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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.
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