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JCB Labs Blog

Compounded Sterile Products-Higher Standards and Increased Patient Safety

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.

Your Partner,

 

Greg Rockers. R.Ph.

VP-Business Development

Tag: Sterile Compounding, USP 797, Quality, Partnership, 503B, compounding, outsourcing facility, FDA, cGMP, CMS, DQSA, innovating,

Importance of Office Use Compounding Part 1

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:

  1. The patient presents with an emergent condition in an emergency room or immediate care facility.

  2. The patient needs a higher dose and therefore more medication than originally anticipated

  3. The physician is in the middle of a surgery and the patient requires a life-saving medication due to an unexpected complication

  4. 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.

Tag: Sterile Compounding, Shortage, compounding, Injectable, office use,

Disney and Amerinet - A Great Combination

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!

Tag: Sterile Compounding, Outsourcing,

Speak Up - Your Patient's Health & Wellbeing May Depend on It

Posted By Brian Williamson on Tue, Mar 12, 2013 @ 08:03 AM

 


Increased scrutiny and regulatory oversight, brought about by the failure of NECC and the resulting tragedy, now threaten to limit your access to sterile compounded products. Many of you contract with a sterile compounding pharmacy, such as JCB Labs, to provide sterile products when a manufactured product is not a viable option.

This vital resource may be severely restricted by looming legislation and/or by reinterpretation of pharmacy laws. Specifically, there are three areas of concern:

1) FDA regulations and oversight - While JCB agrees that further oversight is necessary and could support FDA oversight on some level, the regulations need to be enacted judiciously and with ease of access and patient care in mind.

2) Patient specific prescription requirements - Some states do not allow office-use compounding and require patient specific prescriptions.  This requirement may be difficult or even impossible to work into the logistics of your practice, but it is very important that you follow the board of pharmacy regulations in your state.

3) Out of state pharmacy restrictions - Some boards of pharmacy are considering statutes that would preclude out-of-state pharmacies or non-resident pharmacies from shipping product into their state.  Or, they may put some arbitrary limit on the amount of office-use product a pharmacy can provide.

The end result of such restrictions could severely limit your access to the office-use compounded drugs you depend on. The rhetoric behind these restrictions and requirements indicate they are meant to improve patient safety.  Is that what they would accomplish?  Wouldn’t it be better to focus on creating and enforcing standards that result in products of the highest quality without limiting access?

If your practice relies on compounded products for office-use, it is imperative that you contact your legislators and board of pharmacy in your state.  Express to them the absolute need for office-use sterile compounded products in your practice.  Make sure that your representatives understand that the ONLY source you have for many drugs used in your practice is your compounding pharmacy.  We’ve included a example text for your use at the end of this blog.  Personalize it any way you see fit and email or send it to your board of pharmacy and your state legislators.

On a brighter note, one board of pharmacy has taken an introspective and reasonable approach to office-use compounding.  The Washington State Board of Pharmacy published the following:

“The Washington State Board of Pharmacy recently discussed pharmacy compounding... [T]hey agreed that (4), read independently, could allow a pharmacy to provide compounded products for a practitioner to administer to individual patients without a prescription for a specific patient.  Because this has clearly been the belief of some compounding pharmacies in Washington, the board decided it will honor this interpretation of the rule...”

You CAN make a difference.  Your legislators will listen to you and the board of pharmacy will hear your concerns.


Example letter:

Dear [Board of Pharmacy, Legislator, Congressman, etc]

Thank you for taking time to hear my concern.  I am a [physician, administrator, nurse, etc.] at [Example Surgery Center].  I am concerned about the possible impact that potential regulations and restrictions to compounded drugs for office-use would have on my practice.  

I regularly depend on office-use compounded products to meet my patients’ needs when a suitable manufactured product is not available.  The ONLY alternative I have is from a licensed compounding pharmacy.  Any further regulations or restrictions on office-use compounding need to be carefully weighed against patient need and access to critical drugs.

Please do not restrict or limit my access to vital compounded sterile products without considering the significant impact it would have on my patients and my practice.

Sincerely,
Tag: Sterile Compounding, FDA, Legislator, Health,

Pre-Op Combination Ophthalmic Drops

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.

3 Options to Meet USP 797 Requirements for Combination Ophthalmic Dilating Drops

Calculating the Final Concentration for Combination Ophthalmic Drops

Compounded ophthalmic products are a specialty at JCB and we routinely get asked about pre-op eye drops.  Our team of clinical pharmacists has compiled an extensive library of information regarding various ophthalmic combinations to help answer questions such as:  What combinations are most stable?  What mydriatics last the longest?  What topical anesthetics are available? 

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!

Tag: Sterile Compounding, Ophthalmology,

Podcast 1 of 2: Oversight of sterile compounding

Posted By Brian Williamson on Thu, Jan 31, 2013 @ 08:01 AM

JCB was asked to provide a podcast recording regarding sterile compounding and oversight.  You can listen to the podcast here

In summary, the podcast covers the following topics:

  • The process of sterile compounding, including facility design, training, and USP 797 requirements
  • The role of the FDA and boards of pharmacy
  • Specific training and education requirements for sterile compounding
  • Number of compounded adverse events as reported by the Institute of Safe Medication Practices (ISMP)
  • Questions to ask when considering using a compounding pharmacy

As 2013 is fully underway, we expect to see some significant changes in sterile compounding from a legislative perspective.  JCB is committed to staying in front of the changes and helping guide the process.  

Tag: Sterile Compounding, USP 797,

Podcast 2 of 2: Drug Shortages and Gray Market

Posted By Brian Williamson on Thu, Jan 31, 2013 @ 08:01 AM

JCB was asked to take part in a podcast recording regarding drug shortages and the gray market.  You can listen to the podcast here.

In summary, the podcast covers the following topics:

  • Drug shortages and why they are more common now than ever before
  • Drugs that are the most problematic to obtain
  • Why chemotherapy drugs are hard to find and the resulting consequences of not having them available
  • What is the gray market and how has it evolved
  • What is “pedigree” in the context of drugs
  • Recommendations for handling drug shortages and evaluating alternative sources of drugs

The drug shortage issues may be somewhat relieved in 2013. However, there will still be significant shortages of life-saving and critical medications.  Stay in contact with JCB and keep calling us for information on drug shortages you are facing in your facilities.  

Tag: Sterile Compounding, Shortage, USP 797,

3 Drug Diversion Schemes and How to Stop Them

Posted By Brian Williamson on Wed, Nov 07, 2012 @ 13:11 PM

Prescription drug diversion and theft is nothing new in healthcare.  It is so common that many facilities have implemented procedures to prevent drug theft and diversion.  Unfortunately, as soon as a new procedure is put in place the ever resourceful thieves come up with other schemes designed to fool the system.  On a recent trip to visit surgery centers in the northeast, I had several interesting conversations with nursing staff and even an accreditation inspector on some of the methods being used to steal drugs.  By sharing these alarming practices, I hope you will stay on the lookout for suspicious activity in your facility.

  1.  Many facilities place their used sharps containers in a shipping/receiving area for their local contracted medical waste company to pick up.  Knowing that many sharps containers contain opened vials of drug that have not been completely used, thieves are disguising themselves as the contracted waste pick-up driver and simply walking into the shipping/receiving area and taking the sharps containers without any questions from the staff.  It is important that a staff person identify the pick-up driver as an actual employee of the medical waste company.   Document that the driver is who they say they are, i.e., document employee or driver number before letting them leave. 
  2. If using pre-drawn syringes of anesthesia drugs or narcotics, expel all remaining contents of the syringe into a non-recoverable container.  Non-recoverable containers can be made by placing a paper towel or other absorbent material in the bottom of the sharps containers.  Any liquid placed in these containers is then absorbed and rendered useless.  The drugs have significant street value and drug users and sellers will go to great lengths to steal these products.
  3. Some drug diversion teams are working together within the facility.  In one instance, a purchasing agent, a receiving person, and a person in the accounting office were working together to steal drugs.  The purchasing agent was ordering the product, the receiving person was stealing the product, and the accounting person was doctoring invoices and packing slips to eliminate any record of traceability of the product being ordered or received.  It is very important to have checks and balances in place within the facility so that one or several people can’t get away with these types of activities. 

 I’m sure there are hundreds of more ways to create drug diversions.  If you know of other schemes or have methods that you are using to prevent this problem from happening, please share them with us and we will be happy to post them.  

Tag: Sterile Compounding, Injectables, compounding, Diversion, Propofol,

Drug Shortage Update

Posted By Greg Rockers on Wed, Sep 05, 2012 @ 13:09 PM

As you are all painfully aware, the drug shortages do not seem to be letting up.  It seems that as soon as one product once again becomes available, two others become unavailable.  This on again – off again supply chain makes it extremely difficult to stay on top of the situation.  To help you do just that, JCB will discuss the drug shortages regularly in our blog.

Below are 5 common drugs that are in short supply along and the most recent availability information per the ASHP Drug Shortage Website:

  • Propofol 1% (10mg/mL) Injection.   There are two U.S.  companies currently manufacturing propofol.  Hospira cannot estimate a release date and APP has limited product available but cannot keep up with increased demand.  Some wholesalers, when they can get product, are now restricting sale of propofol only to hospitals and ambulatory surgery centers.  Additionally, only the large volume single dose vials have been available recently. (Leading to waste)
  • Epinephrine 1:1000, preservative free/sulfite free Injection.   While there are manufacturers that make preservative free epinephrine (Hospira and JHP) there is only one manufacturer, ARL, that makes a preservative free AND sulfite free epinephrine.  ARL has no release date on their epinephrine.
  • Metoclopramide 5mg/mL injection.  There is no manufactured product currently available as Hospira is the only manufacturer.  Even though Hospira estimates they will be able to begin releasing some product late August, it will likely take months for the supply chain to stabilize.
  • Nalbuphine 10mg/mL injection.  Hospira is the only company left manufacturing this product.  This concentration is on intermittent back order with no firm date on when product will be readily available.
  • Ketorolac 30mg/mL injection, 1mL vials/syringes.  There are multiple manufacturers but 3 of the largest suppliers stopped making the med within the last 2 years-all because of quality issues.  Hospira has this size and concentration on intermittent backorder and all other manufacturers cannot estimate a release date.

What do all of these shortages have in common?  JCB can help!  In the case of propofol, based on the recent CMS letter (see our related blog) JCB can repackage your large volume, single-dose vials into smaller, unit of use syringes. This can preserve valuable product and reduce waste.  In the case of the other four medications, we can custom-compound these for you when they are unavailable from the manufacturer.  Call us.  We are here to help you better serve your patients.

Tag: Sterile Compounding, Outsourcing, Shortage,

Drug Shortages…Who’s to Blame?

Posted By Brian Williamson on Wed, Aug 29, 2012 @ 13:08 PM

Are politics to blame for the current drug shortage crisis?  Or, is the reason health care providers have to scramble to find drugs for their patients more fundamental than that?  It’s inevitable that when a problem exists and persists that someone or something is blamed.  There has been plenty of finger pointing going on lately as various experts, politicians and government officials try to explain why the United States is in such a dire situation with our drug supply.  Some blame the current administration for the shortage and others blame the manufacturers for lack of quality control.  Two recent reports are linked here. 

http://oversight.house.gov/wp-content/uploads/2012/06/6-15-2012-Report-FDAs-Contribution-to-the-Drug-Shortage-Crisis.pdf

 

http://democrats.oversight.house.gov/images/stories/2012-5778.Cummings.drug%20shortages.response.final.pdf

One blames the FDA for creating the drug shortages due to increased inspections of manufacturing facilities, while the other blames the manufacturers for not creating safe products.  The causes of the drug shortages are complicated and hard to comprehend in some cases but, at the end of the day, the question remains…When will this end?

Tag: Sterile Compounding, Shortage, Injectables, Suppliers,