Class B, D, E, F, G, H Rules Flashcards
Nuclear pharmacy
Regulated by the Texas Department of State Health Services through the Radiation Control Program
Authorized Nuclear Pharmacist Requirements
BPS certified nuclear pharmacist
OR
Completed 700 hours of a structured education program including 200 hours of didactic training and 500 hours of supervised experience
Nuclear pharmacist to technician ratio
1:4 provided that one is a certified technician
Outer container labeling requirements for Class B
Name, address, and phone number of the pharmacy.
Date dispensed.
Directions for use.
Prescription number.
Name of the patient, if known or for physician use if the name of the patient is not known.
Radiation symbol.
The words “caution – radioactive material” or “danger radioactive material”
The name of the radio pharmaceutical or it’s abbreviation. Amount of radioactivity in millicuries or microcuries or bequerels
Initials or identification card of the person preparing and the nuclear pharmacist checking the product.
If a liquid, volume in milliliters.
Requested calibration date and time.
Expiration date and time
Inner container label requirements for Class B
Standard radiation symbol.
The words “caution – radioactive material” or “danger radioactive material”
Name of radiopharmaceutical or at abbreviation.
Prescription number
Refills of radioactive prescriptions
None allowed
Define Clinic
A facility or location other than a physicians office for a limited types of dangerous drugs or devices restricted to those listed in and approved for the clinics formulary are stored, administered, provided, or dispensed only to outpatients of the clinic
Define license
A copy of class D pharmacies policies and procedure manual and formulary is required as part of the license application
PIC Requirements and Responsibilities for Class D
Employed or under written agreement as a consultant
May be a PIC for numerous clinics
Responsibilities: continuous supervision, not on site, documented on site visits, development of a formulary
Define supportive personnel
Responsible for provision of drugs according to written policy and procedures and completion of the drug label
Class D formulary may include:
Anti-infective drugs. Musculoskeletal drugs. Vitamins. Obstetric and gynecological drugs. Topical drugs. Serums, toxoids, and vaccines.
Class D formularies may not include:
Nalbuphine (Nubian)
Drugs to treat ED
Controlled substances
Class D Expanded Formulary
May petition the board for an expanded formulary if serving at least 80% indigent patients
Supportive care must be licensed nurses or practitioners
Must have policies for drugs that require special monitoring
Quarterly, a retrospective random drug regimen reviews must be done
If the pharmacy provides antipsychotics drugs, therapy MUST be initiated by a physician and then a practitioner can monitor ongoing therapy with physician exams annually
Class D Provision of Drug Requirements
Drugs are pre-packaged and labeled with the name and address of the clinic, name and strength of the drug, quantity, lot number and expiration date, directions for use, and appropriate ancillary labels
Drugs are provided by a specific designated supportive personnel Who completes the label with the patients name, any information necessary to complete directions for use, data provision, practitioners name
Patient counseling shall be provided at the time of provision
Class D Supervision Requirements
PIC, consultant pharmacist, or staff pharmacist must personally visit the clinic at least monthly.
Clinics operated by state or local government’s or funded by government sources may petition for an alternative visitation schedule
Class E Pharmacies
Nonresident, not located in Texas, pharmacies whose primary business is to dispense a prescription drug or device under a prescription drug order and deliver the drug or device to patients in Texas
OUT OF STATE PHARMACY!!!
Class E Requirements
License is in good standing
PIC must be a Texas licensed pharmacies
Must be able to provide dispensing records within 72 hours of TSBP request
Required to comply with provisions of TSBP rules relating to purpose, definitions, personnel, operation standards, and records
Patient Counseling is required through written information and a statement that a pharmacist will be available with a tollfree number
Sterile compounding E-S
Class F Pharmacy
A Freestanding Emergency Medical Care Facility
Freestanding facility that is licensed by the Texas Department of State Health Services to provide emergency care to patients
Pharmacist of Class F Institution
Must have one PIC who is employed or contracted at least part time or on a consulting basis
Class F Operational Standards
Pharmacy/storage area must be enclosed and lockable
Authorized individuals may enter the pharmacy/storage areas
Locked storage of C2
In the absence of a pharmacist, only a designated licensed nurse or practitioner may remove drugs from the pharmacy in sufficient quantities for the immediate therapeutic need of a patient
If full time pharmacist, withdrawal must be verified within 72 hours
If part time or consultant pharmacist, the pharmacist must conduct an audit of patient charts according to the schedule set out but at least once every calendar week
Perpetual inventory for all controls - verified at least weekly
Invoices of dangerous drugs and controlled substances must be dated and initialed or signed by the person receiving the drug. The pharmacist verify that the controlled drugs listed on the invoice were added to the pharmacy’s perpetual inventory by recording his or her initials and the date
Prepackaging required for outpatient medications not to exceed 72 hours
Retrospective drug regimen review must be conduct at least every 31 days to verify proper usage
Class G Pharmacy
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 health care provider or a payor
ORDER ENTRY
What can a Class G Pharmacy do?
Does NOT process, store, or dispense drugs
Receive, interpret, or clarify prescription drug or medication drug orders
Data entering and transferring of Prescription Drugs or medication order information
Preforming drug regimen review
Obtaining refill and substitution authorizations
Verifying accurate prescription data entry
Interpreting clinical data for prior authorizations for Dispensing
Preforming therapeutic interventions
Providing drug information concerning a patient’s prescription
Class G Pharmacist to Technician Ratio***
1:8 with only one technician trainee
Class H Pharmacy
Drug delivery Owned by a hospital district and is located in a county without another pharmacy Deliver filled prescriptions for Dangerous Drugs for the class A pharmacy and may not delivery controlled substances
