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| IN THE NEWS | |
Medtronic Issues Clarifications on SynchroMed Infusion System Pocket Fill Recall
Medtronic has issued a statement clarifying the FDA announcement last week regarding Medtronic's SynchroMed Infusion System. The FDA considers changes to instructions used for physicians as a recall. This was the only change to the pocket fill system instructions to physicians.
Medtronic states that
This is not related to faulty or malfunctioning pumps or refill kitsSynchroMed Pumps and refill kits are not being removed from the market.Neither Medtronic nor the FDA is recommending surgical removal of the SynchroMed pump.
A "pocket fill" is the inadvertent injection of medication into the pump pocket, the area under the skin where the pump is placed, instead of in the pump. Medtronic sent a letter to physicians in January that describes the information and provides recommendations regarding the refill procedure and patient management.
Read Medtronic's letter HERE.
Medtronic Recall Clarification |
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NEUROVATION, INNOVATION AND EXCELLENCE . . . BE THERE!
I will be attending a very unique conference in San Francisco in April. Dr Eric Grigsby - President of Neurovations Clinical Research and Education and Medical Director of the Napa Pain Institute - and a targeted group of clinical and theoretical experts will address the focal topic of "Targeted Drug Delivery for Pain and Neurologic Disease" for clinicians, scientists and drug and device industry executives.
Held at the Mark Hopkins Hotel from April 29 through May 1, the conference will include specific discussions on new information regarding receptors within the intraspinal space; development of new pharmacological agents to be delivered directly to a neurologic target and the devices to deliver them; and the exploration of alternative considerations for the intraspinal treatment of various ailments, including Neuropathic Pain, Spasticity, Epilepsy, Alzheimer's Disease, Parkinsonism, Neuro-Oncology, Mood and Affective Disorders.
I have seen the results of numerous studies on intraspinal administration of pharmaceuticals (both clinical and animal testing), read a lot of drug studies and doctor and clinician accounts across the U.S. and internationally - all proposing unique pharmacological agents for intraspinal administration.
Given the fact that from a technical standpoint, we still really don't know completely how the neuronal receptors that are part of the spinal cord work, I am anxious to attend this cutting edge, truly innovative conference.
In the search for new or unexpected drugs that will have some benefit in treating a long list of conditions, these professionals are leading the way.
John Forsayeth, PhD Professor of Neurosurgery University of California at San Francisco
Mr. Tom Tefft President, Medtronic Neurological Minneapolis, Minnesota
Robert Levy, MD, PhD Professor of Neurosurgery Northwestern University Chicago, Illinois Editor in Chief, Neuromodulation
Krys Bankiewicz, MD, PhD Kinetics Foundation Chair in Translational Research Professor of Neurological Surgery UCSF San Francisco, California
Mr. Mir Imran Managing Director, InCube Ventures Chairman, InCube Labs LLC
Dan Abrams, MD President ICVrx, LLC 12635 East Montview Blvd Aurora, CO 80045
Michael Saulino, MD, PhD Moss Rehabilitation Philadelphia, Pennsylvania Assistant Professor Jefferson Medical College
Eric Milligan, PhD Assistant Professor, Department of Neuroscience University of New Mexico
Hope to see you there!
For more information or to register, contact Samantha Ryan: sam@neurovations.com, 707.252.9656.
Not able to attend the San Francisco Conference? You might want to consider another worthwhile venue on the same weekend - Dr. Lisa Stearn's Cancer Pain Conference April 29 through May 1 in Scottsdale, AZ. The speakers - including Dr. Alan Burton from the University of Texas and Anderson Cancer Center, and Dr. Mark Huntoon Chairman of the Pain Medicine Division at the Mayo Clinic, and a host of prominent clinicians and neuro-endocrinologists -- will be addressing issues involved in the treatment of individual cancer patients.
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MARK YOUR CALENDARS
Please plan to join us for the 18th Annual Napa Pain Conference, September 16th - 18th, 2011 at the Meritage Resort, Napa, CA.
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ENVIRONMENTAL MONITORING
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A very significant and important aspect of Hartley Medical's operation is our dedication to environmental monitoring. Much energy and expense has been devoted to this area because we consider it to be absolutely essential to the production of sterile compounded pharmaceuticals of the highest quality and standard.
When we began our push toward optimum environmental monitoring back in 2000, we had a plan - granted, at that time, a rudimentary one. Actually, it was considered advanced at the time for an organization to be seeking to so painstakingly assess particulates and bacteria. In the not-so-recent past, standard requirements dictated testing once or twice a year for particulates, annually for bacteria.
Interesting sidelight: prior to the time that this requirement was declared, the requirement had been "once a month" and apparently was considered too stringent by the rank and file. A serious step backward in our estimation. Early on, I saw this as an area upon which we could and would necessarily improve - and develop as a point of differentiation between Hartley and all the other pharmacies - to more effectively manage and optimize our air quality conditions and meet our own exacting standards.
We chose to go weekly. We needed the staff to make it happen. As discussed in previous newsletters, we had various part-time to full time employees on staff at the outset and dedicated to environmental monitoring. We needed the equipment, and so we acquired it to eliminate the need to outsource.
Our plan was sound. We had the staff, we had the equipment and we made it happen. At that point the question became "Can we do more?"
The answer was "Yes." At present, we successfully implement and support a 20-point sampling plan - a statistically relevant sampling plan that substantiates all that we embrace in the interest of promoting your peace of mind, and ours: The Hartley Standard.
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ON THE ISSUE OF REIMBURSEMENT...
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In the interest of keeping you abreast of Hartley's involvement in reimbursement issues, we wanted you to know that we are working with the Neuromodulation Therapy Access Coalition (NTAC) and various stakeholders in the pain community to improve medical reimbursement for intrathecal drug therapies.
We committed to this effort back in 2003 and have been working with various medical directors and regional carriers since then. I have personally interacted with medical directors and the Director of NTAC in coordinating efforts to improve reimbursement - payment turnaround, remuneration, and reversing acquisition loss (in some cases) - for practitioners.
Those of you fortunate enough to have attended Dr. Lynn Webster's presentation - Economic Issues Relating to Intrathecal Pumps - at this year's NANS (North American Neuromodulation Society) meeting in Las Vegas, Nevada, can appreciate the importance of this issue. His revealing study demonstrated the cost-effectiveness of intrathecal therapies in the range of 7 - 9 months following initiation of therapy. This, in sharp contrast to traditional oral therapy tenets for treatment of chronic pain reveals that IT therapy can be less expensive than using oral medication.
The problem we're still working on: reimbursement based on drug invoice pricing does not provide payment for handling and acquisition. NTAC continues to work with multiple organizations to provide appropriate payment for all aspects of pump therapy . . . and we continue to conduct studies, review data and forward information to the decision makers and appropriate individuals involved with Medicare reimbursement.
We will continue to keep you informed of our progress.
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STANDARD BEARER
Nadia Hasbellaoui
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Originally from Algiers, Algeria, Nadia was an English teacher for 19 years in her native land before emigrating to the U.S. in 2004. Here she became certified in healthcare billing and coding and joined Hartley Medical in 2007 as a part-time customer service representative in nutrition and healthcare products.
Today she is our full-time Billing/Accounts Receivable Customer Service Representative and makes sure that all invoices are accurate, on-time and paid in full.
Nadia is highly detail-oriented, unshakably personable and a master at building and nurturing solid, lasting client relationships. She possesses that rare ability to be firm and professional without being confrontational. Most importantly, she cares.
"I love working with our clients - the interaction, the communication at a personal level . . . and I have always enjoyed working at Hartley Medical. It's like a big family here, and I find that to be of great value."
Thank you, Nadia for your caring, your professionalism and your future-building commitment to the enduring standard of excellence that is Hartley Medical.
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| ABOUT HARTLEY MEDICAL | | |
The national leader in intra-spinal therapy, Hartley Medical specializes in the compounding of quality sterile pharmaceuticals for infusion therapy clients throughout the United States.
Owned and directed by William A. Stuart, RPh, acknowledged pioneer in the field of pharmaceutical sterile compounding, Hartley- prior to its national expansion - established itself as one of the most successful and professionally distinguished pharmacies in the state of California.
We now serve over 400 leading pain physicians and premier health care institutions across the nation.
Visit our web site.
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Disclaimer. The information contained in this publication is provided "as is" and without warranty, express or implied. Hartley Medical assumes no responsibility for any damages of any kind resulting from the procedures contained herein.
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WWW.HARTLEYMEDICAL.COM
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