PART I
ELECTRONIC PRESCRIBING OF CONTROLLED
SUBSTANCES (“NEW” REGS)
(and its relation to current regulations)
-------------------------------------------PART II
PHARMACY LAW UPDATE
Email: lsweeneyrph@comcast.net
Tel :(978) 884-2140
Fax: (978)418-8255
Laurence E. Sweeney, R.Ph., Esq.
© 2013
2
E-SIGN
3
When was the first
court case to
determine the validity
of an electronic
signature……….
E-SIGN
4

In Howley v. Whipple, the New Hampshire
Supreme Court determined that the traditional
method of signing is not the only way to make
a document binding in the absence of
additional proof

This 1869 case dealt with the telegraph as the
means for forming a signature in a contract
5

“It makes no difference whether [the telegraph]
operator writes the offer or the acceptance in the
presence of his principal and by the principal’s
express direction, with a steel pen an inch long
attached to an ordinary penholder, or whether his
pen be a copper wire a thousand miles long. In
either case the thought is communicated to the
paper by the use of the finger resting upon the
pen. Nor does it make any difference that in
one case common record ink is used, while in
the other case a more subtle fluid, known as
electricity, performs the same office.”
6
ELECTRONIC PRESCRIBING OF
CONTROLLED SUBSTANCES
(NEW REGS) (as of 2010)
7

3 Federal Laws affect the practice of
pharmacy with respect to controlled
substances signatures (NOTE: State Law Must Also Allow) :
 1. New federal regulations regarding electronically
prescribing CII-CV Rxs (21 CFR 1311)
 2. Current federal regulations regarding
prescriptions (21 CFR 1300 et seq.)
 3. The E-Sign law of 2000 (and State UETA laws)
 4. State Laws also apply.
8


Title 21 CFR, Part 1300-1399
As of April 1, 2011



PART 1300 - DEFINITIONS
PART 1301- REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF
CONTROLLED SUBSTANCES
PART 1302- LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES
PART 1303 - QUOTAS
PART 1304- RECORDS AND REPORTS OF REGISTRANTS
PART 1305- ORDER FORMS
PART 1306- PRESCRIPTIONS
PART 1307- MISCELLANEOUS
PART 1308- SCHEDULES OF CONTROLLED SUBSTANCES
PART 1309- REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND
EXPORTERS OF LIST I CHEMICALS
PART 1310- RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES

PART 1311- DIGITAL CERTIFICATES


PART 1312- IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES
PART 1313- IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL
CHEMICALS
PART 1314- RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS
PART 1315- IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE,
PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE
PART 1316- ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES
PART 1321-DEA MAILING ADDRESSES












9
21 CFR 1311 et seq.
Requirements for Electronic Orders and
Prescriptions
∞
Published in Federal Register 05-31-2010
∞
Effective 06-01-2010
10


















PART 1311 DIGITAL CERTIFICATES
Subpart A General
Section 1311.01 Scope
Section 1311.02 Definitions
Section 1311.05 Standards for technologies for electronic transmission of
orders
Section 1311.08 Incorporation by reference
Subpart B Obtaining and Using Digital Certificates for Electronic Orders
Section 1311.10 Eligibility to obtain a CSOS digital certificate
Section 1311.15 Limitations on CSOS digital certificates
Section 1311.20 Coordinators for CSOS digital certificate holders
Section 1311.25 Requirements for obtaining a CSOS digital certificate
Section 1311.30 Requirements for storing and using a private key for digitally
signing orders
Section 1311.35 Number of CSOS digital certificates needed
Section 1311.40 Renewal of CSOS digital certificates
Section 1311.45 Requirements for registrants that allow powers of attorney to
obtain CSOS digital certificates under their DEA registration
Section 1311.50 Requirements for recipients of digitally signed orders
Section 1311.55 Requirements for systems used to process digitally signed
orders
Section 1311.60 Recordkeeping
11





















Subpart C—Electronic Prescriptions
§1311.100 General
§1311.102 Practitioner responsibilities
§1311.105 Requirements for obtaining an authentication credential--Individual
practitioners
§1311.110 Requirements for obtaining an authentication credential--Individual
practitioners eligible to use an electronic prescription application of an institutional
practitioner
§1311.115 Additional requirements for two-factor authentication
§1311.116 Additional requirements for biometrics
§1311.120 Electronic prescription application requirements
§1311.125 Requirements for establishing logical access control--Individual practitioner
§1311.130 Requirements for establishing logical access control--Institutional
practitioner
§1311.135 Requirements for creating a controlled substance prescription
§1311.140 Requirements for signing a controlled substance prescription
§1311.145 Digitally signing the prescription with the individual practitioner's private
key
§1311.150 Additional requirements for internal application audits
§1311.170 Transmission requirements
§1311.200 Pharmacy responsibilities
§1311.205 Pharmacy application requirements
§1311.210 Archiving the initial record
§1311.215 Internal audit trail
§1311.300 Application provider requirements--Third-party audits or certifications
§1311.302 Additional application provider requirements
§1311.305 Recordkeeping
12



Background: DEA has previously never
allowed electronic signatures on prescriptions
for controlled substances.
Originally 3 Methods: Oral, written, faxed.
Faxed prescriptions: Have been are still are
allowed, but it must be “a facsimile of a
signed paper prescription transmitted by the
practitioner or the practitioner's agent to the
pharmacy.” 21 CFR 1306.21
13


The DEA considers faxed prescriptions PAPER
prescriptions and, therefore, they MUST be
MANUALLY signed.
“A faxed prescription is a paper prescription and, therefore,
must be manually signed by the prescribing practitioner
registered with DEA to prescribe controlled substances.”
75 FR 16264 March 31, 2010 (interim final rule on elec. Rxs)
 A signature created by a stylus on an electronic
device is digital and is NOT a manual
signature!!!
 Manual Signature = PEN TO THE PAPER!
14
21 CFR 1311 (The New Regs) NOW Electronic
OK – BUT must be in compliance with new regs.
 WRITE --- RECEIVE --- ARCHIVE
 Providers can write for controlled substances
electronically, including schedule II substances.
 Pharmacies can receive electronic prescriptions
for controlled substances in schedule II-V.
 Pharmacies must archive the records
electronically (if electronic rx it must be maintained electronically)

(nothing prevents paper record but it MUST be maintained electronically)
15


Specific software and other requirements and
procedures must be met for valid transmittal of
electronic controlled substance prescriptions .
The new electronic prescribing regs do NOT
mean electronic signatures FAXED to a
pharmacy are valid.
16





NO (but, c.f., NY)
Physicians have the option of writing
electronically for controls.
Pharmacies have the option of accepting
electronically prescribed controls.
The DEA considers the use of electronically
prescribed controls as strictly voluntary
Prescribers may still write for controls as
before, or fax or call in C III, IV and V Rxs.
17

YES. “Nothing in this chapter shall be construed as authorizing or
permitting any person to do any act which such person is not authorized or
permitted to do under other Federal laws or obligations under international
treaties, conventions or protocols, or under the law of the State in which he/she
desires to do such act nor shall compliance with such parts be construed as
compliance with other Federal or State laws unless expressly provided in such
other laws.” 21 CFR 1307.02 [i.e., no preemption]


This is why some states do not allow oral CIII, IV and V Rxs
even though the DEA does.
Generally, the more restrictive law applies. If state law is
more restrictive, must follow state law (unless preempted – e.g.,
See E-Sign Law)
18

NOW.

However, both the prescriber’s computer
system AND the pharmacy’s computer system
must be compliant with the stringent
requirements in the interim final rule.
19

The application provider must either hire a qualified third
party to audit the application or have the application reviewed
and certified by an approved certification body.

The auditor or certification body will issue a report that states
whether the application complies with the DEA’s requirements
and whether there are any limitations on its use for controlled
substance prescriptions.

The application provider must provide a copy of the report to
the practitioners or pharmacies to allow them to determine
whether the application is compliant.
20

YES, BUT
 A practitioner may use an existing electronic prescription or Electronic
Health Record (EHR) application that doesn’t yet comply with the
interim final rule to prepare and print a controlled substance
prescription so that the other electronic prescribing functionality may be
used, but until the application is compliant, the practitioner will have to
print the prescription for manual signature. Such a prescription is a
paper prescription and subject to existing rules. It may then be handed
to the patient or faxed to the pharmacy.
 A pharmacy cannot process electronic prescriptions until the application
is compliant, but it may use the application to store data from printed,
manually signed prescriptions or oral prescriptions entered or scanned
into the computer as they currently do, and the paper records from
controlled substances must be retained
21



BEFORE the application is used to sign or
transmit electronic prescriptions (practitioners)
BEFORE the application is used to process
controlled substance prescriptions (pharmacies)
AFTER the applications are being use by
practitioners or pharmacies WHENEVER a
FUNCTIONALITY as it relates to controlled
substances is ALTERED, or EVERY TWO(2)
YEARS, whichever occurs first
22

Third-Party Audits and Certifications apply to
the application provider, NOT to the
individual practitioner, institutional
practitioner or the pharmacy

UNLESS, the application is proprietary (i.e.,
developed by the individual practitioner,
institutional practitioner or pharmacy)
23
NEED 2 OUT OF THE 3:
 1. Something you know (e.g., a password)
 2. Something you have (a hard token – e.g., a
smart card or USB device) – must be stored or
kept separate from the computer being
accessed with only prescriber control
 3. Something you are (a biometric – e.g., a
fingerprint, iris scan)
24





PRACTITIONER: sole possession of hard token or
password! Notification in 1 business day if lost or
stolen!
If not compliant, can lose DEA registration
2 PEOPLE assigned to issuance and control of
application and one must be a DEA registrant
Requirements for obtaining an authentication
credentials complex - Section 1311.105.
The credential service provider or certification
authority must issue the authentication credential using
two channels ( e.g., e-mail, mail, or telephone call).
25

The practitioner will use the two-factor
credential to sign the prescription; that is,
using the two-factor credential will constitute
the legal signature of the DEA-registered
prescribing practitioner.
26




NO
A practitioner is not permitted to issue prescriptions for
multiple patients with a single signature.
May sign multiple prescriptions for a single patient at
one time as long as he/she indicates each rx is ready to
be signed
Each controlled substance prescription will have to be
indicated as ready for signing, but a single execution of
the two-factor authentication protocol can then sign all
prescriptions for a given patient that the practitioner
has indicated as being ready to be signed.
27



NO.
Signing and transmitting an electronic controlled
substance prescription are two distinct actions.
Electronic prescriptions for controlled substances
should be transmitted as soon as possible after
signing, however, it is understood that
practitioners may prefer to sign prescriptions
before office staff add pharmacy or insurance
information, therefore, DEA is not requiring that
transmission of the prescription occur
simultaneously with signing the prescription.
28




YES.
Electronic prescription application may print copies of
the transmitted prescription(s) if they are clearly
labeled: “Copy only – not valid for dispensing.”
List of prescriptions transmitted may be printed for
patients if the list indicates that it is for informational
purposes only and not for dispensing.
**The copies must be printed after transmission. If
an electronic prescription is printed prior to attempted
transmission, the electronic prescription application
must not allow it to be transmitted. **
29
IF TRANSMISSION FAILS, MAY
INTERMEDIARY CONVERT TO A DIFFERENT
FORMAT (I.E., CHANGE IT TO A FAXED
PRESCRIPTION)?
 NO.


Electronic prescription must be transmitted from the
practitioner to the pharmacy in its electronic form. If
an intermediary cannot complete a transmission of a
controlled substance prescription, the intermediary
must notify the practitioner.
30

Under such circumstances, if the prescription is
for a schedule III, IV, or V controlled substance,
the practitioner can print the prescription,
manually sign it, and fax the prescription directly
to the pharmacy. **This prescription must
indicate that it was originally transmitted to a
specific pharmacy (and name the pharmacy), the
date and time of transmission, and the fact that
the electronic transmission failed.** [see
pharmacy responsibility below if they receive
such a faxed prescription]
31




The DEA-required contents of a prescription shall not
be altered during transmission between the practitioner
and pharmacy.
However, this requirement only applies to the content
(not the electronic format used to transmit the
prescription).
This requirement applies to actions by intermediaries.
It does not apply to changes that occur after receipt at
the pharmacy. Changes made by the pharmacy are
governed by the same laws and regulations that apply
to paper prescriptions. [see below, pharmacy annotations and
alterations]
32
•
•
What must a pharmacy application do? (21 CFR 1311.205)
Accurately and consistently:
• Import
• Display
• Store
all the required contents of a controlled
substance prescription, indication of signing,
digital signature, and number of refills
33

The pharmacy must determine which employees
are authorized to enter information regarding the
dispensing of controlled substance prescriptions
and annotate or alter records of these
prescriptions (to the extent such alterations are
permitted under this chapter). The pharmacy must
ensure that logical access controls in the
pharmacy application are set so that only such
employees are granted access to perform these
functions
34
When a pharmacist receives a paper or oral
prescription that indicates that it was
originally transmitted electronically to the
same pharmacy, the pharmacist must check
its records to ensure that the electronic
version was not received and the prescription
dispensed. If both prescriptions were
received, the pharmacist must mark one as
void.
35
When a pharmacist receives a paper or oral
prescription that indicates that it was originally
transmitted electronically to another pharmacy, the
pharmacist must check with that pharmacy to
determine whether the prescription was received and
dispensed. If the pharmacy that received the original
electronic prescription had not dispensed the
prescription, that pharmacy must mark the electronic
version as void or canceled. If the pharmacy that
received the original electronic prescription dispensed
the prescription, the pharmacy with the paper version
must not dispense the paper prescription and must
mark the prescription as void.
36

What changes can be made by the pharmacy
AFTER receipt of an electronic prescription?

Changes made by pharmacies are subject to
the same rules that apply to all prescriptions
for controlled substances. 75 FR 16281, No. 61
37

CHANGES TO CII vs. CHANGES to CIII,IV, & V

Same rule applies to electronic rxs and paper
rxs for changes to the prescription.
Prohibition to changes of content of
electronic rx applies only to intermediaries.

But what changes can be made?
38

CII Changes:
 Previous DEA policy allowed changes to CII
prescriptions the same as a CIII-V (see below for
such changes that may be made)
 On November 19, 2007, DEA issue rule on Issuance
of Multiple Prescriptions for Schedule II Controlled
Substances.
 PRAMBLE to that rule created problem…..
39


…Preamble to Multiple CII Rxs regulation
stated that: "the essential elements of the
[schedule II] prescription written by the
practitioner (such as the name of the
controlled substance, strength, dosage form,
and quantity prescribed)…may not be
modified orally.“
This contradicted previous policy of allowing
changes to a CII prescription.
40


DEA recognized resulting confusion and
plans on resolving in future with additional
rule….. Until then…
DEA states: Until that time, pharmacists are
instructed to adhere to state regulations or policy
regarding those changes that a pharmacist may make
to a schedule II prescription after oral consultation
with the prescriber.
 What if state law is silent??????
41

Changes to a CII made by the pharmacy AFTER
receipt of an electronic prescription are governed by
the same laws and regulations regarding paper
prescriptions.
42
MASSACHUSETTS – CII changes
MAY CHANGE OR ADD after consultation with
prescriber:









Date Written
Directions for use
Prescribers address
Dosage form
Drug strength
Quantity prescribed
***Patient Address***Can ADD patient address if not on Rx
without consultation; can CHANGE patient address with
consultation with prescriber OR agent!
 ***DEA#*** DEA number may be added to Rx without
consultation with prescriber or agent.
43
44

True Statement: A pharmacist can add the patient’s
address on a controlled substance prescription if
missing and legitimately dispense that prescription
(assuming all other requirements of a valid prescription
are met)

Question: If a prescriber issues a prescription to a
patient without the patient’s address on the
prescription, that prescriber has issued a prescription in
violation of the federal law and action against that
prescriber can be taken by the DEA.
TRUE or FALSE????

45

Answer:

TRUE.
Really???

46








Registrant Actions - 2012
[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45675-45688]
From the Federal Register Online via the Government Printing Office
[www.gpo.gov]
[FR Doc No: 2012-18749]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11-57]
Margy Temponeras, M.D.; Decision and Order
On December 15, 2011, Administrative Law Judge (ALJ) Timothy D. Wing issued
the attached recommended decision. Neither party filed exceptions to the
decision.
Having considered the entire record, I have decided to adopt the ALJ's
recommended rulings, factual findings, and his legal conclusions, except as
discussed below.\1\ I further hold that the record establishes that Respondent
engaged in acts which are sufficiently egregious to warrant the revocation of
her registration and that she has not rebutted this conclusion.\2\
47


“Among the allegations raised by the Government were:
(1) That Respondent had failed to include required
information on various prescriptions (such as a
patient's address) in violation of 21 CFR 1306.05”
“That Respondent frequently issued prescriptions for
controlled substances that did not contain all of the
information required by 21 CFR 1306.05(a) \3\”
\
3\ The section requires in relevant part that "[a]ll
prescriptions for controlled substances shall * * *
bear the full name and address of the patient * * *
[and] directions for use * * *."
(FOOTNOTE 3)

FOOTNOTE
48
Accordingly, I find by a preponderance of the evidence
that Respondent issued approximately eleven
prescriptions between August and November 2006 for
controlled substances without providing a patient
address, in violation of applicable federal regulations.
49

What does this all mean?????
 Physicians are required to put patient’s address on the
rx.
 Failure to do so increases risk of diversion because
adding address at pharmacy does not confirm what
practitioner has on file as address… could be different,
possible diversion issue.
 Example of not doing what you’re supposed to do can
come back to bite you even if it’s not something
normally enforced (i.e., accepting electronic
signatures on faxed rxs for controls (e.g., Robitussin
w/ Codeine, Vicodin, Valium, etc.) Those are NOT
valid if faxed Rx has electronic signature.
50
LAW UPDATES
51
THE “LEARNED INTERMEDIARY DOCTRINE”

Traditionally, the learned-intermediary
doctrine has been used to insulate drug
manufacturers from liability in productsliability lawsuits. The physician becomes
the intermediary between the drug
manufacturer and the patient.
52


Under the learned-intermediary doctrine, a drug
manufacturer is immune from liability to a
patient for “failure to warn” so long as the
manufacturer has provided the patient's doctor
with all relevant safety information for that
drug.
It is then up to the patient's doctor—who has the
benefit of knowing the patient's specific
situation—to convey to the patient any
information that the doctor deems relevant.
That is, the doctor is in the “best position” to
warn the patient. Thus, he is the “learned
intermediary” best suited to provide a warning.
53

EXCEPTIONS:
 Exemptions began to emerge beginning with birth
control pills where the doctor takes almost a passive
role, prescribing the BC to patients at their request.
Drug manufacturers thus were required to provide
additional warnings to the patient by patient package
inserts
 Also, with newer “direct-to-consumer” advertising in
TV, magazines, radio, greater warnings DIRECT to
consumers is required
 But the general rule still applies.
54


Jurisdictions adopting the learned-intermediary
doctrine in the context of pharmacist/customer
tort litigation have put forth a similar
rationale: that between the doctor and the
pharmacist, the doctor is in the best position to
warn the customer of a given medication's
generalized risks
Or, viewed more pragmatically, the doctrine
prevents pharmacists from constantly secondguessing a prescribing doctor's judgment simply
in order to avoid his or her own liability to the
customer.
55

CASES THAT CHIP AWAY AT THE DEFENSE
A TROUBLESOME CASE!

Klasch v. Walgreen Co., Supreme court of the State of
Nevada, 54805, Nov. 23, 2011.
 This case raises concern for the continued viability
of the learned intermediary defense and, indeed, for
the extent of liability imposed even when a
pharmacist takes reasonable steps to avoid injury.
56

Klasch v. Walgreen, Co. (cont’d)
 Background: Helen Klasch visited Fredrick
Tanenggee, M.D., for the first time in December,
2005. On her paperwork she indicated that she
might have a sulfa allergy.
 After discussion, it was recorded in her medical
file under allergies as “Sulfa?”
 In July, 2006, Klasch returned to Dr. Tanenggee
complaining of “abdominal fullness.”
57

Klasch v. Walgreen, Co. (cont’d)
 Klasch was diagnosed with a urinary tract infection.
Dr. Tanenggee told Klasch that under normal
circumstances, her infection could be treated most
effectively with Bactrim.
 Given the notation in her chart, however, Dr.
Tanenggee asked Klasch to clarify how certain she
was of her sulfa allergy. After some further discussion,
Klasch downplayed the previous notation and asked
Dr. Tanenggee to write her a prescription for Bactrim.
 Dr. Tanenggee complied, and Klasch dropped off the
prescription at Walgreens Pharmacy on her way home
from Dr. Tanenggee's office.
58

Klasch v. Walgreen, Co. (cont’d)
 Later that day, Klasch’s caretaker returned to the
pharmacy to pick up the prescription, and a
pharmacy employee told the caretaker the
prescription was not ready because it had been
“flagged” because of the possible sulfa allergy.
 The caretaker asked the pharmacy to call Klasch
directly to discuss the issue. The employee called
Klasch.
59

Klasch v. Walgreen, Co. (cont’d)
 Klasch reportedly indicated that she had taken
Bactrim in the past and that she had not
experienced any adverse reaction to it.
 Based on this information and clarification
provided by the patient, the pharmacist overrode
the “flag” and filled the prescription and released
it to the caretaker.
60

Klasch v. Walgreen, Co. (cont’d)
 Later that day, after taking the medication, Klasch
complained that she felt "itchy." The following day,
Klasch called Dr. Tanenggee's office and left a voice
mail in which she stated that she was wrong about
not having a sulfa allergy.
 Klasch's condition continued to worsen, and she was
taken to the emergency room. After being diagnosed
with SJS/TEN, Klasch was transferred to a burn
center, where she eventually lapsed into a coma and
passed away.
 At the time Klasch was removed from life support, she
had burns covering 40 to 50 percent of her body.
61

Klasch v. Walgreen, Co. (cont’d)
 Klasch's two children brought a wrongful-death action
against Walgreens, alleging that its pharmacist
breached the duty of care owed to their mother.
Specifically, the Klasches contended that Walgreens'
pharmacist breached her duty of care by failing to
adequately warn Klasch of the prescribed
medication's risks in light of her allergy to it or,
alternatively, by failing to call Dr. Tanenggee to clarify
whether he really meant to prescribe a medication to
which she was allergic.
62

Klasch v. Walgreen, Co. (cont’d)
 At the trial level, Walgreen’s filed a motion for
summary judgment, using the “learned
intermediary” defense, claiming that it had no
duty to warn.
 The trial court, following what it perceived to be
the “majority rule” allowed Walgreen’s motion
and dismissed the case.
 Klasch’s estate appealed.
63

Klasch v. Walgreen, Co. (cont’d)
 On appeal, the appellate court for the first time in
that state “adopt[ed] the learned-intermediary
doctrine in the context of pharmacist/customer
tort litigation and [held] that pharmacists have no
duty to warn of a prescribed medication's
generalized risks.”
 BUT, the court went on to address whether the
doctrine applies when there is a “known
customer-specific risk.”
64

Klasch v. Walgreen, Co. (cont’d)
 Despite the fact that there was a discussion
between the pharmacy and the patient about the
possible allergy, and despite the fact that the
patient said she had taken the drug with no
problems before, and despite the fact that the
doctor had the same information as the pharmacy
and prescribed the drug, the court still denied the
learned intermediary doctrine defense in this
case!
65

Klasch v. Walgreen, Co. (cont’d)
 In denying the learned-intermediary defense to
Walgreens, the court stated it rational.
 The Klasch court adopted the reasoning of Happel
v. Wal-Mart Stores, Inc., 199 Ill.2d 179, 262 Ill.Dec.
815, 766 N.E.2d 1118 (2002) (an Illinois case).
 Happel involved a specific known risk to a patient
– an allergy to aspirin and prescribed toradol.
66

Klasch v. Walgreen, Co. (cont’d)
 The Klasch court reasoned:
▪ “We find the analysis of the Happel court persuasive.
Consistent with the Supreme Court of Illinois and what
we perceive to be the modern trend of case law, we hold
that the learned-intermediary doctrine does not insulate
a pharmacist from liability when he or she has
knowledge of a customer-specific risk. Instead, when a
pharmacist has such knowledge, the pharmacist has a
duty to warn the customer or to notify the prescribing
doctor of the customer-specific risk.”
67

Klasch v. Walgreen, Co. (cont’d)


THE COURT’S HOLDING:
“By insulating pharmacists from liability for failing to warn their
customers of a medication's generalized risks, the learnedintermediary doctrine prevents pharmacists from interfering with
the doctor-patient relationship. Because the public-policy
considerations behind this doctrine are sound, we adopt it in the
context of pharmacist/customer tort litigation. These public-policy
considerations are less persuasive, however, when a pharmacist
has knowledge of a customer-specific risk with respect to a
prescribed medication. Accordingly, in such circumstances, the
learned-intermediary doctrine does not insulate a pharmacist
from liability, and the pharmacist instead has a duty to exercise
reasonable care in warning the customer or notifying the
prescribing doctor of this risk.” (Emphasis added).
68

Klasch v. Walgreen, Co. (cont’d)
 The Klasch court holding itself makes sense, that if a
pharmacist knows of a specific risk to a specific
patient (such as a drug interaction or drug allergy) he
should warn the patient or doctor, BUT, in the Klasch
case the pharmacist took reasonable steps to
ascertain whether or not there even was a risk, and
relied on the patient’s information provided BY the
patient :That she wasn’t allergic, that she had had it
before! She even got the doctor to prescribe it
knowing of the initial statement that she might have
been allergic. WHAT’S A PHARMACIST TO DO?
69
70

Who is really to blame????
Owner?
 Staff Pharmacists with knowledge?
 Technicians?
 State inspectors?
 State Board?
 FDA?
 CONGRESS?
THE UNITED STATES SUPREME COURT?


71

The Federal Food and Drug Administration
Modernization Act of 1997

1997 FDAMA did many things:
 Expediting study/approval of “fast track” drugs
 Addressed the pediatric study of drugs
 Eliminated “batch certification” of insulin and
antibiotic products
 Lifted some restriction on “off-label” use of meds
72

The Federal Food and Drug Administration
Modernization Act of 1997

THE FDAMA ALSO ADDED TO THE FOOD,
DRUG AND COSMETIC ACT OF 1938 THE
FOLLOWING SECTION:
 SECTION 503A – PHARMACY
COMPOUNDING
73
 SECTION 503A – PHARMACY
COMPOUNDING


FDA issued Compliance Policy Guide (CPG) on
compounding in 1992. Pharmacy industry
disturbed by how the FDA would exercise its
enforcement discretion, so looked to congress
Congress enacted 503A to ensure the availability
of pharmacy compounding for individuals based
on the traditional physician-patient-pharmacist
relationship, WITH some restrictions…………….
74
 SECTION 503A – PHARMACY
COMPOUNDING

503A exempted compounding pharmacies from the
adulteration, misbranding and new drug application
sections of the FDCA if:
 Unsolicited Prescription from physician for specific
patient
 Small scale (i.e., not manufacturing scale)
 Limited interstate sale
 Follow certain FDA & USP compounding regs/guides
75
 SECTION 503A – PHARMACY
COMPOUNDING



“such drug product is compounded in a State-(i) that has entered into a memorandum of understanding with the
Secretary which addresses the distribution of inordinate amounts of
compounded drug products interstate and provides for appropriate
investigation by a State agency of complaints relating to
compounded drug products distributed outside such State; or
(ii) that has not entered into the memorandum of understanding
described in clause (i) and the licensed pharmacist, licensed pharmacy, or
licensed physician distributes (or causes to be distributed) compounded
drug products out of the State in which they are compounded in
quantities that do not exceed 5 percent of the total prescription
orders dispensed or distributed by such pharmacy or physician.”
76
 SECTION 503A – PHARMACY
COMPOUNDING LAW
Struck Down by Supreme Court in 2002
(why?)
77
 SECTION 503A – PHARMACY
COMPOUNDING LAW
Struck Down by Supreme Court in 2002
WHY: First Amendment – Free Speech
“(c) Advertising and Promotion.--A drug may be compounded
under subsection (a) only if the pharmacy, licensed pharmacist,
or licensed physician does not advertise or promote the
compounding of any particular drug, class of drug, or type of
drug. The pharmacy, licensed pharmacist, or licensed physician
may advertise and promote the compounding service
provided by the licensed pharmacist or licensed physician.”
78

SECTION 503A – PHARMACY COMPOUNDING LAW
Struck Down by Supreme Court in 2002
November 1998, solicitation and advertising provisions of section 503A
challenged by seven compounding pharmacies as an impermissible
regulation of commercial speech.
 The U.S. District Court for the District of Nevada ruled in the plaintiffs’
favor. FDA appealed to the U.S. Court of Appeals for the Ninth Circuit.
On February 6, 2001, the Court of Appeals declared section 503A to be
invalid in its entirety (Western States Medical Center v. Shalala, 238 F.3rd
1090 (9th Cir. 2001)). The government petitioned for a writ of certiorari
to the U.S. Supreme Court for review of the Ninth Circuit’s decision that
the solicitation and advertising provisions of section 503A were
unconstitutional restrictions on commercial speech. The Supreme
Court granted the writ and issued its decision in the case on April 29,
2002.

79

SECTION 503A – PHARMACY COMPOUNDING LAW
Struck Down by Supreme Court in 2002

The Supreme Court affirmed the Ninth Circuit’s decision that
section 503A of the FD&C Act was invalid in its entirety
because it contained unconstitutional restrictions on
commercial speech (i.e., prohibitions on soliciting
prescriptions for and advertising specific compounded
drugs). The Court did not rule on, and therefore left in place,
the Ninth Circuit’s holding that the unconstitutional
restrictions on commercial speech could not be severed from
the rest of section 503A. Accordingly, all of section 503A is
invalid. (c.f. 5th circuit (district court case in TX) severable, new-drug issue)
80

SECTION 503A – PHARMACY COMPOUNDING LAW
Struck Down by Supreme Court in 2002

503A struck down in 2002, and complaints
about NECC to the FDA began in 2002.

Feb. 2003 FDA & MA state officials met: FDA
staff emphasized "the potential for serious
public consequences if NECC's compounding
practices, in particular those relating to sterile
products, are not improved."
81

SECTION 503A – PHARMACY COMPOUNDING LAW
Struck Down by Supreme Court in 2002
82

SECTION 503A – PHARMACY COMPOUNDING LAW
Struck Down by Supreme Court in 2002
The VALID Act
A bill introduced in the
House by Representative Markey of Mass.
‘‘Verifying Authority
and Legality In Drug Compounding Act of 2012’’
83

SECTION 503A – PHARMACY COMPOUNDING LAW
The VALID Act
The VALID Act is basically a re-introduction of Section
503A with some modifications AND the elimination of
the offending portions of the original section 503A
(the solicitation and advertising sections struck down)
Currently pending in congress
States may pass laws and regs also
84

SECTION 503A – PHARMACY COMPOUNDING LAW
The VALID Act
Some new provisions:
LABELING: “this drug has not been tested for safety
and effectiveness and is not approved by the FDA.
Serious adverse reactions to this drug should be
reported to the pharmacy where it was received and
to the FDA at XXXXX”
85

SECTION 503A – PHARMACY COMPOUNDING LAW
The VALID Act
Some new provisions:
MANUFACTURERING : exemption for compounding
pharmacies won’t apply “to the extent to which the
pharmacy is, in effect, manufacturing such drugs, as
determined by the Secretary, taking into consideration the
extent to which such pharmacy sells the drugs across state
lines, the quantities of drugs sold, and any other factors
deemed appropriate by the Secretary.”
86

New Massachusetts laws regarding controlled
substances:
 Massachusetts
Acts of
2012, Chapter 244
AN ACT RELATIVE TO
PRESCRIPTION DRUG DIVERSION,
ABUSE AND ADDICTION.


There are 29 Sections to this Act.
87
 Massachusetts
Acts of
2012, Chapter 244

Section 1.
[Added Sec. 7A of M.G.L. Ch. 94C]
 Practitioners (except veterinarians)
upon obtaining or renewing controlled
substance registration from the State
(not their DEA registraton) shall
automatically and without further action
be registered as a participant in the
prescription monitoring program (PMP)
established in section 24A.
88


Massachusetts Acts of 2012, Chapter
244
Section 2.
[Added a paragraph to Sec. 15 (Record Keeping) of M.G.L. Ch.94C]
 If you have a controlled substance registration from the
state (e.g., practitioners, pharmacIES) and are required to
submit a DEA form 106 (loss or theft of controlled
substance) to the DEA, you must simultaneously file a
copy of the form to the State Police AND local police of
the location of the loss or theft
 NOTE: individual pharmacists do not obtain a controlled
substance registration – the pharmacies they work in do –
BUT remember Manager of Record responsibilities with
recordkeeping (does corporate submit 106 form??? Rx
Manager responsibility!)
89
 Massachusetts
Acts of 2012,
Chapter 244

Sections 3 and 4.
[changed Sec. 18(d) of M.G.L.
Ch.94C and added Section 18(d½ ).
COMMON TO SECTION 18(d) AND 18(d½)
 MGLCh.94C,Sec. 18(d) AND (d½):
▪ authorize out of state prescribing of CII rxs but
only if issued within preceding 5 (FIVE) days, and
must be verified by telephone or other means or
cannot be filled. No liability for not filling if
document good faith attempt to verify.
90
 Massachusetts
Acts of
2012, Chapter 244

Sections 3 and 4.
[changed Sec. 18(d) of
M.G.L. Ch.94C and added Section 18(d½ ) cont’d.
COMMON TO SECTION 18(d) AND 18(d½)
 MGLCh.94C,Sec. 18(d) AND (d½):
▪ Requires pharmacist to send copy of CII rx
from out of state to department of public
health with patient’s name and address
redacted. [Is corporate doing this??]
91


Massachusetts Acts of 2012,
Chapter 244
Sections 3 and 4.
Section 18(d½ ) cont’d.
[changed Sec. 18(d) of M.G.L. Ch.94C and added
DIFFERENCES BETWEEN SECTION 18(d) AND 18(d½)
Sec. 18(d):
▪ Allows out of state prescriptions for NON-NARCOTIC CIIs
(e.g., Adderall, Concerta, Daytrana, Ritalin) from ANY
STATE
Sec. 18(d½): [Note: Delayed until Dec. 1, 2013]
▪ Allows out of state prescriptions for NARCOTIC CIIs (e.g.,
Percocet, Oxycodone, Fentanyl) only from the STATE of
MAINE and all contiguous states (RI, CT, NY, VT, and NH)
▪ So no more of those Florida Oxycodones!!! Finally.
92


Massachusetts Acts of 2012,
Chapter 244
Section 5.
[Added a paragraph to Sec. 21
(Labeling) of M.G.L. Ch.94C]
Requires the department of public health to produce/provide
pamphlets (written or electronic) relative to narcotic drugs to
pharmacies for distribution to a patient picking up a presctiption
for a NARCOTIC in EITHER Schedule II or III.
 information about: (i) pain management; (ii) misuse and abuse by adults and children;
(iii) risk of dependency and addiction; (iv) proper storage and disposal; (v) addiction
support and treatment resources; and (vi) the telephone helpline operated by the
bureau of substance abuse services

93


Massachusetts Acts of 2012,
Chapter 244
Section 6.
[Added Sec. 21B (Lock Boxes) to
M.G.L. Ch.94C]
Pharmacies in MA (but not institutional pharmacies) registered to
dispense drugs in Schedule II, III, IV and V must make “LOCK
BOXES” for medication available for sale to the public.
 Must inform public by a sign “on or near” pharmacy counter.
 Sign must be at least 4” x 5” and say “lock boxes for securing
your prescription medications are available at this pharmacy.”

94
Massachusetts Acts of 2012,
Chapter 244


Section 7.
[Amended Sec. 23(g) (written rx
requirements) to M.G.L. Ch.94C]

Effective July 1, 2013 – TAMPER RESISTANT PAPER FOR ALL RXS

Added the words “on a tamper resistant form consistent with
federal requirements for Medicaid” in the language describing the
requirements for written prescriptions.
 So after July 1, 2013 (unless delayed) ALL rxs written in MA
(control and non-control rxs) must be on tamper resistant paper
95


Massachusetts Acts of 2012,
Chapter 244
Section 8.
[Adds a paragraph to Sec. 24A(c)
(PMP program) of M.G.L. Ch.94C]
Requires the Dept. of Public Health to promulgate regulations
REQUIRING participants in the PMP (practitioners) to utilize the
PMP program PRIOR to seeing a new patient, even where it would
normally not require use of the PMP prior to seeing a new patient.
 Requires pharmacists to be trained in the PMP program by way of
Continuing Education requirements (according to the Board of
Pharmacy, this will be a one-time CE).
 Authorization for support staff to be able to use the PMP on
behalf of the PMP registrant.

96

Massachusetts Acts of 2012,
Chapter 244
Other Sections:





Physicians, Nurse Practitioners and Hospitals treating patients under 18 years of age
for alcohol or drug overdose must notify parent and provide pamphlet on drug/alcohol
abuse to parent upon discharge and provide access to social worker if available.
SECTION 10
MassHealth enrollees who use excessive drugs (“frequent flyers”), shall be restricted
by the Division of Medical Assistance to one primary pharmacy.
SECTION 11
Provides for training for judges, other court employees, and lawyers in substance abuse
and to identify substance abuse treatment resources for those charged with or
convicted of crimes.
SECTIONS 12 and 13.
Provides for a study to be conducted on drug diversion, abuse and addiction among
SENIOR CITIZENS.
SECTION 25
97
NOTE: Delayed until Dec. 1, 2013
cii OR
ciii-v
cii
Out of
State RX
MA RX
30 days to
fill
Ciii-v
5 days to
fill
Out of
State Rx
MA Rx
Verify or
no fill
6 Mos. to
Fill (1 yr
on C-v)
Narcotic?
No
Yes
Any state
o.k.
Must be
Contiguous
State or
Maine
Any state
o.k.
30 Days to
fill
Verify or
no fill
© Laurence E. Sweeney, 2013
98


FEDERAL LAW
Hydrocodone Combo Products (Vicodin, Vicoprofen, Tussionex,
Hycodan) --- Push to RE-SCHEDULE into Schedule II






FDA Advisory Panel on January 24 and 25 of 2013 conducted hearings.
Voted 19-10 in favor of placing Hydrocodone combo products into Schedule II
FDA has not yet determine weather or not to follow recommendation.
Testifying were law enforcement (DEA, police), pain specialists, addiction specialists,
pharmacist, industry advocates, and bereaved families who lost children to pain
prescription medication.
NEW YORK STATE has already placed hydrocodone combo products in Schedule at the
state level.
MASSACHUSETTS Chapter 244 of the Acts of 2012 initially had a provision that would
have moved hydrocodone combo products into schedule II, but it did not find its way to
the final bill that was signed into law by Governor Duval Patrick and became effective
August 18, 2012.
99


FEDERAL LAW
PLAN B:
 Federal court orders FDA to make
Plan B available to all consumers
without a prescription regardless of
age.
 No decision
100
101