NJ Bill to Expand Optometric Scope of Practice Clears First Hurdle

Ophthalmologists in New Jersey were dealt a significant blow when a State Assembly Committee approved a bill that could potentially allow optometrists to prescribe drugs and perform a number of surgical procedures.

If approved by the Legislature, the bill will give the New Jersey State Board of Optometry the power not only to determine training requirements, but also to credential and certify optometrists regarding the following: “the use and prescription of pharmaceutical agents reasonable to the practice of optometry, including controlled dangerous substances . . . except that the board shall determine which controlled dangerous substances may be used and prescribed; the prescription and administration of epinephrine or equivalent medication to counteract anaphylaxis or anaphylactic reaction; the removal of superficial foreign bodies from the eye and adnexae; the delivery of care reasonable to the diagnosis and treatment of conditions or diseases of the eye and adnexae, including, but not limited to diagnostic and therapeutic applications of ophthalmic ultrasound and laser technology, as determined by the board; except that these applications shall not include: (1) invasive intra-ocular surgery; and (2) LASIK surgery, which, for the purposes of this subsection, means the use of a mechanical micro-keratome and blade to create a corneal incision.”

The New Jersey Academy of Ophthalmology (NJAO) has responded with a call to action encouraging its members to become politically involved (the NJAO’s Call to Action can be accessed at www.njao.org). According to Donald Cinotti, MD, Legislative Chairman for the NJAO, the most dangerous part of the bill is that it establishes that the Board of Optometry will determine the training and scope of practice of its members, whereas in ophthalmology, these parameters are determined by hospitals and respective state Healing Arts boards.

“This bill allows the Board of Optometry to decide upon any surgical procedure that their licensees can perform,” says David Ringel, DO, President of the NJAO. “The language, however, is confusing, because the bill initially does not allow optometrists to perform what it terms ‘noninvasive intraocular surgery;’ but a critical read of the entire bill shows that it enables the Board to approve the performance of any surgical procedure based on their ability to include it within the scope of practice of optometry.”
The legislation was originally introduced by Assemblyman Joseph J. Roberts, who holds a 17% ownership share in U.S. Vision, a privately owned eye-care company, which some opponents of the bill believe could substantially benefit from its approval. Roberts withdrew his bill, and a similar bill was later sponsored and introduced to a different Assembly committee by Assemblyman Jeff Van Drew, a dentist from Cape May County. The latter committee, which approved the bill by a 5 to 1 margin, is chaired by the Honorable Nilsa Cruz-Perez, whom Drs. Cinotti and Ringel point out is Roberts’ electoral running mate.

During the proceedings, one ophthalmologist spoke in favor of the proposed legislation. Douglas K. Grayson, MD, Medical Director and Chief of Glaucoma and Cataract Surgery for Omni Eye Services in Iselin, New Jersey, stated that the purpose of the bill was not to allow optometrists to perform surgery, but rather to allow ?a formal structure and framework for the Board of Optometry to make provisions for integration of new technology in the field subject to extensive educational requirements and public and legislative scrutiny.? Drs. Cinotti and Ringel emphasized that the bill in no way improves patient care in New Jersey, which has the eighth highest concentration of eye doctors in the US and borders two major metropolitan areas in neighboring states.

The New Jersey legislative bodies are currently on a budget break, which provides a small but substantial window of opportunity for ophthalmologists to voice their concerns. The final vote will likely take place in May or June, but Dr. Ringel believes that the “political juice” behind the bill could propel the legislature to action at any time.

To view the State Assembly bill in its entirety, visit www.njleg.state.nj.us/2002/Bills/A3500/3364_I1.HTM.

Army Approves of PRK for Special Forces Soldiers Using Night Vision Goggles

The AAO recently reported that a study sponsored by the US Army Medical Command concluded that PRK causes no loss of visual resolution and improves UCVA and resolution during the use of night vision goggles under a range of conditions. The study, which was conducted at the Walter Reed Army Medical Center (Washington, DC), administered PRK to 38 eyes of 19 active-duty US Army Special Forces soldiers for the correction of nearsightedness and astigmatism. Eighty-six percent of the eyes reportedly achieved UCVA of 20/20 or better at 3 months postprocedure, and their uncorrected resolution was significantly enhanced compared to preoperative levels.

“In this important study, Special Forces soldiers achieved great daytime vision without glasses and contact lenses and improved vision through their night vision goggles, compared to their uncorrected vision before surgery,” said AAO spokesperson Robert K. Maloney, MD. “This study should provide [an] impetus to the US military to consider laser vision correction for all combat soldiers with poor vision. Our remarkable soldiers deserve no less.”

HHS Announces New Patient Safety Measures

The US Department of Health & Human Services (HHS) recently announced two FDA-proposed rules intended to improve patient safety. The rules will require bar coding on all medications and will improve reporting requirements for safety issues related to each medication. If implemented, the required bar code would contain the National Drug Code number and unique information about each drug, and its design would allow the addition of new information as technology progresses. An HHS press release states that the expected annual benefit from preventing adverse events due to medication errors is equivalent to $3.9 billion. The rule would apply to all prescription drug products and over-the-counter drugs commonly used in hospitals, and standardized bar coding would be required for prescription drugs used in retail pharmacies.

The proposed changes to the safety reporting protocol would require companies to submit within 15 days all reports that they receive of actual and potential medication errors in the US. In order to raise the quality and consistency of safety reports, the rule would also require the use of internationally agreed-upon definitions, reporting formats, and other reporting standards. The HHS states that the proposal refines and clarifies expectations for amounts of data needed in safety reports, thereby lessening some of the industry’s reporting burdens.

CIBA Vision Purchases Medennium’s PRL Phakic Refractive Lens

CIBA Vision Corporation (Atlanta, GA) recently purchased the PRL posterior chamber phakic refractive lens from Medennium, Inc. (Irvine, CA). CIBA Vision began distributing the lens in July 2000. The PRL, a silicone, plate-haptic, posterior-chamber, foldable phakic refractive lens is designed to float above the anterior surface of the crystalline lens on an aqueous fluid layer. The lens can be implanted through a 3.2-mm incision.

Approved for use in the European Union in December 2000, the PRL has entered FDA phase III clinical trials for myopia and phase II trials for hyperopia. CIBA Vision will now assume responsibility for the clinical trials, and Medennium will continue to manufacture the lens during a transitional period.

FDA Approves B & L’s Technolas 217A for Treating Hyperopia

Bausch & Lomb Incorporated (Rochester, NY) has received FDA approval for its Technolas 217A Excimer Laser System for use in the correction of hyperopia. The system may now be used to treat myopia of up to -12.00 D, and hyperopia of up to +4.00 D, both with and without astigmatism. Stephen G. Slade, MD, of Houston, who served as Medical Monitor for a clinical study that preceded the submission to the FDA, commented that the announcement “means that now I can offer all of my patients, myopic and hyperopic alike, the same superb technology.”

Refractec Completes Phase III Presbyopia Clinical Trial Enrollment

Refractec, Inc. (Irvine, CA), has completed patient enrollment for its FDA Phase III clinical trial evaluating Conductive Keratoplasty (CK) for the treatment of presbyopia. Recent data from the 160-eye CK presbyopia trial show that, at 12 months, 97% of the patients could see 20/20 at distance and read magazine- and newspaper-sized print; 75% could see 20/20 and read J2 at near; and 96% reported being “satisfied” to “very satisfied” with their outcome. The company plans to file for premarket approval later this year.