Law - exam 3 (final exam) 247 CMR 9, 10, 11, 12, 16, 21 policies

Question 1

9
List the 19 items provided under the code of conduct for registered pharmacists, pharmacies and pharmacy departments.

Provide an example of each one of the 19 items that could result in a violation of the code of conduct.

Answer 1

1 conduct professional activities according to laws and board regulations

cannot dispense CS to go around the law

observe the standards of the USP

can not dispense any med. which has been previously provided

responsible for the proper preservation and security of all drugs in the pharmacy or pharmacy department
not engage in fraudulent or deceptive acts

cannot agree with any person for dispensing drugs that have been ordered by coded Rx
cannot promise discounts, rebates, refunds, or commissions to a person who operates or manages, or is employed by a hospital, nursing home, or other health facility

cannot aid or abet unlawful practice of pharmacy

cannot give expired, outdated, or substandard drugs or devices to a person who is not licensed or legally authorized to receive drugs or devices

11 may dispense Rx drugs by mail or common carrier in a manner consistent with federal law. Also, have enough info. to contact the patient and prescriber

12 Unless otherwise by law, an RPh who works for a hospital or clinic cannot dispense drugs to any person other than inpatients outpatients, or employees of hospital. or clinic or to the employee’s family

13 an RPh, pharmacy, pharmacy department, pharmaceutical organization or pharmacy corportaion can not give Rx blanks referring to any other pharmacists, pharmacy or pharmacy department

14 shall keep a perpetual inventory of each CS II that has been dispensed, received or disposed of by them. This must be done or reconciled every 10 days

15 Unless otherwise by law, RPh shall not limit their services to a certain segment of the general public

16 shall not refuse to compound customary pharmaceutical preparations except upon extenuating circumstances

17 shall not purchase drug samples for compounding, dispensing or reselling these samples

18 shall comply with mandatory counseling provisions

19 maintain patient confidentiality at all times

Question 2

9
Describe the process of transferring a prescription listed in schedules III-V.

Answer 2

Rx authorizing refills or schedule III to V CS may be transferred between pharmacies or pharmacy departments on a one-time only basis except as otherwise permitted by law

schedule II can not be transferred!!!!!

Question 3

9
Who is allowed to conduct the transfer of schedules III-V

Answer 3

pharmacists and CPhT I think

pharmacies and pharmacy departments

Question 4

9
Describe the process of transferring a prescription listed in schedules III-V.

Answer 4

A: the RPh must record the following info:
- write the word VOID on the face of the invalidated Rx

• record the the reverse of the invalidated Rx the name, address, and DEA registration number of the pharmacy to which it was transferred, and the name of the RPh receiving the Rx info
• record on the written transfer log or by entry into a computerized system, the Rx number, date of transfer, the name or identification of the pharmacist transferring the info, and the name of the pharmacy or pharmacy department to which the Rx is transferred

B: the transferring RPh shall cancel all refills remaining on the transferred Rx

C: the RPh receiving the transferred Rx info shall complete the following
- write the word “transfer” on the face of the transferred Rx

• write all info required by the state and federal law to be on the Rx and include:
  - date of issuance of the original Rx
  - the original number of refills authorized on the original Rx
  - the date of original dispensing
  - the number of valid refills remaining and the date of the last refill
  - the RPh’s name, address, DEA number, and original Rx from which the Rx info was transferred, and the name of the transferor RPh

D: the RPh receiving the transferred info shall inform the patient that the original Rx’s refills have been canceled at the pharmacy or pharmacy department from which it has been transferred

Question 5

9
What are the responsibilities of the transferring and receiving pharmacy

Answer 5

A
receiving & transferring
- fill out DEA
- 14-day notice

intending to transfer controlled substances schedules II to VI from one pharmacy to another the board must have the following information at least 14 days before the transfer takes place:
❖ The name, address, telephone number, pharmacy permit number of the transferor and the transferee.
❖ For schedule II, form 222 is required
❖ For schedules III to VI, only the invoice is required

but I thought that they could not be refilled so they cannot be transferred…. Schedule II controlled substances are not able to be transferred at all due to the risk of substance abuse and dependency they pose.

Question 6

9
Who is allowed to conduct the transfer of schedules VI

Answer 6

RPh
intern
certified Pharm. tech

Question 7

9
Describe the regulations relating to the advertising of prescription medication prices

Answer 7

• RPh shall not utilize false, deceptive, or misleading advertising
• whenever an RPh advertises the consumer price for a particular Rx drug, said advertisement shall not contain any representation, either expressed or implied, concerning that drug’s safety, effectiveness, or indications for use
• any RPh who advertises a Rx drug in a manner which provides price info. to consumers shall include the following info:
• the proprietary name if any
• the establish or generic name if any
• the quantity of active ingredients per dosage unit of the Rx drug producr whenever the Rx contains a single active ingredient
• the strength of the Rx whenever said product contains more than one active ingredient by a relevant strenght that can be associated witht he product without indicating each active ingredient; the established name and quantityt of each active ingredient shall not be required whenever said product contains more than 1 active ingredient
• the dosage form
• the price charged for filling a Rx

a RPh who advertises Rx drugs in a manner which provdies price info to consumers may idenfity professional or convenience services provided by the pharmacy of pharmacyy department or may include other written, printed or graphic matter, provided that no info included in such advertsisng shall be flase, deceptive or misleading

whenever a RPh adverists Rx drugs in a manner that provides price nfo to consumers, any stated price with respect to a particular Rx drug shall include all charges to the consumer. These charges

yeah yeah

Question 8

9
Describe the requirements for dispensing and refilling prescriptions

Answer 8

if drug is distributed only as generic name then RPh should record on the Rx the name of the manufacturer or if the manufacturer’s name is not available then the name of the distributor, packet or repacker
affixed label must be clearly printed
only RPh, intern and certified tech with approval of PIC, can receive new Rx over the phone from prescriber or authorized agent
if filling CS III-VI, RPh must record:
- the date of dispensing

amount of the drug dispensed
his or her initials
if a dispensing RPh does not indicate the quantity of a drug dispensed on the back of the Rx that the RPh has refilled shall be deemed to have dispensed a refill for the full face amount of the Rx
data-processing system may be used for the storage and retrieval of info. pertaining to the refilling of Rx for CS in III-VI
cannot collect Rxs at industrial plants, places of business, other sites where specific groups of people are regularly employed or affiliated
cannot give hydrocodone ER unless:
- stored in locked cabinet

dispensed with child-proof container or within a locked box
the prescriber has given a letter of medical necessity
RPh gives counseling that includes review of written warnings

Question 9

9
What information needs to be placed on the pharmacy label

Answer 9

the product name and purpose

Dosage and use instructions

Specific instructions for demographics, such as pregnant women and children.

Ingredients, both active and inactive.

Warnings and potential adverse side effects.

Question 10

9
What information is needed for proper records keeping when dispensing and refilling prescriptions

Answer 10

for CS III-VI:

date of dispensing

amount of drug dispensed

initials

Question 11

9
Describe the process and requirements of handling hydrocodone-only extended release medications

Answer 11

cannot give hydrocodone ER unless:
- stored in locked cabinet
- dispensed with child-proof container or within a locked box
- the prescriber has given a letter of medical necessity
- RPh gives counseling that includes review of written warnings

can only be done by RPh & intern

Question 12

9
How are prescriptions files maintained

Answer 12

CS II are separated from other records
CS III-V are separate and identified as such
CS VI, Rx for non-controlled substances, Rx for syringes and instruments adaptable to hypodermic admin. shall be separate from all other records

Question 13

9
Describe the procedures for verifying a practitioner’s prescriptive authority

Answer 13

good RPh judgement determines:
- Rx is issued according to valid patient-prescriber relationship

Rx is authentic
dispensing is according to 94C

Question 14

9
How are patient records maintained, what is the name and abbreviation of the federal law relating to patient health information

Answer 14

patient record system that identifies previously dispensed meds.
may be computerized
kept for more than 12 months from date of last entry in the profile record
record includes
- name
- address
- phone #
- DOB
- gender
- history
- drug allergies/rxns
- list of meds ever dispensed
- comments relevant to drug therapy

abbreviation: PHI confidential under HIPAA

Question 15

9
What information needs to be collected in regards to patient records

Answer 15

record includes
- name
- address
- phone #
- DOB
- gender
- history
- drug allergies/rxns
- list of meds ever dispensed
- comments relevant to drug therapy

Question 16

9
Describe how a pharmacist shall conduct a prospective DUR

Answer 16

• Before each Rx is dispensed or delivered to a patient
  identifies
• over-utilization or under-utilization
• therapeutic duplication
  -drug-disease contraindication
  -drug-drug interaction
  -incorrect drug dosage or duration of drug treatment
  -drug-allergy interactions
  -clinical abuse or misuse
  -any significant change in drug, dose, or directions
  -ensures proper care of patient and may call prescriber to do so

Question 17

9
What needs to be done in the event of identifying a an issues with the prospective DUR

Answer 17

offer to counsel
talk to prescriber

Question 18

9
Describe when counseling needs to be performed

Answer 18

for new Rx or if patient requests

Question 19

9
When is the offer to counsel made, just new prescription, just refills, both new and refills

Answer 19

new

Question 20

9
What is done in real life regarding the offer to counsel, does it differ from the legal requirements

Answer 20

for any meds for anyone

Question 21

9
Describe the process of what needs to be included when counseling a patient

Answer 21

name and description of med
dosage form, dosage, ROA & duration of therapy
special directions for prep. admin and use
common severe side and adverse effects
techniques for monitoring drug therapy
proper storage
Rx refill info
action to be taken if you miss a dose or adverse rxn

Question 22

9
What happens if the patient does not pick up their prescription, do you need to provide a written offer to counsel

Answer 22

yes

Question 23

9
What is the difference between the following, drug information sheet, prescription drug insert, patient drug information sheet, medication guide.

Answer 23

A
drug information sheet
- gives you important information about your medication.

prescription drug insert
- details and directions that health care providers need to prescribe a drug properly, including approved uses for the drug, contraindications, potential adverse reactions, available formulations and dosage, and how to administer the drug.

patient drug information sheet
- gives you important information about your medication.

medication guide
- paper handouts that come with many prescription medicines

Question 24

10
Under what circumstances might the Board impose disciplinary action against and individual or other entity licensed by the Board?

Answer 24

1 - violating any of the duties and standards set out in board regulations

2 - violating any provision or any provision of. state or federal statutes or rules or regulations promulgated thereunder related to the practice of the profession

3 - failing to submit an acceptable plan of correction

4 - failing to remedy or correct a violation cited in a deficiency statement by the date specified in the plan of correction submitted. Plans of correction as accepted or modified by the board, unless the pharmacy or pharmacy department demonstrates to the satisfaction of the board that such failure was not due to any neglect of duty and occurred despite his/her good faith attempt to remedy or correct the violations(s) by the specific time

5 - engaging in misconduct in the practice of the profession

6 - engaging in conduct beyond the authorized scope of a pharmacist, pharmacy intern, or pharmacy technician

7 - practicing the profession while the ability to practice is impaired by illness, use of alcohol, drugs, chemicals, or other type of substances, or as a result of any mental or physical condition

8 - engaging in abuse or illegal use of Rx drugs or controlled substances

9 - continuing to practice the profession after registration is lapsed, suspended, or revoked

10 - violating the terms of a consent agreement, final decision, order, surrender agreement, or any other issued by o agreement entered in with the board

11 - engaging in conduct that has the capacity or potential to place the public health, safety, or welfare at risk

12 - engaging in conduct that has the capacity or potential to deceive or defraud

13 - knowingly permitting, aiding, or abetting an unlicensed person to perform activities requiring a license or registration

14 - being convicted of any crime, entering a plea of guilty to any time, entering a plea of nolo contendere to any crime, or admitting to sufficient facts to warrant a finding of guilty of any crime

15 - fraudulently procuring a license or registration or its renewal

16 - providing false info on an application for a license or registration or its renewal

17 - failing without cause to cooperate with any request by the board to appear before it or to provide requested info; failing to respond to a board subpoena or failing to furnish the money to which the board is legally entitled

18 - engaging in conduct that demonstrates a lack of good moral character

19 - cheating on or attempting to compromise the integrity of any licensing or registration examination

20 - having been disciplined in another jurisdiction in any way for reasons substantially

21 - engaging in conduct which undermines public confidence in the integrity of the profession

22 - committing an act that violates recognized standards of pharmacy practice

23 - failing to comply with recognized ethical standards of the profession, including but not limited to, standards of practice of pharmacists, interns, pharmacies, and pharmacy departments

24 - violation of 94C or any rules or regulations promulgated thereunder

25 - failing to report or failing to accurately report to the board within 7 business days, in a manner and format determined by the board

26 - failing to report to the board in writing within 30 days any pending criminal charge or conviction of a registrant or licensee in MA

27 - duty to comply with reporting requirements, the duty to report certain factors of pharmacy operations

28 - violation of, or failure to comply with an order issued by the commissioner of the Department of pH

Question 25

10
What is a Plan of Correction?

Answer 25

A specific plan of what will be or was done to correct the problem after inspection;
b. A description of what will be done to prevent the recurrence of this problem or problems of this type;

c. Designation of the individual(s) who will be responsible for monitoring the correction to ensure the problem does not recur; and d.

Question 26

10
Describe the Summary Cease and Desist process? When is it conducted?

Answer 26

1. if, based upon affidavits or other evidence, the board or board president determines that a registrant or licensee or the products prepared by a registrant or licensee are an immediate or serious threat to the public health, safety or welfare, the board or board president may:
   a - issue a cease and desist notice and/or quarantine notice, requiring non-disciplinary cessation or restriction of any and all pharmacy operations, and prohibiting the use of medications prepared by or in possession of a pharmacy or,

b - issue a cease and desist notice placing non-disciplinary restrictions on a board registrant or licensee, to the extent necessary, to avert a continued threat, pending final investigation results

2 - requirements of the cease and diss notice and/or quarantine notice shall remain in effect until the board or board president rescinds or amends such requirement for until such time as the board takes final action on any related pending complaint and the board issues a final decision

3 - a hearing limited to the determination of the necessity of notices issued pursuant to blah blah blah shall afforded the registrant or licensee within 15 business days of the board or board president’s action

Question 27

10
What happens if there is disciplinary action against a Massachusetts registrant or licensee taken in another state?

Answer 27

this may be the basis for initiation by the board of disciplinary action against the MA registrant or licensee provided that the conduct disciplined in another state or jurisdiction constitutes a violation of MA law

Question 28

adjudicatory hearing

Answer 28

means a formal administrative hearing held by the board conducted to determine the truth and validity of complaints filed against a registrant or licensee.

Question 29

complaint

Answer 29

means a communication filed with the board or the division of health professions license which the board determines, after investigation, merits further consideration or action

Question 30

conviction

Answer 30

shall include any guilty verdict or finding of guilt and any admission to or finding of sufficient facts to warrant a finding of guilt, regardless of adjudication, a continuance without a finding, and any pleas of guilty or nolo contendere, of to a crime in any jurisdiction, which has been accepted by the court, whether or not a sentence has been imposed. A conviction of any person licensed or registered by the board shall be conclusive evidence of the commission of the crime in any disciplinary proceeding against such person based upon the conviction

Question 31

invetsigative confernece

Answer 31

means an informal discussion relating to a complaint held with the board

Question 32

order to show cause

Answer 32

means a document served by the board upon a registrant ordering the registrant or licensee to appear before the board for a formal adjudicatory hearing

Question 33

11
Why is a Massachusetts Controlled Substance Registration issued?

Answer 33

The Massachusetts Controlled Substance Registry’s primary aim is to ensure controlled substances are handled responsibly and safely within Massachusetts while adhering to rigorous compliance standards when it comes to storage, distribution, and dispensing of controlled substances.

Question 34

11
To whom are they issued to?

Answer 34

Pharmacy

Outsourcing Facility

Wholesale Druggist

every person who manufacturers, distributes, prescribes, administers, dispenses or possesses controlled substances in Schedules II-V to be registered

Question 35

11
What are the requirements for obtaining a Massachusetts Controlled Substance Registration?

Answer 35

1 The Board may issue a controlled substance registration to a pharmacy, outsourcing facility, or wholesale drug business that intends to engage in any activity for which a controlled substance registration is required by law.

(2) No pharmacy, outsourcing facility, or wholesale drug business shall engage in any activity for which registration is required until a controlled substance registration has been issued by the Board.

Question 36

11
Are separate registrations required for a Massachusetts Controlled Substance Registration?

Answer 36

a separate controlled substance registration shall be required at each principal place of business where the licensee or registrant manufactures, distributes or dispenses controlled substances.

Question 37

11
When does a Massachusetts Controlled Substance Registration expire?

Pharmacy
Outsourcing Facility
Wholesale Druggist
Individual

Answer 37

(1) Pharmacy. The controlled substance registration issued to a pharmacy shall be valid for two years beginning January 1st of each even-numbered year. – EXPIRES: December 31 of each odd year

(2) Outsourcing Facility. The controlled substance registration issued to an outsourcing facility shall be valid for two years beginning January 1st of each even-numbered year. Expires December 31 of the odd year

(3) Wholesale Druggist. The controlled substance registration issued to a wholesale druggist shall be valid for one year beginning on December 1st of each year.

(4) Individual. expires December 31st of every even year

The retail pharmacy permit for CS expires on December 31 of the odd year and also the certificate of fitness

DEA expires every 3 years

Question 38

11
What happens if there is a change in name, address or status of the Registrant?

Answer 38

(1) The controlled substance registration of any registrant shall automatically terminate and become invalid if:
(a) the pharmacy, outsourcing facility, or wholesale business named on the controlled substance registration ceases to exist;
(b) the name and/or address ofthepharmacy,outsourcingfacility,orwholesalebusinessto which the controlled substance resignation was issued changes; or
(c) the pharmacy, outsourcing facility, or wholesale business to which the controlled substance registration was originally issued is sold.
(2) A registrant affected by 247CMR11.09(1) shall notify the Board in writing within 14 days of such change(s).

(3) A registrant affected by 247 CMR 11.09(1) may make an application to the Board for the
issuance of a new controlled substance registration. Such application may be submitted to the Board before the effective date of such change. The Board shall review such application as a first-time application for a controlled substance registration.

(4) A registrant affected by 247 CMR 11.09(1) shall promptly provide written notice thereof to the regional office of the U.S. Drug Enforcement Administration.

Question 39

11
When does a registrant need to notify the Board of a change in name, address, or status?

Answer 39

notify the Board in writing within 14 days of such change(s).

Question 40

11
Can a Massachusetts Controlled Substance Registration be transferred or assigned?

Answer 40

A controlled substances registration issued by the Board, or any authority conferred thereby, shall not be assigned or transferred.

no :)

Question 41

11
What is the purpose of a Massachusetts Controlled Substance Registration issued to a Whole Druggist when their activities are limited?

Answer 41

A wholesale druggist which is registered to distribute a controlled substance or class of controlled substances shall be authorized to distribute only that controlled substance or class of controlled substances.

Question 42

11
When can the Massachusetts Controlled Substance Registration be suspended or revoked?

Answer 42

(a) has furnished false or fraudulent material information in any application filed under the provisions of M.G.L. c. 94C;

(b) has been convicted under any state or federal law of any criminal violation relating to his or her fitness to be registered under M.G.L. c. 94C;

(c) has had his or her state or federal controlled substance registration to manufacture, distribute, dispense, administer, or possess controlled substances suspended or revoked, or has voluntarily surrendered said controlled substance registration;

(d) is, upon good cause, found to be unfit or unqualified to manufacture, distribute, dispense, or possess any controlled substance; or

(e) has violated any provision of M.G.L. c. 94C and/or any other applicable federal or state laws and regulations.

Question 43

11
What is the procedure for a summary suspension?

Answer 43

(a) Closure of Pharmacy, Outsourcing Facility, or Wholesale Druggist. Upon receipt by the Board of reliable information that a registrant is an imminent and serious threat to the public health or safety, the Board shall vote to take summary action on the registrant’s controlled substances registration. Upon the Board’s vote to summarily suspend such registration, Board Agents are authorized to:
1. immediately close the registrant’s establishment or business;
2. at the registrant’s expense, replace the locks on all doors to the registrant’s establishment or business and retain the key(s);
3. conspicuously display at the entrance(s) to the registrant’s establishment or business a sign, in letters no less than one inch in height and one inch wide, stating: “THE REGISTRATION OF THIS ESTABLISHMENT HAS BEEN SUSPENDED BY ORDER OF THE MASSACHUSETTS BOARD OF REGISTRATION IN PHARMACY.”; and
4. conduct an inventory and audit of all drugs and record of drugs within the registrant’s establishment or business.

(b) Order of Suspension. The Board shall promptly issue an Order of Suspension of Controlled Substance Registration and shall send such Order, with a Notice of Hearing as set forth in 247 CMR 11.15(3)(c), to the establishment’s owner or pharmacy’s Manager of Record by certified mail, or shall deliver such Order and Notice of Hearing by hand.

(c) Hearing on Necessity for the Summary Action. The Board shall convene a hearing on the necessity for the summary suspension of a controlled substance registration within seven days after the order of suspension. The establishment’s owner and/or pharmacy’s Manager of Record shall be notified of the date, time, and place of the hearing.

At the hearing, the Board shall receive testimony and documentary evidence limited to determining whether the summary suspension of the controlled substance registration shall continue in effect pending a final hearing on the merits of any Order to Show Cause issued by the Board against the pharmacy or establishment in connection with its investigation.

Following the hearing, the Board shall vote on whether to continue the summary suspension in effect and shall promptly notify the registrant in writing of its decision.

Question 44

11
Standard for Issuance of a Controlled Substance Registration

Answer 44

(1) the maintenance of effective controls against diversion of controlled substances;

(2) The maintenance of effective controls against the diversion of controlled substances; compliance with applicable federal, state, and local laws and regulations;
any conviction of the applicant under any federal and/or state law relating to any controlled

(3) any conviction of the applicant under an federal and /or state law relating to any controlled substance

(4) past experience in the manufacture or distribution of controlled substances;

(5) furnishing by the applicant of false or fraudulent material in any application filed under the provisions of M.G.L. c. 94C or other applicable state or federal law or regulation;

(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.

Question 45

12
What is a restricted pharmacy? Provide an example

Answer 45

Restricted Pharmacy means a pharmacy, business, or enterprise that involves the dispensing of Specialty Drugs.

ex: a beneficiary of a trade union, cannot use pharmacy if not a part of the trust, plan, union, etc

registration expires December 31st of the odd year - same as retail pharmacy

Question 46

12
What does it mean to be exempt from247CMR9.1(15)

Answer 46

to be exempt from the code of professionals. conduct; professional standards for registered pharmacists, pharmacies, and pharmacy departments

Question 47

14
What is a waiver

Answer 47

a demonstration, usually in written form, of a party’s intent to relinquish a legal right or claim

Question 48

14
How does one petition the Board for a waiver?

Answer 48

(a) that there is a compelling public interest which would be served by granting the waiver;

(b) that the petitioner’s adherence to the waived regulatory requirement(s) would be impractical and unduly burdensome; and

(c) that there are sufficient safe guards to protect the public health, welfare and safety without the petitioner’s compliance with the waive regulatory requirements.

(a) the proposed manager of record on behalf of an applicant for a pharmacy license;

or (b) the current manager of record on behalf of a licensed pharmacy

Question 49

14
When does the waiver expire?

Answer 49

(a) All waivers granted by the Board on or before June 30, 2013, shall expire on June 30, 2018.

(b) All waivers granted by the board after June 30, 2013, shall expire on the fifth anniversary of the date that it was granted.

(c)A pharmacy may submit a subsequent petition for waiver in anticipation of, or following, the expiration of a previously granted waiver. The subsequent petition for waiver must comply with, and meet the criteria in, 247 CMR 14.01(1) through (4).

(d) A pharmacy must comply with all regulatory requirements in 247CMR after the expiration of the waiver unless the Board has granted a subsequent waiver.

Question 50

14
When would the Board issue a waiver?

Answer 50

A completed petition shall:
(a) list the regulatory requirement(s) for which a waiver is requested and a brief explanation as to why each regulation should not apply to that pharmacy or pharmacy department;
(b) explain why there is a compelling public interest which would be served by granting the waiver;
(c) explain why adherence to the regulation(s) would be impractical and unduly burdensome to the petitioner;

(d) include a comprehensive statement of the policies and procedures of the. proposed operation, including safeguards to protect the public health, welfare, and safety; and

(e) be accompanied by any additional information as determined by the Board.

Question 51

14
Is there a special form to use when petitioning the Board for a waiver?

Answer 51

A petition for waiver of a regulatory requirement set in 247CMR must be submitted on a form supplied by the Board and must be completed and signed by:

(a) the proposed manager of record on behalf of an applicant for a pharmacy license;
or
(b) the current manager of record on behalf of a licensed pharmacy

Question 52

14
What does the petitioner need to do when requesting a waiver?

Answer 52

fill out the form

(a) list the regulatory requirement(s) for which a waiver is requested and a brief explanation as to why each regulation should not apply to that pharmacy or pharmacy department;

(b) explain why there is a compelling public interest which would be served by granting the waiver;

(c) explain why adherence to the regulation(s) would be impractical and unduly burdensome to the petitioner;

(d) include a comprehensive statement of the policies and procedures. of the proposed operation, including safeguards to protect the public health, welfare, and safety; and

(e) be accompanied by any additional information as determined by the Board.

Question 53

15
What is a Quality-Related Event

Answer 53

the incorrect dispensing of a prescribed medication that is received by a patient, including:

(a) a variation from the prescriber’s prescription order, including, but not limited to:
1. dispensing an incorrect drug;
2. dispensing an incorrect drug strength;
3. dispensing an incorrect dosage form;
4. dispensing the drug to the wrong patient; or
5. providing inadequate or incorrect packaging, labeling, or directions; or

(b) a failure to identify and manage:
1. over-utilization;
2. therapeutic duplication;
3. drug-disease contraindications;
4. drug-drug interactions;
5. incorrect drug dosage or duration of drug treatment;
6. drug-allergy interactions; or
7. clinical abuse/misuse.

Question 54

15
What is required under a Continuous Quality Improvement Program?

Answer 54

1) Continuous Quality Improvement Program Requirements. Each pharmacy shall establish a Continuous Quality Improvement (CQI) Program for the purpose of detecting, documenting, assessing, and preventing Quality Related Events (QREs). At a minimum, a CQI program shall include provisions to:

(a) designate an individual or individuals responsible for monitoring CQI Program compliance with the requirements of 247 CMR 15.00;

b) identify and document QREs

(c) minimize the impact of QREs on patients

(d) analyze data collected in response to QREs to assess causes and any contributing factors

(e) use the findings of the analysis to formulate an appropriate response and develop pharmacy systems and workflow processes designed to prevent QREs; and

(f) provide ongoing education at least annually in the area of CQI to pharmacy personnel.

(2) Implementation Date. The CQI Program requirements of 247 CMR 15.00 shall be implemented by each pharmacy by December 31, 2005.

Question 55

15
What happens once a Quality-Related Event is discovered?

Answer 55

All pharmacy personnel shall be trained to bring any QRE to the attention of the pharmacist on duty or the pharmacist Manager of Record immediately upon discovery. The pharmacist who has discovered or been informed of a QRE shall immediately provide:
(2)
(a) notification to the patient or patient’s representative, the prescriber (if indicated in the professional judgment of the pharmacist) and other members of the healthcare team;
(b) directions for correcting the error; and
(c) instructions for minimizing the negative impact on the patient.

QRE Documentation.
(a) A QRE shall be initially documented by the pharmacist who has discovered or been informed of the QRE on the same day the QRE is discovered by or described to the pharmacist.
(b) QRE documentation shall include a description of the event that is sufficient to permit categorization and analysis of the event. QRE documentation shall include:
1. the date when the pharmacist discovered or received notification of the QRE and the name of the person who notified the pharmacy;
2. the names and titles of the persons recording the QRE information and performing the QRE analysis;
3. a description of the QRE reviewed; and
4. documentation of the contact with the patient, or patient’s representative, and prescribing practitioner (if indicated in the professional judgment of the pharmacist), and other members of the healthcare team.

Question 56

15
Who needs to be notified of the Quality-Related Event?

Answer 56

notification to the patient or patient’s representative, the prescriber (if indicated in the professional judgment of the pharmacist), and other members of the healthcare team;

Question 57

15
How are records maintained under the CQI program?

Answer 57

(1) Each pharmacy shall maintain a written copy of its CQI Program description on the pharmacy premises. The CQI Program description shall be readily available to all pharmacy personnel.
(2) Each pharmacy shall maintain a record of all QREs for a minimum period of two years from the date of the QRE report.
(3) QRE records shall be maintained in an orderly manner and filed by date.
(4) QRE records may be stored at a site other than the pharmacy where the QRE occurred.

Question 57

15
What documentation is needed for Quality Related Events?

Answer 57

QRE Documentation.
(a) A QRE shall be initially documented by the pharmacist who has discovered or been informed of the QRE on the same day the QRE is discovered by or described to the pharmacist.
(b) QRE documentation shall include a description of the event that is sufficient to permit categorization and analysis of the event. QRE documentation shall include:
1. the date when the pharmacist discovered or received notification of the QRE and the name of the person who notified the pharmacy;
2. the names and titles of the persons recording the QRE information and performing the QRE analysis;
3. a description of the QRE reviewed; and
4. documentation of the contact with the patient, or patient’s representative, and prescribing practitioner (if indicated in the professional judgment of the pharmacist), and other members of the healthcare team.

Question 58

15
How long are the records to be maintained?

Answer 58

Each pharmacy shall maintain a record of all QREs for a minimum period of two years from the date of the QRE report.

2 years
filed by date

Question 59

15
Is there a requirement to report to the Board all improper drug dispensing?

Answer 59

yes! Report within 15 business days

Question 60

15
Describe the process of reporting to the Board improper dispensing if there is a death or serious injury

Answer 60

Effective January 1, 2010, a pharmacy licensed by the Board is required to report to the Board any improper dispensing of a prescription drug that results in serious injury or death, as defined in 247 CMR 6.14(1), within 15 business days of the pharmacy discovering or being informed of such improper dispensing, in accordance with the requirements of M.G.L. c. 112, § 39D and 247 CMR 6.00.

unrelated but:
2 contact hours for each renewal period for immunizations so 1 every year

Question 61

16
Describe the pharmacist’s qualifications to participate in a collaborative drug therapy management program.

Answer 61

(a) hold a current unrestricted license in good standing to practice pharmacy in the Commonwealth and currently be engaged in pharmacy practice in the Commonwealth;

(b) maintain at least $1,000,000 (peroccurrence) of professional liability insurance during the term of the agreement which specifically covers drug therapy management;

(c) have completed five years of experience as a licensed pharmacist or have satisfied one of the requirements in 247 CMR 16.02(1)(c)1. through

2.:
1. have earned a doctor of pharmacy degree and have entered into a collaborative practice agreement on or before June 30, 2017; or

2. have completed such other education or residency criteria that the Board determines to be the equivalent of five years experience as a licensed pharmacist;

(d) devote a portion of practice to the defined drug therapy area that the pharmacist shall co-manage;

(e) complete, in each year of the term of the agreement, at least five additional contact hours of Board-approved continuing education that address areas of practice generally related to the particular collaborative practice agreement; and

(f)
if prescriptive practices are included in the collaborative practice agreement:
1. maintain a current controlled substance registration issued by the Department during the term of the agreement, pursuant to M.G.L. c. 94C, §§ 7 and 9 and 105 CMR 700.000: Implementation of M.G.L. c. 94C.

2. complete training required pursuant to M.G.L.c.94C,§18(e) prior to initially obtaining a controlled substance registration and at least biennially thereafter as a condition precedent to renewing his or her pharmacist license;
3. submit an attestation, signed under the pains and penalties of perjury, that the pharmacist participates in, or had applied to participate in, MassHealth as either a provider of services or for the limited purpose of ordering and referring services covered by MassHealth, in accordance with M.G.L. c. 112, § 24B1⁄2.

(2) An authorized pharmacist participating in CDTM must maintain evidence of completion of required continuing education for at least two years after the date of the current collaborative practice agreement.

(3) Whenever anauthorized pharmacist participating in CDTM is disciplined by the Board, whether by agreement or Board order, or otherwise subject to any practice restrictions, the authorized pharmacist must provide written notification of such discipline or practice restriction to each supervising physician.

Question 62

16
What is the minimum amount of professional liability insurance that is required?

Answer 62

maintain at least $1,000,000 (per occurrence) of professional liability insurance

Question 63

16
What can a Community Pharmacy engage in under a CDTM?

Answer 63

(5) Community Pharmacies (retail drug business settings) licensed by the Board pursuant toM.G.L. c. 112, § 39, subject to the restrictions listed below and pursuant to a current collaborative practice agreement that includes the following requirements:
(a) Patient Age. Patients must be 18 years of age or older.
(b) Vaccine Administration. Pharmacists, as authorized pursuant to a collaborative practice agreement, may administer vaccines.
(c) Patient Referral and Consent. In accordance with 243 CMR 2.12, the collaborative practice agreement must provide that the supervising physician will:

1. provide a written referral of the patient to the authorized pharmacist;
2. specify the primary diagnosis for the patient and any secondary diagnoses in the written referral or a subsequent referral;
3. provide a copy of the written referral of the patient to the authorized pharmacist for CDTM services to the patient; and
4. obtain the patient’s written informed consent to the collaboration in the collaborative practice agreement and provide a copy of the consent to the patient.

(d) Record of Referral and Consent. The authorized pharmacist and supervising physician must maintain a written record of both the individual patient referral and the patient’s written informed consent to the collaboration in the patient’s records which are maintained by the authorized pharmacist and the supervising physician. In accordance with 243 CMR 2.12, the supervising physician shall:

 (e) 1. maintain the original patient consent to the referral in the record in the custody of the supervising physician; 2. transmit a copy of the patient's consent to the authorized pharmacist within 24hours;and 3. provide copies of the referral and consent to the patient in a timely manner. Limited Prescribing Authority.

1. An authorized pharmacist currently registered by the Department, pursuant to M.G.L.c. 94C, §§ 7 and 9 and 105 CMR 700.000: Implementation of M.G.L. c. 94C, to prescribe and possess controlled substances, who practices in a community pharmacy pursuant to a collaborative practice agreement that includes individually developed prescriptive practice guidelines pursuant to which the supervising physician has authorized the pharmacist to prescribe, may:

a. extend current drug therapy by 30 days for not more than two 30-day periods or as may otherwise be specifically authorized by the supervising physician in the referral of the patient and as provided in the CDTM agreement;

b. initiate,modify or discontinue dosages of medications prescribed by the supervising physician for:
i. asthma;
ii. chronic obstructive pulmonary disease; iii. diabetes;
iv. hypertension;

Question 64

16
What are the practice-setting requirements?

Answer 64

Hospitals licensed pursuant to M.G.L.c.111,§51,
subject to approval by the hospital medical staff executive committee or designee;

(2) Long-term Care Facilities licensed pursuant to M.G.L. c. 111, § 71, subject to approval by the long-term care facility medical director or designee;

Inpatient or Outpatient Hospice Settings licensed pursuant to M.G.L.c.111,§57D, subject to approval by the hospice medical director or designee;

Ambulatory Care Clinics licensed pursuant toM.G.L.c.111,§51,within-site supervision by an attending physician affiliated with the ambulatory clinic and an authorized pharmacist, subject to approval by the ambulatory care clinic medical staff executive committee or designee, or medical director or designee;

Question 65

16
Can a community pharmacist prescribe or be authorized to prescribe Schedule II through V controlled substances?

Answer 65

No authorized pharmacist in a community pharmacy may prescribe or be authorized to prescribe Schedule II through V controlled substances,

no :) only VI

Question 66

16
What is required to be included in a collaborative practice agreement?

Answer 66

A collaborative practice agreement must be a written and signed agreement between an authorized pharmacist with training and experience relevant to the scope of the collaborative practice and a supervising physician that defines the collaborative practice in which the authorized pharmacist and supervising physician propose to engage. The collaborative practice must be within the scope of the supervising physician’s practice. In the community pharmacy setting, the CDTM agreement shall include:

(a) a written referral of a specific patient from the supervising physician to an authorized pharmacist; and

(b) the written consent of the patient to the CDTM agreement.

Question 67

16
How long is a collaborative practice agreement valid?

Answer 67

A collaborative practice agreement must be reviewed and renewed by the authorized pharmacist and supervising physician(s) at least every two years.

Question 68

16
What are the CE requirements for a pharmacist engaged in CDTM?

Answer 68

For each year of a CDTM agreement, pharmacists MUST complete at least 5 additional contact hours (i.e., a total of 25 contact hours yearly) that address areas of practice generally related to the specific collaborative practice agreement.

CDTM pharmacists with prescriptive authority are also required to obtain at least 1 contact hour of pain management training every 2 years. If the training is an accepted type of continuing education as above, it may be used toward the additional 5 contact hours. One such program is from Boston University, Prescribe to Prevent.

Question 69

21
What is an outsourcing facility?

Answer 69

means any compounding facility that is registered as an outsourcing facility, as defined in 21 U.S.C. Section 353b, that distributes sterile compounded human drug products without a patient-specific prescription to an authorized agent or practitioner in this state.

Question 70

21
What are the registration requirements for an outsourcing facility?

Answer 70

(1) Registration under 247 CMR 21.02 is limited to outsourcing facilities located in Massachusetts. Outsourcing facilities located outside Massachusetts shall register in accordance with 247 CMR 21.04.

(2) An application for an outsourcing facility registration shall be made on forms prescribed by, and available from, the Board.

(3) In support of an application for an outsourcing facility registration, the applicant shall submit:
(a) complete application forms;

(b) a complete application, available from the Board, for a Massachusetts controlled substance registration;

(c) check or money order made payable in the proper amount to the “Commonwealth of Massachusetts Board of Registration in Pharmacy”;

(d) proof of a valid, current registration with the FDA pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act;
(e) proof of an inspection by the FDA in connection with the section 503B of the Federal Food, Drug, and Cosmetic Act registration within the two years immediately preceding the application;

(f) if the applicant is an entity:
1. a certificate of good standing and legal existence issued by the Secretary of State, or the equivalent, in the state in which the entity was organized or formed, and other information concerning ownership and control, as the Board may require;
2. a statement of the name and address of each officer, director, or partner of the entity and the position held;
3. the “doing business as” name of the entity;
4. if the corporation is not publicly owned, the total amount and type of stock issued to each stockholder and the names and addresses of said stockholder(s); and

g- any additional information, as required by the Board.

(4) the board may require the applicant(s), interest holder(s) and any other person to
personally appear before the Board to answer questions to enable the Board to determine whether issuance of an outsourcing facility registration would be in the best interest of public health, safety, and welfare.

(5) All fees submitted to the Board in connection with an application for an outsourcing facility registration are nonrefundable.

Question 71

21
What is a provisional outsourcing facility registration?

Answer 71

An entity with a provisional outsourcing facility registration may compound sterile drug preparations, but may not distribute or dispense a sterile drug preparation within or outside the Commonwealth until it has been inspected by the FDA and received a Massachusetts outsourcing facility registration

So it is a warrant to be able to make sterile compounds but you cannot distribute the compounds within or outside the commonwealth of Mass without inspection

and if you apply and after two years of the application you still have not been inspected then you can get the provisional outsourcing facility registration

Question 72

21
When would the provisional outsourcing facility registration be issued?

Answer 72

In the event an applicant for an outsourcing facility registration was not inspected by the FDA within the two years immediately preceding the application, the Board may issue a provisional outsourcing registration, provided the applicant otherwise submitted a complete application for an outsourcing facility registration.

So if the outsourcing facility was never inspected and 2 years has gone by after the application, they can get provisional registration

Question 73

21
Can a non-resident (not from the area) outsourcing facility be granted a provisional (from the area) registration?

Answer 73

A non-resident outsourcing facility is not eligible for a provisional outsourcing facility registration.

So you have to be from the area to get provisional registration

Question 74

Unfilled Original Electronic Prescriptions for Controlled Substances (“EPCS”) in Schedules II – V

Answer 74

On a one-time basis, unfilled EPCS for Schedules II – V may be electronically transmitted (sent from Doctor’s office) from one pharmacy to another without any alteration of the prescription contents in accordance with 21 CFR 1306.08.

doctor prescribes using device and send to pharmacy on a one-time basis

Question 75

Unfilled Paper, Fax, or Oral Prescriptions for Controlled Substances in Schedules II – V

Answer 75

The DEA does not permit the transfer (sent from one pharmacy to another!) of any original unfilled paper, fax, or oral prescription for federally controlled substances. Entering such prescriptions into an electronic database does not transform them into EPCS. They remain subject to all the regulations applicable to paper, fax, and oral prescriptions.

cannot transfer paper, fax or oral Rx for CS has to be electronic and only on a one time basis

So only schedules II-V paper, fax or oral Rx cannot be transferred but schedule VI can be

Question 76

Unfilled Electronic, Paper, Fax, or Oral Prescriptions for Controlled Substances in Schedule VI

Answer 76

Unfilled electronic, paper, fax, and oral Schedule VI prescriptions may either be electronically transmitted or transferred to another pharmacy in accordance with 247 CMR 9.00.

Question 77

Under the following conditions, Schedule VI medications may be provided to ensure patient continuity of care if a prescription has no remaining refills, and the pharmacist is unable to obtain prescriber authorization in a timely manner.

Answer 77

A. Using professional judgement, a pharmacist may dispense a quantity not to exceed a 30-day supply or the smallest available unit of use packaging.
B. Only Schedule VI medications that do not require reporting to the PMP may be provided (i.e., gabapentin cannot be provided).
C. The circumstances regarding the continuity of care dispensing must be documented.
D. The pharmacy must develop policies and procedures for continuity of care dispensing.

Community RPh can prescribe schedule VI!

Question 78

When a prescriber-patient relationship has ended because a prescriber has ceased to practice for any reason, established drug therapy may be continued in order to enable the patient time to establish a relationship with another prescriber. In order to do so, the following conditions must be met:

Answer 78

A. The prescription must have been issued pursuant to a proper prescriber-patient relationship while the prescriber was still in practice.

B. The prescription is within its expiry period based on its date of issuance (e.g., Schedule III written within 6 months, etc.).

C. The previously filled Schedule III – VI prescription has remaining authorized refills.

D. If multiple Schedule II prescriptions had been issued in accordance with 21 CFR §1306.12, they may be honored.

E. The pharmacist uses their professional judgment to ensure that the dispensing of the medication remains appropriate.

Question 79

Prescriptions for EPT

Answer 79

In accordance with 105 CMR 700.003(J), a separate prescription for the sex partner must be provided in one of two ways:
A. A prescription is issued for named sex partner(s) of the infected patient; or
B. A prescription is issued using “Expedited Partner Therapy,” “E.P.T.” or “EPT” in place of the patient’s name and address.

Question 80

Filling of EPT Prescriptions

Answer 80

A. Create a patient profile and prescription label using “Expedited Partner Therapy,” “E.P.T.” or “EPT” in place of the patient’s name and address.
B. If a pharmacist is unable or unwilling to fill an EPT prescription, the pharmacist must refer the patient to an alternate pharmacy.

Question 81

Expedited Partner Therapy Prescriptions

Answer 81

his policy outlines dispensing procedures for Expedited Partner Therapy Prescriptions (“EPT”). EPT is the practice of treating the sex partners of people diagnosed with Chlamydia infection without examining or testing the partner. This policy applies only to the treatment of Chlamydia infection.

Patients diagnosed with Chlamydia infection are at an increased risk of re-infection after treatment if their partner(s) is not treated as well. EPT helps interrupt the spread of disease by providing treatment to those partners who may be unwilling or unable to seek medical care on their own.

Question 82

Prescription information that may NEVER be changed or added:

Answer 82

For all schedules (Schedule II – VI), a new prescription is required for any of the following changes or additions:
patient’s name (i.e., change to different patient)
controlled substance prescribed (except generic substitution)
prescriber’s name
prescriber’s signature
earliest date to be filled (Schedule II only)

Question 83

Prescription information that MAY be changed or added:
Schedule II prescriptions:

Answer 83

The following may be changed or added, after consultation with the prescriber, unless otherwise noted:
date of issue (date written) may only be added if omitted
prescriber’s address
patient’s address
may be added if omitted without consultation
may only be changed after consultation with the prescriber or authorized agent
prescriber’s DEA number may be added without consultation
directions for use
dosage form
drug strength
quantity prescribed

cannot add refill info

supervising physician’s name of mid-level prescriber
The following may be added and the prescriber’s office should be notified if the following language is omitted:
“no substitution” language
“partial fill upon patient request” language

Question 84

Schedule III - VI prescriptions:

Answer 84

The following may be changed or added to new prescriptions, after consultation with the prescriber or authorized agent, unless otherwise noted:
date of issue (date written) may only be added if omitted
prescriber’s address
patient’s address
prescriber’s DEA number
directions for use
dosage form
drug strength
quantity prescribed
refill information

supervising physician’s name of mid-level prescriber
“no substitution” language may be added and the prescriber’s office should be notified if omitted

Question 85

If deemed appropriate in the pharmacist’s professional judgment, the days’ supply dispensed (e.g., 30-day supply with 11 refills vs. 90-day supply with 3 refills) may be changed without consultation only for drugs that do not require PMP reporting.
In the case of drug classes where a change in days’ supply may cause clinical concern, the Board recommends that prescribers be consulted upon initiation of new therapy and for any changes. Examples of such drug classes include behavioral health drugs and narrow therapeutic index drugs.

Answer 85

With each change, the following information must be documented in the computerized pharmacy system or on the written prescription:
the date
item changed or added
name of the authorizing prescriber, if applicable
name of the pharmacist accepting/making the change