USP Chapter 797 was the first set of enforceable sterile compounding standards created by the United States Pharmacopeia. However, only one out of six graduates1 are typically prepared for sterile compounding work. Let's take a look at the history of USP 797, as well as milestones that led to the development of these compounding standards.
1990: Four Patients Die in a Nebraska Hospital due to a Contaminated Solution
The patients died after contracting a bacterial infection from a non-sterile cardioplegia solution, which was compounded in a Nebraska hospital.
1990: Two Patients Lose Vision Due to Contaminated Materials
Two patients went blind in Pennsylvania after becoming infected with pseudomonas aeruginosa. The bacteria was found in their eye drops, which were compounded in a community pharmacy. At the time, commercial non-steroidal drops had been available.
1998: Ten Children Test Positive for Enterobacter Cloacae
Ten children in California tested positive for the bloodstream infection after being exposed to contaminated, pre-filled saline syringes. Poor employee hand hygiene and garbing routines were thought to be the root causes.
2001: Pediatric Patients Fall Ill as a Result of a Hospital Pharmacy
Four patients in Missouri developed an infection after receiving IV ranitidine that had been mixed with Automated Compounding Devices. Poor employee hand hygiene and garbing were thought to be the causes of the issue. A lack of compliance with USP 797 was also cited.
2002: Five Patients Receive Contaminated Steroids, One Dies
In South Carolina, five patients were given contaminated injectable steroids, resulting in one death. Researchers identified exophiala as the primary issue, and the incidents occurred up to 152 days following the injections. In this instance, untrained compounding personnel were deemed the main cause.
2004: Contaminated Radiosotope Equipment Causes Hepatitis C
Sixteen patients in Maryland contracted hepatitis C infections after being exposed to a Tc 99m radiosotope is used during their cardiac stress tests. At the pharmacy responsible for preparing the radiosotope, breaks in aseptic technique were cited.
2007: Study Reveals Lack of Prepared Pharmaceutical Graduates
A study conducted in 2007 regarding the extent of sterile compounding training at U.S. pharmaceutical schools revealed a lack of prepared graduates. About 13 percent 2 of the school's deans claimed that their students were adequately trained in sterile compounding before graduation.
2007: USP Proposes Chapter 797
The USP proposed Chapter 7973 on November 27, 2007, placing an emphasis on individual training and evaluation of sterile compounding standards.4
2008: USP 797 is Launched
Despite the fact that USP 797 emerged in 2008, the pharmaceutical industry has been slow to adopt sterilization standards. A compliance survey5 of compounding pharmacists conducted in 2011 revealed that financial constraints and budget limitations were holding many companies back from complying with the regulations.
2010: Pediatric Patient Dies in Hospital Due to Compounding Error
The child died after receiving a sodium chloride concentrate that was not compounded properly prior to administration.
2011: Multiple Patients Blinded Due to Avastin Contamination
Patients in California, Florida, and Tennessee were blinded6 after receiving Avastin that had been contaminated during medium risk level compounding. Additionally, one patient suffered permanent brain damage.
2012: Fungal Meningitis Outbreak
A widespread fungal meningitis outbreak was linked to contaminated methylprednisolone acetate injections, compounded at a pharmacy that was not in compliance with USP 797 or other regulations. The U.S. Centers for Disease Control and Prevention found 751 people were affected. A total of 384 people had meningitis and spinal infections.
2013: A Connecticut Hospital Identifies Contaminated Magnesium Sulfate
Five bags of the chemical were contaminated with mold. The pharmacy responsible for compounding the product has been shut down.
2013: A Georgia Pharmacy Recalls 79 Lots of Products
Products intended for retinal injections were recalled due to a risk of eye infection.
2013: 15 Patients are Infected in Texas, 2 Die
Patients are infected and two individuals die due to a batch of compounded IV calcium gluconate.
2013: The Drug Quality and Security Act Becomes Law
This law requires the FDA to engage in two-way communication with regulators and eliminates unconstitutional provisions of 503A that "…created uncertainty regarding the laws governing compounding."
2014: Patient Dies After Receiving the Wrong Drug
An Oregon patient dies after receiving rocuronium instead of fosphenytoin. The labeling was correct, but the rocuronium went unnoticed.
2015: Voluntary Recalls Continue Across the U.S.
Recalls impacting compounded drugs continue across the U.S.7
- The FDA announced in Sept. 2015 that U.S. Compounding, Inc., had issued a voluntary recall of all sterile compounded products.
- Downing Labs, Inc., issues a voluntary recall of compounded materials in Oct. 2015.
- Hospira begins a recall in March 2015 due to mold contamination in its compounded drugs.
2015: The National Institutes of Health Suspends 46 Clinical Trials
The U.S. Food and Drug Administration found several defects in drug manufacturing, leading the NIH to suspend 46 clinical studies.8
As this timeline shows, the standards specified in USP 797 only have as big of an impact as the number of pharmacies that comply.
"General Chapter 797 sets practice standards for compounding sterile preparations to ensure that all patients receive sterile, safe and accurate preparations during treatment," said Diane Cousins, USP vice president of healthcare quality and information.9 "This chapter is one of the most important contributions to patient safety in decades."
References
- Archer, Bruce. "S797 Brutal Facts About Compounding." Pharmacy One Source. Retrieved October 12, 2015.
- "Moving Forward For Safer Sterile Compounding." Institute for Safe Medication Practices. November 1, 2012. <http://www.ismp.org/>
- "USP's Revised General Chapter Pharmaceutical Compounding – Sterile Preparations 797 Tightens Patient Safety Guidelines." U.S. Pharmacopeia. November 27, 2007. <http://nuclearpharmacy.uams.edu/>
- Newton, David. "USP 797 - Pharmaceutical Compounding - Sterile Preparations." American Association of Colleges of Pharmacy. July 10, 2011. <http://www.aacp.org/>
- Douglas, Kate. "The 2012 USP 797 Compliance Survey: Measuring Progress." Pharmacy Purchasing and Products Magazine. October 1, 2012. <http://www.pppmag.com>
- St. John, Keith. "USP 797: IP + Pharmacist as Partners in Medication Safety." Pharmacy One Source. Retrieved Oct. 12, 2015.
- "Drug Recalls." U.S. Food and Drug Administration." Retrieved October 12, 2015. <www.fda.gov>
- Burton, Thomas. "NIH Suspends Drug Production for 46 Clinical Trials After Finding Contamination." Wall Street Journal. June 4, 2015 <http://www.wsj.com>
- "USP's Revised General Chapter Pharmaceutical Compounding – Sterile Preparations 797 Tightens Patient Safety Guidelines." U.S. Pharmacopeia. November 27, 2007. <http://nuclearpharmacy.uams.edu/>
