Ординатура / Офтальмология / Английские материалы / Clinical Ocular Pharmacology 5th edition_Bartlett, Jaanus_2008

Box 4-1 Common Auxiliary Information

Used on Prescription Labels or Containers

Shake well before using. For external use only. For the eye.

Keep in refrigerator. Do not freeze. Keep out of the reach of children. No refills.

__ refills available.

Take medication until gone. Store in a cool, dry place. Take with food.

Avoid alcohol.

May cause drowsiness. Take on an empty stomach.

Take 30 to 60 minutes before bedtime. Take every __ hours around the clock.

Pharmacists often make notations on the written prescription usually via the pharmacy computer. These data may include the dispensing pharmacist’s initials, price of the drug, the brand name or generic product dispensed, and other appropriate notations. Prescriptions then are part of a master prescription file for each patient, which is generally kept for many years.

Types of Prescriptions

Errors can occur in all steps of prescription communications, from written to oral to fax transmissions. Patients ultimately suffer the consequences of inappropriate prescription communications, and care must be taken by both the prescribing practitioner and the pharmacist to minimize these concerns.

Most prescriptions continue to be presented to the pharmacist in a written or printed form. However, they can also be relayed over the telephone, by fax, or electronically. When telephoning a prescription to the pharmacist, the practitioner should clearly identify himor herself initially and should verify that the prescription was received and transcribed accurately at the end of the conversation. Prescribers should not be oversensitive to pharmacists who telephone them to verify prescriptions apparently called in by office personnel or nurses. Because prescription drug fraud is common, it is recommended that prescribers not delegate the function of calling in prescriptions to pharmacies; however, this, too, is common practice.

Fax transmission of prescriptions may also lend itself to prescription fraud and drug diversion.Ascertaining the origin of the fax is difficult, so fax prescriptions could be forgeries. Although some states have ruled fax transmission of prescriptions to be invalid, others have developed guidelines for the use of fax transmission.

Similarly, although some states restrict electronic transmission of prescriptions, it is clear that this type of communication of prescriptions is increasing. Medication dispensing errors can be reduced with electronic prescription transmission. Several states have developed or are in the process of developing guidelines to ensure proper handling of electronic prescriptions.

Steps for Effective Prescription Writing

Legibility is fundamental to good prescription writing. Illegibility increases the risk of harmful medication errors. The use of potentially confusing abbreviations, such as “q.d.,” “Q.I.D.,” or “q.o.d.,” should be avoided. Use of bold periods and sloppy lettering have resulted in “q.o.d.” (every other day) being translated to “Q.I.D.” (four times daily). This results in an eightfold (800%) increase in the intended dosage. Several malpractice cases involved a misinterpretation of abbreviations such as “q.d.” and “Q.I.D.”

Abbreviations of drug names are discouraged. For example, zidovudine is often expressed as AZT, but this abbreviation has also been interpreted to be azathioprine or aztreonam. Decimals should be avoided whenever possible.A “500-mg” designation is preferable to a “0.5-g” designation.“Naked” decimals should also be avoided: For example, “0.25 ml” is preferable to “.25 ml.” If a decimal point is not seen, tremendously large multiples of the intended dose can be prescribed and given. The consequence of such errors is the potential to produce profound morbidity and even mortality.

Practitioners should specify the appropriate times during the day at which the prescribed drug should be administered. For example, rather than prescribing a drug four times daily,the exact times may be stated (e.g.,9:00 AM, 1:00 PM, 5:00 PM, and 9:00 PM). If a drug must be administered around the clock, this should be stated clearly, because patients generally take medications only during the waking hours unless advised to do otherwise.

Prescribers are encouraged to include the purpose for the drug treatment on the prescription, as in the following examples:“instill one drop in each eye at 7:00 AM and 7:00 PM for glaucoma”;“take one capsule before bedtime for eye infection”; “take one teaspoonful at 8:00 AM, 2:00 PM, 8:00 PM, and 2:00 AM for eye infection”; or “instill one drop in each eye at 9:00 AM, 3:00 PM, and 9:00 PM to treat eye inflammation” (see Anatomy of the Prescription, above).

Vague instructions such as “p.r.n.” (take as necessary, take as needed) or “ut. dict.” (use as directed or take as directed) are strongly discouraged.“Take as needed” gives patients license to self-assess and self-treat. This introduces subjectivity into the drug use process and invites overuse or underuse, both of which have the potential to produce adverse health consequences. “Take or use as directed” also invites patient subjectivity. Furthermore, it presumes that patients will remember in full the verbal

directions provided by prescribers or pharmacists. It is a dangerous practice to assume that each patient will remember what was intended by the prescriber.

Prescribers should request that the name and strength (or concentration) of the prescribed medication be placed on the prescription label.This can be ensured by indicating the prescription should be “labeled.” Because this information is in the public health interest, most pharmacists routinely provide this information.

The prescription should indicate the number of authorized refills.Although multiple refills may be appropriate for managing chronic diseases, such as open-angle glaucoma, medication prescribed for acute ocular diseases should have few, if any, refills.This is particularly important when prescribing corticosteroids due to the potential for serious adverse effects with prolonged use. If a course of therapy for an acute infection or inflammation does not produce the desired clinical result, prescribers will likely need to see the patient again, to reevaluate his or her condition, and to alter the drug therapy. Refill instructions such as refill “prn” or refill “ad lib” are generally inappropriate.

Controlled Substances

The Comprehensive Drug Abuse Prevention and Control Act of 1970,most commonly known by the Title II section called the Controlled Substances Act, is enforced by the U.S. Department of Justice. This consolidation of laws regulates the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled

substances. Controlled substances are categorized into five classes or “schedules” on the basis of their medicinal value, harmfulness, and potential for abuse or addiction. Practitioners who are registered with the Drug Enforcement Administration (DEA) have been given the authorization to prescribe a drug regulated by the DEA. Their assigned DEA number should be handwritten in ink on prescriptions for drugs covered under the Controlled Substances Act. Widespread dissemination of a DEA number on routine prescriptions containing this number fosters fraud, forgeries, drug diversion, and illegal drug use. Because some third-party programs are now requiring a prescriber’s DEA number for third-party billing, the misuse of this number may increase. Some states require use of specialty prescription forms for controlled substance prescriptions. For similar reasons, prescribers should never presign prescriptions; such prescriptions represent “blank checks” for illegal acquisition of prescription drugs of all types.Table 4-2 summarizes the categories of controlled substances with examples commonly used in optometry.

U.S. federal regulations concerning controlled substances may be superseded by more stringent state regulations, resulting in state-to-state variance. Prescribers must recognize that if scheduled medication is inventoried in the office practice, an additional registration must be filed with the DEA, accurate records must be kept regarding receipt and disbursement of scheduled drugs, and practitioners must submit to DEA inspections. The clinical uses of cocaine are described in Chapters 19 and 22, and the uses of opioid narcotic analgesics are discussed in Chapter 7.

Guarding Against Prescription Forgery

Ophthalmic practitioners and pharmacists are encouraged to collaborate in the prescription verification process to attempt to minimize the problem of prescription forgeries. Figure 4-2 illustrates a prescription for a controlled substance in which the number of dosage units to be dispensed is specified parenthetically to prevent alteration of the dosage units.

GENERIC VERSUS BRAND-NAME DRUGS

The generic drug industry is a vigorous and dynamic component of the health care system.When a drug innovator loses its patent exclusivity on a drug, companies may elect to develop a generic formulation of that drug. Generic drug use has increased dramatically since 1975, when 9.5% of all prescriptions were generic versions. Currently, more than 50% of all prescribed drugs are generic versions of an innovator’s brand-name product that has lost its patent exclusivity. Interestingly, several large brand-name pharmaceutical companies have purchased generic drug companies, formed their own generic drug divisions, or begun to distribute products manufactured for them by generic drug firms under a subsequent brand-name label.

Passage of the 1984 Drug Price Competition and Patent Term Restoration Act (Waxman-Hatch Act) permits the FDA to use an expedited review process for approval of generic versions of brand-name drugs that have been found to be safe and effective but are no longer protected by a patent.The expedited review process is known as an abbreviated new drug application (ANDA).

The Waxman-Hatch Act of 1984 was motivated, to a significant degree, by cost considerations, but quality issues concerning bioequivalency and therapeutic equivalency were addressed as well. All FDA-approved drugs (pioneer brand-name and generic versions) are required to meet the same FDA standards of quality.

Figure 4-2 Prescription for a controlled substance.

Generic versions must be bioequivalent to the innovator’s product, within predetermined limits, to ensure therapeutic equivalency and no greater risk for drug-induced toxicity.The term bioequivalency refers to those pharmaceutically equivalent products that not only contain the same active ingredient in the same concentration and dosage form and are administered by the same route of administration, but also display comparable bioavailability. Bioavailability connotes the rate and extent to which the active or therapeutic ingredient is absorbed from a drug product and becomes available at the site of action.

A generic manufacturer does not have to repeat clinical trials and to redemonstrate drug safety and efficacy. Under the ANDA process, generic manufacturers must provide evidence that the generic version fulfills the following criteria:

•Contains the same active ingredient as the brand-name drug

•Demonstrates similar bioequivalency and bioavailability

•Produces the same pharmacologic and therapeutic activity in the body (in vivo) as does the brand-name product

•Is manufactured according to stringent and universally applied FDA requirements

•Meets FDA requirements for stability, purity, strength, and quality

•Is labeled with the same claims, warnings, and other information as the innovator’s product

The graphic representation of bioavailability for

systemic medications is generally represented by a serum concentration–time curve that plots serum drug concentration on the abscissa against time on the ordinate. Total drug absorption is reflected by area under the curve. Cmax (maximum serum concentration) and Tmax (time to reach maximum concentration) are also important because the pharmacologic effect of several drugs depends on their rate of absorption. In comparing generic formulations with the innovator’s product, the more superimposable the concentration–time curves, the more likely the two products are bioequivalent and therapeutically equivalent.

Although different standards are set for different classes or types of drugs, the general bioavailability standard is an upward or downward variation of no more than 20%. Most generic versions tested to date have demonstrated plasma levels within 3% to 5% of the innovator drug. Sentiment is growing for an achievable ±10% bioavailability criterion.

The FDA “Orange Book,” officially titled Approved Drug Products with Therapeutic Equivalency

Evaluations, provides a list of all drugs that have been fully reviewed by the FDA for safety and efficacy and for which new drug applications and ANDAs have been approved. Equivalence evaluations are provided for generic drugs that are pharmaceutical and therapeutic equivalents of brand-name drugs when administered according to the labeling. Products not included are

generally those marketed before 1938 or those that were brought to market between 1938 and 1962 that the FDA has certified as safe but has not yet approved as effective.

Of the more than 10,000 drugs in the Orange Book, approximately 80% are generic versions. Of the approximately 8,000 multisource generic drugs, more than 90% are considered therapeutically equivalent to the innovator’s product.

Ophthalmic practitioners are encouraged to collaborate with pharmacists in selecting generic versions of drugs. Pharmacists are particularly knowledgeable regarding bioequivalency, product quality, and manufacturer reliability of generic drugs. Prescribers are encouraged to adhere to the following guidelines in prescribing generic drugs:

•Seek bioequivalency information. Only A-rated multisource products should be prescribed.

•Realize that several companies with large generic drug lines are distributors only.They repackage drugs manufactured by other companies.The manufacturer’s reputation and history of producing high-quality generics are paramount. Prescribers may want to specify on the prescription and prescription label the manufacturer of generic versions.

•Do not assume that different dosage forms of the same drug and strength are equivalent.

•Discourage a change in source of supply if a bioequivalent generic product is selected. Patients become confused when, on refill, they receive generically equivalent drugs that differ in color or shape from the medication originally dispensed.

•Assess patient status. Medically fragile patients should avoid changing source of supply.

•Prescribe with great care drugs or drug classes with known bioavailability problems or a narrow therapeutic range.

•Reassure patients that high-quality generic drugs exist in abundance, and teach patients, when using generic medications, to stay with the same “source of supply”

or generic product.

Generic drugs represent a low-cost alternative to more expensive brand-name products. The difference in cost between the average generic prescription and average brand name prescription now exceeds $90.00. Prescribers should take appropriate steps to ensure the prudent use of generic drugs.

COMPLIANCE WITH PRESCRIBED DRUG REGIMEN

The fundamental ubiquitous problem of patient noncompliance (therapeutic nonadherence) continues to be significant in the management of ocular disease in ambulatory outpatients. Much time, effort, and expense are directed at diagnosis and the subsequent selection of drug therapy, but what transpires beyond that point in the patient’s care depends on many factors.

Therapeutic noncompliance is one of the most significant dilemmas in health care today.The financial burden of noncompliance is very high. Attention to instructing patients to take medication correctly and providing follow-up to assess the therapy is essential. Only approximately 50% to 75% of patients for whom appropriate therapy is prescribed achieve full benefit from that therapy through strict adherence.

Clinicians tend to blame patients for failure to comply with a prescribed drug regimen.Though such criticism is appropriate in some instances, prescribers and dispensers of medication also have a significant responsibility for ensuring that patients use their drugs properly. Greater appreciation of the incidence, causes, and clinical implications of therapeutic noncompliance allows a higher degree of role clarification, proper perspective, and, it is hoped, more vigorous and meaningful efforts to optimize therapeutic compliance and ocular health outcomes.

Incidence of Noncompliance

In an ambulatory population at large, the range of noncompliance is typically 25% to 50%.

Common errors of compliance are overuse, underuse, and administration of medications at inappropriate time intervals.Medications can also be administered improperly, taken though expiration dates have passed, or can be taken for the wrong purpose. The ultimate error in noncompliance,however,is failing to have the prescription filled. Approximately 7% (280 million) of the 4 billion prescriptions written each year are never purchased.

Clinical Implications of Noncompliance

Noncompliance with a prescribed regimen frequently produces adverse sequelae.The nature of the consequences depends on the type of error. Underuse can lead to therapeutic failure. In some cases of insufficiently administered therapy, noncompliant patients are assumed to be refractory to the prescribed treatment, and a compensatory aggressive approach to treatment with a higher degree of side effect potential may be instituted.

Noncompliance resulting in overuse predisposes to drug-induced adverse effects. Overzealous patients may believe that if one dose is good, an extra one or two doses per day will hasten a cure or relief of symptoms. Others may not remember taking a dose and may follow with another dose.

Other compliance errors, including improper technique or route of administration, using medication for the wrong purpose, or using outdated medication, also have clinical implications. To optimize absorption, an essential factor is appropriate administration of routine ophthalmic solutions, suspensions, and ointments. In addition, patients may self-diagnose and use stored “leftover” prescription medication to treat symptoms perceived to be similar to

those for which the prescription was originally issued. If a drug is used to treat similar symptoms at a later date, the drug could have aged or otherwise deteriorated to subpotent, inactive, or toxic constituents.

Reasons for Noncompliance

The correlation between noncompliance and several variables has been tested. Significant relationships appear to exist between noncompliance and the factors listed in Box 4-2. The most important reasons for the aforementioned therapeutic noncompliance appear to relate most often to (1) complexity of the drug regimen, (2) lack of understanding of the nature of the illness and the importance of drug therapy, (3) failure to understand thoroughly the instructions for proper use, and (4) a lack of patient instruction. Frequency of interpretive errors of prescription labels ranges between 9% and 64%.

For example, a label instructing patients taking the diuretic furosemide to “take one tablet as needed for fluid retention” led one patient to believe that the drug would cause fluid retention.The instruction to “force fluids” on a prescription for a sulfonamide-containing prescription was interpreted to mean “strain during urination.”

It is clearly short-sighted for ophthalmic practitioners to assume that the drug-consuming public is universally knowledgeable and understanding in matters related to prescription instructions. The public’s knowledge level and ability to comprehend medical matters are highly stratified. Health professionals tend to overestimate the intellectual sophistication of patients, who generally make no request for clarification or additional information. Practitioners should ensure that patients truly comprehend the essence of the message by asking them questions or by encouraging them to ask questions.Verification of patient understanding of the regimen by asking them to restate

Box 4-2 Factors Associated with Noncompliance

Advancing age/dementia Duration of therapy

Number of drugs in the regimen Frequency of administration Drug-induced adverse effects

Asymptomatic disease or relief of symptoms Fear of drug dependence or addiction Interference with daily routine

Poor palatability of drug

Absence of a viable patient–prescriber relationship Excessive waiting to see the prescriber or pharmacist Distrust of the health care system

Lack of continuity of care Nature of the illness Cost of the medication

or demonstrate the instructions can be very helpful.This validation is frequently missing in practitioner–patient encounters. When asked to demonstrate how they instill their topical ophthalmic drops, patients have been known to use their eyedrops in their nose or under their tongue.This reveals why in-office demonstration of technique of administration is often valuable.

Maximizing compliance must be an individualized process. Good communication skills are essential. Warm, empathetic, sincere prescribers generate confidence and trust. Patients cannot be frightened, coerced, or threatened into compliance. Instead, they should be educated, advised, and encouraged to participate in their therapy. Various types of devices have been developed to enhance compliance with administration of medications.

PATIENT EDUCATION AND COUNSELING CONSIDERATIONS

Recognition by both health care providers and patients that medication can be of maximum benefit only if used properly is still not sufficiently reflected in patient education, compliance, and drug use patterns. Medications have the potential not only to do great good but also to produce morbidity, and even mortality, especially if not used properly. Many factors contribute to effective patient education and counseling, including the verbal communication skills of prescribers and pharmacists, the counseling atmosphere and environment, and the receptivity of patients. The education and counseling of patients about their ocular disease and drug therapy involve the following fundamentals:

1.Name of the person for whom the medication is intended. Make patients aware that prescription medication is to be used only by the individual whose name appears on the label.

2.Purpose of the medication. With few exceptions, patients should know what the prescribed medication is intended to treat. General terms understood by lay people are preferred (e.g., “pink eye,” glaucoma, granulated eyelids, stye).

3.Name of the medication.A prescription label should contain the generic name of the drug (and brand name if applicable). Exceptions to this routine practice rarely exist.This information can be valuable for discussions of drug therapy with other health care providers and dispensing pharmacists. This practice also allows easier and more positive identification of the drug if overdose occurs.

4.Directions for using the medication. That most patients use all medication properly is a dangerous assumption. Understanding prescription labels and any instructional “how-to-use” information contained in the package may be difficult or such data may be subject to multiple interpretations. Furthermore, the various precautions and warnings that exist for all drugs must be observed if therapy is to be optimal.

Patients themselves bear considerable responsibility for the achievement of the best possible therapeutic outcome, but they can fulfill their responsibility only if health care providers supply effective instructions on use.

5.Schedule for medication administration. Patients must be made aware of appropriate intervals between drug doses. Timing of administration may affect absorption and blood or ocular levels of the drug. Clinicians should provide verbal definition of label instructions (e.g., before meals, after meals, at bedtime; two, three, or four times daily; every 4, 6, or 12 hours; on an empty stomach).“As directed” is considered an inappropriate form of patient instruction.

6.Duration of treatment. Patients should be encouraged to take a full course of therapy for an acute condition or to continue with prompt refill of chronic medications unless untoward events occur.

This is particularly critical with antibiotics and other anti-infectives, where failure to take the full course of therapy may lead to a therapeutic failure and reinfection. Patients on chronic maintenance therapy should be counseled about the importance of acquiring refills on time, of the need for continuous therapy, and of potential risk associated with abrupt discontinuation of certain drugs, such as corticosteroids.

7.Maximum daily dose. The dose recommended on the prescription label is considered the maximum daily dose and should not be exceeded unless authorized.This limitation is particularly critical with drugs having a narrow therapeutic index or high abuse potential. Clinicians should note that almost all druginduced adverse events are dose related. Increasing doses beyond those prescribed seldom results in additional therapeutic benefits but may markedly increase the risk of experiencing one or more serious adverse drug effects.

8.Adverse effects. All drugs have the potential to produce side effects. Patients should be warned about those most likely to occur and should be told when and how urgently they should report these untoward events. If other steps are required in response to the adverse effect, these should also be communicated.

9.Drug interactions. Prescription and nonprescription drugs may interact adversely with one another, and certain drugs may also interact with components of some foods. Drugs may also alter the results of some laboratory tests. Many drug interactions are of little or no clinical significance, and some drugs or foods may be given together if the potential value of the drug combination outweighs the potential risk. Some interactions lead to such significant problems, however, that some drug combinations are absolutely contraindicated.

10.Storage. Special requirements for storage of certain drugs may be frequently underappreciated or

overlooked. Proper storage is required for maintenance of drug stability and potency. Patients should appreciate the importance of proper storage (e.g., refrigeration, protection from sunlight, protection from moisture, avoidance of extreme heat). All medication should be kept out of the reach of children.

11.Miscellaneous considerations. A variety of specific instructions unique to a particular drug regimen or a specific patient may be required. Patients may require special directions for preparation or administration of drugs, reviews of precautions to be observed during therapy, techniques for self-monitoring response to therapy, prescription refill information, or action to take in the event of a missed dose. Providing this information requires professional judgment and communication skills and is a shared responsibility with prescribers and pharmacists.

Professional practice standards for patient education and counseling are rapidly becoming legal and regulatory mandates. Over-reliance on prescription labels to communicate the essential message is not in the public interest, primarily because of the size limitations of prescription labels. The synergistic combination of a complete prescription label and appropriate verbal counseling appears to be effective in enhancing patients’ ability to recall critical information. Supplemental instructional leaflets, brochures, or information sheets render an optimal therapeutic outcome even more probable. Practitioners, however, must recognize the great difference between providing information and educating patients. Validation of patient understanding of instructions is critical.

SELECTED BIBLIOGRAPHY

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Numerous legal issues are involved in the use or prescription of pharmaceutical agents by optometrists. Legislation permitting ophthalmic drug use is the most significant legal event affecting optometry since the 1960s. Issues such as certification, registration, and comanagement are contemporary offshoots of the regulatory process. Responsibility for care is another important legal issue, requiring optometrists to understand and comply with the demands of informed consent, negligence law, and product liability law. Each of these legal principles has a unique influence on the clinical practice of optometry and the use of ophthalmic drugs. In this chapter these issues and their relevance are described, beginning with the most fundamental consideration of all, the legal authority by which optometrists are permitted to use pharmaceutical agents.

LEGAL BASIS FOR DRUG

USE IN OPTOMETRY

The practice of optometry is regulated by state law.* The original optometry practice acts, which were enacted during the period 1901 to 1924, did not provide for the use of drugs or surgery. Beginning in 1971, however, amendments to optometry laws began to permit the use of drugs, first for diagnosis and then for treatment, and by 1998 all jurisdictions had enacted such laws. Legal challenges to these amendments were uniformly rejected by the courts. Subsequent amendments of state optometry laws permitting an expanded scope of practice (i.e., laser procedures) have met with a similar judicial response.† In fact, no power granted to optometrists by the legislatures has been ruled unconstitutional.

*The 10th Amendment limits federal regulation to matters specifically described in the U.S. Constitution and grants to the states authority over all other matters. Because health care is not mentioned in the Constitution, it must be regulated on a state basis, which is why licensure of optometrists and other health care providers is determined by state law. See Classé JG. Legal aspects of optometry. Boston: Butterworth, 1989:133–156.

Although the right to use ophthalmic drugs may be authorized by a jurisdiction’s optometry statutes, various legal requirements must be satisfied to exercise this right. Two common requirements are certification and registration.

Certification

To use pharmaceutical agents optometrists must have been granted this right at licensure‡ or must be certified by the board of optometry as qualified to exercise it. Certification—a process of education and examination— is necessary to ensure that ophthalmic drugs are used only by qualified practitioners. Optometrists who have satisfied the educational requirements and have passed the examination are given a certificate, which usually must be displayed with the optometrist’s license. Certification confers legal standing on practitioners to use the permitted pharmaceutical agents within the bounds of state law. If optometrists act outside the scope of certification, however, such actions may subject them to discipline by the state board of optometry. Similarly, if optometrists use drugs in the course of patient care without first obtaining the necessary certification, they may be disciplined by the

†A law permitting the use of lasers by optometrists has been enacted in Oklahoma, but there has been no legal challenge to the authority of the legislature to confer this authority on optometrists; however, a legal challenge before this legislation that questioned the state board of optometry’s authority to recognize laser use as part of the practice of optometry was upheld. See Oklahoma Board of Medical Licensure and Supervision v. Oklahoma Board of Examiners in Optometry, 893 P2d 498 (1995).

‡A license confers upon the licensee all rights that may be exercised in the jurisdiction.Therefore optometrists who qualify for licensure within a state receive a license that enables them to use all the techniques and methods available to optometrists within that state. For example, if a state law describes the therapeutic pharmaceutical agents that may be used by optometrists, successful passage of the licensing examination confers on optometrists the right to use these agents. Optometrists who are already licensed at the time the definition of optometry is changed must be certified before they can use this new right.Thus, certification inevitably occurs after licensure.

64 CHAPTER 5 Legal Aspects of Drug Utilization

board, even though state law authorizes use of the drug by optometrists. Certification is a legal prerequisite to drug use in these circumstances, and failure to satisfy certification requirements violates the optometry practice act.

Registration

Even if optometrists have complied with licensure and certification requirements, certain federal regulations must be observed if they wish to use controlled substances. The dispensing of central nervous system drugs with significant potential for abuse is regulated by federal law, and enforcement is the responsibility of the Drug Enforcement Administration (DEA). If a state optometry practice act (or board ruling) authorizes the use of controlled substances, optometrists must register with the DEA and obtain a registration number before using these drugs clinically.The DEA number must also be written on every prescription for controlled substances given to patients. Failure to observe these requirements violates federal law (see Chapter 4).

An additional administrative matter concerns the dispensing of drugs to patients by optometrists.Although state pharmacy acts regulate the sale of pharmaceutical products to consumers, direct sale by licensed health care practitioners to patients is usually excluded from the provisions of these laws. Therefore, unless prohibited by the optometry practice act, optometrists usually can dispense pharmaceutical agents to patients directly. If controlled substances are among the drugs provided to patients, optometrists must be certain to comply with all record-keeping requirements.

Comanagement

Optometrists may provide therapeutic care to patients in conjunction with physicians—referred to as comanage- ment—under certain circumstances. These circumstances most commonly arise in multidisciplinary settings and in practices in which optometrists and physicians work together. Practitioners in separate offices may also find cooperation necessary under certain types of circumstances, such as postoperative care or long-term management of disease. The physician and optometrist comanage patients’ care through a delegation of responsibility to the optometrist, who acts in place of the physician to examine patients and monitor treatment. The optometrist’s role may be described in a comanagement protocol that is specifically written for the individual optometrist and that carefully delineates the manner in which cooperative care may be undertaken.The mode of treatment (tests to be performed, drug dosages, scheduled patient follow-up) may also be specified in the document (Box 5-1). While following the comanagement protocol, the optometrist is acting as the agent of the physician, who remains primarily responsible for the patient’s well-being. Communication between practitioners

Box 5-1 Example Protocol for Postoperative Comanagement of Cataract Patients

1.ZYMAR

Begin day of surgery. Use 1 drop four (4) times a day for one (1) week, then stop Zymar.

2.PRED FORTE (Shake Well)

Begin day of surgery. Start 1 drop four (4) times a day for one (1) week, then 1 drop two

(2)times a day for one (1) week, then stop.

3.ACULAR LS

Start using this drop on first day after surgery. Use 1 drop in the operated eye four (4) times a day until bottle is empty.

4.Allow 5 minutes between each of the above medications and any other eyedrops patient is using (e.g., for glaucoma).

5.Blurred vision should be expected and begins to clear in a few weeks. Final prescription for glasses can be offered at 4–6 weeks.

6.Minor discomfort is normal after surgery and should improve within a few days. Light sensitivity, scratchy sensation, and redness may be noticed. Tylenol may be taken as needed for pain. If this does not control the pain, please contact the office at (123) 123-4567.

7.Eye shield should be worn during sleep during the first week.

8.Patient may wear habitual glasses if vision is better with them on. For outdoors, sunglasses should be worn.

9.Patient can resume regular diet and routine medications.

10.Patient can resume physical activities. Avoid strenuous activities and lifting anything over 10 pounds for at least two (2) weeks.

11.Patient can bathe the day after surgery. May shampoo hair being careful not to get soap or water in eye for two (2) weeks.

12.If patient has excessive pain that is unrelieved with Tylenol, flashes of light that persist, experiences a veil coming over the vision, or vision gets gray or blackens, CALL OUR OFFICE.

is an essential feature of this type of care.The optometrist should communicate with the physician within a reasonable period after examination concerning patient findings, and the physician should receive a written copy of the optometrist’s records (by mail or facsimile transmission) after the examination. These formalities are necessary to ensure that the comanagement protocol is being properly followed.

Should the optometrist be negligent while acting within the scope of the comanagement protocol, both

the physician and optometrist share legal responsibility for any injury suffered by patients. If the optometrist acts outside the limits of delegated authority or in contravention to them, the optometrist is solely liable for any negligence. For this reason the physician must place great confidence in the optometrist’s knowledge and skill before entering into a comanagement arrangement. To limit the potential for liability problems, legal and insurance counsel should be consulted before initiating a comanagement relationship. Under a comanagement protocol, the prescribing of drugs for treatment remains the responsibility of the physician. An optometrist who uses a pharmaceutical agent that is outside the scope of practice commits an act for which discipline may be imposed by the appropriate state regulatory agency.§ Even averring that the circumstances constituted an “emergency”cannot provide legal justification for such an act, for Good Samaritan statutes do not provide legal immunity for in-office procedures even if the condition threatens vision.¶ Optometrists must understand the proscriptions of state optometry laws with regard to the use of ophthalmic drugs and must observe these limitations. Although comanagement allows an optometrist to participate in the medical management of certain types of patients (e.g., patients with glaucoma, individuals needing postoperative care for cataract), the role of the optometrist is to monitor care under the physician-initiated treatment plan. It does not provide legal justification for acts outside the scope of licensure.

The right to use drugs entails certain legal obligations, which are intended to protect patients from the risk of injury.These obligations include the doctrine of informed consent, which in some circumstances requires optometrists to inform patients of the side effects and risks of drug use; the duty to conform to the standard of care, the breach of which may subject optometrists to an action for negligence; and product liability law, under which optometrists can be drawn into the legal dispute created by a drug that is unreasonably dangerous and injures patients. Legal issues involving drugs arise regularly in primary eye care.

INFORMED CONSENT

An important legal duty that must be observed by doctors is the obligation to provide affirmative disclosure, which requires practitioners to communicate warnings, findings, and other pertinent information to patients. The reason for this duty lies in the legal status that doctors occupy as fiduciaries, persons who occupy a special position of trust and confidence with those they serve. The function of this duty of disclosure is to enable the less knowledgeable patient to understand the treatment recommended by the doctor. It has long been a precept of American law that no treatment may be undertaken without the consent of the patient, a philosophy succinctly stated by Judge Benjamin Cardozo: “Any human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable for damages.”

Cardozo’s opinion concerned a case in which surgery was performed without the patient’s consent, but the principle he expressed can be applied to any procedure that contains some risk of patient harm. Treatment may not be instituted without the patient’s consent, and this consent cannot be legally secured without the patients being informed of the hazards, the possible complications, and both the expected and the unexpected results of treatment. In addition, practitioners must not make any misrepresentations, either by misstating known facts or by withholding pertinent information. This obligation to communicate forms the basis for the doctrine of informed consent.

Requirements for informed consent can arise in many areas of optometry: in the diagnosis of disease, in contact lens practice, in the recommendation of binocular vision therapy, or in the use of ophthalmic drugs.The latter category is one that has grown in importance as optometric drug utilization has increased. Optometrists must understand their legal obligation to discuss the risks of pharmaceutical use and must comply with the doctrine of informed consent when doing so. This legal duty has two aspects: (1) recognizing when the duty arises and

(2) determining the amount of information that must be divulged.

§Optometrists who commit an act that is outside the scope of licensure are subject to discipline by the state board of optometry. Disciplinary measures that the board may use include reprimand, suspension of licensure, and revocation of licensure. Boards may also seek injunctions against continuation of the prohibited activity or may enter into consent agreements in which the defendant optometrist agrees not to continue the proscribed conduct. See Classé JG. Legal aspects of optometry. Boston: Butterworth, 1989:152–180.

¶Good Samaritan statutes in most states do not include optometrists as a covered party. Furthermore, these statutes do not provide legal protection for in-office treatment of ocular urgencies or emergencies. See Classé JG. Legal aspects of optometry. Boston: Butterworth, 1989:201–206.

Disclosure Requirements

Although optometrists must disclose information sufficient to engender an informed consent, the legal test of how much information must be divulged to satisfy this duty varies among the states. In fact, conflicting opinions have been expressed by the courts and have proved to be a source of consternation for health care practitioners. Even so, these opinions must be understood and complied with, because informed consent issues routinely arise in clinical practice.