PharmTechhas reported that an estimate of one out of every 100,000 drug containers contains a contaminant, which results in approximately 30,000 accidents in the US due to contaminated drugs. They further state that there are two distinct categories of contamination related to injectable drugs, and these statistics are solely related to single events that occur throughout the US and not representative of other infections seen in outbreak episodes affecting several patients.
Injectable drugs are administered directly into the bloodstream, bypassing the immune defenses associated with the gastrointestinal system. Therefore, it is essential that pharmaceutical companies comply with strict government regulations to guide quality control programs to ensure regulatory requirements are met.
The question is, "If there are strict regulations for production of sterile pharmaceutical supplies, then why are we seeing such statistics related to infectious outbreaks from contaminated drugs?" This article will explore the difference between pharmaceutical manufacturing companies and compounding pharmacies and the regulations specific to each.
A Look at Previous Infectious Outbreaks
TheCDC reported that in 2002, the North Carolina Division of Public Health followed five cases of fungal infections that were associated with contaminated drugs that were prepared by a compounding pharmacy. The affected patients had received epidural injections at outpatient pain clinics. Two cases of meningitis were caused by a rare fungus in these patients.
According to the CDC, In 2012, the New England Compounding Center in Framingham, Massachusetts, a compounding pharmacy, was investigated by the CDC and state and local health departments. The result was that over 800 individuals became ill and 64 died as a result of fungal meningitis and other infections among patients who received contaminated steroid injections.
In-Pharma Technologistreported that in 2013, Specialty Compounding was first under scrutiny when 17 patients who were infused with calcium gluconate developed bacterial bloodstream infections. Currently, Specialty Compounding has been ordered to stop production of pharmaceutical supplies by the US Courts after tests confirmed that the facility in Texas produced injectable drugs that were contaminated by bacteria.
The focus on compounding pharmacies has recently continued as executives for Med Prep Consulting were accused of fraud and violating the Federal Food, Drug and Cosmetic Act for selling drugs that were knowingly produced in unsanitary conditions.
Sterile Pharmaceutical Supplies
TheAmerican Pharmaceutical Reviewreports on the necessity of producing sterile pharmaceutical supplies, and the difference between types of facilities. Pharmaceutical manufacturing companies are licensed facilities that comply with several quality control measures to ensure the sterility of parenteral drugs. These companies develop, produce, and market drugs while also operating under current Good Manufacturing Practices including supplementing pharmaceutical products with antimicrobial preservatives and performing sterility testing. Under these guidelines, these facilities are responsible for ensuring the establishment of reputable management systems, ensuring use of high quality raw materials, adhering to controlled operating procedures, identification of product variances, and the maintenance of reliable laboratories.
The FDA monitors each facilities compliance with regulations by routinely performing inspections and performing reviews of publically generated product reports. Pharmaceutical manufacturing companies are further mandated by the FDA to use protocols described in the United States Pharmacopeia (USP) to ensure production of sterile pharmaceutical supplies.
Pharmaceutical Compounding Companies
These are companies that process or combine FDA approved drugs to produce medications that are individualized to meet the specific needs of each patient. Compounding companies differ from pharmaceutical manufacturing companies as they are regulated by the state Pharmacy Boards in each state with oversight by the FDA.
Compounding pharmacies are required to comply with practices as described in the Federal Food, Drugs, and Cosmetics Act and the USP. However, compounded products are produced in limited volumes, making legitimately prescribed and prepared drugs exempt from review, approval, adverse event reporting, and the utilization of appropriate storage and labeling requirements on product vials.
Unfortunately, compounding pharmacies function inappropriately by acting as drug manufacturers. By doing so, these companies risk the production of large quantities of drugs that are not properly controlled for quality, not manufactured under Good Manufacturing Practices, and are not FDA-approved. Therefore, patients cannot be guaranteed the sterility of their compounded pharmaceutical products.
The American Pharmaceutical Review goes on to report that due to the leniency of regulations related to quality control and the production of sterile products, multiple microbial outbreaks have been linked to compounded parenteral products, in addition to previously mentioned cases.
Despite the need for the regulations related to the quality control of pharmaceutical compounding needing updating, attempts in the past decade have been ineffective. Some argued that imposing additional regulations would negatively affect patient access to necessary compounded medications. However, many feel that related to the increasing numbers of hospitalizations and deaths related to contaminated pharmaceutical supplies, it is essential that the regulations governing the operation, production, and sterility of pharmaceutical supplies be addressed to update regulations so patients can be assured their medications are sterile and of high quality.