Reciprocity Law Review © 2014 Jay Campbell Reproduction prohibited without permission of the author...

Reciprocity Law ReviewReciprocity Law Review

©© 2014 Jay Campbell 2014 Jay Campbell

Reproduction prohibited Reproduction prohibited without permission of the without permission of the

authorauthor

Revised 01/2015Revised 01/2015

What Is A Legitimate Prescription What Is A Legitimate Prescription Under North Carolina Law?Under North Carolina Law?

Rule .1801(b)Rule .1801(b) Rule 1801(b): “A pharmacist shall not fill or refill a Rule 1801(b): “A pharmacist shall not fill or refill a

prescription order if the pharmacist actually knows prescription order if the pharmacist actually knows or reasonably should know that the order was or reasonably should know that the order was issued issued without a physical examination and in the without a physical examination and in the absence of a prior prescriber relationshipabsence of a prior prescriber relationship; unless”:; unless”: Prescription is from a psychiatrist;Prescription is from a psychiatrist; Prescription is issued after discussion of the patient status Prescription is issued after discussion of the patient status

with a treating psychologist, therapist, or physician;with a treating psychologist, therapist, or physician; Flu vaccines for groups of patients;Flu vaccines for groups of patients; Prescription is for prophylactic purposes;Prescription is for prophylactic purposes; Emergency order related to pregnancy prevention;Emergency order related to pregnancy prevention; Prescription for medications to be taken by groups Prescription for medications to be taken by groups

traveling to foreign countries.traveling to foreign countries.

Internet-Based PrescriptionsInternet-Based Prescriptions Internet-based prescriptions generated Internet-based prescriptions generated

without a physical examination or a prior without a physical examination or a prior prescriber-patient relationship are not prescriber-patient relationship are not valid, and filling them violates state law. valid, and filling them violates state law. Filling such prescriptions for controlled Filling such prescriptions for controlled substances also violates federal law.substances also violates federal law.

The Board is aware that some Internet-The Board is aware that some Internet-based operations actively solicit based operations actively solicit pharmacists to act as a dispensing pharmacists to act as a dispensing clearinghouse for Internet-based clearinghouse for Internet-based prescriptions. The Board strongly advises prescriptions. The Board strongly advises pharmacists to reject these offers. pharmacists to reject these offers.

Who Can Prescribe in NC?Who Can Prescribe in NC?

N.C.G.S. N.C.G.S. § 90-85.3: “Prescription § 90-85.3: “Prescription order” means a written or verbal order” means a written or verbal order for a prescription drug, order for a prescription drug, prescription device, or prescription device, or pharmaceutical service from a pharmaceutical service from a person authorized by law to person authorized by law to prescribe such drug, device, or prescribe such drug, device, or service.service.

Who Can Prescribe in NC?Who Can Prescribe in NC? Out-of-State Prescribers. Out-of-State Prescribers.

Non-controlled drugs. Prescriptions are valid, so Non-controlled drugs. Prescriptions are valid, so long as there is an appropriate patient-long as there is an appropriate patient-prescriber relationship.prescriber relationship.

Controlled drugs. N.C. Controlled Substances Controlled drugs. N.C. Controlled Substances Act defines a prescription as “a written order or Act defines a prescription as “a written order or other order . . . issued by a practitioner who is other order . . . issued by a practitioner who is licensed in this State to administer or prescribe licensed in this State to administer or prescribe drugs in the course of his professional practice.” drugs in the course of his professional practice.” N.C.G.S. § 90-87(23). N.C.G.S. § 90-87(23).

The key: Use your professional judgment. The The key: Use your professional judgment. The Board has never taken the position that out-of-Board has never taken the position that out-of-state prescribers cannot write prescriptions for state prescribers cannot write prescriptions for controlled substances so long as the controlled substances so long as the prescriptions are for a legitimate medical prescriptions are for a legitimate medical purpose and issued in the ordinary course of purpose and issued in the ordinary course of medical practice.medical practice.

Who Can Prescribe in NC?Who Can Prescribe in NC? Physician Assistants and Nurse PractitionersPhysician Assistants and Nurse Practitioners

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?Who Can Prescribe in NC?

Clinical Pharmacist PractitionersClinical Pharmacist Practitioners 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 NCFilling Prescriptions in NC

What Must Be Included on a What Must Be Included on a Prescription?Prescription?

N.C.G.S. § 134.1 states that written N.C.G.S. § 134.1 states that written prescriptions for all legend drugs must prescriptions for all legend drugs must bear:bear:

““[T]he printed or stamped name, address, [T]he printed or stamped name, address, telephone number and DEA number of the telephone number and DEA number of the prescriber in addition to his legal signature.” prescriber in addition to his legal signature.”

Though the statute suggests otherwise, a Though the statute suggests otherwise, a DEA number is DEA number is notnot necessary on a necessary on a prescription for a non-controlled substance.prescription for a non-controlled substance.

What Must Be Included on a Label?What Must Be Included on a Label? Name and address of the dispensing pharmacy.Name and address of the dispensing pharmacy. Serial number of the prescription.Serial number of the prescription. Date of the prescription.Date of the prescription. Name of the prescriber.Name of the prescriber. Name of the patient.Name of the patient. Name and strength of the drug.Name and strength of the drug. The generic name of the drug, even if the generic drug is unavailable to 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.dispense or even if the substitution of a generic drug is not authorized. Directions for use.Directions for use. Appropriate cautionary statements.Appropriate cautionary statements. ““Filled by” or “dispensed by” with the name of the dispensing pharmacist. 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 name must include, at a minimum, the first initial and full last name of the dispensing pharmacist.the dispensing pharmacist.

If the dispensed drug is a “tranquilizer or sedative,” it must bear the If the dispensed drug is a “tranquilizer or sedative,” it must bear the warning “The consumption of alcoholic beverages while on this medication warning “The consumption of alcoholic beverages while on this medication can be harmful to your health” unless the prescriber directs otherwise.can be harmful to your health” unless the prescriber directs otherwise.

If the prescription is dispensed in a container other than the If the prescription is dispensed in a container other than the manufacturer’s original container, a discard date, which shall be the earlier 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, of one year from the date dispensed or the manufacturer’s expiration date, whichever is earlier.whichever is earlier.

If the prescription is dispensed in the manufacturer’s original container, the If the prescription is dispensed in the manufacturer’s original container, the label must not obscure the expiration date and storage statement when label must not obscure the expiration date and storage statement when the product is dispensed in the manufacturer's original container.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. 21 U.S.C. § 353(b)(2); N.C.G.S. §§ 90-85.29, 106-134(b); 21 N.C.A.C. 46.1818. 46.1818.

Product SelectionProduct Selection Two-Line Prescription Form, NCGS Two-Line Prescription Form, NCGS § §

90-85.28(b)90-85.28(b) If the prescriber signs on the right-hand If the prescriber signs on the right-hand

“dispense as written” line, substitution “dispense as written” line, substitution is not permitted.is not permitted.

Handwrite “dispense as written” or Handwrite “dispense as written” or “words or abbreviations of the same “words or abbreviations of the same meaning” – substitution not meaning” – substitution not permittedpermitted

Otherwise, pharmacist may choose Otherwise, pharmacist may choose to dispense an “equivalent drug to dispense an “equivalent drug product.”product.”

Product SelectionProduct Selection

Narrow Therapeutic Index (“NTI”) Narrow Therapeutic Index (“NTI”) Drugs, NCGS 90-85.28(b1)Drugs, NCGS 90-85.28(b1) Must be refilled using the same drug Must be refilled using the same drug

product by the same manufacturer that product by the same manufacturer that the pharmacist last dispensed unlessthe pharmacist last dispensed unless

Prescriber gives documented consent to a Prescriber gives documented consent to a change; andchange; and

Patient give documented consent to a Patient give documented consent to a change.change.

Purpose is to ensure Purpose is to ensure appropriate appropriate monitoringmonitoring if a change is made. if a change is made.

Product SelectionProduct Selection

NTI Drug List:NTI Drug List: Carbamazepine (Tegretol, various others) Carbamazepine (Tegretol, various others) CyclosporineCyclosporine Digoxin (Lanoxin and others)Digoxin (Lanoxin and others) EthosuximideEthosuximide Levothyroxine sodium tablets (Levothroid, Levoxyl, Levothyroxine sodium tablets (Levothroid, Levoxyl,

Synthroid, Synthroid, various others) various others)

Lithium (Eskalith, Cibalith)Lithium (Eskalith, Cibalith) Phenytoin (Dilantin)Phenytoin (Dilantin) Procainamide HydrochlorideProcainamide Hydrochloride Theophylline (Elixophyllin, Slo-Phyllin, Slo-bid Gyrocaps,Theophylline (Elixophyllin, Slo-Phyllin, Slo-bid Gyrocaps,

Theochron, Theo-Dur, Theo-24, Uniphyl) Theochron, Theo-Dur, Theo-24, Uniphyl) Warfarin sodium tablets (BMS Warfarin, Coumadin, Warfarin sodium tablets (BMS Warfarin, Coumadin,

Warfarin)Warfarin) Tacrolimus (Prograf)Tacrolimus (Prograf)

Refilling PrescriptionsRefilling Prescriptions

A prescription with refills authorized A prescription with refills authorized “PRN” may be refilled for 1 year.“PRN” may be refilled for 1 year.

A prescription may be authorized for A prescription may be authorized for refills “PRN for three years” or other refills “PRN for three years” or other similar directions.similar directions.

Refills of controlled substances Refills of controlled substances governed by federal law.governed by federal law.

Refilling PrescriptionsRefilling Prescriptions Advance Refills – Rule .1802(b)Advance Refills – Rule .1802(b)

“If deemed appropriate in the “If deemed appropriate in the pharmacist’s professional judgment, a pharmacist’s professional judgment, a patient may receive upon request drug patient may receive upon request drug quantities in excess of the face amount of quantities in excess of the face amount of the prescription for a the prescription for a non-controllednon-controlled substance, up to the total amount substance, up to the total amount authorized. The pharmacist shall not authorized. The pharmacist shall not dispense in excess of the face amount of a dispense in excess of the face amount of a prescription for a controlled substance or a prescription for a controlled substance or a psychotherapeutic drug without psychotherapeutic drug without authorization from the prescriber.”authorization from the prescriber.”

Refilling PrescriptionsRefilling Prescriptions

Emergency 30-Day Refills, Rule .1809Emergency 30-Day Refills, Rule .1809 If a pharmacist is unable to obtain readily refill If a pharmacist is unable to obtain readily refill

authorization for a requested refill, the pharmacist authorization for a requested refill, the pharmacist maymay dispense a one-time 30-day supply provided: dispense a one-time 30-day supply provided:

The prescription is not for a Schedule II controlled The prescription is not for a Schedule II controlled substancesubstance

The medication is essential to the maintenance of life or The medication is essential to the maintenance of life or to the continuation of therapy in a chronic conditionto the continuation of therapy in a chronic condition

In the pharmacist’s professional judgment, the In the pharmacist’s professional judgment, the interruption of therapy might reasonably produce interruption of therapy might reasonably produce undesirable health consequencesundesirable health consequences

The pharmacist creates a written order containing all The pharmacist creates a written order containing all required prescription informationrequired prescription information

The pharmacist notifies the prescriber or prescriber’s The pharmacist notifies the prescriber or prescriber’s office of the emergency dispensing within 72 hours.office of the emergency dispensing within 72 hours.

Refilling PrescriptionsRefilling Prescriptions Emergency 90-Day Refills, Rule 21 NCAC 46.1815Emergency 90-Day Refills, Rule 21 NCAC 46.1815

If a pharmacist is unable to obtain readily authorization If a pharmacist is unable to obtain readily authorization from the prescriber because of the prescriber’s from the prescriber because of the prescriber’s inability inability to provide medical servicesto provide medical services, the pharmacist , the pharmacist maymay dispense a one-time 90-day emergency supply, provided:dispense a one-time 90-day emergency supply, provided:

The prescription is not for a Schedule II controlled substanceThe prescription is not for a Schedule II controlled substance The medication is essential to the maintenance of life or to The medication is essential to the maintenance of life or to

the continuation of therapy in a chronic conditionthe continuation of therapy in a chronic condition In the pharmacist’s professional judgment, the interruption In the pharmacist’s professional judgment, the interruption

of therapy might reasonably produce undesirable health of therapy might reasonably produce undesirable health consequencesconsequences

The pharmacist creates a written order containing all The pharmacist creates a written order containing all required prescription informationrequired prescription information

The pharmacist notifies, or makes a good-faith attempt to The pharmacist notifies, or makes a good-faith attempt to notify, the prescriber or prescriber’s office of the emergency notify, the prescriber or prescriber’s office of the emergency dispensing within 72 hours.dispensing within 72 hours.

Electronic PrescriptionsElectronic Prescriptions Electronic Transmission of Prescription Orders, Rule .1813Electronic Transmission of Prescription Orders, Rule .1813

(a) Prescription orders may be transmitted by using a facsimile machine ("FAX") (a) Prescription orders may be transmitted by using a facsimile machine ("FAX") or by other electronic transmission from a prescriber to a pharmacy. "Electronic or by other electronic transmission from a prescriber to a pharmacy. "Electronic transmission" means transmission of the digital representation of information by transmission" means transmission of the digital representation of information by way of electronic equipment.way of electronic equipment.

(b) All prescription drug orders transmitted by FAX or by electronic transmission (b) All prescription drug orders transmitted by FAX or by electronic transmission shall:shall:

(1) be transmitted directly to a pharmacist or certified technician in a pharmacy (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 of the patient's choice with no intervening person altering the content of the prescription drug order;prescription drug order;

(2) identify the transmitter's phone number for verbal confirmation, the time and (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 date of transmission, and the identity of the pharmacy intended to receive the transmission;transmission;

(3) be transmitted by an authorized practitioner or his designated agent and (3) be transmitted by an authorized practitioner or his designated agent and contain either a written signature or an electronic signature unique to the contain either a written signature or an electronic signature unique to the practitioner; practitioner;

(4) be deemed the original prescription drug order, provided it meets all (4) be deemed the original prescription drug order, provided it meets all requirements of federal and state laws and regulations; andrequirements of federal and state laws and regulations; and

(5) if a refill order, contain all information required for original prescription orders (5) if a refill order, contain all information required for original prescription orders except for the prescriber's signature.except for the prescriber's signature.

* * ** * *

(d) The pharmacist shall exercise professional judgment regarding the accuracy, (d) The pharmacist shall exercise professional judgment regarding the accuracy, validity, and authenticity of a prescription drug order transmitted by FAX or by validity, and authenticity of a prescription drug order transmitted by FAX or by electronic transmission consistent with federal and state laws and regulations.electronic transmission consistent with federal and state laws and regulations.

* * ** * *

(g) No agreement between a prescriber and a pharmacy or device and medical (g) No agreement between a prescriber and a pharmacy or device and medical equipment permit holder shall require that prescription orders be transmitted by equipment permit holder shall require that prescription orders be transmitted by FAX or by electronic transmission from the prescriber to only that pharmacy or FAX or by electronic transmission from the prescriber to only that pharmacy or device and medical equipment permit holder.device and medical equipment permit holder.

Electronic Controlled Substance Electronic Controlled Substance PrescriptionsPrescriptions

ImplementationImplementation

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/thirdparty.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 IssuesControlled Substance Issues

North Carolina-Specific IssuesNorth Carolina-Specific Issues North Carolina law places a six-month expiration date on North Carolina law places a six-month expiration date on

Schedule II controlled substance prescriptions written on Schedule II controlled substance prescriptions written on or after October 1, 2013.or after October 1, 2013.

A North Carolina rule prohibits the preprinting of the A North Carolina rule prohibits the preprinting of the name of the controlled substance on prescription blanks. name of the controlled substance on prescription blanks. 21 NCAC 45G.307 21 NCAC 45G.307 A computer-generated controlled substance A computer-generated controlled substance

prescription is not considered “pre-printed” so long as prescription is not considered “pre-printed” so long as the prescription was generated for an individual the prescription was generated for an individual patient, and not “mass printed.”patient, and not “mass printed.”

Pharmacists should also note that the DEA does not Pharmacists should also note that the DEA does not permit the use of electronic or stamped signatures on permit the use of electronic or stamped signatures on any controlled substance prescription.any controlled substance prescription.

Photo ID for Certain Controlled Photo ID for Certain Controlled SubstancesSubstances

Pharmacies required to obtain a proper ID from a person Pharmacies required to obtain a proper ID from a person seeking dispensing of:seeking dispensing of: All Schedule II controlled substancesAll Schedule II controlled substances Certain Schedule III controlled substances (hydrocodone Certain Schedule III controlled substances (hydrocodone

combination products like Vicodin and its equivalents are now combination products like Vicodin and its equivalents are now Schedule II)Schedule II)

Pharmacy must record the name of the person seeking the Pharmacy must record the name of the person seeking the dispensing and the type and number of the ID (driver’s dispensing and the type and number of the ID (driver’s license, special DOT identification card, military ID, or license, special DOT identification card, military ID, or passport). Must maintain this information for three years.passport). Must maintain this information for three years.

ID information must be provided to a person authorized to ID information must be provided to a person authorized to receive information from the NC CSRS within 72 hours of a receive information from the NC CSRS within 72 hours of a request.request. If this information is reported to the CSRS, requirement is If this information is reported to the CSRS, requirement is

satisfied. But CSRS not currently configured to receive ID satisfied. But CSRS not currently configured to receive ID information.information.

Does not apply to inpatients of health-care facilities.Does not apply to inpatients of health-care facilities. The law says that “the person seeking the dispensation” The law says that “the person seeking the dispensation”

and the “person to whom the prescription was issued” do and the “person to whom the prescription was issued” do not have to be the same person. But whoever picks up the not have to be the same person. But whoever picks up the prescription must provide ID.prescription must provide ID.

Photo ID for Certain Controlled Photo ID for Certain Controlled SubstancesSubstances

Board staff has developed and Board staff has developed and posted an extensive FAQ:posted an extensive FAQ:

http://www.ncbop.org/faqs/PhotoIDFAhttp://www.ncbop.org/faqs/PhotoIDFAQ.pdfQ.pdf

North Carolina Controlled North Carolina Controlled Substance Reporting System ActSubstance Reporting System Act

Reporting RequirementReporting Requirement ““Dispensers” must maintain a “reporting Dispensers” must maintain a “reporting

system of prescriptions for all Schedule II system of prescriptions for all Schedule II through V controlled substances.”through V controlled substances.” Dispenser’s DEA numberDispenser’s DEA number Each patient’s name, address, phone number, Each patient’s name, address, phone number,

and date of birthand date of birth Date of fillDate of fill Prescription numberPrescription number Prescription new or refill?Prescription new or refill? Metric quantity of dispensed drugMetric quantity of dispensed drug Estimated days of supplyEstimated days of supply NDC for dispensed drugNDC for dispensed drug Prescriber’s DEA numberPrescriber’s DEA number

Reports to be submitted electronically.Reports to be submitted electronically.

Confidentiality of InformationConfidentiality of Information

Data submitted may be released to:Data submitted may be released to: Prescribers or dispensersPrescribers or dispensers PatientPatient SBI agents assigned to Diversion & SBI agents assigned to Diversion &

Environmental Crimes UnitEnvironmental Crimes Unit ““Monitoring authorities” in other statesMonitoring authorities” in other states A court pursuant to a lawful order A court pursuant to a lawful order in a in a

criminal actioncriminal action State MedicaidState Medicaid State licensing boardsState licensing boards

Confidentiality of Information (cont.)Confidentiality of Information (cont.)

Data more than six years old “shall” Data more than six years old “shall” be purged.be purged.

Health care providers that report or Health care providers that report or transmit data in good faith are transmit data in good faith are immune from civil or criminal immune from civil or criminal liability.liability.

Information collected, transmitted, Information collected, transmitted, and stored pursuant to the statute is and stored pursuant to the statute is notnot a public record. a public record.

Who Do I Contact About Who Do I Contact About Implementation?Implementation?

Alex Asbun, Program Manager Drug Control Unit, NC

Department of Health & Human Services

Phone: (919) 733-1765 Email: [email protected]

Methamphetamine/PseudoephedrineMethamphetamine/Pseudoephedrine


N.C. N.C. Methamphetamine Methamphetamine Lab Prevention ActLab Prevention Act

Applies to tablets or Applies to tablets or caplets containing caplets containing PSE.PSE.

Does not apply to Does not apply to liquid, liquid capsule, liquid, liquid capsule, gel capsule, or gel capsule, or pediatric formulations.pediatric formulations.

Federal Combat Federal Combat Methamphetamine Methamphetamine Epidemic ActEpidemic Act Applies to all PSE Applies to all PSE

containing containing products.products.

Does apply to gel Does apply to gel capsule capsule formulations.formulations.


N.C. Sales N.C. Sales LimitationsLimitations Covered PSE products Covered PSE products

kept behind the kept behind the counter.counter.

No more than 3.6 No more than 3.6 grams of PSE in a grams of PSE in a single transaction.single transaction.

No more 9 grams of No more 9 grams of PSE in 30 days.PSE in 30 days.

Federal Sales Federal Sales LimitationsLimitations Covered PSE products Covered PSE products

kept behind the kept behind the counter.counter.

No more than 3.6 No more than 3.6 grams of PSE in a day grams of PSE in a day regardless of the regardless of the number of transactions.number of transactions.

No more than 9 grams No more than 9 grams of PSE in 30 days.of PSE in 30 days.


Is PSE a Controlled Substance?Is PSE a Controlled Substance? Not in North Carolina.Not in North Carolina. Therefore, technicians may sell PSE over Therefore, technicians may sell PSE over

the counter.the counter. Recordkeeping requirements are, Recordkeeping requirements are,

however, similar those mandated for a however, similar those mandated for a C-V logbook.C-V logbook.


Do the federal or NC PSE statutes Do the federal or NC PSE statutes apply to hospitals?apply to hospitals? Typically, no. Both impose limitations Typically, no. Both impose limitations

on the “retail” sale of PSE products.on the “retail” sale of PSE products. Hospitals are not normally engaged in Hospitals are not normally engaged in

the “retail” sale of PSE products.the “retail” sale of PSE products. A hospital that does engage in the retail A hospital that does engage in the retail

sale of PSE must comply.sale of PSE must comply.

NPLEX SystemNPLEX System

““Retailers” who sell PSE-containing Retailers” who sell PSE-containing products must participate in the products must participate in the NPLEX system for tracking such NPLEX system for tracking such purchases.purchases.

This requirement went into effect This requirement went into effect January 1, 2012.January 1, 2012.

Use of TechniciansUse of Technicians

Technician Training RequirementsTechnician Training Requirements

The pharmacist-manager must train the The pharmacist-manager must train the technician in the following areas:technician in the following areas: Pharmacy terminologyPharmacy terminology Pharmacy calculationsPharmacy calculations Dispensing systems and labeling requirementsDispensing systems and labeling requirements Pharmacy laws and regulationsPharmacy laws and regulations Record keeping and documentationRecord keeping and documentation Proper handling and storage of medicationsProper handling and storage of medications

The training program “may differ The training program “may differ depending upon the type of employment.”depending upon the type of employment.”

Technician TrainingTechnician Training

Responsibility for technician training lies Responsibility for technician training lies with the with the pharmacist-managerpharmacist-manager..

The Board of Pharmacy does not oversee The Board of Pharmacy does not oversee or otherwise approve any particular or otherwise approve any particular outside pharmacy technician training outside pharmacy technician training program.program.

Training must be completed within 180 Training must be completed within 180 days of the date the pharmacy technician days of the date the pharmacy technician begins employment.begins employment.

Technician SupervisionTechnician Supervision

A pharmacist may only supervise A pharmacist may only supervise twotwo technicians, technicians, unlessunless::

The additional technicians have “passed a The additional technicians have “passed a nationally recognized pharmacy technician nationally recognized pharmacy technician certified board exam” (NCBOP recognizes certified board exam” (NCBOP recognizes PTCB certification); andPTCB certification); and

The pharmacist-manager obtains advance The pharmacist-manager obtains advance permission from the Board of Pharmacy to permission from the Board of Pharmacy to supervise more than two technicians.supervise more than two technicians.

Certified Technician CapabilitiesCertified Technician Capabilities

A certified pharmacy technician A certified pharmacy technician allows the pharmacy to increase the allows the pharmacy to increase the number of technicians. number of technicians.

Certified technicians may transfer Certified technicians may transfer prescriptions and receive transferred prescriptions and receive transferred prescriptions.prescriptions.

Certified technicians may maintain Certified technicians may maintain registration with the Board even registration with the Board even when not employed in a pharmacy.when not employed in a pharmacy.

Refusing PrescriptionsRefusing Prescriptions

Rule .1801(a)Rule .1801(a)

A pharmacist “may refuse to fill or A pharmacist “may refuse to fill or refill a prescription order if, in his refill a prescription order if, in his professionalprofessional judgment, it would be judgment, it would be harmful to the patient, is not in the harmful to the patient, is not in the recipient’s best interest or if there is recipient’s best interest or if there is a question as to its validity.”a question as to its validity.”

““Conscience Issues”Conscience Issues”A pharmacist should function by serving the individual, community A pharmacist should function by serving the individual, community and societal needs while respecting the autonomy and dignity of and societal needs while respecting the autonomy and dignity of each patient. The best practice by a pharmacist is to promote the each patient. The best practice by a pharmacist is to promote the good for every patient in a caring, compassionate and confidential good for every patient in a caring, compassionate and confidential manner. Pharmacists should discuss and resolve any questions manner. Pharmacists should discuss and resolve any questions about emergency contraception prior to employment. about emergency contraception prior to employment. Compassionate care and conscientious objection are not mutually Compassionate care and conscientious objection are not mutually exclusive. A pharmacist has the right to avoid being complicit in exclusive. A pharmacist has the right to avoid being complicit in behavior that is inconsistent with his or her morals or ethics. It is behavior that is inconsistent with his or her morals or ethics. It is unacceptable, however, for pharmacists to impose their moral or unacceptable, however, for pharmacists to impose their moral or ethical beliefs on the patients they serve. Pharmacists who object ethical beliefs on the patients they serve. Pharmacists who object to providing a medication for a patient on this basis alone, to providing a medication for a patient on this basis alone, therefore, should take proactive measures so as not to obstruct a therefore, should take proactive measures so as not to obstruct a patient’s right to obtain such medication. The Board notes that patient’s right to obtain such medication. The Board notes that although pharmacists have a right to avoid moral or ethical although pharmacists have a right to avoid moral or ethical conflict, they do not have a right to obstruct otherwise legitimate conflict, they do not have a right to obstruct otherwise legitimate prescription dispensing or delivery solely on the basis of prescription dispensing or delivery solely on the basis of conscientious objection. Board of Pharmacy staff interprets this conscientious objection. Board of Pharmacy staff interprets this policy to mean that if a pharmacist refuses to fill a prescription for policy to mean that if a pharmacist refuses to fill a prescription for emergency contraception then that pharmacist has an obligation emergency contraception then that pharmacist has an obligation to get the patient and the prescription to a pharmacist who will to get the patient and the prescription to a pharmacist who will dispense that prescription in a timely manner.dispense that prescription in a timely manner.

From: American Pharmacist Association Code of Ethics May From: American Pharmacist Association Code of Ethics May Pharmacists Refuse to Fill Prescriptions for Emergency Pharmacists Refuse to Fill Prescriptions for Emergency Contraception?, Cantor & Baum New England Journal of Medicine, Contraception?, Cantor & Baum New England Journal of Medicine, November 4, 2004, @ Pge. 2008 November 4, 2004, @ Pge. 2008

Self-Prescribing/Prescribing for Family Self-Prescribing/Prescribing for Family MembersMembers

North Carolina Medical Board policy:North Carolina Medical Board policy:

"It is the position of the North Carolina Medical Board that, "It is the position of the North Carolina Medical Board that, except for minor illnesses and emergencies, physicians except for minor illnesses and emergencies, physicians should not treat, medically or surgically, or prescribe for should not treat, medically or surgically, or prescribe for themselves, their family members, or others with whom themselves, their family members, or others with whom they have significant emotional relationships. The Board they have significant emotional relationships. The Board strongly believes that such treatment and prescribing strongly believes that such treatment and prescribing practices are inappropriate and may result in less than practices are inappropriate and may result in less than optimal care being provided. * * * The Board expects optimal care being provided. * * * The Board expects physicians to delegate the medical and surgical care of physicians to delegate the medical and surgical care of themselves, their families, and those with whom they have themselves, their families, and those with whom they have significant emotional relationships to one or more of their significant emotional relationships to one or more of their colleagues in order to ensure appropriate and objective colleagues in order to ensure appropriate and objective care is provided and to avoid misunderstandings related to care is provided and to avoid misunderstandings related to their prescribing practices." their prescribing practices."

By rule, the Medical Board By rule, the Medical Board prohibitsprohibits physicians from physicians from

prescribing controlled substances for themselves, family prescribing controlled substances for themselves, family members, or others with whom they have significant members, or others with whom they have significant emotional relationships.emotional relationships.

Workload IssuesWorkload Issues

Board Rules/Policies Affecting Board Rules/Policies Affecting Working ConditionsWorking Conditions

Rule .1811: “Pharmacists shall not Rule .1811: “Pharmacists shall not dispense and permit holders shall not dispense and permit holders shall not allow a pharmacist to dispense allow a pharmacist to dispense prescription drugs at such a rate per hour prescription drugs at such a rate per hour or per day as to pose a danger to the or per day as to pose a danger to the public health or safety.”public health or safety.”

Rule .2512 – Hours and BreaksRule .2512 – Hours and Breaks

““A permit holder shall not require a A permit holder shall not require a pharmacist to work longer than 12 pharmacist to work longer than 12 continuous hours per workday. A continuous hours per workday. A pharmacist working longer than 6 pharmacist working longer than 6 continuous hours per workday shall continuous hours per workday shall be allowed during that time period to be allowed during that time period to take a 30 minute meal break and one take a 30 minute meal break and one additional 15 minute break.”additional 15 minute break.”

Technician Use During Pharmacist Technician Use During Pharmacist BreaksBreaks

Technicians can be used in the following ways Technicians can be used in the following ways during pharmacists breaks: during pharmacists breaks: Prescriptions which have been previously prepared Prescriptions which have been previously prepared

may be picked up by patients or their may be picked up by patients or their representative. A log of such transactions is kept representative. A log of such transactions is kept with the telephone number at which the patient with the telephone number at which the patient may be reached is available to the pharmacist may be reached is available to the pharmacist upon return from break. upon return from break.

Prescriptions may be received by technicians, and Prescriptions may be received by technicians, and assembly can occur, but pharmacists must check assembly can occur, but pharmacists must check any product and the order before it goes to the any product and the order before it goes to the patient pursuant to Board rule.patient pursuant to Board rule.

Pharmacist-Managers, at their discretion, may Pharmacist-Managers, at their discretion, may develop a policy for certified (by PTCB) technicians develop a policy for certified (by PTCB) technicians to receive telephone prescription orders.to receive telephone prescription orders.

Continuing EducationContinuing Education

Annual Requirements (Rule .2201)Annual Requirements (Rule .2201)

15 hours of continuing education per 15 hours of continuing education per yearyear

Eight (8) of these hours must be Eight (8) of these hours must be “contact”“contact”

Up to five (5) surplus CE hours may be Up to five (5) surplus CE hours may be carried over for a period of one year.carried over for a period of one year.

Continuing education must be Continuing education must be reported to the Board on-line.reported to the Board on-line.

License/Permit RenewalsLicense/Permit Renewals

On-line only.On-line only. Board staff does not send out paper-Board staff does not send out paper-

based renewal reminder notices.based renewal reminder notices. Pharmacists wishing to receive Pharmacists wishing to receive

reminders must provide Board staff reminders must provide Board staff with a valid, current e-mail address.with a valid, current e-mail address.

Pharmacist-Manager Pharmacist-Manager ResponsibilitiesResponsibilities

Pharmacist-ManagerPharmacist-Manager

““The person who The person who accepts accepts responsibilityresponsibility for the operation of a for the operation of a pharmacy in conformance with all pharmacy in conformance with all statutes and regulations pertinent to statutes and regulations pertinent to the practice of pharmacy and the practice of pharmacy and distribution of drugs distribution of drugs by signing the by signing the permit application, its renewal or permit application, its renewal or addenda theretoaddenda thereto.” Rule .1317(25).” Rule .1317(25)


Listed in your handout. Rule .2502Listed in your handout. Rule .2502 Emphasis areas:Emphasis areas:

May only be pharmacist-manager at May only be pharmacist-manager at oneone location, unless additional location holds location, unless additional location holds a limited service permit.a limited service permit.

Must be present 32 hours per week or Must be present 32 hours per week or half the hours the pharmacy is open.half the hours the pharmacy is open.

A A temporarytemporary pharmacy-manager may pharmacy-manager may serve for 90 days, and need only be serve for 90 days, and need only be present in the pharmacy for 20 hours per present in the pharmacy for 20 hours per week.week.


Emphasis areas (cont’d)Emphasis areas (cont’d) Responsible for the security of the pharmacy.Responsible for the security of the pharmacy. Must have a plan to secure records and Must have a plan to secure records and

pharmaceuticals in the event of a natural pharmaceuticals in the event of a natural disaster.disaster.

Must report to the Board “information that Must report to the Board “information that reasonably suggests that there is a probability reasonably suggests that there is a probability that a prescription drug or device dispensed that a prescription drug or device dispensed from a location holding a permit has caused or from a location holding a permit has caused or contributed to the death of a patient or contributed to the death of a patient or consumer.”consumer.”

Pharmacy Quality Assurance Pharmacy Quality Assurance Protection ActProtection Act

Elements of a QA ProgramElements of a QA Program

Each pharmacy “shall establish or Each pharmacy “shall establish or participate in” a QA program to participate in” a QA program to evaluate:evaluate: The quality of the practice of pharmacyThe quality of the practice of pharmacy The cause of medication errors and incidentsThe cause of medication errors and incidents Pharmaceutical care outcomesPharmaceutical care outcomes Possible improvements for the practice of Possible improvements for the practice of

pharmacypharmacy Methods to reduce medication errors and Methods to reduce medication errors and

incidentsincidents

How Does The QA Statute Affect How Does The QA Statute Affect the Board’s Investigations?the Board’s Investigations?

Upon notice of a Board investigation, Upon notice of a Board investigation, the pharmacy “shall” provide within the pharmacy “shall” provide within 10 days documentation of any error 10 days documentation of any error or incident committed by the or incident committed by the pharmacist within the past 12 pharmacist within the past 12 months that resulted in:months that resulted in: A doctor or ER visitA doctor or ER visit An overnight hospitalizationAn overnight hospitalization A deathA death

How Does The QA Statute Affect How Does The QA Statute Affect the Board’s Investigations? (cont.)the Board’s Investigations? (cont.)

The Board members may review these 12-The Board members may review these 12-month incidents only after making findings month incidents only after making findings of fact and conclusions of law about the of fact and conclusions of law about the instant error. The 12-month incidents may instant error. The 12-month incidents may then be used to determine appropriate then be used to determine appropriate remedial measures.remedial measures.

IMPORTANT: “IMPORTANT: “NothingNothing in [the statute] shall in [the statute] shall preclude the Board from obtaining preclude the Board from obtaining information concerning a information concerning a specific alleged specific alleged medication error or incidentmedication error or incident that is the that is the subject of a Board investigation.”subject of a Board investigation.”

Miscellaneous Other IssuesMiscellaneous Other Issues

Immunization AuthorityImmunization Authority

Statute allows an “immunizing pharmacist” to Statute allows an “immunizing pharmacist” to administer any CDC recommended vaccine to a administer any CDC recommended vaccine to a patient age 18 or up upon a prescription order.patient age 18 or up upon a prescription order.

Statute allows administration of pneumococcal, Statute allows administration of pneumococcal, zoster, Hep B, meningococcol, tetanus booster, zoster, Hep B, meningococcol, tetanus booster, TDAP, flu pursuant to standing orders or protocols.TDAP, flu pursuant to standing orders or protocols.

Contains certain notification requirements.Contains certain notification requirements. Within 72 hours to a primary care provider identified by Within 72 hours to a primary care provider identified by

the patient.the patient. Record the administration to the North Carolina Record the administration to the North Carolina

Immunization Registry within 72 hours, when the Immunization Registry within 72 hours, when the Registry is “operable.” Registry is “operable.”

Immunization AuthorityImmunization Authority

Law became effective on October 1.Law became effective on October 1. Pharmacists administering flu, Pharmacists administering flu,

pneumococcal, and zoster vaccines pneumococcal, and zoster vaccines under old Rule .2507 may continue under old Rule .2507 may continue to do so under those standards until to do so under those standards until June 30, 2014. June 30, 2014.

Clinical Pharmacist PractitionersClinical Pharmacist Practitioners

Pharmacists may obtain a CPP Pharmacists may obtain a CPP credential, which carries limited credential, which carries limited prescribing authority upon prescribing authority upon satisfaction of Rule .3101’s satisfaction of Rule .3101’s requirements and approval by the requirements and approval by the Pharmacy and Medical Boards.Pharmacy and Medical Boards.

Board of PharmacyBoard of Pharmacy

Contact InformationContact Information

Address:Address:

6015 Farrington Road6015 Farrington RoadSuite 201Suite 201Chapel Hill, NC 27517Chapel Hill, NC 27517

Phone:Phone:

(919) 246-1050(919) 246-1050(919) 246-1056 (fax)(919) 246-1056 (fax)

MembershipMembership

Five members are registered Five members are registered pharmacists practicing in North pharmacists practicing in North Carolina, and are elected by Carolina, and are elected by pharmacists residing in North pharmacists residing in North Carolina.Carolina.

A sixth member – the public member A sixth member – the public member – is appointed by the governor.– is appointed by the governor.

MembershipMembership

District 1 (Western NC) –William Mixon District 1 (Western NC) –William Mixon District 2 (Northcentral NC) – Carol Y. District 2 (Northcentral NC) – Carol Y. DayDay

District 3 (Southcentral NC) – E. Lazelle District 3 (Southcentral NC) – E. Lazelle MarksMarks

District 4 (Northeastern NC) – Gene District 4 (Northeastern NC) – Gene MintonMinton

District 5 (Southeastern NC) – Joey District 5 (Southeastern NC) – Joey McLaughlinMcLaughlin

Public Member – Parker Chesson Public Member – Parker Chesson

ResourcesResources StaffStaff

Jay Campbell Jay Campbell Executive Director Executive Director (Legal questions) (Legal questions) Ellen VickEllen Vick Associate Executive Director Associate Executive Director (Legal questions, Case (Legal questions, Case

Review Officer)Review Officer) Kristin MooreKristin Moore Director of Operations Director of Operations (Board elections, Website (Board elections, Website

administration)administration) Gail BrantleyGail Brantley Financial and Administrative Services Director Financial and Administrative Services Director

(Personnel, Budget, Purchasing)(Personnel, Budget, Purchasing) Rhonda JonesRhonda Jones Financial and Human Resources Analyst Financial and Human Resources Analyst

(HR/Benefits administration, Personnel, Accounts (HR/Benefits administration, Personnel, Accounts Payable/Accounts Receivable) Payable/Accounts Receivable)

Debbie StumpDebbie Stump Director of Licensing Director of Licensing (Technicians & Dispensing (Technicians & Dispensing Physicians/PA/NPs, Pharmacist CE, CE Audit, CPPs)Physicians/PA/NPs, Pharmacist CE, CE Audit, CPPs)

Wendy WatsonWendy Watson Permitting Specialist Permitting Specialist (Pharmacy and DME permits, (Pharmacy and DME permits, Pharmacist-Manager changes)Pharmacist-Manager changes)

Missy BetzMissy Betz Licensing Specialist Licensing Specialist (Licensure by Reciprocity, (Licensure by Reciprocity, Business Address changes)Business Address changes)

Stacie MasonStacie Mason Licensing Specialist Licensing Specialist (Licensure by Examination)(Licensure by Examination) Leslie WilsonLeslie Wilson Administrative Assistant to Licensing & OperationsAdministrative Assistant to Licensing & Operations Thomas BuedelThomas Buedel IT Manager IT Manager (Forgery alerts, Website)(Forgery alerts, Website) Nellie JonesNellie Jones ReceptionistReceptionist

ResourcesResources Investigative PersonnelInvestigative Personnel

Joshua Kohler Joshua Kohler Director of Investigations & Inspections Director of Investigations & Inspections (Complaints, Investigations, Legal questions) (Complaints, Investigations, Legal questions)

Krystal Brashears Krystal Brashears Associate Director of Investigations & Associate Director of Investigations & InspectionsInspections

Cindy ParhamCindy Parham Investigations and Inspections Coordinator Investigations and Inspections Coordinator (Board Meeting and Disciplinary Information)(Board Meeting and Disciplinary Information)

Ken Wilkins Ken Wilkins Senior InvestigatorSenior Investigator Loretta WiesnerLoretta Wiesner Investigator/Field Training CoordinatorInvestigator/Field Training Coordinator Melinda SmithMelinda Smith InvestigatorInvestigator Holly Price Holly Price Investigator/Field Training CoordinatorInvestigator/Field Training Coordinator Jason Smith Jason Smith Senior InvestigatorSenior Investigator Maria FabianoMaria Fabiano InvestigatorInvestigator Olivia CuthrellOlivia Cuthrell InvestigatorInvestigator Liz Collier Liz Collier InvestigatorInvestigator Lisa MendezLisa Mendez InvestigatorInvestigator

ResourcesResources

WebsiteWebsite

www.ncbop.orgwww.ncbop.org

Monitor the website frequently for Monitor the website frequently for news and alerts. The FAQ sections news and alerts. The FAQ sections answer most commonly-asked legal answer most commonly-asked legal questions.questions.

“The Safety of the People shall be the Highest Law”

~~~Cicero

Reciprocity Law Review © 2014 Jay Campbell Reproduction prohibited without permission of the author...

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