FDA’s MedWatch Program Facilitates Reporting on Suspected, Identified Problems

FDA pharmacist Captain Catherine Chew recently appeared in a video that advertised the importance of being vocal about problems during clinical use. On behalf of the FDA, she asked that professionals and patients utilize MedWatch if they suspect or identify problems with medical products within a clinical setting. FDA’s MedWatch program is a tool that will be essential for reporting these serious issues.

“When you report adverse events to the FDA’s MedWatch program, you provide a vital source of information to the FDA. Today, resources are available to you, a health care professional, to make reporting to MedWatch easier than ever,” said Capt. Chew in the PSA video. “The FDA needs to know when a serious problem with a medical product is suspected or identified during clinical use. That’s why the MedWatch program makes it easy to get important information from you to us.”

Anyone can submit a MedWatch report online at FDA.gov/MedWatch. Also, the site features guidelines regarding what should and shouldn’t be reported to MedWatch. The reporting forms can be completed online, the form can also be printed out and completed by hand. There is a report form designated for health professional, and a consumer form designed specifically for patients.

The MedWatchLearn section teaches healthcare professional, students, and consumers how to complete the forms necessary to submit suspected or identified problems to the FDA. MedWatchLearn is a teaching tool that allows students, professionals and consumers to learn how to complete a MedWatch report by using a case study that’s based on an actual report. The resource also provides information to patients and providers about clinical safety. There’s an additional 24-minute tutorial available for public consumption, offering information on post-marketing safety surveillance.

Providers and patients are encouraged to call or email FDA’s Division of Drug Information or submit a report via MedWatch.

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FDA Releases DSCSA Guidance Plan for 2016

The U S Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) recently released insights regarding off-label communications, generics products, and pharmaceutical quality. More importantly, the FDA released the Drug Supply Chain Security Act (DSCSA) guidance plan for 2016.

There are 15 categories of guidance documents planned for 2016. Included: advertising, biopharmaceutics, biosimilarity, clinical/antimicrobial, clinical/medical, clinical pharmacology, clinical/statistical, drug safety, electronic submissions, generics, labeling, pharmaceutical quality/CMC, pharmaceutical quality/manufacturing standards (CGMP), pharmacology/toxicology and procedural. There is a total of 102 planned guidance documents, considerably more than what’s been planned in the recent past.

Additionally, the FDA has planned six guidance documents for DSCSA implementation. These guidance documents were carried over from last year, with the exception of Field Alert Submission. The others are Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers; Products Eligible for Grandfather Status; Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs; The Product Identifier for Human, Finished, Prescription Drugs; Verification Systems for Prescription Drugs; Waivers, and Exceptions and Exemptions from Product Tracing Requirements.

The DSCSA guidance documents will offer information about reporting requirements and procedures, the status of products within a supply chain before a deadline, the exchange of information when tracing RX products, and exemptions for certain products and scenarios.  The agenda will outline steps that must be taken to build an interoperable system that traces prescription drugs as they are purchased in the U.S. Traceability should focus on T3 management, exchange and repository, and detection and response.


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Senate Finance Committee Proposes Ways For Medicare to Address Chronic Illness Care

Senate Finance Committee Proposes Ways For Medicare to Address Chronic Illness Care

sharon roberts attorney medicareThe Bipartisan Chronic Care Working Group’s Policy Options Document was released by the Senate Finance Committee in late December. It’s a publication that grew from a hearing which occurred during the summer of 2014, “Chronic Illness: Addressing Patients’ Unmet Needs.” Chairman Orrin Hatch, along with the rest of Senate Finance Committee, gathered proposals and feedback to chronic illness through Medicare.

This proposition was initially addressed in a statement released May 22, 2015, formally inviting all invested healthcare stakeholders to submit realistic pragmatic ideas that could provide a solution for Medicare patients requiring chronic care. Proposed ideas could have been based on real world experience or data-driven evidence.

Senators Johnny Isakson and Mark Warner and Ranking Member Ron Wyden were, of course, party to the compilation of materials from the Medicare Payment Advisory Commission (MedPAC), the Centers for Medicare & Medicaid Services (CMS) and industry stakeholders, resulting in the thorough report. They devised an outline that acknowledged the numerous ways policies could be utilized to improve the lives of Medicare recipients living with multiple, complex chronic illnesses.

It’s stated that the policy proposals represented in the report are non-committal and won’t necessarily become legislation. It’s also stated that policies would have to be scored by the Congressional Budget Office (CBO) to confirm that the piece of legislation would be cost-saving or revenue neutral. The workplace group kept this in mind when crafting three policy goals.

Those three goals include the streamlining of Medicare payment systems, the increase of provider-administered care coordination across the care continuum and improved quality care coordination to increase spending efficiency. By adopting some of the initiatives listed in the paper, it would be possible to achieve the goals proposed.

The prospective policy initiatives were broken down into six groups and they were wide-ranging. Everything from expanding home health care to advancing team-based care was proposed. As well as a need to expand innovation and technology, empower individuals and caregivers, construct transparent policies to improve healthcare, and identify chronically ill populations to improve quality.

The Senate Finance Committee is also considering telehealth options to improve access to lower costs and superior care.

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Insight into the Generic Drug Market and the Factors to Run a Generic Drug Manufacturing Plant

While there always seems to be some sort of debate regarding the merits and potential disadvantages regarding the patient’s experience with generic drugs as opposed to the name-brand version, this article focuses on a different aspect of the supply chain. That is to say, this article focuses on what it is that goes in to running a compliant, successful and reputable generic drug manufacturing plant. While it’s important to keep in mind that specific regulations and standards may vary by your state or region, this piece does an excellent job exploring world of what it takes to run a well-regarded generic drug manufacturing plant – no matter what the specific regulations are in your particular area.

Source: Insight into the Generic Drug Market and the Factors to Run a Generic Drug Manufacturing Plant

The top pharmacy challenges in 2016

Photo post.

A great article from Henry Kotula examining what the year may have in store for us directly involved with the pharmaceutical industry, as well as those impacted by it… which is essentially everyone. While it’s likely that many of the challenges we faced this year will continue into the new year, it’s interesting to see what sorts of shakeups may greet us in coming months.

Source: The top pharmacy challenges in 2016