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IN THIS ISSUE
INTRA-THECAL PHARMACEUTICALS
PHARMACOLOGY REVIEW: CLONIDINE
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DID YOU KNOW...

The key element in Bacterial Endoxin Testing (BET) is a lysate (enzyme) known as LAL (Limulus Amebocyte Lysate). Derived from a five-million year old species of HORSESHOE CRAB [Limulus polyphemus] found only on the eastern seaboard of North America (along the various coastal bays of Massachusetts and Connecticut) and Japan, the lysate acts to clot and expel bacteria with which the horseshoe crab comes into contact. Want to know more? Read the blog.

SPEAKING OF STANDARDS

Mirian Lim is our Quality Control Technician.  She embodies the high standards that set Hartley apart from the rest of the field.

 

Born in Seoul, South Korea, Mirian emigrated to this country and earned her degree at UCLA in biochemistry. It is her career goal to become a pharmacist. Here at Hartley, she is responsible for performing qualitative assessment of our compounded products for endotoxins, augmenting our microbiological testing of sterile compounds and environment using on-site instruments and procedures.

 

Mirian is critical to our quality assurance program -- helpful in enabling us to examine stability studies, assess bioburdens and non-viable particulates. What's more, she is a technician capable of integrating HPLC (High Performance Liquid Chromatography) into our quantitative analysis of compounded preparations.

 

Perhaps most importantly, Mirian leads by example merely setting the standard, but opening the eyes of everyone at Hartley to the future, to possibility... to the more that can be done. Hartley is the national leader in the compounding of intra-thecal medications because of team members like Mirian.

 mirian

IN THE NEWS

Senate Passes Six-Month SGR Fix


WASHINGTON -- The U.S. Senate has passed a bill to push back the 21% cut for physicians who treat Medicare patients until Nov. 30.

The bill -- which also gives doctors a 2.2% increase in reimbursements -- was approved by voice vote Friday afternoon, on the same day that the Centers for Medicare and Medicaid Services (CMS) announced it would begin processing Medicare claims at the 21% lower rate. We are working with the regional carriers to enhance reimbursement for our clients and we shall keep you informed as to our progress. 

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 the one of the most successful and professionally distinguished pharmacy 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.

man and syringeWelcome

I'm honored to once again be a featured speaker at the 17th Annual Napa Pain Conference, August 13-15, at the Meritage Conference Center and Resort in Napa, California. 

 

My topic this year is Pharmacology. I will be discussing Drug Interactions, Compounded Agents Stability, Dosing and Utilization.

 

Dr. Eric Grigby's vision with the Napa Pain Conference has been to create an optimal learning environment where cutting edge clinical knowledge is exchanged in a warm and conducive environment.

 

The conference is an opportunity to interact with leaders in pain management and with over 200 healthcare providers expected to attend, and a faculty composed of internationally recognized leaders of the interventional pain management community, I am predicting a great turnout.  This conference also supports the HealthRoots Foundation and its mission of providing health care and community development in the country of Malawi. We hope you'll join us in Napa.

 

On the evening of Friday August 13th, Hartley Medical will sponsor a wine tasting with local vineyards presenting their latest creations. We will also be raffling off wine at our booth, so make sure you stop by. 

 

Click here for more about the conference. 

 
 

 All the best, 
 

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William A. Stuart, RPh

 

P.S.: We want to hear your comments and feedback.  Send us an e-mail and let us know what you think - and what you'd like to see in future issues.

ON THE SUBJECT OF INTRA-THECAL PHARMACEUTICALS

This month's topic is solubility and syringe composition limits - information which has proven of significant value in my personal consultations with physicians over many years.

 

Maximum Solubility of Common Intraspinal Drugs at Room Temperature (21° C):

 

Baclofen: 5.0 mg/ml

Bupivacaine HCL: 40.0 mg/ml

Clonidine HCL: 76.0 mg/ml

Fentanyl Citrate: 25.0 mg/ml

Hydromorphone HCL: 250.0 mg/ml

Morphine Sulf.: 64.5 mg/ml

Sufentanil Citrate: 25.0 mg/ml

 

As most of you out there are aware, the drugs noted above are maintained in the pump's reservoir at 37° C. Solubility of IT meds is affected by additional drugs contained within the mixture. 

 

OUR TAKE:  Poly pharmaceutical solutions will interact and thereby alter certain chemical states of the combined drugs. For that reason, we do not recommend maximizing the drug concentration when used in combination with other agents.

 

Obviously, the maximum concentrations of these pharmaceuticals exceed clinical applications. The chart below shows the lipid solubility and equal analgesic conversions when drug alternation is required.  Please keep in mind, this is a guide - and that thorough understanding of each drug is necessary prior to dosage change. 

 

Intra-thecal Analgesic Properties / Dosing Conversions

 

Opioid

Lipid Solubility

Equal Analgesic Conversion (mg)

Morphine

1

1

Hydromorphone

1.4

0.25

Fentanyl Cit.

580

0.01

Sufentanil Cit.

1270

0.001

 

Questions? Happy to address them. Just contact me at wstuart@hartleymedical.com or call our office at 562.595.7548.

Pharmacology Review: Clonidine

Synthesized in 1962 as a derivative of the known alpha sympathomimetic drug naphazoline, clonidine hydrochloride acts centrally to inhibit sympathetic tone on systemic blood vessels, thereby reducing mild to severe hypertension. Marketed under the brand name of Catapres, it is classified as an "alpha 2 adrenergic agonist for the treatment of high blood pressure."

Clonidine was recently discovered to have analgesic properties when administered intraspinally. Studied extensively for the treatment of pain, it has been recognized as a second-line drug  (Polyanalgesic Consensus Conference 2007) and is currently administered for the treatment of chronic and neuropathic pain.

Stability
Stability studies of long-term use of intrathecal clonidine have been documented as far back as the early 1990s. Stable in various concentrations with opioid analgesics (as well as anesthetics), Clonidine can be administered as a sole agent for the treatment of pain via an implantable infusion pump.

Dosing Considerations
Clonidine dosing should be based upon the patient's condition, pain level, age, weight, and pre-existing conditions. Therapy should be introduced slowly -- starting with initial doses of 50 to 100 micrograms per day. Discontinuing treatment should be approached cautiously, and a slow titration (to remove clonidine from intraspinal infusion) should also be performed. At the conclusion of therapy or after complete withdrawal, oral or topical treatment (for three to seven days) should be considered in interest of preventing adverse reactions.

Solubility & Side Effects

Clonidine has a solubility of 76.9 mg/ml at room temperature, (20ēC). Because clonidine hydrochloride is non-ionic in solution, it penetrates the brain to a much greater degree. This enables the drug to have a positive effect on tissues and receptors within the brain to relieve systemic vascular tone, thereby giving it anti-hypertensive properties. Side-effects associated with clonidine are hypotension, drowsiness and lethargy. [More info]

 
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WWW.HARTLEYMEDICAL.COM

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