Module 2 - People and Organizations

What is the composition of the Pharmacy Examining Board in Wisconsin?  How are members appointed?

7 members appointed for staggered 4-year terms; 5 of these members are pharmacists and two are public members

All board members must be residents of Wisconsin; They are nominated by the Governor and, with the advice and consent of the state Senate, officially appointed; Terms expire on July 1 and members may not serve more than two consecutive terms

The Pharmacy Examining Board or its designee may authorize two things that allow pharmacies to deviate from rules promulgated by the board. What are the two things that can be authorized, and the length of time permitted?

• Temporary variance when there is a natural or man-made disaster or emergency and a pharmacist requests it to protect public health, safety, or welfare – 90 days

• A pilot program intended to improve the safety, quality, or efficiency 1of pharmacy practice or prescription verification - 3 years

What 6 types of businesses are subject to licensure by the PEB in Wisconsin?

• Pharmacies, drugstore, apothecary

• Out-of-state pharmacies

• Manufacturers

• Wholesale distributors

• Third-party logistics providers

• Home medical oxygen providers

What information must be provided to the board in order to issue a license for an in-state pharmacy?

• The location of the pharmacy.

• A floor plan of the pharmacy.

• The name and address of the person holding title and ownership control of the location.

• The name of the managing pharmacist of the pharmacy

A pharmacy license application and fee shall be on file with the board at least how many days prior to the granting of the license?

30 days

An out-of-state pharmacy must be licensed in Wisconsin to be able to do what?

Ship, mail, or otherwise deliver a prescribed drug or device to persons within Wisconsin

Do pharmacists employed at an out-of-state pharmacy need to be licensed in Wisconsin?

No, a pharmacist employed in a pharmacy licensed under this section is not required to be licensed

Does the managing pharmacist of an out-of-state pharmacy need to be licensed in Wisconsin? What must the MP do?

• No, a pharmacy licensed under this section is not required to be under the control of a managing pharmacist licensed

• The MP must submit a statement in a form prescribed by the board from the owner or managing pharmacist that indicates they know the laws related to the practice of pharmacy in Wisconsin

When are pharmacy licenses renewed?

June 1 of each even-numbered year

Under what circumstance does an outpatient pharmacy located in a hospital need a separate license from the inpatient pharmacy?

When the outpatient pharmacy is physically separate from, and not contiguous to the area from which inpatient pharmacy services are provided

A change in either of what two things requires a new pharmacy license?

Ownership or location

Except for pharmacies licensed by the Pharmacy Examining Board, no person in the state of Wisconsin may use or display what titles, symbols or insignia?

Pharmacy, drugstore, apothecary

What is the “Professional Service Area?”

he area of a pharmacy in which prescriptions are compounded or dispensed, hypodermic needles, syringes, poisons and schedule V controlled substances are available, or where patients are consulted

What must occur if the Professional Service Area is closed yet the rest of the building remains open?

• A locked, secure physical barrier surrounds the professional service area of the pharmacy and precludes access to the area by unauthorized personnel

• Signs of reasonable size are posted at the professional service area which prominently display the hours the professional services are available

• The manner in which the telephone is answered does not imply that the professional services are available

What are the sanitation requirements for pharmacies?

• 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

• 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

What resources must be present within a pharmacy?

The latest available or immediately accessible version of federal and state pharmacy laws consisting of:

(a) Drug enforcement administration regulations, 21 CFR 1300 to end.

(b) Wisconsin pharmacy laws, ch. 450, Stats.

(c) Wisconsin controlled substances act, ch. 961, Stats.

(d) Wisconsin administrative code, rules of the pharmacy examining board

What are the storage requirements for controlled substances?

- The storage of drugs shall be secure, neat, clean and orderly

- All 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 or diversion

What is required in the pharmacy for security?

A pharmacy shall have a centrally monitored alarm system in the pharmacy.

Temperature and humidity must be measured in what areas and how often?

• “Freezer” means a place in which the temperature is maintained between -13 and +14 degrees Fahrenheit

• “Refrigerator” means a place in which the temperature is maintained between 36 and 46 degrees Fahrenheit

• The temperature of the refrigerator, freezer and pharmacy and the humidity of the pharmacy shall be continuously monitored. At least once each business day, the minimum and maximum temperature and humidity since the previous documented reading shall be recorded.

How long must temperature and humidity records be kept or maintained?

5 years

What is required to transfer business to a new owner and what is the timeline for doing so?

• The name, address, registration number, and authorized business activity of the registrant discontinuing the business (registrant-transferor) and the person acquiring the business (registrant-transferee);

• Whether the business activities will be continued at the location registered by the person discontinuing business, or moved to another location (if the latter, the address of the new location should be listed); and

• The date on which the transfer of controlled substances will occur

• Any change in pharmacy ownership shall be reported to the board office and the pharmacy license of the former owner returned. A pharmacy license shall be granted to the new pharmacy owner before the pharmacy may operate.

If a pharmacy sells drugs other than in the normal course of business or practice (i.e. at a bankruptcy auction following closure of the pharmacy), what notice must be given to the board before and after the sale?

The seller shall give written notice of the sale to the board at least one week prior to the date of sale and shall make a complete and accurate written report of the sale to the board within 10 days after the sale, showing the name and address of all of the purchasers of prescription drugs together with an itemized inventory of the prescription drugs sold to each purchaser.

What are the requirements for original licensure as a pharmacist in Wisconsin (non-foreign graduate)?

-       A statement from the dean of the school of pharmacy or the academic records office of the respective educational institution that the applicant has graduated from the pharmacy school

-       If foreign educated, evidence to show proof of certification

-       1500 hours of internship practice with statement from dean of COP or academic records to back it up

-       Fees required

-___Evidence of passing NAPLEX and MPJE with Wisconsin as primary state

What are the 3 requirements for transfer of license to Wisconsin from another state?

-       Completion of application form with signature of applicant and fee

-       NABP Clearinghouse license transfer application

-___Evidence of passing MPJE in Wisconsin as primary state

Within what timeframe must a pharmacist report a change of name or address to the board?

Within 30 days of the change

What may the board do if a pharmacist fails to obtain license renewal on time?

If a pharmacist fails to obtain renewal by that date, the board may suspend the pharmacist’s license, and the board may require the pharmacist to pass an examination to the satisfaction of the board to restore that license.

If a pharmacist renews license within 5 years of expiration, what do they need to do?

-       Pay the renewal fee as determined by the department under s. 440.03 (9) (a), Stats., and any applicable late renewal fee.

-__Certify the completion of 30 hours of continuing education during the last biennium.

If license has been expired between 5 and 10 years, what are the requirements to renew?

-       Completion of 160 hours of internship for each year the pharmacist license was expired, not to exceed 1000 hours.

-__Completion of 15 hours of continuing education for each year the pharmacist license was expired or within the last two years passing the NAPLEX.

If license has been expired for more than 10 years, what are the requirements to renew?

-       Completion of 1000 hours of internship.

-__Passing the NAPLEX

How many hours of CE are required for the first pharmacist license renewal?

None for the first renewal after a pharmacist is initially licensed

How many hours of CE /CEUs are required for each subsequent license renewal period?

30 hours within the two-year period

What CE programs are approved and recognized by the board?

The board recognizes only those educational programs offered by a provider approved by the Accreditation Council for Pharmacy Education at the time of attendance, or other board approved programs.

How long should a pharmacist keep evidence of CE for audit purposes?

Three years following the renewal date for be biennium for which 30 hours of credit are required for renewal of a license

What is a “Pharmacy Owner”?

A person or entity to whom a pharmacy license is issued

What is a “Managing Pharmacist”?

(look at all definitions given)

-       The managing pharmacist shall be responsible for the professional operations of the pharmacy.

-       A pharmacist designated by the pharmacy owner to have responsibility for and direct control of pharmaceutical operations in a pharmacy

-__A pharmacist who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy, and who is personally in full and actual charge of the pharmacy and personnel

A pharmacist in Wisconsin can be the “Managing Pharmacist” at how many pharmacies (not including remote dispensing sites)?

A pharmacist may be the managing pharmacist of not more than one community and one institutional pharmacy at any time and shall be engaged in the practice of pharmacy at each location he or she supervises.

What are the general responsibilities of a “Managing Pharmacist”?

-       The managing pharmacist shall be responsible for the professional operations of the pharmacy.

-       They are ultimately responsible for ensuring compliance with all professional service area security requirements—specifically, those measures required when the pharmacy is open as a non-prescription or sundry outlet, i.e., when no pharmacist is present in the professional service area.

-       The managing pharmacist shall determine which acts may be delegated in a pharmacy. The managing pharmacist has a duty to notify all pharmacists practicing in that pharmacy which acts may be delegated to specific uncredentialed pharmacy staff. This record shall be provided to the board upon request.

-__A pharmacist may delegate to an uncredentialed pharmacy staff person any delegated act approved by the managing pharmacist outside of the restrictions in sub

How long must a managing pharmacist be continuously absent from this role for before delegating this responsibility to another pharmacist?

30 days

Within what period of time must a change in managing pharmacist be reported to the PEB?

5 days

What services may be delegated to a pharmacist by a physician?

A pharmacist may perform any patient care service delegated to the pharmacist by a physician

What must the pharmacist do prior to performing a delegated service?

The pharmacist shall document the delegation by a physician and the delegated act may not be started prior to the documentation. Must be maintained for a minimum of 5 years after the last delegated act under that delegation.

What are the requirements for registration as a pharmacy technician?

-       Application is submitted with home address and name and address of employer

-__At least 18 years of age and graduated high school OR in a youth apprenticeship program for pharmacy technicians

Within how many days must a tech report a change of address or employer to the board?

10 days

What is the definition of “direct supervision”?

Immediate, whether in person or real time video conferencing where all parties can communicate by simultaneous means of audio, video, or data communications, availability to continually coordinate, direct and inspect in real time the practice of another.

What is the definition of “general supervision”

To continually coordinate, direct and inspect the practice of another.

What activities may a pharmacy technician do?

Administer vaccines, perform technical dispensing functions, compounding, packaging, labeling and storage, pharmacy and inventory management, and other activities involved in the practice of pharmacy delegated by a pharmacist

What activities may a pharmacy technician not perform?

-       Provide final verification of a prescription or medication order

-       Complete a drug utilization review

-       Administer prescribed drug products or devices

-       Provide patient specific counseling or consultation

-       Make therapeutic alternate drug selections

-__Provide supervision over the practice of pharmacy to other pharmacy technicians

What is the definition of an “intern?”

A person completing an internship in order to meet the requirement

What is an “internship?”

A practical experience consisting of the practice of pharmacy under the general supervision of a supervising pharmacist.

An internship must consist of a minimum of what number of hours? How must this be documented to the board?

-       1500 hours

-__Documented by either statement from dean of COP or academic records AND/OR statement from pharmacist certifying hours supervised OR verification of practical practice by another state

Who is a “pharmacy graduate?”

A graduate of a school of pharmacy approved by the board, who has submitted an application for pharmacist licensure or a qualified applicant awaiting examination for licensure approved by the board.

A practitioner must be licensed where to have their prescriptions filled in Wisconsin?

A person licensed in this state to prescribe and administer drugs or licensed in another state and recognized by this state as a person authorized to prescribe and administer drugs

What may a practitioner not prescribe for themselves?

Controlled substances included in schedule I, II, III, or IV for the practitioner’s own personal use

What drug classes and routes may an optometrist prescribe?

Only for ocular therapeutic purposes only

- Eye-related only

- Oral agents such as analgesics, antihistamines, antibiotics, antivirals, carbonic anhydrase inhibitors

What are limitations on optometrist’s CS prescribing?

• Schedule II: only hydrocodone – either <15 mg per doage unit or 300 mg/100 mL or in combo with non-narcotic ingredient

• Schedules III-V: Limited to narcotic analgesics

• Required on each RX:

--- Statement the OD is certified to prescribe

--- Indication

--- DEA registration number

What must an APNP include on each CS prescription?

Their ARNP certification number

What CS restrictions are in place for APNPs?

- Can’t prescribe, dispense, or administer amphetamines, sympathomimetic amine drug or compound any schedule II.

- Limited to 6 conditions:

1. Brain dysfunction, drug induced

2. ADHD/hyperkinesis

3. Depression

4. Opioid adjunct for cancer pain

5. Narcolepsy

6. Epilepsy

 

BAD ONE

 

- Also no anabolic steroids for purpose of enhancing athletic performance