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314 Cards in this Set

  • Front
  • Back
When do C-II Rx become invalid in MA?
30 days after date of issue (1st day is after day of issue so 31 altogether)
In MA when can a C-II be refilled?
it can't
In MA how long is the day supply limited to for C-II or C-III?
30 days (except 60 days for methylphenidate or d-amphetamine for minimal dysfunction or narcolepsy)
How long of a supply is allowed for implantable infusion pumps for dosing C-II or C-III drugs?
90 days
When do all personal registrations expire?
on dec. 31st of each even numbered year
Failure to renew by the deadline results in what?
payment of registration fee plus any late fees
Failure to renew registration for a period of more than 60 days could result in what?
if personal reg. has not been revoked or suspended you may apply to the board for renewal upon satisfying any cond.s imposed by them (such as extra CEUs)
If you have failed to renew your registration for more than 2 years what happens?
have to retake law exam (MPJE)
-sometimes have to retake naplex as well
What must accompany for applications of license renewal?
a signed statement indicating satisfactory completion of req. CE
How many CEUs are req'd for each applicant?
a minimum of 1.5 CEUs (15 contact hours) for each calendar year in the two years per cycle (cannot be carried over from year to year) 30 hours in 2 least 15 each year
How many contact hour per year have to be in the area of law?
2...(so 4 altogether in 2 years)
Can the law CE hours be done online?
Not more than ? contact hours shall be acquired thru home study? So how many have to be live? at least 5 have to be live
When may one be exempted from CE?
While serving on active duty in the military (unless your practicing independent of the service)
A registrant may not earn more than ? contact hours per day? a result of "jam sessions"
Other than military service when are registrants not reqd to earn CEs?
the calendar year in which they graduate...(1st year you graduate, not first year if you wait you are not exempt)
Who must approve all programs for CE credit in advance?
the board
If a program has been approved by ? it will also be approved by the ? as well.
ACPE (national)...board
If a program is only approved by the board but not the ACPE then what does that indicate?
that the CE credit is only good for that state
4 things that CE programs must include?
1. evaluation of program content

2. methods of instruction

3. facilities

4. faculty presenters
5 things that are reqd on the certificates issued by the program sponsor?
1. # CEUs completed

2. name and address of provider

3. participant's name

4. title of program

5. date of completion
How long do CE providers need to keep program records?
minimum of 3 years
Pharmacist must keep CEU certificates for how long?
a minimum of 2 years (registration period)
Pharmacists who present approved CE programs may receive ? on a ?.
may receive credit on a one-time basis annually
If a pharmacists takes postgrad courses in pharmacy and it is ACPE accredited what can they use the school credits for?
as CE credits
DEA registration #?
1. 2 letters seven digits

2. 1st letter either A,B, or M

3. 2nd letter is 1st letter of registrants name

4. 1st 6 digits are random

5. last digit calculated
How is the last digit of a DEA number calculated?
(sum of 1st, 3rd, and 5th) + (sum of 2nd, 4th, and 6th X 2)...take the right most number of the total
MA law for electronic transmission of Rx for C-II?
same as fed...only to expedite filling...still need script to dispense

1. pts. undergoing home infusion pain tx

2. pt. in LTC facility

3. hospice
Faxes for scripts other than C-IIs?
can be treated as original
A st. specific MA law concerning orally and electronically transmitted Rxs? (concerning conflict of interest)
pharmacy can not enter into agreement concerning or offer as an incentive the provision of a computer, fax, modem etc. which could adversely affect a pt.s freedom to select the pharmacy of his choice
In an emergency an Rx for a controlled substance in C-II may be orally or electronically transmitted provided that the prescriber determines what 3 things?
1. pt.s need is immediate

2. no alternative Rx avail. or appropriate

3. it is not possible to deliver a written Rx prior to dispensing

(same as fed)
A pharmacist may dispense CIIs upon receiving an oral or fax Rx provided that what 4 things are met?
1. Qty is only adequate for emergency period (3 days tops)

2. all necessary prescribing info is attached

3. reduce oral Rx to written

4. reasonable good faith effort by pharmd to determine that Rx is valid (call md etc)

(same as fed)
Once authorization has been given for emergency dispensing what must the prescriber do (involving a written prescription)?
must get written Rx to pharm. within 7 days with the words "authorization for emergency dispensing" written on it's face
Upon receipt of a written copy of Rx for emergency dispensing what must the Rph do?
attach it to the orally transmitted Rx
If the prescriber fails to send written Rx to pharm. within 7 days what must the pharm. do?
notify the DEA, USDOJ, and the commisioner of the mass. dept. of PH

(same as fed)
The number currently known as the NCPDP number will soon be replaced by what?
NPI number starting next year
What are the 8 reqt.s that an Rph that dispenses CIIs pursuant to an Rx must transmit to the DPH or its agent?
1. Rx #

2. NCPDP (soon the NPI)

3. pt identifier, where feasible (license #, etc)

4. metric qty dispensed

5. date dispensed

6. NDC #

7. estimated days supply

8. prescriber's DEA #
After emergency dispensing and subsequent receiving of hard copy of Rx how long does the pharm. have to transmit the info to the DPH?
1st 15 days of next month
4 methods that a Rph can use to transfer info about emergency dispensing to DPH?
1. electronic device (diskette, tape, etc)

2. a universal claim form

3. if more than 25 Rx's a month, must use the 1st method

4. failure to comply may result in formal disc. action against the pharmacist or pharmacy
Who must a pharmacist submit an application to in order to open a pharmacy?
the board of pharmacy
What statement must be included on request to manage and operate a pharmacy?
scheduled hours...opening and closing time for each day of week
What certificate should accompany a request to open a pharmacy if they want to sell alcohol?
certificate of fitness
Is there a fee reqd for application to open a pharmacy?
If a corporation is incorporated in MA what must they submit a copy of with an application to open a pharmacy?
a copy of their Articles of Organization, signed and sealed by the Secretary of State
If a corporation incorporated in another state applys to open a pharmacy in MA what must they submit a copy of with their application?
a copy of the corporations Foriegn Corporation Certificate signed and sealed by the sec. of st.
What name of a corporation must be submitted with an appl. to open a pharmacy?
d/b/a name
If a corp. is not publicly owned what must be included with their appl. to open a new pharmacy?
the total amount and type of stock issued to each stockholder and the names and addresses of each stockholder
Who shall the board not register nor permit ownership of a pharmacy to?
any practititioner with prescriptive in MA no Dr.s, Vets, NPs etc.
What must be maintained of the pharmacy premises?
1. current copy or elec. version of MA list of interchangeable drugs (orange book, additional list, exception list, and latest supplements

2. current copy or elec. vsn (with quarterly updates) of a compendia appropriate to the practice setting approved by the pic

3. copy of the board of pharm. regulations

4. a balance (weigh as little as 13 mg.s)...has to be electronic

5. equipment necessary to conduct the practice of pharmacy according to standards of current edition of USP

6. Rx labels with pharm. name and address

7. appropriate sanitary appliances (sink with both hot and cold)

8. bound book for recording sales of OTC controlled substances without Rxs (technically always empty in MA)

9. bound book for recording sale of alcoholic beverages and the signatures of the purchasers (if have cert. of fitness)
What is the smallest an Rx area can be?
300 sq ft
If a central IV admixture svc wil be operated on same premises as pharmacy how much more room is reqd?
another 72 sq ft...constructed according to USP guidelines
A patient ? area must be maintained on all pharm premises?
consultation...must be designated with sign...and have adequate privacy for confidential visual and auditory pt counseling...must be accesible without pt. going into Rx area
When did consulation area req't go into effect and when must all pharm's be compliant by?
in effect in 2005 and all must be compliant by 1/1/07
What is required of equip. and publications in pharmacy?
kept up to date
4 things that must be conspicously displayed in a pharmacy?
1. pharmacy permit

2. pharmacy's mass CS registration

3. the pharmacys USDEA registration

4. Cert. of fitness (if applicable)
Pharm. must maintain sufficent amounts of medicinal chemicals and supplies for community. Indicates?
pharmacy can't refuse to stock something (such as plan B)
A pharmacy may choose not to stock what? What is the stipulation?
oxycontin...must provide adequate notification to pt.s and prescribers and provide info on alternate sources for obtaining
The pharmacy should have a working what seperate from the rest of the store?
alarm and it can close when store is open
Who controls access and is responsible for security of pharmacy?
PIC (manager of record)
Where must all CS be delivered to?
directly to pharmacy or to secured area if pharm is closed (PIC in charge)
How would you know who the PIC is when you walk in a pharmacy?
the dept. must display in legible letters not less than 1 in. high on or adjacent to the main entrance
Where must all hours of operation be posted?
at entrances of pharmacy or store
What must be distinguished clearly in posting of hours?
pharmacy hours vs store hours if different
When may a pharmacist in charge leave the pharmacy?
if they are the single staff person...they may leave temp. for necessary and appropriate breaks and meal periods w/out closing the pharmacy and removing ancillary staff from the pharmacy if the pharmacist believes that the security of the dangerous drugs and devices will be maintained in his or her absence (involves trust)
Which Rx's can and can't be distributed while pharmacist is on break?
No new Rx...only refills that have already been filled and checked and don't req. consultation
When can a new Rx be given while a pharm. is on break?
when the tech keeps a log so the pharm. can call when they get back and provide appropriate counseling
What can tech's do while pharmacist is on break?
still work and complete everything up to the final verification
Who can take orders over the phone in absence of the pharmacist?
certified techs or interns (if their is a written policy developed by the PIC)
How long can a pharmacist break be?
no longer than 30 min. during any work period of 6 hours
Where can a pharmacist go on break?
does not have to stay in pharm area but does have to stay on premises (break room, etc)
When there is more than one pharmacist on the premise what is reqd concerning breaks?
that they stagger them so that there is always supervision
What "protects" pharmacist during break?
the fact that they cannot be held resp. for or subj. to MA board of Reg and Pharm disciplinary actions for acts that he did not authorize and that they could not have prevented in their absence
Concerning their registration what must every pharmacist have?
their cert. of registration readily avail. or in a conspicous place and the original or a copy of his or her current wallet registration card
A registered pharmacist must not remain on duty for more than how many hours in a day?
12 (could work more if you split between 2 pharmacies technically)
What must a pharm. do in the event of a theft or loss?
report it (form 106) to dea and board within 7 days
What must be submitted to the board whenever the PIC is changed?
an application must be submitted to the board
What 3 things must be included in application for changing of a PIC?
1. sworn statement confirming complete inventory of controlled substances by outgoing MOR and incoming MOR (staff can do it for outgoing if there is an explanation, death, abuse, etc)

2. application for cert. of fitness if applicable

3. appropriate fee
How long does a pharmacist who manages and operates a pharmacist have to notify the board if they commence or are terminated from employment?
10 working days before quitting
If a pharmacy owner dies what does a spouse have to do to take over?
just notify the board within 5 days
Who do you notify before you change anything structurally about your pharmacy?
the board
If a pharm. changes its address what does it need?
all new permits (and return all previous permits with the application for the new one)
If a pharmacist changes his name or address how long does he have to notify the board? what must he supply?
withing 10 working days...(must supply sworn stmnt indicating name change and a photocopy of picture ID)
Where can a pharmacist not display his certificate of personal registration?
in a pharmacy where he is not employed
When do pharmacY (not pharmacIST) permits expire)?
on dec. 31st of every odd number year following the date of issue
Is their a fee every time a pharmacy applies for renewal?
When MOR is not on duty what are they responsible for?
delegating authority to another pharmacist
MOR is in charge in the maintenance of ? staff in the pharmacy for what?
adequate ensure that the practice is carried out in accordance with board reg.s and all other st. and fed laws and reg.s
The MOR is responsible for the maintenance of what records concerning techs?
records relating to the responsibilities of pharmacy tech.s as outlined in the board regulations
How often must an MOR take inventory of CII - CV?
biennial (in accordance with the reqt.s of fed. CSA)
MOR must est. procedures for validating what?
questionable RXs of CS
How many pharmacys can one pharm. be an MOR for?
not more than one at a time
If a MOR is planning on being away for more than ? days what must occur?
more than 30 interim manager must be appointed and a CS inventory needs to taken which must be signed by both
If an MOR is going to be away for more than a 100 days what must occur?
an application for a new MOR must be submitted and CS inventory needs to be taken and signed by both
What is a Certificate of fitness?
issued to MOR to use alcohol for manufacture of usp/nf prep.s and all medicinal prep.s unfit for beverage purposes.
-also may sell alcoholic bvgs pursuant to Rx of a physician
-also without Rx pursuant to a "druggist license" (obtainable from city or town govt)
What may be reqd for cert. of fitness?
personal interview with board
A cert. of fitness is only issued to who?
MOR...not transferable
Where should Rx for alc. bvgs be maintained?
in a seperate file
Can you refill Rx for alc.?
A pharmacy may not advertise the sale of what?
alcoholic bvgs
When buying alc. the purchaser must sign the bound book and indicate what?
that the use is either mechanical, chemical, or medicinal
Where must all Rxs for alc. be kept?
in bound book with all other sales of alc
What is the max. space allowed for display of alc. bvgs and where should it be located?
18 ft. in rear of store (pharmacy)
Intent to close a pharmacy must be made at least how long before actually closing?
14 days
Intent to close a pharmacy should contain what information when submitted to the board (14 days prior to closing)? (9)
1. name, address, and phone # of pharmacy

2. pharmacy permit #

3. the pharmacy CS registration number issued by the board

4. the certificate of fitness number

5. name of MOR

6. date closure will take place

7. the intended procedures for closing

8. verification that adequate advance notice of closure has been given to customers

9. the intended procedures for the disposal or transfer of CS
Within 10 days of closing a pharmacy what 4 things shall be completed?
1. pharmacy permit shall be returned to the board

2. pharmacy CS registration shall be returned to the board

3. cert. of fitness shall be returned to the board

4. notification to the board that all CS have been transferred or disposed of according to fed. regs
Any person intending to transfer CS in schedule C-II thru C-VI from one pharmacy to another has how many days to notify the board?
14 days prior to transfer at least
When transferring CS due to the closing of a pharmacy what info shall be provided to the board? (7)
1. name, add., phone of transferor pharm.

2. same for transferee pharm

3. pharm permit # for both

4. pharm CS registration # for both

5. name of MOR for both

6. date the intended transfer will take place

7. the intended security procedures for transfer of the CS
After proper notification the transfer of CS from a closing pharmacy to another may occur provided what 5 procedures are adhered to?
1. on the date of transfer a complete inventory of CII thru CV is taken in accordance with st. and fed. law

2. said inventory must be signed by transferor MOR (or assigned staff) and transferee MOR

3. both pharmacies must maintain a copy of the inventory for 2 years

4. copy of inventory must be filed with the board within 10 days or transfer

5. transferor shall not possess any CS after the date of transfer
To be eligible for personal registration as a pharmacist the candidate must have completed what? (general)
a pharmacy internship
If you drop out of school for a semester what can you not count?
can't count hours in a pharmacy towards internship hours
In terms of school when may a student be considered an intern?
completed 2 years of educ. or achieved standing as a student beyond the 2nd year in an approved school in which the candidate is CURRENTLY enrolled
To be eligible for personal registration as a pharm. in MA how many hours of board-approved pharmacy internship experience must one have?
1500 hours
Of the 1500 internship hours reqd by MA at least 500 have to be acquired where?
in a pharmacy of pharmacy related setting approved by the board
Of the 1500 internship hours reqd by MA not more than a 1000 could be acquired where?
in any one, or any combination of board-approved internships in the following areas
1. clinical pharmacy

2. demonstration project

3. manufacturing

4. analytical and/or industrial pharmacy
An internship shall be performed under what?
the direct supervision of a registered pharmacist preceptor
How many hours a day can a pharmacy intern receive credit for?
up to 12 hours (can work more but won't receive credit)
In MA when during the year can an intern accrue hours?
throughout the calendar year
Before beginning an internship persons enrolled in a pharm school must submit what to the board? What 3 pieces of info should it include?
an application with

1. name, address, DOB

2. recent passport sized photo

3. cert. stmt by an approved college official indicating the applicant has achieved standing beyond the 2nd year of standard college of pharmacy curriculum
What is the FPGEE?
foreign pharmacy graduate equivalency exam
Graduates of non-approved colleges of pharmacy must have what to provide with their application to the board?
need to provide a copy of authorization by NABP to sit for FPGEE issued within the preceding year
An intern who has graduated from a school of pharmacy may continue to act as an intern for how long?
until they register as a pharmacist
Will the board grant credit for out-of-state internship?
yes, if a cert. of approval issued by the jurisdiction where the internship was acquired accompanies the application
What is an intern capable of doing in a pharmacy?
anything the pharmacy can do...with the permission of their Rph preceptor
What must a pharmacy interns name tag bear?
his name and the words "pharmacy intern"
An ? can supervise ?. But a ? can not supervise an ?.
interns can supervise techs. but techs cannot supervise interns
(interns supervising techs must be under the direct supervision of an Rph preceptor)
A registered pharmacist can only directly supervise how many interns per shift?
2 (can have more interns but can only supervise 2 per shift)
When may an intern be prohibited from taking the exam or personal registration as a pharmacist?
if they have engaged in conduct in violation of fed/state laws and/or regulations
5 requirements that need to be met for registration as a pharmacy TECHNICIAN?
1. at least 18 yo

2. must be high school grad or equivalent

3. good moral character

4. no drug related felonies or admitted to such facts to warrant such findings

5. succesful completion of board approved technician training program
A board approved technician training program must cover what 7 theoretical topics at least?
1. job descript.

2. security

3. med. abbrs.

4. routes of admin.

5. product selection

6. final check by pharm.

7. guidelines for use of pharm techs
3 board-approved pharmacy technician training programs?
1. one accred. by the amer. soc. of hlth systems pharmacist

2. one provided by a brand of the US Armed Services or PHS

3. program approved by the board that includes a min. of 240 hours of theoretical and practical instruction (with a min. of 120 hours of theoretical)
How many hours of employment must one complete as a pharm. tech. trainee before becoming a pharm tech?
How many exams must a pharm. tech. take prior to becoming one? name them.

1. board-approved pharm tech assessment exam administered by the employer


2. board-approved national certification examination
5 req.s of board approved pharm tech assessment exam administered by employer?
1. practice settings

2. duties and responsibilities of ph. tech

3. laws and regulations

4. drug identification, dosages, routes of admin., and storage requirements
What must a pharmacy technician wear while on duty?
name tage with name and words "pharmacy technician"
What offer may a tech relay to patient?
"offer to counsel"
Circumstances under which a tech may accept or request authorization for refills from prescriber or prescribers agent?
with pharmacist on dury approval and only if no info has changed from the previous Rx
What 7 things can a Tech NOT perform?
1. drug utilization review

2. conduct clinical conflict resolution

3. contact prescribers concerning drug order clarification or therapy modification

4. provide patient counseling

5. dispensing process validation

6. receive new RX orders

7. conduct Rx transfers
4 reqts of pharmacy tech TRAINEEs?
1. 16 yo

2. HS graduate or equivalent

3. good moral character]

4. not been convicted of drug related felony or admitted to such sufficient facts to warrant such findings
Name tag of pharm. tech. trainee must include what?
name, words "pharmacy technician trainee"
Pharm. tech. trainee may not take what over the phone?
The max. service as a trainee is what? What are the 2 exceptions?
1000 hours...unless under 18 or permission from the board
Do people need a ged or diploma to work as an intern?
no, just need to be enrolled in a program working towards an equivalent
Does a college of pharmcacy student who is not registered as an intern have to register as a pharmacy technician?
yes, if a student not registered as an intern reaches the 1000 hour maximum # of hours allowed as a pharm. tech. trainee, the student is reqd to take a board-approved examination and apply for registration as a pharmacy technician
In what capacity can a person under age 18 work in a pharmacy?
a person who is at least 16yo. may be employed as a tech. trainee, provided that they are a high sch. grad (or ged) or CURRENTLY ENROLLED in a program which awards a diploma or certificate-to encourage a high school senior or junior to consider a career

Request and accept new Rx authorization

yes* no no

(provided the pharmacist on duty approves)

Request and accept refill authorization

yes* yes* no

(provided the pharmacist on duty approves)

Enter Rx data into a data processing system

yes yes yes*

(provided the pharmacist on duty approves)

Transfer CII - CV

no no no

transfer C-VI Rx

yes no no

take a stock bottle from the shelf for an Rx

yes yes yes*

(provided the pharmacist on duty approves)

reconstitute an Rx

yes yes yes*

(provided the pharmacist on duty approves)

Affix label to the prescription container

yes yes yes*

(provided the pharmacist on duty approves)

Prepare unit-dose, modified unit-dose and medication cards

yes yes yes*

(provided the pharmacist on duty approves)

make the offer to counsel

yes yes yes*

(provided the pharmacist on duty approves)

bulk compounding

yes yes yes*

(provided the pharmacist on duty approves)

assist in transport of C-II controlled substances

yes* yes* no

(provided the pharmacist on duty approves)

assist in handling of C-II controlled substances

yes** no no

(provided the pharmacist on duty approves and the approval is documented in written policies and procedures made available to the board upon request)
10 pharmacy display reqts.?
1. pharmacy permit

2. pharmacy's MA controlled substance registration

3. pharmacy's U.S. DEA controlled substance registration

4. Cert. of fitness (when applicable)

5. name of MOR at the main entrance of the pharmacy or dept. in word's not less than one inch high

6. a reasonably sized sign affixed to the main entrance of the business in an easily observable area identifying the presence of a pharm. or pharm. dept.

7. the hours of operation at all customer entrances

8. a sign at least 11 inches in ht. and 14 inches in width informing customer's of their rights to counseling by a pharmacist...including the drive thru

9. name tags with job title on all personnel

10. Each full-time pharmacist's certificate of registration to practice pharmacy and the original or copy of the current wallet registration card
Do part time pharmacists need to post their cert. of registration to practice pharmacy?
no...just need to carry their license ("the original or copy of the current wallet registration card")
Does a pharmacy need to have a copy of facts and comparisons on site?
not necessarily...but they do need a compendia with quarterly updates (can be electronic) appropriate to the practice setting approved by the MOR
Is a current copy of the Board Regulations reqd on premise?
yes (a current copy or electronic version)
Other than F&C (or equivalent compendia) and a copy of the Board Regulations...what other 5 references are to be maintained on the pharmacy premises?
A current copy or electronic version of the Massachusetts List of Interchangeable Drugs (MLID), including the Orange Book, Additional List, Exception List, and the latest supplements to all.
Does the board/law require a pharmacy to have an electric balance?
no...just implies it because balance has to be sensitive enough to weigh as small as 13 mg
What kind of sink is reqd n the pharmacy?
hot and cold running water
In addn to 300 sq ft reqd for pharmacy what is the minimal working area for an IV room?
72 sq ft
Reqts. of IV room?
72 sq ft...clean room adj to Rx area...closed on all sides but door...laminar flow hood...under positive pressure unless hood is self-venting
Where do you have to keep CII - CV?
stored w/n Rx area in a locked cabinet or dispersed throughout the C-VI controlled substances in a manner that obstructs theft or diversion
How ofter is inventory of CII - CV?
What are the Rx file reqts in MA?
1. CIIs


3. CVI
Can a non-emergency CII substance be prepared in advance?
yes, however cannot be advanced until the original signed Rx is presented to the Rph and compared to the prepared Rx before being released to the pt
Who can counsel?
pharmacist or intern under direct supervision of the pharmacist
3 reqts of cert. ph. technician?
1. must be registered by the board

2. must be certified by a board-approved certifying body

3. must maintain certification
If a cpht's certification lapses what must he function as?
must fn as and be counted as a non-certified tech for supervisory ratios
What must a cpht's name tag read?
name and words "certified pharmacy technician"
Can a cpht relay a pharmacist's "offer to counsel"?
Can a cpht request refill authorizations from prescriber or agent?
Concerning new Rx's what can a cpht do that is a step above an uncertified tech?
with permission of Rph on duty they may receive NEW or OMITTED Rx info from prescriber
Cpht can with the approval of Rph transfer between pharmacies CS in which category?
C-VI only (non-narcotics)
5 things a cpht cannot do?
1. perform Dur

2. conduct clinical conflict resolution

3. contact prescriber regarding Rx clarification or tx modification

4. provide counseling

5. perform final Rx validation
Accountability for CII CS is the direct responsibility of whom?
the pharmacist
With rph approval who may assist in transporting CII?
techs and certified techs
Can tech or certified techs handle CIIs?
What is transporting?
taking off the shelf to the counter
What is handling?
taking the pills out of the bottle
Who may be involved with record keeping of CIIs with permission or rph?
MOR utilizing support personnel must provide to the board upon request what 2 pieces of documentation?
1. list of currently employed certified techs, techs, and tech trainees

2. a written descript. of the duties delegated to these personnel
Can techs and trainees be trained "on the job"?
supervisory ratios of Rph support personnel 1:4? (reqts)
one rph for up to 4 personnel

- at least one of the four is cpht and one is an intern


-at least two of the four are cpht
Supervisory ratios of Rph support personnel 1:3?
one rph for up to 3 support personnel provided that

-at least one of the three is cpht or an intern
How many intern's allowed per pharmacist? if you have one pharmacist you can't have 3 interns
Who are not included in the ratio?
any techs or other personnel that do not fill, work behind the counter, or help the pharmacist in any professional capacity
how often do tech registrations expire?
every two years on their DOB
When may a lapsed registration by a tech be renewed?
upon filing an application, payment of back fees and late fee
If a techs license has lapsed more than TWO years what do they have to do?
meet reqt set forth by the board (need to take exam again, etc)
What must a tech carry evidence of?
current registration or have readily available at all time at place of employment
If tech moves how long do they have to notify the board?
within 10 business days
Can a rph redispense previously dispensed meds?
Can a rph ever enter into agreement or arrangement offering rph svcs for rebates or commissions?
Can an rph dispense Rx drugs by mail or common carrier?
Can a pharm. provide a practitioner with Rx blanks with a pharm. name on it?
A rph has to keep a perpetual inventory of each cs in CII which the rph has done what with? How often does this need to be reconciled?
every CII they have received, dispensed, or disposed of in accordance with the law...reconcile at least once every 10 days
Can a rph limit services to a particular segment of the public?
no...unless permitted by law
When can a rph refuse to compound?
they cant...unless extenuating circumstance
Can a rph purchase drug samples?
no...not for any reason
When transferring an Rx in CIII - CV what must the transferring pharm do to the RX?
1. void original Rx

2. record the name, address, and DEA # or pharmacy to which the Rx was transferred and name of Rph receiving the info

3. record the date of transfer, name of Rph transferring the info

4. cancel all refills remaining on Rx
What shall the receiving Rph complete for a transferred CIII-CV Rx?
1. write the word transfer on the face of the Rx

2. the date of issuance of the original Rx

3. the original # of refills authorized

4. the date of original dispensing

5. the # of valid refills remaining

6. transferring pharmacy's name, address, DEA# and original Rx number and the name of the transferring Rph

7. inform pt. that original Rx and refills have been cancelled
For C-VI (non-narcotic) what must the transferring Rph OR cpht do?
1. record the Rx #

2. record the date of transfer

3. record the name of the rph transferring the info

4. record the naem of the pharmacy to which it is being transferred

5. cancel all refills remaining on the transferred Rx
For C-VI what must receiving rph or Cpht do?
1. write the word transfer on the face of the RX

2. the date of issue of the original Rx

3. the original # of refills authorized

4. the date of orig. disp

5. the # of valid refills remaining

6. the pharmacy's name, address, and orig. Rx # and name of transferring Rph from which it was transferred

7. inform the pt that the original Rx and refill has been cancelled
How many times may schedule CIII - CV be transfered?
1 time only
For how long can C-VIs be transferred?
within one year from date of issuance
Both the original and transferred Rx's must be maintained for how long?
two years from date of last refill
When advertising Rx drugs with price what needs to be included?
1. trade and generic name

2. strength, dosage form, and qty

3. total price to patient

4. may include info about other services offered provided that they are not false, or misleading
If an Rx is written for a generic name what must the Rph indicate?
the name of the manufacturer, distributor, packer or repacker on RX
Who may receive new Rxs over the telephone?
only rph, interns, and cpht (who have the rph approval)
Rx files in MA?
1. C-IIs seperate

2. C-IIIs - C-Vs seperate

3. C-VIs and Rxs for syr. and needles seperate from rest maintained together in a sep file
How long must records for all pt.s whom have had dispensed Rxs be kept for?
not less than 12 months from date of last entry
What should a pt.s record include?
1. name

2. address

3. phone

4. dob

5. gender

6. drug allergie/rxns

7 med history

8. any pertinent comments reg. therapy
Prospective DUR by Rph? (9)
1. over-under utilization of meds

2. tx duplication

3. drug-disease contraindication

4. drug/drug intrxn

5. correct dose/duration of tx

6. potential allergies

7. clinical abuse or misuse

8. any sig. change in drug,dose, or directions

9. consult with prescriber as necessary for resolution
Does an offer for Rph counseling need to be made to all customers?
no...just those with new Rx
How large do the letters have to be on a right to counsel sign have to be?
no less than .5in high
What a counsel sign should say?
"dear pts, you have the right to know about the proper use of your medication and its effect. if you need more information please ask the pharmacist."
9 reqts of pt. consultation?
1. name and desc. of med

2. dosage form, dosage, rt. of admin.

3. duration of tx

4. any special directions for prep, admin., or use

5. common severe side/effects, pot. interactions, contraindications, precautions (including OTC meds)

6. pt. monitoring of drug therapy

7. storage

8. refills

9. what to do if missed dose or adverse rxn
Offer to counsel must be made to whom?
the user or ultimate pt...whether in person, by phone, writing
In hosp. settings who is counseling reqd for?
outpt.s or those being discharged...but not inpt.s
Cert. tech.s and techs can request refill info but who can not?
If an audit reveals a CE deficiency of CE < 5 hours what will be reqd?
rph will have to complete 3 hours for each deficient hour
If an audit reveals a CE def. of CE > 5 hours what will be reqd?
rph will have to complete 3 hours for each def. hour AND the board may initiate formal disciplinary proceedings or suspend the license for a min. of 2 weeks
A med pak needs what info?
day and time med is to be taken, exp date of 60 days (or less if med expires sooner)
What is the beyond use date for a dispensed drug?
one year unless the drug actually expires before then
If two different meds used to fill an Rx how do you date it for exp?
if either med expires in less then a year then you go by that...other wise a year
What are the exception to the re-dispensing rule?
can redispense meds from a LTCF (need written policies on premise)
If LTCF is returning drugs does it have to be to the same pharmacy?
When LTCF returns drugs what are the reqts concerning the exp. date?
have to have a min of 3 months (90 days) remaining on the beyond use date or exp. date (whichever is earlier)
Even with LTCFs what meds cannot be returned/redispensed?
1. temp sensitive (refrigeration)

2. misbranded or adulterated

3. compounded or reconstituted

4. no CII-CV

5. no pkg comprimised
What rph may admin. influenza vaccine?
rph who have completed duly accredited training may administer injectable influenza vaccine as well as FLUmist, intranasal flu vaccine
What is recommended of rph who admin. flu vaccines?
cpr training
What is it recommended that pharmacist who admin. flu vaccine report?
# doses admin. to DPH
How long can a rph refill Rxs for a Dr that has stopped practicing?
90 days (refills)(each refill should be limited to 30 day supply)
Do you have to be a pharmacist to be a wholesale druggist?
Who are cardinal regional distributors?
not manufacurer...not retail...a go between
For licensure as a wholesale druggist what must be given to the board?
an application with notarized signatures
What info is on appl. for wholesale druggist?
1. name, full business address and tel # of the applicant

2. all trade or business names used by the applicant

3. addresses, tel #s, and names of contact persons for EACH FACILITY used by the appl. for the storage, handling, and distribution of Rx drugs

4. Type of ownership

5. indication of types to be dispensed (Rx, OTC, schedules, etc)
A person who is licensed to conduct a wholesale drug business can not operate as a pharmacy? explain.
can sell or deliver drugs to any unauthorized person upon Rx, retail, or otherwise
As far as packaging goes what can a wholesaler not do?
can't package or repackage any drug for resale, nor label or relabel any container...not a repacking plant
What is important for drug integrity in their storage?
temp. and humidity
What is a quarantine area at a place where drugs will be stored, warehoused, held, or displayed?
area where expired, damaged, deteriorated or otherwise unsaleable drugs may be stored
What is an adjudicatory hearing?
a FORMAL admin. hearing conducted to determine the truth and validity of complaints filed against a registrant/license
What is a complaint?
a COMMUNICATION filed with the board that after investigation, the board merits further consideration of action (so if they don't look into it they don't consider it an offical complaint)
What is an Investigative conference?
an INFORMAL discussion relating to a complaint held at any time prior to the commencement of a formal proceeding. Timely notice shall be given by the Board and a general statement of the nature of issues to be discussed shall be included.
What is an order to show cause?
a document served by the board upon a registrant/licensee ordering that person to appear before the board for an adjudicatory hearing.
What is a Grounds for Complaints?
acts that indicate that the registrant/licensee is in violation of relevant provisions of federal/st. laws and/or regulations
What is disposition by the board?
(board's decision)...after receipt of a complaint and all related investigative materials, the board may schedule an investigative conference or an adjudicatory hearing
When there is a dismissal of a complaint what goes on the record of the pharmacist?
What is an advisory letter?
an official written doc. retained in the board's files delineating concerns with the reg/lic.s professional practice of conduct

-NOT a formal disciplinary action
What is a Reprimand or Censure of the Registrant/Licensee?
-A reprimand is a FORMAL disciplinary action.

-A censure is a SEVERE reprimand (a higher level of reprimand)
What is probation?
a disc. action consisting of a period of time during which the registrant/licensee may practice under cond.s imposed by the board pursuant to a formal adjudicatory hearing or consent agreement

-can still practice just being watched

-may have restrictions, like don't work alone
What is Suspension/Revocation?
-a disc. action consisting of a period of time where the personal registration, pharmacy permit, license or CS registration is inactivated
What is consent agreement? what things must in include?
an official doc. stating the cond.s agreed upon by the board and the reg/lic. in response to the resolution of a complaint against said reg/lic.

1. signed by reg/lic and the board

2. recite the facts upon which the agreement is based

3. shall incl. provisions addressing reinstatement and any cond.s the board may impose

4. agree that you won't fight it in court (not subj. to judicial review)

5. be place in the reg/lic.s permanent file in the boards records (will show up in other states)
If you are licensed in 2 states and violate the law in one what can happen in the other?
you will probably be investigated and probably receive the discipline
Who are MA CS registration cert.s issued to?
pharmacies or wholesale drug business
Applicants for a MA CS reg. cert. must already have a what?
a valid and current DEA registration cert.
When do MA CS registrations for retail pharmacies expire?
on 12/31 of odd numbered years
When do MS CS reg. for wholesale drug businesses expire?
on 11/30 or EACH year
What is a restricted pharmacy?
-a board registered pharm. for the limited transaction of a drug business for svcs, only to beneficiaries of a trust, fund, pension plan, combination plan or profit-sharing plan.

-may limit it's operation to specific schedules

-can not operate as a retail pharmacy
What is a nuclear pharmacy?
under the direct supervision of a pharmacist and reg. by board to ONLY dispense radiopharmaceutical drugs
What is a qualified nuclear pharmacist?
a rph who is empl. in a nuclear pharm. and who has submitted evidence satisfactory to the board that he meets the min. reqts. in regard to educ., training and experience, and who has received from the board an official letter stating that he has been qualified
3 publ.s reqd at nuclear pharm.?
1. most recent USP and supplements

2. Remington's

3. Current texts on practice of nuc. pharm. and radiation safety
10 pieces of equipment reqd for nucl. pharm.?
1. dose prep station

2. dose calibrator

3. exhaust hood and filter system

4. fridge for exclusive storage of radioactive chemicals

5. chromatographic app. for qlty assurance

6. portable radiation survey meter (0.005 microcuries)

7. area/room radiation detection monitors

8. personal dosimeters

9. scintillation analyzer

10. supplies for dispensing (sterile multi-dose vial, syr.s, alc. swabs, adequate shielding for dispensed doses)
When does reg. for nuclear pharmacy expire?
12/31 each odd year
What must be done with radioactive doses not administered?
must be returned to pharm. for proper disposal as est. by NRC
Can a nuclear pharm. also operate as a retail pharm.?
3 educ. reqt.s for Nuclear pharmacists in MA?
1. currently registered as pharm. in MA

2. 200 contact hours formal ed. in area of radiopharmaceutical prep. and handling with NMT 60 of these hours in laboratory training

3. a min. of 3 months of full-time, or 500 hours of actual on-the-job training in the field of radiopharm. drugs and svcs under the supervision of a qualified nuc. pharm. or in a structured nuc. pharm. training program of a board-approved college/school of pharmacy
What is a petition for waiver?
a special or limited-use pharmacy permit. when the scope, degree, or type of pharmacy practice is of a special, limited or unusual nature as compared to a reg. pharmacy service

-different from restricted pharmacy (serve a pop)

-these serve a specific disease
What does CQI stand for?
continous quality improvement program
What is a CQI?
a system of standards and procedure to id. and evaluate quality related events and improve pt. care
What does QRE stand for?
Quality related event ("errors")
What is a QRE?
the incorrect dispensing of a prescribed med. that is RECEIVED by a pt.

-includes (but not limited to)

1. incorrect drug

2. incorrect strength

3. incorrect dosage form

4. dispensing to the wrong pt

5. providing inadeq./incorrect pkg, labeling or directions

-failure to id and manage

1. over-utilization

2. therapeutic duplication

3. drug-disease contraindications

4. drug-drug interactions

5. incorrect drug dosage or duration of tx

6. drug-allergy interactions

7. clinical abuse/misuse
6 reqts of each pharmacy in relation to a CQI program for QREs?
1. indiv. resp. for monitoring CQI compliance at each pharm.

2. id. and doc. all QREs

3. minimize the impact of QREs on pt

4. analyze data collected in response to QREs to assess causes and any contributing factors

5. use findings of analysis to formulate and dev. pharmacy systems and workflow processes designed to prevent QREs

6. provide ongoing educ. at least annually in the area of CQI to pharm. personnel
A rph making a discovery of a QRE or having been informed of a QRE shall do what 3 things?
1. notify pt. or rep, the prescriber (if feel need), and other tx team members

2. provide directions for correcting the error

3. immediately provide instructions for minimizing the neg. impact on the pt.

-GENERAL RULE: if pt. took wrong med you need to notify the prescriber/physician, family, pt. etc.
When should a QRE be documented?
on the same day that the Rph becomes aware of it
What is 105 CMR 720?
inv.s the DPH...MA interchangeable Drug Regulations
What is purpose of MA interchangeable drug regulations?
to est. a formulary or list of interchangeable drg prod.s so that consumers may realize cost savings of buying less exp., safe products
What does 105 CMR 720 est. a list of?
interchangeable drugs that a pharm MUST interchange an available less exp. drug other than that written by prescriber (unless they write NO SUBSTITUTIONS) in the space below the signature line of the Rx blank
What are Bioequivalent drug products?
generics whose rate and extent of absorption do not show a signif. difference from brand names or other brands
Bioequiv. is esp. important for what?
those drugs with a narrow ther./toxic dosage range
What is a generic name?
a non-proprietary or common name used to id a drug as listed by the US Adopted Names Council and the USP in the USAN/USP Dictionary of Drug Names
What is a trade name?
a proprietary name and trademark, owned by a specific pharmaceutical company (can be a generic company)
What are Pharmaceutically Equivalent Drug Products?
drugs that contain the same active ingredients and are identical in strength or concentration, dosage form and route of administration
What are Therapeutically Equivalent Drug Products?
drugs that are pharm. equiv., met applicable standards for strength, quality, purity, and identity and are bioequivalent?
What is MLID aka?
MA List of Interchangeable Drugs
What is the MLID
recommended additions and deletions from the state drug req.s interchange of less exp., ther. equivalent drug products listed in the MLID
How many members are on the formulary commission?
9 members appt. by the governor
Who makes up the 9 members of the formulary commision?
-a clinical pharm

-a pharm. chemist

-a clinical pharm

-a retail pharm

-a person with experience in pharmaceutical manufacturing

-2 practicing physicians

-2 persons not involved in the del. of Hlth svcs (reps of the needs to rep elderly)
How long is the term for the 9 members of the formlary commision?
3 years
What drugs are incl. in MLID?
those products considered by the FDA to be ther. equiv. to other pharm. equiv. products listed with the same generic or chm. name according to the most recent addn. of "approved drug products with ther. equiv. evaluations" and it's supplements.
What is the Orange Book also known as?
Approved Drug Products with Therapeutic Equivalence Evaluations"
The orange book is pub. by who and how often?
by FDA...annually...with monthly supplements
Orange book uses what 2 designations for drugs?
"A" or "B"
What are the A drugs in the orange book?
"A" rated drugs are considered to be ther. equiv. and may be interchanged
What are the B drugs in the orange book?
"B" rated drugs are not ther. equiv. and may not be interchanged
What is the second letter besides A or B?
refers to a variety of stuff (dosage form, delivery system, rating status, etc)
What is the MA ADDITIONAL List of Interchangeable Drugs?
drug products specified on a list est. by the Dept. for which the Commision has determined that bioequiv. is not essential or if it is essential that it has been established.
What is the MA EXCEPTION List of Interchangeable Drugs?
a list of "A" rated drugs that MA will not allow to be interchanged (currently nothing on this list)
3 drugs products specifically excluded from the MLID?
1. bioequivalence essential but not established

2. products subject of patent rights issues for which provision by other than the patent holder would violate the patent

3. products available from oly one manufacturer at one price
In terms of MA Interchangeable Drug Relations what must an Rx blank have on it?
a single signature line...and must incl. in the lower right hand corner of the form the phrase "Interchange is mandated unless the practitioner writes the words "NO SUBSTITUTION" in this space
If pract. fails to sign his/her name on the signature line what happens to the Rx?
invalid...does not get filled
If an Rx is for a pt. on MA medicaid (Mass Health) what must the addition write if they do not want any substitutions?
"NO SUBSTITUTION" + "brand name medically necessary"
If an Rx bears a generic name with no indication of the manufacturer what may the Rph dispense?
-any product that bears that name from any manufacturer even if the prescriber writes "No Substitution" in the designated space
When taking an oral Rx for a brand name drug product, what shall a pharm. ask about substitution?
if the doc wants "NO SUBSTITUTION" to be marked on the RX
In times of Medical Emergencies what can a pharm. do regarding "NO SUBST."?
can fill with generic...or may dispense more expensive brand if generic is marked on the label (if they don't have what's indicated)

-Have to record date, hour, and nature or emergency and have pt. sign Rx
-pt. needs to accept deviation from the law
What 10 things are required on an Rx label?
1. date of original filling

2. pharmacy name, address, and phone #

3. rph initials

4. assigned serial number

5. name of pt

6. name of prescriber

7. drug name, qty dispensed, directions for use

8. C-II, III, or IV need "Federal Caution Label"

9. exp date


Interchange or IC: (generic name and mfgr)
Interchange or IC (less exp. brand name)


Interchange or IC (generic name plus mfgr)
How may the brand name for the prescribed drug product appear on the label?
Interchange or IC (less expensive brand name)


(generic name plus mfgr) for (brand name of drug prescribed)