Thursday, November 29, 2012

DEA probes Walgreens pharmacies over drug diversion in Florida

The Miami Field Division of the DEA issued 3 Walgreens pharmacies in FL with orders to show cause - notifications that are given to facilities requiring them to prove why they should be allowed to keep their licenses.

DEA probes Walgreens pharmacies over drug diversion in Florida - South Florida Sun-Sentinel.com:

"In April the DEA said it would inspect six Walgreens pharmacies and its Florida distribution center after the agency noticed a jump in purchases of the painkiller oxycodone. On September 14, the distribution center's registration was suspended. An administrative hearing is scheduled to begin on that matter on January 7, 2013.

The DEA has been ratcheting up its focus on drug wholesalers and pharmacies over the past year as attempts to battle what the Centers for Disease Control and Prevention calls a prescription drug abuse epidemic. Deaths from narcotic pain-killers now exceed those of heroin and cocaine combined.

Florida has long been considered the epicenter of prescription drug abuse and the DEA has dismantled dozens of "pill mills" - sham pain clinics whose doctors write prescriptions for thousands of pain pills to drug dealers and addicts."

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Monday, November 26, 2012

Deaths and Injuries Associated With Bed Rails

Something of interest for HME and DME providers . . .

Agency Investigates Deaths and Injuries Associated With Bed Rails - NYTimes.com:

". . . death certificates and hospital emergency room visits from 2003 through May 2012 shows that 150 mostly older adults died after they became trapped in bed rails. Over nearly the same time period, 36,000 mostly older adults — about 4,000 a year — were treated in emergency rooms with bed rail injuries. Officials at the FDA and the commission said the data probably understated the problem since bed rails are not always listed as a cause of death by nursing homes and coroners, or as a cause of injury by emergency room doctors.

Experts who have studied the deaths say they are avoidable. While the F.D.A. issued safety warnings about the devices in 1995 . . ."

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Tuesday, November 20, 2012

Entrepreneur Shares His Formula in "The Next Step-Retail HME" - Book Release

The book:
  • is a step-by-step guide to starting up and making a retail home medical equipment business successful
  • includes his original business plan for use as a guide
  • provides his most recent profit and loss statement with percentages for comparison
Home healthcare entrepreneur Michael Kuller, RPh shares his formula for retail success in "The Next Step-Retail Home Medical Equipment":
""Using the information provided in this book, anyone can open a retail home healthcare store and make it successful. For those considering a retail home medical equipment business, this book is a must-read ", says Jack Evans, Retail Home Healthcare Expert."
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Follow this link to purchase the book:
The Next Step: Retail Home Medical Equipment: Step by Step Building Your Retail Business

You might also be interested in:
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   (The CA Department of Public Health administers the Home Medical Device Retailer (HMDR) Licensing Program)

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Monday, November 19, 2012

California HMDR Exemptee Training Requirements

Q.  I'm submitting an application for a Home Medical Device Retailer (HMDR) Exemptee license, as a new applicant.  What are the things that I need to pay attention to, regarding training requirements?

A.  According to the referenced CDPH HMDR license application form:

  • New applicants must meet minimum qualifications, including proof of completing a training program (that addresses 5 topic areas).
  • In order to prove training completion, the applicant must submit a copy of the completed training certificate (or transcript).
  • Specifically, in the Minimum Qualifications - Training Programs section: Indicate by yes or no the training you have completed specific to the five topics listed. Attach copies of certificates or transcripts.
Be forewarned, the application states, "Unsigned or incomplete applications cannot be processed and will be returned."

Reference:
Application for Home Medical Device Retailer (HMDR) Exemptee license - New and Renewal (Form CDPH 8695 (04/16))

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FDA Law Blog: FDA and CA Board of Pharmacy Talk Pedigree - Annual HDMA Track and Trace Conf

FDA Law Blog: FDA and California Board of Pharmacy Talk Pedigree at Annual HDMA Track and Trace Conference:

"The Healthcare Distribution Management Association (“HDMA”) held its annual Track and Trace Technology Seminar on November 12 – 14, 2012, designed to address drug pedigree and track and trace requirements being developed in the United States and to explore how stakeholders will play a role---and what those roles may be---going forward.  Perhaps most interesting at the conference was the seemingly unanimous support from industry for the implementation of a national pedigree program in some form.  What follows below are some of the highlights of the conference speakers. . . ."

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In case you're interested:
The CA Board of Pharmacy announced that its Licensing Committee Meeting meeting will be combined with its Board meeting in which regulations for e-Pedigree will be discussed. The meeting is scheduled for December 13, 2012. For a complete list of meetings please go to: http://www.pharmacy.ca.gov/about/meetings.shtml

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TrackBack URL for the referenced article:
http://www.typepad.com/services/trackback/6a00d8341d150c53ef017ee557842d970d

Friday, November 16, 2012

Florida Compounder Tied to Tainted Eye Meds - Sight Lost

Compounder Tied to Tainted Eye Meds, Lost Sight:

"Cultures for 10 patients came up positive for Streptococcus mitis or oralis, matching the strains in seven unused syringes prepared during the same time by the compounder.

An FDA investigation of the company revealed insufficient testing and monitoring of equipment, dirty lab equipment, a failure to maintain sterilization tools, and a leaking boiler near the clean room."

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ASHP's Sterile Compounding Checklist

Updated June 2, 2016:

The link in the original post below is broken.  You might also be interested in:

ASHP - Sterile Compounding Resource Center

= = = original post below = = =

The American Society of Health-System Pharmacists (ASHP) just published this document:
     Eight Critical Steps Related to Sterile Compounding Services - Member Action Check List

In the checklist, ASHP says:
"ASHP strongly encourages you to review this list, even if your pharmacy department does not have a contract with an external compounding facility. This is important because off-site clinics or affiliated entities within your health system may have developed independent contracts that the pharmacy department was not involved in securing."

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Thursday, November 15, 2012

Pt & Disability Groups Support Bill to Begin Market Pricing System for HME in Medicare

Patient and Disability Groups Support Bill to Begin Market Pricing System for Home Medical Equipment in Medicare - PR Newswire - The Sacramento Bee:

"More than 30 patient advocacy and consumer groups endorsed a bill in Congress that would replace Medicare's current "competitive bidding" program for durable medical equipment with a better market pricing system that preserves access to homecare. Millions of Americans use medically required durable medical equipment and services at home, including oxygen therapy, wheelchairs, and hospital beds.

The bill, H.R. 6490, was introduced in the House of Representatives by a bipartisan group of lawmakers in September and has gained strong bipartisan support from several dozen members of Congress. The bill would replace the current, controversial bidding program with a more sustainable system, says the American Association for Homecare."

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Wednesday, November 14, 2012

California HMDR Law (Home Medical Device Retailer)

By the way, the FAQs are no longer available from the CDPH.

HMDR Law and FAQ:
"The Home Medical Device Retailer (HMDR) licensing program is administered as part of the Medical Device Safety and Youth Tobacco Enforcement Section and is governed by law sections found in the California Sherman Food, Drug and Cosmetic Law.  The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program.  This section of the Sherman Law can be found by following the link below.  It is in the Adobe PDF format so you will need an Adobe reader program to open and print the document."
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California HMDR Sherman Law Abstract (PDF)
(NB: on the date of this blog post, the PDF carried an effective date of January 1, 2016)

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Tuesday, November 13, 2012

The ASHP Compounding Resource Center

ASHP (The American Society of Health-System Pharmacists) has created a webpage full of compounding information. It includes current news, reference books, publications, and resources.

Compounding Resource Center:

"Welcome to the ASHP Compounding Resource Center, the first stop for ASHP information and resources on compounding standards and practices."

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Monday, November 12, 2012

CA Board of Pharmacy - Track your license expiration date & renew on time

Track your license expiration date, so that you can renew on time. This is important, just in case you don't get the automatically generated renewal notice.

Don't get caught scrambling!  Make sure you start the renewal process no later than 4 weeks before your license expires.

CA Board of Pharmacy:
"I did not receive my renewal notice and my license is coming up for renewal. What do I do? 
Approximately six weeks before the expiration date of your license, a renewal application will be mailed to your last known address of record. Licensees are responsible for renewing their licenses even if they do not receive a renewal notice. The board does not send duplicate renewal applications.   
If you have not received the renewal notice within 4 weeks of expiration of the license, you may renew your license by submitting a Request for Renewal form. Do not submit a renewal request more than 60 days before the expiration date of the license. 
A renewal request form may be viewed and printed by clicking on the appropriate license type below: . . . "
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Thursday, November 8, 2012

Fungal Meningitis Outbreak - State Pharmacy Chief Fired

More die in fungal meningitis outbreak; state pharmacy chief fired - Vitals:

"Massachusetts officials have fired the director of the state’s pharmacy board and suspended its attorney for failing to alert them that the company at the center of an outbreak of fungal meningitis was making and distributing drugs in mass quantities even though it wasn’t licensed to do so, the Boston Globe reported Wednesday.

Federal health officials say the outbreak of fungal meningitis traced to contaminated pain injections from the pharmacy has killed 31 people. They said 424 people have been confirmed sick in 19 states, including 10 who don’t have meningitis but who have infections in the ankle, shoulder or other joints."

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