Technician CE LESSON
By Laura A. Carpenter, BSPharm, J.D.,
L.LM, CEO, BulaLaw and Kellie Manders, J.D., staff attorney, BulaLaw
Author Disclosures: Laura Carpenter,
Kellie Manders and the DSN editorial
and continuing education staff do not
have any actual or potential conflicts of
interest in relation to this lesson.
Universal program number: 0401-0000-15-203-H03-T
Activity type: Knowledge-based
Initial release date: Nov. 15, 2015
Planned expiration date: Nov. 15, 2018
This program is worth one contact hours (0.1 CEUs).
Target Audience
Pharmacy technicians in community-based practice.
Program Goal
To improve the pharmacy technician’s understanding of and ability
to comply with current Texas laws and rules regulating the dispensing of controlled substances and minimizing drug diversion.
Learning Objectives
Upon completion of this program, the technician should be able to:
1.Outline the legal requirements for dispensing controlled substances in Texas law.
2.List the Texas laws and regulations implemented to deter drug
diversion.
3.Identify the red flags during pharmacy technician dispensing
decision-making.
To obtain credit: Complete the learning assessment and evaluation questions online at DrugStoreNewsCE.com. A minimum
test score of 70% is needed to obtain a statement of credit. Your
statement of credit will be available at CPE Monitor (NABP.net).
Your correct e-PID number must be included in your DSN CE
profile to ensure transmission of credit to CPE Monitor.
Questions: Contact the DSN customer service team at (800)
933-9666.
Drug Store News is accredited by the
Accreditation Council for Pharmacy Education as a provider
of continuing pharmacy education.
1 • NOVEMBER 2015
Texas pharmacy
technician controlled
substances law —
Drug diversion
INTRODUCTION
In the United States, prescription
drug abuse has become an increasingly prevalent issue. Pharmacies
are continuously challenged when it
comes to balancing patient care and
navigating intricate pharmacy laws
regulating the practice of pharmacy
and dispensing controlled substances. On one hand, pharmacists have
a legal responsibility to prevent diversion of controlled substances. On
the other hand, they have an ethical
duty to treat patients and dispense
legitimate prescriptions. Beyond the
federal laws and regulations, each
state creates laws and regulations to
address state-specific issues, some of
which are created to prevent certain
issues from occurring in the future,
while others are made in reaction to
a specific situation that occurred in
the past.
STATISTICS
The Centers for Disease Control
and Prevention has classified the
prescription drug abuse problem
as an epidemic.1 Approximately 6.5
million Americans use prescription
medications — including opioids,
tranquilizers and stimulants — for
nonmedical purposes.2 During the
past decade, the proportion of individuals admitted for substance
abuse treatment has grown more
than 400%.3
Many patients suffer from chronic
pain, which often involves prescribing opioids. Although the Joint Commission considers it a patient right
to receive the assessment and treatment of pain,4 prescribers must properly assess and treat that pain — and
pharmacists have a corresponding
responsibility to determine whether
the treatment is being used for a legitimate medical purpose.
The most frequently dispensed
medication between 2009 and 2013
was hydrocodone/acetaminophen,
averaging approximately 132.8 million prescriptions each year.5 (At the
time, these combination-hydrocodone products were Schedule III controlled substances. As of Oct. 6, 2014,
these products were federally re-classified as Schedule II.) Forty percent
of opioid deaths occur in individuals
abusing the drugs obtained through
multiple prescriptions, doctor shopping and drug diversion.6
FEDERAL CONTROLLED SUBSTANCE LAWS
The Drug Enforcement Administration is the federal agency responsible for regulating and enforcing
federal controlled substances laws.
The Controlled Substances Act, or
CSA, of 1970 defines the federal policy on the manufacture, importation,
possession, use, distribution and
dispensing of controlled substances.7
The CSA establishes security and recordkeeping requirements, provides
that a pharmacist has a corresponding responsibility when dispensing
controlled substances, establishes
what constitutes a valid prescription
and limits dispensing requirements,
among various other mechanisms to
reduce drug diversion.
Corresponding responsibility
All pharmacists dispensing prescriptions for a controlled substance
have a corresponding responsibility with the prescriber to ensure
the prescription is issued for a “legitimate medical purpose by an
individual practitioner acting in
the usual course of his professional
practice.”8 Meaning, the prescriber
and the pharmacist are equally responsible for ensuring the prescription is for a legitimate medical pur-
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Technician CE LESSON
pose. While “legitimate medical purpose in
the usual course of professional practice”
is not defined with the CSA, it essentially
means the prescriber is acting in accordance
with the generally accepted standard of
medical practice and has taken certain steps
before prescribing the controlled substance,
such as, meeting the patient in person, taking a medical history, conducting an examination or assessment, creating a treatment
plan and discussing follow up care.
Pharmacy technicians play a significant
role in filling and dispensing prescriptions,
so while they may not have a legal corresponding responsibility with the prescriber,
it is essential for pharmacy technicians to
be aware of the repercussions if an illegitimate prescription is dispensed.
TEXAS CONTROLLED SUBSTANCE LAWS
The Texas Department of State Health Service and Texas Department of Public Safety
are the agencies that address controlled substances. The Department of State Health Service provides health-related services and licenses, and regulates various health-related
professions. The Drugs and Medical Devices
Group protects citizens from adulterated,
misbranded and unsafe drugs and medical
devices. The Department of Public Safety
enforces laws, administers regulatory programs, manages records, educates the public
and manages emergencies.
Practitioner-patient relationship and professional responsibility
Texas state law also requires the prescription to be issued for a legitimate medical purpose by a practitioner acting in the
usual course of professional practice, but
also requires there to be a practitioner-patient relationship.9 A practitioner must conduct at least one in-person medical evaluation before the prescription is written.10 No
prescription should be dispensed if there is
reason to suspect the prescription was written in violation of the practitioner’s standard of practice.11 Reasons to suspect the
prescription was authorized in the absence
of a practitioner-patient relationship or in
violation of the practitioner’s standard of
practice include:12
• Number of prescriptions authorized
on a daily basis by the practitioner;
• Disproportionate number of patients
of the practitioner receive controlled
substances;
• Manner in which the prescriptions are
authorized by the practitioner or received by the pharmacy;
• Geographical distance between practitioner and the patient, or between the
pharmacy and the patient;
• Knowledge by the pharmacist that the
pharmacy directly or indirectly partici-
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pates or is associated with an Internet
site that markets prescription drugs to
the public without requiring the patient to provide a valid prescription order from the patient’s practitioner; and
• Knowledge by the pharmacist that the
patient has exhibited doctor-shopping
or pharmacy-shopping behavior.
Beyond the lack of a practitioner-patient
relationship, if the pharmacist, after exercising sound professional judgment, questions the accuracy and authenticity of a
prescription, they must first verify the order with the practitioner before dispensing.13 Moreover, the pharmacist must make
“every reasonable effort” to ensure that the
prescription has been issued for a legitimate medical purpose by a practitioner in
the course of medical practice. Pharmacy
technicians should bring any prescriptions
with questionable practitioner-patient relationships or questionable accuracy and authenticity to the attention of the pharmacist.
Security
Every pharmacist is responsible for the
security of the prescription department,
including control against theft and diversion. The prescription department must
be locked by key, combination or other
mechanical or electronic means to prevent
unauthorized access. The pharmacy department must have a basic alarm system
with off-site monitoring and perimeter and
motion sensors. The pharmacy must establish written policies and procedures to address drug diversion, which may include
quarterly audits of controlled substances,
perpetual inventories, monthly reports,
opening and closing procedures and product storage and placement.14
Identification
A controlled substance cannot be provided to a patient without first checking
their identification. If a pharmacist determines an emergency exists and the controlled substance is needed for the immediate well-being of the patient, the patient’s
identification does not need to be checked.
However, there must be an accurate record
of the name, address, date of birth or age of
the person whom the controlled substance
was given to; that record must be maintained for at least two years.15
Pharmacist away from prescription department
If a pharmacist is onsite but away from
the prescription department, pharmacy
technicians, trainees and other personnel
can remain in the prescription department
as long as at least one pharmacy technician
remains in the prescription department,
the pharmacist is onsite and immediately
available, the pharmacist believes the secu-
rity of the prescription department will be
maintained in their absence and a notice is
posted. Pharmacy technicians can begin the
processing of prescription drug orders or
refills, but the prescription or refill cannot
be delivered to the patient until the pharmacist verifies the accuracy of the prescription. While a pharmacist is gone, trained
pharmacy technicians can:
• Initiate and receive refill authorization
requests;
• Enter prescription data into the
computer;
• Take a stock bottle from the shelf for
a prescription;
• Prepare and package prescription
drug orders;
• Affix prescription labels and auxiliary
labels to prescription containers; and
• Prepackage and label drugs.
When the pharmacist returns, they should
verify the accuracy of all tasks and functions
performed by the pharmacy technician.
However, if the pharmacist is off-site, the
prescription department must be secured,
and pharmacy technicians and trainees cannot perform any duties of a technician during the time the pharmacist is away.16
Schedule II controlled substances
Official prescription forms
Prescriptions for Schedule II controlled
substances must be on Official Prescription
forms provided by the Texas Department of
Public Safety, or DPS, or with an electronic
prescription that meets certain requirements.17 Each form contains multiple safety
features, including a control number, pantograph, thermochromic ink and the DPS
seal. The control number is located in the
uppermost portion of the form above the
line for the patient’s name and is unique for
each prescription form. The number must be
transmitted to DPS when a Schedule II prescription is filled. The pantograph produces
the word “VOID” multiple times on the face
of the prescription if someone attempts to
copy or scan the prescription. If the feature
is missing, the prescription form is not an
original from DPS. The thermochromic ink
is on the back of the prescription form. The
word “SAFE” is revealed, or the check mark
will disappear briefly then reappear, if heat
is applied. If anything else occurs when heat
is applied, the prescription form is suspect.
Finally, the DPS seal is a watermark on the
face of the prescription; without it, it was
likely not provided by DPS. An Official Prescription form is not required for patients
admitted to a hospital, inmates or for patients in long-term care facility, or LTCF, if
certain requirements are met.18
Refills and multiple prescriptions
No refills are permitted for a Schedule II
NOVEMBER 2015
•2
Technician CE LESSON
Table 1
Checklist before filling a controlled
substance prescription
Table 2
DEA registration number validation25
STRUCTURE: TWO ALPHABETICAL NUMBERS FOLLOWED BY A SEVEN-DIGIT NUMBER (AM6125341)

Does the prescription look authentic?

Do drug, dose, duration and quantity seem to
be in normally observed prescribing patterns?

Does your initial encounter with the patient
warrant any discussion with the pharmacist
for points to consider in their assessment?

Is there anything in the patient’s profile
that should be called to the attention of the
pharmacist?

Check the state PMP report.

Call the physician to verify information, if
necessary.

Verify the prescriber’s DEA registration*.

Document all actions taken to verify questionable details!
controlled substance.19 A practitioner may issue multiple prescriptions for Schedule II controlled substances. The additional prescriptions must be limited to a 90-day supply and
must be filled within 21 days of issuance. Other requirements for this situation include:20
•Each separate prescription is for a
legitimate medical purpose by a prescriber acting in the usual course of
professional practice.
•The practitioner provides instructions
on each prescription to be filled at a
later date, indicating the earliest date
the pharmacy can fill each prescription.
•The practitioner concludes that providing the patient with multiple prescriptions does not create a risk of diversion or abuse.
Partial filling
A schedule II controlled substance
can be partially filled if the pharmacy is
unable to supply the full quantity. The
pharmacist must write the quantity supplied on the face of the prescription or
in the electronic prescription record. The
remaining portion must be filled within
72 hours. If it cannot be filled within 72
hours, the pharmacist must notify the
prescribing practitioner, and no further
quantity can be supplied beyond 72 hours
without a new prescription.21
Schedule III to V controlled substances
Schedule III through V prescriptions can
be prescribed using Official Prescription
forms or order forms through individual
sources. These prescriptions can be refilled
up to five times within six months after the
3 • NOVEMBER 2015
1. First letter = Type of Practitioner (A/B/F — M.D.s, doctors, dentists and veterinarians; M — mid-level practitioners, PA, NP, mid-wives, etc.)
2. Second letter = First letter of practitioner’s last name
STEPS/FORMULA TO VERIFY THE DEA NUMBER: (AM6125341)
1. Add the first, third and fifth digits (6+2+3 = 11)
2. Add the second, fourth and sixth digits (1+5+4 = 10)
3. Multiple the result of step two by two (10x2 = 20)
PATIENT SCENARIO: PHARMACY PERSONNEL INTERACTION
M.O. presents a Schedule II opioid prescription at a very busy pharmacy in a high-traffic area. As
M.O. gives the prescription to the pharmacy technician, he indicates that he has never been to this
pharmacy to fill his prescriptions or any of the other pharmacy’s chain locations. M.O. is unable to find
his third-party prescription card and decides he must have forgotten it at home. He inquires with the
pharmacy technician if he can use his medical insurance card and a photo ID to access his insurance
prescription drug benefits. The technician takes the prescription, the insurance card and photo ID to
the pharmacist for review. The pharmacist looks at the documents and then the patient and verbally
tells the information to the pharmacy technician. The pharmacy technician then returns to the counter
and tells M.O. that the medication is not in stock.
Discussion
1. Did the pharmacy personnel properly deny the prescription?
2. Did the pharmacy personnel jump to conclusions without resolving the red flags?
3. Should the fact that M.O. has never been to this pharmacy or one of the chain locations to fill his
prescription alone serve as evidence of an inappropriate prescription?
4. Is the lack of third-party prescription card evidence of an inappropriate prescription?
5. What could the pharmacy personnel have done to assist the patient in filling the prescription?
The pharmacist may be in a difficult position if put in this scenario. While there is a need for reasonable
suspicion with some red flags being raised, with the pharmacy located in a high-traffic area, where
the pharmacist likely does not know the patients well, it is important to carefully assess the entire
situation to ensure quality patient care. The pharmacist’s actions in this scenario might have been
unreasonable because there is no evidence that the patient intended to pay in cash rather than through
a third party — he gave the pharmacy technician his insurance card. Moreover, just because M.O. has
not filled a prescription at the pharmacy or another chain location does not automatically indicate a
fraudulent controlled substance prescription. If the pharmacist had concerns or questions about the
validity of the prescription, he could have requested M.O.’s information in the PMP or contacted the
prescriber directly. Pharmacists need to be careful not to make any assumptions about the patient or
the prescription without first utilizing resources available to address the red flags. Doing this allows
the pharmacist to meet their responsibility, comply with laws and regulations and provide the patient
with his or her medication.
date of issuance.22
RED FLAGS FOR INAPPROPRIATE PRESCRIPTIONS
As the treatment and assessment of pain
is a patient right, pharmacy technicians
have an important role in the management and treatment of pain when dispensing prescriptions. There is a balance between providing quality customer service,
avoiding stigmatizing patients, avoiding
incorrect assumptions about patients and
allowing the pharmacy to become a point
of interest for drug abusers. Moreover,
the pharmacists have a legal and ethical
obligation to prevent drug abuse and di-
version. It is worth noting that patients
are not the only source of potential drug
abuse and diversion; pharmacists must be
aware of colleagues’ behaviors and recognize risk factors and signs for potential
drug abuse by other individuals working
in the pharmacy.
When dispensing a prescription for a controlled substance, be aware of the red flags.
Be prepared to identify red flags and then
address and resolve the issues. Just because a
red flag is triggered does not mean a patient
should be denied their prescription, it indicates when pharmacy personnel should contact a prescriber; request data from the state
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Technician CE LESSON
or InterConnect prescription drug monitoring
program, or PMP; ask the patient questions;
or look more closely at the prescription itself.
The NABP, along with the Anti-Diversion Industry Working Group, or ADIWG,
a group of pharmaceutical manufacturers
and distributers, created an educational
video to help identify the red flags when
dispensing controlled substances.23 The
DEA also has indicated criteria that may indicate a prescription has been written for a
non-legitimate medical purpose.24
Prescription validity
• When reviewing the prescription,
does it look valid, or does it raise reasonable suspicion to the pharmacist
regarding its validity?
• Does the prescription look “too
good?” Is the prescriber’s handwriting extremely legible?
• Does the prescription appear to
be photocopied?
• Are the abbreviations used accurate,
or is the prescription written in full
with no abbreviations?
• Is the prescription a drug cocktail, or
combination of three common drugs
(opiate, benzodiazepine and muscle
relaxant) that is commonly used for
nonmedical purposes?
• Is this a normal dose of the
controlled substance?
• Does the patient record reveal multiple prescribers? Could this patient be
doctor shopping?
• Was the prescription prescribed at a
distant location?
• Does this prescriber write significantly
PRACTICE POINTS
• Federal law and the Drug Enforcement Agency regulate and enforce controlled substances laws,
with state laws adding restrictions to react to state-specific issues.
• Pharmacy technicians are a necessary component of helping to identify potential concerns when
dispensing.
• There is a balance between providing quality customer service, avoiding stigmatizing patients,
avoiding incorrect assumptions about patients and allowing the pharmacy to become a point of
interest for drug abusers.
more prescriptions (or larger quantities) compared with other prescribers
in the area?
• Is the patient seeking an early refill?
• Have you heard of a possible federal
or state action against the prescriber?
Patient behavior
• Are multiple patients receiving the
same controlled substance, regardless
of patient weight or age?
• Did multiple patients come in as a
group all with the same prescriber?
Could these prescriptions come from
a possible “pill mill?”
• Did the customer pay cash for an opioid? Did the customer pay cash for
some prescriptions and use third-party payers for other prescriptions?
• Do you notice any unusual behavior
from the patient, including slurred
speech, lack of balance and coordination, pinpoint pupils or the use of
street slang?
CONCLUSION
There is a prescription drug-use epidemic in the United States. Pharmacists and
pharmacy technicians at the forefront of
this issue face a dilemma on a daily basis.
They grapple with, on one hand, providing
adequate patient care, treating chronic pain
and dispensing legitimate prescriptions
and, on the other hand, preventing drug
diversion, misuse and abuse and not negatively contributing to the copious number
of deaths annual from drug overdoses. Federal law and the DEA regulate and enforce
controlled substance laws, with state laws
adding restrictions to react to state-specific
issues. As long as pharmacy technicians
are aware of the red flags that indicate an
inappropriate prescription, drug diversion
will be significantly decreased. As pharmacists have a corresponding responsibility to dispensing legitimate prescriptions,
pharmacy technicians are a necessary component of helping to identify potential concerns when dispensing.
Odd details
• Was the prescription written by
a physician not associated with pain
management?
• Is the patient filling multiple
prescriptions?
1 Prescription Drug Abuse, https://www.whitehouse.gov/ondcp/prescription-drug-abuse (last visited Sept. 16, 2015). 2 AWARxE Prescription Drug Safety, www.awarerx.org (last
visited Sept. 16, 2015). 3 AWARxE Prescription Drug Safety, www.awarerx.org (last visited Sept. 16, 2015); Amanda Gardner, Prescription Drug Abse: Who Gets Addicted?,
WebMD.com (Apr. 2, 2015), at http://www.webmd.com/mental-health/addiction/features/prescription-drug-abuse-who-gets-addicted-and-why (last visited Sept. 16, 2015). 4 The
Joint Commission, Facts About Pain Management (Feb. 2, 2015), http://www.jointcommission.org/pain_management/. 5 IMS INSTITUTE FOR HEALTHCARE INFORMATICS,
MEDICINE USE AND SHIFTING COSTS OF HEALTHCARE: A REVIEW OF THE USE OF MEDICATIONS IN THE UNITED STATES IN 2013 (Apr. 2014), available at http://www.
imshealth.com/deployedfiles/imshealth/Global/Content/Corporate/IMS%20Health%20Institute/Reports/Secure/IIHI_US_Use_of_Meds_for_2013.pdf; DeNoon DJ, Most Prescribed
Drug List Differs from list of Drugs with Biggest Market Share. April 20, 2011, at www.webmd.com/news/20110420/the-10-most-prescribed-drugs. 6 RON GASBARRO, PROTECTING
YOUR PRACTICE AND PATIENTS FROM PRESCRIPTION DRUG ABUSE 4 (Sept. 15, 2014). 7 21 USC §§ 801-971. 8 21 CFR 1306.04(a). 9 Tex. Occ. Code § 562.056(a); Tex.
Health & Safety Code § 481.071(a)l Tex. Health & Safety Code § 481.074(a).10 22 TAC § 291.29(b)(1). 11 22 TAC § 291.29(b)(2). 12 22 TAC § 291.29(c). 13 22 TAC § 291.29(a).
14 22 TAC § 291.33(b)(2). 15 Tex. Health & Safety Code §§ 481.074(a)(5), 481.074(n). 16 22 TAC § 291.33(b)(3). 17 Tex. Health & Safety Code § 481.074(b); 37 TAC § 13.72(a).
18 37 TAC § 13.73. 19 Tex. Health & Safety Code § 481.074(d). 20 Tex. Health & Safety Code § 481.074(d-1); 37 TAC § 13.72(a)(3). 21 Tex. Health & Safety Code § 481.074(e).
22 37 TAC § 13.72(b). 23 AWARxE, Red Flags (May 20, 2014), at https://www.youtube.com/watch?v=WY9BDgcdxaM. 24 U.S. Dep’t of Justice Drug Enforcement Administration,
Pharmacist’s Manual - Appendix D: Pharmacist’s Guide to Prescription Fraud (2010), at http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/appendix/appdx_d.htm. 25 Mary
Jo Carden, Pharmacists’ Responsibility in Appropriate Controlled Substance Dispensing, Pharmacist CE Lesson 3 (Nov/Dec. 2012).
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NOVEMBER 2015
•4
Technician CE LESSON
Learning Assessment
Successful completion of “Texas pharmacy
technician controlled substances law —
Drug diversion ” (0401-0000-15-203-H03-T)
is worth one contact hours of credit. To
submit answers, visit our website at
www.DrugStoreNewsCE.com. Please note:
Assessment questions submitted online
will appear in random order.
1.The No. 1 prescribed medication is:
a.Oxycodone
b.Adderall
c.Hydrocodone/acetaminophen
d.Percocet
2.There is a dilemma for pharmacies to
balance serving patients by treating
pain with valid prescriptions, and the
legal and ethical duty to prevent drug
diversion, abuse and misuse.
a.True
b.False
5 • NOVEMBER 2015
3.Which federal agency is responsible
for the regulation and enforcement of
controlled substances laws?
a. Institute of Medicine
b.U.S. Drug Enforcement Agency
c. U.S. Department of Health and
Human Services
d.Office of National Drug Control
Policy
4.The pharmacist and physician each
have a responsibility to determine if a
prescription is issued for a legitimate
medical purpose in the normal course
of business.
a.True
b.False
5.A practitioner-patient relationship is
not required before a prescription is
written or dispensed.
a.True
b.False
6.An Official Prescription form is required to prescribe which drugs?
a. Schedule II , III, IV and V controlled
substances
b.All dangerous drugs
c. Schedule II controlled substances
d.Schedule II and III controlled
substances
7.If a pharmacist is away from the
prescription department and off site, a
pharmacy technician can do which the
following?
a. Initiate and receive refill
authorization request
b.Affix prescription labels to
prescription container
c. Prepare and package prescription
drug orders
d.None of the above
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