Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
35 Cards in this Set
- Front
- Back
|
* Define: Professional service area |
the area of a pharmacy in which prescriptions are compounded or dispensed, hypodermic needles, syringes, poisons and schedule V controlled substances as listed in s. 961.22, Stats., and Ch. CBS 2 are available, or where patients are consulted |
|
|
* Define: owner |
a person or entity to whom a pharmacy license is issued |
|
|
* Define: managing pharmacist |
a pharmacist designated by the pharmacy owner to have responsibility for and direct control of pharmaceutical operation in a pharmacy |
|
|
* Define: pharmacist-in-charge |
a pharmacist who is physically present in the licensed facility and responsible for the routine operation of a pharmacy for the period of time specified by the managing pharmacist |
|
|
* Define: technician |
a non-pharmacist or non-pharmacist intern who who, under the general supervision of a pharmacist who regularly coordinates, directs and inspects the activities of the pharmacy technician, assists the pharmacist in the technical and nonjudgemental functions related to the practice of pharmacy in the processing of prescription orders and inventory management. |
|
|
* Define: clerk |
ancillary person who may be present in the pharmacy (??) |
|
|
* Define: community pharmacy |
practice in a licensed pharmacy providing pharmaceutical services primarily on an outpatient basis |
|
|
* Define: medication profile record |
profile record system of all drug products dispensed for a particular patient |
|
|
* Define: system |
(Self- explanatory ??) |
|
|
* Discuss the procedure for the licensing of in-state pharmacies in WI |
Ch 450.06(2) , Ch. Phar 6.01
Application including: 1. location of the pharmacy 2. floor plan 3. name and address of the person holding title and ownership control of the location 4. name of the managing pharmacist of the pharmacy 5. the location has been inspected and found to meet all the requirements of ch 450 6. the initial credential fee is paid
Board must take action in 60 days
|
|
|
* Discuss the procedure for the licensing of out-of-state pharmacies in WI |
Ch. 450.065 Application must include: 1. the location of the pharmacy 2. the name and address of the person holding title and ownership control of the location 3. name of the managing pharmacist of the pharmacy
Must also submit: 1. a statement from the owner or managing pharmacy indicating that they know the laws relating to the practice of pharmacy in WI 2. evidence that it is licensed in its home state 3. pays the initial credential fee
The pharmacy must provide a telephone number that allows a person in WI to contact the pharmacy during business hours that is available for the use by a person in the other state at least 40 hours/ week |
|
|
Exceptions to out-of-state licensure |
Out-of-state pharmacies may not be required to comply with any provision in this Ch450 relating to the professional service area of a pharmacy or the minimum equipment requirements for a pharmacy
A pharmacist employed in an out-of-state pharmacy licensed under Ch450.065 is not required to be licensed under Ch450 |
|
|
* Describe the standards for pharmacy license holders regarding the managing pharmacist |
Ch450.09 (1) - Every pharmacy shall be under the control of the managing pharmacist - The managing pharmacist shall be responsible for the professional operations of the pharmacy. - A pharmacist may be the managing pharmacist of not more than one community and one institutional pharmacy at any time and shall be engaged at operations at each location - If the managing pharmacist is going to be gone for more than 30 days then they must delegate the supervisory responsibility to another pharmacy by power of attorney and keep that on file in that pharmacy |
|
|
* Describe the standards for pharmacy license holders regarding the presence of pharmacists
|
Ch450.09(2) No pharmaceutical service may be provided to any person unless a pharmacist is present in the pharmacy to provide or supervise the service |
|
|
* Describe the standards for pharmacy license holders regarding the equipment |
Ch450.09(3) Every pharmacy shall be equipped with proper pharmaceutical utensils for compounding and dispensing prescriptions. The board shall prescribe, by rule, minimum standards of professional and technical equipment |
|
|
* Describe the standards for pharmacy license holders regarding the pharmacy condition |
Ch450.09(4) The pharmacy shall be maintained in a clean and orderly manner and the professional service area shall be equipped with proper fixtures and equipment for sanitation |
|
|
* Describe the standards for pharmacy license holders regarding the display of license |
Ch450.09(5) Every original license issued by the board and the renewal license currently in force, if any, shall be displayed in the place of practice |
|
|
* Describe the standards for pharmacy license holders regarding the medication profile record system |
Ch450.09(6) Every pharmacy shall maintain a medication profile record system of all drug products dispensed for a particular patient according to the minimum standards for such systems established by the board by rule. Every practitioner shall maintain a record of all drug products dispensed to each patient according to standards established by the appropriate examining board by rule. The standards established by each examining board shall require the recording of all renewal dispensing information required by federal and state law and related rules and regulations |
|
|
* Describe the standards for pharmacy license holders regarding the selection of drugs |
Ch450.09(7) Drug products purchased for subsequent sale and dispensing at a pharmacy shall be selected for purchase by a pharmacist |
|
|
* Describe the standards for pharmacy license holders regarding the general floor design |
The professional storage area of a pharmacy shall not be less than 250 sq. ft. No more than 20% of the space may be used for storage of bulk pharmaceuticals. A variance to the 250 sq. ft. professional service area requirement may be authorized by the board upon submission of a specific plan describing the manner in which the proposed professional service area plan varies from the requirement |
|
|
* Describe the standards for pharmacy license holders regarding the storage |
Ch Phar 6.07 (1) The professional storage area shall have a refrigerator adequate for the storage of biological and other drugs requiring refrigeration (2) The professional service area shall have sufficient shelf, drawer or cabinet space for the proper storage of a representative stock of prescription labels, an assorted stock of prescription containers, and an adequate stock of prescription drugs, chemicals and required pharmacy equipment (3) Controlled substances shall be stored in a securely locked, substantially-constructed cabinet or dispersed throughout the inventory of non-controlled substances in a manner that obstructs theft |
|
|
Prescription Counter space |
Ch. Phar 6.04(2) A pharmacy shall have a prescription counter with a free working surface of 18 or more inches in width and at least 12 sq ft in area. This free-working surface must be used only for the compound and dispensing of prescriptions |
|
|
What is the importance of having a pharmacy licensure ? |
Ch 450.06 No pharmacist may dispense at any location which is not licensed as a pharmacy
No person may use or display the title "pharmacy", "drugstore", "apothecary", or any other title symbol, or insignia having the same or similar meaning |
|
|
Exceptions to dispensing without a pharmacy licensure |
Ch. 450.062 - nursing home/ mental institution - office/clinic of a practitioner - county jail - juvenile correctional facility |
|
|
Changes that Require New License |
Location (Ch. Phar 6.02(1)) - can't carryover license to a new location - outpatient pharmacies that are separate from the inpatient pharmacy must have a separate license
Ownership (Ch. Phar 6.02(2)) (Ch 450.06(3)) - Any change in pharmacy ownership shall be reported to the board office and the pharmacy license shall be granted to the new pharmacy owner before the pharmacy may operate
|
|
|
Changes that do not require a new license |
Changes in managing pharmacist (Ch Phar 6.03) - board must be notified within 5 days following the change
Floor plan remodel (Ch. Phar 6.04(4)) - any changes must be submitted to and approved by the board. The board must take action within 60 days |
|
|
Failure to license |
Fine no less than $25 & nor more than $50/ separate offense |
|
|
Professional Service area when the pharmacist is absent |
Ch. Phar 6.04(3) 1. Barrier around professional service area 2. The barrier is locked 3. Pt telephone request to renew a Rx may be accepted but a telephone message from a practitioner giving a new Rx order or renewal authority may not 5. Signs of reasonable size are posted at the entrance of the building and the professional service area prominently displaying the hours the pharmacist will be on duty 6. The manner in which the telephone is answered does not imply that the location is, at that time, operating as a pharmacy 7. The PEB is notified of the hours during which the establishment is operated as a sundry outlet
The managing pharmacist is responsible for compliance with all professional service area requirements |
|
|
Times when no pharmacist is present in the professional area but the pharmacy is NOT required to convert to a non-prescription or sundry outlet & what requirements have to be met |
Ch. Phar 6.04(3) 1. The pharmacist is absent for one half hour or less a. The pharmacist must be accessible for communication with the remaining pharmacy staff by phone, pager or another device b. The pharmacy must indicate that the pharmacist is not available in the professional service area and indicate the period of absence and the time of the pharmacists return c. Pharmacy technicians may only perform duties allowed by Phar. 7.015(2) |
|
|
Professional Service area Sanitation |
Ch Phar6.05 The professional service area of a pharmacy shall have a sink convenient and suitable for cleaning pharmaceutical equipment and supplied with hot and cold running water. Detergent and a waste disposal container also shall be provided in the professional service area |
|
|
Professional Service area minimum equipment |
1. An electronic balance that has a sensitivity of 1 mg or a mechanical torsion balance that has a sensitivity of 6mg 2. One set of accurate weights appropriate for any mechanical torsion prescription balance being used for the purpose of compounding 3. Supply of transparent glass graduates in single metric scale capable of measuring 5-100mL 4. An accurate device to measure less than 5mL 5. A supply of Wedgewood and glass mortars and pestles 6. A supply of acid, base, and solvent-resistant funnels 7. A heating device for any preparation that requires heat for compounding 8. Ointment slap or ointment paper 9. The latest available or immediately accessible version of federal and state pharmacy laws (DEA regulations, Wi pharm laws, WI controlled substances act, WI admin code) 10. References appropriate to the individual pharmacy practice (drug interactions, pt counseling, compounding, calculations, generic substitution, etc.) 11. The telephone number of poison control center (should be conspicuously posted in the prescription department)
Any person may apply for a variance by filling a written request to the board
|
|
|
Security |
Ch Phar 6.08 A pharmacy shall have a centrally monitored alarm system in the pharmacy. A security system or plan tat does not utilize a centrally monitored alarm system may be used if reviewed by and prior approval is obtained from the board |
|
|
Sterile Pharmaceuticals Physical Requirements |
Ch Phar 15.04(1) 1. Structurally isolated area 2. only used for preparation and documentation of sterile pharmaceuticals 3. Sufficient size to accommodate a laminar airflow hood and to provide for proper storage of drugs and supplies under appropriate conditions of light, temp, moisture, sanitation, ventilation, and security 4. Additional bulk supplies shall be stored in a separate area |
|
|
Sterile Pharmaceuticals Aseptic Environment |
Ch Phar 15.04(2) 1. at least class 100 environment 2. appropriate disposal containers (needles/syringes, other compounding items, and chemo agents--if applicable) |
|
|
Sterile pharmaceuticals records and reports |
Ch. Phar 15.05(1) 1. training and competency evaluations of personnel 2. Documentation of refrigerator and freezer temperatures 3. Certification of laminar airflow hoods |
