law exam 2 - policies, ACPE & CS examples Flashcards
how many CEs must be completed in a year?
who is exempt from this
when must it be completed by
at least 20 contact hours of CE
Except for CDTM pharmacistswhich have to complete 25 in total
including specialized topics/requirements below
must be completed by December 31 of each calendar year.
can CEs be carried on from one calendar year to another
how many CE hours can be completed in 1 calendar day
how many contact hours must be live
how many contact hours must be in law
Contact hours may not be carried over from one calendar year to another.
A maximum of 8 contact hours may be claimed each calendar day.
At least 5 contact hours must be “live”.
At least 2 contact hours must be in the area of pharmacy law (does not need to be Massachusetts-specific or “live”).
what types of credit does the board accept
For any non-ACPE / ICPE credits that will not appear on your CPE Monitor profile, pharmacists must retain documentation (i.e., certificates of completion) of completed programs that must include what
The Board accepts the following types of credit: Accreditation Council for Pharmacy Education (“ACPE”), Interprofessional Continuing Education (“IPCE”), AMA PRA Category 1 Credit, and any U.S. pharmacy Board approved programs.
includes:
participant’s name;
title and activity number of the program;
credit type (e.g., ACPE, etc.);
name of the authorized provider;
whether the program was obtained in a “live” or “home study” format;
date of completion of the program; and
number of contact hours earned.
All pharmacists, including non-resident pharmacists practicing immunizations, compounding, CDTM must do what
what must a pharmacist do if they failed to complete the requisite number of contact hours
are contact hours required in the calendar year that a pharmacist graduated
MUST complete immunization, compounding, Collaborative Drug Therapy Management, and other CE requirements if they oversee or engage in these practices, as applicable.
A pharmacist who has failed to complete the requisite number of contact hours must email the Board with a detailed statement explaining the reasons.
Pharmacists who have obtained their Massachusetts license via exam or transfer on or after October 1 will be granted a grace period through April 30 of the next calendar year to obtain all required contact hours for the previous year;
Contact hours are not required for the calendar year of graduation from an ACPE accredited college / school of pharmacy.
how many contact hours do immunizing pharmacist have to complete
how many contact hours do CDTM pharmacist have to complete
How many contact hours do CDTM pharmacists with prescriptive authority have to get
how many contact hours to sterile compounding pharmacists have to get
how many contact hours to non-sterile compounding pharmacists have to get
do the 5 sterile and 3 non-sterile complex compounding CE contact hours count for the 20 years that are needed by 12/31 of that year
what do both sterile and non-sterile compounding pharmacists have to be trained in
1 contact hour
In CDTM: 5 additional contact hours (i.e., a total of 25 contact hours yearly); that address areas of practice generally related to the specific collaborative practice agreement.
CDTM pharmacists with prescriptive authority are also required to obtain at least 1 contact hour of pain management training every 2 years.
Each calendar year, pharmacists MUST complete 5 contact hours in the area of sterile compounding
Each calendar year, pharmacists MUST complete 3 contact hours in the area of complex non-sterile compounding
The 5 sterile or 3 complex non-sterile compounding CE contact hours may count towards the 20 contact hours required for each calendar year and may be completed as home study or in live format.
sterile is trained in USP 797
Non-sterile is trained in USP 795
what are the temps for the Refrigerator and freezer
what kind of fridge or freezer must a pharmacy use, what kind of fridge is not permitted
what must the units be and what cycle should it have
what must the thermometers be
how often should the temps be documented, what must pharmacy do if it is closed
what must each log have
what is considered good circulation around the outside of the unit
Refrigerator: between 36ºF to 46ºF (2ºC to 8ºC)
Freezer: between -13°F and 14°F (between -25°C and -10°C)
Utilize a combination refrigerator / freezer, standalone refrigerator, or standalone freezer. A unit that contains a freezer compartment within the refrigerator space, such as a dorm-style refrigerator, is not permitted.
Utilize thermometers that have a certificate of calibration testing from an accredited laboratory
Review and document temperatures of each unit at least twice daily.
On any days the pharmacy may be closed, the pharmacy must have a mechanism in place to identify any temperature excursions.
each temperature log must identify the corresponding refrigerator or freezer unit, identify the reviewer (e.g. name or initials), and be readily retrievable upon request.
As recommended by the CDC, promote good air circulation around the outside of the unit:
- allow for space on all sides and top;
- allow at least 4 inches between the unit and the wall;
- do not block motor cover; and
make sure there are at least 1 to 2 inches between the bottom of the unit and the floor.
what must fridge not be and how must inventory be organized
what standard should the fridge follow
where should biologics be stored
what should not be stored in a fridge
what must containers of waters be labeled with
unit must not be overstocked, and inventory must be organized to allow for proper air flow. Cardboard or solid plastic shelving must not be utilized as they would impede proper air circulation.
follow USP 800 or board regs.
Store biologics in a separate unit, or at the bottom of the unit, to reduce the risk of contamination to other products.
NOT store food or beverage products in refrigerators or freezers used for medications.
Containers of water may be used for temperature stabilization as long as they are labeled “Do NOT Drink”.
when can an Rx be issued?
what must you utilize when evaluating processing CS Rx
prescriptions must be issued under a valid patient/prescriber relationship and for a legitimate medical reason by a prescriber acting in the usual course of his / her professional practice.
Utilize the Prescription Monitoring Program (“PMP”) when evaluating and processing controlled substance prescriptions. The Massachusetts PMP (“MassPAT”) is a tool that supports safe prescribing and dispensing
When evaluating a prescription, consider the following points as potential “Red Flags,” indicating the potential for misuse and diversion:
Prescriber is located at a great geographic distance from the pharmacy.
Patient lives a great geographic distance from the pharmacy or prescriber.
Patient frequently requests early refills.
Patient often runs out of or “loses” their medications.
Patient requests to bypass insurance and pay with cash.
Prescriptions written for combinations known as “cocktails” (i.e., containing an opioid, a benzodiazepine, and a muscle relaxant).
Prescriptions written for unusually large quantities for a single patient.
Multiple prescribers for a single patient.
Multiple pharmacies used by a single patient.
Groups of patients that present at the same time with the same prescriptions.
Strong analgesic prescriptions written by a prescriber that is not associated with pain management.
Prescriptions written by prescribers with federal or state regulatory actions against them.
Prescriptions that appear to be written in multiple colors or printing/writing.
Patients that use street slang and present with unusual or aggressive behavior.
Patients that rush or try to distract you while you fill their prescription.
what can a Pharmacist do
what can an intern do
to order drug-related laboratory tests and prescribe medications, what must a pharmacist have
can a pharmacist who pratices independently order or possess drugs without Massachusetts Controlled Substances Registration
pharmacist can:
-managing chronic diseases
- perform medication management
- administer immunizations
- partner with health care providers
interns
- same as pharmacist but just supervised
order drug-related laboratory tests and prescribe medications, pharmacists need a CDTM agreement
without a Massachusetts Controlled Substances Registration, no they cannot
what tests can pharmacists and interns do?
Telepharmacy
Health Promotion Screening Tests:
- can administer, process, read, and report the results of Health Promotion Screening tests to patients
- can not interpret results
COVID-19 Tests:
- can give a test and report results
- cannot interpret or diagnose
CDTM Testing:
- order and evaluate the results of laboratory tests
for telepharmacy
- need a state license
- for a pharmacy technician to fill and dispense a prescription, it not allowed in MA
what immunizations can interns and pharmacists give?
what can a licensed pharmacist do?
what immunizations can pharmacists not give?
can give
- vaccines to manage adverse events
- meds for mental illness and substance use
- COVID-19 that is approved by FDA
- “travel vaccines” well as other indicated “non-routine” vaccines i
Board-licensed pharmacies may conduct off-site immunization clinics utilizing trained pharmacy personnel
At this time, pharmacists may not administer any other medications or perform skin testing.
can a pharmacist recommend a human OTC for an animal?
what CS can they compound for vets
yes they can recommend
can compound Schedule VI emergency medications for veterinary office use
what can a Pharmacy Technician do:
- can they enter Rx into the system
- what CS can they fill from stock bottles
- what can they do to Rx containers
- can they reconstitute a med
- what can they prepare with CIII-VI
- what CS can they sterilely and non-sterilely compound
- can they offer counseling
- what can they do for packaged CII-VI
-
enter prescription data into a computerized pharmacy system;
take stock bottles from the shelf to fill prescriptions for Schedules III through VI medications
affix label to a prescription container;
reconstitute a medication;
prepare patient compliance packaging with Schedule III through VI medications;
compound sterile and non-sterile Schedule III through VI medications;
extend the offer to counsel;
assist in the transport of filled and verified
Schedule II through VI prescriptions or orders (e.g., delivering filled prescriptions from the pharmacy to a nurse, retrieving the medication from a pickup bin ringing out the transaction at the register, etc.)
transport, load, remove, and/or perform expiration date checking of non-patient-specific medications in Schedules III through VI
All techs except trainees can:
request and accept orally transmitted REFILL authorizations for Schedule III through VI medications if there have not been any changes to the prescription;
conduct remote processing of prescriptions
trained pharmacy technicians may prepare and administer COVID-19 and other vaccines
transport, load, remove, and/or perform expiration date checking of Schedule II medications in ADDs within a Massachusetts-licensed health care facility (e.g., hospital)
certified tech can
what can they use technology for
what can they do for CII
what can they do for CII inventory?
can they make entries for CII
What can they accept and for what CS
What can they perform between pharmacies?
can they perform med. histories
use technology to conduct certain inventory management functions for Schedule VI medications (excluding PMP drugs such as gabapentin)
transport, load, remove, and / or perform expiration date checking of Schedule II medications in ADDs;
perform Schedule II perpetual inventory counts with a second licensed nationally certified technician provided that the supervising pharmacist verifies that the perpetual inventory has been completed in accordance with Board regulations;
make entries into the Schedule II perpetual inventory;
accept NEW orally transmitted Schedule III through VI prescriptions;
perform prescription transfers between pharmacies for Schedule VI drugs;
assist in the HANDLING of Schedule II medications (e.g., counting pills, working in a vault, performing inventory-related tasks, filling/checking ADDs, compounding, etc.) EXCEPT for any hydrocodone-only extended-release medication that is not in an abuse-deterrent form
perform medication histories.
what can techs not do
administer medications, unless permitted by Board policy;
perform final patient dispensing process validation;
counsel patients;
perform a drug utilization review (“DUR”);
resolve clinical issues;
contact prescribers concerning drug therapy clarification or modification;
compound, fill, and / or dispense prescriptions without a pharmacist on site.
Sample ACPE Number: 0204-0000-20-001-L01-P
the placements of these numbers stand for
what is 0204
what is 0000
what is 20
what is 001
what is L01
what is P
0204
- Provider ID Number
- ASHP’s provider ID is 0204. Any ACPE numbers that begin with 0204 are provided by ASHP.
0000
- Joint Providership
- 0000: No Cosponsoring organization
- 9999: Cosponsoring with another organization
20
- Year of Release
- All activities released in 2020 will have “20” in this spot, etc.
001
- Activity ID
- Each activity is given a three-digit number that distinguishes it from others. That ID is included here.
L01
- Format/Topic Designator
- An “L” indicates a live activity.
- An “H” indicates a home study activity.
P
- Accreditation Audience
- A “P” indicates the activity is accredited for Pharmacists.
- A “T” indicates the activity is accredited for Pharmacy Technicians.
Topic 01
Disease State Management/Drug Therapy
Activities that address drugs, drug therapy, and/or disease states.
Topic 02
HIV/AIDS Therapy
Activities that address therapeutic, legal, social, ethical, or psychological issues related to the understanding and treatment of patients with HIV/AIDS
Topic 03
Law
Activities that address federal, state, or local laws and/or regulations affecting the practice of pharmacy.
topic 04
Pharmacy Administration
Activities that address topics relevant to the practice of pharmacy that include the economic, social, administrative and managerial aspects of pharmacy practice and health care.
topic 05
Patient Safety
Activities that address topics relevant to the prevention of healthcare errors and the elimination or mitigation of patient injury caused by healthcare errors.
topic 06
Immunizations
Activities related to the provision of immunizations, i.e., recommend immunization schedules, administration procedures, proper storage and disposal, and record keeping. This also includes review for appropriateness or contraindication and identifying and reporting adverse drug events and providing necessary first aid.
topic 07
Compounding
Activities related to sterile, nonsterile, and hazardous drug compounding for humans and animals. This includes best practices and USP quality assurance standards, environmental testing and control, record keeping, error detection and reporting, and continuous quality improvement processes.
topic 08
Pain Management/Opioids
Activities that address any component regarding the treatment and management of pain, including the prescribing, distribution and use of opioid medications, and/or the risks, symptoms, and treatment of opioid misuse/addiction.
topic 99
Additional Topic Areas
Activities related to topics relevant to the practice of pharmacy not included in the classifications of the topic designators 01-08.
what are examples of CI
I
- heroin
- marijuana
- methaqualone
- lysergic acid diethylamide (LSD)
- 3,4 methylenedioxymeaphetamije (ecstasy)
what are examples of CII
II
- amphetamine
MethMphetamine
Methylphenidate
Amobarbital
Gluethimide
Pentobarbital
Hydrocodone
what are examples of CIII
III
Anabolic steroids
Benzphetamine
Phendimetrazine
Ketamine
Tylenol with codeine
What are examples of CIV
IV
Alprazolam
Diazepam
Clonazepam
Midazolam
Lorazepam
what are examples of CV
V
Cough syrup with codeine
Lyrica
Lomotil
Motormenarapeclotin
what are examples of CVI/additional drugs?
gabapentin (can heighten effects of CII)
amoxicillin
lisinopril
HCTZ
is there a restriction on the quantity and type of hypodermic syringes or needles that can be used
is anything needed to sell hypodermic syringes
what should the pharmacy stock
no there is no restriction
there are no requirements to get hypodermic syringes like age, sex, etc
It is strongly recommended that the pharmacy stock single unit-of-use syringes for individual sale.
how long are CII Rx from out of state valid for
CII Non-narcotic Rx can be filled from where
CII narcotic Rx can be filled from where
valid for 5 daysfrom the date of issuance.
Schedule IInon-narcoticprescriptions may be filled from any state.
Schedule IInarcoticprescriptions may only be filled if issued from states contiguous to Massachusetts
- Vermont
- New Hampshire
- New York
- Connecticut
- Rhode Island
- Maine
what are non-narcotic CII?
drugs that do not affect mood or behavior and is consumed for nonmedical purposes, especially one sold illegally
what is a narcotic
a drug or other substance that affects mood or behavior and is consumed for nonmedical purposes, especially one sold illegally
what are examples of narcotic CIIs
hydromorphone (Dilaudid®)
methadone (Dolophine®)
meperidine (Demerol®)
oxycodone (OxyContin®, Percocet®)
fentanyl (Sublimaze®, Duragesic®).
what are examples of non-narcotic CIIs
Amphetamine
Methamphetamine
Nabilone.
Rx:
Patient address: 172 Ford st Newton, MA
date: 10/23/23 today is 10/2523
oxycodone-acetaminophen 5mg/325mg tablets
1-2 tablets every 4-6 hours as needed for pain
36 tablets
partial fill upon patient request
MD: Paul O’Brien
DEA: AO171383028
Phone: 162837393
Address: 123 Pearly Gates Boston, MA
Can you fill this?
yes you can
even though oxycodone-acetaminophen 5mg/325mg tablets is a narcotic CII, the prescriber is in MA
DEA # also looks good
The date looks fine too (valid for 30 days in MA, 5 days out of non-contiguous state)
Rx:
Patient address: 172 Ford st Newton, MA
date: 10/23/23 today is 10/2523
Percocet 5mg-325mg
take 1 tablet every 6 hours
12 tablets
no substitution
partial refill upon the patient request
MD: Paul O’Brien
DEA: AO171383028
Phone: 162837393
Address: 123 Pearly Gates Princeton, NJ
Can you fill this?
No, you cannot because this is a narcotic CII and the prescriber is out of a contiguous state (NJ is not VT, NH, NY, RI, CT or ME)
The date looks fine tho (valid for 30 days in MA, 5 days out of non-contiguous state–for out-of-state narcotics)
and the fact that it is a physician is good (can be a physician, dentist, mid-level practioner too)
Rx:
Patient address: 172 Ford st Newton, MA
date: 10/23/23 today is 10/2523
Percocet 5mg-325mg
take 1 tablet every 6 hours
12 tablets
no substitution
partial refill upon the patient’s request
MD: Paul O’Brien
DEA: AO171383028
Phone: 162837393
Address: 123 Pearly Gates Princeton, NH
Can you fill this?
YES, you can because this is a narcotic CII and the prescriber is out of a contiguous state (VT, NH, NY, RI, CT or ME–this Rx is from NH!)
The date looks fine too (valid for 30 days in MA, 5 days out of non-contiguous state–for out-of-state narcotics)
the fact that it is a physician is good (can be a physician, dentist, mid-level practioner too)
Rx:
Patient address: 172 Ford St Newton, MA
date: 10/1/23 today is 10/25/23
Adderall XR 5mg
take 1 tablet every 6 hours
12 tablets
no substitution
partial refill upon the patient’s request
MD: Paul O’Brien
DEA: AO171383028
Phone: 162837393
Address: 123 Pearly Gates Los Angeles, CA
Can you fill this?
Adderall is a CII Non-narcotic!
non-narcotic CII that can be from any state
The date is too old (valid for 30 days in MA, 5 days out of non-contiguous state–for out-of-state narcotics). This Rx is 24 days old so we cannot fill
but the fact that it is a physician is good (can be a physician, dentist, mid-level practioner too)
rule: non-narcotic from any state and has to be within 5 days
Rx:
Patient address: 172 Ford St Newton, MA
date: 10/23/23 today is 10/25/23
Acetaminophen with Codeine
take 1 tablet every 6 hours
12 tablets
no substitution
partial refill upon the patient’s request
MD: Paul O’Brien
DEA: AO171383028
Phone: 162837393
Address: 123 Pearly Gates Boston, MA
Can you fill this?
Rules for CIII:
- issued within the preceding 30 days
- can have 5 monthly refills on CIII & CIV
Yes you can fill
Rx:
Patient address: 172 Ford St Newton, MA
date: 10/1/23 today is 10/25/23
Diazepam 5mg
12 tablets
no substitution
partial refill upon the patient’s request
MD: Paul O’Brien
DEA: missing
Phone: 162837393
Address: 123 Pearly Gates Boston, MA
Can you fill this?
this is CIV
can put in DEA # - a part of what you can include if omitted, do not need to call the prescriber
directions are missing but can call prescriber and add it in
after that, you can fill! everything looks fine :)
can you take fax for CII?
yes if LTC, hospice, or subcutaneous infusion pump
meant to be electronic or can be written
electronic CII is the preferred
CIII & CIV
meant to be electronic
can take
- fax
- oral
need a hard copy and that serves as the original
Prescription information that may NEVER be changed or added:
For all schedules (Schedule II-VI), a new prescription is required for any of the following changes or additions:
A. patient’s name (i.e., change to different patient)
B. controlled substance prescribed (except generic substitution)
C. prescriber’s name
D. prescriber’s signature
E. earliest date to be filled (Schedule II only)
Prescription information that MAY be changed or added: CII
The following may be changed or added, after consultation with the prescriber, unless otherwise noted:
a. date of issue (date written) may only be added if omitted
b. prescriber’s address
c. patient’s address
- i. may be added if omitted without consultation
- ii. may only be changed after consultation with the prescriber or authorized agent
d. prescriber’s DEA number may be added without consultation
e. directions for use
f. dosage form
g. drug strength
h. quantity prescribed
i. supervising physician’s name of mid-level prescriber
- ii. The following may be added and the prescriber’s office should be notified if the following language is omitted:
—–a. “no substitution” language
—–b. “partial fill upon patient request” language
Prescription information that MAY be changed or added: CIII-IV
The following may be changed or added, after consultation with the prescriber, unless otherwise noted:
a. date of issue (date written) may only be added if omitted
b. prescriber’s address
c. patient’s address
- i. may be added if omitted without consultation
- ii. may only be changed after consultation
d. prescriber’s DEA number may be added without consultation
e. directions for use
f. dosage form
g. drug strength
h. quantity prescribed
i. Refill information
j. supervising physician’s name of mid-level prescriber
k.“no substitution” language may be added and the prescriber’s office should be notified if omitted
can the day supply be changed?
If deemed appropriate in the pharmacist’s professional judgment, the days’ supply dispensed (e.g., 30-day supply with 11 refills vs. 90-day supply with 3 refills) may be changed without consultation only for drugs that do not require PMP reporting.
With each change
A. the date
B. item changed or added
C. name of the authorizing prescriber, if applicable
D. name of the pharmacist accepting/making the change
