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.
|In the News …|
■ Hydrus I microstent study data. Ivantis Inc. said a multicenter, international clinical trial of its Hydrus I microstent for the treatment of primary open-angle glaucoma has shown excellent results at one year.
The 69 patients in the study had been diagnosed with mild to moderate open-angle glaucoma. Study data indicated that IOP was reduced to acceptable levels in 100% of participants after they received minimally invasive stent-implant surgery. In 40 patients, the tiny nickel/titanium stent was placed during cataract surgery while the other 29 patients had the Hydrus stent placed without cataract surgery to assess whether the stent would be effective on its own.
No significant complications occurred in either patient group. At the six-month follow up, 85% of combined surgery and 70% of stent-only patients no longer needed eyedrops to control their IOP. Reductions in IOP were consistent among all patients and remained stable at the one-year follow up.
■ Femto-phaco makes list of top innovations. The Cleveland Clinic ranks femto-phaco number six on the list of the top medical innovations that will have an impact in the coming year. The list is headed by stomach-shrinking bariatric surgery for diabetes control, followed by neuromodulation devices that can nip cluster and migraine headaches before they become painful and debilitating.
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.
|In the News …|
■ B+L acquires laser company. Bausch + Lomb has exercised its option to purchase all outstanding and unowned shares of Technolas Perfect Vision GmbH (TPV), a leading ophthalmology laser company. Technolas Perfect Vision was established in 2009 through a joint venture between Bausch + Lomb and 20/10 Perfect Vision AG to develop and sell advanced refractive and cataract technologies. The deal is expected to close at the end of January.
■ Alcon acquires surgical guidance technology. Alcon has acquired the ophthalmic division of SensoMotoric Instruments (SMI), a private company based in Berlin. The acquisition provides Alcon with leading ocular surgical guidance technology, such as real-time eye tracking, automatic registration of ocular imaging and IOL positioning and alignment guidance. Alcon plans to integrate the newly acquired ocular surgical guidance technology into its existing global cataract portfolio.
■ Ophthalmologist loses re-election bid. Nan Hayworth, MD, a Republican representing the 18th Congressional District in the New York City suburbs, lost her bid for a second term in Congress to former Bill Clinton adviser Sean Patrick Maloney, who carried 52% of the vote. Dr. Hayworth won her first term in 2010 by defeating Democrat incumbent John Hall. The 2010 election saw Republicans gain control of the House of Representatives. For the past two years Dr. Hayworth has been the only female physician in Congress.
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.
|In the News …|
■ Recurrent erosion syndrome and EBMD. Recurrent erosion syndrome (RES) is commonly associated with epithelial basement membrane dystrophy (EBMD), according to a recent study by the Wills Eye Cornea Service. In the study, the etiology of RES was EBMD in 53.3% or 145 eyes, and 51.7% of cases overall were managed conservatively with 54% success. Diamond burr, the most common surgical option, was used in 40% of cases; of those, 74% were successful.
The study looked at 272 eyes in 230 cases between April 2007 and September 2011. Demographic data, treatment modality and recurrence of erosions were all noted. The second-leading etiology of RES was listed as trauma, associated with 25.7% of cases in the study. Major recurrences, defined as documented episodes of erosion on exam or by patient history, occurred in 14.8% of the 68 eyes treated with diamond burr. Minor recurrences, defined as the presence of mild pain, photophobia or irritation at least six weeks after the procedure, occurred in 11.1% of diamond burr-treated cases. With only conservative management, major recurrences were seen in 34.6% of cases whereas minor recurrences were seen in 11.5%.
■ Cataract surgery and hip fractures. A major study of Medicare beneficiaries has suggested that cataract surgery is a key contributor to improved quality of life for seniors, with fewer accidents and falls among the key factors that significantly reduced their risk of hip fractures compared to patients who have not had cataract surgery.
Researchers tracked the incidence of hip fracture occurring within one year of cataract surgery in 400,000 Medicare patients from 2002 to 2009. They then compared the data with hip fracture incidence in a matched group of patients who had cataracts but did not have them removed. Researchers attributed the 16% decrease in patients’ adjusted odds of experiencing a hip fracture to improved vision that enabled them to avoid falling. The study was published in a recent issue of the Journal of the American Medical Association.