Outsourcing sterile product preparation and the importance of quality assurance

I’m sure you’ve heard about the recent meningitis outbreak tied to a contaminated batch of preservative-free methylprednisolone acetate. The story has received significant attention as more that 100 people have been sickened and as many as eight have died as a result of receiving an injection of the contaminated steroid (this data is already out of date since I started composing this post yesterday).

The tragedy of this incident has brought to light one of the unforeseen consequences of purchasing sterile compounded products from a third party. Outsourcing sterile preparations is not uncommon. In fact, many hospitals have turned to outsourcing sterile preparations as a way to not only meet the demand caused by drug shortages, but also as a way to achieve compliance with USP Chapter <797> for high-risk compounding.

There are a lot of reasons for wanting to outsource sterile product compounding. One only has to take a quick peak at the literature to see why1-4. But it’s important to remember that outsourcing sterile compounding isn’t without risks, which may include loss over quality control for your sterile product preparation. You really don’t know how someone else handles their QA, and in this case whether or not it may lead to the death of a patient or patients.

When considering whether or not to purchase sterile preparations from a third party consider the following:2

  • Product match
  • Extended beyond-use dating
  • Risk of product shortages
  • Company reputation
  • Scope of product line
  • Vendor proximity
  • Product cost

Company reputation and scope of product line will help one determine if the company is a good candidate for sterile product preparations. However, you really should go beyond that to ensure quality and product safety. Quality assurance procedures should be readily available and easily accessible. Don’t be afraid to ask questions. Above all else, be diligent in your selection process as these products will ultimately be used in your patients. Saving a little money isn’t worth the risk of getting a product that isn’t safe.

There’s no positive to take away from this devastating incident. People died and lives have been forever changed. While no one can fix that, it’s clear that the incident has put a spotlight on the danger associated with medications made during the sterile compounding process. It’s also given compounding pharmacies a black eye, which is unfortunate because they serve a purpose. Please don’t condemn the entire discipline because of this incident. As cliché as it sounds mistakes do happen. Until this is all sorted out and a thorough investigation performed we won’t know where the system broke down or whether negligence was involved.

One thing is for sure, pharmacists everywhere should use this as an opportunity to refocus on ensuring that our patients receive medications in the safest, most cost effective and efficient manner possible. There are no short cuts boys and girls. Remember that.

  1. ASHP Guidelines on Outsourcing Pharmaceutical Services. Am J Health-Syst Pharm. 1998;55:1611-17.
  2. Donnelly, A. Outsourcing Your Sterile Product Preparation. Pharmacy Purchasing and Products. Vol. 2, No. 2. pages 6-7.
  3. If You Outsource It, What Benefits Will Come? Pharmacy Practice News. 2006;May; 1, 40.
  4. Belden, H. What To Watch For When Choosing a Compounder. Drug Topics Health- System Edition. 2005;Sept 26:10.

6 thoughts on “Outsourcing sterile product preparation and the importance of quality assurance”

  1. I agree, compounding pharmacies do serve a good purpose and provide a benefit to the community. But, within limits.

    Providing compounding services to neighborhood providers and patients you have a close-relationship with, defines the contribution of compounding pharmacies.

    When that service begins to expand to larger and larger areas, and from state to state, and becomes less personal, then the lines become blurred between providing compounding services and pharmaceutical manufacturing.

    Manufacturers are more regulated because of the greater risks attributed to expanded compounding and distribution, but compounding pharmacies are exempt from similar regulation.

    Unfortunately, because of the high number and wide distribution of patients harmed from this incident, IMO it’s almost a given that the discipline will receive a black-eye and become more regulated and restricted in the near future.

  2. I think you hit it on the head. I used to work for a compounding pharmacy in the San Jose, CA area and he had a great relationship with his customers and the physicians, dentists and vets that he worked with. He was also above board on everything he did. He was a stickler for safety and the law. He didn’t like working in gray areas like you describe in your comment, i.e. expanded compounding area, larger batches, etc. I loved that job. To date it’s still the best job I ever had. Woke up every day and looked forward to going in. Can’t say that about any other job I’ve had since.

    There was also a compounding pharmacy in the area that was a bit shady. It’s those guys that give the profession a bad rap, but I guess it comes with the territory.

    Compounding is unique and is definitely needed. More regulation will only hurt the discipline as it’s already a nightmare in paperwork and record keeping. Unfortunately our system is designed in such a way that reaction is always swift and complicated.

    Thanks for your thoughts.

  3. “To date it’s still the best job I ever had. Woke up every day and looked forward to going in. Can’t say that about any other job I’ve had since.”

    I’m envious. I’ve never had a job like that. What happened? What did you leave?

  4. Oh, it’s not a very interesting story. I’m a chemist at heart. Compounding was the closest thing I could find in pharmacy that reminded me of being in a lab, so I started working for a compounding pharmacy in San Jose during my second year of pharmacy school. Loved it. The co-owners were great people and the atmosphere was just so incredible. It’s hard to describe. Sounds corny, I know. After school I stayed on, but was also working nights as an inpatient pharmacist at Salinas Valley Memorial Hospital in Salinas, CA about an hour south. That went on for about a year. At that point the owners of the pharmacy offered me a great deal: take 5% of the business each year you work in exchange for a reduced salary. Wanted to do it, and my wife and I tried to buy a house in the San Jose area, but we just couldn’t make it work. Then some family things came up and we moved back to the Central Valley of California to be closer to my mom because we were told she only had 5 yrs left (that was about 12 yrs ago now and she’s still kickin’). I continued to work at that San Jose compounding pharmacy one day a week for another year, but it was just too difficult. The job was totally worth it, but the 4 hour drive each way, cost of gas and the wear and tear on my body weren’t. And the rest is history. Six jobs and 12 years later I still haven’t found anything that comes close to the joy I felt working in that little compounding pharmacy in San Jose.

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