Law exam 2 - 94C & C13

Question 1

C13
Describe the composition of the Massachusetts Board of Pharmacy (Board).

Answer 1

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.

Question 2

C13
How many members are on the Board?

Answer 2

13

8 pharmacists

5 other members

Question 3

C13
What are the requirements to becoming a Board member?

Answer 3

no disciplinary action
no felonies

Question 4

C13
Who appoints the Board members?

Answer 4

the governor

Question 5

C13
What are the experience requirements for a Board member?

Answer 5

7 consecutive years

Question 6

C13
How is an Independent Pharmacist defined?

Answer 6

a pharmacist actively engaged in the business of retail pharmacy

example: beacon pharmacy, Prescott pharmacy

Question 7

C13
How is a Chain Pharmacist defined?

Answer 7

a pharmacist employed by a retail drug organization that operates 10 or more retail drug stores

Question 8

C13
What is the term of years that a Board member can serve?

Answer 8

3

Question 9

C13
Can a Board member be re-appointed

Answer 9

yes

Question 10

C13
What are the requirements for a Board Meeting?

Answer 10

organize by electing a president and secretary, who shall be members of the board, and shall hold their offices for one year.

Question 11

C13
How often does the Board meet?

Answer 11

The board shall meet on the first Tuesday of December each year, The Meeting is to elect the 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

Question 12

C13
Can the Board appoint agents? If yes, describe who the agents are and their roles.

Answer 12

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

Question 13

C13
What training is required for Board agents?

Answer 13

Need to be trained in USP 795 & 797

Question 14

C13
What information can you find on the Board’s website?


Answer 14

check a license
File a complaint
Search
Members
Leaders
More actions on licensing, resources
Meetings
Previous meetings too

Question 15

Administer

Answer 15

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

Question 16

Class

Answer 16

the lists of controlled substances for the purpose of determining the severity of criminal offenses under this chapter.

Question 17

Controlled Substance

Answer 17

a drug, substance, controlled substance analogue or immediate precursor in any schedule or class referred to in this chapter.

Question 18

Counterfeit Drug

Answer 18

a substance which is represented to be a particular controlled drug or substance, but which is in fact not that drug or substance.

Question 19

Deliver

Answer 19

to transfer, whether by actual or constructive transfer, a controlled substance from one person to another, whether or not there is an agency relationship.

Question 20

Dispense

Answer 20

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 under the order of a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling, or compounding necessary for such delivery

Question 21

Distribute

Answer 21

to deliver other than by administering or dispensing a controlled substance.

Question 22

Drug

Answer 22

(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.

Question 23

Electronic Prescription

Answer 23

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.

Question 24

Extended-release long acting opioid in a non-abuse deterrent form

Answer 24

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 under section 13 of chapter 17

(iii) identified by the drug formulary commission under said section 13 of said chapter 17 as posing a heightened level of public health risk.

Question 25

Manufacture

Answer 25

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

Question 26

Narcotic

Answer 26

(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

Question 27

Drug

Answer 27

(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.

Question 28

Oral prescription

Answer 28

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.

Question 29

Outsourcing facility

Answer 29

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.

Question 30

Pharmacist, Pharmacy

Answer 30

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.

Question 31

Practitioner

Answer 31

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.

Question 32

Prescription Drug

Answer 32

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’’.

Question 33

Registrant
Registration
Registration Number

Answer 33

a person who is registered pursuant to any provision of this chapter.

unless the context specifically indicates otherwise, such registration as is required and permitted only pursuant to the provisions of this chapter.

such registration number or numbers, either federal or state, that are required with respect to practitioners by appropriate administrative agencies.

Question 34

Retail drug business

Schedule

Ultimate user

Written Prescription

Answer 34

a store for the transaction of ‘‘drug business’’ as defined in section thirty-seven of chapter one hundred and twelve.

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

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.

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.

Question 35

2
How many schedules of controlled substances are there in Massachusetts?

Answer 35

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

Question 36

2
Is that different from the Federal Controlled Substance Act? Explain.

Answer 36

yes, there are 5

Question 37

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?

Answer 37

the commissioner

Question 38

2
Describe the process that the commissioner needs to follow to reschedule a controlled substance.

Answer 38

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.

Question 39

2
What should the commissioner consider when rescheduling a controlled substance?

Answer 39

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.

Question 40

2a
Under what circumstances may the commissioner place a substance in schedule I on a temporary basis?

Answer 40

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.

Question 41

2a
What should be considered by the commissioner in placing the substance in schedule I on a temporary basis?

Answer 41

the commissioner shall consider the substance’s actual or relative potential for abuse and its history and current patterns of abuse.

Question 42

2a
How long may the emergency regulation remain in effect?

Answer 42

the emergency regulation may remain in effect for up to 1 year.

Question 43

2a
When does the temporary rescheduling take effect?

Answer 43

When the commissioner forwards the order to the attorney general

Question 44

3
Describe the six Schedules under Chapter 94C

Provide at least 5 examples in each of the Schedules

Answer 44

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.

Question 45

4
What can be exempt from scheduling?

Answer 45

Older drugs that no one uses any more
old old product that is probably not made anymore
OTC outside of the scheduling, acetaminophen, robitussin

Question 46

5
What are the limits of what CS can be dispensed or sold?

Are there any sales limitations?

Is a record book required? If yes, what needs to be included in the book?

Answer 46

(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

(3) that of such preparation not more than four ounces are dispensed, or sold to a person during any 48 hour period.

Yes a record book is required: The pharmacist dispensing 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.

Question 47

6
What does the Board of Pharmacy oversee?

What does the Commissioner oversee?

Answer 47

the board and the commissioner may promulgate (promote and make known) rules and regulations relative to registration and control of the manufacture, distribution, dispensing and possession of controlled substances within the commonwealth.

Question 48

6a
Who is required to be licensed under this section?

Try to find the best practice guidance referenced in the Section. Where would it be found

Answer 48

A corporate entity that provides for more than 300 patients receiving treatment for opioid dependency

not a hospital or clinic

not an opioid treatment program

best practice guidance:
- routine toxicology screenings

• maximum take-home dosages
• behavioral health referrals for practitioners who provide opioid agonist therapy in the commonwealth

Question 49

7
Who is required to obtain a registration- provide a list

How long is the registration valid for each?

Who can issue prescriptions? Are there any limits?

Answer 49

wholesale druggist

outsourcing facility

every person who
- manufactures
- distributes
- dispenses
- possesses with intent to manufacture
distribute or dispense any controlled substance
in the commonwealth

valid for how long?
- registration is effective for one year from the date of issuance or until the completion of the period

• July 1st of 1974 (? lol what)

issue Rx
- certified nurse-midwives
- PAs
- RPh in collaborative drug therapy management (CDTM)
- Optometrists
all wthin the scope of practice!

Question 50

7a
How is registration done for the prescription monitoring program for a prescriber?

What is this called in Massachusetts

What does a pharmacy need to do?

Describe the impact on pharmacy

Answer 50

prescriber has
- unique user name
- access code

PMP - prescription monitoring program

Question 51

8
What needs to be done in order to conduct a research project or study?

Is a registration required?

Answer 51

before conducting the study:
- supply the commissioner with satisfactory evidence of compliance with any applicable federal law

• protocol describing the research project or study if the commissioner asks for it

Question 52

9
Who may possess controlled substances? Provide a list

Are there any restrictions? If yes describe.

Are there any restrictions regarding samples? If yes, describe.

What are therapeutic contact lenses?

Describe the record-keeping requirements that need to be complied with in this section.

Answer 52

who can possess CS:
- physician
- dentist
- podiatrist
- nurse practitioner
- nurse anesthetist
- psychiatric nurse mental health clinical specialist
- optometrist
- PA
- certified nurse midwife
- pharmacist
- veterinarian

Restrictions:
- under good faith
- in professional practice to alleviate pain and suffering
- treatment or alleviation of disease

samples, CS VI can be given as a sample:
- dispensed to the patient by a professional authorized to dispense controlled substances under this section;

• dispensed in the package provided by the manufacturer
• provided at no charge to the patient.

therapeutic contacts
- contact lenses that contain 1 or more medications and which deliver such medication to the eye.

all practitioners listed above must keep records that:
- names and quantities of controlled substances in schedules I, II, or III

• the name and address of each patient
• the name, dosage, and strength per dosage unit of each such controlled substance
• the date of administration or dispensing.

Question 53

10
Are each places of business that manufacturers, distributes or dispenses controlled substances separately registered?

Answer 53

yes, each one needs their registration

Question 54

11
What does the Board of Pharmacy inspect?

What does the commissioner inspect?

Answer 54

the board and the commissioner inspect the establishment of a registrant or applicant for registration

Question 55

12
What does the Board of Pharmacy register?

What does the commissioner register?

List the factors that the Board of Pharmacy and commissioner will consider during the registration process.

Answer 55

the board and commissioner register an applicant to
- manufacture or distribute controlled substances
unless he determines that the issuance of that registration would be inconsistent with the public interest.

factors they consider:
- maintenance of effective controls against the diversion of controlled substances into other than legitimate medical, scientific, or industrial channels

• compliance with applicable federal, state, and local law
• any conviction of the applicant under any federal and state law relating to any controlled substance
• experience in the manufacture or distribution of controlled substances, and the existence in the applicant’s establishment of effective controls against diversion
• furnishing by the applicant of false or fraudulent material in any application filed under the provisions of this chapter
• suspension or revocation of the applicant’s federal registration to manufacture, distribute, or dispense controlled substances as authorized by federal law
• any other factors relevant to and consistent with the public health and safety.

Question 56

13
Under what circumstances would the Board of Pharmacy or commissioner suspend or revoke a registration?

What is an embargo?

Answer 56

suspend or revoke registration if registrant:
- has furnished false or fraudulent material information in any application

• has been convicted under any state or federal law of any criminal violation
• has had his federal registration suspended or revoked to manufacture, distribute, dispense, administer, or possess controlled substances
• is, upon good cause, found to be unfit or unqualified to manufacture, distribute, dispense, or possess any controlled substance.

embargo:
an official ban on trade or other commercial activity with a particular country.

Question 57

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?

Answer 57

may without hearing suspend or refuse to renew any registration

Question 58

15
How are records and inventories maintained?

Which form is used to report a theft or loss of a controlled substance?

Who are the DEA 106 forms sent to?

Answer 58

CII
CIII-V
CVI, syringes and other supplies

theft or loss of CS: 106

106 forms are sent to
- DEA
- state Police department

Question 59

16
How are distributions made between registrants- describe the process for the various schedule

Answer 59

Schedules I and II shall be distributed by a registrant to another registrant only through a form in FDCA

Question 60

17
What are the prescription requirements for controlled substances in Schedule II, III, IV, V and VI. Push to issue physicians to electronically issue an Rx

yes or no and are there exceptions
II - written oral fax electronic
III - written oral fax electronic
IV - written oral fax electronic
V - written oral fax electronic
VI- written oral fax electronic

Answer 60

II
- cannot be oral unless in an emergency
- written or electronic (electronc is enforced)

III
- written, oral, electronic

IV
- written, oral, electronic

V
- written, oral, electronic

VI
- written, oral, electronic

Question 61

18
What are the requirements to verify that the practitioner has prescriptive authority?

Who can call the pharmacy with an oral prescription?

Are there any time requirements to fill Schedule III to V oral prescriptions?

Are there any requirements for the written prescription cover prescription for the orally dispensed prescription?

Schedule II non-narcotic written by in-state practitioners

Schedule II non-narcotic written by out-of-state practitioners

Schedule II narcotic written by in-state practitioners

Answer 61

verify:
- authorized to prescribe controlled substances

• registered
• An oral prescription issued by a practitioner may be communicated to a pharmacist by an expressly authorized employee or agent of the practitioner.
• nonnarcotic substance contained in Schedule II if licensed and authorized to prescribe

who can call in oral Rx?
- prescriber

• agent of prescriber

time requirements to fill Schedule III to V oral prescriptions

time requirements to fill CIII - V
- In 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.

Schedule II non-narcotic written by out-of-state practitioners can be issued

Question 62

18
Schedule II narcotic written by out-of-state practitioners

What are the requirements for each of the above? Are there any time fill restrictions?

What are the good-faith efforts a pharmacist shall conduct to protect from liability under this section?

Can a pharmacist fill a Schedule II opioid substance for quantity less than what was prescribed?

What are the requirements for the pharmacist when fill less than the face amount?

What training is required for practitioners who prescribe controlled substances?

Answer 62

narcotic out of state
- needs to be continguous state
- needs to be within 5 days

narcotic in state
- needs to be within 30 days

non-narcotic
- can be from any state
- has to be within 5 days out of state
- 30 days in state

quanity less than what is prescribed
- yes if patient requests
- pharmacists filling a prescription for a Schedule II opioid may dispense less than the prescribed quantity if requested by the patient. If a patient requests a lesser amount
- The remaining portion may be filled upon patient request in accordance with federal law; provided, however, that only the same pharmacy that originally dispensed

good faith
- if it was made and that Rx is not proven authentic then the RPh does not have to fill and will not be held liable as long as good faith efforts are recorded
- efforts include: calling prescriber, addressing if the Rx can be filled or not

training
- (i) effective pain management;

• (ii) the risks of abuse and addiction associated with opioid medication;
• (iii) identification of patients at risk for substance use disorders;
• (iv) counseling patients about the side effects, addictive nature and proper storage and disposal of prescription medications;
• (v) appropriate prescription quantities for prescription medications that have an increased risk of abuse; and (vi) opioid antagonists, overdose prevention treatments

Question 63

18 A
What needs to be done before issuing an extended-release long-acting opioid in a non-abuse deterrent form for an outpatient for the first time?

Is a written pain management treatment agreement needed?
If yes where are the agreements filed?

Answer 63

First time:
-evaluate the patient’s current condition, risk factors, history of substance abuse, if any, and current medications

• inform the patient and note in the patient’s medical record that the prescribed medication is needed

agreement needed:
- if extended-release long-acting opioid be utilized during the course of long-term pain management

• must be filed in the patient’s medical record or included in the patient’s electronic health record.

Question 64

18 B
Where can the non-opiate directive form be found
Who may execute such a form?
What is the impact on pharmacy?

Answer 64

The form shall be posted on the department’s searchable website

An individual may execute and file a voluntary non-opiate directive form with a practitioner registered

Question 65

18 C
What does a practitioner need to speak to the patient about?

What patient education is required?, Mass. corresponds responsibility
Under DEA pertains to schedules II-V but in Mass. for schedules II-VI
Explain corresponding responsibility

What schedules does the Massachusetts corresponding responsibility apply to?

Can a prescription be written for a practitioner to obtain controlled substances to dispense to the practitioner’s patients?

Explain who can be dispensed naloxone or other opioid antagonists.

Where can you find information relating to the pharmacist’s obligations regarding naloxone?

Answer 65

talk to the patient about:
- the quantity of the opioid and the patient’s option to fill the prescription in a lesser quantity

• inform the patient of the risks associated with the opioid prescribed.

patient educated on opioid quantity and risks

corresponding res. applies to CII

No Rx written for a practitioner to obtain controlled substances to dispense to the practitioner’s patients

Naloxone should be given to any person who shows signs of an opioid overdose or when an overdose is suspected.

Question 66

19 A
How is emergency contraception defined?

What must the pharmacist comply with regarding emergency contraception?

What is a standing order?

What does the training program need to consist of?

What is included in the annual report to DPH?

What has the Board of Pharmacy adopted to implement this section?

Answer 66

defined as
- any drug approved by the federal Food and Drug Administration as a contraceptive method for use after sexual intercourse.

RPh must comply with:
- complete a training program approved by the commissioner on emergency contraception

• proper documentation
• quality assurance
• referral to additional services
• an appropriate recommendation that the patient follow up with a medical practitioner.
• annually provide to the Department of Public Health the number of times such emergency contraception is dispensed.

standing order
- order without an opportunity for notice or public comment.

training program:
- proper documentation

• quality assurance
• referral to additional services
• an appropriate recommendation that the patient follow up with a medical practitioner.

implemented
- adopt regulations to implement this section.

Question 67

19 B
What is an opioid antagonist?

Are there any requirements relating to naloxone for pharmacists?

Are there any requirements relating to naloxone for pharmacies?

Is there a training program this is required?

What needs to be included in the annual report to DPH?

What has the Board of Pharmacy adopted to implement this section?

Answer 67

opioid antagonist
- naloxone or any other drug that is competitive narcotic antagonist used in the reversal of overdoses caused by opioids.

RPh
- can only dispense naloxone

• opioid must be written, standardized procedures or protocol
• cannot dispense if it is an act of gross negligence or willful misconduct,
• shall annually report to the department the number of opioid antagonist doses dispensed.
• unless paying out of pocket: identify the purchaser’s insurance coverage and submit a claim for the opioid antagonist to the insurance carrier before dispensing the opioid antagonist.

yes a training program is required

annually provide to the Department of Public Health the number of times such emergency contraception is dispensed.

implemented
- adopt regulations to implement this section.

Question 68

19 C
What has the Board of Pharmacy adopted to implement this section?

Answer 68

rules and regulations

mandates a maintenance of a continuous supply of naloxone rescue kits or opioid antagonist medications,

Question 69

19 D
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.

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.

Answer 69

7

7

Question 70

19 D
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?

Answer 70

documented in the patient’s medical record

the practitioner shall indicate that a non-opiate alternative was not appropriate to address the medical condition.

Question 71

20
What does a pharmacist need to include on an oral prescription

What can a pharmacist do to verify the oral authorization came from the practitioner?

Is a written hard copy required? If yes for what schedules

When is the hard copy required to be received by the pharmacy?

What does the pharmacist do when they receive the hard-copy cover?

What if the hard copy cover prescription is not received by the pharmacy?

Answer 71

RPh should include on oral Rx:
- reduce the prescription to writing on a prescription form

• 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 using
• any cautionary statements required
• a statement indicating the number of times to be refilled.

verify by
- calling prescriber

• checking DEA #

hard copy
- required for CII and all others

• electronic needed 2 days after Rx
• The practioner should include on Rx: being issued to document an oral prescription.
• once received, RPh: shall attach the prescription to the oral prescription which the pharmacy has reduced to writing.
• written copy can be delivered by mail, but shall be postmarked within 7 days or such shorter period
• if not received, contact the DEA

Question 72

21
What information needs to be included on the pharmacy label?-

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. Larger than 12 characters because there are fewer characters on the prescription

What needs to be included in the educational information pamphlets relative to narcotic drugs?-

When should a pharmacist distribute the pamphlet?

What needs to be included on the label for a compounded prescription?

What do pharmacies who are engaged in sterile or complex non-sterile compounding need to do to comply with this section?

Does this apply to inpatients?

Answer 72

in pharmacy label:
- 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 if any, contained in such prescription or required by law,
• the amount of tablets or capsules

10 characters per inch

on educational pamphlets:
- pain management

• misuse and abuse by adults and children
• risk of dependency and addiction
• proper storage and disposal
• addiction support and treatment resources
• the telephone helpline

RPh gives pamphlets to
- consumers relative to narcotic drugs, specifically opiates

on the label for a compounded prescription
- a label notifying prescribed users and practitioners that the drug is either a sterile or non-sterile compounded drug preparation.

pharmacies that are engaged in sterile or complex non-sterile compounding need to:
- 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

does not apply to inpatient

Question 73

21 A
What is the purpose of a prospective drug review?

2. What should be included in the prospective drug use review?

To whom is the offer to counsel to be made to?

4. Who can make the offer the counsel?
5. Who can counsel the patient?
   Pharmacist (for new Rx!) with interns who is under direct supervision of the pharmacist
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.

7. If counseling is accepted how should the pharmacist counsel the patient?
8. What if the patient declines to be counseled?
   How should the offer to counsel be documented?

Answer 73

To whom is the offer to counsel to be made?
- The patient for new Rx

Who can make the offer the counsel?
- Pharmacists

• pharmacy techs
• pharmacy interns via face-to-face or telephone

Who can counsel the patient?
- Pharmacist (for new Rx!) or intern who is under the direct supervision of the pharmacist

What if the prescription drug is delivered to the patient? How is the offer to counsel made?
- provide a toll-free telephone service to facilitate communication between a person and the pharmacist

If counseling is accepted how should the pharmacist counsel the patient?
(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

What if the patient declines to be counseled? document:
(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

(3) any additional comments relevant to the patient’s drug use, including any failure to accept the pharmacist’s offer to counsel.

Question 74

21 B
What is a lock box?

What is the purpose of the lock box

What needs to be included in the sign for the lock boxes and the size of the sign?

Where should the sign for lock boxes be located?

Answer 74

lock box: a locking mechanism that cannot be tampered with or opened without extreme force.

purpose of it:
- to secure CS from theft

made avable for CS II-V

Lockbox sign:
- 4 inches by 5 inches

• '’Lockboxes for securing your prescription medications are available at this pharmacy’’.
• placed on or near the pharmacy counter

Question 75

22
What does a practitioner need to include on a written prescription?

What needs to be included in the pharmacy label?

What shall be included on a schedule II opioid prescription?

Answer 75

include:
- the 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 using any cautionary statements required, and a statement indicating the number of times to be refilled.

on pharmacy label:
- practitioner’s name and address

• the date of dispensing
• the name of the patient unless it is a veterinary prescription
• the names, dosage, and strength per dosage unit, of the controlled substance, directions for use, and any necessary cautionary statements.

on CII
- a notation on the prescription that the patient may fill, upon request, the prescription

• can not exceed the full prescribed quantity.

Question 76

23
When do schedule II controlled substance prescriptions expire?

How are prescriptions filed?

How does a pharmacist cancel out a Schedule II prescription?

What are the quantity limits for Schedule II and III

How long are the records to be retained?

Are refills allowed for II, III, IV, V, VI?

What are PRN Refills? Are they allowed in Massachusetts?

How are prescriptions to be written?
Can prescriptions be transmitted electronically?

Answer 76

CII Rx expires 30 days after the date of issuance

Rx filed spearate from all other records

records are mainatined for 2 years

RPh cancels out by signature

quantity limits for CII & III
- 30 days

• 60 days if dextro amphetamine sulfate and methylphenidate hydrochloride
• 90 days for subcutaneous implantable pump

refills
- no allowed for CII

• permitted if original Rx gives refill and specific
• III or IV 5 times or before 6 months of original Rx
• V controlled substances may be refilled as authorized and may not be subject to the 6 month, 5-refill limit not subject to 5 times or before 6 months of the original Rx
• silent on VI

PRN refills
- As-needed refills

• not allowed in MA

Question 77

23
What happens if a research subject or patient is receiving a controlled substance from more than one source and in quantities that are determined to be harmful to the patient or research subject?

Answer 77

commissioner will notify the practitioners who have dispensed the controlled substance.

Question 78

24A
What system has the department established to monitor prescribing and dispensing of controlled substances?

What schedules of drugs are to be monitored?

What is an additional drug? Provide an example.

Does the Commonwealth have the authority to enter into reciprocal agreements with other states?

Does this reporting requirement apply to inpatients in a hospital?

What are the reporting requirements for pharmacies?

What is an acceptable customer identification number?

How often does this need to be reported to the DPH?

What if a pharmacy cannot provide the information electronically?

Is there a training requirement for pharmacists?

What does the DPH do with the data collected?

Answer 78

prescription monitoring program to monitor prescribing and dispensing of controlled substances

in the PMP:
- CS II-V

• CS VI + additional drugs

Additional drugs
- substances determined by the department to carry a bona fide potential for abuse.

• For example: gabapentin

The department shall enter into reciprocal agreements with other states that have compatible prescription drug monitoring programs to share prescription drug monitoring information among the states.

PMP does not apply to the dispensing of controlled substances to inpatients in a hospital.

requirement for pharmacy
- submit to the department, by electronic means, information regarding each prescription dispensed for a drug

• submit info regarding transmission methods and frequency requirements

report to the DPH
- submit an annual report on the effectiveness of the prescription monitoring program

If cannot provide info electronically
- the department may issue a waiver to a pharmacy that is unable to submit prescription information by electronic means.

training
- pharmacists be trained in the use of the prescription monitoring program as part of the continuing education requirements

data collected
- If there is reasonable cause to believe a violation of law or breach of professional standards may have occurred, the department shall notify the appropriate law enforcement or professional licensing, certification, or regulatory agency or entity and provide prescription information required for an investigation.

Question 79

24B, 25 & 26
Briefly describe the purpose of this section.

Answer 79

24B
- the department to annually keep track of the mean and median quantity and volume of prescriptions for opiates contained in Schedules II and III issued by practitioners

25
- restrictions of CS, cannot do bad stuff basically

26
- restrictions of CS, cannot do bad stuff basically
- false info

Question 80

27
What are the age requirements for the sale of hypodermic syringes or needles?

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.

Answer 80

no age requirements for hypodermic syringes or needles

can only be sold by an RPh or wholesale druggist

Question 81

27A
Briefly describe the purpose of this section.
What is the impact on pharmacy?
Is there a requirement for pharmacies to provide an information sheet?

Answer 81

purpose
- Collection and disposal of spent non-commercially generated hypodermic needles and lancets

• sharps disposal

pharmacy
- yes provide info sheet

Question 82

28, 29, 30
Briefly describe the purpose of this section and impact on pharmacy.

Answer 82

28
- Jurisdiction of superior court
- has juris. power

29
- Educational programs for the prevention of abuse of controlled substances

30
- Administrative inspection of controlled premises

Question 83

30
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.

Answer 83

What is an Administrative inspection warrant?
- used for inspecting, copying, and verifying the correctness of records, reports, or other documents required

• to be kept by a registrant on controlled premises and for the seizure of property appropriate to such inspection.

How does an Administrative inspection warrant differ from a search warrant?
- administrative inspection warrants can be issued without proof of probable cause

• AIW, you cannot say no
• search warrant, you can say no

Who can issue an Administrative inspection warrant?
- commissioner or his designee

• designee of the board of registration in pharmacy
• police officer

Why are Administrative inspection warrants issued?
- inspection of controlled premises

Define valid public interest.
- anything affecting the well-being, the rights, health, or finances of the public at large

Provide at least three examples of valid public interest.
- public health

• education
• environment
• social justice,

What shall the warrant describe?
- authorizing an administrative seizure of property

What can be inspected and copied?
- area, premises, buildings or conveyances to be inspected, the purpose of the inspection, and, if appropriate, the type of property to be inspected,

Question 84

37
What happens if you rob a pharmacy

Answer 84

go to jail!