question

-when not under pharmacist supervision must act like technician BUT NOT COUNTED IN THE 1:4 RATIO FOR CLASS A. -notify the board NAME CHANGE or ADDRESS CHANGE in writing within 10 DAYS along with: 1- Copy of the official document reflecting the name change 2- returning the current pharmacist-intern certificate which reflects the previous name 3- paying a fee of $20.

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Student intern Pharmacy intern (2nd, 3rd, 4th year pharmacy students) Extended intern (after intern hours expire or are a foreign grad) ALL MUST BE REGISTERED WITH THE BOARD.

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-Receive REFILL authorization requests; -Accept Verbal RX orders for CS and dangerous drugs -perform a CS transfer to another pharmacist -Prescription Data entry -Preparing and packaging prescription drug orders -Reconstituting medication -Prepackaging and labeling prepackaged drugs; -Loading bulk unlabeled drugs into ADS -Bulk compounding; -Non-sterile AND sterile compounding with the completion of required training -Administering immunizations with the completion of required training

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Registered Pharmacy Intern UNDER pharmacist supervision (preceptor)

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-Cannot say they are pharmacists -Cannot supervise technicians -Cannot sign for Pharmacist.

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LIMITATIONS of Registered Pharmacy Intern (2nd, 3rd, 4th year pharmacy student)

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-first year pharmacy student cannot take new verbal prescriptions or refill rx authorizations or counsel patients.

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intern trainees

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-1 year experience, (6 months if residency) -3 CE CERTIFICATION Of separate training -1:1 ratio if not a TX program -No ratio if TX program. -must be direct supervision of intern for DISPENSINg which includes pt COUNSELING.

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Preceptor requirements

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-Drugs not labeled for dispensing -NO DEA registration ONLY DPS. -can have one at a non-dea registered location i.e. nursing homes.

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Emergency Medication Kits / tackle Box -DPS registration only

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-for medically underserved; rural area w/ no pharmacy - can serve MAX 3 remote sites which are open simultaneously. -perpetual inventory of all CS + nalbuphine must be kept. ***in this area, the prescriber may DISPENSE a 3 days supply of meds to patient at cost.***

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TelePharmacy -DEA and DPS registration required

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machine that performs storage, packaging, counting, labeling, dispensing, and distribution of medications, and which collects, controls, and maintains all transaction information example: BoxPicker

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Automated Pharmacy dispensing system example: BoxPicker

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A mechanical system that dispenses prescription drugs and maintains related transaction information. Provided by class A or C pharmacy for *Nursing homes *Prison systems *Hospice -PIC is responsible for all operations involving APS -Routine dispensing requires DEA and DPS registration -Class A or C pharmacy must apply to the board to provide remote pharmacy services using APS.

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automated pharmacy system (APS) pyxis -DEA and DPS registration.

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-packaged in original containers -prepackaged to meet board requirements -drugs can be reused if they are sealed in tamper evident packaging and unopened

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medications for automated pharmacy system (APS ) pyxis -DEA and DPS registration.

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- pharmacist - pharmacy technician or technician trainee under direct supervision of the pharmacist -Intern trainee or student intern under direct supervision of the pharmacist

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APS stocking pyxis -DEA and DPS registration.

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-if the system uses removable cartridges, it may be loaded at the provider pharmacy in tamper evident containers and GIVEN to the PIC designated Faculty personnel for loading into the ADS -Perpetual inventory of all CS must be maintained separately for each ADS location -Inventory must be made SAME DAY as the provider pharmacy's inventory.

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APS -designated personnel stocking, (must keep perpetual inventory) pyxis -DEA and DPS registration.

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May be filled by: -Pharmacist -Pharmacy technician -technician trainee -Intern trainee -Student intern

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Automated compounding or counting device (machine that counts, measures and/or packages a qt or dosage unit)

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- drug name, strength, dosage form - manuf/dist, lot #, - exp date - load date - Name or initial of loader - Signature of pharmacist responsible

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Automated compounding or counting device BULK load records to include:

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*** cannot dispense NEW prescriptions OR Controlled substance prescriptions*** -Device must be located inside the pharmacy building with a phone to call another pharmacy for counseling. -Cannot be a drive through or outside the building. -must have adequate security to prevent theft or compromise pt confidentiality. -must record a digital image of the individual accessing a pick-up. -Techs/ trainees can load previously verified Rx under pharmacist supervision.

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Automated storage and distribution device:

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-expires MAY 31 each year. -renew every 2 yrs.

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PHARMACY license

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each pharmacy must show: -PIC license -Pharmacy license (DO NOT have to show staff pharmacist license and DEA registration license)

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Display of Pharmacy license

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- Expire last day of birth month. - CE 30 hours; 1hr must be law or rules - If working at a sterile compounding in TX, need: *Low to Mod risk compounding = 2hrs CE *High risk compounding= 4 hrs CE - Records kept for 3 years

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Pharmacist (PharmD.) license

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-pay 1.5 x renewal fee -report completed CE hours (30 hours; 1hr must be law or rules -records kept for 3 years)

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Pharmacist license expired < or = 90 days

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-pay 2 x renewal fee -report completed CE hours (30 hours; 1hr must be law or rules -records kept for 3 years)

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Pharmacist license expired for >90 days but < 1 year

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immunizing-= 3 hrs vaccination related Preceptor= 3 hours initial preceptor training and 3 hrs q2years. must be texas college/school of pharmacy developed

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Additional CE requirtements

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-Basic cpr from AHA = 1 hr -ACLS or PedALS = 12 HRS!!! -Recertification of ACLS or PedALS = 4 hrs -Attending a full board meeting = 3 hrs... MAX 6/ 2 yrs. - Pharmacy appointed Task Force = 3 hrs - ISMP Medication Safety Self Assessment = 3hrs - Passing Geriatric Pharmacy Practice certification = 3hrs - Passing Board of Pharmaceutical Specialties certification examination = 3hrs

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CE credits earned by

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-apply for new license -re-examination

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Pharmacist license expired 1 year or more

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Pharmacist, Student-Intern OR Extended Intern approved by the board. Not Intern-Trainee

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Who can provide counseling in TX?

question

Not allowed because they won't be on an official CS pad issued by the director of DPS.

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Out of state, Mexico or Canada prescribers for C2

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-NO CONTROLLED SUBSTANCES even if its a written prescription -NO ORAL MEDICATION ORDERS -Can prescribe paper or electronic prescriptions for dangerous drugs. *** only exception is if the practitioner is licensed in TX as well.***

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Canada and mexico prescriptions (prescriber not licensed in TX)

question

- Performed YEARLY (PIC responsible but can delegate it to others) -If pharmacy provided APS: must inventory that on same day as the yearly inventory and keep records separately. - Filed separately from all other records. - Must include all CS including Nalbuphine ( NUBAIN ) ***The signature of the PIC and the date of the inventory shall be NOTARIZED within 72 HOURS or three Business days for : - Annual - Change of ownership (not change in PIC) - Closing inventory

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CS INVENTORY

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-Annual -change of Owner (NOT change of PIC) -Closing of business

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72 hr Notary of CS Inventory for:

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-Class C for C2's -Remote pharmacies (APS) for ALL Controls

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WHO must have a perpetual CS inventories?

question

- DEA order forms - Prescription drug orders - Controlled substance inventories

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RECORDS that MUST STAY at the Pharmacy

question

***14 days before*** -notify DEA -Post notice of closing ***Closing DAY*** -CS inventory + Nubaine --> NOTARIZE it! -Transfer the files ***Within 10 DAYS after closing*** Written notice to the board listing the following: - Actual date of closing - license issued to the pharmacy - Statement attesting that an inventory has been conducted (notarized for CS and Nubian) - How all dangerous drugs and controlled substances possessed by the pharmacy were disposed of or where they were transferred to - The name and address of the pharmacy to which the prescription drug orders, including refill information, and patient medication records were transferred. To DEA local field office: - Return DEA registration certificate - Return DEA 222 forms with void written on the face - Send Copy 2 of transferred CS drugs.

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Closing a Pharmacy

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10 days to notify the board in writing the chance in PIC of which must include: - Outgoing PIC name and license # -Incoming PIC name and license # -Date of change -Signature of incoming PIC -Inventory taken by outgoing and incoming.

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Incoming PIC

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72 hours

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ALL records (inventory or others) requested by Texas State Board of Pharmacy shall be supplied within what time frame?

question

Prescriptions are stored in 3 separate files: -C2 - (MAY NOT be stored in a digital imaging system) -C3-5 Can be stored in a digital imaging system. -dangerous drugs and non prescription drugs Inventory records: -C2 (copy 3 of 222) -C3-5 maintained separately OR readily retrievable/ identifiable from other records.

answer

records storage

question

- must contain: Brand name, Generic Name(if dispensed), Manuf name (abbreviated): Lipitor 10 mg or Atorvastatin (Sandoz) 10 mg - Substituted for Lipitor - non-sterile compounding: Principal Active ingredient only.

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Label requirements:

question

The species of animal The full name and address of the owner of the animal

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Animal Rx label must contain

question

- The drug is for an institutionalized patient - Max 90-day supply is dispensed at one time; - The drug is not in the possession of the ultimate user prior to administration - PIC has determined that the institution maintains adequate records for ordering, receipt and administration and properly stores them

answer

Dispensing container does not require a label if

question

(1). Patient or the patient's agent; (2). Practitioner or another pharmacist (3). the board, state, or federal agency authorized by law to receive the confidential record; (4). a law enforcement agency under a subpoena (5). a person employed by a state agency that licenses a practitioner, if the person is performing the person's official duties (6). an insurance carrier or other third party payor

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confidential records may be released to

question

Consultant pharmacist is authorized to destroy dangerous drugs and controlled substances dispensed to patients in health care facilities or institutions -written agreement between faculty and consultant pharmacist -Inventoried drugs are verified by consultant pharmacist

answer

actual destruction of the Controlled Substances from institutions and facilities 1 of 2

question

actual destruction is witnessed by one of below: - An agent of the Texas State Board of Pharmacy - An agent of the Texas Health and Human Services Commission - A commissioned peace officer - Any of the two from the institution: Facility administrator Director of nursing Acting director of nursing Licensed nurse

answer

actual destruction of the Controlled Substances from institutions and facilities 2 of 2

question

* NOT FOR CS. * Pharmacist verifies INVENTORY and seals the container with Tamper resistant tape. AND SIGNS the top of the tape seal. * a record of the transfer should record date of the actual pickup and signature of person transferring to the waste disposal --> signature of the waste disposal employee receiving such container. -records kept for 2 years AT the institution/facility.

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Destruction of dangerous drugs using waste disposal service for Class C institutions 1 of 2

question

* Inventory must contain: - Each Rx name, strength, qt, Rx #, date dispensed, name of dispensing pharmacy - Name, license #, and signature of consultant pharmacist packing and sealing the container - Name and address of facility/Institution - Signature of witness

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Destruction of dangerous drugs using waste disposal service for Class C institutions 2 of 2

question

NOT CONTROLLED SUBSTANCES -Only dangerous drugs

answer

Can a pharmacy accept returned meds for destruction?

question

ONLY for Nursing homes and Jails -drugs must be sealed in tamper evident packaging -120 days or more before expiration date.

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Pharmacy to accept returned medication for resale?

question

Class H satellite pharmacy only unless... class A pharmacy uses an Automated storage and distribution device

answer

designate outside pharmacy pickup location

question

NOT Allowed in TX

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Non prescription Codeine and Dihydrocodeine

question

15mg/30ml or 0.5mg/ml Max 240ml / 48 hours -purchaser must be 18 yrs -Only pharmacist may dispense and log it in. (others can ring out the transaction.)

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Non prescription OPIUM

question

within 30 days

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If a practitioners license is suspended/revoked must return all unused prescription forms...

question

-Name, Address, DOB or AGE of pt. -QT: -if hand written: numerical QT AND spelled out QT -if electronic: numerical Qt only. -if communicated orally: As written by pharmacist -DATE of issue (IF C2 to be filled at later late, the earliest date it can be filled.) -drug name and strength -sig - intended use unless the practitioner determines best not to

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Controlled Substance prescription MUST contain 1 of 2

question

- Name, address, DEA number, phone number of the practitioner at the practitioner's usual place of business - Signature of the prescribing IF handwritten -C3 to 5 may by written, oral, or transmitted by fax. - C3 to 5 can be prepared for signature but only signed by practitioner. - BUT C2's must be WRITTEN and SIGNED by the practitioner.

answer

Controlled Substance prescription MUST contain 2 of 2

question

-must fill within 21 days of issue date. -90 days supply max IF multiple rx's -No limit on QT /script.

answer

C2

question

-Only issued by The Director and nominal fee for printing. -Each form is sequentially numbered -Only issued to practitioners NOT PA or APRN ***official prescription form ONLY to prescribe Controlled Substances ***

answer

Official Prescription forms

question

-LTCF patient -if compounded for direct parenteral administration: iv,im,subq,intraspinal infusion -Enrolled in a Medicare certified HOSPICE care program -terminally Ill patient

answer

FAXED C2's valid for...

question

-Designated in writing by practitioner to verbally communicate prescriptions -List of agents must be kept at the practitioner's usual place of business. -Upon pharmacists request Provide a copy if the list.

answer

Designated Agent

question

YES... -If paper, sign by hand -If electronic: record electronic ID of dispensing pharmacist -SEND ALL INFO TO DIRECTOR WITHIN 7 DAYS OF FILL OR DISPENSING. (PMP)

answer

Pharmacist must SIGN (not initial) each official CONTROLLED SUBSTANCE prescription

question

***only 1 prescription per form or pad*** -Date of issue - plus the earliest date can fill for multiple Rx up to 90days -Drug name -Drug Quantity -if handwritten: numerically, followed by written word -if electronic: numerically only -Diagnosis or the intended use -The practitioner's name, address, DEA -Patient name, address, DOB or age

answer

C2 Rx requirements

question

-Species of Animal and -Name and Address of owner (no age or DOB) -All the previous 2 slides.

answer

Controlled Substance prescription for an Animal MUST contain

question

May be called in by designated agents, prescribers, and mid-level practitioners

answer

Verbal or Oral Prescriptions

question

C3 -C5 and dangerous drugs...May be transmitted by a designated agent directly to the pharmacy C2 may be transmitted as an electronic prescription must be e-signed and transmitted by Prescriber only... not designated agents!

answer

Electronic prescriptions

question

-ONCE between pharmacies -Number of refills remaining for pharmacies sharing real time electronic database.

answer

Transfer of C3-5

question

DEA DPS...Department of Public Safety (state police) Tx BOP -submit a copy of DEA 106 to EACH agency immediately -complete an inventory of all remaining drugs with date it was conducted,

answer

If a CS, Dangerous drug, or DEA 222 froms are lost or destroyed in a disaster (i.e. fire)... notify

question

-dispensed under a medication order while the patient was admitted to the hospital - the controlled substance is in a properly labeled container -Maximum 7 DAY Supply

answer

institutional practitioner may not allow a patient, on the patient's release from the hospital, to possess a controlled substance prescribed by the practitioner unless

question

may dispense up to 30 days supply and inform the practitioner of the refill at the earliest available time. NO C2's, all other allowed.

answer

during a declared state of disaster

question

NO C2's, All other allowed for a 3 days supply of medication if it will interrupt therapy or creates patient suffering. practitioner is notified asap. record of emergency fill is kept.

answer

no refills, emergency fill

question

-NOT for PSYCHOTROPICS and CONTROLLED SUBSTANCES -Not if Dr. specifies to refrain . -MUST notify practitioner electronically or verbally. max-90 days supply can be dispensed. -pt must be at least 18 years.

answer

Accelerated refills

question

*11 members appointed by Governor -7 members are pharmacists (from class A and C) -1 member is a pharmacy technician -3 members represent the public -office oath taken by the 15th day of appointment. - 6 year terms... 2 terms max -MEETS QUARTERLY. ***BOARD CANNOT WAIVE A LAW (STATUTE). CAN WAIVE BOARD RULES.

answer

State Board of Pharmacy

question

-Protect public health -Administration and Enforcement of Act -Regulation of the Practice of Pharmacy -Administration of Drugs (immunization) -Allow pilot and demonstration projects -BOARD CANNOT WAIVE A LAW (STATUTE). CAN WAIVE BOARD RULES. -CANNOT REGULATE WHOLESALERS AND MANUFACTURERS. (This is done by DPH)

answer

Board Power and Duties

question

A patient following a transplant: Cannot interchange an immunosuppressant drug formulation, brand or generic, without prior consent to the interchange from the prescribing practitioner. If no transplant, can do it if pt concents... must notify prescriber with 24 hours. Narrow therapeutic index... same thing as above, only must notify prescriber in 72 hours.

answer

Formulation substitution: brand-generic dosage form

question

Can substitute if: -contains identical amount of active ingredient -not enteric coated or timed release -doesn't alter clinical outcomes -is not a different delivery system(tabs to inhalers) -excludes: non antibiotic injectable suspensions and suppositories. **cannot substitute NEBULIZER for INHALER**

answer

Dosage form substitution

question

(1) Gets consent from the patient, at the time the prescription is dispensed, to substitute the prescribed drug product AND (2) Notifies the practitioner of the drug product substitution orally or electronically within 24 HOURS after dispensing the prescription.

answer

If you don't have the same manufacturer's drug in stock to refill the prescription, or if the practitioner is unavailable to give authorization, the pharmacist may dispense a drug product that is generically equivalent if the pharmacist, before dispensing the generally equivalent drug product: For immunosuppressant drugs not following a transplant?

question

(1) Gets consent from the patient, at the time the prescription is dispensed, to substitute the prescribed drug product AND (2) Notifies the practitioner of the drug product substitution orally or electronically within 72 HOURS after dispensing the prescription.

answer

A prescription for a NARROW THERAPEUTIC INDEX drug may be refilled only by using the same drug product by the same manufacturer that the pharmacist last dispensed under the prescription, unless otherwise agreed to by the prescribing practitioner.

question

can disclose medication records or medication history of MINORS designated by the court.

answer

HIPPA rules exception

question

1. Licensed administrator is not reasonably available 2. Failure to administer the medication might result in a significant delay or interruption of a critical phase of therapy 3. A pharmacist administers an immunization or vaccination under a physician's written protocol.

answer

When can a pharmacist administer medication... includes vaccinations

question

At the patient's HOME, except at a licensed nursing home or hospital

answer

When can a pharmacist NOT administer medication... includes vaccinations

question

each balance registered Annually ($12.50 / balance) Biennially ($25 / balance) -board shall verify accuracy -if it fails, it will be tagged and cannot use till repaired by an authorized person.

answer

Pharmacy Balance

question

have 30 days to respond... can either mail it OR arrange a time and place to inspect and obtain the record.

answer

on-emergency confidential records request

question

-have 24 hours if records on-site -have 72 hours if records are off-site

answer

medical emergency confidential record request

question

1. Complete an ACPE approved Evidence-Based course that includes hands-on technique and requires a Passing Score. 2. Hold certification in AHA's BCLS or equivalent 3. Meet CDC training guidelines with 20 hrs of training 4. Maintain 3 vaccine related CE hrs every 2 years.

answer

Immunizing Pharmacist requirements

question

-Pursuant to standing order with Prescriber -FLU: 7 yrs old -All other immunizations: 14 yrs old. -Must notify protocol Physician within 1 day of immunization -Must notify PCP within 14 days (2 wks). -All records kept for 2 yrs.

answer

IMMUNIZATIONS

question

Class A = 1: 4 (3 trainees, 1 regular tech) Class A that dispenses <20 drugs 1:5 (4 trainees) class c = NO ratio g =1:8

answer

Pharmacist : Technician ratio (Pharmacist: tech trainee ratio)

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