Law exam 2 - 247 CMR 2-9 Flashcards

1
Q

all of the definitions

A

ACPE means the Accreditation Council for Pharmacy Education.

ACPE-approved Provider means an institution, organization or agency that is recognized by the ACPE, in accordance with its policies and procedures, as qualified to provide continuing education for pharmacists.

Approved College/School of Pharmacy means a college or school of pharmacy which has been accredited by the ACPE or approved by the Board.
Authorized Provider means a person who or agency which, sponsors or co-sponsors one or more contact hours of continuing education for pharmacists and which has received the approval of the ACPE, CME/Category 1, or the Board.

Blood means whole blood collected from a single donor and processed, whether for transfusion or further manufacturing.

Blood Component means that part of blood separated by physical or mechanical means.

Board means the Massachusetts Board of Registration in Pharmacy.

Board-approved Program means a program which has been approved by the Board for continuing education credits. Such program may be sponsored by the ACPE, and/or sponsored or co­ sponsored by any person who has been granted prior written approval by the Board for the particular program. The Board may, within its discretion, accept comparable continuing education hours approved by other Boards of Pharmacy.

Certificate of Approved CEUs means a document, issued to a named pharmacist by an authorized provider, certifying that the pharmacist has satisfactorily completed a specified number of CEUs.

Certificate of Fitness means a document issued by the Board to a pharmacy or pharmacy department which permits a pharmacy or pharmacy department to use alcohol for the manufacture of U.S. Pharmacopoeia or National Formulary preparations and all medicinal preparations unfit for beverage purposes, and to sell alcohol as authorized under M.G.L. c. 138.

Certified Pharmacy Technician means a pharmacy technician who is currently:
(a) registered by the Board; and
(b) certified by a Board-approved certifying body.

A pharmacy technician may perform the duties authorized to be performed by a certified pharmacy technician in 247 CMR 8.04: Certified Pharmacy Technicians when Board-approved certification is current. If certification lapses, the individual is required to function as a pharmacy technician until certification is current.

Contact Hour means a unit of measure of educational credit which is a minimum of 50 minutes, or the equivalent as determined by the Board, of satisfactory participation in a Board-approved program of continuing education.

Continuing Education (CE) means participation by registered pharmacists in Board-approved educational programs and is a prerequisite for the renewal of a personal registration.

Continuing Education Unit (CEU) means a unit of measure of educational credit which is equal to ten contact hours, or it’s equivalent as determined by the Board, of satisfactory participation in a Board-approved program of continuing education.

Controlled Substance means a drug, substance, or immediate precursor in any schedule or class referred to in M.G.L. c. 94C.

Controlled Substance Registration means a document issued by the Board which allows the holder to receive and dispense, pursuant to a valid prescription, controlled substances.

CME/Category 1 means continuing medical education (CME) credits sponsored by an organization accredited for CME by the Accreditation Council for Continuing Medical Education, the Postgraduate Medical Institute or the state medical society.

Customer Identifier means the identification number on a valid government issued identification, as specified by the Department, which a pharmacy obtains by inspecting the identification of the ultimate user or agent of the ultimate user to whom a prescription is dispensed. (105 CMR 700.001: Purpose)

Department means the Massachusetts Department of Public Health.
Direct Supervision means:
(a) the type of supervision a Board approved registered pharmacist preceptor in a pharmacy, pharmacy department, or institutional pharmacy is required to provide to a pharmacy intern when said preceptor oversees and directs the professional activities of the pharmacy intern, and includes directly reviewing the work of the intern; and
(b) the type of supervision a registered pharmacist in a pharmacy, pharmacy department, hospital pharmacy, or institutional pharmacy is required to provide a pharmacy technician when said pharmacist oversees and directs the activities of the pharmacy technician.

Dispensing means the physical act of delivering a drug, chemical, device or combination thereof to an ultimate user pursuant to the lawful order of a practitioner, as defined in M.G.L. c. 94C, § 1, including the utilization of the professional judgment of the pharmacist and the packaging, labeling, or compounding necessary to prepare the drug, chemical, or device for delivery.
Drug Sample means a unit of a prescription drug that is not intended to be sold.

Electronically Transmitted Prescription means an order of a practitioner which has been transmitted electronically to a pharmacy in accordance with 105 CMR 721.020: Prescription Formats.

Facsimile Machine (fax) means a machine that electronically transmits exact images through connection with an electronic network.
FPGEC means the NABP’s Foreign Pharmacy Graduate Examination Committee.

FPGEC Certificate means a document issued by the NABP evidencing the assessment of the educational equivalency of a graduate of a non-approved college/school of pharmacy.

FPGEC Certification means the NABP’s Foreign Pharmacy Graduate Examination Committee’s process of documenting and assessing the educational equivalency of a graduate of a non- approved college/school of pharmacy.

FPGEE means the NABP’s Foreign Pharmacy Graduate Equivalency Examination.

Good Moral Character means those virtues of a person which are generally recognized as beneficial to the public health, safety and welfare.

Good Standing means the pharmacist’s personal registration is not currently being sanctioned by the Board.

Graduate of Non-approved College/School of Pharmacy means a pharmacist whose undergraduate pharmacy degree was not conferred by an ACPE-accredited or Board-approved college/school of pharmacy yet was conferred by a recognized college/school of pharmacy outside of the United States, the District of Columbia and Puerto Rico. Recognized colleges/schools of pharmacy are those colleges and universities listed in the World Health Organization’s World Directory of Schools of Pharmacy, or otherwise approved by the FPGEC.

Home-study and Other Mediated Instruction means continuing education activities which do not provide for direct interaction between faculty and participants and may include audio tapes, video tapes, cable television, computer assisted instruction, journal articles and monographs.

Institutional Pharmacy means the physical portion of an organization, including but not limited to hospitals, health maintenance organizations and clinic pharmacies, whose primary purpose is to a provide a physical environment for patients to obtain health care services under the supervision and direction of a registered pharmacist and is authorized to dispense controlled substances.

Internship means the period of training under the supervision of a Board-approved registered pharmacist preceptor, which training is a prerequisite to examination for personal registration as a pharmacist in the Commonwealth of Massachusetts.

Legend Drug, Device or Gas means a drug, device or gas which by federal law must bear the legend: “Caution: Federal law prohibits dispensing without prescription.”

Live Program means a continuing education program that provides for direct interaction between faculty and participants and may include, but not be limited to, lectures, symposia, live teleconferences and workshops.

Manager of Record or Pharmacist Manager of Record means a pharmacist, currently registered by the Board pursuant to 247 CMR 6.07: Pharmacist Manager of Record, who is responsible for the operation of a pharmacy or pharmacy department in conformance with all laws and regulations pertinent to the practice of pharmacy and the distribution of drugs.

Manufacturer means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging or labeling a prescription drug.

MPJE means the Multistate Pharmacy Jurisprudence Examination. NABP means the National Association of Boards of Pharmacy.

NABP Number is a unique seven digit number issued by the National Council for Prescription Drug Programs.

NAPLEX means the North American Pharmacist Licensure Examination.

National Drug Code (NDC) Number means a nationally recognized standard which identifies drug products using a unique number issued by the United States Food and Drug Administration. The NDC number has three components: the first component identifies the drug manufacturer (“Labeler No.”); the second component identifies the product (“Product No.”); and the third component identifies the package size (“Pkg.”).

NCPDP means the National Council for Prescription Drug Programs.
Over-the-counter Drug means any drug whose availability is not restricted to an order of a practitioner.

Person means an individual, corporation, government, governmental subdivision or agency, business trust, estate trust, partnership or association, or any other legal entity.

Personal Registration means a document issued by the Board to a qualified pharmacist, under the provisions of M.G.L. c. 112, § 24, permitting the pharmacist to engage in the practice of pharmacy.

Pharmacy means a facility under the direction or supervision of a registered pharmacist which is authorized to dispense controlled substances. The term “pharmacy” shall not include institutional pharmacies or pharmacy departments except as otherwise provided in 247 CMR.

Pharmacy Department means that part of a retail store registered by the Board in which a drug business, as defined in M.G.L. c. 112, § 37, is transacted.

Pharmacy Intern means an individual who has completed two years of academic curriculum or who has standing as a student beyond the second-year class in the undergraduate academic sequence of an approved college/school of pharmacy, and who is registered by the Board to acquire, under the direction of a Board-approved registered pharmacist preceptor to whom he or she has been assigned, that practical experience which is a prerequisite to examination for personal registration as a pharmacist. A pharmacy intern may engage in the full range of activities conducted by a registered pharmacist provided that at all time he or she is under the direct supervision of a registered pharmacist preceptor.

Pharmacy Permit means a document issued by the Board to a registered pharmacist in the name of a pharmacy or pharmacy department to manage and operate a pharmacy or a pharmacy department.

Pharmacy Technician means an individual who is registered by the Board, pursuant to 247 CMR 8.02: Pharmacy Technicians, who performs pharmacy duties under the direct supervision of a pharmacist.

Pharmacy Technician Trainee means an individual preparing to be registered as a pharmacy technician who performs pharmacy duties under the direct supervision of a pharmacist.

Postgraduate means graduation and award of an entry-level degree in pharmacy from a Board- approved or ACPE-accredited college/school of pharmacy.

Practitioner means any person with prescriptive privileges as defined in M.G.L. c. 94C, § 1.

Preceptor means a registered pharmacist in good standing who has completed at least one year of the actual practice of pharmacy and who the Board has approved to supervise and direct the training of pharmacy interns and to assist in the training of other pharmacy interns.

Prescription means an order for a drug, chemical, device or combination thereof, either written, given orally or otherwise transmitted to a registered pharmacy by a practitioner or his or her expressly authorized agent, to be dispensed or compounded in a registered pharmacy and dispensed by a registered pharmacist to a patient or his or her agent with necessary and appropriate counseling.

Prescription Drug means any and all drugs which, under Federal Law, are required, prior to being dispensed or delivered, to be labeled with the statement “Caution, Federal law prohibits dispensing without prescription” or a drug which is required by any applicable Federal or State law or regulation to be dispensed pursuant only to a prescription drug order.

Prescription Device means an instrument, apparatus, implement, machine, contrivance, implant, or other similar related article, including any component part or accessory, which is required by federal law and regulations to bear the label, “Caution, Federal law prohibits dispensing without prescription” or a device which is required by any applicable Federal or State law or regulation to be dispensed pursuant only to a prescription order.

Program means an educational course, lecture, seminar, conference, session or exercise.

Registered Pharmacist (R.Ph.) means a pharmacist who, pursuant to the provisions of M.G.L. c. 112, § 24, is registered by the Board to practice pharmacy.

Restricted Pharmacy means a pharmacy licensed by the Board for the limited transaction of a drug business as defined in M.G.L. c. 112, § 37.

Universal Claim Form (UCF) means a nationally recognized standard form developed by the NCPDP used for billing prescription drug claims to insurance plans. Universal Claim Forms are available through a pharmacy’s local wholesaler.

Wholesale Distribution means distribution of prescription drugs and prescription devices to persons other than a consumer or patient, but does not include:
(a) Intracompany sales;
(b) the purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug or device for its own use from the group purchasing organization or from other hospitals or healthcare entities that are members of such organizations;
(c) the sale, purchase or trade of a drug or device or an offer to sell, purchase or trade a drug by a charitable organization described in section 501(c)(3) of the Internal Revenue Code of 1954 to a nonprofit affiliate of the organization to the extent otherwise permitted by law; (d) the sale, purchase or trade of a drug or device or an offer to sell, purchase or trade a drug or device among hospitals or other health care entities that are under common control; for purposes of 247 CMR 7.00, “common control” means that power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract or otherwise;
(e) the sale, purchase or trade of a drug or device or an offer to sell, purchase, or trade a drug or device for emergency medical reasons; for purposes of 247 CMR 7.00, “emergency medical reasons” includes transfers of prescription drugs or devices by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;
(f) the sale, purchase or trade of a drug or device, an offer to sell, purchase or trade a drug or device, or the dispensing of a drug or device pursuant to a prescription;
(g) the lawful distribution of drug samples by manufacturers’ representatives or distributors’ representatives; or
(h) the sale, purchase or trade of blood and blood components intended for transfusion.

Wholesale Distributor means a person engaged in wholesale distribution of prescription drugs or devices including, but not limited to, manufacturers; repackers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers’ and distributors’ warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

section 3
Describe the requirements for obtaining a pharmacist license via the examination process.

what if the school is not accredited

A

1- graduate ACPE-accredited and Board-approved college/school of pharmacy
- at least 18 years old
- completed an internship according to section 8
- a good moral person

2- apply to take the exam
- correctly filled by the applicant
- passport-size photograph
- birth certificate
- pay

3- take and pass both NAPLEX and MPJE.

4- score at least 75% on both exams (if not apply to take both exams again)
- if failed, reapply for the exam and take it within one year of the reapplication

if the school is not accredited
- at least 18 years old
- has a Foreign Pharmacy Graduate Examination Committee (FPGEC) Certification from NABP
- submit a certification to the board
- completed an internship
- good morals person

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

3
Describe the requirements for licensure by reciprocity.

A

in general:
1 - proof that they are licensed by examination in another state or jurisdiction and that the applicant is in good standing in all states where the applicant holds a license

2- submit a preliminary application to NABP for license transfer,

3- if the board does not approve, the applicant may in writing request the Board to review the basis of NABP’s decision.

4- The board makes the final decision

5- the fee paid is nonrefundable

if you graduated from an ACPE-accredited
1- NABP approval

2- documentation of internship experience

  1. Passing score (at least 75%) on MPJE
  2. if requested, the applicant shall personally appear before the Board to discuss any matter related to the application

5- if approved by NABP and all fee(s), unless waived are made, the applicant may register with NABP to take MPJE.

if did not graduate from ACPE accredited program
1- Receipt by the Board of an official copy of the applicant’s FPGEC Certificate from NABP

2- documentation of internship experience

3- passing score (at least 75%) on MPJE

4- if requested, the applicant shall personally appear before the Board to discuss any related matter

5- if approved by NABP and all fee(s), unless waived are made, the applicant may register with NABP to take MPJE.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

3
Explain the difference between score transfer, reciprocity and examination by license.

A

license by:

score transfer- allows you to move ahead with licensure in more than one state as soon as you pass the NAPLEX

reciprocity- you are already a pharmacist, but you are applying to practice in another state

examination- you are taking an exam to become licensed and apply to take exam to do that

:)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

3
What is the passing grade needed for each component for licensure of a pharmacist by examination.

A

75% for both NAPLEX & MPJE

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

3
What is licensure retirement?

A

uhhh, he did not go over cause we are not thinking of that right now :)

YOU’RE DOING GREAT

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

4
Provide a chart describing the expiration date of the various types of licenses and registrations (personal, business, DEA)

A

Personal
- expire on December 31st of each even-numbered year and shall be renewed before January 1st of the following year
- so every 2 years!

business (pharmacy store)
- each uneven year (or I also saw every 2 years)

DEA
- 3 years

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

4
Provide a chart with dates and requirements for reinstating a lapsed license.

A
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

4
Describe the requirements for pharmacist CE.

Be sure to include types of CE needed, max per day, Sterile, Non-Sterile, immunizations, PMP, and Collaborative Practice.

A

general:
- need 40 hours before renewal
- 20 hours a year
- at least 2 hours per year in law
- no more than 15 contact hours may be at-home study
- cannot be carried over from year to year
- do not have to complete CE in the year you graduated

need for registration renewal!

types of CE

max per day
- 8 hours

Sterile
- if you oversee are involved in sterile compounding: 5 contact hours a year

Non-Sterile
- if you oversee are involved in non-sterile compounding: 3 contact hours a year

immunizations (or vaccines)
- if you oversee are involved in immunizations: 1 contact hours a year

PMP
- for CS
- Have to file and track how much Rx the patient takes and monitor even between other pharmacies
- patient profile for RPh to keep track of what CS the patient gets
- The PMP tracks statewide Schedule II-V prescriptions. With this system in place, we can give practitioners the tools they need to make the best clinical decisions

Collaborative Practice
- RPh can have prescribing authority, and can complete a few prerequiisites and complete CE per year
- CDTM
- 247 16

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

4
How many CEs are needed per calendar year

A

20

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

4
How many CEs are needed per renewal period

A

40

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

4
What types of CEs are allowed

A

Board approved

ACPE

CME

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

4
How long are you require to keep records of CEs

A

at least 2 years from the date of completion

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

5
What are the requirements for electronically transmitted prescriptions.

A
  • can be given by an authorized prescriber
  • can be given by the agent of the authorized prescriber
  • given to the pharmacy of the patient’s choice
  • Rx must maintain patient confidentiality
  • pharmacist or pharmacy may not agree to provide to the patient a computer, facsimile (fax) machine, computer modem, or any other electronic device that will affect the patient’s freedom to choose the pharmacy they want
  • The pharmacist or pharmacy may not provide to the prescriber or healthcare facility a computer, facsimile (fax) machine, computer modem, or any other electronic device to get an incentive for referring the patient to a pharmacy
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

5
What types of prescriptions can be sent electronically?

A

CII-CVI
all prescriptions for controlled substances and medical devices must be issued electronically

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

5
Describe when an oral CII may be accepted.

A

for emergencies!
where the prescriber says
- the CII is needed for the immediate treatment of the ultimate user

  • there is no other option, not even any other CS
  • they cannot give a written Rx by the time of dispensing

where the pharmacist
- only gives enough CS for the emergency

  • sees that the Rx has everything an Rx should except for a signature
  • makes a good-faith effort to verify the Rx was given by an authorized prescriber
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

5
Describe the requirements for an Emergency Situation for oral CII.

A

for emergencies!
where the prescriber says
- the CII is needed for the immediate treatment of the ultimate user

  • there is no other option, not even any other CS
  • they cannot give a written Rx by the time of dispensing

where the pharmacist
- only gives enough CS for the emergency

  • sees that the Rx has everything an Rx should except for a signature
  • makes a good-faith effort to verify the Rx was given by an authorized prescriber
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

5
What are the pharmacist’s obligations for filling a Emergency CII?

A

where the pharmacist
- only gives enough CS for the emergency

  • sees that the Rx has everything an Rx should except for a signature
  • makes a good-faith effort to verify the Rx was given by an authorized prescriber
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

5
What is the time period required to receive a hard copy for an oral controlled substance?

A

2 days electronic, 7 days hard copy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

5
What are the requirements for a prescriber to do on the hardcopy follow-up for a oral controlled CII.

A
  • must include the additional notation, “Authorization for Emergency Dispensing.”
  • have “to document an oral prescription.” on its face
  • delivered either by mail (post marked for 7 says) or in-person
  • No written follow-up is required for schedule VI oral prescriptions
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

5
What happens if a hardcopy follow up prescription is not provided for a CII

A

if they fail to issue a follow-up written or electronic prescription within seven business days, the pharmacist is required to notify the U.S. Drug Enforcement

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

5
Describe the PMP requirements

A

Pharmacy
- applies to registered pharmacies and pharmacies in a health facility

  • give the Department the required information for each Rx according to CMR 7

Penalties
- if fails to comply with CMR 7, or state law or regulation, there will be disciplinary action

  • disciplinary action against pharmacist or pharmacy by the board or state and federal law enforcement
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

6
Describe the application process for a new pharmacy

A
  • signed by a pharmacist who wants to manage and operate a new pharmacy
  • include days and hours of operation (opening and closing)
  • separate application from the board for an MA CS registration and certificate of fitness
  • check or money order for the Commonwealth of MA Board of registration in pharmacy
  • any info. given by the board
  • a copy of the corporation’s Articles of Organization, signed and sealed by the Secretary of the Commonwealth
  • a copy of the corporation’s Foreign Corporation Certificate, signed and sealed by the Secretary of the Commonwealth
  • a statement of the name and address of each officer and director of the corporation and the position
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

6
Will the Board register a pharmacy where the owner has prescriptive privileges?

A

no

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

6
Describe the equipment and referenced need for a pharmacy

A

when inspected, the pharmacy must have:

-equipment compliant with USP

  • Massachusetts List of Interchangeable Drugs (MLID)
  • Orange book
  • current copy of compendia
  • a copy of board regulations
  • a balance that can weigh as small as 13 mg, tested and sealed by state or local sealer of weights and measured annually
  • Rx labels with name and address of pharmacy
  • sanitary appliances like sinks with hot and cold water
  • 1 bound book for recording CS sold w/o Rx
  • 1 book for recording sales of alcoholic beverages and signatures of the purchasers of alcohol
  • clean room for IV meds- closed, laminar flow, minimum 72 sq ft, hood,
  • consultation area
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

6
Explain what the patient consultation area is, are there any requirements for a sign and location

A
  • designed to provide adequate privacy for confidential visual and auditory patient counseling
  • needs a sign that says “Patient Consultation Area”
  • needs to be accessible for the patient to not have to go through the stockroom or Rx area
  • 4 by 5-inch sign
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

6
What is the minimum size requirements for a pharmacy?

A
  • There shall be a minimum working area of 300 square feet;
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

6
Describe the security requirements for a pharmacy

A
  • CS II-V stored within Rx area
  • CS VI stored within Rx area or clean room
  • CS II-V must be stored in a securely locked cabinet, or dispersed in the prescription-drug storage area throughout the stock of Schedule VI–obstruct theft
  • separate alarm activated for when the pharmacy is closed
  • secured by a floor and ceiling barrier
  • locked and alarmed separately at all times
  • pharmacy manager and pharmacist on duty control access to the Rx area
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

6
Is a sign required identifying the location as having a pharmacy

A

yes
visible to signal the presence of a pharmacy
ex: CVS Pharmacy, Wholefoods has a pharmacy sign outside

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

6
What form is used to report a theft or loss of a controlled substance

A

106

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

6
Provide a chart describing the various signs that are requirement in a pharmacy and if there are size requirements for the sign or letters, if yes what are the size requirements

A
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

6
What are the requirements for notifying the Board of a loss of a controlled substance

A
  • report within 7 days of the theft or loss
  • comply with state and local police reporting requirements
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
32
Q

6
Describe the process for a change in the manager of record

A
  • apply to the board
  • a statement saying that the old manager is handing off the complete inventory of the CS to the new manager. If the old one is not available then the staff RPh can sign off
  • application for a certificate of fitness
  • the pharmacy permit
  • required fees
  • any more info. by the board
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
33
Q

6
Provide a chart listing requirements and dates that a pharmacist needs to provide the Board. For example, how many days to report a name change, new manager of record, etc

A
  • changes his or her mailing address or name shall notify the Board in writing within ten working days
  • notification to the Board in writing of his or her termination as pharmacist Manager of Record within ten working days
  • closure of pharmacy or department is within 10 days
  • written plan of correction of violations cited in a deficiency statement within 15 business days after the deficiency statement is sent.
  • seven business days to Report Certain Factors of Pharmacy Operations
  • changes like withdrawal, discontinuance, termination, revocation, suspension, probation, or warning reported within 7 business days
  • report within seven business days of identification of all errors relating to the preparation of medications in that pharmacy inconsistent with United States Pharmacopeia
  • seven business days all abnormal results, including failure of certification as required
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
34
Q

6
Who is required to verify that a pharmacist is registered by the Board.

A

the pharmacist’s employer

or

the pharmacist Manager of Record

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
35
Q

6
What needs to be done if there is a remodel or change in the square footage of the pharmacy?

A

submit copies of its structural plans to the Board for approval.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
36
Q

6
Describe the requirements for a pharmacist manager of record

A
  • maintain necessary pharmaceutical equipment and reference
  • the proper maintenance of records as required by the Massachusetts Controlled Substances Act
  • the maintenance at all times of adequate pharmacy and pharmacy department security consistent Board regulations
  • the establishment, monitoring and enforcement of policies and procedures that encourage acceptable standards of practice
  • the establishment, monitoring and enforcement of policies and procedures which maintain the standards of professional practice
  • the maintenance of adequate staff in the pharmacy or pharmacy department in order to ensure that the practice of pharmacy
  • the maintenance of records relating to the responsibilities of pharmacy technicians
  • notification to the Board in writing of his or her termination as pharmacist Manager of Record within ten working days;
  • taking an inventory of controlled substances in Schedules II, III, IV, and V, based upon federal biennial inventory requirements,
  • the establishment of procedures for validating questionable purported controlled sub­ stance prescriptions and for reviewing existing prescription information, to deter the willful and unlawful dispensing of controlled substances.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
37
Q

6
What is a certificate of fitness, when is it used

A

certifies an individual or organization as being competent to engage in a particular work activity or industrial project.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
38
Q

6
When can a pharmacy be inspected and by whom?

A
  • before the final approval of application is granted

when inspected, the pharmacy must have:

-equipment compliant with USP

  • Massachusetts List of Interchangeable Drugs (MLID)
  • Orange book
  • current copy of compendia
  • a copy of board regulations
  • a balance that can weigh as small as 13 mg, tested and sealed by state or local sealer of weights and measured annually
  • Rx labels with name and address of pharmacy
  • sanitary appliances like sinks with hot and cold water
  • 1 bound book for recording CS sold w/o Rx
  • 1 book for recording sales of alcoholic beverages and signatures of the purchasers of alcohol
  • clean room for IV meds- closed, laminar flow, minimum 72 s
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
39
Q

6
What are the requirements for closing a pharmacy, provide a description of the process, dates for notifications, and description of how to return a license/registration

A
  • notify the board within 14 days before closing

shall provide
- The name, address, and telephone number of the pharmacy or pharmacy department

  • the pharmacy permit number
  • the pharmacy controlled substance registration number issued by the Board
  • the pharmacy certificate of fitness number issued by the Board
  • the name of the pharmacist Manager of Record of the pharmacy or pharmacy department
  • date of intended closure
  • intended procedures for closing
  • verification that customers know about the closure
  • the intended procedures for the disposal of controlled substances
  • the intended procedures for the transfer of controlled substances

within 10 days
- the pharmacy permit shall be returned to the Board

  • the pharmacy controlled substance registration shall be returned to the Board
  • the pharmacy certificate of fitness returned to the Board
  • the Board shall be notified that all controlled substances have been disposed of
40
Q

6
What happens in the event of a deficiency statement

A
  • after inspection, the board or its designees shall prepare a deficiency statement citing every violation observed
  • a copy of which shall be sent to the pharmacy or pharmacy department.
41
Q

6
What is a plan of correction?

A
  • submit a plan of correction of violations 15 days after the deficiency statement
  • includes steps to be taken
  • written to promise a correction of the deficiencies that were found during inspection
42
Q

6
Under what circumstances are you required to report improper drug dispensing to the Board?

A
  • if results in serious injury or death no later than 15 business days after discovery
43
Q

6
What is the time frame for reporting an improper drug dispensing to the Board.

A

15 business days

44
Q

6
How long are the records for an improper drug dispensing of a prescription required to be kept?

A

minimum of two years from the date the report

45
Q

6
What are the requirements under USP 795
What are the requirements under USP 797
What are the requirements under USP 800

A

795
- “component evaluation before use.”

  • visually re-inspect all components to detect any container breakage, looseness of the cap or closure, or deviation from the expected appearance or texture of the contents that might have occurred before use

797
- staff training and ongoing guidance, determination of categories, and development and implementation of appropriate policies and procedures.

800
- describes requirements including responsibilities of personnel handling hazardous drugs
facility and engineering controls
-procedures for deactivating, decontaminating, and cleaning; spill control; and documentation.
.

46
Q

6
Describe any duties to report certain factors of pharmacy operations.

A
  • report to the Board within seven business days all non-routine notices, correspondence, and disciplinary actions
  • report to the Board any adverse change in the status of accreditation, including but not limited to withdrawal, discontinuance, termination, revocation, suspension, probation, or warning. Within 7 business days
  • provide the Board with responsive documents sent from a registrant or licensee to a state or federal agency concerning reports or responses. within 7 business days
  • if pharmacy does central intravenous admixture services (CIVAS), or engages in sterile compounding, shall report to the Board every six months: total number and type of prescriptions dispensed, distribution data identifying the states in which the prescriptions were distributed, status of any non-resident licenses issued by other states, All such reports shall be accurate and comply with the Board’s reporting requirements. (c) All reports shall be accompanied by an affidavit attesting compliance with all laws and regulations pertinent to sterile compounding and United States Pharmacopeia General Chapter 797
  • if sterile compounding, report within seven business days of identification of all errors relating to the preparation of medications in that pharmacy inconsistent with United States Pharmacopeia
  • shall report within seven business days all abnormal results, including failure of certification identification of environmental contaminants or improper potency in that pharmacy inconsistent with United States Pharmacopeia
  • Failure to comply with reporting requirements will result in disciplinary action
47
Q

6
Provide a chart for the days to report certain factors of pharmacy operations.

A

always 7 business except if for central intravenous admixture services (CIVAS), or engages in sterile compounding–it is 6 months

48
Q

6
Define Serious injury and Serious Disability

A

Serious Injury
- a life-threatening injury
- results in serious disability or death
- requires a patient to undergo significant additional treatment measures

Serious Disability
- injuries requiring major intervention and loss, or substantial limitation, of bodily function lasting greater than seven days (e.g. bodily function related to breathing, dressing/undressing; drinking; eating; eliminating waste products; getting into and out of bed, chair, etc.; hearing; seeing; sitting; sleeping or walking).

49
Q

7
What federal law amendment to the Food, Drug, and Cosmetic Act required states to register wholesalers?

A

PDMA

50
Q

7
Describe the licensing requirements for wholesalers.

A

general:
- must be licensed

  • Each application shall be filled out and signed by each applicant under oath before a notary public.
  • The Board shall not consider any applications within 15 days after the date of its filing with the Board.
  • the board may conduct hearings

minimum requirements
- The name, full business address, and telephone number of the applicant or licensee

  • all trade or business names used by the applicant or licensee;
  • addresses, telephone numbers, and the names of contact persons
  • the type of ownership or operation (partnership, corporation, or sole proprietorship)
51
Q

7
What is the minimum required information for wholesaler licensure

A

minimum requirements
- The name, full business address, and telephone number of the applicant or licensee

  • all trade or business names used by the applicant or licensee;
  • addresses, telephone numbers, and the names of contact persons
  • the type of ownership or operation (partnership, corporation, or sole proprietorship)
52
Q

7
Describe the minimum qualifications the Board shall consider for issuing, renewing or revoking a wholesaler.

A
  • any convictions
  • past experiences
  • furnishing of any false or fraudulent material on the application
  • suspension, revocation or sanction
  • compliance with licensing or registration requirements
  • compliance with the requirements to maintain and/or make available to state licensing authorities
  • failure to provide adequate control over the distribution, diversion, theft, and or loss of drugs
  • compliance with everything in CMR7
  • any other factors
53
Q

7
Describe any penalties that the Board can impose on a wholesaler.

A
  • report all violations of Board regulations and statutes to the Board.
  • Every person who is licensed to conduct a wholesale drug business shall not sell or deliver drugs to any unauthorized person, whether upon prescription, at retail, or otherwise.
  • if licensed to conduct a wholesale drug business, can not package or repackage any drug for resale, or label or relabel any drug container unless under the supervision of an RPh and compliant with CGMPs
  • suspend or revoke any licenses
54
Q

7
Describe the minimum requirements wholesalers need to comply for the storage and handling of prescription drugs.
Be sure to include Facilities, Security, Storage requirements, Examination of Materials and Return of Damaged/outdated prescription drugs.

A

Facilities
- be a suitable size

  • have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions
  • have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed secondary containers that have been opened
  • be maintained in a clean and orderly condition
  • be free from infestation by insects, rodents, birds, or vermin of any kind

security
- minimal access from the outside

  • outside perimeter well-lighted
  • Rx drug areas are limited to authorized personnel
  • alarm if someone tries to get into the facility after hours
  • suitable protection against theft
  • thorough background checks for each employee
  • submit 106 if theft occurs

Storage requirements
- all Rx drugs in good temps. such as controlled room temp.

  • have a manual, electromechanical, or electronic temperature and humidity recording

Examination of Materials
- Examine outside shipping container for tampering

  • each outgoing shipment must be inspected well to ensure no damaged goods/Rx drugs

Return of Damaged/outdated prescription drugs
- shall be quarantined and physically separated from other prescription drugs until destroyed

  • tampered Rx drugs will be quarantined until destroyed
  • if the safety, identity, strength, quality, or purity of the drug is tampered with then the drug will be destroyed
55
Q

7
What records need to be maintained by wholesalers?

A
  • complete and accurate inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs
56
Q

7
Describe the Written Policies and Procedures required for wholesalers

A
  • A procedure for the oldest approved stock of Rx is distributed first
  • A procedure to be followed for handling recalls and withdrawals of prescription drugs
  • a procedure to handle any crisis that affects the security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency.
  • a procedure to quarantine outdated/damaged drugs

-

57
Q

7
Describe any other federal, state, and local laws wholesalers need to comply with

A
  • comply with federal, state, and local laws
  • permit board to inspect premises and delivery vehicles
  • deal with CS according to 94C
  • comply with salvaging or reprocessing
58
Q

8
Describe the requirements to become a pharmacy intern

A
  • at least 1500 hours of board-approved pharmacy internship - 1000 hours in a pharmacy, 500 hours either in clinical pharmacy, demonstration project, manufacturing, analytic, or industrial pharmacy
  • at least 1500 inter hours through experiential pharmacy education from an ACPE school
  • first professional year in pharmacy school
  • enrolled in PharmD program
  • good moral character
59
Q

8
Who can become a preceptor, are there any requirements and limits on the number of interns

A
  • cannot supervise more than 2 interns
  • need at least one (1) year of full-time pharmacy practice experience
60
Q

8
Describe the duties and functions of a pharmacy intern

A
  • no more than 12 hours of pharmacy internship in a day
  • hours may be acquired throughout a calendar year
  • A pharmacy intern shall wear a name tag that indicates the intern’s name and the words “pharmacy intern.”
  • may supervise pharmacy technicians while under the supervision of a Pharmacy preceptor
  • may handle hydrocodone-only extended-release medication that is not in an abuse-deterrent formulation. Only under supervision of preceptor
61
Q

8
When does an intern license expire

A

every 5 years

62
Q

8
What are the three levels of pharmacy technicians

A

Certified Pharmacy Technicians

Pharmacy Technicians

Pharmacy Technician Trainees

63
Q

8
Develop a chart detailing the duties, responsibilities/functions, testing requirements, and qualifications for each level of technician

A

Certified Pharmacy Technicians
duties
- name tag with “Certified Pharmacy Technician.”

  • make an “offer to counsel.”
  • may request refill authorizations from the prescriber or prescriber’s agent if PIC allows
  • perform prescription transfers between pharmacies for prescriptions issued for controlled substances in Schedule VI only
  • cannot administer medications or vaccines, perform drug utilization reviews, conduct clinical conflict resolution, contact prescribers concerning therapy clarification or therapy modification, provide patient counseling, or perform final patient dispensing process validation.
  • may assist in the transporting and handling of Schedule II controlled substances;

testing; cannot
- administer medications or vaccines

  • perform drug utilization reviews
  • conduct clinical conflict resolution
  • contact prescribers concerning therapy clarification or therapy modification
  • provide patient counseling
  • perform final patient dispensing process validation.

qualifications
- need a pharm. tech license

Pharmacy Technicians
duties
- wear a name tag with “pharm. tech” on it

  • offer to counsel
  • may request and accept authorizations for refills from a prescriber or a prescriber’s agent if PIC allows and info. is the same as the previous Rx

testing requirements; cannot
- administer medications or vaccines

  • perform drug utilization reviews
  • conduct clinical conflict resolution
  • contact prescribers concerning therapy clarification or therapy modification
  • provide patient counseling
  • perform final dispensing process validation.

qualifications
- need a pharm. tech license

  • at least 18
  • be a high school graduate or the equivalent or currently enrolled in a program
  • be of good moral character
  • no felonies
  • hold certification conferred by a board-approved certifying body
  • hold a license as a pharmacy technician in another state and good standing
  • achieve a Board-approved passing score on a Board-approved pharmacy technician assessment– a Board-approved pharmacy technician training program or a minimum of 500 hours as a trainee

Pharmacy Technician Trainees’
duties
- wear a name tag with “pharm. tech trainee on it”

  • perform the duties of a pharmacy technician while acting under the direct supervision of a pharmacist.
  • may not take prescriptions over the telephone.

testing
- assuming all that a certified or pharm. tech cannot do

qualifications
- be at least 16 years of age or older

  • be a high school graduate or the equivalent

-be of good moral character

  • not convicted of a drug-related felony or admitted to sufficient facts to warrant such findings.
64
Q

8
When does a technician license/registration expire

A

every 2 years on their birthday

65
Q

8
What is reciprocity registration as it relates to technicians

A

what are the requirements to be a tech:
- HS grad.
- 18 years old
- good moral behavior
- no drug felony

66
Q

8
Can a technician counsel a patient

A

no!

67
Q

8
Can a technician make the offer to counsel

A

yes :)

68
Q

8
What are the requirements for handling Schedule II Controlled Substances by pharmacy interns and each level of pharmacy technician?

A

intern
- under the direct supervision of a registered pharmacist may handle hydrocodone-only extended-release medication that is not in an abuse-deterrent formulation.

tech
- a pharmacy technician may assist in the transporting of Schedule II controlled substances
- cannot handle hydrocodone ER

certified
-may assist in the transporting and handling of Schedule II controlled substances as long as PIC allows
- cannot handle hydrocodone ER

69
Q

8
What are the duties of a pharmacist utilizing a pharmacy intern, certified pharmacy technician, pharmacy technician and trainee

A

must provide the board with:
- a list of currently employed certified pharmacy technicians, pharmacy technicians, and pharmacy technician trainees

  • a written description of the duties delegated to certified pharmacy technicians, pharmacy technicians, and pharmacy technician trainees
  • a written description of the scope of responsibility for certified pharmacy technicians, pharmacy technicians, and pharmacy technician trainees.
  • may train a tech. or trainee through an on-the-job training program
70
Q

8
Describe the supervisory ratio

A

One pharmacist for a maximum of four support personnel if:

  • one certified pharmacy technician and one is a pharmacy intern
  • at least two of the support personnel are certified pharmacy technicians
  • two of the support personnel are pharmacy interns

anyone else in the store does not count!

71
Q

8
Who does not fall under the supervisory role, explain when they could.

A
  • preceptor not more than 2 interns at a time
72
Q

8
Describe the registration and renewal of registration procedure for technicians

A
  • expires every 2 years on their birthday
  • penalties if you practice with an expired license
  • renew by filing of a renewal application and payment of an annual license
  • if expired for more than 2 years, may be required to meet other conditions
73
Q

8
When must a technician notify the Board of a change in name or address?

A

within ten business days of such changes

74
Q

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.

A

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

75
Q

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

A
  • write “VOID” on the face of Rx
  • record on the reverse of the invalidated Rx: name, address, DEA number of the pharmacy
  • record on a log, the Rx number, date of the transfer, name or ID of the RPh transferring the info. and the name of the pharmacy or pharmacy department to which the Rxs transferred
  • cancel. all refills remaining on the transferred Rx

when receiving transferred Rx
- write “transfer” on the face of the transferred Rx

  • write all info. on Rx: date of issuance of the original Rx, original refills, date of original dispensing, the number of valid refills remaining, RPh name address DEA # and original Rx number
  • receiving a transferred Rx must inform the patient that the original Rx refills have been canceled at the pharmacy or pharmacy department from which it has been transferred
76
Q

9
What are the responsibilities of the transferring and receiving pharmacy

A

update the prescription record with the following information:
the name, address, and DEA registration number of the pharmacy to which the prescription was transferred;

the name of the pharmacist receiving the transfer; the name of the transferring pharmacist; and the date of the Rx

77
Q

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

A

pharmacies or pharmacy departments on a one-time only basis except as otherwise permitted by law.

78
Q

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

A
  • write “VOID” on the face of Rx
  • record on the reverse of the invalidated Rx: name, address, DEA number of the pharmacy
  • record on a log, the Rx number, date of the transfer, name or ID of the RPh transferring the info. and the name of the pharmacy or pharmacy department to which the Rxs transferred
  • cancel. all refills remaining on the transferred Rx

when receiving transferred Rx
- write “transfer” on the face of the transferred Rx

  • write all info. on Rx: date of issuance of the original Rx, original refills, date of original dispensing, the number of valid refills remaining, RPh name address DEA # and original Rx number
  • receiving a transferred Rx must inform the patient that the original Rx refills have been canceled at the pharmacy or pharmacy department from which it has been transferred
79
Q

9
What are the responsibilities of the transferring and receiving pharmacy

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 require

80
Q

9
Who is allowed to conduct the transfer of schedules VI

A

pharmacist or certified pharmacy technician

81
Q

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

A
  • when RPh advertises the consumer price for a particular Rx drug, the advertisement shall not contain any representation of drug safety, effectiveness or indications for use

-

82
Q

9
Describe the requirements for dispensing and refilling prescriptions

A
  • 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
83
Q

9
What information needs to be placed on the pharmacy label

A

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.

84
Q

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

A

for CS III-VI:

date of dispensing

amount of drug dispensed

initials

85
Q

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

A

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
86
Q

9
How are prescriptions files maintained

A
  • 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
87
Q

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

A

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

  • Rx is authentic
  • dispensing is according to 94C
88
Q

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

A
  • 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

89
Q

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

A

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

90
Q

9
Describe how a pharmacist shall conduct a prospective DUR

A
  • 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

-

91
Q

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

A
  • offer to counsel
  • talk to prescriber
92
Q

9
Describe when counseling needs to be performed

A

for new Rx! and if patient requests

93
Q

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

A

new

94
Q

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

A

everyone can be offered regardless if they have a new Rx or not

95
Q

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

A
  • 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
96
Q

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

A

yes

97
Q

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

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