Greater prescriptive authority in recent decades has been an all-important catalyst in developing the medical model of practice, but how can doctors continue this momentum into the future by prescribing?
By Will Pinkston, AOA Focus, June, 2015, pages 22-29
It's not so much the speech delivered by then-AOA President Richard L. Hopping, O.D., that Jimmy Bartlett, O.D., recalls more than 40 years later, but rather a single line of it.
"Optometry is a drugless profession," Dr. Bartlett recollects of the address given at Southern College of Optometry in the early 1970s. Little could anyone know then the irony of that statement.
Possible sampling protocols for practitioners
Below are a few examples of protocols that ODs might employ for the use of pharmaceutical samples in their practice. These are not intended to imply a standard of care, nor do they necessarily represent the most efficient use of samples. However, this list—drafted by Drs. Tom Annunziato and John Coble—offers doctors a good starting point for developing their own sampling etiquette.
• Sample one bottle initially to evaluate drug's effect on IOP.
• Write prescription after successful follow-up.
• Write prescription refill on future follow-up visits—do not provide additional samples.
• Sample one bottle to patient with new diagnosis; write prescription.
• Sample drop while patient is "in the chair" for previously diagnosed patients—one dose to the eye to ensure tolerability; write prescription.
• Do not sample returning allergy patients; write prescription refills.
• Sample drop while patient is "in the chair" to start therapy; write prescription for patient to fill immediately.
• Only provide sample in extreme situations in which patient cannot get to a pharmacy on the same day.
• Never provide a sample without prescription.
Dry Eye OTC
• Sample only one bottle of one product during eye examination; provide written prescription for product to increase patient compliance.
• Do not give patient multiple samples.
• Do not give patient different sample products on same visit.
Contact lens care solutions
• Sample only one starter kit per patient each year, or coupons; provide written prescription for the product to increase patient compliance.
• Do not give patient multiple sample starter kits or rewetting drops.
• Do not give patient different sample starter kits or rewetting drops on same visit.
New pharmaceutical products
• Newly introduced OTC or prescription products might be sampled by doctors to achieve a level of clinical comfort with the product.
• Samples should, generally, be accompanied by a written prescription for both OTC and prescription products.
Before the decade's close, three states would grant optometrists varying degrees of pharmaceutical authority, becoming a catalyzing moment in the evolution of optometry's scope of practice. It set off a chain of events that Dr. Hopping, himself, called one of the most significant events of his lifetime. Today, optometrists in every state have some degree of prescriptive authority for diagnostic or therapeutic pharmaceutical agents (DPA/TPA).
"Prescriptive authority has certainly changed the stature of our profession," says Dr. Bartlett, professor emeritus at the University of Alabama at Birmingham School of Optometry.
And how ODs exercise that ability to prescribe and provide medical eye care helps ensure that prominence.
So just how far has optometry come? Jim Thimons, O.D., co-founder of a multidisciplinary referral center in Connecticut and an ophthalmic clinical educator, says the decades of investment to grow the profession's scope of practice—both in pharmaceutical utilization and procedures—have not only produced a notable change in public perception, but also a shift in the self-perceived status of the profession and an acceptance by the medical community of the full-scope optometric provider.
"There's hardly a profession in health care over the past 30 years that has had more growth than us," Dr. Thimons says.
Consider that it took only 26 years from the passage of the first pharmaceutical optometric act to widespread therapeutic legislation (read In scope, from the November/December 2014 edition of AOA Focus), and it's clear to see. Look to even the past 15 years where practitioners were granted authority to prescribe oral agents, further solidifying the profession's distinction as primary eye care providers.
"The capacity to take care of patients across all levels of complexity has become a part of the day-today practice," Dr. Thimons says.
But every victory comes at a price—be it the hours AOA-member doctors spent advocating or the cost of legislative battles over the years. Therefore, it's important for doctors to utilize those privileges that have been long fought for, Dr. Bartlett says.
"Patients like the care they're receiving therapeutically in optometric practices today," Dr. Bartlett says. "They like the convenience, and patients are on our side when it comes to this subject. We need to make sure practitioners are fully embracing their privilege."
Pharmaceuticals in practice
To some extent, that self-review of how practitioners are embracing prescriptive authority boils down to a question of comfort level and style of practice. Dr. Bartlett says to look to the rural optometric practices 125 miles outside of Birmingham, Alabama, for example, where he estimates the majority of ODs emphasize medical optometry out of necessity for their patients.
"But go to a metropolitan area, for instance, and there's everything in between," he says. "There's a very, very wide diversity of styles of practice in our profession."
That's a sentiment clearly reflected by continuing education (CE) in the past 15 years, says William Marcolini, O.D., an ophthalmic clinical educator and a referral center doctor in New Jersey. Initially motivational in its approach toward prescriptive action, CE on the topic these days tends to focus more on practice pearls to enhance practitioners' comfort level with appropriate drugs.
"I've found in the referral center there are less referrals for common conditions—especially with new graduates' higher level of comfort and experience—I think optometrists are prescribing more topicals and oral medications for common conditions," Dr. Marcolini says.
Agustin Gonzalez, O.D., of Texas, has authored multiple posters and studies on prescribing habits of optometrists dating back to 2007. Among them, a 2014 survey of 107 practitioners published in Clinical Optometry.
According to Dr. Gonzalez's A survey of optometrists' ophthalmic medication prescribing, 90 percent of respondents were at least somewhat likely to prescribe a dry-eye product, followed by anti-infectives (86 percent), a combination anti-infective/steroid (84 percent) and antihistamine (80 percent).
On the opposite end of the spectrum: Only 36 percent of respondents were at least somewhat likely to prescribe nonsteroid anti-inflammatories (36 percent), antivirals (12 percent) or antifungals (2 percent). It is worth noting that state prescribing limitations, geographic distribution of participants as well as individual preferences for combination medications over individual therapy drops were noted study limitations.
Dr. Gonzalez cautions how the data is interpreted, noting that it is meant to be directional in manner, but also agrees. Also, the data likely reflects what practitioners are most commonly seeing, diagnosing and prescribing in their practices—i.e., more dry eye cases than allergies.
A more recent study presented at the 2015 Academy of Optometry Meeting analyzed 2.2 million prescriptions for ocular allergies written by both optometrists and ophthalmologists over a 52-week period. He found a near-even split in prescriptions written by ODs versus MDs.
Dr. Gonzalez states that "when accounting for volume of eye care and optometric manpower, it appears that optometrists seek palliative treatments or over-the-counter as initial treatment." He adds, "It's also clear this is a very big area for optometry to grow."
So how can doctors maximize their therapeutic practice? Drs. Bartlett and Thimons, both presenters of pharmaceutical courses at Optometry's Meeting® 2015, offered suggestions for developing this area. And it starts by getting in the know.
Know the disease state, know the patient and know the drugs, Dr. Bartlett says. Reach out to a fellow doctor who uses therapeutics, or visit a local optometry school to gain that hands-on knowledge. Gain experience to gain confidence.
And once doctors are confident with their therapeutic knowledge, Dr. Thimons says to reinforce this confidence with staff so they, too, understand the importance and value of services rendered. Staff will effectively bring patients into the practice.
"The doctor needs to effectively educate their staff and patients, that the doctor is available for these services," Dr. Thimons says. "I see young doctors do this on a regular basis, and within a year or two they have a thriving medical practice because they've announced to the world that they're there."
"That's what patients want," he adds. "Doctors who they can trust and who are willing to give the extra effort."
Use of pharmaceutical samples
Clearly, optometrists have embraced their prescriptive authority as an important step in medical eye care, but this emergence also has sustained debate about how pharmaceutical samples are to be used.
Current AOA Industry Relations Committee Chair Tom Annunziato, O.D., and John Coble, O.D., Meetings Center Executive Committee chair, and a former Industry Relations Committee member, wrote in a 2006 article titled, "Appropriate use of pharmaceutical samples in the optometric practice": "Many optometrists believe pharmaceutical companies fail to recognize the important role optometry now plays in medical eye care. They frequently complain that they are unable to obtain enough pharmaceutical samples from drug makers (while) ... manufacturers have long complained that optometrists are not appropriately using the samples they do receive."
This isn't a debate solely confined to optometry. Health care professionals recognize the importance of using samples to test treatment efficacy. Likewise, industry recognizes the importance of using samples as a way to introduce new products to the market. But contention develops over the question "how much is too much?"
"That's what we wanted to answer when we saw sampling practices," Dr. Annunziato says.
Surveyed for the paper: 10 optometrists of varying degrees of pharmaceutical use and geographic location, and 10 ophthalmic pharmaceutical industry representatives. The informal survey determined these optometrists issued anywhere from a few prescriptions per month to 175 per month, while virtually no prescription samples were dispensed in one case, compared to dozens over the course of a month.
According to the paper, a self-described "conservative prescriber" with a large base of medical eye care patients wrote about 20 prescriptions per month and preferred to use a full sample bottle for each patient. The practitioner reported frequently dispensing samples for ocular lubricants, antibiotics, ocular vitamins and dry-eye therapies, as well as over-the-counter (OTC) products. "We have to pass out nonprescription samples regularly or our office would become a storage facility," the respondent said.
Compare that to a respondent who wrote about 175 prescriptions per month, but rarely issued any prescription samples, except for glaucoma patients while adjusting medications. One respondent with multiple locations and five associates wrote about 60 prescriptions per month—double that amount when accounting for their associates—with fewer than 10 prescription samples given each month. However, about 300 to 400 contact lens solution samples or other non-prescription products were provided to patients monthly.
From an industry standpoint, samples represented about 21 percent ($5.7 billion) of the total pharmaceutical marketing dollars spent in 2012, according to the Pew Charitable Trusts' Prescription Project. Dr. Annunziato noted a pharmaceutical representative who said the manufacturer would have to give away 10 samples to sell one product.
In the long run, giving away samples without also writing a prescription could raise the cost of doing business, he says.
"It was clear we'd have to reach some kind of consensus and develop a guideline," Dr. Annunziato says.
Referring to this guideline, Dr. Coble explains doctors might choose only to give samples for chronic conditions as a means for testing efficacy, to be followed up with a prescription; use samples of contact lens solutions only for starter kits; and solely write prescriptions for any acute conditions.
"We would see a patient come in with conjunctivitis and the doctor provide a sample, 1 milliliter antibiotic—enough to get started. The eye would often start clearing up and so the prescription was never filled," Dr. Coble says. "If you give a sample out (in this case), you may not be taking care of the patient in the proper way, such that their condition could bounce back and possibly the bacteria could become resistant."
The debate over pharmaceutical samples also can be attributed to the societal expectation that patients receive a free sample when they visit the doctor, such as the toothbrush from a dentist. The optometric equivalent might be contact lens care solution. Dr. Coble suggests using sample solution in patients' starter kits yearly along with a prescription to increase patient compliance.
And as Drs. Coble and Annunziato wrote: "The best policy regarding pharmaceutical samples may simply be: Use them, don't abuse them."
On the horizon
While optometry has come far in its prescriptive authority with landmark scope of practice legislation on a state-by-state basis, the endeavor is not complete. The AOA, affiliate associations and volunteer members work tirelessly to ensure practitioners can continue to practice full-scope medical optometry for the benefit of their patients. And there's no limit to the profession's promising future.
"The potential is just unlimited for optometry to play a role in the future of health care," Dr. Thimons says.