Tuesday, December 28, 2010

Tuesday, December 7, 2010

Tuesday, November 30, 2010

News On FDA Home Use Device Initiative

Updated May 12, 2016

You might be interested in:
FDA Home Use Devices Initiative Webpage

- - - original post below - - -

The FDAnews reports, "The FDA may suggest devicemakers create different written instructions for the patient, prescriber of the device and the person training the consumer on how to use the device, Mary Weick-Brady, a senior policy analyst at CDRH, said."

New sets of instructions for patient, prescriber, and trainer will have ramifications for home care providers.

Learn more about the FDA Home Use Device Initiative:
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Tuesday, November 16, 2010

Hiring Felons As Senior Care Providers



According to KGO-TV's Michael Finney, "An alarming number of senior care providers in people's homes have felony convictions."

His news report is important for the following highlights:
  • Background checks conducted by the state under a new law passed last year have found nearly 1,000 convicted felons working or seeking jobs as caretakers for seniors and disabled in California.
  • Anybody can go out and call themselves a home care worker, put an ad in the paper, and they're not required to have a criminal background check, 
  • In 2008, the Legislature passed a law that provides at least some protection, but little is done to enforce it.  
Source:
Felony rates for home care providers alarming

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Tuesday, October 12, 2010

HMDR Inspectors Asking About Refresher Training

Don't forget about keeping up-to-date. Refresher training is a recommended best practice to keep current.

This might sound obvious, but stop and think about it. If you're already recognized by the Board of Pharmacy or the Department of Health Services as a Designated Representative, or Exemptee, respectively, when was the last time you took a refresher training course?

Rules and regulations can change over time, and it's easy to forget things over time. Additionally, it's been heard on the street that some inspectors are asking about evidence of refresher training.

Isn't it time you get refreshed every couple of years?

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Tuesday, September 28, 2010

FDA - Medical Devices and Disaster Preparedness

Whether it's a hurricane, gas main explosion, or something else, it's important to be thinking about how it'll affect one's use of a medical device in the setting of a disaster, according to FDA Offers Tips about Medical Devices and Hurricane Disasters.

The recent devastating gas main explosion in San Bruno, CA, just 20 minutes by car from where I live, highlights the need for preparedness.

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Tuesday, September 14, 2010

HMDR - Home Medical Device Retailer License Applications

According to the California Department of Public Health (CDPH), the California Home Medical Device Retailer (HMDR) License Applications page:
"links to the current application forms for both the firm license application needed by each individual facility location where home medical devices (prescription Rx devices and non prescription devices) will be sold, leased or rented when ordered by a physician or other prescriber. The application for the HMDR exemptee is also linked here for firms who wish to sell prescription Rx devices such as respiratory equipment, medical oxygen and other equipment identified as dangerous or legend devices under California law."

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Tuesday, August 31, 2010

CA Pharmacy - Wholesaler Surety Bond Info

According to the California Board of Pharmacy - Instructions for Filing a Nonresident Wholesaler Application webpage, in addition to addressing other requirements, an application for a nonresident wholesaler must also include a surety bond or other equivalent means of security.

Here's how to find the forms and more information about surety bonds. I haven't provided the pdf links because it's important to me that you access the most current forms and information available. Therefore, it's best to follow this clickpath:  
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Tuesday, August 17, 2010

CA Pharmacy Designated Representative - Contact Information

Here's the contact information that appears on the California State Board of Pharmacy Designated Representative Requirements and Application Form:
California State Board of Pharmacy
1625 N. Market Blvd, Suite N219, Sacramento, CA 95834
Phone (916) 574-7900
Fax (916) 574-8618
http://www.pharmacy.ca.gov/

Source:  Form 17M-27 (Rev. 1.10)
 
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Tuesday, August 3, 2010

Licensure Standards for Medical-Surgical Products Distributors - from HIDA

Updated 6/29/2015:

The original post below is out of date with broken links.

You might also be interested in:  HIDA Licensure Resource Center

= = = original post follows = = =

I stumbled across this resource the other day and hope you can make use of it, Licensure Standards for Medical-Surgical Products Distributors.

It's intended to provide licensure information to single-state and multi-state distributors.

For more information:
Health Industry Distributors Association (HIDA)

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Wednesday, July 21, 2010

Group Letter - Repeal Medicare Competitive Bidding for HME and Services

Thought you'd be interested in this Medical News Today article, Nearly 60 Homecare And Patient Advocacy Groups Urge Congress To Repeal Medicare's "Competitive" Bidding For Home Medical Equipment And Services.

Tyler J. Wilson, president of the American Association for Homecare in the open letter to Congress says:
"Our national, state and local organizations believe that this program is fundamentally flawed and will create significant obstacles to patient care while threatening the homecare infrastructure for our nation's seniors and disabled."

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Monday, July 19, 2010

FDA Orders Baxter Colleague Pump Refunds and Replacements

The FDA Issues Requirements for Baxter Healthcare Infusion Pump Recall - Company must provide transition guide for facilities using Colleague infusion pumps.
 
In brief, in a Colleague Pump - Consent Decree letter to two Baxter executives, the FDA orders Baxter to take the following actions:

  • Recall and destroy all Colleague infusion pumps covered by the Consent Decree that are manufactured, distributed, or sold by Baxter or that are under the custody and control of Baxter's agents, distributors, or customers from the US market..
  • Provide either a replacement infusion pump (other than the Colleague model) or refund to all owners, and a lease termination to all lessees, of Colleague infusion pumps no later than the date that is twenty four months after the date of this final order (“the transition period”).
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Wednesday, July 14, 2010

How To Renew Your CA Pharmacy Designated Representative License

According to the CA Board of Pharmacy:

"Approximately 6 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." (Source: Information for Licensees)
In case you need the Request for Renewal form, go here, to License Renewal, to find the link to the most current version of the Request for Renewal of Designated Representative form.

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Wednesday, June 23, 2010

Distributors - Avoid DEA License Suspension

Operation Mallorca, U.S. Drug Enforcement Admi...Image via Wikipedia
Michigan Pharmaceutical Supplier’s DEA License Suspended - Harvard Drug Group, LLC distributed 13 million doses of Oxy from 2008-2010 is yet another warning shot to pharmaceutical distributors.

Adam Fein says "the DEA seems intent on holding drug wholesalers accountable for diversion of controlled substances by the wholesaler’s pharmacy customers." (The DEA Nabs Another Wholesaler)

Robert L. Corso, Special Agent in Charge of the Detroit Field Division, Drug Enforcement Administration (DEA), states in the DEA news release:
"Pharmaceutical companies have a responsibility to ensure that the drugs they sell don’t end up in the hands of drug traffickers or businesses that are conducting their business illegally. Harvard Drug Group, LLC, should have known, based on the large, frequent quantities, that their customers were diverting oxycodone into arenas that were not legitimate. Today’s action sends the message that the DEA is working hard to hold accountable those companies that are operating in a manner outside of federal law."
Be forewarned.

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Tuesday, June 8, 2010

Designated Representative Violations

The alcohol can fall down to anyoneImage via Wikipedia
The California Board of Pharmacy files cases against designated representatives where the violation(s) involve significant misconduct on the part of the licensee. The board believes that revocation is typically the appropriate penalty when grounds for discipline are found to exist. Grounds for discipline include, but are not limited to, the following violation(s) of law(s) involving:
  • Possession of dangerous drugs and/or controlled substances
  • Use of dangerous drugs and/or controlled substances
  • Possession for sale of dangerous drugs and/or controlled substances
  • Personal misuse of drugs or alcohol
If revocation is not imposed, the board recommends a minimum Category III level of discipline be imposed on the designated representative. This would include suspension and probation.
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Tuesday, May 25, 2010

Common HMDR Renewal Inspection Violations

California HMDR renewal inspections can take place annually, unannounced, at any HMDR facility during normal business hours. A customer complaint or other referral may trigger an inspection.

Common violations reported include:
  • Dispensing legend devices without a valid HMDR exemptee on premise
  • Lack of dispensing records for legend devices
  • Inadequate procedures for the cleaning and repair of rental devices
  • Inadequate staff training or patient/caregiver consultation
  • Inadequate record of complaints or review of customer complaints to prevent reoccurrence
Source:   California HMDR FAQ Listing (PDF)

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Tuesday, May 18, 2010

Proposed CA Budget Cut To In Home Care

Kaiser Health News reports, Schwarzenegger Budget Proposal Cuts In-Home Care.

In summary:
Schwarzenegger proposed ending the entire state welfare program along with most state-subsidized child care, cutting mental health services by 60 percent and considerably slashing in-home care services for elderly, sick and disabled people.
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Tuesday, May 11, 2010

CA Designated Representative - Qualification Requires 1 Year Experience

Applicants often have questions about the work experience requirement. Bottomline, the requirement is non-negotiable, you either have the required work experience or you're not eligible.

I've reproduced the requirements for your reference:

CA DESIGNATED REPRESENTATIVE CERTIFICATION REQUIREMENTS


An individual applying to become a designated representative shall meet the following requirements:
- Be a high school graduate or possess a general education development equivalent
- Have a minimum of one year of paid work experience related to the distribution or dispensing of dangerous drugs or dangerous devices or meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board, and
- Complete a training program that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of California and federal law relating to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of California and federal law relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology, abbreviations, dosages and format.

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Friday, May 7, 2010

FDA Orders Recall and Destruction of Baxter Colleague Infusion Pumps

Updated August 25, 2016:

You might also be interested in this FDA communication:
Syringe Pump Problems with Fluid Flow Continuity at Low Infusion Rates Can Result in Serious Clinical Consequences: FDA Safety Communication

- -  original post follows below  - -

Uh-oh. The FDA believes there may be as many as 200,000 of these pumps currently in use. And they want them recalled and destroyed, as announced in FDA Issues Statement on Baxter’s Recall of Colleague Infusion Pumps.

The FDA has been working with Baxter since 1999 to correct numerous device flaws. Since then, Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors, and other issues. In June 2006, the FDA obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the Colleague pump until the company corrected manufacturing deficiencies and until devices in use were brought into compliance. Since then, Baxter has made numerous changes to the Colleague pumps but these changes have not corrected the product defect leading to the permanent injunction.

If you have questions about what this might mean for you, then read this, FDA - Questions and Answers About the Baxter Colleague Recall, Refund, and Replacement Action.

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Tuesday, May 4, 2010

FDA Wants Infusion Pump Risk Reduction

The U.S. Food and Drug Administration (FDA) announced a new initiative to address safety problems associated with external infusion pumps, which are devices that deliver fluids, including nutrients and medications, into a patient’s body in a controlled manner.

As part of its initiative, FDA is moving to establish additional premarket requirements for infusion pumps, in part through issuance today of a new draft guidance and letter to infusion pump manufacturers. FDA is also announcing a May public workshop on infusion pump design, and launching a new Web page devoted to infusion pump safety, FDA - Infusion Pumps.

Although this is directed toward manufacturers, it's probably a good idea for everybody using pumps to follow what emerges from this initiative.

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Saturday, May 1, 2010

FDA Urges Companies To Prevent Cargo Thefts

According to this blog post, the FDA wants companies to review their security practices to prevent "cargo theft" from warehouses and tractor trailers, FDA Wants Companies To Prevent Cargo Theft.

This should be of some interest to wholesalers handling a variety of FDA-regulated products such as prescription or over-the-counter medicines, medical devices, or infant formula.

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Tuesday, April 20, 2010

Sherman Law Amendment Spawned HMDR Licensing

According to the California Department of Public Health:
"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 (January 1, 2008 Edition). The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program."

Tuesday, March 16, 2010

FDA Warning - DST Might Create Problems For Medical Equipment

When I went to work yesterday, under Daylight Savings Time, my meeting times for recurring meeting times in a popular web meeting software application were inconsistently wrong. Now apply the time change problem to medical devices.

The FDA advises in, Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way:

"If you have any medical equipment that uses, creates or records time information about your diagnosis or treatment and the manufacturer has not updated it, the equipment may not work properly when Daylight Saving Time (DST) starts and ends."
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Tuesday, February 2, 2010

It Is Up To You - To Renew Your Designated Representative License

see filenameImage via Wikipedia
The CA Board of Pharmacy will mail you a renewal application to your last known address of record, six (6) weeks before your Designated Representative license expires.

If for some reason you don't receive the renewal application, you're still responsible for renewing on time. Here's how, according to the Board:
"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."
Download the Request for Renewal of Designated Representative form

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Tuesday, January 12, 2010

CA Board of Pharmacy - Designated Representative Search Tool

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Nice little search tool, compliments of the California Board of Pharmacy, License Search for Designated Representative (Exemptees).

Enter some basic information about a person or licensee, and you can see the status of their designated representative license.

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