Stability and Sterility of Parenteral Solutions – A Short Case

Posted by Dr Dan Carter

A prospective patient called my office and inquired about intramuscular vitamin B12 injections. She stated that she had undergone an ileectomy and required B12 injections since that time. She had heard from a friend that methylcobalamin may be more beneficial for her than the “regular kind” she was using. After a rather pointed question and answer period I found that her “regular kind” was cyanocobalamin, 30 mL vial, 1000 micrograms per mL and she was injecting 2 mL once a month. She stated that the vial was stored at room temperature and was used until gone, which typically took over a year. She admitted that effectiveness seemed less when the vial was getting empty, but said that no infection occurred at injection sites.

There were two important issues the patient brought up: how long can a multi-dose vial maintain sterility after multiple entries, and what happens to drug potency after prolonged exposure to variable room temperature and air? Sterility is the main safety issue and prevention of iatrogenic infection is a primary objective of any physician.

The current practice guideline for multiple dose vials is that they may be used for one month after first entry. Storage recommendations depend on what type of drug is involved. Cyanocobalamin is usually stored at room temperature, whereas other B-vitamins, methyl and hydroxo cobalamins, and minerals are normally stored in the refrigerator after first entry.

What is the best procedure to prevent infection when using parenteral drugs? Every check on the following list needs to be followed with every use of the drug. Note: this list covers correct drug use only. It does not address administration.

  1. Confirm the drug name
  2. Check the expiration date
  3. Check for clarity if the drug is a solution. Suspensions may be cloudy. Examine for precipitates
  4. Clean the top of the vial well with IPA or other approved antiseptic
  5. Enter the vial with a new sterile needle attached to an unused sterile syringe, introduce a volume of air that matches the drug volume and withdraw the drug
  6. Store appropriately

Another method to decrease contamination of frequently used vials is to use a needleless vial adapter. Vial adapters are inserted into a vial once, and stay in place until the vial is empty or it outdates. Air does not need to be pushed into the vial because the adapter has a filter that allows air entry as the drug is withdrawn. Here are two different brands:

This one is a Codan C350N vial adapter with Swan Lock needless entry.

And here is a B Braun Ultrasite adapter

 

I ordered her some methylcoblamin and instructed her in its proper and safe application.

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Vertisis Custom Pharmacy

Vertisis Custom Pharmacy

Vertisis is one of the most unique sterile-injectable compounding pharmacies in the United States. Our focus is on going “above and beyond” traditional compounding pharmacies by raising the standards of 503A compounding pharmacies to include exceptional products, unique delivery, advanced education, and an amazing relationship with health care providers with a seamless delivery of care. Vertisis originates from over 20 years of clinical practice in custom compounded pharmaceutical agents and over 100 years of combined compounding pharmacy experience with clinical usage of the latest technologies. We have intimate knowledge of hundreds of thousands of custom compounded pharmaceutical treatments with a team of knowledgeable pharmacists to help answer your questions.

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TransLite LLC

345 Commerce Green Blvd.
Sugar Land, TX 77478

TransLite LLC is a small high tech company comprising dedicated people who design, manufacture and sell medical devices that can help reduce the pain and trauma to patients during venous access and treatment of varicose veins.
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McGuff Family of Companies

Legacy Corporate Contributor
2921 W. MacArthur Blvd., Suite 142
Santa Ana, CA 92704

McGuff Company Inc. is a wholesale distributor of over 5,000 competitively prices pharmaceuticals, IV related products, physician office & exam room supplies and an extensive oral nutritional line to support your patient’s treatments. Our experienced customer service staff are experts at finding hard-to-find products. We maintain close relations with both large and small manufacturers of quality products to assure we will meet all of your needs. Competitive prices for over 35 years!

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SterileDrugs.com is committed to helping medical providers and practices overcome the challenges of acquiring the very best custom and non-custom medications. By contracting with multiple FDA-Registered Outsourcing Facilities (503B pharmacies), our goal is to be your source, resource, and solution for the highest quality medications at the most competitive prices.

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SterileDrugs.com partners with 503B pharmacies that specialize in manufacturing medications for IV Nutritional Therapy, Hormone Replacement Therapy & Weight Loss. Our pharmacy partners are held to the highest quality standards by the FDA and comply with USP 795, 797 & cGMP guidelines. For a complete list of the medications we offer, as well as pricing, please contact us at: www.steriledrugs.com or 844-73DRUGS

Doctor’s Data, Inc.

3755 lllinois Avenue.
St. Charles, IL 60174 – 2420 USA
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Doctor’s Data, Inc. has provided innovative specialty testing to healthcare practitioners around the world from our advanced, CLIA-licensed clinical laboratory since 1972. Choose DDI to help you assess and treat heavy metal burden, nutritional deficiencies, gastrointestinal function, hormone and HPA/adrenal function status, cardiovascular risk, liver and metabolic abnormalities, and more.

Simply O3

We help you get started with ozone therapy in your clinic – Grow your income and improve patient outcomes.  Download the DEFINITIVE Guide to Getting Started with Ozone Therapy by going to www.DrsOzone.com/Guide.  Full training and support available  Equipment has a 6 month money back guarantee and is easy to use.  Go download your FREE guide to getting started now at www.drsozone.com/guide.

Merit Pharmaceutical

2611 N. San Fernando Road
Los Angeles, CA 90065
Phone (800) 421-9657 Toll Free US & Canada
Fax (323) 227-4833
solutions@meritpharm.com

Offering IV infusion from Merit? Getting your med/surg/pharma from us? Your colleagues are and they have higher profits. Merit supplies Anti Aging/Aesthetic/Integrative practitioners better prices on the products you use. Call us and learn why successful clinics partner with Merit. IV Therapy Nutrition/Hydration, Weight Loss, Hormones, IV solutions, PRP products, exam/surgical supplies and more. Merit offers pharmaceuticals (2, 3, 3N, 4), and related medical products. www.meritpharm.com or (800) 69-MERIT

Perfect Balance

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Contributor, Sponsor and Supporter
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