Documentation 98

Documentation 98

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

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.

Documentation 119

Documentation FDA 119

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

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

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 59

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.

Documentation 52

Documentation Dosage Communication Insurance 52

IDStewardship

APRIL 13, 2023

An important accompanying document for Joint Commission standards are Critical Access Hospital Accreditation Survey Activity Guide, for which the January 2023 guide can be found here. The latest antimicrobial stewardship regulations from The Joint Commission went into effect in January 2023.

Hospitals 246

Hospitals Documentation Communication Patient Care 246

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.

Documentation 52

Documentation 52

European Pharmaceutical Review

JANUARY 13, 2023

and implemented from January 2024. Approval of the Guide on the declassification of documents pertaining to the work of the Ph. Recent feedback from Heads of Medicines Agency (HMA), and European Medicines Agency (EMA), groups and from the national competent authorities of non-EU Ph. Member States. Supplement 11.3 The post Ph.

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Documentation Vaccines 105

The FDA Law Blog

JUNE 10, 2024

Submit documentation as evidence of addressing the observations (e.g., Document all corrective actions and follow-up to ensure sustained compliance. Comments on the draft guidance can be submitted to the docket by August 5, 2024. Provide a method of verifying or monitoring the effectiveness of the actions.

FDA 111

FDA Communication Documentation 111

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Through a recent (and very short) Guidance document, FDA indicated that, starting on October 1, 2023, FDA may base “refuse to accept” (RTA) decisions on the information required by section 524B.

FDA 105

FDA Documentation Labelling Communication 105

The FDA Law Blog

MAY 6, 2024

The guidance does not define “on a reasonably justified regular cycle” or “as soon as possible” but instead recommends manufacturers should “update appropriate cybersecurity documentation (e.g., Appendix 4) for the documentation requirements to “demonstrate reasonable assurance that the device and related systems are cybersecure”.

FDA 105

FDA Documentation 105

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.

Hospitals 52

Hospitals Documentation 52

The FDA Law Blog

DECEMBER 12, 2024

4, 2024), at 1. The parties have noticed their intentions to offer into evidence documents they identified in their prehearing statements and must serve each other with a copy of the documents noticed in their prehearing statements no later than January 3, 2025. Prehearing Ruling (Dec.

Controlled Substances 52

Controlled Substances Documentation 52

European Pharmaceutical Review

FEBRUARY 1, 2024

Even though patients are on existing [statins] that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death” We are recognising now is that there is great data on how to reduce risk by applying lipid lowering therapy like statins.

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Documentation Pharmaceutical Companies Pharmaceutical Companies 97

IDStewardship

DECEMBER 13, 2024

BCPS, BCIDP Article posted 13 December 2024 If you cannot measure it, you cannot determine if you have changedit. In this article an experienced antimicrobial stewardship pharmacist discusses lessons learned from navigating antimicrobial stewardship metrics. Authored by: Timothy P. Gauthier, Pharm.D.,

Communication 130

Communication Medical Records Documentation 130

The FDA Law Blog

MAY 13, 2024

Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. This guidance, when finalized, will replace the original version of this document finalized in 2017. Patients that use ESD undergo continuous 24/7 monitoring.

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FDA Medical Records Documentation 111

pharmaphorum

JUNE 10, 2022

The FDA reviewer said in briefing documents published ahead of the advisory committee meeting that there had been cases of myelodysplastic syndrome (MDS), a form of cancer, in around 4% of children treated with eli-cel, leading to speculation that the panel may have taken a more guarded stance on the therapy.

FDA 98

FDA Documentation Immunization 98

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 64