Medication Prescribing InformationTable of ContentsClinical Standards of Prac0ce: S0mulant Dosages...................................................................1TL;DR:..............................................................................................................................................1References.......................................................................................................................................2Mul0ple Post-Dated Scripts Can Be Wri>en Up to90-day Supply............................................5Quan0ty Limits: No law/rule limits maximum supply; Medicaid pays for 30 days or 100 days if maintenance medica0on for chronic condi0on (Dr’s discre0on to define chronic)...................5Early Refills: Medicaid refills CII currently aTer 50% of prior rx 0me has lapsed by default, or prior to 50% if necessary by phone request;at 85% prior to COVID19, 1x/life0me/drug if lost; immediately if rx is a “dose increase”.....................................................................................6OTC Drugs Paid For: Aspirin and various others labeled “OTC” in the PDL...............................7Paper Scripts Can Be Wri>en for CII Drugs..............................................................................7Pharmacist Authority: CAN dispense alterna0ve dose; CAN dispense a subs0tute (non-psychotropic) drug; CAN dispense emergency refill w/o an rx.................................................7Clinical Standards of Prac0ce: S0mulant DosagesTL;DR:American Academy of Sleep Medicine (formerly American Sleep Disorders Associa5on), Standards of Prac5ce Commi;ee, 1994, 2000, 2007, 2021:•Pa5ents have a wide varia5on in response to s5mulants... therefore, full therapeu5c response in adult pa5ents with narcolepsy can usually be obtained with daily medica5on doses below the recommended maximal doses of:... dextroamphetamine sulfate, 100 mg"Understanding Unapproved Use of Approved Drugs "Off Label", United States Federal Drug Administra;on, 02/05/2018The approved drug labeling for healthcare providers gives key informa5on about the drug that includes:

Please note that DEA does not assign a numerical limit to the amount of schedule II controlledsubstance to be prescribed. Instead, DEA recognizes that these are medical decisions within theprescribing practitioner’s sound medical discretion, as guided by any limitations imposed by thestate medical board and state law

8.800.14 PRESCRIPTION QUANTITIES8.800.14.A For chronic conditions requiring maintenance drugs, the maximum dispensing quantities for new and refill prescriptions shall be a 100-day supply. For all other drugs, the maximum dispensing quantities for new and refill prescriptions shall be a 30-day supply. The Department may set or change minimum or maximum dispensing quantities of certain drugs

practitioner must signand date the multiple prescriptions as of the date issued, (21 CFR 1306.05(a)); and, write on eachseparate prescription the earliest date on which the prescription can be filled (21 CFR1306.12(b)(ii)).

ursuant to 21CFR 1306.12(b) “an individual practitioner may issue multiple prescriptions authorizing the patientto receive a total of up to a 90-day supply of a schedule II controlled substance, subject to specificconditions are met

This does not prohibit thepractitioner from issuing one prescription for a 90-day supply if allowed by state law and regulationthat otherwise comport with 21 CFR 1306.04(a)

U. S. Department of JusticeDrug Enforcement Administration

The prescriber reasonably determines that the patient would be unable to obtain controlled substances prescribed electronically in a timely manner and that the delay would adversely affect the patient’s medical condition.

12-30-111. Electronic prescribing of controlled substances - exceptions - rules - definitions

Electronic prescribing of controlled substances: What physicians and practices need to know

Practice Standards& Regulations: Stimulant Dosingfor Hypersomnias

c. Amphetamine, methamphetamine, dextroamphetamine, andmethylphenidate are effective for treatment of daytime sleepinessdue to narcolepsy [4.1.1.1] (Guideline).This recommendation is unchanged from the previous recom-mendation. These medications have a long history of effective usein clinical practice

Practice Parameters for the Treatment of Narcolepsy and other Hypersomnias ofCentral OriginAn American Academy of Sleep Medicine Report

FIG. I. Relative efficacy of stimulant drugs commonly used to treat narcolepsy. The lighter shading denotes baseline sleep latencies on either MSLT or MWT, expressed in terms of percent of normal levels (13.4 minutes for the MSLT and 18.9 minutes for the MWT), and the darker shading denotes values observed at the highest dose of each drug evaluated. See text for methods. Abbreviations: PEM, pemoline; MOD, modafinil; DEX, dextroamphetamine; MAM, methamphetamine; MPD, methylphenidate.

ASDA Standards of Practice Narcolepsy and Its Treatment With Stimulants Merrill M. Mitler, Michael S. Aldrich, George F. Koob and Vincent P. Zarcone

7. Side effects Most patients with narcolepsy can be effectively treated with stimulants without developing significant side effects.

ASDA Standards of Practice Practice Parameters for the Use of Stimulants in the Treatment of Narcolepsy

11. Follow-up (a) A patient stabilized on stimulant medication should be seen by a physician at least once per year, and preferably once every 6 months, to assess the de-velopment of medication side effects

Little evidence suggests that stimulants in therapeu-tic doses cause a significant increase in blood pressure in normo-or hypertensive paiients~

6. Abuse (a) Patients with narcolepsy are no more likely to become drug abusers or to use stimulant medications illicitly than any other group of patients treated with stimulants [5.5]

(b) Full therapeutic response in adult patients with narcolepsy can usually be obtained with daily medi-cation doses below the recommended maximal doses of: pemoline, 150 mg; methylphenidate hydrochloride, 100 mg; dextroamphetamine sulfate, 100 mg;

Patients have a wide variation in response to stim-ulants and in the incidence of side effects; therefore,

4. Dosage

(b) Methamphetamine hydrochloride generally pro-duces the most improvement in alertness and has the most rapid onset of action. Dextroamphetamine sulfate and methylphenidate hydrochloride are only slightly less effective.

2. Treatment objectives and indications (a) The objective of treatment with stimulants should be to alleviate daytime sleepiness, thereby allowing the fullest possible return of normal function for patients at work, at school and at home [1.0]. (b) Stimulants are most effective at producing im-provement in fatigue and sleepiness in boring and in-active situations;

Treatment aims are to improve daytime alertness with stimulant medication

The American Sleep Disorders Association (ASDA) ex-pects these guidelines to have an impact on profes-sional behavior

This report provides the first clinical guidelines on the appropriate use of stimulants in the treatment of narcolepsy.

Unapproved use of an approved drug is often called “off-label” use. This term can mean that the drug is:

From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.

The approved drug labeling for healthcare providers gives key information about the drug that includes:

Understanding Unapproved Use of Approved Drugs "Off Label"

The ultimate judgment regarding the suitability of any specific recommendation must be made by the clinician and the patient

differentchoices may be appropriate for different patients. The clinician must help each patientdetermine if the suggested course of action is clinically appropriate and consistent withhis or her values and preferences.

udies demonstrated clinically significantimprovements in excessive daytime sleepiness

Recommendation 6: We suggest that clinicians usedextroamphetamine (vs no treatment) for the treatmentof narcolepsy in adults.

Treatment of central disorders of hypersomnolence: an American Academyof Sleep Medicine clinical practice guideline

“The biggest implication of this change is that we were not able to make any recommendation for some interventions that have been widely used in clinical practice and were recommended in the 2007 guideline

“The prior set of treatment recommendations was published in 2007,” says Lynn Marie Trotti, MD, MSc, an associate professor of neurology at Emory University School of Medicine in Atlanta. Trotti is on the board of directors at the AASM and co-authored the new hypersomnolence recommendations

New AASM recommendations released in August 2021 on medications to treat these disorders

It’s been more than a decade since the American Academy of Sleep Medicine (AASM) last issued guidelines for the treatment of central disorders of hypersomnolence

A new American Academy of Sleep Medicine clinical practice guideline details “strong” and “conditional” recommendations for the treatment of central disorders of hypersomnolence in adults and children.

Stimulant and Related Medications: U.S. Food and Drug Administration-Approved Indications and Dosages forUse in AdultsThe therapeutic dosing recommendations for stimulant and related medications are based on U.S. Food and Drug Administration (FDA)-approvedproduct labeling. Nevertheless, the dosing regimen is adjusted according to a patient’s individual response to pharmacotherapy.

Risks of High-Dose Stimulants in the Treatment of Disorders of Excessive Somnolence: A Case-Control Study

Practice Parameters for the Treatment of Narcolepsy: An Update for 2000