Module 10

Lecture 35
Drug Schedules and Prescription
Writing
Clifford M. Knapp, Ph.D.
 Objectives
Understand the necessary
components of writing an inpatient
or outpatient prescription.
Describe the differences between an
unscheduled and controlled
prescription.
Understand the definition of a
boxed warning.
Define drugs that are for off-label
use.
Define the term dispense as written
DAW in prescribing.
 Controlled
Substa nces
Substances which may produce
physical and/or psychological
dependence; controlled by
both State and Federal laws;
established by law into
"Schedules" in decreasing
order of abuse potential.
Regulated by the DEA, FDA
State Regulations
 Regulation of Prescribing
The prescription must conform to
both state and federal laws and
regulations
Only NYS Regulations Reviewed Here
(i.e. of the state regulations
reviewed)
Many states require prescription
blanks for controlled substances to
designed to minimize diversion
New York State now requires when
possible electronic prescribing to
minimize the diversion problem
 Prescription
Prescription Only Status
Designated by the FDA.
(A physician can write Rxs for
OTC and compounded drugs)
Package insert is required for
all prescription drugs.
Forms part of the drug labelling
Includes the FDA approved
indications for the drug
 Boxed Warning
Strongest warning the
FDA requires of the
drug company to
inform the public
about a drugs serious
effects.
 Off Label Prescribing
The physician is legally
allowed to prescribe any drug
for non-approved indications
Assumes liability for off label
use
Pharmaceutical companies are
forbidden to market drugs for
unlabeled use.
 80.65 Purpose of issue.
A prescription, in order to
be effective in legalizing the
possession of controlled
substances, shall be issued
for legitimate medical
purposes only. The
responsibility for the proper
prescribing and dispensing
of controlled substances
shall be on the physician
Do Not Divert Drugs for Personal
Use

80.61 A person
authorized by law to
obtain controlled
substances for
professional use shall
not use such drugs for
the treatment of his
own addiction, or
Steps in writing a prescription
Need a specific diagnosis
Understand the disorder being
treated
Specific therapeutic objective
Select the drug
dosing regimen: consider age,
other diseases/drugs,
toxicities, contraindications,
compliance, and cost.
 Record Keeping
Physicians are required to
keep written records of
concerning the diagnosis
that is basis for
represcribing a controlled
drug.
The record should include
the drug name, amount,
dose, and directions for
use.
 Inpatient
Prescription (Order)
Physicians order sheet (POS), chart
order.
(May be automated)
Pharmacy and Therapeutics committee
determines policies for institutional drug
use
Hospital Formulary specifies medications
available for use within an institution
Patient name, drug name, strength, dose,
route/frequency, signature of physician.
Medication continued until stop-order
is placed in the patients chart.
 Outpatient
prescription
Patient's full name and address
Prescriber's full name, address,
telephone number, license
classification, and Drug
Enforcement Agency (DEA) number
Date written- Must be the actual
date written for controlled drugs
Prescriber signature
Drug name, dose, dosage form,
amount
Directions for use (Sig)
Refill instructions
Prescription blank
 DAW Dispense as written
Cheapest equivalent drug mandated by state
legislation and most 3rd party payers.
Physician must indicate if specific
formulation is required. DAW written in box.
Approved Drug Products with Therapeutic
Equivalent Evaluations
A rated drug is therapeutic equivalent to
another product
B rated drug not considered
therapeutically equivalent
AB (most drugs come under this rating).
Bioequivalence demonstrated
 Some abbreviations
ac (before food); pc (after food)
q (every); qam (every morning); q3h (every 3 hours), etc
bid (twice daily); tid (three times a day); qid (four times a
day)
gtt (drops)
hs (bedtime)
ss (one half)
OD (right eye)
OS (left eye)
OU (both eyes)
qs (sufficient quantity)
Teaspoonful (5 ml)
Tablespoonful (15 ml)
QD (daily).
Use of these abbreviations have fallen out
 Joint Commission Banned Abbreviations
Do Not Use Potential Problem Use Instead
U, u (unit) Mistaken for 0 (zero), the Write "unit"
number 4 (four) or cc
Mistaken for IV
IU (International Unit) Write "International Unit"
(intravenous) or the number

10 (ten)
Q.D., QD, q.d., qd (daily) Mistaken for each other Write "daily"
Q.O.D., QOD, q.o.d, Period after the Q mistaken Write "every other day"
qod(every other day) for "I" and the "O" mistaken
for "I"

Trailing zero (X.0 mg)* Decimal point is missed
Write X mg
Lack of leading zero (.X
Write 0.X mg
mg)

MS Can mean morphine sulfate Write "morphine sulfate"

or magnesium sulfate
MSO4 and MgSO4 Confused for one another Write "magnesium sulfate"
 Electronic Prescribing
Effective March 27, 2016,
practitioners are mandated to
electronically prescribe both
controlled and non-controlled
substances. However, there are
a number of exceptions in which
a practitioner may issue an
Official New York State
prescription (ONYSRx) form, oral
prescription or a fax of an
ONYSRx.
 E-prescribing
Computerized, no
worries about illegible
handwriting.
Patient chart is present
as Rx is written
(allergies, other drugs).
Convenient to patient.
Reduces Drug Diversion
 Non-electronic Prescription
Issued under circumstances
when it is not practical for the
patient to obtain an electronic
prescription in a timely
manner, and a delay would
adversely impact the patient's
medical condition
For a controlled substance,
the quantity prescribed
cannot exceed a 5 day supply.
 How long is a NY
prescription
valid
Non-controlled Rxs valid
for 1 year from the date
Controlled substances: 30
Days
Medical insurance policies
may place stricter limits on
the amount of time that an
Rx remains valid
New York State Medicaid
prescriptions valid for 2
months
Non-controlled Medications
Include the patient's age and weight if
relevant on the prescription
Use the metric system unless dealing
with units
Avoid uncommon abbreviations
Sign your own prescriptions
Inform patient about medication
Never add a decimal point (1 mg not
1.0 mg)
Non-controlled
Prescriptions
Unlimited refills
Valid for 12 months
from date written
May be given verbally
by phone.
 Controlled substances
Schedule I
No currently accepted
medical use and a high
potential for abuse.
Heroin, lysergic acid
diethylamide (LSD),
Marijuana (cannabis), 3,4-
Methylenedioxymethamph
etamine (ecstasy)
 Schedules for Controlled Drugs
Schedule II
Schedule II High potential for
abuse, with use potentially leading
to severe psychological and/or
physical dependence. Some
examples of Schedule II drugs are:
Stimulants: cocaine,
dextroamphetamine
Opioids: morphine, oxycodone,
fentanyl
Barbiturates: pentobarbital
 C-II
Prescriber's DEA Number
Valid 30 days of date written
Must be signed by
prescriber
Phone in orders only for
emergency dispensing (No
more than 5 day supply)
Send written prescription
within 72 h to the dispensing
pharmacy
 Refills Controlled Rx

Prohibited for
Schedule II
IN NYS prohibited
for
benzodiazepines &
Anabolic steroids
 Schedule III-IV Drugs
Schedule III
Moderate to low potential for physical and
psychological dependence. Schedule III drugs
abuse potential is less than Schedule I and
Schedule II drugs but more than Schedule IV.
Products containing less than 90 milligrams of
codeine per dosage unit (Tylenol with codeine),
ketamine, anabolic steroids, testosterone
Schedule IV
Low potential for abuse and low risk of
dependence.
Benzodiazepines, Pentazocine, Zolpidem,
Tramadol
 Schedule V
Lower potential for abuse than
Schedule IV and consist of
preparations containing limited
quantities of certain narcotics.
Schedule V drugs are generally used
for antidiarrheal, antitussive, and
analgesic purposes.
Cough preparations with less than
200 milligrams of codeine or per 100
milliliters (Robitussin AC),
Diphenoxylate + Atropine,
Pregabalin
 C-III-IV
Refillable up to 5 times in a 6 month
period
But refills are not permitted for
benzodiazepines or anabolic
steroids in New York
Valid 30 days from date written
May be given as verbal
prescriptions for no more than a 5
day supply
Must mail the Rx to the pharmacy
within 72 hours.
 Rx for Controlled
(1) Patients name, sex,Drugs
address and age
(2) Physicians the printed name, address, DEA number,
(3) Physicians Telephone number
(4)Physicians handwritten signature
(6) Physician Printed NAME imprinted (stamped)on the
prescription
(5) Specific directions for use: dosage & frequency of
dosage & the maximum daily dosage; and
(6) the date upon which such prescription was prepared
and actually signed by the prescribing practitioner. A
prescription shall be dated as of, and signed on, the date
it is issued.
(7) Quantity of dosage units prescribed.
indicated in both numerical and written word form.
 Limit to 30 day Supply
Except as provided for in subdivision (d) of this
section, no such prescription shall be made for a
quantity of substances which would exceed a
30-day supply if the substance were used in
accordance with the directions for use...
No additional prescriptions for a controlled
substance may be issued to a patient within 30
days of the date of any prescription previously
issued unless and until the patient has used all
but a 7-days' supply of that controlled
substance
 Exceptions to 30 day Supply
Rule substance, including
3 month supply of a controlled
chorionic gonadotropin, or up to a 6 month supply of
an anabolic steroid when the prescription has been
issued for the treatment of:
(i) panic disorders
(ii) attention deficit disorder
(iii) chronic debilitating neurological conditions
characterized as a movement disorder or exhibiting
seizure, convulsive or spasm activity,
(iv) relief of pain in patients suffering from conditions
or diseases known to be chronic or incurable
(v) narcolepsy, designated
(vi) hormone deficiency states in males, gynecologic
conditions that are responsive to treatment with
anabolic steroids or chorionic gonadotropin, metastatic
 For Exceptions
Indicate the condition being
treated on the face of the
prescription. Either:
(i) specify the name of
condition on the face of the
prescription;
(ii) specify a code on the
prescription to denote the
condition for which the
prescription has been
Prescription Monitoring
Program
Prior to writing a prescription for a
controlled substance review the
NYS Prescription Monitoring
Program to determine whether the
patient has been doctor
shopping- i.e. going to multiple
practitioners to obtained
controlled substance for abuse
purposes.
Usually does not apply to inpatient
drug orders and prescriptions for
nursing home, hospices, assisted
living and correctional facilities.
Objectives
Understand the necessary components of
writing an inpatient or outpatient prescription.
Describe the differences between an
unscheduled and controlled prescription.
Understand the definition of a boxed warning.
Define drugs that are for off-label use.
Define the term dispense as written DAW in
prescribing.