IN THIS ISSUE
Don't Touch! Hand Hygiene for Sterile Compounding
Guidelines on Outsourcing Compounding Services
Ask William!
About Hartley Medical





View this video to see Hartley Medical's state-of-the-art compounding facility located in Long Beach, CA.


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Hartley Medical - William's Notations on Aseptic Technique.mp4
Click on the video above to find out how Hartley Medical's staff undergo rigorous training to prevent potential contamination in compounded sterile products. 

      

IN THE NEWS!

Reject Costly Pain-Management Bill

Health care in the United States is rapidly evolving in a way that has nothing to do with the Affordable Care Act. As patients have grown increasingly concerned about having access to safe, cost-effective health care provided by qualified professionals, they have become increasingly comfortable with the wide variety of credentials qualified professionals may have behind their names. Tennesseans are no different.

 

And yet, a bill proposed in the Tennessee legislature (SB 1935/HB 1896) would actually prevent many Tennesseans from having access to safe, cost-effective pain management services provided by qualified health-care professionals, namely certified registered nurse anesthetists (CRNAs). How? By requiring a limited group of physicians to provide on-site supervision of pain-management services, a burdensome, expensive and unmanageable restriction that could shut down pain management services in many facilities across the state, especially those in rural and other medically underserved areas

 

Click here  to read the full article.

LAL Testing for Bacterial Endotoxins




Click the video above to see how the horse shoe crab is used in the detection of bacterial endotoxins, as well as the technology and procedures that Hartley Medical employs to detect these pyrogens in compounded sterile products.

 

MARK YOUR CALENDARS

DON'T FORGET . . .
 

The 2nd Annual
Targeted Drug Delivery Meeting
presented by

Neurovations

 

May 4-6, 2012 

at the InterContinental Mark Hopkins Hotel. in San Francisco, CA.

   

 For more information, or to register for this event, click here .

 


 

IN THE NEWS

Mesothelioma Study Reveals Need to Step Up Pain Control

Healthcare providers should make pain control a higher priority for their patients with mesothelioma and other lung-related cancers.
 

That is the message of a recent University of Pennsylvania study on pain management.  The study gathered information on pain and pain control from patients with mesothelioma or lung cancer between 2005 and 2008. Participants were asked to fill out an Internet-based questionnaire that included 22 questions designed to assess their symptoms, evaluate their pain, and appraise their attitudes toward pain medication.

 

Of the ninety people who filled out the survey, nine percent had mesothelioma, a rare cancer of the lining of the chest or abdominal cavity.  The other 91 percent had either small-cell or non-small-cell lung cancer. Most were men and 89 percent were Caucasian.  Almost half of the survey respondents had undergone surgery for their mesothelioma or lung cancer, 58 percent were treated with chemotherapy and 44 percent had had radiotherapy.


Click here to read the full article.

Don't Touch!  

Hand Hygiene for Sterile Compounding 

 

Recently released in the Infectious Disease Special Edition (March 2012 Issue) is an article entitled, "Hand and Glove Hygiene: Keys to Safe Compounding." This article discusses the importance of establishing and adhering to strict cleaning and quality assurance policies and procedures to assure patient safety.

 

In the 2011 Midyear Clinical Meeting of the American Society of Health-System Pharmacists (ASHP), a group of pharmacists from New York City presented their findings on a 100-participant study on hand washing and glove sterilization processes used by pharmacists compounding drugs in IV admixture clean rooms.

 

According to Vickie L. Powell, MS, RPh, FASHP, co-author of the study and pharmacy director of one of the sites in the study, "Potential risk of transmission from the staff who are making sterile products for patients can happen in many ways, such as not washing your hands, then touching the wrong thing and then touching the compound you're making. You can contribute to infection risk. Numerous organisms can grow and potentially be transmitted."

 

This study initially found that only 30% of the participating staff had no colony-forming units of microorganisms growing on their gloved fingertips before beginning to compound. This high percentage of contamination demonstrated inadequate compliance with USP 797 guidelines.

 

Since the study's inception in 2010, on average, 95% of staff have been free of microbial growth. This came from a necessary change in policies to strict adherence to USP 797. Ongoing monthly maintenance programs, coupled with required re-education and training on proper procedures for non-compliant staff, facilitated this effort.

 

The study concluded that strict adherence to proper hand washing and sterile compounding procedures decreases microbial growth and virtually eliminates the risk for nosocomial infections from compounded admixtures. Hartley Medical agrees.

 

In fact, Hartley Medical has been adhering to both USP 797 guidelines, as well as to rigorous internal policies and procedures for safe sterile compounding, for many years now. Staff members are not permitted into the clean room without being appropriately gowned and their hands properly sanitized. All staff undergo annual re-certifications, and our robust quality assurance and environmental monitoring programs encompass both weekly and monthly assessments, including: fingertip assessment for sterile

Fingertip Assessment
Fingertip Assessment
compounding staff, active air sampling for microbial content, surface microbial testing, in-house HPLC quantitative analysis potency testing, and sterility and endotoxin testing per USP. Hartley Medical dedicates more than $100,000 annually to quality assurance testing.

 

But as important as adhering to USP 797 is, Hartley Medical believes it is imperative to take safety even further. The best sterile compounding pharmacies are those that meet the compounded pharmaceutical industry's highest quality and safety standards. These pharmacies, like Hartley Medical, are also PCAB-Accredited.

 

Hartley Medical is Setting the StandardTM nationally for quality and safety. We are dedicated to protecting our patients by practicing safe, high-quality compounding.

 

IN THE NEWS!

Congressional Testimony Reinforces the Mission of PAINWeek

Congress addresses how U.S. healthcare providers have been inadequately educated to properly assess, diagnose, and manage chronic pain. Preparing frontline practitioners to provide more effective pain management is the overarching mission of PAINWeek, now the largest national conference on pain.

 

Montclair, NJ (PRWEB) February 18, 2012

Expert testimony heard this week during the first congressional hearing ever held on chronic pain and pain management reaffirms the importance of PAINWeek in addressing this critical public health concern.

 

Sen. Tom Harkin (D-Iowa) chaired the meeting of the Senate Committee on Health, Education, Labor & Pensions to draw attention to what he called an "epidemic" of chronic pain. Harkin stated his belief that the nation's doctors are being poorly prepared to deal with the challenges of treating chronic pain, and asked "How do we educate our doctors to understand this and make the right kind of diagnosis?"

 

  To read the full article, click here

Are Stability Labels Outdated?  

WILLIAM'S NOTATIONS ON USE DATING  

 

I would like to open up this topic for discussion. I recently read an article entitled, "Pharmacy Professionals Believe CMS Rules Contribute to Drug Shortages." This article, authored by Jamie Oh, states:

 

"Almost all surveyed pharmacy professionals believe outdated federal mandates requiring adherence to drug labels and expiration dates contribute to the national drug shortage, according to an American Medical News report."

 

The Institute for Safe Medication Practices (ISMP) surveyed 715 hospital-based pharmacists and pharmacy managers where 96 percent of respondents consider a CMS mandate to follow FDA-approved drug labels and expiration dates a contributor to the drug shortages. According to the report, respondents believe that some drugs may have a longer shelf life - demonstrated through medical research.

 

The article cited the example of neuromuscular blocker drug succinylcholine that is labeled as "stable" for 14 days at room temperature. However, research reveals the drug may be stable for 30 days at room temperature, and its shelf life extends as room temperature drops. More than 1/3 of respondents claim that adhering to FDA labeling often results in wasted drugs, while another 43 percent believe that following labels always results in wasted drugs.

  

I posted this same discussion on LinkedIn a few weeks back, and I received mixed responses on the topic. A pain relief specialist from the UK stated:

 

"Drugs are wasted most of the time as they not only do not produce the cure, but also cause so many misunderstood or so called side-effects. ... We may consider drug shortages are because of the economic downturn and the drug companies' instructions from shareholders to cut back to pave the way for dividends."

 

A Florida MD added:

 

"I know for a fact that many of the expired drugs end up in Latin America when missions are organized to go there by some US medical schools."

 

I have performed numerous stability tests with compounded sterile pharmaceuticals to investigate use dates, and I have found many drugs to be within USP specifications well beyond the labeled use date. I am simply stating that I have performed critical analyses regarding this topic and found several labeled expiration dates to be premature; by no means am I saying that beyond-date drugs should be used for patients.

 

Do I believe that outdated federal mandates contribute to the drug shortage crisis? I don't know. I have done a lot research into the drug shortages, and most signs point to delays in new and existing manufacturing facility applications, plant shutdowns due to quality assurance issues and outdated manufacturing technologies, and stringent government price controls for generic drugs. Are there other contributing factors, such as the economic downturn and shareholder cutbacks? Possibly, but my research has not confirmed this.

 

Patient safety is at the forefront of all medical professionals' minds. Therefore, we would never provide patients with drugs that could be harmful or life-threatening. But if science has proven that drugs are stable beyond current federal mandates, and if we trust utilizing expired drugs for patients of countries lacking proper medical regulation as suggested by the Florida MD, then should we consider the possibility of extending certain drug use dates if there is sound research supporting such a move? If this could decrease drug waste and somewhat alleviate shortage problems, might it be a win-win?

 

I would be interested in hearing your comments on both use dating and the drug shortage dilemma. Please write to [email protected].  

 

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Article Source: http://www.beckershospitalreview.com/quality/pharmacy professionals-believe-cms-rules-contribute-to-drug shortages...  




Watch as a qualified and skilled Hartley Medical staff member walks you through the steps for compounding topical cream products for pain management.
Watch as a qualified and skilled Hartley Medical staff member walks you through the steps for compounding topical cream products for pain management.

Guidelines on Outsourcing Compounding Services

 

In light of the recent drug shortage crisis plaguing the medical world, many hospitals, physicians, and traditional pharmacies (both in and out of hospital settings) are outsourcing to compounding pharmacies. It is evident that compounding pharmacies can help alleviate the current problem ... but it is important to note that selecting just any compounding pharmacy will not suffice.

 

"Properly trained and equipped compounding pharmacies can provide physicians and patients access to these much-needed medications. Often times, compounding pharmacies are able to still acquire the active ingredients of the discontinued or backordered medications. It is, however, important to select the proper compounding pharmacy. A compounding pharmacy accredited by PCAB (Pharmacy Compounding Accreditation Board) is often the best choice." [1] 

- MDNews.com, March 30th 2012

 

Hartley Medical is a PCAB-Accredited pharmacy headquartered in Long Beach, CA. We currently provide drug shortage services to a number of physicians and organizations - but our experience teaches us that health systems can benefit from utilizing compounding pharmacies' services beyond solely emergency situations.

 

According to the American Society of Health-System Pharmacists' (ASHP) Guidelines on Outsourcing Compounding Services [2], there are certain reasons to, and not to, outsource to compounding pharmacies; and only after a careful internal assessment of its needs and capabilities should a health system decide to outsource sterile compounding. Traditionally, however, health systems should outsource to compounding pharmacies to:

 

  • provide consistent pharmacy and sterile compounding services, including documented beyond-use dating;
  • resolve operational inefficiencies in areas such as batch compounding, or to ease consolidation of pharmaceutical services during high-demand periods;
  • allow their systems to reach optimal staffing levels to achieve productivity targets;
  • minimize the cost of facility remodeling to meet USP 797 requirements;
  • control or reduce the cost of the organization's services by shifting costs associated with IV admixture production from fixed to variable;
  • and to reduce and/or control labor costs by shifting responsibility for employees, benefits, and liabilities to a compounding pharmacy.

 

As with the drug shortage dilemma, it is important to select the proper compounding pharmacy because all compounding pharmacies are not the same. It is no longer sufficient for pharmacies simply to meet standards; they must exceed standards.

 

According to ASHP, compounding pharmacies should allow an organization's representatives to visit their compounding facilities. 

 

"The compounding pharmacy should provide ample opportunity for the organization's representatives to confer with the compounding pharmacy's corporate, pharmacy, and compounding staff."            

- ASHP, Jan. 14th, 2010

 

Listen to William's notations regarding FAQs when researching a sterile compounding pharmacy.
Listen to William's notations regarding FAQs when researching a sterile compounding pharmacy.
Hartley Medical agrees. We continually ask physicians and organizations, "Do you know what your compounding pharmacy is doing?" That answer should always be, "yes." This is why we encourage
all individuals and health systems who utilize, or are interested in utilizing, our services to perform a site visit. Please visit our facilities.

 

We operate at the highest of quality standards and exceed USP 797 guidelines on a daily basis. Our door is always open.

 

We urge you to fully read ASHP's Guidelines on Outsourcing Compounding Services.

 

Or read 4 Steps to Choosing the Right Compounding Pharmacy - William's notations on choosing the right compounding pharmacy.



[1] http://www.mdnews.com/news/2012_03/05731_marapr2012_drug-shortages-compromise 

[2] http://www.ashp.org/doclibrary/bestpractices/mgmtgdloutsourcingsterilecomp.aspx 

 

 

MARK YOUR CALENDARS

DON'T FORGET . . .
 

The 14th Annual Meeting
for the 

American Society of Interventional Pain Physicians (ASIPP)

 

June 9-10, 2012 

at the Crystal Gateway Marriott in Arlington, VA.

   

 For more information, or to register for this event, click here .

 


 
Ask William!
man and syringe

 

Do you have questions for William? Send them to:

[email protected]

You will receive a personal e-mail response addressing your question; which could be featured in Hartley Medical's next edition of The Hartley Standard*.

*If you would like to opt out of having your question published, simply state that in your e-mail! You will still receive a personal response from William.

About Hartley Medical

 

 

Hartley Medical is the nation's leading provider of the highest quality sterile pharmaceuticals for intra-spinal, infusion therapy patients. Our world-class pharmacy is exclusively dedicated to the custom compounding of medications for the treatment of pain and movement disorders.

 

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 at www.hartleymedical.com

Disclaimer. The information contained in this publication is provided "as is" and without warranty, expressed or implied.  Hartley Medical assumes no responsibility for any damages of any kind resulting from the procedures contained herein. 
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