Prior to 2012, compounding pharmacies were not required by law to follow current good manufacturing practices. Then, in October 2012 there was an outbreak of fungal meningitis reported. The Center for Disease Control traced the outbreak to fungal contamination in an injectable corticosteroid that was compounded by New England Compounding Center. Doses from the lots found to be contaminated had been shipped to 75 medical facilities in 23 states, and doses had been administered to about 14,000 patients.
Following this tragedy, the Drug Quality and Security Act was enacted, a bill that would modify the Federal Food, Drug, and Cosmetic Act and give more authority to regulate and monitor the manufacturing of compounded medication.
For this assignment, research the Drug Quality and Security Act, which was signed into law by President Obama in November 2013.
Answer key question such as:
- What are some of the changes that were a result of this Act being signed that effect the compounding industry
- Do you believe this tragedy would have been prevented had this bill already been in place? How?
- How could it prevent an outbreak like that which occurred in 2012 from happening again?
- What drawbacks do you see if any and in what ways could this law be improved?
Conduct online research, and then write a 2-page paper, remembering to answer the above listed questions. Be sure to also include your references
Expert Solution Preview
Introduction:
The Drug Quality and Security Act was enacted in November 2013 to regulate and monitor the manufacturing of compounded medication. This assignment requires research on the changes that resulted from the Act, its effectiveness in preventing outbreaks like the 2012 fungal meningitis case, drawbacks, and suggestions for improvement.
1. What are some of the changes that were a result of this Act being signed that affect the compounding industry?
The Drug Quality and Security Act created a new category of compounding pharmacies, known as “outsourcing facilities,” that are subject to FDA oversight and inspection. These facilities can produce larger quantities of compounded medication and are required to adhere to current good manufacturing practices. The Act also enables the FDA to recall compounded drugs that pose a health risk and establish a national system to track drug distribution.
2. Do you believe this tragedy would have been prevented had this bill already been in place? How?
Yes, it is highly likely that the 2012 fungal meningitis outbreak would have been prevented if the Drug Quality and Security Act had been in place. The Act provides regulations, oversight, and inspections that would have ensured the compounding pharmacy followed current good manufacturing practices and produced safe medication free of contamination. The FDA oversight would have detected the contamination, and the pharmacy would have been required to recall the tainted medication.
3. How could it prevent an outbreak like that which occurred in 2012 from happening again?
The Drug Quality and Security Act empowers the FDA to regulate compounding pharmacies and requires them to follow current good manufacturing practices, which would reduce the risk of contamination and ensure safety. Compounding pharmacies are subject to FDA inspections and must adhere to strict quality control processes. The national tracking system implemented by the Act enables the FDA to locate and recall contaminated medication quickly.
4. What drawbacks do you see if any, and in what ways could this law improve?
One potential drawback is that the regulations may be too costly for small compounding pharmacies to comply with, leading to close shop or not produce medications. To improve the law, the FDA could provide an affordability scale for smaller compounding pharmacies. Additionally, the law could establish specific criteria that determine when a compounding pharmacy must become an outsourcing facility and subject to FDA oversight.
References:
1. FDA. Drug Compounding. https://www.fda.gov/drugs/human-drug-compounding/drug-compounding
2. The Drug Quality and Security Act Frequently Asked Questions. https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/drug-quality-security-act-frequently-asked-questions
3. The New England Journal of Medicine. NECC and the Fungal Meningitis Outbreak of 2012. https://www.nejm.org/doi/full/10.1056/NEJMsr1501197
