Compounded Ophthalmology Options at O’Briens
Eric Everett, RPh, FIACP
Solving the difficult problems gives us our greatest satisfaction. For example, how do you accurately dose different drugs, in multiple eye drops, into the eyes of a thrashing two-year-old? As many ophthalmologists and optometrists know, it’s a little like a WWF free-for-all: a tag team of staff to pin the shoulders, hold the head, open the eyes and instill the drops – never knowing how many drops really go in.
The answer came in a solution containing all of the drugs, in a metered-dose applicator that is sprayed on the eyelid, documented (and published) to provide the same effect as the medications painstakingly and individually instilled. Stressed staff, patients and parents are now smiling. O’Brien Pharmacy has provided this customized agent for almost 10 years, containing as many as four medications in a sterile, stabilized, preserved, and pH adjusted spray.
When a disease or condition of the human body demands the care of a specialist, like an ophthalmologist, sometimes the situation warrants the individualized, innovative and flexible drug therapy of O’Brien Pharmacy.
We provide sterile solutions, ointments, suspensions and injections to greatly increase the breadth and depth of drug therapies for the eye care specialist. This frees the practitioner from the limited choices of commercial medications and opens a world of therapeutic possibilities.
Preservative-free? Benzalkonium chloride is found in most commercial preparations at concentrations 100 times the amount shown to be toxic to the corneal endothelium. Other preservatives can be irritating or cause allergic reactions. Many medications, or suitable alternatives, can be prepared preservative-free. Retinologists often prefer a preservative-free intravitreal triamcinolone, which is only available from a sterile-qualified compounding pharmacy.
Higher or lower drug concentration? Long-term therapy, pediatrics, geriatrics, aggressive therapy, and other circumstances can occur where a higher or lower drug concentration would be preferable to a standard commercial product.
Increased viscosity or a multi-drug product, or both? This is inherently important since the eye barely holds even one drop in five to ten minutes. When multiple drops and multiple drugs are prescribed, complexity quickly escalates as drops are instilled too close together, causing a diluting and flushing effect. By incorporating multiple drugs into a single drop and/or increasing viscosity, tissue contact time and effect are therefore enhanced. A multi-drug product can reduce administration time and improve patient compliance.
Although an abundance of antibiotics and antifungals are commercially-available, resistance still occurs. Compounded eye drops like vancomycin, tobramycin, ceftazidime, gentamycin, and cefazolin increase prescribing flexibility for the ophthalmologist. Amphotericin B, clotrimazole, miconazole, fluconazole and polyhexamethyline biguanide provide additional options.
Commercial drugs are often discontinued based on profit and loss, not safety and effectiveness. Dexamethasone, hydroxyamphetamine, idoxuridine, vidarabine and other ophthalmic agents have left the market simply because of sales.
When Wyeth discontinued Wydase® in 2000, many doctors turned to sterile-qualified compounding pharmacies for hyaluronidase, and continue to do so today. Dr. John Hagan of Kansas City and Dr. Warren Hill of Mesa, Arizona published a study demonstrating hyaluronidase from O’Brien Pharmacy was actually superior to the commercial product.
Parameters of sterility, tonicity, pH, preservatives, stability, viscosity and packaging are considered with each compound. In addition, it is best practice for a compounding pharmacy to test every compound for sterility, and have a program in place for testing potency by independent laboratory analysis.
When a condition presents with complexities in drug therapy and a commercial product is less than optimal, a pharmacy specializing in compounded medications may be the answer. Chances are good it will be “problem solved.”
From: MD News June, 2007 – Ophthalmology
References are available by contacting Eric Everett, RPh, FIACP at O’Brien Pharmacy, firstname.lastname@example.org.
No other pharmacy or drug company has the published research that compares their enzyme to the original Wydase®
We have prepared thousands of doses of hyaluronidase during the last decade with excellent results reported by physicians. Every lot is tested for sterility, endotoxins and potency.
Our hyaluronidase originates from a U.S. manufacturer using bovine testicles and is certified . We purchase the enzyme from a FDA-inspected facility that verifies identity by mass spectrograph and gas chromatography and provides a certificate of analysis.
It is important to note an independent study compared our hyaluronidase directly to Wydase and found our product to be superior in pain outcomes and equal in other areas (J Cataract Refract Surg Vol27, Nov 2001; Cataract and Refract Surg Today, May 2003). This is outstanding documentation for any compliance or risk issues you may have. This study alsodemonstrates a significant difference in hyaluronidase preparations.
As a PCAB-Accredited Compounding Pharmacy, our quality assurance program and policies and procedures are based on USP<797>, <795>, and other applicable chapters. This is the standard of care for sterile compounding and exceeds most state regulations. Only trained, validated pharmacists are used for all compounding, sterile or non-sterile. No medications are made by technicians.
Orders are sent refrigerated, UPS overnight or second day. No second day orders are sent on Thursday, and no shipments go out on Friday because of the weekend. Product expiration is 180 days from the time of compounding, and this is documented in our own stability studies.
Bevacizumab from O’Brien Pharmacy comes in a “no waste” syringe so you don’t pay for medication you don’t use. With a virgin needle that has not punctured a stopper, the original edge is maintained.
We have the equipment, policies, procedures and protocols in place to meet all state and federal guidelines and regulations. In addition, everything is made by a pharmacist, not a technician, in a Class 10 sterile environment, and each lot is tested for sterility.
We have many long-term clients, and have been published for our work with hyaluronidase (an independent study proved our product was superior to Wydase®).
SOME OF THE BEST MEDICATIONS WILL NEVER BE MADE…
For 15 years and thousands of patients, O’Brien Pharmacy has compounded cycloplegic/mydriatic eye sprays for pediatric
eye care specialists, with excellent results reported by practitioners.
O’BRIEN PHARMACY has the equipment, materials and expertise to deliver custom medications to your patients that meet your specifications, and the specifications of the United States Pharmacopeia. That is “Compounding without Compromise.”
The topical spray concept was reviewed in the Binocular Vision and Strabismus Quarterly 1997, Vol. 12(3) and 1999, Vol. 14(2). Both studies concluded favorably.
Because the entire preparation is compounded, we have a great deal of flexibility in the concentration and combinations of medications. The standard formula is tropicamide .5%, cyclopentolate .5% and phenylephrine 2.5%. However, we have made many variations of this formula in different concentrations and combinations, and may also include homatropine, scopolamine or proparacaine.
The sterile, preserved and pH adjusted solution is provided in a 30ml (300 sprays) bottle with a metered-dose, long-stem sprayer that dispenses exactly .1ml per actuation.
Remember, all O’Brien Pharmacy compounds are made by pharmacists, not technicians, and we source the highest quality chemicals and spend in excess of $20,000.00 per year on testing our products for sterility, potency and endotoxins. We have tested many lots for potency, and every lot is tested for sterility. This is more expensive, but we place a higher value on patient safety, quality and effectiveness. This is also excellent documentation for the healthcare provider. We have also been published in several journals for our work in supplying hyaluronidase, including a study that proved our product superior to Wydase.