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A THREE-YEAR WAIT FOR PRESCRIPTION PRIVILEGES

New Jersey Oral TPA Licensure Requirements Finalized
By Jennifer Kirby, senior associate editor

Almost three years after the New Jersey legislature passed a bill allowing optometrists to prescribe oral therapeutic pharmaceutical agents (OTPA) and the regulation was formally adopted, the New Jersey Board of Optometrists (NJSBO) has finalized the oral TPA licensure requirements.

What are these requirements? If you graduated from a college of optometry before August 5, 2005, you must take 30 hours of coursework in ocular pharmacology administered by a school accredited by the United States Department of Education and the Council on Postsecondary ac-creditation and approved by the NJSBO. (Those who graduated on or after August 5, 2005 are grandfathered into this requirement, as the established necessary coursework — explained below — is a prerequisite for graduation.) The New Jersey Society of Optometric Physicians (NJSOP) has contracted with the Pen- nsylvania College of Optometry and the State University of New York (SUNY) College of Optometry to administer the coursework.

The TPA curriculum

The 30 hours of coursework must be distributed amongst the following nine courses:
• General pharmacology of appropriate agents
� Pharmacokinetics (including drug absorption, distribution, metabolism and elimination)
• Special populations, such as geriatrics and pediatrics
• Prescription writing and appropriate dosages
• Appropriate ethical uses of off-label medications
• Safety issues (adverse drug reactions and interactions, recognition of systemic side effects, awareness of medication errors, inappropriate use of medical abbreviations, proper notification of FDA MedWatch and prevention of errors)
• Addiction recognition of pa-tient, self and impaired practitioner
• Record-keeping
• CPR.

Once an optometric physician has completed this educational component and passes a written examination, he'll be credentialed to pre- scribe oral agents for the treatment of ocular conditions. Successful applicants can then also apply for a Drug Enforcement Agency (DEA) number.

The state of N.J. OTPA

There is no deadline for O.D.s to gain their TPA licensure in New Jersey. The only requirement: New Jersey O.D.s who sit for the course- work must have a valid topical TPA license. (The state still has a small pool of diagnostic-only O.D.s, and they are not eligible to become certified in oral TPAs.) In addition, from this point on, all new licensees in New Jersey must be licensed at the highest level, meaning they must be oral TPA certified.

The first round of courses is being offered this winter. The cost to NJSOP members is $1,325, and the cost to non-members is $1,987. There is a slightly lower rate for 2005 graduates. More information can be found at www.njsop.org.

The benefits of licensure

Michael Veliky, O.D., current president of the NJSOP, says the certification offers three benefits:

"It [the orals certification] allows New Jersey optometrists to better care for their patients who require oral TPAs, as they no longer have to refer these patients to their general practitioner or an ophthalmologist to receive the prescription their medical condition requires," he says. "It also emphasizes once again that optometry is not just a spectacles-dispensing profession; we're an integral part of the medical team, and we have been all along."

The third benefit: "Currently, optometric patients often have a difficult time filling a topically prescribed medication because the pharmacy, per the insurance carriers, asks for a DEA number. It's not required by law; rather, it's an inappropriate use of the DEA number by the insurance industry to track prescribing doctors and prescriptions," Dr. Veliky ex-plains. "As New Jersey optom- etrists currently don't have DEA numbers, the patient ends up with difficulty filling a legally prescribed medication. On some level, orals certification and DEA numbers will end this battle between optometric physicians and insurance companies and pharmacies." For more information on this certification, visit www.state.nj.us/lps/ca/adoption/optado1218.htm

CIBA Recalls Select Lots of O2Optix

Last month, CIBA Vision issued a voluntary recall of selected lots of O₂Optix (lotrafilcon B) soft contact lenses after the company found some lenses in those lots may fall below the standard for ion permeability. CIBA discovered the ion permeability issue as a routine part of the company's quality control process. "With soft or HEMA lenses, ion permeability is not a concern because salts readily pass through the lens," said Rick Weisbarth, O.D., vice president, professional services CIBA Vision. "This is not the case with sili- cone hydrogels, where ion permeability is an important material characteristic, which contributes to lens movement on the eye."

The affected lenses were distrib-uted between Sept. 2006 and Dec. 2006 and include all lot numbers starting with 6644001 through 6721262 with expiration dates starting from 2011/09 through 2011/11, as well as lot numbers 6626127, 6636101, 6637017, 6637019, 6637103, 6640120, 6640124, 6642109, 6642119 and 6643080, all with the expiration date of 2011/08.

The company says external experts confirmed that the probability of a serious adverse event associated with these lenses is remote. The recalled lenses may cause persistent discomfort, foreign body irritation and superficial corneal staining, usually within the first one to four hours of wear.

As with any staining, the risk of corneal infection is somewhat in-creased, although the probability is remote. Signs and symptoms generally resolve quickly (within two to 24 hours) upon removal of the lens.

CIBA Vision notes that no serious adverse events related to this issue have been reported globally. "Not all of the lenses are affected, but to facilitate a smooth recall, CIBA is recalling all lots produced within the Sept. to Dec. time frame," said Dr. Weisbarth. Only seven, non-serious complaints that are likely related to the use of O₂Optix lenses with reduced ion permeability have been reported to the company.

Effected lenses should be sent back to the company along with the "Recall tracking form." If you have not received this form, contact CIBA Vision Customer Service at (800) 241-5999. The company says it has already implemented manufacturing process improvements and addressed the ion permeability issue. However, product availability will continue to be affected. In the United States supply constraints and backorders into the second quarter are expected, with increasing improvements through mid year.

PERSONNEL

The American Academy of Optometry inducted Richard E. Weisbarth, OD, FAAO, as President. Joe Yager, OD, 2005 and 2006 president, will continue on the Academy board of directors as past president. Mark Eger, OD, was voted president-elect and Karla Zadnik, OD, was elected Secretary-Treasurer. Elected board members were Drs. Brett G. Bence, Bernard J. Dolan, Barbara Caffery and Joseph P. Shovlin.

The National Optometry Hall of Fame selection committee invites nominations for this year's induction ceremony, which is scheduled for October at the EastWest Eye Conference at the Cleveland Convention Center. Mail letters of nomination and all other supporting documentation to: National Optometry Hall of Fame, P.O. Box 6036, Worthington, Ohio 43085, or email to info@ooa.org. The deadline for Hall of Fame nominations is March 9.

Bausch & Lomb announced that Gary M. Phillips, M.D., corporate vice president-global pharmaceuticals, will head the company's U.S. pharmaceuticals and surgical business as part of a realignment of B&L's Americas region. Angela J. Panzarella, corporate vice president-global vision care, will head commercial operations in Canada and Latin America. Paul G. Howes, current president of the Americas region, will resign.

Optos, an imaging devices company, appointed Thomas W. Butts as Chief Executive Officer and a member of their Board of Directors.

New Alcon Site Includes Information for Docs

Alcon has launched the Web site, alcon.com, for physicians, patients caregivers and media. The section alcon.com/professionals includes sections on product advances, medical education, FAQs, U.S. sample requests and interactive features.

FDA APPROVALS

Alimera Sciences announced approval of its ophthalmic solution Rx-to-OTC-switch new drug application (NDA) for Alaway (ketotifen fumarate ophthalmic solution 0.025%). The multiple action eye anti-allergic drug is Alimera's first NDA submission and its first to win approval.

Carl Zeiss Meditec, reported it has received FDA clearance to market the laser keratome applications of its VISUMAX femtosecond laser system. A commercial launch of the femtosecond technology is planned for mid 2007.

INDUSTRY BRIEFS

Accutome, Inc. has announced it has become an official distributor of Volk Lenses, makers of aspheric optics. Accutome will carry the full line of Volk lenses.

Why do your patients drop out of contact lenses? Tell us at opto metricmanagement.com.

 Advanced Medical Optics has acquired Wavefront Sciences, a provider of wavefront diagnostics systems for refractive surgery and medical research. AMO also announced an agreement to acquire IntraLase for $808 million.

Eyemaginations announced it has signed a graphics licensing agreement with the American Optometric Association (AOA). The agreement will provide Eyemagination's eyecare images and animations for the AOA's various educational and marketing materials through print and electronic media.

Paragon Vision Sciences announced the launch of Paragon Z CRT in the United States. With the addition of the Menicon Z material to the Paragon CRT product line, practitioners now have access to two high Dk GP materials that are FDA approved for an overnight corneal reshaping

Transitions Fund Supports Sight for Life

Transitions Optical introduced the Transitions Healthy Sight for Life Fund, which will encourage people to take steps to help enhance and protect their vision today and for a lifetime.

The Fund will feature a stand-alone consumer-targeted Web site (healthysightforlife.org), video and brochure to address the importance of healthy sight at every stage in life and provide information on the steps people should take to protect and optimize their vision. The Web site, video and brochure will be available in English, Spanish and French.

A toolkit with educational materials and marketing tools will also available in 2007 to help charity and trade professionals reach out to consumers within their local communities.

As a grant-making entity, the Fund will offer financial support for qualified charities and optical professionals. Details on eligibility and the grant submission process will be released later in 2007.
 

Borish Biography is Released

The biography of Dr. Irvin Borish, written by Dr. Bill Baldwin, has been recently released. According to Jack Runninger, O.D., consulting editor for Optometric Management, the biography "is the story of a remarkable man who combines genius, common sense, professional devotion, impressive work ethic and unbounded energy, even now at the age of 94.

"As the most significant contributor to the growth and education of optometry over the past 75 years, he has earned the title "Optometry's Architect."'

The son of impoverished immigrants, Dr. Borish became an intellectual giant, although he was too poor to afford high school or college textbooks. "In the telling of the fascinating story of this extraordinary man, we also see an absorbing history of optometry over the past 75 years," says Dr. Runninger.

To obtain ordering information, call (812) 855-4447, or visit www.opt.indiana.edu. All proceeds from the book go to optometric education.