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.
