Transcript Reciprocity Meeting PowerPoint Presentation (Review)

Reciprocity Law Review
© 2014 Jay Campbell
Reproduction prohibited without
permission of the author
Revised 01/2015
What Is A Legitimate Prescription
Under North Carolina Law?
Rule .1801(b)
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Rule 1801(b): “A pharmacist shall not fill or refill a
prescription order if the pharmacist actually knows or
reasonably should know that the order was issued
without a physical examination and in the absence of a
prior prescriber relationship; unless”:
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Prescription is from a psychiatrist;
Prescription is issued after discussion of the patient status with a
treating psychologist, therapist, or physician;
Flu vaccines for groups of patients;
Prescription is for prophylactic purposes;
Emergency order related to pregnancy prevention;
Prescription for medications to be taken by groups traveling to
foreign countries.
Internet-Based Prescriptions
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Internet-based prescriptions generated without
a physical examination or a prior prescriberpatient relationship are not valid, and filling
them violates state law. Filling such
prescriptions for controlled substances also
violates federal law.
The Board is aware that some Internet-based
operations actively solicit pharmacists to act as a
dispensing clearinghouse for Internet-based
prescriptions. The Board strongly advises
pharmacists to reject these offers.
Who Can Prescribe in NC?

N.C.G.S. § 90-85.3: “Prescription order”
means a written or verbal order for a
prescription drug, prescription device, or
pharmaceutical service from a person
authorized by law to prescribe such drug,
device, or service.
Who Can Prescribe in NC?
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Out-of-State Prescribers.
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Non-controlled drugs. Prescriptions are valid, so long
as there is an appropriate patient-prescriber
relationship.
Controlled drugs. N.C. Controlled Substances Act
defines a prescription as “a written order or other
order . . . issued by a practitioner who is licensed in
this State to administer or prescribe drugs in the
course of his professional practice.” N.C.G.S. § 9087(23).
The key: Use your professional judgment. The Board
has never taken the position that out-of-state
prescribers cannot write prescriptions for controlled
substances so long as the prescriptions are for a
legitimate medical purpose and issued in the ordinary
course of medical practice.
Who Can Prescribe in NC?
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Physician Assistants and Nurse Practitioners
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PAs and NPs may prescribe controlled substances (II-V)
providing that these drugs are included in the supervisory
arrangement with the supervising physician and the PA or NP
has a DEA registration number.
PA and NP prescriptions must contain the prescriber’s name,
practice address, telephone number and the license number and,
if controlled substances are prescribed, the prescriber’s DEA
number. The supervising physician’s name and telephone
number also needs to be on each prescription.
To prescribe controlled substances both the PA/NP and the
supervising physician must have a valid DEA registration and all
prescriptions for drugs in Schedules II and III shall not exceed a
30 day supply. PAs/NPs may authorize refills for other Schedule
III, IV, and V controlled substances, consistent with state and
federal law, as well as other prescription drugs.
Who Can Prescribe in NC?
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Clinical Pharmacist Practitioners
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Clinical Pharmacist Practitioners may prescribe
drugs pursuant to a practice agreement with
a supervising physician.
Clinical Pharmacist Practitioners who issue
orders for controlled substances must have a
DEA registration number.
Filling Prescriptions in NC
What Must Be Included on a
Prescription?
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N.C.G.S. § 134.1 states that written
prescriptions for all legend drugs must
bear:
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“[T]he printed or stamped name, address,
telephone number and DEA number of the
prescriber in addition to his legal signature.”
Though the statute suggests otherwise, a DEA
number is not necessary on a prescription for
a non-controlled substance.
What Must Be Included on a Label?
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Name and address of the dispensing pharmacy.
Serial number of the prescription.
Date of the prescription.
Name of the prescriber.
Name of the patient.
Name and strength of the drug.
The generic name of the drug, even if the generic drug is unavailable to dispense or
even if the substitution of a generic drug is not authorized.
Directions for use.
Appropriate cautionary statements.
“Filled by” or “dispensed by” with the name of the dispensing pharmacist. The name
must include, at a minimum, the first initial and full last name of the dispensing
pharmacist.
If the dispensed drug is a “tranquilizer or sedative,” it must bear the warning “The
consumption of alcoholic beverages while on this medication can be harmful to your
health” unless the prescriber directs otherwise.
If the prescription is dispensed in a container other than the manufacturer’s original
container, a discard date, which shall be the earlier of one year from the date
dispensed or the manufacturer’s expiration date, whichever is earlier.
If the prescription is dispensed in the manufacturer’s original container, the label
must not obscure the expiration date and storage statement when the product is
dispensed in the manufacturer's original container.
21 U.S.C. § 353(b)(2); N.C.G.S. §§ 90-85.29, 106-134(b); 21 N.C.A.C. 46.1818.
Product Selection
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Two-Line Prescription Form, NCGS § 9085.28(b)
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If the prescriber signs on the right-hand
“dispense as written” line, substitution is not
permitted.
Handwrite “dispense as written” or “words
or abbreviations of the same meaning” –
substitution not permitted
Otherwise, pharmacist may choose to
dispense an “equivalent drug product.”
Product Selection
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Narrow Therapeutic Index (“NTI”) Drugs,
NCGS 90-85.28(b1)
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Must be refilled using the same drug product
by the same manufacturer that the
pharmacist last dispensed unless
Prescriber gives documented consent to a change;
and
 Patient give documented consent to a change.
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Purpose is to ensure appropriate monitoring if
a change is made.
Product Selection
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NTI Drug List:
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Carbamazepine (Tegretol, various others)
Cyclosporine
Digoxin (Lanoxin and others)
Ethosuximide
Levothyroxine sodium tablets (Levothroid, Levoxyl, Synthroid,
various others)
Lithium (Eskalith, Cibalith)
Phenytoin (Dilantin)
Procainamide Hydrochloride
Theophylline (Elixophyllin, Slo-Phyllin, Slo-bid Gyrocaps,
Theochron, Theo-Dur, Theo-24, Uniphyl)
Warfarin sodium tablets (BMS Warfarin, Coumadin, Warfarin)
Tacrolimus (Prograf)
Refilling Prescriptions
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A prescription with refills authorized “PRN”
may be refilled for 1 year.
A prescription may be authorized for refills
“PRN for three years” or other similar
directions.
Refills of controlled substances governed
by federal law.
Refilling Prescriptions
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Advance Refills – Rule .1802(b)
“If deemed appropriate in the pharmacist’s
professional judgment, a patient may receive
upon request drug quantities in excess of the
face amount of the prescription for a noncontrolled substance, up to the total amount
authorized. The pharmacist shall not dispense
in excess of the face amount of a prescription
for a controlled substance or a
psychotherapeutic drug without authorization
from the prescriber.”
Refilling Prescriptions
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Emergency 30-Day Refills, Rule .1809
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If a pharmacist is unable to obtain readily refill
authorization for a requested refill, the pharmacist
may dispense a one-time 30-day supply provided:
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The prescription is not for a Schedule II controlled substance
The medication is essential to the maintenance of life or to
the continuation of therapy in a chronic condition
In the pharmacist’s professional judgment, the interruption
of therapy might reasonably produce undesirable health
consequences
The pharmacist creates a written order containing all
required prescription information
The pharmacist notifies the prescriber or prescriber’s office of
the emergency dispensing within 72 hours.
Refilling Prescriptions
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Emergency 90-Day Refills, Rule 21 NCAC 46.1815
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If a pharmacist is unable to obtain readily authorization from the
prescriber because of the prescriber’s inability to provide medical
services, the pharmacist may dispense a one-time 90-day
emergency supply, provided:
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The prescription is not for a Schedule II controlled substance
The medication is essential to the maintenance of life or to the
continuation of therapy in a chronic condition
In the pharmacist’s professional judgment, the interruption of
therapy might reasonably produce undesirable health consequences
The pharmacist creates a written order containing all required
prescription information
The pharmacist notifies, or makes a good-faith attempt to notify,
the prescriber or prescriber’s office of the emergency dispensing
within 72 hours.
Electronic Prescriptions
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Electronic Transmission of Prescription Orders, Rule .1813
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(a) Prescription orders may be transmitted by using a facsimile machine ("FAX") or by other
electronic transmission from a prescriber to a pharmacy. "Electronic transmission" means
transmission of the digital representation of information by way of electronic equipment.
(b) All prescription drug orders transmitted by FAX or by electronic transmission shall:
(1) be transmitted directly to a pharmacist or certified technician in a pharmacy of the
patient's choice with no intervening person altering the content of the prescription drug
order;
(2) identify the transmitter's phone number for verbal confirmation, the time and date of
transmission, and the identity of the pharmacy intended to receive the transmission;
(3) be transmitted by an authorized practitioner or his designated agent and contain either
a written signature or an electronic signature unique to the practitioner;
(4) be deemed the original prescription drug order, provided it meets all requirements of
federal and state laws and regulations; and
(5) if a refill order, contain all information required for original prescription orders except for
the prescriber's signature.
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(d) The pharmacist shall exercise professional judgment regarding the accuracy, validity,
and authenticity of a prescription drug order transmitted by FAX or by electronic
transmission consistent with federal and state laws and regulations.
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(g) No agreement between a prescriber and a pharmacy or device and medical equipment
permit holder shall require that prescription orders be transmitted by FAX or by electronic
transmission from the prescriber to only that pharmacy or device and medical equipment
permit holder.
Electronic Controlled Substance
Prescriptions
Implementation
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On August 1, 2012, DEA announced that it had approved
certification processes for e-prescribing systems
conducted by several entities. More information is found
here:
http://www.deadiversion.usdoj.gov/ecomm/e_rx/thirdpa
rty.htm#approved
As a result, various ECSRx systems (both transmitting
and receiving) are coming on line. Once a system has
been approved as meeting DEA’s security requirements,
it may be used in North Carolina. There is no state-law
barrier to ECSRx. Pharmacies are urged to check with
their software vendors to determine their systems’
certification status.
Controlled Substance Issues
North Carolina-Specific Issues
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North Carolina law places a six-month expiration date on
Schedule II controlled substance prescriptions written on
or after October 1, 2013.
A North Carolina rule prohibits the preprinting of the
name of the controlled substance on prescription blanks.
21 NCAC 45G.307
 A computer-generated controlled substance
prescription is not considered “pre-printed” so long as
the prescription was generated for an individual
patient, and not “mass printed.”
 Pharmacists should also note that the DEA does not
permit the use of electronic or stamped signatures on
any controlled substance prescription.
Photo ID for Certain Controlled
Substances
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Pharmacies required to obtain a proper ID from a person seeking
dispensing of:
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Pharmacy must record the name of the person seeking the
dispensing and the type and number of the ID (driver’s license,
special DOT identification card, military ID, or passport). Must
maintain this information for three years.
ID information must be provided to a person authorized to receive
information from the NC CSRS within 72 hours of a request.
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All Schedule II controlled substances
Certain Schedule III controlled substances (hydrocodone combination
products like Vicodin and its equivalents are now Schedule II)
If this information is reported to the CSRS, requirement is satisfied. But
CSRS not currently configured to receive ID information.
Does not apply to inpatients of health-care facilities.
The law says that “the person seeking the dispensation” and the
“person to whom the prescription was issued” do not have to be the
same person. But whoever picks up the prescription must provide
ID.
Photo ID for Certain Controlled
Substances
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Board staff has developed and posted an
extensive FAQ:
http://www.ncbop.org/faqs/PhotoIDFAQ.p
df
North Carolina Controlled
Substance Reporting System Act
Reporting Requirement
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“Dispensers” must maintain a “reporting system
of prescriptions for all Schedule II through V
controlled substances.”
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Dispenser’s DEA number
Each patient’s name, address, phone number, and
date of birth
Date of fill
Prescription number
Prescription new or refill?
Metric quantity of dispensed drug
Estimated days of supply
NDC for dispensed drug
Prescriber’s DEA number
Reports to be submitted electronically.
Confidentiality of Information
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Data submitted may be released to:
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Prescribers or dispensers
Patient
SBI agents assigned to Diversion &
Environmental Crimes Unit
“Monitoring authorities” in other states
A court pursuant to a lawful order in a
criminal action
State Medicaid
State licensing boards
Confidentiality of Information (cont.)
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Data more than six years old “shall” be
purged.
Health care providers that report or
transmit data in good faith are immune
from civil or criminal liability.
Information collected, transmitted, and
stored pursuant to the statute is not a
public record.
Who Do I Contact About
Implementation?
Alex Asbun, Program Manager
Drug Control Unit, NC Department of
Health & Human Services
Phone: (919) 733-1765
Email: [email protected]
Methamphetamine/Pseudoephedrine
Methamphetamine/Pseudoephedrine
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N.C. Methamphetamine
Lab Prevention Act
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Applies to tablets or
caplets containing PSE.
Does not apply to liquid,
liquid capsule, gel
capsule, or pediatric
formulations.
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Federal Combat
Methamphetamine
Epidemic Act
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Applies to all PSE
containing products.
Does apply to gel
capsule formulations.
Methamphetamine/Pseudoephedrine
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N.C. Sales Limitations
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Covered PSE products
kept behind the counter.
No more than 3.6 grams
of PSE in a single
transaction.
No more 9 grams of PSE
in 30 days.
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Federal Sales Limitations
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Covered PSE products
kept behind the counter.
No more than 3.6 grams
of PSE in a day regardless
of the number of
transactions.
No more than 9 grams of
PSE in 30 days.
Methamphetamine/Pseudoephedrine
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Is PSE a Controlled Substance?
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Not in North Carolina.
Therefore, technicians may sell PSE over the
counter.
Recordkeeping requirements are, however,
similar those mandated for a C-V logbook.
Methamphetamine/Pseudoephedrine
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Do the federal or NC PSE statutes apply to
hospitals?
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Typically, no. Both impose limitations on the
“retail” sale of PSE products.
Hospitals are not normally engaged in the
“retail” sale of PSE products.
A hospital that does engage in the retail sale
of PSE must comply.
NPLEX System
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“Retailers” who sell PSE-containing
products must participate in the NPLEX
system for tracking such purchases.
This requirement went into effect January
1, 2012.
Use of Technicians
Technician Training Requirements
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The pharmacist-manager must train the
technician in the following areas:
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Pharmacy terminology
Pharmacy calculations
Dispensing systems and labeling requirements
Pharmacy laws and regulations
Record keeping and documentation
Proper handling and storage of medications
The training program “may differ depending
upon the type of employment.”
Technician Training
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Responsibility for technician training lies with the
pharmacist-manager.
The Board of Pharmacy does not oversee or
otherwise approve any particular outside
pharmacy technician training program.
Training must be completed within 180 days of
the date the pharmacy technician begins
employment.
Technician Supervision
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A pharmacist may only supervise two
technicians, unless:
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The additional technicians have “passed a
nationally recognized pharmacy technician
certified board exam” (NCBOP recognizes
PTCB certification); and
The pharmacist-manager obtains advance
permission from the Board of Pharmacy to
supervise more than two technicians.
Certified Technician Capabilities
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A certified pharmacy technician allows the
pharmacy to increase the number of
technicians.
Certified technicians may transfer
prescriptions and receive transferred
prescriptions.
Certified technicians may maintain
registration with the Board even when not
employed in a pharmacy.
Refusing Prescriptions
Rule .1801(a)
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A pharmacist “may refuse to fill or refill a
prescription order if, in his professional
judgment, it would be harmful to the
patient, is not in the recipient’s best
interest or if there is a question as to its
validity.”
“Conscience Issues”
A pharmacist should function by serving the individual, community and
societal needs while respecting the autonomy and dignity of each patient.
The best practice by a pharmacist is to promote the good for every patient
in a caring, compassionate and confidential manner. Pharmacists should
discuss and resolve any questions about emergency contraception prior to
employment. Compassionate care and conscientious objection are not
mutually exclusive. A pharmacist has the right to avoid being complicit in
behavior that is inconsistent with his or her morals or ethics. It is
unacceptable, however, for pharmacists to impose their moral or ethical
beliefs on the patients they serve. Pharmacists who object to providing a
medication for a patient on this basis alone, therefore, should take
proactive measures so as not to obstruct a patient’s right to obtain such
medication. The Board notes that although pharmacists have a right to
avoid moral or ethical conflict, they do not have a right to obstruct
otherwise legitimate prescription dispensing or delivery solely on the basis
of conscientious objection. Board of Pharmacy staff interprets this policy to
mean that if a pharmacist refuses to fill a prescription for emergency
contraception then that pharmacist has an obligation to get the patient and
the prescription to a pharmacist who will dispense that prescription in a
timely manner.
From: American Pharmacist Association Code of Ethics May Pharmacists
Refuse to Fill Prescriptions for Emergency Contraception?, Cantor & Baum
New England Journal of Medicine, November 4, 2004, @ Pge. 2008
Self-Prescribing/Prescribing for Family
Members
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North Carolina Medical Board policy:
"It is the position of the North Carolina Medical Board that, except
for minor illnesses and emergencies, physicians should not treat,
medically or surgically, or prescribe for themselves, their family
members, or others with whom they have significant emotional
relationships. The Board strongly believes that such treatment and
prescribing practices are inappropriate and may result in less than
optimal care being provided. * * * The Board expects physicians
to delegate the medical and surgical care of themselves, their
families, and those with whom they have significant emotional
relationships to one or more of their colleagues in order to ensure
appropriate and objective care is provided and to avoid
misunderstandings related to their prescribing practices."
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By rule, the Medical Board prohibits physicians from prescribing
controlled substances for themselves, family members, or others
with whom they have significant emotional relationships.
Workload Issues
Board Rules/Policies Affecting
Working Conditions
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Rule .1811: “Pharmacists shall not dispense and
permit holders shall not allow a pharmacist to
dispense prescription drugs at such a rate per
hour or per day as to pose a danger to the
public health or safety.”
Rule .2512 – Hours and Breaks
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“A permit holder shall not require a
pharmacist to work longer than 12
continuous hours per workday. A
pharmacist working longer than 6
continuous hours per workday shall be
allowed during that time period to take a
30 minute meal break and one additional
15 minute break.”
Technician Use During Pharmacist
Breaks
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Technicians can be used in the following ways
during pharmacists breaks:
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Prescriptions which have been previously prepared
may be picked up by patients or their representative.
A log of such transactions is kept with the telephone
number at which the patient may be reached is
available to the pharmacist upon return from break.
Prescriptions may be received by technicians, and
assembly can occur, but pharmacists must check any
product and the order before it goes to the patient
pursuant to Board rule.
Pharmacist-Managers, at their discretion, may
develop a policy for certified (by PTCB) technicians to
receive telephone prescription orders.
Continuing Education
Annual Requirements (Rule .2201)
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15 hours of continuing education per year
Eight (8) of these hours must be “contact”
Up to five (5) surplus CE hours may be
carried over for a period of one year.
Continuing education must be reported to
the Board on-line.
License/Permit Renewals
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On-line only.
Board staff does not send out paper-based
renewal reminder notices.
Pharmacists wishing to receive reminders
must provide Board staff with a valid,
current e-mail address.
Pharmacist-Manager
Responsibilities
Pharmacist-Manager
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“The person who accepts responsibility for
the operation of a pharmacy in
conformance with all statutes and
regulations pertinent to the practice of
pharmacy and distribution of drugs by
signing the permit application, its renewal
or addenda thereto.” Rule .1317(25)
Pharmacist-Manager
Responsibilities
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Listed in your handout. Rule .2502
Emphasis areas:
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May only be pharmacist-manager at one
location, unless additional location holds a
limited service permit.
Must be present 32 hours per week or half
the hours the pharmacy is open.
A temporary pharmacy-manager may serve
for 90 days, and need only be present in the
pharmacy for 20 hours per week.
Pharmacist-Manager
Responsibilities
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Emphasis areas (cont’d)
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Responsible for the security of the pharmacy.
Must have a plan to secure records and
pharmaceuticals in the event of a natural disaster.
Must report to the Board “information that reasonably
suggests that there is a probability that a prescription
drug or device dispensed from a location holding a
permit has caused or contributed to the death of a
patient or consumer.”
Pharmacy Quality Assurance
Protection Act
Elements of a QA Program
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Each pharmacy “shall establish or
participate in” a QA program to evaluate:
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The quality of the practice of pharmacy
The cause of medication errors and incidents
Pharmaceutical care outcomes
Possible improvements for the practice of
pharmacy
Methods to reduce medication errors and
incidents
How Does The QA Statute Affect
the Board’s Investigations?
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Upon notice of a Board investigation, the
pharmacy “shall” provide within 10 days
documentation of any error or incident
committed by the pharmacist within the
past 12 months that resulted in:
 A doctor or ER visit
 An overnight hospitalization
 A death
How Does The QA Statute Affect
the Board’s Investigations? (cont.)
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The Board members may review these 12-month
incidents only after making findings of fact and
conclusions of law about the instant error. The
12-month incidents may then be used to
determine appropriate remedial measures.
IMPORTANT: “Nothing in [the statute] shall
preclude the Board from obtaining information
concerning a specific alleged medication error or
incident that is the subject of a Board
investigation.”
Miscellaneous Other Issues
Immunization Authority
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Statute allows an “immunizing pharmacist” to administer
any CDC recommended vaccine to a patient age 18 or
up upon a prescription order.
Statute allows administration of pneumococcal, zoster,
Hep B, meningococcol, tetanus booster, TDAP, flu
pursuant to standing orders or protocols.
Contains certain notification requirements.
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Within 72 hours to a primary care provider identified by the
patient.
Record the administration to the North Carolina Immunization
Registry within 72 hours, when the Registry is “operable.”
Immunization Authority
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Law became effective on October 1.
Pharmacists administering flu,
pneumococcal, and zoster vaccines under
old Rule .2507 may continue to do so
under those standards until June 30,
2014.
Clinical Pharmacist Practitioners
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Pharmacists may obtain a CPP credential,
which carries limited prescribing authority
upon satisfaction of Rule .3101’s
requirements and approval by the
Pharmacy and Medical Boards.
Board of Pharmacy
Contact Information
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Address:
6015 Farrington Road
Suite 201
Chapel Hill, NC 27517

Phone:
(919) 246-1050
(919) 246-1056 (fax)
Membership
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Five members are registered pharmacists
practicing in North Carolina, and are
elected by pharmacists residing in North
Carolina.
A sixth member – the public member – is
appointed by the governor.
Membership
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District 1 (Western NC) –William Mixon
District 2 (Northcentral NC) – Carol Y. Day
District 3 (Southcentral NC) – E. Lazelle
Marks
District 4 (Northeastern NC) – Gene
Minton
District 5 (Southeastern NC) – Joey
McLaughlin
Public Member – Parker Chesson
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Staff
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Resources
Jay Campbell Executive Director (Legal questions)
Ellen Vick Associate Executive Director (Legal questions, Case Review
Officer)
Kristin Moore Director of Operations (Board elections, Website
administration)
Gail Brantley Financial and Administrative Services Director (Personnel,
Budget, Purchasing)
Rhonda Jones Financial and Human Resources Analyst (HR/Benefits
administration, Personnel, Accounts Payable/Accounts Receivable)
Debbie Stump Director of Licensing (Technicians & Dispensing
Physicians/PA/NPs, Pharmacist CE, CE Audit, CPPs)
Wendy Watson Permitting Specialist (Pharmacy and DME permits,
Pharmacist-Manager changes)
Missy Betz Licensing Specialist (Licensure by Reciprocity, Business
Address changes)
Stacie Mason Licensing Specialist (Licensure by Examination)
Leslie Wilson Administrative Assistant to Licensing & Operations
Thomas Buedel IT Manager (Forgery alerts, Website)
Nellie Jones Receptionist
Resources
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Investigative Personnel
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Joshua Kohler Director of Investigations & Inspections (Complaints,
Investigations, Legal questions)
Krystal Brashears Associate Director of Investigations & Inspections
Cindy Parham Investigations and Inspections Coordinator (Board
Meeting and Disciplinary Information)
Ken Wilkins Senior Investigator
Loretta Wiesner Investigator/Field Training Coordinator
Melinda Smith Investigator
Holly Price Investigator/Field Training Coordinator
Jason Smith Senior Investigator
Maria Fabiano Investigator
Olivia Cuthrell Investigator
Liz Collier Investigator
Lisa Mendez Investigator
Resources

Website
www.ncbop.org
Monitor the website frequently for news
and alerts. The FAQ sections answer most
commonly-asked legal questions.
“The Safety of the People shall be the
Highest Law”
~~~Cicero