MD MPJE

CURES?
Controlled Substance Utilization Review and Evaluation System
-a program where RPh and MD can access pt’s hx of controlled drug use when abuse is suspected for C2-4 drugs

C1 Meds:
-heroin
-lysergic acid diethylamide (LSD)
-marijuana (cannabis)

In CA, under proposition 215, marijuana may be legal for research purposes

C2 Meds:
-fentanyl
-methadone
-morphine
-methylphenidate
-amphetamine
-lisdexamfetamine

C3 Meds:
-dronabinol
-hydrocodone
-codeine + APAP
-testosterone
-buprenorphine

C5 Meds:
-codeine cough syrup
-pregabalin
-diphenoxylate/atropine

If the prescribed does NOT have the security form and a pt needs a controlled drug, the pharmacy can…
-exception code 11167 is used
-oral order or e-order, including fax, or written order can be used if the pharmacy puts it into writing (hard copy)
-a legitimate Rx on a security form must be received by the pharmacy by the 7th day if not, RPh is req to notify the DEA

Everything on a script can be typed EXCEPT…
FOLLOWING MUST BE WRITTEN BY PRESCRIBER
-signature
-date

FOR ALL CONTROLLED DRUGS

Exception code 11159.2
-a controlled drug may be written or typed by MD on a regular Rx if it is for a terminally ill pt & “11159.2 exemption” is written on it
-this can also be done for C3-5 meds

Controlled meds must be filled within…
6 months

Partially filled for a terminally ill pt…
filled only up to 60 days from the original fill (different for terminally-ill script under 11159.2)

Days pharmacy must complete a partial for a scheduled drug
72 hrs (3 days)
-if not, a new security Rx must be written for remainder by prescriber

(T/F) if a small qty was request per pt, the pharmacist MUST contact prescriber for approval of small amt and approval must be documented
T: when lesser amt is approved, a note should be made. Remainder cannot be filled at a later time b/c it would constitute as a refill

EXCEPTION: terminally ill, SNF, or hospice pt but must be filled within 60 days from DOI

Time pharmacy has to report a C2 prescription was not received by the 7th day following the transmission on an oral order
144 hrs

Who keeps the last copy of the DEA 222 form?
-whoever is asking for the C2
-the receiving

Who keeps the 1st 2 copies of the DEA 222 form?
-whoever is providing the C2
-they keep top page and DEA gets the middle page

When is the DEA 222 form required?
Whenever the drug is being moved (relocated)

(T/F) For C3-5 drugs that are electronically created or transmitted, either directly to a comp or via facsimile machine, should be treated as an oral prescription
T: the prescription has to be reduced to hard copy by the pharmacist and retained for at least 3 yrs

(T/F) ALL pharmacies can receive faxed C2s
F: some pharmacies can and the ability to or not is determined by the board

What elements on a controlled dangerous prescription
received from a patient can be changed by a pharmacist?
A. After consultation with the prescribing practitioner,
the pharmacist is permitted to add or change the dosage
form, drug strength, drug quantity, directions for use, and
issue date. The pharmacist is permitted to make informational
additions that are provided by the patient or bearer,
such as the patient’s address, and such additions should
be verified with the prescriber and documented on the
prescription. The pharmacist is never permitted to make
changes to the patient’s name, controlled substance
prescribed (except for generic substitution permitted by
state law) or the prescriber’s signature

Is it true that prescriptions cannot be filled after being
on file for 120 days, according to State law?
A. In accordance with Health Occupations Article,
12-503, Annotated Code of Maryland, the 120 day period
is determined by the date the prescriber writes, or issues, the prescription, not how long it has been on file at a
pharmacy.
(a) An authorized prescriber who issues a prescription shall
indicate on the prescription the date of its issuance.
(b) Unless otherwise instructed by the authorized
prescriber who issues the prescription, a pharmacist
may not dispense any drug or device on a prescription
presented more than 120 days after the date the
prescription was issued.

Is it acceptable for a provider to give the patient a
printed prescription with an electronic signature and not sign it by hand?
Once a prescription is handed to a patient, it is no
longer an electronic prescription and must have the handwritten
pen to paper signature of the prescriber. Pharmacists
should verify with the prescriber any prescription
received from a patient with an electronic signature.

Prescription drugs or medical supplies may not be accepted for dispensing if the prescription drugs or medical supplies:
1) Bear an expiration date that is less than 90 days from the date the drug is donated to ensure the potency and quality of the prescription drugs or medical supplies;
2) Have been adulterated, according to the standards of Health-General Article, §21-216, Annotated Code of Maryland, because adulterated prescription drugs or medical supplies

A donor of a prescription drug or medical supply shall sign a form containing the following statements:
1) That the donor is the owner or the owner’s representative of the prescription drug or medical supply; and 2) That the donor intends to voluntarily donate the prescription drug or medical supply to the Program.

Drop off Site require that the donor form contain:.
a) The signature of the donor or the donor’s representative

Repository recipient of this program shall be a resident of the State.. B. A health care practitioner with prescribing authority shall determine
1) the financial need of a patient to participate in the Program; and 2) Indicate on the patient’s prescription eligibility for this Program..

Recipients of a donated prescription drug or medical supply under this Program shall sign a form before receiving the prescription drug or medical supply to confirm that the recipient understands that:
A. The recipient is receiving prescription drugs or medical supplies that have been donated to the Program; and B. Entities involved in the program have immunity from liability in accordance with Health-General Article,

Drop-off sites and repositories shall maintain the following records for a minimum of
5 years:. 1) Inventory;. 2) Donor forms; and. 3) Prescription records..

Drop-off sites and repositories shall maintain records required by this Program separately from
other prescription records.

T/F controlled dangerous substances may BE donated under a repository program IF CIII, CIV OR CV
NO controlled dangerous substances may not be donated under a repository program;

Can insulin be donated?
NO -drugs requiring refrigeration because the potency and quality may not be guaranteed; or

Can lorazepam gel be donated?
NO controlled dangerous substances may not be donated under a repository program; ALSO
NO -drugs requiring refrigeration because the potency and quality may not be guaranteed; or

Maintain a copy of the repository donor form FOR HOW LONG
Maintain a copy of the donor form for 5 years.

Minimum Requirements for Maintenance of Drug Acquisition Records.. B. The records maintained shall include:
Maintenance of Drug Acquisition Records..1) The name and principal address of the source of the drugs;. 2) The identity and quantity of the drugs received; and. 3) The date the drugs were received..

Maintenance of Drug Acquisition Records..C. The acquisition records shall be kept for a period of ?? years from the date the inventory was received.
Maintenance of Drug Acquisition Records..period of 2 years from the date the inventory was received.

A pharmacy permit holder shall make the drug inventory acquisition records required under this chapter available for inspection upon request by any federal, state, or local law enforcement agent, or any other duly authorized agent of the Board of Pharmacy or the Division of Drug Control, within ?? hours/days of the request.
A pharmacy permit holder shall make the drug inventory acquisition records within 72 hours of the request.

Discontinued Medications — Controlled Dangerous Substances.

(1) Except as provided in drugs classified as
C II, C III, C IV, and C V may/may not be returned to the inventory of the pharmacy??

Discontinued Medications — Controlled Dangerous Substances.

C II, C III, C IV, and C V may not be returned to the inventory of the pharmacy.

E. Drugs requiring refrigeration may not be returned to the inventory of a pharmacy. any exceptions?
no

D. A compounded sterile preparation may not be returned to the inventory of a pharmacy. any exceptions?
no

Schedule III, Schedule IV, and Schedule V medications may be returned to inventory of a pharmacy when the pharmacy uses
when the pharmacy uses a distribution system that classifies medications as pharmacy inventory until the utilization of the medication by the patient.

The exterior of the emergency drug kit is labeled to indicate the:
(i) Names of the drugs contained in the emergency drug kit;

(ii) Strengths of the drugs contained in the emergency drug kit;

(iii) List of contents with expiration dates, with the date of the first item to expire in bold print; and

(iv) The quantity of each drug contained in the emergency drug kit

Medications contained in the emergency drug kit are labeled with the:
(i) Name of the drug;

(ii) Strength of the drug;

(iii) Expiration date of the drug;

(iv) Lot number of the drug; and

(v) Other information required by the medical staff.

Replacement of Medications.
A licensed pharmacist or licensed pharmacist’s designee shall replace the emergency drug kit or replenish used or expired drugs contained in the emergency drug kit within
72 hours of notification of use or expiration.

(b) A licensed pharmacist shall perform the final check on the contents of the emergency drug kit.

A chart order shall be considered a prescription drug order provided that the prescription drug order contains:
(a) name of the patient (FULL NAME)
(b) Dosage form
(c) The name, strength, and date of issurance of the drug prescribed;
(d) The name, type, and specifications of any device;
(e) The directions for use;

If verbal,
If verbal, the name of the prescriber and the prescriber’s agent, if applicable.

*Packaged from Another Pharmacy.* The licensed pharmacist may package patient specific medication received from another pharmacy licensed in Maryland or operated by the government of the United States provided that:
(3) The manufacturer’s name is present on the container received from the other pharmacy; and
(4) The licensed pharmacist maintains a master log that includes the following information:
(k) Name and initials of verifying licensed pharmacist; and
(l) Name of the patient.
(a) Name of the drug;
(b) Lot # assigned by the packaging pharmacy;
(c) Strength;
(d) Manufacturer;
(e) Name, address, and telephone number of the original dispensing pharmacy;
(f) RX# for the original dispensing pharmacy;
(g) Quantity packaged;
(h) Expiration date as assigned by the original dispensing PHARMACY;
(i) Date of packaging;
(j) Name of pharmacy technician packaging;

The LABEL OF dispensed container for any compounded sterile preparation (FED LAW)
(1) The date of preparation
(2) Time prepared, if applicable;
(3) Storage;
(4) TRUE The name of the prescriber,
unless in an inpatient hospital setting;
(5) The name of the patient;
(6) Directions for use;
(7) for infusion preparations, The name of the BASE solution for infusion preparations
(8) The name and concentration or amount of active drugs contained in the final sterile preparation;
(9)TRUE- RPH NAME OR INITIALS CAN BE RECORDED/ readily retrievable from prescription records;
(10) The name, address, and telephone number of the pharmacy unless in an inpatient hospital facility;
(11) The beyond-use/expiration dating and time of the compounded sterile preparation, and if no time is stated, the time is presumed to be at 11:59 p.m. of the stated beyond use date;
(12) Any ancillary and cautionary instructions as needed; and
(13) A pertinent warning consistent with applicable federal and State law that cytotoxic preparations are biohazardous, when applicable.

T/F pharmacy compounding sterile infusion preparations shall provide a 24-hour telephone number to allow its patients or other health care providers who may be administering its prescriptions to contact its pharmacists.
TRUE

Wholesale DISTRIB. APPLICANT

(a) T/F Is18 years old or older;
(b) Has been employed full time for at least XX years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and record keeping relating to, prescription drugs;
(c) Is employed by the applicant full time in a MANGERIAL level position;

Is 21 years old or older;

at least 3 years in a pharmacy or

Within 2 weeks of receiving the decision of the Boards, the Board of Pharmacy shall notify the applicants of:
(a) The approval or denial of a physician-pharmacist agreement or protocol; and

Therapy management contract shall terminate ?? year from the date of ??
1 year from the date of signing unless renewed by the parties to the therapy management contract, including the patient

Physician-pharmacist agreement is valid for a period of ?? years from the date of ??
physician-pharmacist agreement is valid for a period of 2 years from the date of approval by the Boards u

Pharmacy technician whose Maryland registration expired > 2 years before applying for reinstatement, shall:

(1) Complete ?? hours of continuing education;

pharmacy technician whose Maryland registration expired more than 2 years before applying for reinstatement, shall:

(1) Complete 20 hours of continuing education;
(2) Pay to the Board the reinstatement fee established by the Board in COMAR 10.34.09; and

(3) Pass a Board-approved exam.

A. A pharmacy technician whose Maryland registration expired < 2 years before applying for reinstatement shall:
(1) Complete 20 hours of continuing education; and
(2) Pay to the Board the reinstatement fee established by the Board in COMAR 10.34.09.

If a pharmacy is not an operational pharmacy within ?? days following the initial issuance of a pharmacy permit, the Board shall notify the permit holder of the Board’s intent to rescind the pharmacy permit.
60 DAYS

Pharmacy technician’s REGISTRATION shall expire
pharmacy technician’s registration shall expire on the last day of the birth month following 1 year after initial registration.

National pharmacy technician certification program
17 years old or older;

(a) Be a high school graduate or have attained a high school equivalency diploma;

(b) Be enrolled and in good standing at a high school; or

An TECH who does not meet the EDUCATIONATION REQ.
(3) Provide written verification OF work in the pharmacy area of a pharmacy operated by the same pharmacy permit holder continuously since January 1, 2006;

(4) Provide written verification from the pharmacist who has supervised the applicant for at least 6 months that the applicant has performed competently;

TRAINING OF PHARM TECH:

(a) Is no longer than X months duration; and
(b) Includes ?? hours of work experience;
(5) Pass an examination approved by the Board as set forth in Regulation .06 of this chapter;

(a) Is no longer than 6 months duration; and
(b) Includes 160 hours of work experience;
(5) Pass an examination approved by the Board as set forth in Regulation .06 of this chapter;

(4) A pharmacist licensed in another state and actively engaged in the practice of pharmacy in that state, whose Maryland license expired 2 years but less than 5 years before applying for license reinstatement, shall:
(b) Submit evidence satisfactory to the Board which documents the applicant’s pharmacy EXPERIENCE during the 2 years immediately preceding the date of the applicant’s reinstatement application; and
(c) Pass the MPJE.

A pharmacist not actively engaged in the practice of pharmacy in another state, whose Maryland license expired more than 5 years but less than 10 years before applying for reinstatement, shall:
(b) Pass the MPJE; and
(c) Submit evidence satisfactory to the Board of having performed 1,000 hours of service in a pharmacy with a valid pharmacy permit under the supervision of a licensed pharmacist

(7) A pharmacist not actively engaged in the practice of pharmacy, whose Maryland license expired 10 or more years before applying for reinstatement, shall:
(b) Pass the MPJE;
(c) Submit evidence satisfactory to the Board of having performed 1,000 hours of service in a pharmacy with a valid pharmacy permit under the supervision of a licensed pharmacist; and
(d) Pass the NAPLEX.

IF pharmacy CLOSING: NOTIFY

A. At least XX days before a location’s anticipated date of ceasing to operate as a licensed pharmacy

A. At least 14 days before a location’s anticipated date of ceasing to operate as a licensed PHARMACY. *(This notification shall be sent by certified mail, return receipt requested, or hand delivered to thE BOARD’S OFFICE)

B. Within XXX hours before or after ceasing to operate, the pharmacy permit holder shall request a closing inspection from the Division of Drug Control.

C. Upon notification by a pharmacy permit holder of the proposed date on which a licensed pharmacy will cease to operate, the Board shall notify the Division of Drug Control to schedule the closing inspection.

B. Within 72 hours before or after ceasing to operate, the pharmacy permit holder shall request a closing inspection from the Division of Drug Control.

A pharmacist licensed to practice in Maryland applying for renewal shall:

(a) Earn ?? hours of approved CE within the 2-year period immediately preceding the license expiration date that include:
(b) Attest to the fact that the pharmacist has completed the CE requirement on a Board approved form

30 W/ (i) 1 hour on the topic of preventing medication errors; and

(ii) 2 hours of CE obtained through live instruction;

RPH Retain supporting CE documents for XXXX years after the date of renewal for which the CE credits were used.
4 years after the date of renewal for which the CE credits were used.

(b) If registered to administer vaccines before October 1, 2008 for the first renewal of the registration after that date, demonstrate that XX CE credits taken include education about the herpes zoster and pneumococcal pneumonia vaccines.
(b) If registered to administer vaccines before October 1, 2008 for the first renewal of the registration after that date, demonstrate that 4 CE credits taken include education about the herpes zoster and pneumococcal pneumonia vaccines.

E. Pharmacists may receive ?? CE credits for attending a Public Board meeting in its entirety.
(1) The Board shall issue a certificate of proof of attendance at a public Board meeting.
2 CE

E. Pharmacists may receive 2 CE credits for attending a public Board meeting in its entirety.

(1) The Board shall issue a certificate of proof of attendance at a public Board meeting.
(2) A pharmacist may not earn more than ??? CE credits per renewal period for attendance of a public Board meeting.

(2) A pharmacist may not earn more than 4 CE credits per renewal period for attendance of a public Board meeting.

T/F Make-up may not be worn in the clean room.
TRUE

Report to the Board the pharmacist’s place of employment on the pharmacist’s biennial license renewal form. A pharmacist employed at more than one location shall report?
A pharmacist employed at more than one location shall report the primary employment location at the time the renewal form is submitted to the Board.

Within ?? days of a change in the pharmacist’s primary employment location, the pharmacist shall notify the Board in writing … If the pharmacist’s primary employment location changes and the pharmacist’s new primary employment location is owned by the same corporation,then what??
Within 30 days of a change in the pharmacist’s primary employment location If location change but same boss(owned by the same corporation,) the pharmacist is NOT required to report the change except when completing a biennial license renewal form.

Within ?? days of the date a pharmacist changes the pharmacist’s mailing address,
Within 30 days change of addy of residence

Documentation by the Secondary Pharmacy Receiving a Permanent Prescription Transfer. **********
B. The name AND location of the primary pharmacy;
T/F The INITIALS of the pharmacist TRANSFERRING/RECEIVING.
FALSE-WHOLE NAME OF RPHS

Documentation by the Secondary Pharmacy Receiving a Permanent Prescription Transfer. **********
T/F The date of issuance of the original prescription order;
TRUE

Documentation by the Secondary Pharmacy Receiving a Permanent Prescription Transfer. **********
T/F The date on which the prescription order was first filled;
TRUE

Documentation by the Secondary Pharmacy Receiving a Permanent Prescription Transfer. **********
T/F The date of the last refill;
H. The number of remaining refills;
I. The original prescription number;
J. The date transferred
TRUE

Permanent Transfer of a Prescription Between Pharmacies. **********
not for a Schedule II ONLY
OTHER SCHEDULES ARE OK CIII,CIV,CV

The pharmacist transferring the prescription from the primary pharmacy indicates on the prescription, within the prescription computer database and within any appropriate other records used for dispensing:
That the prescription has been permanently transferred; The name of the secondary pharmacy; DO NOT need the location of secondary pharmacy; The date on which the prescription was transferred to the secondary pharmacy; Name of the pharmacist transfer/receive.

Outsourcing means
the transmitting of a prescription order from a primary pharmacy to a secondary pharmacy that prepares the prescription.

Use of unified prescription records by more than one pharmacy through a computerized prescription database does/does not constitute a permanent TRANSFER of a prescription order.
does not

Outsourcing of a Prescription Order.
************
T/F for return to the primary pharmacy for final dispensing to a specific patient if:
T/F transmit a prescription order to a secondary pharmacy for preparation and final dispensing to a specific patient
TRUE

Outsourcing of a Prescription Order.
************
The label contains the ___, ____, AND ____ OF THE ??? pharmacy;
Outsourcing of a Prescription Order.
************
The label contains the name, address, and phone number of the PRIMARY pharmacy;

Outsourcing of a Prescription Order.
************
T/F The patient is informed in writing of the NAME and ADDRESS of the SECOND pharmacy;
TRUE

T/F Outsourcing of a Prescription Order.
************
The patient is informed in writing that the prescription order was PREPARED at a secondary pharmacy;
TRUE

Outsourcing of a Prescription Order.
************DOCUMENTS******

(1) That the prescription order was prepared by a secondary pharmacy
(2) The name of the secondary pharmacy;
(3) The name of the BOTH RPH
(4) DATE OF _____ AND _____

(5) The date on which the prescription was TRANSMITTED to the secondary pharmacy AND
(6) The date on which the medication was SENT to the primary pharmacy;

Outsourcing of a Prescription Order.
************BY 2ND PHARMACY DOCUMENTS******
A. That the prescription order was transmitted from another pharmacy;
B. The name AND location of the primary pharmacy;
C. The name OF BOTH RPH INVOLVED W/ TRANSFER
E. The name of the RPH WHO at the secondary pharmacy prepared the rx order
F. The date OF which the prescription order was received AND DATE on which the PREPARED PRODUCT was sent to the primary pharmacy IF IT WAS SENT BACK TO THE PRIMARY PHARMACY

DOES THE PRIMARY PHARMACY THAT OUTSOURCED NEED TO RECORD LOCATION OF SECONDARY PHARMACY?
NO

A pharmacist may prepare, package, and label INVESTIGATION drugs not destined for a specific individual AT THE TIME (=STOCK) of preparation, packaging, and labeling if:
(1) The study IS APPROVED
(2) The pharmacy permit holder ensures that records disclosing the identity of the subject who eventually receives the medication are:
(a) Received by a pharmacist on duty at the pharmacy within 30 days after being provided to a patient; and
(b) Maintained in the pharmacy.

An infusion pharmacy shall maintain an adequate reference library to enable it to prepare and dispense infusion therapy properly.

B. In addition to the requirements of COMAR 10.34.07.03, an infusion pharmacy’s reference library shall include:

(1) (MSDSs) = Material Safety Data Sheets
(2) IV compatibility references;
(3) Stability and extended stability references;
(4) Websites and electronic references authored by established medical publishers recognized within the field of infusion pharmacy practice
(5) Pediatric dosing reference, if applicable; and
(6) Appropriate clinical references for the population served.

“Anteroom” means
the area, room, or rooms where personnel perform hand hygiene and garbing immediately adjacent to the designated clean room where the compounding of sterile preparations is performed.

“Clean room”
means an International Standards Organization (ISO) Class 7 environment that meets USP 797 Standards, inside which compounding occurs within an ISO Class 5 engineering control device such as a laminar airflow workstation or a biological safety cabinet.

“Compounding aseptic isolator”
means an enclosed positive or negative pressure environment especially designed for sterile preparation compounding that maintains a physical barrier between the workspace and the operator.

“Laminar air flow workstation”
means an ISO Class 5 (“Class 100”) laminar airflow hood inside which sterile compounding occurs.

Pharmacist may administer a vaccination for Herpes zoster or Pneumococcal pneumonia to an individual if the individual has a .
PRESCRIPTION from a physician

Once the pharmacist has administered the vaccination, the pharmacist shall:

(1) Inform the prescribing physician by reasonable means within 7 days of the following:

(a) patient;
(b) vaccination;
(c) Administration ROUTE
(d) Administration SITE
(e) Administration DOSE
(F) Administration DATE

(1) A drop-off site shall:

(a) Place the donated prescription drug or medical supply and the ____ WHERE
(b) Store in an area accessible only to those pharmacists or health care practitioners who have been assigned the responsibility to accept the donated prescription drugs or medical supplies; and
(c) Forward the STUFF to the _________ at least every ??.

(a) Place the donated prescription drug or medical supply and the donor form in a sealed bag;

(c) Forward the STUFF to the repository at least every 2 weeks.

T/F A drop-off site
TF Dispense donated prescription drugs or medical supplies;
TF Resell prescription drugs or medical supplies donated to the Program;
TF Charge a fee for accepting a donation; or
(d) Accept donated prescription drugs or medical supplies until the drop-off site applicant has been approved by the Board.
TRUE

A repository shall designate a pharmacist who shall:
(1) Accept donated prescription drugs or medical supplies forwarded by:
(a) A drop-off site; or
(b) A MFG regulated by the FDA
(c) Obliterate from the labels of donated prescription drugs or medical supplies PT SENSITIVE INFO

A repository shall:
(1) Maintain a separate inventory of donated prescription drugs or medical supplies;
(2) Maintain separate prescription files for patients receiving donated prescription drugs or medical supplies; and
(3) Submit an ANNUAL report on its activities to the Board that includes at least information on the:
(a) # of recipients by COUNTY
(b) Approximate $$$ of the prescription drugs or medical supplies dispensed;
(c) 50 prescription drugs or medical supplies most frequently dispensed; and
(d) Total number of donations to the Program.

Repository may /MAY NOT

(a) Resell prescription drugs or medical supplies donated to the Program; or
(b) Establish or maintain a waiting list for prescription drugs or medical supplies dispensed by the Program.
(3) A repository may charge a fee
(4) A repository IS UNDER obligation to obtain a prescription drug or medical supply that is not in inventory at the time of the request.

CANNOT RESELL
CANNOT KEEP WAITING LIST
CAN CHARGE FEE of not more than $10 for each prescription drug or medical supply dispensed under the Program.
NOT OBLIGATED TO GET STUFF AT REQUEST OF PT

Following information shall be legibly entered on all original and refill prescriptions or patient drug profiles or computerized patient drug records:
The date of filling or refilling;
The initials of, or other identifying symbol for:
The pharmacist responsible for filling or refilling the prescription; and
The data-entry pharmacy technician involved in the dispensing process.

Internship Program or Training Required.

An applicant shall complete one of the following as a prerequisite to Board license:

A. 1,000 hours of a school-supervised professional experience program conducted by a school of pharmacy accredited by the American Council of Pharmaceutical Education; or
B.1,560 hours of full-time training, under the direct supervision of licensed pharmacists

schedule IV
-Carisoprodol (Soma)
-Alprazolam (Xanax)

-Barbital (Barbitone)

-Butorphanol (Stadol, Stadol NS, -Torbugesic, Torbutrol)

-Chloral hydrate (Noctec)

-Chlordiazepoxide (Librium, Libritabs, Limbitrol, SK-Lygen)

-Clonazepam (Klonopin, Clonopin)

-Clorazepate(Tranxene)

-Dexfenfluramine (Redux)

-Diazepam (Valium, Valrelease)
Dichloralphenazone (Midrin)

-Difenoxin 1 mg/ Atropine 25 mcg (Motofen)

-Estazolam (ProSom, Domnamid, Eurodin, Nuctalon)

-Ethchlorvynol (Placidyl)

-Fenfluramine (Pondimin, Ponderal)

-Flurazepam (Dalmane)

-Fospropofol (Lusedra)

-Lorazepam (Ativan)

-Mazindol (Sanorex, Mazanor)

**Schedule III Controlled Drug in Maryland, Schedule IV in DEA**
Meprobamate (Miltown, Equanil, Deprol, Equagesic, Meprospan)
Midazolam (Versed)
Modafinil (Provigil)
Oxazepam (Serax, Serenid-D)
Pemoline (Cylert)
Pentazocine (Talwin, Talwin NX, Talacen, Talwin Compound)

**Schedule III Controlled Drug in Maryland, Schedule IV in DEA**

Phenobarbital (Luminal, Donnatal, Bellergal-S)

Phentermine (Ionamin, Fastin, Adipex-P, Obe-Nix, Zantryl)

Prazepam (Centrax)

Propofol (Diprivan)

Propoxyphene dosage forms with other ingredients

Quazepam (Doral, Dormalin)

Sibutramine (Meridia)

Temazepam (Restoril)

Triazolam (Halcion)

Zaleplon (Sonata)

Zolpidem (Ambien)

Zopiclone (Imovane)

Eszopiclone (Lunesta

BOP members
-12 members
2 chain
2 independent
2 acute care
1 long term care
1 infusion/home care
2 at large
2 consumers

if close permit holder must:
1) write to BOP 14 days before closing
2) need closing inspection from division within 72 hrs before or after
3) remove all signs within 30 days

need to complete what prerequisite to board licensure
1) 1000 hours in school accredited by acpe

or

2) 1560 hours full time under pharmacy supervision

keep rx record for
5 years from date of dispensing

animal rx needs
1) the species of animal
2) the full name and address of the owner of the animal

cant compound
-drugs commercially available
-bulk compounding
– with any drugs removed from the market

a pharmacy permit expires on
-pharmacy permit and sterile compounding permit expires on may 31

whats needed for transfer
(1). That the prescription has been permanently transferred;

(2). The name of the secondary pharmacy;

(3). The name of the pharmacist who transferred the prescription to the secondary pharmacy;

(4). The name of the pharmacist at the secondary pharmacy to whom the prescription was transferred if the transfer occurred in an oral manner; and

(5). The date on which the prescription was transferred to the secondary pharmacy.

A. A pharmacist at the primary pharmacy may not refill a prescription that has been permanently transferred to a secondary pharmacy.

B. The use of unified prescription records by more than one pharmacy through a computerized prescription database does not constitute a permanent transfer of a prescription order.

schedule III
Pentazocine (Talwin) (Schedule III controlled drug in Maryland, in Federal – It is Schedule IV controlled drug, Maryland Criminal Law Section 5-404(d)(7))

Butalbital (Fioricet, Butalbital with acetaminophen) (Schedule III controlled drug in Maryland, in Federal it is Non-Controlled)

Mazindol (Sanorex, Mazanor) **Schedule III Controlled Drug in Maryland, Schedule IV in DEA**

Buprenorphine (Buprenex, Temgesic) (** Maryland State still classify this under Schedule V Controlled Substance; Maryland Criminal Law Section 5-406)

Amobarbital and noncontrolled active ingredients

Amobarbital suppository dosage form

Anabolic steroids

Barbituric acid derivative

Benzphetamine (Didrex, Inapetyl)

Butabarbital (Butisol, Butibel)

Butalbital (Fiorinal, Butalbital with aspirin)

Codeine and isoquinoline alkaloid (Codeine with papaverine or noscapine)

Codeine combination product (Empirin, Fiorinal, Tylenol, ASA or APAP w/codeine)

Butalbital (Fiorinal, Butalbital with Aspirin)

Dronabinol in sesame oil in soft gelatin capsule (Marinol)

Hydrocodone and isoquinoline alkaloid

Hydrocodone combination product (Tussionex, Tussend, Lortab, Vicodin, Hycodan, Anexsia)

Lysergic acid

Lysergic acid amide

Methyltestosterone (Android, Oreton, Testred, Virilon)

Nalorphine (Nalline)

Nandrolone (Deca-Durabolin, Durabolin, Durabolin-50)

Norethandrolone(Nilevar, Solevar)

Opium combination product (Paregoric)

Pentobarbital and noncontrolled active ingredients

Pentobarbital suppository dosage form

Phendimetrazine (Bontril)

Secobarbital and noncontrolled active ingredients

Secobarbital suppository dosage form

Testosterone (Android-T, Androlan, Depotest, Delatestryl)

Thiopental (Pentothal)

schedule II
Alfentanil (Alfenta)

Amobarbital (Amytal, Tuinal)

Amphetamine (Dexedrine, Biphetamine)

Lisdexamfetamine (Vyvanse)

Coca Leaves

Cocaine

Codeine

Dextropropoxyphene, bulk (non-dosage forms)

Dihydrocodeine (Didrate, Parzone)

Diphenoxylate

Diprenorphine

Ecgonine (Cocaine precursor, in Coca leaves)

Ethylmorphine (Dionin)

Fentanyl (Innovar, Sublimaze, Duragesic)

Glutethimide (Doriden, Dorimide)

Hydrocodone (dihydrocodeinone)

Hydromorphone (Dilaudid, dihydromorphinone)

Levo-alphacetylmethadol (LAAM, long acting methadone, levomethadyl acetate)

Meperidine (Demerol, Mepergan, pethidine)

Methadone (Dolophine, Methadose, Amidone)

Methamphetamine (Desoxyn, D-desoxyephedrine, ICE, Crank, Speed)

Methylphenidate (Ritalin)

Morphine (MS Contin, Roxanol, Duramorph, RMS, MSIR)

Opium poppy

Opium tincture

Opium, granulated

Opium, powdered

Opium, raw

Oxycodone (OxyContin, Percocet, Tylox, Roxicodone, Roxicet)

Oxymorphone (Numorphan)

Pentobarbital (Nembutal)

Poppy Straw Concentrate

Remifentanil (Ultiva)

Secobarbital (Seconal, Tuinal)

Sufentanil (Sufenta)

Tapentadol (Nucynta)

dea 222
order schedule I and II
-pharmacy keeps copy 3

codeine amounts and classes
-less 1.8 g per 100 cc / <90 per unit dose = III -less 200mg per 100 = V

plan b
-pt under 15 need rx

Schedule V drugs
Codeine preparations – 200 mg per 100 ml or 100 gm (Robitussin AC, Phenergan with Codeine)

Difenoxin preparations – 0.5 mg Difenoxin + 25mcg Atropine sulfate (Motofen)

Dihydrocodeine preparations 10 mg per 100 ml or 100 gm

Diphenoxylate preparations- 2.5 mg Diphenoxylate + 25mcg Atropine sulfate (Lomotil, Logen)

Ethylmorphine preparations 100 mg per 100 ml or 100 gm

Opium preparations – 100 mg per 100 ml or gm (Parepectolin, Kapectolin PG, Kaolin Pectin P.G.)

Pregabalin – Lyrica

Lacosamide – Vimpat

Ezogabine – Potiga

drug thefts reported to:
1. Board,
2. Division of Drug Control,
3. U.S. Drug Enforcement Administration and
4. Local police.

expiration of pre-packaged drugs
-12 months from date of packaging
-manufacturer’s listed date
-max time period allowed for specific packaging

schedule 2 drugs can only be transferred from pharmacy to pharmacy with
DEA 222 form

can give flu shot to what age
9 years or older

contact who when emergency rx not received
Department of Health and Mental Hygiene upon not receiving a written prescription from the prescriber within 7 days of an emergency oral authorization.

controlled substance inventory must be done
-every 2 years
-keep record for 2 years

C II fax only when
-for pt undergoing home infusion/ iv pain therapy
-LTCF
-medicare certified hospice
-for direct admin. to pt by parenteral, iv, im, sc, intraspinal infusion

qualify for certified tech
-certified as national pharmacy tech certification program
or
-at least 17 years
-high school grad or equivalent
-be enrolled in good standing in hs
-pass board examination
-training of 160 hours in < 6 months -state criminal history records check

transfer by reciprocity
-submit application
-fee
-evidence of 520 hrs post grad
-mpje
-english comp exam

how often a pt record should be reviewed at ltcf
monthly

pharmacy permit holder should maintain records of all drug inventory acquisitions for
2 years

mid level that can prescribe controls
1. AS (Animal Shelters): Can only administer Schedule II to V controlled substances.

2. NP (Nurse Practitioner): Can prescribe and/or administer Schedule II to V controlled substances.

3. PA (Physician assistants): Can prescribe and/or administer Schedule II to V controlled substances.

hospital practitioner must out on all rx
– registration number of the hospital
– special internal code number assigned to individual

** controlled rx can only be called in by practitioner not agent
**

vaccine related AR report to
CDC

do not fill past 120 days
if do not fill date is after 120 days — must have first will before 6 months from date written

ce for vaccinations
to give vaccinations
– 4 of the 30 must be vaccination related

auto medication system can be stocked by
(need positive drug identification — bar code)
-intern
-pharmacist
-tech

t/f pharmacy student in experiential program that completed approved certifications can give vaccinations
true

OTC do not need
ndc

DUR include review of
1. known allergies.

2. rational therapy-contraindication.

3. reasonable dose, direction for use and route of administration.

4. duplication of therapy.

5. drug-drug, drug-food and drug-disease interactions.

6. adverse drug reactions.

7. overutilization or underutilization of prescribed drugs.

what can be changed on controlled after talking to prescriber
a). add or change the dosage form, drug strength, drug quantity, directions for use, and issue date.

The pharmacist is permitted to make informational additions that are provided by the patient or bearer, such as the patient’s address, and such additions should be verified with the prescriber and documented on the prescription.

The pharmacist is never permitted to make changes to the patient’s name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescriber’s signature.

maryland health care commission
over sees electronic rx processes

all anti-neoplastic drugs should be compounded in
vertical laminar flow hood

labeling requirements not needed if
a. To an inpatient in a hospital or related institution;
b. In an emergency situation;
c. As a sample drug or device dispensed in the regular course of the authorized prescriber’s practice.

destroying controlled drugs
-forward to DEA reverse distributors at any time
-for C-II the distributor must issue a DEA 222 form to the pharmacy
– distributor must submit DEA 41 form to DEA

if you move must notify board with in
30 days

Motofen vs lomotil
motofen= Difenoxin 1 mg/ Atropine 25 mcg (IV)
motofen= 0.5 mg Difenoxin + 25mcg Atropine sulfate (V) ???
lomotil =2.5 mg Diphenoxylate + 25mcg Atropine sulfate (V)

morphine cIII
Not more than 50 milligrams of Morphine per 100 cc

must be able to retrieve e-records upon request in
48hrs

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