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MPJE Ch. 7
Other classes of Pharmacies
| Question | Answer |
|---|---|
| Class C (institutional): Facility with 101 beds or more shall be under the _______ on-site supervision of a pharmacist when the pharmacy department is open for services | continuous |
| Class C (institutional): Facility with 100 beds or fewer shall ahve the services of a pharmacist at least ____ ____ or on a ____ basis, but the pharmacist must be on-site at least once every __ days | part time; consulting; 7 |
| Class C (institutional): If it operates a outpatient pharmacy, there must be a pharmacist on-site when its open. Must also meet all Class __ rules, including the staffing ratio | A |
| Class C (institutional): Facilities with 101 or more bedsmust have 1 ___-___ PIC who can only be PIC for 1 such facility. may not serve as PIC for Class A or B pharmacy | Fulll-time |
| Class C (institutional): For facilities with 100 or fewer beds must have a PIC who may be employed or under contract as a consultant and may be part-time. One pharmacy may be PIC of no more than __ such facilities or ___ beds | 3; 150 |
| Class C (institutional): a pharmacist may be the PIC of 1 facility with 101 beds or more and the 1 facility with 100 beds or fewer as long as the total number of beds does not exceed ___ | 150 |
| Class C (institutional): Pharmacy Techs w/ 101 beds or more, the following duties may be performed under physically present pharmacist supervision: | - prepackaging and labeling unit-dose and multi-dose packs - preparing/packaging/ compounding/labeling rx pursuant to med orders - compounding nonsterile/sterile after training (C-S only)/ bulk or batch - distribute routine orders for stock supplies to pt care areas - enter med orders and drug distribution info into computer system - loading un-labeled drugs into an automated compounding or counting device - accessing automated med supply system |
| Class C (institutional): Pharmacy Techs w/ 100 beds or fewer, the following duties may be performed under physically present pharmacist supervision: | - prepackaging and labeling unit-dose and multi-dose packs - bulk compounding or batch prep - loading un-labeled drugs into an automated compounding or drug dispensing system - compounding Medium and High-risk sterile preps after training (C-S only) |
| Class C (institutional): Pharm Techs with 100 beds or fewer, the following duties MUST be performed under the physically present or Electronic supervision of a pharmacist: | - preparing/packaging/compounding/labeling rx drugs pursuant to med orders - distributing routine orders for stock supplies to pt care areas - entering med orders and drug distribution info into a computer system - Accessing automated supply system - compounding nonsterile preps - compounding LOW-risk sterile preps |
| Class C (institutional): There is ___ ratio of pharmacists to pharmacy tehnicians in a Class C pharmacy | NO |
| Class C (institutional): If it has an ongoing clinical pharmacy program has what's called a ____-____-___ program relating to the filling of floor stock and unit-dose distribution systems if previously reviewed by a pharmacist | Tech-Check-Tech |
| Class C (institutional): Rural hospitals are defined as? | w/ 75 or fewer beds and located in a county with less than 50,000 or designated as a critical access hospital, rural referral center, or sole community hospital |
| Class C (institutional): Rural hospitals: if the pharmacist is not on duty or when the pharmacy is closed, a ____ or a ______ may withdraw the drug from the pharmacy in sufficient quantity to fulfull the order | nurse; practitioner |
| Class C (institutional): Rural hospitals: Withdrawn meds: the hospital pharmacist must verify the withdrawal and perform a drug regimen review no later than ___ days after the withdrawal | 7 |
| Class C (institutional): Rural hospital when a pharmacist is not on duty, techs, not trainees, may perform the following duties WITHOUT direct supervision of a pharmacist: | - enter med orders and drug distribution info into a computer system - Prepare/Package/Labeling prescription drugs pursuant to med orders if a licensed nurse or practitioner or pharmacist verifies the accuracy by electronic supervision before administration to pt - Fill med carts - distributing routine orders for stock supples to pt care areas - accessing and restocking automated med supply cabinets |
| Class C (institutional): With a full-time pharmacist when pharmacy is closed and drugs withdrawn: who can remove meds? | - a designated licensed nurse or practitioner may remove drugs for the pt's immediate therapy needs |
| Class C (institutional): With a full-time pharmacist when pharmacy is closed and drugs withdrawn: what is recorded? when should this be verified? | Record of the withdrawal must be made containing - Name of pt - strength, dosage form of device or drug - dose prescribed - quantity taken - time and date taken - signature *must verify withdrawal as soon as possible but no more than 72h after withdrawal |
| Class C (institutional): With a part-time pharmacist when pharmacy is closed and drugs withdrawn: who can remove meds? | - a designated licensed nurse or practitioner may remove drugs AND devices for the pt's immediate therapy needs |
| Class C (institutional): With a part-time pharmacist when pharmacy is closed and drugs withdrawn: when should this be verified? | verify withdrawal of the drugs from the pharmacy after a reasonable interval but in no event may the interval exceed 7 days |
| Class C (institutional): With a part-time pharmacist when pharmacy is closed and drugs withdrawn: How soon should a pharmacist conduct a drug regimen review? | within 96h if the facility has an average daily census above 10 and within 7 days if the facility has an average daily census of 10 or fewer |
| Class C (institutional): With a part-time pharmacist when pharmacy is closed and if using a floor stock system of distribution, the same rules apply, and the pharmacist must verify withdrawal no later than ___ days after withdrawal | 7 |
| Class C (institutional): Library requirements: | - current copies of the Texas Pharmacy Act and rules; Texas Dangerous Drug Act and riles, TCSA, FCSA and riles - DI reference - General drug info reference - Injectable drug product reference - Basic antidote info and phone # of the nearest regional poison control center - Metric/apothecary weight and measure convsersion chart |
| Class C (institutional): Operational Standards: Drug regimen review must be conducted on a _______ basis when a pharmacist is on duty and on a _______ basis when a pharmacist is not on duty. The retrospective review must be conducted within ___ hours for full-time and ___ hours for part-time | prospective; retrospective; 72h; 96h * part-time: 96h if census above 10 and with 7 days if facility has an average of 10 or fewer |
| Class C (institutional): Operational Standards: Floor stock records must be reviewed by a pharmacist every ___ days and a ____ inventory of Schedule II CS is required | 30; perpetual |
| Class C (institutional): Meds for outpatient (including ER) must be dispensed by the pharmacist. If not on duty, dangerous drugs and CS may be suppled to pt's admitted to the ER under the following conditions: | - only drugs on an ER drug list may be provided - drugs are suppled in pre-packaged quantities not to exceed a 72-hr supply - drugs are pre-packaged by the pharmacy dept and at time of delivery, the label is completed by the practitioner or nurse - pharmacist verifies the contents of the ER drug list record at least every 7 days |
| Class C (institutional): Automated Medication Supply systems which require continuous monitoring and tests accuracy at least every ___ months or when an upgrade or change is made to the system | 6 |
| Class C (institutional): Records must be maintained for __ years and must be suppled within __ hours upon request. A perpetual inventory must be maintained for all ____ _ drugs in a Class C pharmacy; Audit trails requested must be provided within ___ hours | 2; 72; Schedule II; 72 |
| Class C (institutional) in a Freestanding Ambulatory Surgical Center (C-ASC): Full-time pharmacist and drugs withdrawn? | review within 72h for CS and at a reasonable interval but at least once per calendar week for dangerous drugs |
| Class C (institutional) in a Freestanding Ambulatory Surgical Center (C-ASC): Part-time or consultant pharmacist and drugs withdrawn? | verify withdrawal of ALL drugs at a reasonable interval but such verification must occur at least once every calendear week when the pharmacy is open |
| Class C (institutional) in a Freestanding Ambulatory Surgical Center (C-ASC): must maintain a ____ inventory of all controlled substances. | perpetual; |
| Class C (institutional) in a Freestanding Ambulatory Surgical Center (C-ASC): A pharmacist must conduct an audit by randomly comparing the distribution records with the medication orders at least every ___ days | 30 |
| Class C (institutional) in a Freestanding Ambulatory Surgical Center (C-ASC): Drugs may only be supplied in prepackaged quantities not to exceed a ___hr supply | 72 |
| Class B (Nuclear) is regulated by the Texas Department of State Health Services through its _____ ______ _____ (Radioactive Material License) | Radiation Control Program |
| Class B (Nuclear): An authorized nuclear pharmacist must be either be a board Certified Nuclear Pharmacist or must complete ___ hours of a structured education program: ____ hours of didactic training approved by the TDSHS Radiation Control Program and ____ hours of supervised experience | 700; 200; 500 |
| Class B (Nuclear): Nuclear pharmacist to tech ratio is? | No more than 1:6 as long as the maximum # of trainees is 3 |
| Class B (Nuclear): Outer Container label requirements: Name, address, phone # of the pharmacy; date dispensed; directions for use; rx number; name of the pt if known or "for physician use" if the name of the pt is not known as well as? | - radiation symbol - words "caution-- radioactive material or dangerous radioactive material" - name of the radiopharmaceutical or abbrev. - amount of radioactivity (milli/micro -curies or bequerels and corresponding time that apples to activity if diff. from requested calibration date/time - initials or ID code of preparer and nuclear pharmacist - mL if liquid - requested calibration date/time - expiration date/time |
| Class B (Nuclear): Inner Container label requirements: | - Standard radiation symbol - words "caution-- radioactive material or dangerous radioactive material" - name of radiopharmaceutical or its abbreviation - Rx number |
| Class B (Nuclear): ______ of radioactive prescriptions are not allowed. Sterile radiopharmaceutical preparations must meet requirements of _____ compounding which contain special exemptions/exceptions for certain provisions that cannot be met in nuclear pharmacies | Refills; sterile |
| Class D (Clinic) is defined as? | a facility/location other than a physician's office where limited types of dangerous drugs or devices restricted to those listed in and approved for the clinic's formulary are stored, administered, provided, or dispensed only to outpatient's of the clinic |
| Class D (Clinic): PIC is employed or under a written agreement as a consultant to the facility. They may be the PIC for ___ number of clinics | ANY |
| Class D (Clinic): responsibilities include: | 1. continuous supervision (not on-site) of nurses, physician assistants, and others carrying out pharmacy-related aspects of the provision of drugs 2. document on-site visits 3. Development of a formulary |
| Class D (Clinic): Formulary may include | - anti-infective drugs - MSK drugs - Vitamins - OB/GYN drugs - topical drugs - Serum, toxoids, and vaccines |
| Class D (Clinic): What may NOT be included on Formulary? | - Nalbuphine (nubain) - Drugs to treat ED - Controlled Substances |
| Class D (Clinic): Expanded Formulary requirements: may petition TSBP for an expanded formulary if serving at least ___ indigent pts and may provide for other drugs based upon the documented _____ of the clinic | 50%; objectives |
| Class D (Clinic): Additional requirements to Expanded Formulary: | - supportive personnel providing drugs must be licensed nurses or practitioners - policies/procedures for drugs on the formulary that require spcieal monitoring - Retrospective drug regimen reviews done on a Quarterly Basis - if antipsychotics, must be initiated by a physician of the clinic and monitor ongoing therapy and pt shall be physically examined by a physician at least YEARLY |
| Class D (Clinic): Provision of Drug: prepacked and labeled with name and address of clinic, name and strength of drug, quantity, lot number, and expiration date, directions but may be incomplete along with appropriate ancillary labels. Provided to pt by? | designated supportive personnel who complete the label with the pt's name, any info necessary to complete directions for use, date of provision, and practitioner's name. |
| Class D (Clinic): Pt counseling is provided at the time of ______. If using an expanded formulary, only licensed _____ or ____ may provide drug | provision; nurses; physicians |
| Class D (Clinic): May store and provide ______ of dangerous drugs on the clinic's formulary that have been supplied to the clinic's practitioner's from a ________ | samples; manufacturer |
| Class D (Clinic): Supervision: A PIC, consultant pharmacist, or staff pharmacist MUST personally visit the clinic at least ____. Clinics operated by state or local govt or funded by govt sources may petition _____ for an alternative visitation schedule | monthly; TSBP |
| Class E (Nonresident) pharmacies are defined as? | not located in TX whose primary business is to dispense a rx drug or device under a rx drug order and deliver to pt in TX, process a rx drug order for a pt in TX, or perform another pharmaceutical service as defined by Board rule |
| Class E (Nonresident): Licenses are only issued to out-of-state pharmacies. A mail-order pharmacy would not have a class ___ license and instead would have an class __ licenses | E; A |
| Class E (Nonresident): The PIC of a class E pharmacy must be a ____-licensed pharmacist and be able to provide dispensing records within ___ hours and are expected to compley with the provisions of _____ rules relating to purpose, definitions, personnel, operational standards, and records | Texas; 72; TSBP *unless compliance would violate the pharmacy or drug laws in the residing state the class E pharmacy is in. |
| Class E (Nonresident): Pt counseling is required for all new rx drug orders. Since these are mailed to pts, tehy are treated as ____ rx and must provide written info regarding drug, along with pharmacist info on a toll-free #. if compounding sterile products, must register with TSBP as a class __-__ pharmacy | delivered; E-S |
| Class F (Freestanding Emergency Medical Care Facility) (FEMCF) is defined as? must ahve 1 PIC who is employed on a ____ or __- __ basis | freestanding facility that is licensed by the TDSHS to provide emergency care to pts; consulting; part-time |
| Class F (Freestanding Emergency Medical Care Facility): absence of a full-time pharmacist verify withdrawal of CS? Dangerous drugs? | ASAP but no more than 72h from the time of such withdrawal; reasonable interval for dangerous drugs but at least once in every calendar week |
| Class F (Freestanding Emergency Medical Care Facility): absence of a part-time pharmacist verify withdrawal of ALL drugs at a ____ ____ but such verification must occur at least once in every calendar week that the pharmacy is open | reasonable interval |
| Class F (Freestanding Emergency Medical Care Facility): must maintain a ____ inventory of ALL controlled substances which shall be verified by a pharmacist for completeness and reconciled at least once in every calendar ___ that the pharmacist is open | perpetual; week |
| Class F (Freestanding Emergency Medical Care Facility): Drugs suppled for outpatient use only in prepacked quantities not to exceed a __-hr supply if prelabeled by pharmacy and practitioner or licensed nurse under the practitioner's supervision must complete the label | 72 |
| Class F (Freestanding Emergency Medical Care Facility): A _____ random drug regimen review must be conducted at least every __ days | Retrospective; 31 |
| Class G (Central Prescription Drug Order or Medication Order Processing) is defined as? | license is issued to a facility established for the primary purpose of processing prescription drug or medication drug orders on behalf of another pharmacy, a healthcare provider, or a PAYOR |
| Class G (Central Prescription Drug Order or Medication Order Processing) pharmacy cannot possess, store, or dispense drugs but may perform the following: | 1. Receiving, interpreting, or clarifying rx drug or med drug orders 2. Data entering; transferring order info 3. performing drug regimen review 4. obtain refill and substitute authorizations 5, Verifying accurate rx data entry 6. interpret clinical data for prior auth. for dispensing 7. Performing therapeutic interventions 8. Providing DI concerning a pt's rx |
| Class G (Central Prescription Drug Order or Medication Order Processing) do not have a _____ ratio of pharmacists to techs | maximum |
Created by:
Xander635
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