Saturday, March 23, 2013

Colorado Board of Pharmacy--Compounded versus Repackaged Drugs-Patient Specific Office Use

Compounded versus repackaged drugs
Access issues spike debate on cost effective care
Colorado ophthalmologists are at the heart of what is increasingly becoming an access to cost-effective care issue. Over the past few months access to ophthalmic drugs, specifically Avastin for retina patients, has come to represent all of complexities of on-the-ground health care reform including regulation, marketplace reactions and misinterpretations about technical practices including the difference between compounding and repackaging drugs.
After the tragic meningitis outbreak in the northeast last year tied to the New England Compounding Center, the FDA directed pharmacy boards around the country, including Colorado, to contact registered pharmacies to remind them what current law requires. Colorado sent a letter in December. An article in the January CSEPS newsletter featured information on options for ophthalmologists seeking compounded drugs for in-office use. The article correctly noted that the only way physicians can obtain a supply of compounded drugs without using “patient-specific” prescriptions is from in-state pharmacies. If out-of-state pharmacies are used then doses have to be tied to individual patient prescriptions.
Muddled response
According to Denver retina surgeon Alan Kimura, MD, the response to the reminder letter by many pharmacies has been swift if not muddled. Kimura notes that his group has been using out-state pharmacies for years to provide a cost-effective supply of Avastin for retina patients and since the turn of the year those pharmacies either stopped supplying Avastin or significantly increased their prices. The net effect has had a devastating impact on patients and physicians are struggling to provide cost-effective alternatives.
Avastin isn’t the only drug to treat wet macular degeneration but the Lucentis and Eylea alternatives can be thirty times more expensive to both patients and the health system. Montrose retina surgeon Nicholas Neubaum, MD, sums up what many CSEPS members are facing. “I had a patient come in the other day and tell me that she cannot afford the increased $150 co-pay for her Lucentis after the switch from Avastin and I didn’t have any solutions for her,” he said. Kimura agrees. He notes that using in-state pharmacies would skyrocket his group’s acquisition costs, while switching to Lucentis as an alternative would significantly increase costs to patients and add an additional $25 million dollars to Colorado’s health care system. “At a time when we are trying to enhance value in health care, this seems like such a waste of precious resources,” he says.
Compounding vs. repackaging
According to Colorado State Board of Pharmacy the issue is not new.  Colorado has never allowed out of state pharmacies to ship drugs into Colorado without them being dispensed pursuant to a patient prescription. The NECC tragedy surfaced activity that is actually illegal under current Colorado law. Perhaps more importantly for retina patients, pharmacies that send a supply of Avastin to physicians for in-office use are notcompounding the drug they are actually repackaging it according to the pharmacy board.
Pharmacies that repackage drugs must register and comply with different FDA safety regulations. Apparently many pharmacies are disinterested in becoming registered with the FDA.
As a result, obtaining a cost effective supply of certain ophthalmic drugs is becoming an increasingly hot topic as patients and the overarching system are being impacted. Ophthalmologists can play an important role as Kimura says, “We know that if we act as good stewards of the health care dollar, we can provide excellent care and help patients and the system save money.”
CSEPS is actively working with the Colorado State Board of Pharmacy (CSBP) to educate ophthalmologists about these issues and explore possible policy solutions. If you have questions or ideas for potential solutions, please contact CSEPS Executive Director  Chet Seward . Questions about CSBP rules should be directed to Chris Gassen, chief pharmacy inspector at CSBP, at 303-894-7887 . Watch for more information in the future. 
Quoted from here

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