EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/115557
March 2013 not commercially available. Some compounding examples are drugs for Acanthamoeba keratitis, our compound to treat hypotony, our drug to treat cystinosis, and a substitute for preservative-free epinephrine. Without compounding, these medications would not be available. We can meet a patient's individual medical need by customizing a drug specifically for them as prescribed by the doctor. Meeting individual patient needs rather than a "one prescription fits all" approach is truly the future of medicine as treatments become more individualized and specific. Compounding also is a tremendous asset with the current state of drug shortages. Dr. Chang: The NECC disaster has made many M.D.s and patients understandably anxious about the drug compounding industry. Is this concern justified? Mr. Leiter: What happened at NECC was a disaster. They were operating under horrific, unsafe conditions, and they never should have been in business. They've unfairly tarnished our entire industry. No responsible doctor should have ever ordered from NECC. The FDA and pharmacy boards should have shut them down years ago, and the owners should never have allowed product to ship. There are so many people to blame for this fiasco, but the owners bare the ultimate responsibility for this preventable catastrophe. NECC was not PCAB accredited. The No. 1 rule for doctors when ordering a compounded medication is to verify that the pharmacy is PCAB accredited. Doctors or buyers at their clinics or ASCs should know and trust who they are doing business with and should not procure on the basis of selecting the lowest cost provider. Following are the six things that any doctor and patient should look for in a compounding pharmacy: 1. PCAB accreditation 2. Investment in quality 3. Standards of compliance 4. Lab environment 5. Certifications 6. Quality assurance practices NECC failed in all of these areas. It was run by greedy owners, and their lower prices drove their volume and profits. There was no con- cern for patient safety. Individual families made the greatest sacrifice, with illness and the loss of lives. Rhein Fire & Ice Mask Product #85-9005 Dr. Chang: Increased regulation and oversight over drug compounding is sure to follow. How do you think this will affect or even threaten patient access to various ocular medications? Mr. Leiter: The increase in regulation and oversight is causing a lot of confusion, additional paperwork and reporting. This is driving additional staffing, which will lead to price increases. Even with potential price increases, the compounding industry should have additional regulation and oversight, but it should be thoughtful and relevant yet not cause unnecessary bureaucracy. For instance, 15 states are now requiring patient names be provided for every Rx, so in these states, there is no more ordering "for office use" allowed. I am not sure how this is helping with quality and safety, but it is causing a lot of extra work and confusion, and it is inhibiting a doctor's ability to treat patients in the office with compounded medications. This means that some patients will have to wait 24-48 hours to get a prescription filled for an in-office procedure such as an antibiotic or Avastin injection. The very real impact of this could mean the difference between a good outcome and a bad outcome for a patient's health and welfare. I do not believe compounding by qualified PCAB accredited pharmacies will be prohibited. Compounding pharmacies provide an important service by meeting specific individual patient needs in a very tangible and personal way, and when this service is provided correctly, compounded medications are safe and effective. I believe that the FDA should take an active role in approving qualified compounding pharmacies. I think everyone needs to make a personal commitment and work together to prevent another NECC disaster from ever happening again. EW s &OR (EAT 4HERAPY 0LACE )T )N ! -ICROWAVE &OR 3ECONDS 7ARM 2ELIEF ,ASTS -INUTES s &OR #OLD 4HERAPY !FTER 0LACING )N 4HE &REEZER (OURS #OOL 2ELIEF ,ASTS -INUTES s )NCLUDES #LOTH 3LEEVE &OR !DDITIONAL ,ID 0ROTECTION s %ASY 4O 5SE !ND #AN "E #LEANED !ND 2EUSED -ULTIPLE 4IMES s !VAILABLE 5NITS 0ER "OX &OR -ORE )NFORMATION #ALL #OME 3EE 5S !T !3#23 "OOTH 3360 Scherer Drive, Suite B, St. Petersburg, FL 33716 s 4EL s &AX %MAIL )NFO 2HEIN-EDICALCOM 7EBSITE WWW2HEIN-EDICALCOM Contact information Chang: dceye@earthlink.net Leiter: cleiter@leiterrx.com Woman Wearing Dry Eye Heat Mask RHEIN CODE 1301 Rev.C VIDEO CODE ACBB