Showing posts with label BHRT. Show all posts
Showing posts with label BHRT. Show all posts

Friday, August 17, 2012

FDA Question and Answers Regarding Compounded Memopausal Hormone Therapy

Compounded Menopausal Hormone Therapy Questions and Answers

     

Pharmacy Compounding 


1. What is pharmacy compounding?
FDA regards traditional pharmacy compounding as the combining or altering of ingredients by a pharmacist, in response to a licensed practitioner’s prescription, to produce a drug tailored to an individual patient’s special medical needs. In its simplest form, traditional compounding may involve reformulating a drug, for example, by removing a dye or preservative in response to a patient allergy. In the case of menopausal hormone therapy, an FDA approved progesterone product contains peanut oil. Progesterone compounded without peanut oil in response to a prescription for a specific patient who is allergic to this ingredient might allow the patient to safely use the drug.
2. Is combining two or more drugs considered compounding?
FDA would consider the combining of two or more FDA-approved drugs into a single medication, in a manner not described in a drug’s FDA-approved labeling, to be compounding if it is done by a pharmacist in response to a licensed practitioner’s prescription and produces a medication tailored to an individual patient’s special medical needs.
3.  Is pharmacy compounding beneficial for patients?
It can be.  Traditional pharmacy compounding enhances patient treatment with individually-tailored drugs when a physician deems that an FDA-approved drug may not be available or appropriate for that patient's care.  Thus, traditional compounding is an important component of patient care.
  
4. What are the risks associated with compounded drugs?
Compounded drugs can pose both direct and indirect health risks. Direct health risks include unsafe compounded products. Compounded drugs may be unsafe and compounded drugs made using poor quality compounding practices may be sub- or super‑potent, contaminated, or otherwise adulterated. Indirect health risks include the possibility that patients will use ineffective compounded drugs instead of FDA-approved drugs that have been shown to be safe and effective.  
Some pharmacists are well-trained and well-equipped to compound certain medications safely. But not all pharmacists have the same level of skills and equipment, and some drugs may be inappropriate for compounding. In some cases, compounders may lack sufficient controls (e.g., equipment, training, testing, or facilities) to ensure product quality or to compound complex drugs like sterile or extended-release drugs. The quality of the drugs that these pharmacists compound is unknown and these drugs pose potential risks to the patients who take them.
When pharmacy compounders both operate like drug manufacturers and engage in high‑volume distribution, the risk of patient harm increases. Over the past several years, FDA has become aware of serious adverse events, including deaths, associated with compounded drugs. For example:
  • In December 2006, FDA issued warning letters to five firms about their standardized compounded, high‑strength topical anesthetic creams. Two deaths were connected to the topical anesthetics compounded by two of the pharmacies.
  • In August 2006, FDA warned three firms to stop manufacturing and distributing thousands of doses of unapproved inhalation drugs under the guise of compounding. Warning letters to these firms identify a range of serious concerns including inadequate quality control, concerns about potency, and compounding copies of FDA-approved drugs.
  • In March 2006, FDA issued a warning letter to a Maryland firm regarding its compounding of cardioplegia solutions – used in open-heart surgery – that were contaminated. The contaminated solutions caused severe systemic infections in five patients at a hospital in Virginia. Three of the five patients died from their infections.
5. Does FDA want to prevent pharmacy compounding?
No. FDA believes that pharmacists engaging in traditional compounding provide a valuable medical service that is important to patient health. FDA has no interest in ending traditional pharmacy compounding and focuses instead on the subset of inappropriate compounding described in FDA’s Pharmacy Compounding CPG. The CPG is available on FDA’s pharmacy compounding Web page.

Wednesday, June 20, 2012

FDA's Questions and Answers to Compounded Menopausal Hormone Therapy for Humans

Compounded Menopausal Hormone Therapy Questions and Answers

     

Pharmacy Compounding 


1. What is pharmacy compounding?
FDA regards traditional pharmacy compounding as the combining or altering of ingredients by a pharmacist, in response to a licensed practitioner’s prescription, to produce a drug tailored to an individual patient’s special medical needs. In its simplest form, traditional compounding may involve reformulating a drug, for example, by removing a dye or preservative in response to a patient allergy. In the case of menopausal hormone therapy, an FDA approved progesterone product contains peanut oil. Progesterone compounded without peanut oil in response to a prescription for a specific patient who is allergic to this ingredient might allow the patient to safely use the drug.
2. Is combining two or more drugs considered compounding?
FDA would consider the combining of two or more FDA-approved drugs into a single medication, in a manner not described in a drug’s FDA-approved labeling, to be compounding if it is done by a pharmacist in response to a licensed practitioner’s prescription and produces a medication tailored to an individual patient’s special medical needs.
3.  Is pharmacy compounding beneficial for patients?
It can be.  Traditional pharmacy compounding enhances patient treatment with individually-tailored drugs when a physician deems that an FDA-approved drug may not be available or appropriate for that patient's care.  Thus, traditional compounding is an important component of patient care.