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THERAPEUTICS AND OCULAR HEALTH The Art of Compounding Ophthalmic Medications What you should know about selecting a pharmacy. BY CHARLES W. LEITER, P HARM D C ompounding pharmacists play an important role in ophthalmology by allowing doctors to prescribe individualized prescriptions. For many people with unique health care needs, commercially available products are suboptimal. Compounded prescription medications may represent the best available treatment, particularly for patients with specific eye-related issues. Examples of commonly used ophthalmic medications that must be created by a compounding pharmacy are fortified antibiotics, preservative-free formulations, discontinued medications (eg, dexamethasone ophthalmic ointment, dapiprazole ophthalmic, ibopamine, dipivefrin, disodium EDTA, and polyhexamethylene biguanide), and specialty items such as bevacizumab (Avastin; Genentech, Inc.). This article provides an overview of what a compounded medication is, how it differs from a commercially manufactured medication, and—perhaps most importantly—what to look for when selecting a compounding pharmacy. WHAT IS COMPOUNDING? What is the difference between a commercially manufactured drug and a compounded drug? Compounding is a traditional method of preparing a customized medication to meet the specific needs of physicians and patients. With a compounded medication, the order is filled specific to the doctor’s request. Manufacturing, on the other hand, includes the preparation and promotion of commercially available products from bulk medicines. Drug manufacturers have economic considerations that can influence the availability of various agents and result in limited choices in terms of dosage and formulation. Compounded drugs are custom made by the pharmacist and can come in just about any formulation the patient and doctor require, including oral capsules and liquids; transdermals; lollipops and popsicles; “An improved therapeutic outcome may be achieved by the use of a compounded opthalmic treatment.” troches, tablet triturates and sublingual drops; suppositories, enemas, and rectal rockets; nasal and otic preparations; topical creams, ointments, gels, powders, and sprays; oral adhesives, mouthwashes, and rinses; and sterile products (eg, inhaled solutions, injections, ophthalmic, and total parenteral nutrition). WHY SHOULD A PHYSICIAN CONSIDER A COMPOUNDED OPHTHALMIC THERAPY? An improved therapeutic outcome may be achieved by the use of a compounded ophthalmic treatment. The pharmacy can create combined therapies to improve application or administration (eg, dilating sprays or combined drops) and targeted therapies (eg, fortified antibiotics and antifungals). Often, the compounded agent is more cost effective than the commercially available alternative (eg, Avastin for agerelated macular degeneration). Compounded prescriptions may be a way to provide orphan drugs or medications that are in short supply or discontinued. For example, no known commercially available medication exists for the treatment of Acanthamoeba keratitis. The multiple medications employed to treat this disease must be compounded. Perhaps the most commonly prescribed compounded ophthalmic solutions are made for patients who cannot tolerate preservatives. A few examples are serum tears, cyclosporine in various concentrations, pilocarpine, and preservative-free steroids. These agents are JULY/AUGUST 2010 ADVANCED OCULAR CARE 29 THERAPEUTICS AND OCULAR HEALTH invaluable to patients with sensitivities and allergies to the preservatives in commercially available products. Other common compounded ophthalmic drugs include medications not commercially available for ophthalmic administration. Diagnostic agents include corneal staining drops (lissamine green, rose bengal, and fluorescein sodium solutions) and compounds to diagnose Horner’s syndrome (cocaine hydrochloride and hydroxyamphetamine hydrochloride). The shelf life of compounded medications is typically shorter than that of commercially available products, and most must be stored in the refrigerator to inhibit bacterial growth and to extend the expiration date. CONSIDERATIONS WHEN SELECTING A COMPOUNDING PHARMACY Quality A proven track record of quality is the most important factor in the selection of a compounding pharmacy. The best way to ensure that pharmacies have strict quality standards is to use only those that are accredited by the Pharmacy Compounding Accreditation Board (PCAB).1 The PCAB assesses and inspects pharmacies and awards the PCAB Seal of Accreditation only to those select pharmacies that meet or exceed the PCAB requirements and comply with the rules and terms of the PCAB program. The PCAB Seal of Accreditation provides evidence of adherence to quality standards and to principles of the profession of pharmacy compounding. References Physicians should ask the compounding pharmacist for references. The type, quality, and quantity of the pharmacy’s customers can give a picture of its expertise. Pharmacies that are used by large HMOs and universities for their compounding needs have likely undergone extensive audits and selection procedures. Most HMOs and universities regularly audit the quality-assurance standards and practices of their providers. Size It takes a substantial investment of capital to be a firstclass compounding pharmacy. Typically, only a large pharmacy will have the resources necessary to adequately maintain a premium facility. Compounding pharmacies should be highly computerized to ensure that all medications are made the same way every time, and chemical barcode scanning should be used to avoid errors. The pharmacy should have a good qualityassurance program, and compounded drugs should be sent out for testing to an independent FDA-approved 30 ADVANCED OCULAR CARE JULY/AUGUST 2010 analytical laboratory for verification of sterility, potency, and endotoxins. There should also be drug-recall procedures in place. Knowledge and Experience Practitioners should learn how many years the compounding pharmacy has been in business and how familiar its staff is with the practice’s particular requirements. It is important that doctors work with established, experienced, reputable companies and be wary of Internet firms and those that are new to the business. Customer Service The physician should have a rapport with the staff at the compounding pharmacy. An excellent compounding pharmacist will have all the latest information regarding which agents are commercially available versus those that are better compounded. The pharmacy must be licensed in all of the states to which it provides medications and have the ability to ship overnight. CONCLUSION The role of the compounding pharmacist is to work with the prescribing doctor to individualize drug therapy. Patients’ care often involves specialized medications, and these agents require compounding. Compounding pharmacists are some of the most highly educated, professionally involved clinical pharmacists in practice today. Selecting the right pharmacy for the practice’s needs is imperative to ensuring that patients achieve the best therapeutic outcomes possible. ■ Charles W. Leiter, PharmD, is the owner of Leiter’s Rx Compounding Pharmacy in San Jose, California. He acknowledged no financial interest in the product or company mentioned herein. Mr. Leiter may be reached at [email protected]. 1. Pharmacy Compounding Accreditation Board (PCAB) Rules & Terms for Obtaining and Maintaining PCAB Accreditation.PACB.http://www.pcab.info/rules.shtml.Accessed June 28,2010. SHARE YOUR FEEDBACK Would you like to comment on an author’s article? Do you have an article topic to suggest? Do you wish to tell us how valuable Advanced Ocular Care is to your practice? We would love to hear from you. Please e-mail us at [email protected] with any thoughts, feelings, or questions you have regarding this publication.