At Press Time

How to Choose A Compounding Pharmacy

PCAB accreditation is an assurance of quality control.

By Jerry Helzner, Senior Editor

■ Ophthalmologists have a long history of dealing with compounding pharmacies. Several years ago the FDA conducted a study comparing the safety and potency of 29 specific drugs that compounders provided against the same drugs in branded form. Of the 29 drugs, nine were commonly used in ophthalmic procedures.

The troubling result of this study was that 10 of the 29 compounded drugs failed to meet potency requirements, including four in the ophthalmic category.

The quality of compounded drugs has long been an issue in the ophthalmic community, especially after several serious incidents involving tainted bevacizumab that compounders supplied for use in treating retinal disease.

However, the recent nationwide outbreak of deadly meningitis cases traced to tainted drugs for back pain manufactured by the New England Compounding Center has put a national spotlight on the need for more regulation of this widely dispersed and fragmented industry.

PCAB Sets Standards

While any ophthalmology practice planning to purchase from a compounding pharmacy would have numerous questions about the compounder’s history and quality standards, an organization called the Pharmacy Compounding Accreditation Board (PCAB) conducts a thorough review of any compounding pharmacy seeking accreditation. This review encompasses a check of the compounder’s regulatory record, an extensive on-site evaluation of the company’s manufacturing processes, including staff competency, and an assessment of the pharmacy’s systems for ensuring and maintaining product quality and staff competency.

“We currently have 170 accredited compounding pharmacies,” says Joe Cabaleiro, RPh, PCAB executive director. “No PCAB-accredited compounding pharmacy has been involved in any of the incidents of tainted products that have occurred. The problem is that only about 10% of the nation’s compounding pharmacies are accredited by the PCAB.”

Mr. Cabaleiro says the good news is that the recent bad publicity for compounders has led to more of these pharmacies seeking PCAB accreditation.

“Compounding pharmacies deliver real benefits,” he notes. “We would like to see the industry have a better image than it currently has, and PCAB accreditation can be a big part of improving that image.”

Mr. Cabaleiro cautions that even when compounding pharmacies meet the highest quality standards, the medical practice that receives the drugs must store and use them responsibly. These drugs have strict requirements for storage conditions, administration and shelf life, he noted.

“We are doing our part to ensure quality, but the practices that use these drugs must also tighten their own procedures,” he says.

Further information on PCAB and the accreditation process can be accessed at the PCAB Web site, www.pcab.org.

Mitosol: The New Face of Mitomycin

This FDA-approved, branded product offers consistency and convenience.

■ While many ophthalmic innovators have dreams of developing a transformative drug or device, Mobius Therapeutics’ founder Ed Timm and COO Jim Anderson essentially embraced the more basic concept of creating “the better mousetrap.” In their case, they wanted to take the commonly used drug mitomycin away from compounding pharmacies and hospital labs and make it an FDA-approved branded product in a convenient-to-use kit form.

Mobius’ Mitosol product offers safety, sterility, consistency, extended shelf life and a minimum of waste compared to the other methods used to formulate, store and mix mitomycin for ophthalmic procedures.

After six years of effort, Mobius succeeded this year in receiving FDA approval for Mitosol. In November, the company announced that CMS has assigned a product-specific HCPCS code for Mitosol (mitomycin for solution) 0.2mg/vial, Kit for Ophthalmic Use. Mitosol is used as an adjunct to ab externo glaucoma surgery. The new J-code, J7315, becomes effective January 1.

“When we set out to develop Mitosol, our goals were to create a standard-of-care product, solve a real problem for surgeons and offer true value,” Mr. Timm says. “I feel we have delivered on all three of those aims. In addition, our product does not require any change in the surgical procedure.”

Surgeons Praise Mitosol

Mr. Timm says the response from surgeons who have used Mitosol has been overwhelmingly positive. He says they have been primarily impressed by the consistency of the dose. This is important because mitomycin degrades quickly if it loses stability.

The Mitosol kit is intended to provide safety, consistency and convenience.

“A surgeon told me that his blebs are all the same now,” Mr. Timm says. “When he used mitomycin from a compounding pharmacy, the blebs were not uniform.”

In terms of convenience, Mitosol comes in powdered form and can be safely stored for up to 24 months. Mitomycin from a compounding pharmacy comes in liquid form and can only be stored for two weeks in a refrigerator.

“Hospitals that mix their own mitomycin often have to throw out more than 90% of it,” Mr. Timm says. “The waste is tremendous. When you take all the factors of cost and convenience into account, Mitosol offers ophthalmologists a true value proposition.”

Mr. Timm says St. Louis-based Mobius has also applied to the FDA for more indications for Mitosol, including preventing haze after PRK and recurrence of pterygium following surgical excision.

Gains in Sustained-release Drug Delivery

Punctal plugs show promise in treating glaucoma.

■ Two companies studying the use of punctal plugs as a sustained-release delivery system for glaucoma medications are reporting progress in their efforts. The companies, QLT and Ocular Therapeutix, are working independently to develop what could become a transformative method for treating glaucoma.

QLT Inc. says it has achieved improved results in its ongoing effort to demonstrate consistent sustained-release delivery of the glaucoma medication latanoprost. The advance is largely attributed to the use of company-designed, proprietary upper punctal plugs in new studies.

Data from the two new phase 2 12-week studies have demonstrated clinically significant IOP-lowering and a higher percentage of long-term plug retention beyond four weeks using the proprietary upper punctal plugs rather than the commercial upper punctal plugs used in the previous phase 2 study. The delivery system uses simultaneous placement of a combination of lower and upper punctal plugs, each filled with a reservoir of the drug.

“Clinical compliance with eye drops for the treatment of glaucoma is recognized as a major therapeutic issue, particularly in the elderly, who experience considerable difficulty in managing the use of an eyedrop bottle,” says Jason Aryeh, chairman of QLT. “The ability to deliver long-lasting, clinically significant IOP lowering that is well tolerated is, therefore, a significant therapeutic goal.”

In another trial using punctal plugs to deliver glaucoma medication in a sustained-release format, Ocular Therapeutix says it achieved promising results in its sustained-release travoprost study for the treatment of glaucoma and ocular hypertension. OTX-TP2, a drug-eluting intracanalicular plug, was evaluated for the reduction of elevated IOP over a two-month period.

The pilot phase 2 study enrolled 20 patients (36 eyes) at two sites in South Africa.

The study enrolled patients with documented open-angle glaucoma or ocular hypertension, with a mean baseline IOP of 28.7 mm Hg. A single plug was placed in each enrolled eye. Analysis showed a decrease in IOP of 6.8 mm Hg over two months of treatment. No excessive tearing or other unanticipated adverse events occurred.