To Retinal Specialists About Compounding Pharmacies and Avastin
Retinal specialists have asked me about compounding pharmacies around the country that have offered Avastin® in small doses for intraocular injection. I asked the Director of the Pharmacy here at The University of Iowa Hospitals and Clinics how one can tell if these pharmacies are any good. There have been problems with bacterial contamination, including Pseudomonas, in some compounded drugs.
The director said the waters are muddy but offered these tips:
The director said the waters are muddy but offered these tips:
- The pharmacy should be licensed in the state where it is located, say Texas. If the pharmacy sends drugs into another state, most states require that it also be licensed in that state, say, California. The director said however, that most licensing procedures involve only paperwork and aren’t a guarantee of quality.
- He said that the doctor should ask, and get in writing, that the compounding pharmacy follows USP 797 Standards. 797 is a chapter dealing with the sterile technique and handling of drugs. If they won’t give you that in writing, I would avoid that pharmacy.
- Life of Avastin®. I read 797, a summary of which is available on the net; Avastin® is considered a low risk drug. The standard in 797 states that even a low risk drug that is refrigerated should be used within 14 days. If the drug is frozen, it can be used up to 45 days. Therefore, if a compounding pharmacy says that their refrigerated Avastin® can be used after 14 days, they are not following the 797 standards.
- Finally the director said that he would call the Board of Pharmacy in the state where the compounding pharmacy is located. That number is easy to get on the internet by combining the state with Board of Pharmacy in the search or by checking the National Association of Boards of Pharmacy's website.
If any compounding pharmacies read this blog and comply with these standards, they can send an e-mail or letter to that effect and I’ll publish their name, address, and telephone number. For convenience, I ask them to include the number of their state’s Board of Pharmacy.
I’ve talked a lot about Avastin® on this blog. We have to be careful though, since we’ve not followed these patients for very long and we also have the proven treatments of Visudyne® and Macugen®.
Once again, I am not paid by any company.
posted by James C. Folk, M.D. at 9:15 AM
4 Comments:
Dr. Folk,
I am curious how you decide whether to try Visudyne/IVK or Avastin initially at this point in time. How frequently are you reinjecting Avastin. How long do you plan to continue injections if patients continue to look good. What do you think you are going to do once Lucentis gets approved. Obviously all of the above are questions of opinion based on a paucity or absence of good data. Nonetheless I am curious about your thoughts as I agree with you on most of the views you've posted on this topic. Thanks. PW
These are all good questions. I tend to use Visudyne®/Kenalog® if the CNV is smaller and classic however the adjunct use of Kenalog® seems to increase the success of PDT for occult CNV also. I tend to use Macugen® for larger, occult, less discrete CNV, and CNV obscured by hemorrhage. I use Avastin® if the eye doesn’t “respond” to these treatments per the information in the blogs.
I have not followed enough Avastin® patients to say for sure how many injections are needed. The CNV seem to respond rapidly in most cases. My plan is to give three injections of 1.25mg at monthly intervals then re-evaluate. If the CNV looks inactive and the fluid is gone after the three injections, I’ll watch. I suspect that a lot of these patients will need more Avastin® later. If all of the CNV recur, we may want to try Visudyne with Macugen® or Avastin® to decrease the frequency of the injections.
If Lucentis® is approved, I’ll probably use it rather than off-label Avastin®. I hope that Genentech prices it reasonably. I don’t like comments though, like, “Genentech screwed up,” or Genentech shot themselves in the foot with this one.” Genentech should be applauded for their excellent science. They were striving to make a drug that worked in AMD. On the other hand, I hope there is no litigation that casts a chill on the use of intraocular Avastin® either. We’re just trying our hardest to save our patient’s vision.
Prescribing Compounded Drugs calls for thorough BENFIT-RISK Assessment
It may be attractive to solve a drug shortage problem by outsourcing to a compounding pharmacy. But, as eluded to in a previous post, this is a Prescriber Beware market.
Compounded drugs are not approved for safety and efficacy, and they are not manufactured according to FDA standards. Physicians have been sued in cases where patients have been injured by compounded drugs; as learned intermediaries, they are held responsible for understanding and communicating potential risks associated with compounded drugs to patients.
Potental risks may include but are not limited to:
Use of unproven formulas
Use of expired or contaminated chemicals
Lack of assurance of potency
Potential super-potency
Lack of assurance of purity
Lack of assurance of sterility
Lack of assurance of stability
Use of flawed delivery systems
Meeting guidelines under USP Chapter 797 does not provide the same sterility assurance as those mandated under the Food Drug and Cosmetic Act (FDCA). A compounded drug should not be considered interchangeable with an approved product--it is not a generic drug (generic drugs are manufactured in compliance with the FDCA).
Because of potential liablity concerns, physicians should consult with their risk management departments before outsourcing to compounding pharmacies.
We are a compounding pharmacy in the Dallas area (Frisco, TX). Dr. Folk is correct on most points he made concerning compounders and them following USP 797 guidelines. You should definitely investigate the pharmacy you chose to work with. Another good indicator of a pharmacy that will provide good service is being a member of a national compounding organization like, PCCA (Professional Compounding Centers of America). This Organization provides invaluable consultation and support concerning compounding. Another organization would be International Academy of Compounding Pharmacists (IACP). Checking with the State Board of Pharmacy is a must to see if there are any complaints or restrictions on thier license. Also, you might consider talking to the pharmacist(s) on staff about their experience level with compounding. Another question you should ask the pharmacist is the procedure for sterility testing (Do they test every batch?). If the doctor and the pharmacy are both local, I encourage the doctor to go and check out the facility where it is being made. We have offered snap shots of our facility so out-of state and out-of-town physicians can see where their product is being made. We DO comply with USP 797, and we have a brand new state-of-the-art facility. Upon request we can fax you a sterility report on the product you are getting compounded. The Texas State Board of Phamacy can be contacted at 512-305-8000. Please feel free to call me and them for any additional information.
Joe Gallucci, R.Ph.
Drug Crafters Compounding Pharmacy
3550 Parkwood Blvd. Ste. 630
Frisco, TX 75034
214-618-3511
1-877-DrugCrafters
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