EXPERTS IN STERILE PHARMACEUTICAL SOLUTIONS
503B HUMAN DRUG OUTSOURCING
|Providing high-quality sterile preparations that are produced with industry-leading automation and quality control systems.|
Posted By Greg Rockers on Tue, Feb 24, 2015 @ 09:02 AM
In the world of sterile compounding, much has changed over the last two years. Prior to the passage of the Drug Quality and Security Act (DQSA) in November 2013, USP 797 was the quality standard for compounded sterile products (CSPs). Now that the DQSA has passed, providers have the option of getting their CSPs from 503B Outsourcing Facilities (OF) that must follow current Good Manufacturing Processes (cGMP). This significantly higher cGMP standard is preferred among physicians, pharmacists and nurses who want to make sure they give their patients CSPs of the highest possible quality. In fact, both the FDA and CMS have stated their preference that providers purchase CSPs only from FDA registered 503B Outsourcing Facilities.
One significant change that is a result of becoming a 503B Outsourcing Facility is the CSP testing requirements. The requirements are so much more than simply sterility, endotoxin and potency testing. The level of rigor, suitability and specificity is significantly higher. The sterility test must comply with United States Pharmacopeia (USP) 71, the endotoxin test must comply with USP 85 and the potency tests must be based on the compendial method described in the products’ USP monograph. Make sure your CSP provider is performing these tests at the required level and make sure you ask your Outsourcing Facility for these test results!
As a consequence of the cost and lengthy time requirements of this level of testing, the days of compounding sterile products one, two or even fifty at a time are over. To maximize efficiency, control costs and ensure consistent, high-quality products, Outsourcing Facilities must produce their products in larger batches. JCB Laboratories’ has decreased its’ formulary of products and invested considerable time and resources into manufacturing processes to make sure all products meet the highest standard. That is the JCB commitment to your patients and that is what I call value!
While, in rare cases, this may mean the product you used to get from JCB is no longer available, it certainly does not mean we are not innovating, researching and compounding new products. We have been and always will be a dependable, reliable source for innovative new compounds and for drug shortage products. As you go to conferences and learn about new CSP options or when a drug shortage has an adverse effect on your ability to take care of patients, let us know. We welcome the opportunity to compound CSPs that you need the most.
Greg Rockers. R.Ph.
Posted By Greg Rockers on Wed, Feb 11, 2015 @ 08:02 AM
To our valued partners:
I am pleased to announce Steve Strickland as the new National Sales Director for JCB Laboratories. Steve has over 20 years of experience in the pharmaceutical industry in a variety of roles and is a tremendous addition to the JCB team. With his considerable sales leadership experience, I am confident you will find Steve a welcome resource. His record of success is a clear indication of his commitment to providing excellent customer service with uncompromising integrity. Steve’s values are a perfect fit with the JCB commitment to deliver the safest, highest quality products to your patients.
This commitment to quality is something you have come to know over the past decade and is the hallmark of JCB Laboratories. Unmatched customer service is a pillar to that commitment. Steve looks forward to enhancing our mutual partnership through an expanded direct account management team which will further improve our first in class service you have come to expect and deserve.
In the coming weeks, Steve and his sales team look forward to the opportunity to meet you and continue to develop the trust you have placed in JCB Laboratories.
We appreciate your business!
Greg Rockers, R.Ph.
Posted By Greg Rockers on Wed, Oct 29, 2014 @ 16:10 PM
I could have also given this blog the title, “Help, I am a consultant pharmacist and I have a director of nursing that is going crazy trying to keep up with a group of surgeons who each want a different pre-op standing order for cataract surgeries!”
I speak to nurses at surgery centers every day. A common topic of conversation is the issues that can arise when every surgeon wants a different regimen of pre-op dilating and numbing drops prior to a cataract procedure. Most understand why a physician wants to stick with his/her protocol. It works for them and this is the way they have been doing it for years! However, in today’s ambulatory surgery center (ASC) world, where reimbursement continues to shrink, surveyors are vigilant and lawsuits are not uncommon, finding ways to increase efficiency, lower costs and reduce risk is critical.
This brings me back to the consultant pharmacist. The nurse in question had a great consultant pharmacist who was ready and willing to help her tackle this problem. When the pharmacist offered to help, the nurse handed the consultant 30 pages of standing orders. Both realized that this situation was untenable. The facility was wasting valuable nursing time trying to find the correct meds for the different orders, spending 30 to 45 minutes giving a series of 3-4 individual drops up to 3 different times and the rate of medication wastage was high. Additionally, there was a real fear that a medication mix-up was inevitable.
The nurse and the pharmacist got together and committed to fixing this problem. They went through each order and found that, from a clinical perspective, there really was not significant differences in the vast majority of the orders. They decided to call their compounding pharmacy to find a combination ophthalmic drop that would work for most of their surgeons, and present it at the next meeting.
It took a little convincing but the proof was in the results. Having just one or two different pre-op eye drop combinations allowed the facility to streamline the medication ordering and administration process. The surgeons got the results they wanted and the nurses were able to shave almost 30 minutes off of their normal pre-op time. This also made the surgeons happy because the shorter pre-op time allowed them to schedule more cases per day.
Change can be challenging for everyone. In this case, the nurse and pharmacist had good data that showed their proposal would result in therapy that was safer, more efficient and cost effective. This was a winning solution for everyone - physician, nurse, patient and facility!
Posted By Greg Rockers on Thu, Oct 09, 2014 @ 09:10 AM
The absolute favorite part of my job is interacting with our customers. Every day brings a unique situation - some good, some not so good, but all important. Feedback from customers is crucial to any business and it is certainly true in the world of sterile compounding. It is amazing what I learn from conversations with physicians, nurses, administrators and buyers.
I have a yellow legal pad on my desk and take notes when speaking with customers. It is very helpful to have a record of my day and I routinely review those notes. This really helps in identifying patterns.
Drug shortages are a great example. Those of you reading this blog often find out about drug shortages before they become an issue nationally. When you call JCB and talk to me, our customer service representatives or our sales team concerning a need, we all share that with each other. When we talk to other customers, we ask them if they are experiencing similar issues. This allows us to get out in front of a drug shortage and start production earlier so you do not run out of a critical medication. We are going to start sending out a drug shortages email blast once a week with drugs we are compounding in response to shortages.
New and popular products. Sometimes, your feedback leads to the formulation of a new product. For example, customers call us and ask if we can combine two or more products into one compound to make administration more efficient. Our cataract surgery, preoperative combination dilation drops are a great example of this. So, in addition to the drug shortages email blast, we will also send out a regular email with information on new and popular products we compound.
(If you want to receive either of the emails described above, send us an email at firstname.lastname@example.org and we will add you to our email list. Also, I plan to share tidbits and best practices on a regular basis and publish them in this blog space. Do not hesitate to contact me at email@example.com with ideas, questions or concerns. You are the reason we are here!)
Posted By Greg Rockers on Thu, Mar 06, 2014 @ 13:03 PM
In the high-risk sterile compounding world, quality is absolutely critical. Providers should demand quality compounded products and patients deserve quality compounded products. But, while quality is a word that is used often, it can be extremely difficult to truly grasp what it takes to produce the highest quality sterile products. I believe, if you ask physicians and nurses, they will say quality is extremely important in choosing a sterile compounder. Yet, when it comes to choosing what compounder to use, all too often the question of price comes first. Price has to be a factor but, if the product is not safe, choosing the wrong sterile compounder can be extremely expensive.
So, how do you make sure you are getting the absolute highest quality product at a fair price? The answer is due diligence. You must thoroughly qualify your compounding provider. Now that the Drug Quality and Security Act (DQSA) has passed, there is a higher standard in place for sterile compounders that choose to register as an Outsourcing Facility with the FDA. But verifying that your compounder is registered with the FDA is just the first step. Do not stop there when doing your research. Ask your compounder these questions:
● Do they have an automated system in place to continuously monitor the pressure, temperature and humidity in the clean room?
● How often do they conduct environmental monitoring for viable and non-viable particulate counts in the clean room)? (Monthly is good. Weekly is better.)
● Are the aseptic processing personnel tested daily for fingertip contamination?
● How do they train their employees? (Ask for specific examples)
● Do the aseptic processing personnel wear all-sterile garb?
● Do the aseptic processing personnel have any exposed skin while working in the clean room? (A hair net, mask and gown is good but complete sterile garb with no exposed skin is much better.)
● Does your compounder have a Validation Master Plan?
● Does all equipment have supporting documentation that is in working order and is all equipment checked and certified on a regular basis?
■ Has Installation Qualification been performed and documented?
■ Has Operational Qualification been performed and documented?
■ Has Performance Qualification been performed and documented?
● Does your compounder have stability and sterility studies for their compounds that they will openly share with customers
● Will they share the sterility and potency tests for products they send you?
● Will they supply quarterly Quality Assurance reports?
● How do they address audit requests?
● Do they allow unannounced audits?
● How many audits did they have last year?
● Were there any unfavorable reports?
● Have they been inspected by the FDA?
By asking these questions and carefully evaluating a high risk sterile compounder, you can make an informed decision. You deserve to rest easy knowing that your compounder spares no expense in producing sterile products of the highest quality.
JCB Labs - helping you protect your patientss.
Posted By Greg Rockers on Sun, Jan 19, 2014 @ 15:01 PM
JCB Laboratories is excited to announce that we have installed a new continuous monitoring system in our cleanroom and drug storage areas. This system is typically found in FDA-registered facilities or large manufacturing plants. This system is the first in the country to be introduced and commissioned in a sterile compounding pharmacy. What does this mean to you? It gives you and your patients an added layer of security and safety. This state-of-the-art system (called Lighthouse) gives us LEADING indicators of potential environmental and system failures vs. traditional TRAILING indicators that only allow the user to respond after a problem has occurred. Much like you constantly monitor a patient during surgery we are constantly monitoring the health of our clean room. If you know what’s happening to the patient/cleanroom at all times you can usually correct the issue before it escalates. See the press release below for details!
Posted By Greg Rockers on Fri, Jan 17, 2014 @ 15:01 PM
JCB Laboratories has long been an advocate for more stringent guidelines for high risk sterile compounding so we applaud Congress for the passage of the Drug Quality and Security Act (DQSA). The passage of this bill is the result of a bipartisan effort between the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pension Committee. Now that the President has signed this piece of legislation, we will be following it closely and look forward to seeing the final regulations.
DQSA creates a new category of compounders, called Outsourcing Facilities, that will be regulated by the FDA. JCB Labs has the expectation that the DQSA will benefit our industry by leading to a higher level of integrity in compounded sterile products and therefore increasing patient safety. Since the tragedy in New England a little over a year ago, it was clear that Congress saw a need to address this issue. Choosing to register with the FDA to become an Outsourcing Facility is voluntary. It it is our expectation that providers will overwhelmingly choose sterile compounders that commit to the more stringent regulations and register with the FDA.
We hear from providers every day that sterile compounders fill a vital role in making sure critical medications are available when they need them. With a higher standard in place, and regulations that allow non-patient specific ordering, quality compounded medications can be readily available to providers. To show our support for the new legislation, JCB has started the registration process and we expect to be listed as an Outsourcing Facility very soon
Posted By Greg Rockers on Fri, Aug 30, 2013 @ 09:08 AM
Criteria to Demand From Your Sterile Compounding Partner
The compounding pharmacy supplying sterile office use products must place quality above everything else. For a sterile products compounding pharmacy, this means, at a minimum, that the pharmacy:
Maintains a constant state of control in their cleanroom
Continuous monitoring of temperature, humidity and pressure differentials
Daily, weekly and monthly environmental monitoring
Regular certification of all cleanrooms and laminar flow hoods by an accredited third party
Meets or exceeds USP <797>
This includes meeting the requirements for sterility, fungal, endotoxin and potency testing
Is accredited by the Pharmacy Compounding Accreditation Board
Has a robust set of Standard Operating Procedures that have been reviewed by an accrediting body
This includes a recall procedure that is regularly tested and allows the pharmacy to track every ingredient and device used to compound a particular product and recall it within hours.
Labeling products with labels that meet ISMP (Institute for Safe Medication Practices) guidelines.
This includes a barcode that allows health systems to integrate compounded medications into their automated dispensing systems
All labels for compounded product will clearly state:
This Is A Compounded Product
For Office Use Only
Not for Resale
Posted By Greg Rockers on Fri, Aug 23, 2013 @ 10:08 AM
One of the fundamental tenets of the practice of pharmacy is the physician-patient- pharmacist triad. It has been argued that this triad is not complete without a patient-specific prescription. While this may be true in a retail situation, the presence of a prescription does not enhance patient care or improve patient safety when the med is administered by or under the supervision of a physician (office/institutional use) in a controlled setting. In many cases where the medication is used in the physician’s office, surgery center or hospital, the physician does not know if he/she will need a particular med in sufficient time to write a prescription. Examples of such situations:
The patient presents with an emergent condition in an emergency room or immediate care facility.
The patient needs a higher dose and therefore more medication than originally anticipated
The physician is in the middle of a surgery and the patient requires a life-saving medication due to an unexpected complication
The physician needs to add a surgery case to his schedule unexpectedly
In all of these instances, if the medication was not on hand, requiring a prescription would force the physician to make a choice regarding which med to use based not on what is best for the patient but based on what medications are in stock. I hear time and again of instances where a physician would prefer to use a special compounded medication but the laws in his/her state do not allow him/her to keep the med in stock for use in unforeseen, emergency situations.
Compounding for office/institutional use plays an integral part in providing quality patient care and maximizing efficiencies for health care providers. Indeed, compounded medications have been a tremendous help in mitigating the effects of supply chain inadequacies and the record drug shortages over the past few years. In the fourth quarter of 2012 the number of active shortages hit an all-time high of 299. In the first quarter of 2013, there were still 295 active drug shortages.1 Almost half of these drug shortages are sterile injectable meds. Bottom line, unless physicians can access a compounded form of medications that are in short supply, patient care suffers and costs to the health care system increase.
Even in instances where a patient’s procedure is scheduled far enough in advance to write a prescription for the compounded medication needed, medications labeled with a specific patient’s name may not get used and have to be wasted if the patient has to cancel the procedure. This results in wasted medication, wasted time by the medical staff and wasted health care dollars. Worse yet, these unused medications place the healthcare provider in a situation where they may be tempted to use a patient-specific medication on another patient because of an urgent need or a desire not to waste the drug.
1. Julia Talsma. Drug Shortages Still at Crisis Levels. Drug Topics pg 32-45, June 2013
Part 2 of the Importance of Office Use Compounding coming next week: Criteria to Demand From Your Sterile Compounding Partner.
Posted By Greg Rockers on Thu, Aug 15, 2013 @ 13:08 PM
I wrote my last blog on the drug shortage crisis almost 10 months ago and it is clear from the daily calls we get at JCB Laboratories that the drug shortage crisis is far from resolved. The names of the drugs in short supply may have changed but the reasons for and the effects of the shortages are all too familiar.
Recently, I have seen a new way to quantify the drug shortages. Because of the length of time some of the drug shortages are lasting, the number of drugs in short supply are described as “active” drug shortages rather than “new” drug shortages. If you look at the new drug shortages thus far in 2013, the number is down dramatically (40 for the first quarter of 2013).
However, active drug shortages paint another picture entirely. At the end of the fourth quarter of 2012, the number of active drug shortages hit an all-time high of 299. In the first quarter of this year, there were still 295 active drug shortages.
Those drugs that are in short supply continue to be drugs that are used in emergent situations, antibiotics, chemotherapeutics and CNS medications. Over the last three years, the common drug classes in short supply are shown below:
Additionally, I am sure none of you will be surprised to hear that injectables continue to represent a large portion of the drug shortages:
There is no single reason for all of these drug shortages but, like in 2012, quality issues at the manufacturing level and manufacturing issues account for 80% of the shortages. The last report I read separated out these two causes but many of the manufacturing issues are also related to quality. Erin Fox, manager of the University of Utah Drug Information Service describes the current drug shortage situation as a “public health crisis as patients and clinicians are impacted daily.”
We are seeing some relief with the passage of the Food and Drug Administration Safety and Innovation Act of 2012. Included in this legislation is an early notification system requiring drug manufacturers to notify the FDA of any production issues at their facilities and to give the FDA 6 months notice for a planned discontinuation of a medication. Additionally, in February of this year, the FDA formed an internal Drug Shortage Task Force and called for stakeholders to provide suggestions for a strategic plan to enhance efforts to address and prevent drug shortages.
These actions will certainly help but, until manufacturing facilities are improved, drug shortages that affect patient care will continue for the next few years. It is prudent for your facility to have plans in place to mitigate the effects of these shortages. A reliable pillar in this plan is finding a properly vetted, high quality compounding pharmacy that can be a partner in providing solutions to many short supply medication issues.