Starting from the time I attended pharmacy school at the University of Arizona, I have been interested in sterile compounding. I was intrigued by this part of the medical world, and I knew this was the path I was destined to take. Over the years, the landscape of health care changed, and Hartley Medical changed along with it. We have constantly evolved to enhance our processes and technology to stay ahead of the game – continually increasing our dedication to patient safety and only the highest-quality products. What an adventure it has been.

Relive my and  Hartley Medical’s journey  by viewing this brief video on the History of Hartley Medical. Enjoy!

Did You Know that healthcare-associated infections (HAIs) account for an estimated two million infections and over 90,000 deaths annually? According to the article, “Spread the Word: Aseptic Technique Prevents Infection,” (http://www.clinicaliq.com/content/aseptic_technique.pdf) one way that pharmacists and technicians can impact HAI reductions is by using proper aseptic technique when preparing compounded sterile preparations.

Several non-surgical procedures require aseptic techniques in order to minimize the transmission of infectious agents. Those non-surgical procedures with the highest risk for causing infection include: the placement of medication or devices into sterile body spaces (i.e. IV lines and indwelling urinary catheters), wound care, and the insertion of intravenous or intramuscular injections of medication (especially from multi-dose vials). Many of these procedures are directly related to the use of sterile compounded medications. Therefore, when it comes to sterile compounding, safety is a never-ending concern. This is why a sterile compounding pharmacy must ALWAYS practice only the highest-quality aseptic techniques to minimize the chance of contamination. A well designed and executed aseptic process monitors and decreases both the risk of impurities within of the sterile preparation environment itself and potential threats due to personnel involvement.

One definition of aseptic technique is: a set of specific practices and procedures performed under carefully controlled conditions with the goal of minimizing contamination by pathogens.

The purpose of aseptic technique is to maximize and maintain asepsis – the absence of pathogenic organisms in the clinical environment. The goal of aseptic technique is to protect the patient from infection.

Aseptic technique training should be performed before permitting a staff member to compound sterile products. Here at Hartley Medical, all staff members directly involved with compounding are trained immediately upon hiring. This process consists of reading and comprehending Hartley Medical’s policies and procedures, review of USP 797 guidelines, intensive visual observation, and three media fill process Tests. Media fill process testing is conducted to get an adequate representation of sterile compounding. It consists of substituting the actual drug product with a microbiological growth medium (such as soybean-casein digest medium) to simulate admixture compounding. In addition to media fills, these staff members are required to compound three additional preparations that are then subjected to testing for bacteria, endotoxins, and quantitative analysis.

The entire aseptic technique training program here at Hartley Medical costs approximately $1500 per individual. Upon completion of this regimen, an employee involved with sterile compounding commences to the compounding of actual prescriptions. This system is employed to assure the proper training and maintenance of aseptic technique for the dispensing of quality medications.

Ronald Reagan stated on many occasions, “Trust but verify.”

To perform aseptic technique one must constantly assess the processes and verify finished preparations with testing. All sterile compounding staff are assessed monthly with media fill tests and random sampling to document accuracy and purity.

Though, the aseptic technique processes mentioned above are only a small fraction of the overall programs employed at Hartley Medical, this helps give an idea of the thought, training, design, practices, and assessments that go into developing the highest-quality sterile product. And here at Hartley Medical, we are Setting the Standard^TM.

Click on the image below to view William’s Notations on Aseptic Technique.

http://www.enotes.com/aseptic-technique-reference/aseptic-technique-171744

During the NANS meeting, a physician approached me to discuss the Polyanalgesic Consensus guidelines for intrathecal therapy treatments. His question was, “Who do they serve?”  He was concerned about his own treatment regimens, as he seemed to be outside the guidelines in some cases. I stated to him that the guidelines were being re-assessed, and there would be more to come for the 2011/2012 publication. I have been involved in some of the working documents of the new publication, and my advice was sought after regarding compounding pharmacy issues, as well as dosing.

A lot has changed over the years. In the past, clinicians were dosing at higher concentrations and higher daily doses, and these guidelines have been established, in part, to steer people toward more conservative measures to reduce adverse events and optimize patient care. Additionally, they are established to assist and aid individuals who are initially getting into intraspinal infusions. However, there are still situations where more experienced clinicians will treat patients outside those guidelines. The doctor expressed some concern, essentially asking, “Am I exposed?” or “Is there a problem with my treatment of my patients?” And I think all doctors, in all parameters, experience this.

The guidelines, in my opinion, are designed for those with less familiarity; but you have clinicians who have been in the practice for 25-30 years and understand the intrathecal space and the drugs involved for intraspinal infusion. The issue with the guidelines is that they are thinking on behalf of all practitioners.  Experienced practitioners have a proven track record, and there are exceptions to the guidelines that they fall outside of.

The doctor posed the question, “How hard and true are these?” I expressed to him that I don’t think they are hard and true, but rather to simply guide people. One shoe doesn’t fit all – nor does one guideline fit all practices. You have to be aware of the guidelines while simultaneously understanding your treatment programs.

The conversation continued with, “How do doctors decide on dosing?” It’s a consensus panel, and these individuals put forth their opinion based on what they are doing to treat patients, but they also understand that what they are stating is there to provide guidance.

During the conversation, we discussed trial dosing. We talked about the polyanalgesic panel meeting that I attended and how, for trial dosing, some panel members recommended a 24-hour hospitalization. However, other panel members said, “I do not always do this.” These members expressed that they are comfortable monitoring for a shorter period of time, then sending the patient home – and they have many years of experience with this. So, do they fall outside the guidelines?

These guidelines are conservative, but people with greater experience, those with some latitude in their practice, feel comfortable operating outside the guidelines. Is there a legal component to this? I do not know. This is a difficult conversation. I am trying to convey that these guidelines are good for everyone – both clinicians and patients – but what your practice is, what your experience has been, and what is best for the patient all must be taken into consideration.

I would like to end by referring to the movie Pirates of the Caribbean: The Black Pearl. In the movie, there is a scene where Keira Knightley’s character was abducted by pirates, and in order to be brought in front of the ship’s captain, Captain Barbosa, she used the pirate’s code-word “parlay.” After negotiating with the captain – who ultimately breaks his bargain with the young woman – she expresses that he is a pirate and must follow the pirate’s code. His response was, “The code is more what you’d call ‘guidelines’ than actual rules.”

Not too long ago, my wife and I took a vacation to Kiawah Island in South Carolina to celebrate her birthday. Early one morning we took a walk along the beach, and after a few hundred yards I came across numerous horseshoe crab exoskeletons lying in the sand. I immediately recognized the arthropod for its importance in pharmaceutical quality assurance; more specifically for the detection of endotoxins.

Bacterial endotoxins, often called pyrogens, are poisonous substances produced within living cells or organisms. These fever-producing materials most often originate from gram-negative bacterial cell walls, but can also originate as leachates from some chemicals and materials. In pharmaceutical production, especially sterile compounding, it is necessary to reduce traces of endotoxins in drug products as even small amounts will cause illness in humans.

According to USP 797 guidelines, “All high-risk level compounded sterile products (CSPs) … before they are sterilized shall be tested to ensure that they do not contain excessive bacterial endotoxins.”

Here at Hartley Medical, we allocate a substantial annual budget solely to quality assurance testing. We perform both sterility and endotoxin testing per USP requirements.

A very sensitive procedure for detecting the presence of endotoxins in drugs is the Limulus Amebocyte Lysate (LAL) test. The LAL assay utilizes the amoebocytes (blood cells) of a horseshoe crab. The lysate found in the blood binds with the dangerous endotoxins present creating a clot via a cascade of reactions; thus, forming the basis of their detection and quantification.

When it comes to LAL testing for bacterial endotoxins, there are three techniques: 1) the gel-clot technique, which is based on gel formation; 2) the turbidimetric technique, based on the development of turbidity after cleavage (the division or splitting of form) of an endogenous substrate; and 3) chromogenic technique, based on the development of color after cleavage of a synthetic peptide-chromogen complex.[1]

Hartley Medical began endotoxin testing in 1999 utilizing the gel-clot test. In 2003, we advanced our technology to test using the turbidimetric technique; a method we still use today. This is a photometric test to measure the increase in turbidity (the cloudiness or haziness of a fluid caused by individual particles that are generally invisible to the naked eye). More specifically, we utilize kinetic-turbidimetric testing, which measures both the time (onset time) needed for the reaction mixture to reach a predetermined absorbance, and the rate of turbidity development. In the presence of endotoxins, the lysate begins to gel – causing the solution to become turbid. Higher concentrations of endotoxins cause the increase in solution turbidity to occur faster than lower concentrations. A standard curve is always run with each test. The concentration of the unknown is extrapolated from the standard curve. The time required for the appearance of turbidity is inversely proportional to the amount of endotoxins present.[2]

It is fascinating to think of how intertwined nature and science are. Bacteria are everywhere. And, for the most part, bacteria are beneficial as they reduce organic waste and recycle nutrients back into the food chain. Sometimes, however, bacteria cause disease if they enter parts of our body that are usually bacteria-free, such as the bloodstream or the intra-spinal space– causing severe illness (such as sepsis) and/or death. Therefore, pharmaceutical companies, especially sterile compounding pharmacies, must take great care in producing drugs that are free of bacteria and non-pyrogenic. Hartley Medical recognizes the horseshoe crab’s contribution to the world of pain management; and we are happy to change and save lives.

Starting now, Hartley Medical is beginning to build an informational video library for you! These videos are, and will be, provided to you via YouTube (YouTube.com/HartleyMedical). We encourage you to take advantage of this source of sterile compounding information, as it is here for one purpose, and one purpose only – education. We want to provide you with top-quality resources to grow your knowledge of the field of intrathecal pain medications.

William Stuart, RPh – President and Owner of Hartley Medical – will be sharing his vast knowledge of the world of sterile compounding. There are, and will be, video demonstrations of certain processes, notations on various topics given by William himself, and video recaps of key conferences and events that Hartley Medical attends. Videos will be uploaded at random, and will remain on YouTube for you to access at your leisure. If you have a topic that you would like to hear William speak about, we urge you to e-mails us at questions@hartleymedical.com. We are here for you – utilize us!

Want to see a sample of these videos? Then click on the captions or images below to see video demonstrations of two Environmental Monitoring processes performed at Hartley Medical: Active Air Sampling, Microbial and Active Air Sampling, Particulates. Then, view William’s Notations on Environmental Monitoring by watching the third video provided.

Active Air Sampling, Microbial

Active Air Sampling, Particulates

William’s Notations on Environmental Monitoring

We encourage you to subscribe to our YouTube account to follow our videos, or become a Fan on Facebook to receive updates pertaining new video uploads.

Compounding pharmacies ARE regulated by state boards, but whether or not compounding pharmacies have to be in compliance with USP 797 guidelines is completely up to those individual states. This creates a quality assurance disparity from state-to-state. Therefore, the question of, “Is simply meeting requirements good enough?” must be asked. In the wake of the nine deaths that occurred nearly seven months ago in Alabama that were linked to contaminated admixtures, the answer to this question has to be, “no.”

If a compounding pharmacy is meeting all of the requirements set forth by its state, but is still experiencing contaminated admixtures, then there is a major problem … especially for you and your patients. You obviously do not want to run the risk of putting contaminated “sterile” medications into your patients. Therefore, you must find those pharmacies that are exceeding standards – or even setting standards of their own – by performing  at a level that is exceeding regulations in ALL states while simultaneously adhering to USP 797 standards; whether required or not.

In our past blog entry titled “4 Steps to Choosing the Right Compounding Pharmacy” (click here to read), I gave my recommendations for properly researching and selecting the right compounding pharmacy for your practice. In the article, I discuss the importance of doing a site visit – as you can directly see what goes on behind the scenes (and a pharmacy with nothing to hide should not deny this to you). Additionally, in Hartley Medical’s November-December 2011 newsletter, I included an article titled, “Would You Eat From This Kitchen” (click here to view the newsletter) where I discuss the importance of utilizing a “clean room” with an advanced sterile preparation environment cleaning program. I strongly urge you to read these two articles, as they can be extremely useful resources to help verify whether or not your current or potential compounding pharmacy is providing sterile medication of the highest quality possible.

Here at Hartley Medical, we provide the highest quality sterile preparations compounded in a state-of-the-art compounding facility that implements rigorous quality assurance and environmental monitoring programs. We pride ourselves in the fact that we exceed USP 797 guidelines on a daily basis.

If you have any questions about Hartley Medical and how we prepare our sterile compounds, or have questions about compounding pharmacy guidelines in general, I encourage you to use me as an immediate source of information. I am here for you, and I have nothing to hide.

The question is, “Do you know what your sterile compounding pharmacy is doing?”

Source:

D’Arrigo, Terri. “A Call to Action on Sterile Compounding Gains Traction.” Pharmacy Practice News. McMahon Publishing. July 2011: Issue 38. <http://www.pharmacypracticenews.com/ ViewArticle.aspx?d=Policy&d_id=51&i=July+2011&i_id=749&a_id=17543>. 7 Nov. 2011.

With the 15^th Annual North American Neuromodulation Society’s (NANS) Meeting just around the corner, I couldn’t help but think about the importance of this conference to both my organization and to all of those who will be attending. These conferences give all of us a chance to interact with current clients, friends, and respected colleagues throughout the world of pain medicine … but we also hope to form new bonds as well. It is important, though – especially for practices seeking new providers for pain products – that these conferences don’t just provide false first impressions … but rather long-lasting relationships.

Hartley Medical strives to be a source of information, as well as a provider of the highest quality sterile pharmaceuticals. In doing so, we know that clients and potential clients need to be given the chance to make decisions based on as much information about a company as possible – which is why I want to provide my recommendations as to the process of choosing the right compounding pharmacy. These four simple steps will help you gain a plethora of insight into a company that will sail beyond your initial impressions.

1. Do Your Research: Companies will often give you information that highlights only the best aspects of the organization. While this is great information to view, you must do your own research to find if there are any negatives. The best way to do this is by simply doing a Google search. Look at the company Web site to see if there are any discrepancies between the materials you’ve been given and the information on their Web site. View their social media sites (Facebook, YouTube, LinkedIn, etc.) and see what they are saying, and also what people are saying about them. It is important to expand your search to include the pharmacist(s) in charge as well. What is/are his/her/their background(s)? Do they have any past indiscretions? Are they highly qualified? Recommended? Look for any information that tells you who they are. Investigate news articles, peer reviews, etc. to obtain useful information to help influence your decision. Don’t be afraid to call the pharmacy and request information that is not found during research.

2. Check References: Your sterile compounding pharmacy should provide you with a list of references, either voluntarily or by request. Even if a pharmacy presents well during the consultation phase, this is not always reflective of their future performance. This allows you to find out what advantages come from choosing a particular pharmacy, and sometimes the disadvantages. Pharmacies that overplay their features and benefits can often be exposed during this process.

3. Doing Site Visits: Again, pharmacists might give you pictures, videos, slideshows, etc. of their facilities and/or processes. These are often taken during abnormal conditions (so that things look better than they actually are). The best way to find out is to perform a random site visit. Just show up at their facility and ask for a tour. No compounding pharmacy should deny this to a current or potential client. And this allows you to judge the quality of both the facility and their products first-hand.

4. Stay Involved: Once you have chosen which sterile compounding pharmacy to utilize, don’t just lose touch. Check in and stay on top of the company. Make sure that they continue to perform at, or exceed, the level of expectation that you have for them. Call and have conversations with the pharmacist(s) in charge and/or the staff pharmacist(s). Visit their locations when you are in their area. Do whatever you need to in order to ensure that you are getting the most optimal service and top-quality products.

Here at Hartley Medical, we are very open about our organization. We encourage you to come and inspect our facility. You can find YouTube videos online that demonstrate normal business etiquette – not staged for the camera. We welcome phone calls and e-mails at random, just to say, “Hi” and check in with us. And we readily have a list of references on hand.

The best sterile compounding pharmacy is the one that has nothing to hide – and Hartley Medical is an open book. Why? Because this is the Hartley Standard.

I hope to see you at this year’s NANS Meeting – but if not, please contact me for any reason at all. I am here for you.

RPh – President/Owner

Find this article, and more, in the November-December 2011 edition of The Hartley Standard – Hartley Medical’s bi-monthly newsletter – by clicking here.

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In the past, traditional compounding pharmacies – both hospital and retail – had laminar airflow workbenches in a common area of the pharmacy. Pharmacists and technicians were expected to safely compound medications in that type of environment. Changes have occurred over time, and focus is now shifting toward an enclosed, dedicated space designed to provide an optimal environment for sterile compounding. This space is accessible by door to minimize the exposure of outside room or building air from entering the sterile preparation area. This area is also known as a clean room facility.

A sterile preparation area takes a considerable amount of time, resources, and components to develop and construct. The materials are designed to be low-shedding, meaning they do not contribute particulates to the air within the clean room facility. The floor is made of vinyl, the walls are non-porous, and the ceiling panels are designed specifically for sterile preparation environments.

The facility has to have what is called an advanced air management system – which includes heating and cooling along with a filtration system. The temperature and humidity of the room is maintained not only to inhibit bacterial and fungal growth, but also to make it comfortable enough for employees to work.

The quality of air within the preparation area is directly related to the metric of what’s called “air changes per hour.” Air changes are the number of room air (the entire volume-metric size of air in the room) changes per hour that occur. Your facility must be able to demonstrate that the filtration system is turning over the room air volume at a certain rate per hour. The USP 797’s minimum standard is 30 air changes per hour. Hartley Medical’s sterile preparation area has 180 air changes per hour . . .

Additionally, these facilities require a certain amount of maintenance. You need a cleaning program, and the materials utilized in this program must not deteriorate the surfaces and must be successful in eliminating bacteria. The cleaning process must also have a monitoring program that allows you to assess the surfaces for bacteria. Here at Hartley Medical, just to be as thorough as possible, we also perform fungal testing.

The clean room facility is an integral part of optimal sterile compounding, but not all pharmacies have them. Those that do are ensuring that your sterile medications are being prepared in an ideal compounding environment. Hartley Medical believes that it is important to be introduced to some of the parameters of a clean room facility to be properly educated in understanding how sterile pharmaceuticals are aseptically prepared. This is why we encourage you to visit our state-of-the art clean room facility first-hand! Or, take an online tour at http://www.hartleymedical.com/tour.html. You will be pleased with what you see.

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The reimbursement for intrathecal drug therapy is a very complex process. I wanted to take some time to answer the question that I have been increasingly receiving, “What the heck is going on with reimbursement?” Therefore, I want to provide information regarding reimbursement issues to ensure proper payment for the treatment of your patients. One of the unique things about intrathecal therapy reimbursement is that it is extremely complicated with its various codes, diagnoses, treatment policies, and reimbursement rates. Overall, there is a lack of consistency with reimbursement from various insurance companies, third party payers, Medicare, and so forth. Administrative bodies have different policies/procedures for reimbursement, and if they are not adhered to they can delay or even deny proper reimbursement for services rendered. In today’s world, this is something that requires you to pay close attention, and perform diligence.

Recently, we have heard of a few compounding pharmacies that are currently billing Medicare on behalf of the patients and physicians they serve. It is Hartley Medical’s understanding that this is improper activity contrary to Medicare policies, and Medicare has issued several “desist” orders regarding this practice. We have selected to, and are currently doing, research into this topic. If we find that providing Medicare billing services on behalf of those we serve is ethically appropriate, then Hartley Medical will happily institute this service. Until that time, though, we will not act in ways that may be inconsistent with Medicare policies. After all, we want to provide superior service – which includes looking out for you and your patients.

So what is our advice for you? Follow and research your reimbursement to ensure proper payment, and examine reimbursement versus costs of goods to ensure profitability. I encourage you to seek counsel, or advisors – such as individuals from Medtronic, the various insurance companies, or even through Hartley Medical. By reaching out to these individuals, you can eliminate problems and ensure good cash flow. Do not look away for your reimbursement. I am increasingly hearing providers saying that they have a problem … but the problems have been going on for over a year. Perform due diligence – look at reimbursement on either a monthly or quarterly basis to ensure proper remuneration and also profitability.

If you have any questions regarding reimbursement, please consider Hartley Medical as a source.

Please find this article and more in The Hartley Standard – Hartley Medical’s bi-monthly newsletter. Click here to read the September – October, 2011 edition.  Or follow us online! 

I Just returned from London, where I attended the International Neuromodulation Society Meeting. I felt compelled to be present and keep pace with developments and discussions regarding intrathecal drug deliveries. I saw many I knew and many others that, gratifyingly, knew me.  It was fascinating seeing and experiencing some of these things and I was stunned to learn what professionals on the other side of the pond were engaged in. Great, notable speakers – among them Dr. Eric Buchser on “Mechanism of Drug Distribution in the CSF: How it May Affect Outcome;” Dr. Timothy Deer presenting “Algorithms for Patient Selection & Drug Algorithms;” and Dr. William Raffaeli on “Italian Registry of Long Term Intrathecal Ziconotide Treatment.”

One of the more fascinating lectures presented a case wherein doctors had identified a section of the brain that controls hand movement.  The subject for study was a young patient , a quadriplegic with a C2 spinal cord injury. The physicians surgically placed a unique fingertip sized electrode with many probes in this section, and connected it to a computer.

The computer screen had a red dot in the middle. A cursor point indicated the position of the mouse. The patient was shown to be able to operate the mouse with his brain – each time moving the cursor to the red dot on the screen and demonstrating the ability to “catch” the dot when it was moved to a different location. Astounding.

I later sat down with Dr. Elliot Krames and solicited his take on one of the presentations. He surprised me by stating “I disagreed with him.  Told him directly at the meeting.”

I found it fascinating that many of the professional people in attendance at the meeting, when in disagreement with certain opinions and findings presented, felt free to voice their disagreement. Egos remained in check…and the interchange of ideas, theories and new knowledge prevailed.

Refreshing. Enlightening. And to say the least, liberating.