law exam 2- section 22-25A, Chapter 95C <3, CMR 1-9, Licensure, CE, definitions Flashcards
Describe the composition of the Massachusetts Board of Pharmacy (Board), so what makes up the board of pharmacy.
8 registered pharmacists
- 2 independent pharmacists
- 2 chain pharmacists
- 1 hospital pharmacists
- 1 long-term care pharmacist.
- 1 sterile compounding pharmacist
- 1 academic pharmacist
1 pharmacy technician
1 representative of the public with experience in health care service delivery
administration or consumer advocacy, subject to section 9B
1 physician registered pursuant to chapter 112
1 nurse registered pursuant to said chapter 112
1 expert in patient safety and quality improvement.
How many members are on the Board?
13 members
What are the requirements to becoming a Board member?
- no disciplinary action
- no felonies
What are the experience requirements for a Board member?
- 7 consecutive practice in pharmacy whether a pharmacist or technician
Who appoints the Board members?
governor of commonwealth
How is an Independent Pharmacist defined?
what are some examples
a pharmacist actively engaged in the business of retail pharmacy
example: beacon pharmacy, Prescott pharmacy
How is a Chain Pharmacist defined?
a pharmacist employed by a retail drug organization that operates 10 or more retail drug stores
What is the term of years that a Board member can serve?
3 years
Can a Board member be re-appointed
yes, only once
What are the requirements for a board meeting?
organize by electing a president and secretary, who shall be members of the board, and shall hold their offices for one year.
How often does the Board meet?
The board shall meet on the first Tuesday of December in each year, Meeting is to elect president and secretary
The board shall annually hold regular meetings on the first Tuesdays of January, May and October and have additional meetings if need
On mass board of pharmacy, they meet on Thursdays really… twice a month
No need to know days of the week :)
Can the Board appoint agents? If yes, describe who the agents are and their roles.
why is an agent ever sent
what does the board oversee
Could board of pharmacy come to hospital pharmacy?
yes
They shall inspect drug stores and all other places of business wherein drugs, medicines, patent medicines, medical preparations and medical supplies of any kind are sold or distributed
so…agents are board of pharmacy inspectors who go out and inspect pharmacies
Why board would send an agent to the pharmacy: complaints, violations, regular point of inspection, pre-opening inspection, could be for cause or not for cause
Board oversee retail pharmacies, health souring facilities, whole sales, pharmacist, interns and technicians
Could board of pharmacy come to hospital pharmacy?- yes, they would not be inspecting cause that would be under DPH but if issue with techs, interns and pharmacist then they will go to hospital
What training is required for Board agents?
Need to be trained in USP 795 & 797
Explore the mass. board of pharmacy website, provide a reference link to the website.
- https://www.mass.gov/orgs/board-of-registration-in-pharmacy
What information can you find on the Board’s website?
check a license
File a complaint
Search
Members
Leaders
More actions on licensing, resources
Meetings
Previous mtgs too
section 1
Administer
the direct application of a controlled substance whether by injection, inhalation, ingestion, or any other means to the body of a patient or research subject by
a practitioner, or
(b) a nurse at the direction of a practitioner in the course of his professional practice, or
(c) a registered pharmacist acting in accordance with regulations promulgated by the department, in consultation with the board of registration in pharmacy and the department of mental health, governing pharmacist administration of medications for treatment of mental health and substance use disorder and at the direction of a prescribing practitioner in the course of the practitioner’s professional practice; or
(d) an ultimate user or research subject at the direction of a practitioner in the course of the practitioner’s professional practice
section 1
Class
the lists of controlled substances for the purpose of determining the severity of criminal offenses under this chapter.
section 1
Controlled Substance
a drug, substance, controlled substance analogue or immediate precursor in any schedule or class referred to in this chapter.
section 1
Counterfeit Drug
a substance which is represented to be a particular controlled drug or substance, but which is in fact not that drug or substance.
section1
Deliver
to transfer, whether by actual or constructive transfer, a controlled substance from one person to another, whether or not there is an agency relationship.
section 1
Dispense
to deliver a controlled substance to an ultimate user or research subject or to the agent of an ultimate user or research subject by a practitioner or pursuant to the order of a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling, or compounding necessary for such delivery
section 1
Distribute
to deliver other than by administering or dispensing a controlled substance.
section1
Drug
(a) substances recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;
(b) substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals;
(c) substances, other than food, intended to affect the structure, or any function of the body of man and animals; or
(d) substances intended for use as a component of any article specified in clauses (a), (b) or (c), exclusive of devices or their components, parts or accessories.
section 1
Electronic Prescription
a lawful order from a practitioner for a drug or device for a specific patient that is generated on an electronic prescribing system that meets federal requirements for electronic prescriptions for controlled substances, and is transmitted electronically to a pharmacy designated by the patient without alteration of the prescription information, except that third-party intermediaries may act as conduits to route the prescription from the prescriber to the pharmacist; provided however, that electronic prescription shall not include an order for medication, which is dispensed for immediate administration to the ultimate user; and provided further, that the electronic prescription shall be received by the pharmacy on an electronic system that meets federal requirements for electronic prescriptions. For the purposes of this chapter, a prescription generated on an electronic system that is printed out or transmitted via facsimile is not considered an electronic prescription.
section 1
Extended-release long acting opioid in a non-abuse deterrent form
a drug that is: (i) subject to the United States Food and Drug Administration’s extended release and long-acting opioid analgesics risk evaluation and mitigation strategy; (ii) an opioid approved for medical use that does not meet the requirements for listing as a drug with abuse deterrent properties pursuant to section 13 of chapter 17; and (iii) identified by the drug formulary commission pursuant to said section 13 of said chapter 17 as posing a heightened level of public health risk.
section 1
Manufacture
the production, preparation, propagation, compounding, conversion or processing of a controlled substance, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, including any packaging or repackaging of the substance or labeling or relabeling of its container except that this term does not include the preparation or compounding of a controlled substance by an individual for his own use or the preparation, compounding, packaging, or labeling of a controlled substance:
(a) by a practitioner as an incident to his administering a controlled substance in the course of his professional practice, or
(b) by a practitioner, or by his authorized agent under his supervision, for the purpose of, or as an incident to, research, teaching or chemical analysis and not for sale, or
(c) by a pharmacist in the course of his professional practice.
section 1
Narcotic drug
any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:
(a) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate;
(b) Any salt, compound, isomer, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in clause (a), but not including the isoquinoline alkaloids of opium;
(c) Opium poppy and poppy straw;
(d) Coca leaves and any salt, compound, derivative, or preparation of coca leaves, and any salt, compound, isomer, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extractions of coca leaves which do not contain cocaine or ecgonine
section1
Oral prescription
an oral order for medication which is dispensed to or for an ultimate user, but not including an order for medication which is dispensed for immediate administration to the ultimate user by an individual who is authorized to administer such medication under this chapter.
section 1
Outsourcing facility
an entity at 1 geographic location or address that: (i) is engaged in the compounding of sterile drug preparations; (ii) has registered with the federal Food and Drug Administration as an outsourcing facility pursuant to 21 U.S.C. section 353b; and (iii) has registered with the board of registration in pharmacy pursuant to section 36E of chapter 112.
section 1
Pharmacist, Pharmacy
any pharmacist registered in the commonwealth to dispense controlled substances, and including any other person authorized to dispense controlled substances under the supervision of a pharmacist registered in the commonwealth.
a facility under the direction or supervision of a registered pharmacist which is authorized to dispense controlled substances, including but not limited to ‘‘retail drug business’’ as defined below.
section 1
Physician assistant, Practitioner
a person who is a graduate of an approved program for the training of physician assistants who is supervised by a registered physician in accordance with sections nine C to nine H, inclusive, of chapter one hundred and twelve.
'’Poppy straw’’, all parts, except the seeds of the opium poppy, after mowing.
'’Practitioner’’,
(a) A physician, dentist, veterinarian, podiatrist, scientific investigator, or other person registered to distribute, dispense, conduct research with respect to, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research in the commonwealth;
(b) A pharmacy, hospital, or other institution registered to distribute, dispense, conduct research with respect to or to administer a controlled substance in the course of professional practice or research in the commonwealth.
(c) An optometrist authorized by sections 66, 66B and 66C of chapter 112 and registered pursuant to paragraph (h) of section 7 to utilize and prescribe therapeutic pharmaceutical agents in the course of professional practice in the commonwealth.
(d) A nurse practitioner registered pursuant to subsection (f) of section 7 and authorized by section 80E of chapter 112 to distribute, dispense, conduct research with respect to or use in teaching or chemical analysis a controlled substance in the course of professional practice or research in the commonwealth.
(e) A nurse anesthetist registered pursuant to subsection (f) of section 7 and authorized by section 80H of chapter 112 to distribute, dispense, conduct research with respect to or use in teaching or chemical analysis a controlled substance in the course of professional practice or research in the commonwealth.
(f) A psychiatric nurse mental health clinical specialist registered pursuant to subsection (f) of section 7 and authorized by section 80J of chapter 112 to distribute, dispense, conduct research with respect to or use in teaching or chemical analysis a controlled substance in the course of professional practice or research in the commonwealth.
section 1
Prescription Drug
any and all drugs upon which the manufacturer or distributor has, in compliance with federal law and regulations, placed the following: ‘‘Caution, Federal law prohibits dispensing without prescription’’.
section 1
Registrant
a person who is registered pursuant to any provision of this chapter.
section 1
Registration
unless the context specifically indicates otherwise, such registration as is required and permitted only pursuant to the provisions of this chapter.
section 1
Registration Number
such registration number or numbers, either federal or state, that are required with respect to practitioners by appropriate administrative agencies.
section 1
Retail drug business
a store for the transaction of ‘‘drug business’’ as defined in section thirty-seven of chapter one hundred and twelve.
section 1
Schedule
the list of controlled substances established by the commissioner pursuant to the provisions of section two for purposes of administration and regulation.
focus on this not class (which has to do with jail time and law enforcement
section 1
Ultimate user
a person who lawfully possesses a controlled substance for his own use or for the use of a member of his household or for the use of a patient in a facility licensed by the department or for administering to an animal owned by him or by a member of his household.
section 1
Written Prescription
a lawful order from a practitioner for a drug or device for a specific patient that is communicated directly to a pharmacist in a licensed pharmacy; provided, however, that ‘‘written prescription’’ shall not include an order for medication which is dispensed for immediate administration to the ultimate user by a an individual who is authorized to administer such medication under this chapter.
section 2
How many schedules of controlled substances are there in Massachusetts?-
Is that different from the Federal Controlled Substance Act? Explain.
6
yes there are 5
I
II
III
IV
V
VI - gabapentin (and additional drug), briith control pills, hydrocholorthiazide, lisinopril, amoxicillin
need a Rx for V & VI
section 2
Who in the Commonwealth of Massachusetts can delete or reschedule a controlled substance (provided that it does not conflict with the Federal Controlled Substances Act?
The commissioner
section 2
What should the commissioner consider when rescheduling a controlled substance?
except that if any substance that has not been scheduled pursuant to the provisions of this section is designated a controlled substance under the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970
or any amendment thereof, or if any substance that has been scheduled pursuant to the provisions of this section is designated a controlled substance of greater abuse liability under the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970
or any amendment thereof, the commissioner, pursuant to the provisions of chapter thirty A, shall, not more than thirty days after publication of final notice in the federal register
or not more than thirty days after the effective date of any federal statute affecting the scheduling of controlled substances under said federal act
or any amendment thereof, issue a regulation controlling the substance in a schedule corresponding to the federal schedules.
section 2
Describe the process that the commissioner needs to follow to reschedule a controlled substance.
he must know and consider
1) Its actual or relative potential for abuse.
(2) Scientific evidence of its pharmacological effect, if known.
(3) The state of current scientific knowledge regarding the drug or other substance.
(4) Its history and current pattern of abuse.
(5) The scope, duration and significance of abuse.
(6) What, if any, risk there is to the public health.
(7) Its psychological or physiological dependence liability.
(8) Whether the substance is an immediate precursor of a substance already controlled under this chapter.
section 2A
Under what circumstances may the commissioner OR gov of the commonwealth place a substance in Schedule I temporarily?
if the commissioner finds:
(i) it is necessary to avoid an imminent hazard to the public safety;
(ii) it is necessary for the preservation of the public health, safety, or general welfare;
(iii) the substance is not listed in any other schedule identified in section 3;
(iv) no exception is in effect for the substance pursuant to section 4, and (v) the substance is not excluded under subsection (c) of section 2.
section 2A
What should be considered by the commissioner in placing the substance in schedule I on a temporary basis?
the commissioner shall consider the substance’s actual or relative potential for abuse and its history and current patterns of abuse.
section 2A
How long may the emergency regulation remain in effect?
An order issued under subsection (a) shall be an emergency regulation and subject to section 3 of chapter 30A; provided, however, that: (i) no further approval by designated persons or bodies, as referenced in said section 3 of said chapter 30A, shall be required before the emergency regulation becomes effective; and (ii) the emergency regulation may remain in effect for up to 1 year.
section 2a
When does the temporary rescheduling take effect?
When the commissioner forwards the order to the attorney general
section 3
Describe the six Schedules under Chapter 94C
1) SCHEDULE I.—
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has no currently accepted medical use in treatment in the United States.
(C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.
(2) SCHEDULE II.—
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.
(C) Abuse of the drug or other substances may lead to severe psychological or physical dependence.
(3) SCHEDULE III.—
(A) The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.
(4) SCHEDULE IV.—
(A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.
(5) SCHEDULE V.—
(A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV.
(B) The drug or other substance has a currently accepted medical use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.
(6) SCHEDULE VI.—
(A) The substance is a prescription drug; and
(B) Said prescription drug has not been included in Schedules I through V.
section 3
Provide at least 5 examples in each of the Schedules
I
- heroin
- marijuana
- methaqualone
- lysergic acid diethylamide (LSD)
- 3,4 methylenedioxymeaphetamije (ecstasy)
II
- amphetamine
MethMphetamine
Methylphenidate
Amobarbital
Gluethimide
Pentobarbital
Hydrocodone
III
Anabolic steroids
Benzphetamine
Phendimetrazine
Ketamine
Tylenol with codeine
IV
Alprazolam
Diazepam
Clonazepam
Midazolam
Lorazepam
V
Cough syrup with codiene
Lyrica
lomotil
Motormenarapeclotin
section 4
What can be exempt from scheduling?
Older drugs that no one uses any more
old old product that is probably not made anymore
OTC outside of the scheduling, acetaminophen, robitussin
section 5
What are the limits of what can be dispensed or sold?
(1) that such preparation shall be dispensed, or sold in good faith as a medicine, and not for the purpose of evading the provisions of the controlled substances law; (2) that the purchaser of such preparation identify himself to the satisfaction of the pharmacist; and (3) that of such preparation not more than four ounces are dispensed, or sold to a person during any 48 hour period.
The pharmacist dispensing such excepted substances shall keep an accurate record book including the name and address of the purchaser, the name of the preparation, the strength per dosage unit, the quantity dispensed and the date.
section 5 dispensing controlled substance
Is a record book required? If yes, what needs to be included in the book?
The pharmacist dispensing such excepted substances shall keep an accurate record book including the name and address of the purchaser, the name of the preparation, the strength per dosage unit, the quantity dispensed and the date.
Site Information & Links
section 5
Are there any sales limitations?
that such preparation shall be dispensed, or sold in good faith as a medicine, and not for the purpose of evading the provisions of the controlled substances law; (2) that the purchaser of such preparation identify himself to the satisfaction of the pharmacist; and (3) that of such preparation not more than four ounces are dispensed, or sold to a person during any 48 hour period.
section 6
What does the Board of Pharmacy oversee?
The board of registration in pharmacy in the case of a retail drug business, wholesale druggist or outsourcing facility
section 6
What does the Commissioner oversee?
the commissioner in all other cases may promulgate rules and regulations relative to registration and control of the manufacture, distribution, dispensing and possession of controlled substances within the commonwealth.
Section 6A Licensure of certain corporate entities with patients receiving opioid agonist therapy; best practice guidance for practitioners
Who is required to be licensed under this section?
A corporate entity
- other than a hospital or clinic licensed under section 51 of chapter 111 or an opioid treatment program licensed under chapter 111E, doing business in the commonwealth, which has more than 300 patients receiving treatment for opioid dependency in the form of opioid agonist therapy provided by physicians who are associated with the entity by contract, fee for service or other arrangement other than as members of the practice, shall be licensed by the department and shall comply with requirements established by the department to limit the diversion of opioid drugs and ensure patient safety.
The department shall issue best practice guidance related to routine toxicology screenings, maximum take home dosages and behavioral health referrals for practitioners who provide opioid agonist therapy in the commonwealth. Practitioners shall adhere to said best practices promulgated by the department.
section 6a
Try to find the best practice guidance referenced in the Section. Where would it be found
The department shall issue best practice guidance related to routine toxicology screenings, maximum take home dosages and behavioral health referrals for practitioners who provide opioid agonist therapy in the commonwealth. Practitioners shall adhere to said best practices promulgated by the department.
section 7
How long is the registration valid for each?
If the commissioner finds that sufficient data and funding sources exist to conduct a valid study, he shall conduct a study within 2 years after that finding.
section 7
Who is required to obtain a registration- provide a list
a pharmacy
wholesale druggist
outsourcing facility
hospital
section 7
Who can issue prescriptions? Are there any limits?
certified nurse midwives
physician assistants
idk if there are limits
section 7a
How is registration done for the prescription monitoring program for a prescriber?
Upon obtaining or renewing a registration under section 7, a practitioner who prescribes controlled substances shall automatically and without further action be registered as a participant in the prescription monitoring program
section 7a - Registration as participant in prescription monitoring program
What is this called in Massachusetts
prescription monitoring program
section 7a
What does a pharmacy need to do?
section 7a
Describe the impact on pharmacy
section 8
What needs to be done in order to conduct a research project or study?
must supply the commissioner with satisfactory evidence of compliance with any applicable federal law, and, if the commissioner so requires, with a protocol describing the research project or study to be undertaken.
section 8
Is a registration required?
yes
section 9
Who may possess controlled substances? Provide a list
physician
dentist
podiatrist
nurse practitioner
nurse anesthetist
psychiatric nurse mental health clinical specialist
optometrist
physician assistant
certified nurse midwife
pharmacist
veterinarian
section 9
Are there any restrictions? If yes describe.
physician
dentist
podiatrist
nurse practitioner
nurse anesthetist
psychiatric nurse mental health clinical specialist
optometrist
as limited by sections 66, 66B, and 66C of chapter 112 and subsection (h) of section 7
physician assistant
as limited by said subsection (g) of said section 7 and section 9E of said chapter 112
certified nurse midwife as provided in section 80C of chapter 112
pharmacist as limited by said subsection (g) of said section 7 and section 24B.5 of said chapter 112
veterinarian when registered under said section 7,
section 9 Are there any restrictions regarding samples? If yes, describe.
C-VI samples cannot be prohibited or limited if
if the prescription medication is:
(i) dispensed to the patient by a professional authorized to dispense controlled substances pursuant to this section
(ii) dispensed in the package provided by the manufacturer
(iii) provided at no charge to the patient.
section 9
What are therapeutic contact lenses?
yes
physician or optometrist can give them from the in-office dispensing as long as the medication in the contact is in their scope of practice
'’therapeutic contact lenses’’ shall mean contact lenses that contain 1 or more medications and that deliver such medication to the eye.
section 9
Describe the record-keeping requirements that need to be complied with in this section.
Every physician
physician assistant
dentist
podiatrist
certified nurse midwife
nurse practitioner
psychiatric nurse mental health clinical specialist
nurse anesthetist
pharmacist
veterinarian
shall keep and maintain records, open to inspection by the commissioner during reasonable business hours
in the record:
- the names and quantities of any controlled substances in schedules I, II, or III received by the practitioner
- the name and address of each patient to whom such controlled substance is administered or dispensed
- the name, dosage, and strength per dosage unit of each such controlled substance; and the date of such administration or dispensing.
section 10
Are each places of business that manufacturers, distributes or dispenses controlled substances separately registered?
yes
A separate registration shall be required at each principal place of business or professional practice where the registrant manufactures, distributes, or dispenses controlled substances.
section 11
What does the Board of Pharmacy or commissioner inspect?
the establishment of a registrant or applicant for registration pursuant to the provisions of this chapter
if CS violation, then notify DPH
section 12
What does the Board of Pharmacy register?
shall register an applicant to manufacture or distribute controlled substances included in the schedules established pursuant
unless he determines that the issuance of that registration would be inconsistent with the public interest
wholesalers, retail pharm.
section 11
What does the commissioner inspect?
the establishment of a registrant or applicant for registration pursuant to the provisions of this chapter.
same of board of pharmacy
section 12
What does the commissioner register?
shall register an applicant to manufacture or distribute controlled substances included in the schedules established pursuant
unless he determines that the issuance of that registration would be inconsistent with the public interest
same as board of pharmacy
section 12
List the factors that the Board of Pharmacy and commissioner will consider during the registration process.
(1) maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific, or industrial channels;
(2) compliance with applicable federal, state and local law;
(3) any conviction of the applicant under any federal and state law relating to any controlled substance;
(4) past experience in the manufacture or distribution of controlled substances, and the existence in the applicant’s establishment of effective controls against diversion;
(5) furnishing by the applicant of false or fraudulent material in any application filed under the provisions of this chapter;
(6) suspension or revocation of the applicant’s federal registration to manufacture, distribute or dispense controlled substances as authorized by federal law; and
(7) any other factors relevant to and consistent with the public health and safety.
(b) Registration under subsection (a) of this section shall not entitle a registrant to manufacture or distribute controlled substances in Schedules I or II established pursuant to the provisions of section two except to the extent specified in the registration.
section 13
Under what circumstances would the Board of Pharmacy or commissioner suspend or revoke a registration?
may suspend or revoke a registration to manufacture, distribute, dispense or possess a controlled substance
(1) has furnished false or fraudulent material information in any application filed under the provisions of this chapter
(2) has been convicted under any state or federal law of any criminal violation relating to his fitness to be registered under this chapter
(3) has had his federal registration suspended or revoked to manufacture, distribute, dispense, administer or possess controlled substances
(4) is, upon good cause, found to be unfit or unqualified to manufacture, distribute, dispense, or possess any controlled substance.
(b) The board of registration in pharmacy in the case of a retail drug business, wholesale druggist or outsourcing facility and the commissioner in all other cases may pursuant to the provisions of this section or section fourteen suspend or revoke any registration issued by him or it for violation of any provision of this chapter.
(c) Whenever the commissioner, the board of registration in pharmacy, or the commissioner of mental health has substantial reason to believe that a registrant has committed a criminal violation of any provision of this chapter, he or it shall promptly report all pertinent facts to the district attorney in the county where the violation is believed to have occurred, or to the attorney general.
(d) The board of registration in pharmacy in the case of a retail drug business, wholesale druggist or outsourcing facility and the commissioner in all other cases may limit revocation or suspension of a registration to the particular controlled substance with respect to which grounds for revocation or suspension exists.
(e) If the board of registration in pharmacy in the case of a retail drug business, wholesale druggist or outsourcing facility or the commissioner in all other cases suspends or revokes a registration, all controlled substances which are affected by such suspension or revocation order at the time of suspension or the effective date of the revocation order shall be placed under embargo pursuant to the procedures prescribed in sections one hundred and eighty-nine and one hundred and eighty-nine A of chapter ninety-four. No disposition may be made of substances under such embargo until the time for taking an appeal has elapsed or until all appeals have been concluded unless a court, upon application therefor, orders the sale of perishable substances and the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all controlled substances may be forfeited to the commonwealth under the provisions of section forty-seven.
(f) The board of registration in pharmacy in the case of a retail drug business, wholesale druggist or outsourcing facility and the commissioner in all other cases shall promptly notify the bureau of all orders suspending or revoking a registration and all forfeitures of controlled substances.
section 13
What is an embargo?
legal prohibition by a government or group of governments restricting the departure of vessels or movement of goods from some or all locations to one or more countries
section 14
What happens if the Board of Pharmacy or commissioner finds that there is an imminent danger to the public health or safety which warrants action?
there shall be a suspension
The suspension shall continue in effect until the conclusion of the proceedings including judicial review thereof, unless sooner dissolved by a court of competent jurisdiction, or withdrawn by the board of registration in pharmacy in the case of a retail drug business, wholesale druggist or outsourcing facility, or withdrawn by the commissioner in any other case.
pharmacy can be shut down if compounding sterile in nonsterile
section 15
How are records and inventories maintained?
shall keep records and maintain inventories in conformance with the record-keeping and inventory requirements of the Federal ‘‘Comprehensive Drug Prevention and Control Act of 1970’’ or any amendment thereof, and the Federal Food, Drug and Cosmetic Act, and with any additional rules or regulations promulgated by the board of registration in pharmacy in the case of a retail drug business or wholesale druggist or by the commissioner in all other cases.
section 15
Which form is used to report a theft or loss of a controlled substance?
106, notify DEA within 24 hours
CS II-V
If VI then MA board
section 15
Who are the DEA 106 forms sent to?
file a copy of that form with the department of state police so send to police department
section 16
How are distributions made between registrants- describe the process for the various schedules
Controlled substances in Schedules I and II shall be distributed by a registrant to another registrant only pursuant to such order form as may be required by the Federal ‘‘Comprehensive Drug Abuse Prevention and Control Act of 1970’’ or any amendment thereof and the Federal Food, Drug, and Cosmetic Act.
222 form if
section 17
What are the prescription requirements for controlled substances in Schedule II, III, IV, V and VI.
(a) No controlled substance in Schedule II may be dispensed without an electronic prescription from a practitioner, except that—
(b) In emergency situations, as defined by the commissioner, a schedule II, III, IV, V or VI substance may be dispensed upon written prescription or oral prescription in accordance with section 20 and related regulations.
(c) A controlled substance included in Schedule III, IV, V or VI shall not be dispensed without an electronic prescription from a practitioner.
section 18
What are the requirements to verify that the practitioner has prescriptive authority?
(1) authorized to prescribe controlled substances; and
(2) registered pursuant to the provisions of this chapter.
(b) An oral prescription issued by a practitioner may be communicated to a pharmacist by an expressly authorized employee or agent of the practitioner.
A prescription for a controlled substance contained in schedules III to VI, inclusive, as defined in section three may also be issued by an authorized practitioner who is duly licensed and authorized to engage in prescriptive practice and duly registered in the state wherein he resides,
A prescription for a nonnarcotic substance contained in Schedule II of section three may also be issued by a practitioner who is licensed and authorized to engage in prescriptive practice and registered in another state where he resides or practices, if required, and registered under federal law to write prescriptions
Except as provided in section 18A, a prescription for a narcotic substance contained in Schedule II of section 3 may also be issued by a practitioner who is licensed and authorized to engage in prescriptive practice and registered in Maine or in a state contiguous with the commonwealth wherein such practitioner resides or practices, if required, and registered under federal law to write prescriptions.
DEA resgtration for II-V
section 18
Who can call the pharmacy with an oral prescription?
) An oral prescription issued by a practitioner may be communicated to a pharmacist by an expressly authorized employee or agent of the practitioner.
pharm. or intern can take Rx over phone
section 18
Are there any time requirements to fill Schedule III to V oral prescriptions?
a pharmacist filling such prescription shall within thirty days after the filling of such prescription deliver to the department a copy of each such Schedule II prescription; provided, however, that such copy shall not include the name and address of the patient for whom the prescription is issued and that such copy and the information contained thereon shall not be deemed to be public record
section 18
Are there any requirements for the written prescription cover prescription for the orally dispensed prescription?
the case of any oral prescription for a schedule III through V substance, the pharmacist shall record that he has requested that the practitioner deliver or mail to the dispensing pharmacy a written prescription for the controlled substance within seven days or such shorter period required by Federal law.
if electronic, within 2 days
section 18
Schedule II non-narcotic written by out-of-state practitioners
A prescription for a nonnarcotic substance contained in Schedule II may also be issued by a practitioner who is licensed and authorized to engage in prescriptive practice and registered in another state where he resides or practices, if required, and registered under federal law to write prescriptions.
quantity: 30 days for CII
exception: 60 days for methylphenidate and something else….
if never had before 7 days
section 18
Schedule II non-narcotic written by in-state practitioners
Except as provided in section 18A, a prescription for a narcotic substance contained in Schedule II of section 3 may also be issued by a practitioner who is licensed and authorized to engage in prescriptive practice and registered in Maine or in a state contiguous with the commonwealth wherein such practitioner resides or practices, if required, and registered under federal law to write prescriptions.
come from any state
from any prescription
section 18
Schedule II narcotic written by in-state practitioners
allowed
written preceding 5 days
by practioner
section 18
Schedule II narcotic written by out-of-state practitioners
only allowed if the state touches MA & is ME
states that touch MA:
RI
CT
VT
NH
NY
Except as provided in section 18A, a prescription for a narcotic substance contained in Schedule II of section 3 may also be issued by a practitioner who is licensed and authorized to engage in prescriptive practice and
section 18
What are the requirements for each of the above? Are there any time fill restrictions?
section 18
What are the good-faith efforts a pharmacist shall conduct to protect from liability under this section?
the dispensing of a controlled substance pursuant to a prescriber’s order which, in the professional judgment of the pharmacist, is lawful.
section 18
Can a pharmacist fill a Schedule II opioid substance for quantity less than what was prescribed?
no
section 18
What are the requirements for the pharmacist when fill less than the face amount?
A pharmacist filling a prescription for a schedule II substance shall, if requested by the patient, dispense the prescribed substance in a lesser quantity than indicated on the prescription. The remaining portion may be filled upon patient request in accordance with federal law; provided, however, that only the same pharmacy that originally dispensed the lesser quantity shall dispense the remaining portion.
What training is required for practitioners who prescribe controlled substances?
section 18 a
What needs to be done prior to issuing an extended release long-acting opioid in a non-abuse deterrent form for an outpatient for the first time?
a practitioner registered under section 7 shall:
(i) evaluate the patient’s current condition, risk factors, history of substance abuse, if any, and current medications;
(ii) inform the patient and note in the patient’s medical record that the prescribed medication, in the prescriber’s medical opinion, is an appropriate course of treatment based on the medical need of the patient.
section 18 a
Is a written pain management treatment agreement needed? If yes where are the agreements filed?
yes
appropriately addresses the benefits as well as the risk factors for abuse or misuse of the prescribed substance under guidelines published by the department. Such an agreement shall be filed in the patient’s medical record or included in the patient’s electronic health record.
section 18b
Where can the non-opiate directive form be found
department’s searchable website
section 18 b
Who may execute such a form?
An individual may execute and file a voluntary non-opiate directive form with a practitioner registered under section 7 or other authority authorized by the secretary to accept the voluntary non-opiate directive form for filing
section 18b
What is the impact on pharmacy?
section 18 c
What does a practitioner need to speak to the patient about? Quantity and risks
(i) consult with a the patient regarding the quantity of the opioid and a patient’s option to fill the prescription in a lesser quantity
(ii) inform the patient of the risks associated with the opioid prescribed.
section 18 c
What patient education is required?, Mass. corresponds responsibility
tell them the quantity and risks of the opioid
section 18 c
What schedules does the Massachusetts corresponding responsibility apply to?
schedule II
section 18 c
Explain corresponding responsibility
While the prescriber has the responsibility for the proper. prescribing and dispensing of controlled substances, the pharmacist. filling the prescription has a corresponding responsibility to ensure the prescription is legal and not for purposes of abus
section 18 c
Can a prescription be written for a practitioner to obtain controlled substances for the purpose of dispensing to the practitioner’s patients?
section 18 c
Explain who can be dispensed naloxone or other opioid antagonists?
A pharmacy may dispense naloxone either pursuant to a patient-specific prescription or via the statewide standing order.
section 18 c
Where can you find information relating to the pharmacist’s obligations regarding naloxone?
section 19 a
How is emergency contraception defined?
mean any drug approved by the federal Food and Drug Administration as a contraceptive method for use after sexual intercourse.
section 19 a
What must the pharmacist comply with regarding emergency contraception?
(d) A pharmacist dispensing emergency contraception under this section shall annually provide to the department of public health the number of times such emergency contraception is dispensed. Reports made pursuant to this section shall not identify any individual patient, shall be confidential and shall not be public records as defined by clause twenty-sixth of section 7 of chapter 4.
(c) Before dispensing emergency contraception authorized under this section, a pharmacist shall complete a training program approved by the commissioner on emergency contraception, which training shall include but not be limited to proper documentation, quality assurance, and referral to additional services, including appropriate recommendation that the patient follow-up with a medical practitioner.
(b) Notwithstanding any other law, a licensed pharmacist may dispense emergency contraception in accordance with written, standardized procedures or protocols developed by an actively practicing physician registered with the commissioner to distribute or dispense a controlled substance in the course of professional practice pursuant to section 7 if such procedures or protocols are filed at the pharmacist’s place of practice and with the board of registration in pharmacy before implementation.
section 19 a
What is a standing order?
Standing orders authorize nurses, pharmacists, and other healthcare providers where allowed by state law, to assess a client’s immunization status and administer vaccinations according to a protocol approved by an institution, physician, or other authorized provider.
The department shall ensure that a statewide standing order is issued to authorize the dispensing of emergency contraception by a licensed pharmacist.
section 19 a
What does the training program need to consist of?
section 19 a
What is included in the annual report to DPH?
section 19 a
What has the Board of Pharmacy adopted to implement this section?
section 19 b
What is an opioid antagonist?
what is an example of one
designed to rapidly reverse opioid overdose.
It is an opioid antagonist—meaning that it binds to opioid receptors and can reverse and block the effects of other opioids, such as heroin, morphine, and oxycodone
example: naloxone
section 19 b
Are there any requirements relating to naloxone for pharmacists?
section 19b
Are there any requirements relating to naloxone for pharmacies?
(c) Notwithstanding any general or special law to the contrary, a licensed pharmacist may dispense an opioid antagonist in accordance with the statewide standing order issued under subsection (b). Except for an act of gross negligence or willful misconduct, a pharmacist who, acting in good faith, dispenses an opioid antagonist shall not be subject to any criminal or civil liability or any professional disciplinary action by the board of registration in pharmacy related to the use or administration of an opioid antagonist.
can be dispensed by any licensed pharmacist
(d) A pharmacist who dispenses an opioid antagonist shall annually report to the department the number of opioid antagonist doses dispensed. Reports shall not identify an individual patient, shall be confidential and shall not constitute a public record as defined in clause Twenty-sixth of section 7 of chapter 4. The department shall publish an annual report that includes aggregate information about the dispensing of opioid antagonists in the commonwealth.
(e) A pharmacist or designee who dispenses an opioid antagonist pursuant to this section shall, for the purposes of health insurance billing and cost-sharing, treat the transaction as the dispensing of a prescription to the person purchasing the opioid antagonist regardless of the ultimate user of the opioid antagonist. Unless the person purchasing the opioid antagonist requests to pay for the prescription out-of-pocket, the pharmacist or designee shall make a reasonable effort to identify the purchaser’s insurance coverage and to submit a claim for the opioid antagonist to the insurance carrier prior to dispensing the opioid antagonist.
section 19 b
Is there a training program this is required?
section 19 b
What needs to be included in the annual report to DPH?
A pharmacist who dispenses an opioid antagonist shall annually report to the department:
the number of opioid antagonist doses dispensed
Reports shall not identify an individual patient
shall be confidential and shall not constitute a public record as defined in clause Twenty-sixth of section 7 of chapter 4.
The department shall publish an annual report that includes aggregate information about the dispensing of opioid antagonists in the commonwealth.
section 19 b
What has the Board of Pharmacy adopted to implement this section?
section 19 c
What has the Board of Pharmacy adopted to implement this section?
section 19d
When issuing a prescription for an opiate to an adult patient for outpatient use for the first time, a practitioner shall not issue a prescription for more than ___ supply.
7
section 19d
A practitioner shall not issue an opiate prescription to a minor for more than ___ supply at any time and shall discuss with the parent or guardian of the minor the risks associated with opiate use and the reasons why the prescription is necessary.
7day
exceptions: cancer pain, palliative care
section 19d
If, in the professional medical judgment of a practitioner, more than a 7-day supply of an opiate is required to treat the adult or minor patient’s acute medical condition or is necessary for the treatment of chronic pain management, pain associated with a cancer diagnoses or for palliative care, then the practitioner may issue a prescription for the quantity needed to treat such acute medical condition, chronic pain, pain associated with a cancer diagnosis or pain experienced while the patient is in palliative care. How and where must this be documented?
the condition triggering the prescription of an opiate for more than a 7–day supply shall be documented in the patient’s medical record and the practitioner shall indicate that a non-opiate alternative was not appropriate to address the medical condition.
section 20
What does a pharmacist need to include on an oral prescription- list
the pharmacist shall immediately reduce the prescription to writing on a prescription form and shall record:
the name, address and registration number of the practitioner
the name of any expressly authorized representative
the date of the prescription, the name, dosage and strength per dosage unit of the controlled substance
the serial number assigned to the prescription by the dispensing pharmacy
the name of said pharmacy
the name and address of the patient unless it is a veterinary prescription
the directions for use
any cautionary statements required
a statement indicating the number of times to be refilled.
section 20
What can a pharmacist do to verify the oral authorization came from the practitioner?
section 20
Is a written hard-copy required? If yes for what schedules
section 20 oral prescription
When is the hard-copy required to be received by the pharmacy?
section 20
What does the pharmacist do when they receive the hard-copy cover?
section 20
What if the hard copy cover prescription is not received by the pharmacy?
section 21
What information needs to be included on the pharmacy label?
the date of filling, the pharmacy name and address, the filling pharmacist’s initials, the serial number of the prescription, the name of the patient, unless it is a veterinary prescription, the name of the prescribing practitioner, the name of the controlled substance, directions for use and cautionary statements
section 21
Upon the request of an elderly person, or a person visually impaired, directions on the label affixed by the pharmacist to a container of a prescription drug shall be typed in a print size allowing no more than ___ characters per inch.
is it larger or smaller than 12 characters
10
Larger than 12 characters because there are less characters per inch on the prescription
section 21
What needs to be included in the educational information pamphlets relative to narcotic drugs?
section 21
When should a pharmacist distribute the pamphlet?
A pharmacist shall distribute the pamphlet when dispensing a narcotic or controlled substance contained in Schedule II or III.
section 21
What needs to be included on the label for a compounded prescription?
pharmacy shall have affixed to their container by the compounding pharmacy a label notifying prescribed users and practitioners that the drug is either a sterile or non-sterile compounded drug preparation.
section 21
What do pharmacies who are engaged in sterile or complex non-sterile compounding need to do to comply with this section?
shall provide a telephone number to foster communication between patients in the commonwealth and a pharmacist employed by the pharmacy who has access to the patient’s records. The phone shall be staffed during regular hours of operation every day and not less than 56 hours per week. The phone number shall be affixed to the drug’s container, alongside the label notifying prescribed users and practitioners of the fact that the drug is a compounded drug preparation. This paragraph shall not apply to an institutional pharmacy licensed pursuant to section 39I of chapter 112 if the sterile drug preparation compounded by such pharmacy is to be administered to an individual admitted as an inpatient within the same hospital.
section 21
Does this apply to inpatients?
This paragraph shall not apply to an institutional pharmacy licensed pursuant to section 39I of chapter 112 if the sterile drug preparation compounded by such pharmacy is to be administered to an individual admitted as an inpatient within the same hospital.
section 21 A
1. What is the purpose of a prospective drug review?
allows the pharmacist to identify and resolve problems before the patient has received the medication, drug drug
Section 21A
What should be included in the prospective drug use review?
screening for potential drug therapy problems due to therapeutic duplication
drug disease contraindication, drug interactions, including serious interactions with nonprescription or over-the-counter drugs
incorrect drug dosage
duration of drug treatment
drug allergy interactions
clinical abuse or misuse.
Section 21 a
3. To whom is the offer to counsel to be made to?
The patient for new Rx
section 21 a
4. Who can make the offer the counsel?
Pharmacist, pharmacy techs, pharmacy interns via faec to face or telephone
section 21 a
5. Who can counsel the patient?
Pharmacist (for new Rx!) or with interns who is under direct supervision of the pharmacist
secton 21a
6. What if the prescription drug is delivered to the patient? How is the offer to counsel made?
providing such person with access to a toll-free telephone service to facilitate communication between such person and the pharmacist at such pharmacy.
- If counseling is accepted how should the pharmacist counsel the patient?
According to and must address
(1) the name and description of the medication;
(2) the dosage form, dosage, route of administration and duration of drug therapy;
(3) special instructions and precautions for preparation, administration and use by the patient;
(4) common adverse or severe side effects or interactions and therapeutic contraindications that may be encountered, including their avoidance and the action required if they occur;
(5) techniques for self-monitoring drug therapy;
(6) proper storage;
(7) prescription refill information;
(8) Action to be taken in the event of a missed dose.
section 21a
8. What if the patient declines to be counseled?
Then don’t have to counsel but if something of severe side effects then document that you rejected it
section 21a
9. How should the offer to counsel be documented?
The pharmacist or his designee shall make reasonable efforts to obtain, record and maintain the following patient information generated at an individual pharmacy:
(1) the name, address, telephone number, date of birth or age, and gender;
(2) individual history where significant, including known allergies and drug reactions, and a comprehensive list of medications and relevant devices; and
(3) any additional comments relevant to the patient’s drug use, including any failure to accept the pharmacist’s offer to counsel.
Such information may be recorded in the patient’s manual or electronic profile or in the prescription signature log, or in any other system of records and may be considered by the pharmacist in the exercise of his professional judgment concerning both the offer to counsel and the content of counseling.
The absence of any record of a failure to accept the pharmacist’s offer to counsel shall create a presumption that such counseling was provided.
Section 21A
Prescriptions; prospective drug review and counseling by pharmacist
10. Does this section apply to inpatients or residents of nursing homes?
shall not apply to any drug dispensed to an inpatient at a hospital or nursing home, except to the extent required by regulations promulgated by the Federal Health Care Financing Administration pursuant to the provisions of 42 USC 1396r–8.
section 21 b
What is a lock box?
a box with a locking mechanism that cannot be tampered with or opened without extreme force.
Kind of like a safe
section 21b
What is the purpose of the lock box
For dispensing schedules II, III, IV or V
Sign: needs to be at least 4 inches by 5
section 21b
What needs to be included in the sign for the lock boxes and the size of the sign?
includes the following statement in legibly printed font: ‘‘Lock boxes for securing your prescription medications are available at this pharmacy’’.
section 22
What does a practitioner need to include on a written prescription?
name, address and registration number of the practitioner, the date of delivery of the prescription, the name, dosage and strength per dosage unit of the controlled substance, the name and address of the patient unless it is a veterinary prescription, the directions for use and any cautionary statements required, and a statement indicating the number of times to be refilled.
section 22
What shall be included on a schedule II opioid prescription?
a notation on the prescription that the patient may fill, upon request, the prescription in compliance with subsection (d.75) of section 18 (CARA act) in an amount not to exceed the full prescribed quantity
Patient can request partial fill
section 23
When do schedule II controlled substance prescriptions expire?
30 days from the date of issuance in the state
5 days for out of state
section 23
How are prescriptions filed?
3 different files: for II for III, IV, V and for V
and anything else
section 23
How does a pharmacist cancel out a Schedule II prescription?
Sign on the face (the front) of Rx with your signature (full name; not the same as initals) if electronic follow what the law says
section 23
What are the quantity limits for Schedule II and III
what are the exceptions
II & III: max quantity is 30 day supply - general rule
exceptions:
dextroamphetamine sulfate and methylphenidate hydrochloride, a prescription may be filled for up to a 60 day supply of such substance upon any single filling if said substance is being used for the treatment of minimal brain dysfunction or narcolepsy
prescriptions for implantable infusion pumps, subq consisting of Schedule II or Schedule III controlled substances may be filled for a maximum of 90 days.
v
section 23
How long are the records to be retained?
2 years except with medicare which is 10 yrs
no refills for CII
V or VI are silent
PRN = zero refills
section 23
How are prescriptions to be written?
(i) All written prescriptions shall be written in ink, indelible pencil or by other means on a tamper resistant form (which can probably change color if tampered) consistent with federal requirements for Medicaid and signed by the prescribing practitioner.
section 21A
What system has the department established to monitor prescribing and dispensing of controlled substances?
Mass pat program
section 24A
What schedules of drugs are to be monitored?
II to V
Section 24a
What is an additional drug? Provide an example.
It is a schedule VI drug which is Gabapentin — has potential for abuse. Pharmacy has 24 hours to report
Section 24B Mean and median quantity and volume of prescriptions for opiates; notification of practitioner’s own percentile ranking
Briefly describe the purpose of this section.
Who are high prescribers (prescribe a lot of opiates)
What are the volume that the prescriber is prescribing the opioid then go and talk to them
Can go to jail
section 27
With no Rx, can sale to them and no age limit or quantity limit
With no Rx, can sale to them and no age limit or quantity limit
section 27
What are the sale requirements for the sale of hypodermic syringes or needles? Consider who needs to be involved, ID required, type of needle/syringe and quantity to be sold.
Do not need ID, can buy lots of them
on exam, can specify age so know that there is no age requirement
Examination for Licensure as a Pharmacist
where must you graduate from
what age
what must you earn?
what must you complete
what must be your moral character
A graduate of an ACPE-accredited and Board-approved college/school of pharmacy shall be eligible for examination for licensure as a pharmacist provided the applicant:
(a) is 18 years of age or older by the scheduled date of the examination applied for;
(b) has earned a doctor of pharmacy degree from a college/school of pharmacy accredited by the ACPE or approved by the Board;
(c) has completed a pharmacy internship in accordance with 247 CMR 8.01(1); and
(d) is of good moral character.
Licensure by Reciprocity
what can the applicant do that they have now been notified by the NABP
who can make the final decision for a person to be registered as a pharmacist by reciprocity
how long is a reciprocity application valid
are the fees connected with the licensure by reciprocity application refundable
(a) Whenever an applicant has been notified by NABP that the applicant does not meet the requirements for licensure by reciprocity, the applicant may in writing request the Board to review the basis of NABP’s decision.
(b) The Board shall make the final determination of any applicant’s eligibility to be registered as a pharmacist by reciprocity.
(c)A reciprocity application shall be valid for one year after the date of approval by NABP.
(d) All fees submitted to the Board in connection with an application for licensure by reciprocity, reviewed and acted upon by the Board, are nonrefundable.
licensure by reciprocity
what are the requirements for the board of a license
who must approve
what document must be provided
what score do you at least need on the MPJE
if asked, what must the applicant do
- NABP approval;
- documentation of internship experience in accordance with 247 CMR 8.01: Pharmacy Interns;
- Passing score (at least 75%) on MPJE;
- if requested, the applicant shall personally appear before the Board to discuss any matter related to the application.
when can a Rx be issued
In accordance with M.G.L. c. 94C §19(a), prescriptions must be issued pursuant to a valid patient / prescriber relationship and for a legitimate medical reason by a prescriber acting in the usual course of his / her professional practice.
red flags when evaluating an Rx
location of prescriber
location of patient
refills and frequency
running out or losing
insurance and cash
cocktails
Prescriber is located at a great geographic distance from the pharmacy.
Patient lives a great geographic distance from the pharmacy or prescriber.
Patient frequently requests early refills.
Patient often runs out of or “loses” their medications.
Patient requests to bypass insurance and pay with cash.
Prescriptions written for combinations known as “cocktails” (i.e., containing an opioid, a benzodiazepine, and a muscle relaxant).
red flags when evaluating an Rx
quantity for one patient
amount of prescribers
amount of pharmacies
groups and Rx
regulatory actions
colors
language & behavior of the patient
distractions
Prescriptions written for unusually large quantities for a single patient.
Multiple prescribers for a single patient.
Multiple pharmacies used by a single patient.
Groups of patients that present at the same time with the same prescriptions.
Strong analgesic prescriptions written by a prescriber that is not associated with pain management.
Prescriptions written by prescribers with federal or state regulatory actions against them.
Prescriptions that appear to be written in multiple colors or printing / writing.
Patients that use street slang and present with unusual or aggressive behavior.
Patients that rush or try to distract you while you fill their prescription.
Prescription information that may NEVER be changed or added
For all schedules (Schedule II – VI), a new prescription is required for any of the following changes or additions:
who’s name
medications unless what
who else’s name
who’s signature
date but for what schedule
patient’s name (i.e., change to different patient)
controlled substance prescribed (except generic substitution)
prescriber’s name
prescriber’s signature
earliest date to be filled (Schedule II only)
Prescription information that MAY be changed or added for CIII
The following may be changed or added, after consultation with the prescriber, unless otherwise noted
date
who’s address
who else’s address
- without consultation
- after consultation
DEA # w/o what
drug what
- directions
- form
- strong
- #
who’s supervisor
The following may be added and the prescriber’s office should be notified if the following language is omitted:
- what kind of language for alternatives
- what kind of language for filling
date of issue (date written) may only be added if omitted
prescriber’s address
patient’s address
maybe added if omitted without consultation
may only be changed after consultation
with the prescriber or authorized agent
prescriber’s DEA number may be added without consultation
directions for use
dosage form
drug strength
quantity prescribed
supervising physician’s name of mid-level prescriber
The following may be added and the prescriber’s office should be notified if the following language is omitted:
“no substitution” language
“partial fill upon patient request” language
Schedule III - VI prescriptions:
The following may be changed or added to new prescriptions, after consultation with the prescriber or authorized agent, unless otherwise noted:
date
who’s address
who else’s address
- without consultation
- after consultation
DEA # w/o what
drug what
- directions
- form
- strong
- #
- refill
who’s supervisor
-what kind of language may not be added
If deemed appropriate in the pharmacist’s professional judgment, the days’ supply dispensed (e.g., ___-day supply with ___refills vs. 90-day supply with 3 refills) may be changed without consultation only for drugs that do not require ____reporting (cannot be __-V and ____).
date of issue (date written) may only be added if omitted
prescriber’s address
patient’s address
maybe added if omitted without consultation
may only be changed after consultation
with the prescriber or authorized agent
prescriber’s DEA number may be added without consultation
directions for use
dosage form
drug strength
quantity prescribed
refill information
supervising physician’s name of mid-level prescriber
“no substitution” language may be added
If deemed appropriate in the pharmacist’s professional judgement, the days’ supply dispensed (e.g., 30-day supply with 11 refills vs. 90-day supply with 3 refills) may be changed without consultation only for drugs that do not require PMP reporting (cannot be II-V and Gabapentin).
With each change, what information must be documented in the computerized pharmacy system or on the written prescription:
the date
item changed or added
name of the authorizing prescriber, if applicable
name of the pharmacist accepting / making the change
I. General Compliance Information
how many hours of CE must be completed in the calendar year
what cannot be carried over
a maximum of how many contact hours can be completed in a day
at least how many contact hours must be live
how many contact hours must be on. law
what two kinds of credits does the board accept?
what must be provided if you have credts from other source
what other CE requirements must a pharmacist have
when is the grace period and what is it for
Except for CDTM pharmacists, at least 20 contact hours of CE, including specialized topics/requirements below, must be completed by December 31 of each calendar year.
Contact hours may not be carried over from one calendar year to another.
A maximum of 8 contact hours may be claimed each calendar day.
At least 5 contact hours must be “live”.
At least 2 contact hours must be in the area of pharmacy law (does not need to be Massachusetts-specific or “live”).
The Board accepts the following types of credit: Accreditation Council for Pharmacy Education (“ACPE”), Interprofessional Continuing Education (“IPCE”), AMA PRA Category 1 Credit, and any U.S. pharmacy Board approved programs.
For any non-ACPE / ICPE credits that will not appear on your CPE Monitor profile, pharmacists must retain documentation (i.e., certificates of completion) of completed programs that must include:
participant’s name;
title and activity number of the program;
credit type (e.g., ACPE, etc.);
name of the authorized provider;
whether the program was obtained in a “live” or “home study” format;
date of completion of the program; and
number of contact hours earned.
All pharmacists, including non-resident pharmacists practicing in other states or U.S. jurisdictions, MUST complete immunization
compounding,
Collaborative Drug Therapy Management
other CE requirements if they oversee or engage in these practices, as applicable. See below for details on these specific practices.
A pharmacist who has failed to complete the requisite number of contact hours must email the Board with a detailed statement explaining the reasons.
II. Newly Licensed or Recently Transferred Pharmacists
Pharmacists who have obtained their Massachusetts license via exam or transfer on or after October 1 will be granted a grace period through April 30 of the next calendar year to obtain all required contact hours for the previous year. Need to get CE from prior year and new year too
what happens if a pharmacist practices and their license is expired
Any practice of pharmacy by a registrant after the expiration of his or her personal registration shall constitute the unlicensed practice of pharmacy and shall be subject to any and all penalties established for such unlicensed practice of pharmacy.
how many hours of immunization related pharmacy education is there
Each calendar year, pharmacists who physically immunize or directly supervise immunizing activities MUST complete 1 contact hour of ACPE-approved, immunization-related continuing pharmacy education.
what happens if a pharmacist fails to renew their license for more than 60 days
An applicant who has failed to renew his or her personal registration for a period of more than 60 days, and whose personal registration has not been suspended or revoked by the Board, may apply for a renewal of personal registration upon satisfying conditions imposed by the Board, which may include the completion of additional contact hours of continuing education.
what happens if your license has been expired for more than 2 years
An applicant for personal registration renewal who has failed to renew his or her personal registration for more than two years, and whose personal registration has not been suspended or revoked by the Board, shall take and pass the Multistate Pharmacy Jurisprudence Examination and meet all other conditions as determined by the Board as a prerequisite to registration renewal.
what happens if your license has been suspended for more than 6 months and 2 years
An applicant for personal registration renewal whose personal registration has been revoked or has been suspended for between six months and two years shall take and pass the Multistate Pharmacy Jurisprudence Examination and meet all conditions as determined by the Board as a prerequisite to registration renewal.
true or false
A registrant who oversees or is engaged in the administration of vaccines must complete at least one contact hour of continuing education on the topic of immunizations during the two-year renewal cycle
false
but instead: each calendar year has 1 contact hour
not every 2 years
:).
ACPE
means the Accreditation Council for Pharmacy Education.
ACPE-approved Provider
means an institution, organization or agency that is recognized by the ACPE, in accordance with its policies and procedures, as qualified to provide continuing education for pharmacists.
Approved College/School of Pharmacy
means a college or school of pharmacy which has been accredited by the ACPE or approved by the Board.
Authorized Provider
means a person who or agency which, sponsors or co-sponsors one or more contact hours of continuing education for pharmacists and which has received the approval of the ACPE, CME/Category 1, or the Board.
Blood
means whole blood collected from a single donor and processed, whether for transfusion or further manufacturing.
Blood Component
means that part of blood separated by physical or mechanical means.
Board-approved Program
means a program which has been approved by the Board for continuing education credits. Such program may be sponsored by the ACPE, and/or sponsored or co sponsored by any person who has been granted prior written approval by the Board for the particular program. The Board may, within its discretion, accept comparable continuing education hours approved by other Boards of Pharmacy.
Certificate of Approved CEUs
means a document, issued to a named pharmacist by an authorized provider, certifying that the pharmacist has satisfactorily completed a specified number of CEUs.
Certificate of Fitness
means a document issued by the Board to a pharmacy or pharmacy department which permits a pharmacy or pharmacy department to use alcohol for the manufacture of U.S. Pharmacopoeia or National Formulary preparations and all medicinal preparations unfit for beverage purposes, and to sell alcohol as authorized under M.G.L. c. 138.
Certified Pharmacy Technician
means a pharmacy technician who is currently:
(a) registered by the Board; and
(b) certified by a Board-approved certifying body.
A pharmacy technician may perform the duties authorized to be performed by a certified pharmacy technician in 247 CMR 8.04: Certified Pharmacy Technicians when Board-approved certification is current. If certification lapses, the individual is required to function as a pharmacy technician until certification is current.
Contact Hour
means a unit of measure of educational credit which is a minimum of 50 minutes, or the equivalent as determined by the Board, of satisfactory participation in a Board-approved program of continuing education.
Continuing Education (CE)
means participation by registered pharmacists in Board-approved educational programs and is a prerequisite for the renewal of a personal registration.
Continuing Education Unit (CEU)
means a unit of measure of educational credit which is equal to ten contact hours, or it’s equivalent as determined by the Board, of satisfactory participation in a Board-approved program of continuing education.
Controlled Substance
means a drug, substance, or immediate precursor in any schedule or class referred to in M.G.L. c. 94C.
Controlled Substance Registration
means a document issued by the Board which allows the holder to receive and dispense, pursuant to a valid prescription, controlled substances.
CME/Category 1
means continuing medical education (CME) credits sponsored by an organization accredited for CME by the Accreditation Council for Continuing Medical Education, the Postgraduate Medical Institute or the state medical society.
Customer Identifier
means the identification number on a valid government issued identification, as specified by the Department, which a pharmacy obtains by inspecting the identification of the ultimate user or agent of the ultimate user to whom a prescription is dispensed. (105 CMR 700.001: Purpose)
Department
means the Massachusetts Department of Public Health.
Direct Supervision
(a) thetypeofsupervisionaBoard-approvedregisteredpharmacistpreceptorinapharmacy, pharmacy department, or institutional pharmacy is required to provide to a pharmacy intern when said preceptor oversees and directs the professional activities of the pharmacy intern, and includes directly reviewing the work of the intern; and
(b) the type of supervision a registered pharmacist in a pharmacy, pharmacy department, hospital pharmacy, or institutional pharmacy is required to provide a pharmacy technician when said pharmacist oversees and directs the activities of the pharmacy technician.
Dispensing
means the physical act of delivering a drug, chemical, device or combination thereof to an ultimate user pursuant to the lawful order of a practitioner, as defined in M.G.L. c. 94C, § 1, including the utilization of the professional judgment of the pharmacist and the packaging, labeling, or compounding necessary to prepare the drug, chemical, or device for delivery.
Drug Sample
means a unit of a prescription drug that is not intended to be sold.
Electronically Transmitted Prescription
means an order of a practitioner which has been transmitted electronically to a pharmacy in accordance with 105 CMR 721.020: Prescription Formats.
Facsimile Machine (fax)
means a machine that electronically transmits exact images through connection with an electronic network.
FPGEC
means the NABP’s Foreign Pharmacy Graduate Examination Committee.
FPGEC Certificate
means a document issued by the NABP evidencing the assessment of the educational equivalency of a graduate of a non-approved college/school of pharmacy.
FPGEE
means the NABP’s Foreign Pharmacy Graduate Equivalency Examination.
Good Moral Character
means those virtues of a person which are generally recognized as beneficial to the public health, safety and welfare.
Good Standing
means the pharmacist’s personal registration is not currently being sanctioned by the Board.
Graduate of Non-approved College/School of Pharmacy
means a pharmacist whose undergraduate pharmacy degree was not conferred by an ACPE-accredited or Board-approved college/school of pharmacy yet was conferred by a recognized college/school of pharmacy outside of the United States, the District of Columbia and Puerto Rico. Recognized colleges/schools of pharmacy are those colleges and universities listed in the World Health Organization’s World Directory of Schools of Pharmacy, or otherwise approved by the FPGEC.
Home-study and Other Mediated Instruction
means continuing education activities which do not provide for direct interaction between faculty and participants and may include audio tapes, video tapes, cable television, computer assisted instruction, journal articles and monographs.
Institutional Pharmacy
means the physical portion of an organization, including but not limited to hospitals, health maintenance organizations and clinic pharmacies, whose primary purpose is to a provide a physical environment for patients to obtain health care services under the supervision and direction of a registered pharmacist and is authorized to dispense controlled substances.
Internship
means the period of training under the supervision of a Board-approved registered pharmacist preceptor, which training is a prerequisite to examination for personal registration as a pharmacist in the Commonwealth of Massachusetts.
Legend Drug, Device or Gas
means a drug, device or gas which by federal law must bear the legend: “Caution: Federal law prohibits dispensing without prescription.”
Live Program
means a continuing education program that provides for direct interaction between faculty and participants and may include, but not be limited to, lectures, symposia, live teleconferences and workshops.
Manager of Record or Pharmacist Manager of Record
means a pharmacist, currently registered by the Board pursuant to 247 CMR 6.07: Pharmacist Manager of Record, who is responsible for the operation of a pharmacy or pharmacy department in conformance with all laws and regulations pertinent to the practice of pharmacy and the distribution of drugs.
Manufacturer
means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging or labeling a prescription drug.
MPJE
NABP
NABP Number
NAPLEX
MPJE means the Multistate Pharmacy
Jurisprudence Examination.
NABP means the National Association of Boards of Pharmacy.
NABP Number means a unique seven digit number issued by the National Council for Prescription Drug Programs.
NAPLEX means the North American Pharmacist Licensure Examination.
National Drug Code (NDC)
NCPDP
Over-the-counter Drug
Person
Personal Registration
National Drug Code (NDC) Number means a nationally recognized standard which identifies drug products using a unique number issued by the United States Food and Drug Administration. The NDC number has three components: the first component identifies the drug manufacturer (“Labeler No.”); the second component identifies the product (“Product No.”); and the third component identifies the package size (“Pkg.”).
NCPDP means the National Council for Prescription Drug Programs.
Over-the-counter Drug means any drug whose availability is not restricted to an order of a practitioner.
Person means an individual, corporation, government, governmental subdivision or agency, business trust, estate trust, partnership or association, or any other legal entity.
Personal Registration means a document issued by the Board to a qualified pharmacist, under the provisions of M.G.L. c. 112, § 24, permitting the pharmacist to engage in the practice of pharmacy.
Pharmacy
Pharmacy Department
Pharmacy Intern
Pharmacy Permit
Pharmacy Technician
Pharmacy Technician Trainee
Pharmacy means a facility under the direction or supervision of a registered pharmacist which is authorized to dispense controlled substances. The term “pharmacy” shall not include institutional pharmacies or pharmacy departments except as otherwise provided in 247 CMR.
Pharmacy Department means that part of a retail store registered by the Board in which a drug business, as defined in M.G.L. c. 112, § 37, is transacted.
Pharmacy Intern means an individual who has completed two years of academic curriculum or who has standing as a student beyond the second-year class in the undergraduate academic sequence of an approved college/school of pharmacy, and who is registered by the Board to acquire, under the direction of a Board-approved registered pharmacist preceptor to whom he or she has been assigned, that practical experience which is a prerequisite to examination for personal registration as a pharmacist. A pharmacy intern may engage in the full range of activities conducted by a registered pharmacist provided that at all time he or she is under the direct supervision of a registered pharmacist preceptor.
Pharmacy Permit means a document issued by the Board to a registered pharmacist in the name of a pharmacy or pharmacy department to manage and operate a pharmacy or a pharmacy department.
Pharmacy Technician means an individual who is registered by the Board, pursuant to 247 CMR 8.02: Pharmacy Technicians, who performs pharmacy duties under the direct supervision of a pharmacist.
Pharmacy Technician Trainee means an individual preparing to be registered as a pharmacy technician who performs pharmacy duties under the direct supervision of a pharmacist.
Postgraduate
Practitioner
Preceptor
Prescription
Prescription Drug
Prescription Device
Postgraduate means graduation and award of an entry-level degree in pharmacy from a Board- approved or ACPE-accredited college/school of pharmacy.
Practitioner means any person with prescriptive privileges as defined in M.G.L. c. 94C, § 1.
Preceptor means a registered pharmacist in good standing who has completed at least one year of the actual practice of pharmacy and who the Board has approved to supervise and direct the training of pharmacy interns and to assist in the training of other pharmacy interns.
Prescription means an order for a drug, chemical, device or combination thereof, either written, given orally or otherwise transmitted to a registered pharmacy by a practitioner or his or her expressly authorized agent, to be dispensed or compounded in a registered pharmacy and dispensed by a registered pharmacist to a patient or his or her agent with necessary and appropriate counseling.
Prescription Drug means any and all drugs which, under Federal Law, are required, prior to being dispensed or delivered, to be labeled with the statement “Caution, Federal law prohibits dispensing without prescription” or a drug which is required by any applicable Federal or State law or regulation to be dispensed pursuant only to a prescription drug order.
Prescription Device means an instrument, apparatus, implement, machine, contrivance, implant, or other similar related article, including any component part or accessory, which is required by federal law and regulations to bear the label, “Caution, Federal law prohibits dispensing without prescription” or a device which is required by any applicable Federal or State law or regulation to be dispensed pursuant only to a prescription order.
Program
Registered Pharmacist (R.Ph.)
Restricted Pharmacy
Universal Claim Form (UCF)
Program means an educational course, lecture, seminar, conference, session or exercise.
Registered Pharmacist (R.Ph.) means a pharmacist who, pursuant to the provisions of M.G.L. c. 112, § 24, is registered by the Board to practice pharmacy.
Restricted Pharmacy means a pharmacy licensed by the Board for the limited transaction of a drug business as defined in M.G.L. c. 112, § 37.
Universal Claim Form (UCF) means a nationally recognized standard form developed by the NCPDP used for billing prescription drug claims to insurance plans. Universal Claim Forms are available through a pharmacy’s local wholesaler.
Wholesale Distribution
distribution of prescription drugs and prescription devices to persons other than a consumer or patient, but does not include:
(a) Intracompany sales;
(b) the purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug or device for its own use from the group purchasing organization or from other hospitals or healthcare entities that are members of such organizations;
(c) the sale, purchase or trade of a drug or device or an offer to sell, purchase or trade a drug by a charitable organization described in section 501(c)(3) of the Internal Revenue Code of 1954 to a nonprofit affiliate of the organization to the extent otherwise permitted by law; (d) the sale, purchase or trade of a drug or device or an offer to sell, purchase or trade a drug or device among hospitals or other health care entities that are under common control; for purposes of 247 CMR 7.00, “common control” means that power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract or otherwise;
(e) the sale, purchase or trade of a drug or device or an offer to sell, purchase, or trade a drug or device for emergency medical reasons; for purposes of 247 CMR 7.00, “emergency medical reasons” includes transfers of prescription drugs or devices by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;
(f) the sale, purchase or trade of a drug or device, an offer to sell, purchase or trade a drug or device, or the dispensing of a drug or device pursuant to a prescription;
(g) thelawfuldistributionofdrugsamplesbymanufacturers’representativesordistributors’ representatives; or
(h) the sale, purchase or trade of blood and blood components intended for transfusion.
Wholesale Distributor
a person engaged in wholesale distribution of prescription drugs or devices including, but not limited to, manufacturers; repackers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers’ and distributors’ warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions.
Describe the requirements for obtaining a pharmacist license via the examination process.
Describe the requirements for licensure by reciprocity.
Explain the difference between score transfer, reciprocity and examination by license.
What is the passing grade needed for each component for licensure of a pharmacist by examination.
Describe the requirements for pharmacist CE. Be sure to include types of CE needed, max per day, Sterile, Non-Sterile, immunizations, PMP, Collaborative Practice.
How many CEs are needed per calendar year
How many CEs are needed per renewal period
What types of CEs are allowed (Board approved, ACPE, CME)
How long are you require to keep records of CEs
What are the requirements for electronically transmitted prescriptions.
What types of prescriptions can be sent electronically
Describe when an oral CII may be accepted.
Describe the requirements for an Emergency Situation for oral CII.
What are the pharmacist’s obligations for filling a Emergency CII?
What is the time period required to receive a hard copy for an oral controlled substance
What are the requirements for a prescriber to do on the hardcopy follow-up for a oral controlled CII.
What happens if a hardcopy follow up prescription is not provided for a CII
Describe the PMP requirements
Describe the application process for a new pharmacy
Will the Board register a pharmacy where the owner has prescriptive privileges?
Describe the equipment and referenced need for a pharmacy
What is the minimum size requirements for a pharmacy
Explain what the patient consultation area is, are there any requirements for a sign and location
Describe the security requirements for a pharmacy
Is a sign required identifying the location as having a pharmacy
What form is used to report a theft or loss of a controlled substance
What are the requirements for notifying the Board of a loss of a controlled substance
Describe the process for a change in the manager of record
Who is required to verify that a pharmacist is registered by the Board.
What needs to be done if there is a remodel or change in the square footage of the pharmacy?
Describe the requirements for a pharmacist manager of record
What is a certificate of fitness, when is it used
What are the requirements for closing a pharmacy, provide a description of the process, dates for notifications, and description of how to return a license/registration
When can a pharmacy be inspected and by whom?
What happens in the event of a deficiency statement
What is a plan of correction?
Under what circumstances are you required to report improper drug dispensing to the Board?
What is the time frame for reporting an improper drug dispensing to the Board.
How long are the records for an improper drug dispensing of a prescription required to be kept?
What are the requirements under USP 795
What are the requirements under USP 797
What are the requirements under USP 800
Describe any duties to report certain factors of pharmacy operations.
Define Serious injury and Serious Disability
What federal law amendment to the Food, Drug and Cosmetic Act required states to register wholesalers?
Describe the licensing requirements for wholesalers.
Describe the minimum qualifications the Board shall consider for issuing, renewing or revoking a wholesaler.
What is the minimum required information for wholesaler licensure
Describe any penalties that the Board can impose on a wholesaler.
Describe the minimum requirements wholesalers need to comply for the storage and handling of prescription drugs. Be sure to include Facilities, Security, Storage requirements, Examination of Materials and Return of Damaged/outdated prescription drugs.
What records need to be maintained by wholesalers?
Describe the Written Policies and Procedures required for wholesalers
Describe any other federal, state and local laws wholesalers need to comply with
Describe the requirements to become a pharmacy intern
Who can become a preceptor, are there any requirements and limits on the number of interns
Describe the duties and functions of a pharmacy intern
When does an intern license expire
What are the three levels of pharmacy technicians
Develop a chart detailing the duties, responsibilities/functions, testing requirements, and qualifications for each level of technician
When does a technician license/registration expire
What is reciprocity registration as it relates to technicians
Can a technician counsel a patient
Can a technician make the offer to counsel
What are the requirements for handling Schedule II Controlled Substances by pharmacy interns and each level of pharmacy technician
What are the duties of a pharmacist utilizing a pharmacy intern, certified pharmacy technician, pharmacy technician and trainee
Describe the supervisory ratio
Who does not fall under the supervisory role, explain when they could.
Describe the registration and renewal of registration procedure for technicians
When must a technician notify the Board of a change in name or address.
List the 19 items provided under the code of conduct for registered pharmacists, pharmacies and pharmacy departments.
Provide an example of each one of the 19 items that could result in a violation of the code of conduct.
Describe the process of transferring a prescription listed in schedules III-V.
What are the responsibilities of the transferring and receiving pharmacy
Who is allowed to conduct the transfer of schedules III-V
Describe the process of transferring a prescription listed in schedules III-V.
What are the responsibilities of the transferring and receiving pharmacy
Who is allowed to conduct the transfer of schedules VI
Describe the regulations relating to the advertising of prescription medication prices
Describe the requirements for dispensing and refilling prescriptions
What information needs to be placed on the pharmacy label
What information is needed for proper records keeping when dispensing and refilling prescriptions
Describe the process and requirements of handling hydrocodone-only extended release medications
How are prescriptions files maintained
Describe the procedures for verifying a practitioner’s prescriptive authority
How are patient records maintained, what is the name and abbreviation of the federal law relating to patient health information
What information needs to be collected in regards to patient records
Describe how a pharmacist shall conduct a prospective DUR
What needs to be done in the event of identifying a an issues with the prospective DUR
Describe when counseling needs to be performed
When is the offer to counsel made, just new prescription, just refills, both new and refills
What is done in real life regarding the offer to counsel, does it differ from the legal requirements
Describe the process of what needs to be included when counseling a patient
What happens if the patient does not pick up their prescription, do you need to provide a written offer to counsel
What is the difference between the following, drug information sheet, prescription drug insert, patient drug information sheet, medication guide.
Under what circumstances might the Board impose disciplinary action against and individual or other entity licensed by the Board?
What is a Plan of Correction?
Describe the Summary Cease and Desist process? When is it conducted?
What happens if there is disciplinary action against a Massachusetts registrant or licensee taken in another state?
Why is a Massachusetts Controlled Substance Registration issued?
To whom are they issued to?
What are the requirements for obtaining a Massachusetts Controlled Substance Registration?
Are separate registrations required for a Massachusetts Controlled Substance Registration?
When does a Massachusetts Controlled Substance Registration expire?
Pharmacy
Outsourcing Facility
Wholesale Druggist
Individual
What happens if there is a change in name, address or status of the Registrant?
When does a registrant need to notify the Board of a change in name, address or status?
Can a Massachusetts Controlled Substance Registration be transferred or assigned?
What is the purpose of a Massachusetts Controlled Substance Registration issued to a Whole Druggist when their activities are limited?
When can the Massachusetts Controlled Substance Registration be suspended or revoked?
What is the procedure for a summary suspension?
section 12
What is a restricted pharmacy? Provide an example
What does it mean to be exempt from247CMR9.1(15)
What are the requirements for the Board to issue a nuclear pharmacy permit
When does the permit expire
What are the general requirements for nuclear pharmacies
How does a pharmacist train to become a nuclear pharmacist? What are the education and experience requirements
What is a waiver
How does one petition the Board for a waiver?
When does the waiver expire?
When would the Board issue a waiver?
Is there a special form to use when petitioning the Board for a waiver?
What does the petitioner need to do when requesting a waiver?
What is a Quality Related Event
What is required under a Continuous Quality Improvement Program?
What happens once a Quality Related Event is discovered?
Who needs to be notified of the Quality Related Event?
What documentation is needed for Quality Related Events?
How are records maintained under the CQI program?
How long are the records to be maintained?
Is there a requirement to report to the Board all improper drug dispensing?
Describe the process to reporting to the Board improper dispensing if there is a death or serious injury
- Describe the pharmacist qualifications to participate under a collaborative drug therapy management program.
What is the minimum amount of professional liability insurance that is required?
What are the practice setting requirements?
What can a Community Pharmacy engage in under a CDTM?
Can a community pharmacist prescribe or be authorized to prescribe Schedule II through V controlled substances?
What is required to be included in a collaborative practice agreement?
How long is a collaborative practice agreement valid?
What are the CE requirements for a pharmacist engaged in CDTM?
What is an outsourcing facility?
What are the registration requirements for an outsourcing facility?
- What is a provisional outsourcing facility registration?
- When would the provisional outsourcing facility registration be issued?
- Can a non-resident outsourcing facility be granted a provisional registration?
- What are the requirements to obtain a non-resident outsourcing facility registration?
- When does an outsourcing facility registration expire?
- Is there a difference in the expiration date for non-resident vs resident outsourcing facility registration?
- Under what grounds may the Board deny, revoke, suspend or not renew an outsourcing facility registration?
- What does it mean to be registered by the FDA pursuant to 503B of the FDCA?
Section 30 Administrative inspection of controlled premises
Briefly describe the purpose of this section
Held a license, DPH can insect pharmacy
If decline inspection, then can come back with AIW
What is an Administrative inspection warrant?
How does an Administrative inspection warrant differ from a search warrant?
Who can issue an Administrative inspection warrant?
Why are Administrative inspection warrants issued?
Define valid public interest.
Provide at least three examples of valid public interest.
What shall the warrant describe?
What can be inspected and copied?
What are excluded, unless consent is provided.
Section 37 Theft of controlled substances from persons authorized to dispense or possess
Briefly describe the purpose of this section
Whoever robs a pharmacy can go to jail no more than 2 years and a $500 fine
