Point/Counter

Are the compounded drugs you used in your practice before 2013 equally accessible in 2017?

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POINT

No change with some drugs

Because I work at a university hospital, all of our drugs for intravitreal injections in the clinic and others used in the operating rooms come from our hospital pharmacy, which is responsible for purchasing, preparing and dispensing. In addition, we cannot use compounded medications. For instance, brilliant blue G, which is an intraoperative staining agent and may be safer than indocyanine green and widely used in Europe, cannot be used in our hospital operating rooms because it can be obtained only through compounding pharmacies in the United States. Also, because it is not FDA approved, our hospital drug approval committee has not been willing to have us use it.

Judy E. Kim

On the other hand, intravitreal antibiotics, antivirals, antifungals, subretinal tissue plasminogen activator and Avastin (bevacizumab, Genentech) are prepared in our hospital pharmacy, and we have not had any problems obtaining them over the years. While there have been recent reports of problems with retained silicone oil droplets from the insulin syringes that were used for Avastin from the compounding pharmacies, we have not had any similar issues with Avastin because we have been using silicone-free syringes for more than a decade. We worked closely with our pharmacy shortly after Avastin became widely used for various retinal conditions in order to find a type of syringe that would avoid silicone oil droplet issues and minimize wastage of Avastin during overfilling of the syringes to reduce drug costs. Having hospital pharmacy personnel with whom we can discuss various needs of the clinicians has been great. I guess when it comes to the availability of compounded drugs, this is one of the incidences in which working at an academic center that has a hospital pharmacy is advantageous over many of the private practices.

Judy E. Kim, MD, is an OSN Retina/Vitreous Board Member. Disclosure: Kim reports she is a member of the advisory board for Genentech.

COUNTER

Eric D. Donnenfeld

Balance is necessary

The use of compounded drugs has long been a fundamental manifestation of physician practice of medicine and gives us the ability to use medications in an off-label manner to better treat patients. The use of compounded drugs can provide significant benefit to patients both in terms of cost and effectiveness of therapy, but their use has to be valued against the risk of using a medication that might not have FDA validation of safety, manufacturing sterility or efficacy. Recent epidemics of infections related to compounded products are a clear reminder to use compounded drugs that are manufactured in the highest-quality environment. In addition, the FDA requires pharmaceutical companies to perform studies at a cost that can often be measured in the range of hundreds of millions of dollars. These companies take expensive risks to benefit patients and may often end up with a drug that is not approved. From my perspective, they are entitled to a certain level of protection against compounding drug companies that circumvent the arduous FDA process of drug approval.

From my perspective the most important consideration, however, remains the patient. Requiring companies that create compounded drugs to live up to the same manufacturing standard as FDA products is a good thing, and if that makes them a little less accessible, that is OK with me. On the other hand, when beneficial medications cannot be obtained for our patients, even when they are not FDA approved, then we as physicians need to voice our concerns and take action.

Eric D. Donnenfeld, MD, is an OSN Cornea/External Disease Board Member. Disclosure: Donnenfeld reports no relevant financial disclosures.

Click here to view the Cover Story for this Point/Counter.

POINT

No change with some drugs

Because I work at a university hospital, all of our drugs for intravitreal injections in the clinic and others used in the operating rooms come from our hospital pharmacy, which is responsible for purchasing, preparing and dispensing. In addition, we cannot use compounded medications. For instance, brilliant blue G, which is an intraoperative staining agent and may be safer than indocyanine green and widely used in Europe, cannot be used in our hospital operating rooms because it can be obtained only through compounding pharmacies in the United States. Also, because it is not FDA approved, our hospital drug approval committee has not been willing to have us use it.

Judy E. Kim

On the other hand, intravitreal antibiotics, antivirals, antifungals, subretinal tissue plasminogen activator and Avastin (bevacizumab, Genentech) are prepared in our hospital pharmacy, and we have not had any problems obtaining them over the years. While there have been recent reports of problems with retained silicone oil droplets from the insulin syringes that were used for Avastin from the compounding pharmacies, we have not had any similar issues with Avastin because we have been using silicone-free syringes for more than a decade. We worked closely with our pharmacy shortly after Avastin became widely used for various retinal conditions in order to find a type of syringe that would avoid silicone oil droplet issues and minimize wastage of Avastin during overfilling of the syringes to reduce drug costs. Having hospital pharmacy personnel with whom we can discuss various needs of the clinicians has been great. I guess when it comes to the availability of compounded drugs, this is one of the incidences in which working at an academic center that has a hospital pharmacy is advantageous over many of the private practices.

Judy E. Kim, MD, is an OSN Retina/Vitreous Board Member. Disclosure: Kim reports she is a member of the advisory board for Genentech.

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COUNTER

Eric D. Donnenfeld

Balance is necessary

The use of compounded drugs has long been a fundamental manifestation of physician practice of medicine and gives us the ability to use medications in an off-label manner to better treat patients. The use of compounded drugs can provide significant benefit to patients both in terms of cost and effectiveness of therapy, but their use has to be valued against the risk of using a medication that might not have FDA validation of safety, manufacturing sterility or efficacy. Recent epidemics of infections related to compounded products are a clear reminder to use compounded drugs that are manufactured in the highest-quality environment. In addition, the FDA requires pharmaceutical companies to perform studies at a cost that can often be measured in the range of hundreds of millions of dollars. These companies take expensive risks to benefit patients and may often end up with a drug that is not approved. From my perspective, they are entitled to a certain level of protection against compounding drug companies that circumvent the arduous FDA process of drug approval.

From my perspective the most important consideration, however, remains the patient. Requiring companies that create compounded drugs to live up to the same manufacturing standard as FDA products is a good thing, and if that makes them a little less accessible, that is OK with me. On the other hand, when beneficial medications cannot be obtained for our patients, even when they are not FDA approved, then we as physicians need to voice our concerns and take action.

Eric D. Donnenfeld, MD, is an OSN Cornea/External Disease Board Member. Disclosure: Donnenfeld reports no relevant financial disclosures.