The Tennessee Board of Pharmacy on Wednesday learned for the first time how widespread the practice of sterile compounding is across the state as it considers additional regulations of the industry.
According to preliminary survey results disclosed to the board at its meeting, 352 pharmacies licensed in Tennessee practice sterile compounding. The mandatory survey was prepared late last year after the national meningitis outbreak that has taken a heavy toll in Tennessee.
So far, 44 people nationwide, including 14 Tennesseans, have died after contracting a rare form of fungal meningitis. The infections came from tainted steroids prepared at New England Compounding Center in Massachusetts.
In response to the outbreak, the pharmacy board created a task force to study the state’s compounding regulations and how oversight could be improved. Compounding involves combining multiple medications to fill prescriptions for specific patients. Often the practice requires sterile conditions to prepare the prescriptions.
Late last year, the board sent surveys to 2,350 facilities licensed in Tennessee. Of the 1,893 that responded, 352 stated they conduct sterile compounding. Of that group, 65 prepare more than 100 doses of sterile drugs daily. Nearly 500 facilities have not yet responded to the survey, so the number could grow.
“The issue is if it’s that wide — and those who didn’t respond are the ones you especially want to worry about — that is a lot of pharmacies involved in this,” said public health expert Dr. Diana Zuckerman, who is president of the National Research Center for Women and Families.
However, board member Nina Smothers, who is leading the task force, said other improvements could be made administratively. For instance, Smothers said, the board could improve oversight by ensuring its inspectors were properly trained in how to inspect compounding pharmacies.
Smothers said adopting the U.S. Pharmacopeia’s model compounding regulations, which are called USP 797, is one possibility. USP 797 was created by the U.S. Pharmacopeial Convention, a nonprofit scientific organization that sets the national standard regarding the strength and purity of medications.
USP 797, which has been adopted in 18 states, provides guidelines for how pharmacists should prepare and handle compounded drugs.
The Tennessee Pharmacists Association’s executive director, Baeteena Black, told the pharmacy board that current laws are generally sufficient but instead the board should be adequately funded, its inspectors properly trained and out-of-state compounding facilities required to comply with state laws.
The board, which is mostly funded by licensure fees paid by pharmacists, has just five inspectors for 1,905 pharmacies and 706 manufacturers, wholesalers and distributors.
- Discuss the fungal meningitis outbreak on Facebook
- Continuing coverage of the fungal meningitis outbreak
According to preliminary survey results disclosed to the board at its meeting, 352 pharmacies licensed in Tennessee practice sterile compounding. The mandatory survey was prepared late last year after the national meningitis outbreak that has taken a heavy toll in Tennessee.
So far, 44 people nationwide, including 14 Tennesseans, have died after contracting a rare form of fungal meningitis. The infections came from tainted steroids prepared at New England Compounding Center in Massachusetts.
In response to the outbreak, the pharmacy board created a task force to study the state’s compounding regulations and how oversight could be improved. Compounding involves combining multiple medications to fill prescriptions for specific patients. Often the practice requires sterile conditions to prepare the prescriptions.
Late last year, the board sent surveys to 2,350 facilities licensed in Tennessee. Of the 1,893 that responded, 352 stated they conduct sterile compounding. Of that group, 65 prepare more than 100 doses of sterile drugs daily. Nearly 500 facilities have not yet responded to the survey, so the number could grow.
“The issue is if it’s that wide — and those who didn’t respond are the ones you especially want to worry about — that is a lot of pharmacies involved in this,” said public health expert Dr. Diana Zuckerman, who is president of the National Research Center for Women and Families.
Oversight studied
The pharmacy board is considering recommendations for state legislation that would create new regulations for sterile compounders.However, board member Nina Smothers, who is leading the task force, said other improvements could be made administratively. For instance, Smothers said, the board could improve oversight by ensuring its inspectors were properly trained in how to inspect compounding pharmacies.
Smothers said adopting the U.S. Pharmacopeia’s model compounding regulations, which are called USP 797, is one possibility. USP 797 was created by the U.S. Pharmacopeial Convention, a nonprofit scientific organization that sets the national standard regarding the strength and purity of medications.
USP 797, which has been adopted in 18 states, provides guidelines for how pharmacists should prepare and handle compounded drugs.
Funding, training
Smothers’ task force also concluded that communication among Tennessee’s board of pharmacy, pharmacy boards in other states and the Food and Drug Administration regarding disciplinary action could improve.The Tennessee Pharmacists Association’s executive director, Baeteena Black, told the pharmacy board that current laws are generally sufficient but instead the board should be adequately funded, its inspectors properly trained and out-of-state compounding facilities required to comply with state laws.
The board, which is mostly funded by licensure fees paid by pharmacists, has just five inspectors for 1,905 pharmacies and 706 manufacturers, wholesalers and distributors.
Source found here
1 comment:
Most of the time the implementation of the law is not carried out to the letter and cutting corners is possible. That needs to be prevented.
http://compoundingrxusa.com/
Post a Comment