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, 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 Brian Williamson on Wed, Mar 12, 2014 @ 16:03 PM
There have been a lot of questions surrounding the Drug Quality and Security Act (DQSA) that created the 503B Outsourcing Facility category. Now it looks like CMS may not authorize payment for compounded drugs covered by Medicare unless those drugs were supplied by an Outsourcing Facility that is compliant with FDCA Section 503B.
JCB Labs was one of the first sterile compounding pharmacies to register with the FDA as a 503B Outsourcing Facility. That means that there should be no question whether or not drugs you buy from us will be covered. For more information on this very important topic, please go to this link for an interesting article and food for thought.
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.
Posted By Greg Rockers on Tue, Jun 18, 2013 @ 15:06 PM
The Group Purchasing Organization, Amerinet, had a member conference in May and it was a tremendous success. The only thing better than the venue at the Dolphin in Disney World were the people. The Amerinet representatives did their usual stellar job of connecting suppliers with customers and the members were extremely gracious with their time when they came by the JCB Laboratories booth in the exhibit hall.
As a high risk sterile compounding pharmacy, JCB sees the need for compounded sterile products on a daily basis. This need was never more evident than in my conversations with customers at the Amerinet Member Conference (AMC). The main topic of conversation surrounding sterile compounding was quality – how do you know you are using an experienced compounding pharmacy with the highest standards? I have blogged before about choosing the correct type of compounding pharmacy. Once you have decided on the correct type, the vetting process of your compounding provider must be thorough. At the AMC, the members and I talked at length about the decision process in selecting a sterile compounding pharmacy. Visiting the pharmacy is a great way to vet a sterile compounder. A review of outside pharmacy audits, credentials and pharmacy quality documentation is also critical.
I recommend keeping a “pharmacy audit packet” on file and this type of packet was my handout at AMC. The JCB packet includes a Pharmacy Compounding Accreditation Board (PCAB) certificate, results of a USP 797 audit and a completed Pharmacy Compounding Assessment Questionnaire (CPAQ). Every facility should have a packet of this information filed away so when a surveyor asks how you vetted your compounding pharmacy, you can pull out this packet and blow them away with thorough documentation!
Posted By Brian Williamson on Wed, Apr 24, 2013 @ 15:04 PM
The sterile compounding industry has been under a microscope for the last six months. Since the New England Compounding Center tragedy, a few other compounding pharmacies have issued voluntary and mandatory product recalls. The recalls have been primarily related to “lack of assurance of sterility” and have been brought about by either patient infections, floating material in products, or both. Additionally, the FDA has completed the inspection of 30 compounding pharmacies and the information gathered is being summarized and processed to determine how to regulate compounders going forward.
It is important to note that all the FDA inspections were done using current Good Manufacturing Practices (cGMP) standards instead of USP 797. Sterile compounding pharmacies are regulated by state boards of pharmacy and most boards require sterile compounding pharmacies to be compliant with USP 797. So, it is not surprising that all of the pharmacies received inspectional observations form FDA 483 when inspected against cGMP standards. USP 797 has been the “gold standard” for sterile compounding pharmacies for years. Products prepared and the testing of those products using USP 797 procedures results in sterile products that are safe. It is when sterile compounding pharmacies cut corners or do not follow USP 797 to the letter that problems can occur.
The cGMP standards are more stringent than USP 797 in some areas, most notably in air sampling requirements and validation of compounding and testing methods. Going forward, we expect there to be requirements put in place that incorporate parts of USP 797 and cGMP. The greatest predictor of things to come can be summarized by a statement made on March 23, 2013 by FDA Commissioner, Margaret A. Hamburg, M.D. Her statements indicate that the FDA, in cooperation with state boards of pharmacy, will continue inspections of compounding pharmacies. Commissioner Hamburg asked Congress to draft legislation establishing minimum federal standards for firms that compound sterile drug products, and wants Congress to enhance the FDA’s authority to inspect pharmacies, asking for the “FDA [to] have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations.” Two areas that the FDA seems to be set on changing or adding oversight is compounding of sterile products in anticipation of an order or prescription and large-scale interstate shipping of products. We have already seen many states either starting to enforce their regulations regarding “office-use vs. prescription” compounding, or implement emergency regulations to prohibit office-use compounding, or both.
So, what does this mean for you, for JCB, and for the patients you serve? As many of you know, the changes made by many states requiring prescriptions for compounds is a logistical nightmare. It is time consuming, costly, and likely not the best approach to ultimately protecting patient safety. There are better ways to track lot numbers of products to individual patients and many of you are already doing this. Nevertheless, JCB Labs will comply with the rules and regs put in place by each state board of pharmacy and will help you remain compliant as well. If you are in a state that requires prescriptions for office use compounds, we will continue to ask you for prescriptions unless or until the regulations are changed.
It appears that the FDA will likely have more oversight in the compounding industry. Whether or not this happens, JCB will continue to provide sterile products of the highest quality and help ensure the safety of your patients. JCB’s facility is always open for you to visit or audit. If you do come to visit JCB, we are confident that you will leave completely satisfied that you are working with a sterile compounding partner you can trust.
Posted By Brian Williamson on Tue, Mar 12, 2013 @ 08:03 AM
Posted By Brian Williamson on Thu, Feb 21, 2013 @ 14:02 PM
While the aforementioned article was referring to commercial manufacturers, I think some people have the same opinions regarding compounded products. I have two concerns with this focus on the lowest price and the belief that all products are equivalent. First, do you really want to use the compounding pharmacy that competes solely by offering the lowest price? The customers I speak with want a sterile compounder that is accredited by the Pharmacy Compounding Accreditation Board (PCAB) and one that meets or exceeds the United States Pharmacopeia (USP) 797 requirements. They want a compounding pharmacy they can trust to make sure their patients receive the best care possible. Secondly, it appears that not all products undergo the same sterility, endotoxin and potency testing. Ask your compounder for their policy and procedure on testing sterile products. Does your compounding pharmacy test per USP 797 guidelines? They should, but the recent dramatic increase in the number of test samples sent in to analytical labs appears to indicate that not every pharmacy follows USP 797. I recently spoke with one of our independent testing laboratories and they said their business tripled in the two months following the deadly meningitis outbreak caused by contaminated compounded steroids. That seems to indicate that not everyone was testing properly prior to the tragedy.
Now is the time for you to take critical look into your compounding pharmacy. Ask the tough questions of your high risk sterile compounding pharmacy. Make sure you have all the documentation you need not only to give you peace of mind but also to satisfy your regulatory auditors.
Posted By Greg Rockers on Thu, Feb 07, 2013 @ 14:02 PM
Previously we have posted blogs about combining ophthalmic drops for pre-operative use in cataract surgeries and YAG laser procedures. See the two blogs below.
From our research, we have developed a list of pre-op combination drops that represent the most popular combinations across the country. A best-practice guideline if you will. By focusing on a finite number of combinations, JCB is able to increase the efficiencies of our compounding processes and, thereby, control costs.
Chances are the combination you want is on this list. If not, give us a call at 316-773-0405 and ask for me, Greg Rockers. I will help you find a combination that best suits your needs.
Now more than ever, you need a sterile products compounding pharmacy that is a trusted clinical partner. At JCB Laboratories, we are here to help!