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 143

Documentation Patient Care Hospitals Insurance 143

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.

FDA 91

FDA Documentation 91

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 94

Documentation 94

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.

FDA 97

FDA Documentation Insurance 97

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.

Documentation 97

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

Documentation 70

Documentation 70

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.

Packaging 92

Packaging Documentation 92

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

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.

Documentation 40

Documentation Insurance FDA 40

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!

Community Pharmacies 52

Community Pharmacies Specialty Pharmacies Independent Pharmacies Documentation 52

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.

Documentation 45

Documentation 45

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).

Documentation 40

Documentation 40

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 89

Documentation 89

European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs. MHRA announced that it will publish its guidance in 2024.

Documentation 92

Documentation FDA 92

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.

Documentation 100

Documentation Communication 100

The FDA Law Blog

JUNE 20, 2023

The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry. Draft Guidance Finally, as part of MDUFA V , FDA has committed to issuing an updated draft of this Q-Sub guidance, by March 31, 2024.

FDA 45

FDA Documentation Communication 45

PQA

DECEMBER 1, 2023

In support of this goal, PQA has performed a review of its bylaws and proposes revisions which modernize and streamline this important governing document. Save the date to join us at the 2024 PQA Annual Meeting, May 14-16, at the Baltimore Inner Harbor in Baltimore, Md. Learn more in the Member Resources Library.

Community Pharmacies 59

Community Pharmacies Documentation Communication 59

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

PQA

JULY 28, 2023

CMS has proposed expanding the eligibility for MTM beginning as soon as 2024 for Part D beneficiaries, estimated to increase the number of Part D enrollees eligible for MTM services from 4.5 million to 11 million.To encourage and reward high-quality care, the Completion Rate for CMR measure is part of the Medicare Part D Star Ratings program.

Documentation 40

Documentation 40

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.

Documentation 96

Documentation Vaccines 96

Board Vitals - Pharmacist

DECEMBER 1, 2023

With 2024 rapidly approaching, there comes the question of New Year’s Resolutions. To simplify our EHR and make documentation easier and quicker. I hope to work with different EHRs to find one where surgeons can put the focus back on the patient and allow the surgeon to quickly and completely document the encounter.

Communication 98

Communication Patient Care Documentation Insurance 98

pharmaphorum

FEBRUARY 9, 2022

The main bullet points in the plan include an objective of eliminating any delays to procedures of 18 months or more by April 2023 and over 65 weeks by March 2024, and reducing all waits to less than a year by 2025 – a year after the next scheduled general election. end waits over a year for 99% of people by 2024, and everyone by 2025.

Hospitals 52

Hospitals Documentation Insurance 52

Hospital Pharmacy Europe

NOVEMBER 2, 2023

To support the documents, in spring 2024 the RPS will launch a Greener Pharmacy Toolkit, allowing pharmacies to self-accredit their sustainability status. Pharmacies will be able to upload evidence and write reflections, resulting in a ‘green achievement level’ badge of bronze, silver or gold.

Hospitals 52

Hospitals Community Pharmacies Documentation Communication 52

Birth Control Pharmacist

FEBRUARY 12, 2024

Pharmacists must be familiar with billing codes, insurance coverage policies, and documentation requirements to facilitate seamless transactions and ensure fair compensation for their services. Candidate, is a 4th-year student pharmacist in the Class of 2024 at Shenandoah University Bernard J. About the Author Rebecca Exantus , Pharm.D

Insurance Coverage 52

Insurance Coverage Documentation Insurance 52

pharmaphorum

MARCH 8, 2022

The company didn’t conduct a conference call to discuss the findings, but took the unusual step of publishing a frequency asked questions (FAQ) document on the study, headlined with a non-committal statement about whether the data were “clinically meaningful.”

Chemotherapy 52

Chemotherapy Documentation Labelling 52

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

Hospital Pharmacy Europe

MAY 22, 2023

Last week, the GPhC proposed raising its fees by 7.5% – meaning that from April 2024, the pharmacist registration renewal fee would increase by £19, from £257 to £276. GPhC also highlighted information about its budget and spending published within the consultation documents.

Hospitals 98

Hospitals Documentation 98

DiversifyRx

NOVEMBER 24, 2023

While DSCSA (the Drug Supply Chain Security Act) enforcement is postponed until November 2024, it is critical to move forward in becoming compliant sooner rather than later. This record-keeping includes detailed documentation of the product’s history and movement through the supply chain. To achieve this, the U.S.

Independent Pharmacies 52

Independent Pharmacies Packaging Documentation FDA 52

Hospital Pharmacy Europe

NOVEMBER 23, 2023

A revised version of its 2017 statement of policy on the control of AMR, the document offers up-to-date recommendations to reflect current issues around the regulation and monitoring of antimicrobial consumption and their routes of access, as well as data availability in humans and animals.

Documentation 52

Documentation Hospitals 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 236

Hospitals Documentation Communication Patient Care 236

pharmaphorum

AUGUST 11, 2022

The score measures rates of nutrition screening, assessment by a registered dietitian nutritionist, malnutrition diagnosis by a physician, and nutrition care plan documentation. What is the Global Malnutrition Composite Score?

Hospitals 52

Hospitals Documentation 52

PQA

MARCH 22, 2023

CMS has proposed expanding the eligibility for MTM beginning in 2024 for Part D beneficiaries, estimated to increase the number of Part D enrollees eligible for MTM services from 4.5 Since its inception, the Medicare Part D MTM program requirements have changed to enhance enrollment, improve quality of services, and reduce gaps in care.

Documentation 52

Documentation 52

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.

Documentation 73

Documentation Hospitals 73

The FDA Law Blog

FEBRUARY 29, 2024

FDA’s February 23, 2024 decision says that “the grounds for withdrawing approval have been met because: (1) the confirmatory study conducted as a condition of accelerated approval did not confirm Pepaxto’s clinical benefit and (2) the available evidence demonstrates that Pepaxto is not shown to be safe or effective under its conditions of use.

FDA 59

FDA Documentation 59

The Checkup by Singlecare

MAY 1, 2024

In 2024, the household income limit to qualify is under $27,180 for an individual or under $36,620 for a two-person household. In 2024, this is $30,120 for an individual and $40,880 for a couple. Necessary documentation and information Financial assistance programs may require proof of income. The application fee is $300.

Health and Personal Care Stores 52

Health and Personal Care Stores Insurance Insurance Coverage Communication 52

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.

FDA 90

FDA Documentation Method Validation Packaging 90

Pharmacy Friday Pearls

AUGUST 29, 2022

mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET. Intensive care medicine , 33 (11), 2019–2024. Greene et al., units/kg/hr) Euglycemia was maintained using 5-10% dextrose infusions. Potassium was maintained within low normal range (3.8-4.0 M., & Isbister, G.

Packaging 52

Packaging Documentation 52