The fungal meningitis Outbreak created such a scare it effected everyone from patients to pharmacist’s throughout the US. It is caused by a compounding pharmacy in Massachusetts.
What is a compounding pharmacy and how regulates it.
Compounding pharmacy is an operation which tailor-makes prescription drugs for special needs not able to be filled from commercial sources. There are many reasons for compounding pharmacy: this could include special dye-free oral or topical solutions, special amount of ingredients, hormone replacement therapy drugs, etc. Compounding pharmacy may involve a more restrictive environment for parenteral products such as eye drops or intravenous infusion. Recently due to the injectables medication shortages increasing number of injectables are compounded by compounding pharmacy from sodium bicarbonate injections to methylprenisolone (an anti-inflammatory drug) which was the culprit causing nationwide fungal meningitis, and vital but in severe shortage at the moment calcium chloride injections. Most of these injection drugs are generic but are used in large quantities in hospitals. Currently, in the US, over 200 drugs are in critical shortage some are among lifesaving drugs. Thus, pharmacy compounding is needed and allowed to practice to fill the need.
Unlike manufacturers which are governed and inspected by the FDA; compounding pharmacy is regulated by the state board of pharmacy only. The pharmacy laws varied by states generally require the compounding pharmacy product to be one-patient-specific or one-institution-specific and no more than a 30 days supply to be compounded at one time or 28 days expiration rule in inject-ables. About 3% of the prescriptions in the US are compounded and there were no major problems reported before the fungal meningitis outbreak. In recent years, the number of injectables compounding are on the rise and injectables compounding requires that pharmacies follow the USP (US pharmacopoeia) clean room guideline <797>. This is a gray area which poses regulation and inspection challenges for the state boards of pharmacy. From this “outbreak” a new and more effective oversight of compounding pharmacy will be implemented for sure. In the end, the compounding pharmacy will be regulated by more than one regulatory agency.
Unlike manufacturers which are governed and inspected by the FDA; compounding pharmacy is regulated by the state board of pharmacy only. The pharmacy laws varied by states generally require the compounding pharmacy product to be one-patient-specific or one-institution-specific and no more than a 30 days supply to be compounded at one time or 28 days expiration rule in inject-ables. About 3% of the prescriptions in the US are compounded and there were no major problems reported before the fungal meningitis outbreak. In recent years, the number of injectables compounding are on the rise and injectables compounding requires that pharmacies follow the USP (US pharmacopoeia) clean room guideline <797>. This is a gray area which poses regulation and inspection challenges for the state boards of pharmacy. From this “outbreak” a new and more effective oversight of compounding pharmacy will be implemented for sure. In the end, the compounding pharmacy will be regulated by more than one regulatory agency.
Patients and pharmacist’s need to be mindful:
- Use compounding pharmacy products, only when the alternative therapeutics are absolutely not available or possible.
- Never use single use vials twice.
- Inspect the product for color change or prescription and use before expiration date .
- Make sure the compounding product has a control number (lot number) on its label.
- Stick with local compounding pharmacies because the varied temperatures during transportation from a far may affect the integrity of the products.
Source found here
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