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28 Cards in this Set

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*Define: Pharmacy Examining Board

Full description is Ch 450



Created by state laws regulating the practice of pharmacy



Responsibility is to administer and enforce pharmacy laws and administrative rules


- protect the public health, safety and welfare


- Create rules and regulations, provide licenses, conduct hearings, etc.

*Define: enforcement

to put or keep in force; compel obedience to (dictionary.com)



(no definition given in any reading I can find, but it's pretty self-explanatory)

*Define: license

A document granted to pharmacists that represents that the state board of pharmacy ensures the competence of the individuals who practice pharmacy and the appropriateness of the physical facilities and business organizations within which they practice



Usually requires:


1. graduation from pharmacy school


2. completion of a specified internship requirements


3. Attainment of a specified age


4. A passing score on the licensure examination


5. demonstration of good moral character

*Define: credential

evidence of authority,status, rights, entitlement to privileges, or thelike, usually in written form (dictionary.com)



(no definition given in any reading I can find, but it's pretty self-explanatory)

*Identify the location in the WI government of the Department of Safety and Professional Services (DSPS)

Executive branch

*Identify the location in the WI government of the Pharmacy Examining Board (PEB)

Executive branch--> DSPS--> Examining Boards, credentialing Boards & Councils --> PEB & Pharmacy Advisory Council

*Describe the location of the Division of Enforcement within the DSPS

Created by WI Ch15


DSPS --> Deputy Secretary --> Enforcement

*Describe the functions of the Division of Enforcement within the DSPS


Separated into 3 parts:


- intake, screening, auditing, monitoring


- Business team


- health team

*Identify the composition and structure of the PEB

- 7 members = 5 pharmacists + 2 public, non-pharmacist members


- Appointed by Governor, confirmed by Senate, to serve four years and may serve for 2 consecutive terms


- Board elects its Chair, Vice-Chair, & Secretary


- Should met as a body 12x/year (typically 7-8x/ year)

*Discuss the role of the PEB in regulating drugs, pharmacy, and pharmacy practice in WI

Ch 450.02


- licensing pharmacists, pharmacies, manufacturers, and distributors of prescription drugs and devices


- adopting administrative rules


- preparing and conducting licensure examinations


- investigating violations of laws under its jurisdiction


- taking disciplinary action against its licensees

*Discuss the scope of the PEB's authority to set standards for pharmacy practice

Ch 450.02(3): the board may promulgate rules to:


1. relating to the manufacture of drugs and the distribution and dispensing of prescription drugs


2. Establishing security standards for pharmacies


3. Relating to the manufacture, distribution, and dispensing of hypodermic syringes, needles and other objects used, intended for use or designed for use in injecting a drug


4. Necessary for the administration and enforcement of Ch450


5. Establishing minimum standards for the practice of pharmacy


6. Establishing procedures for identifying pharmacists impaired by alcohol or other drugs or physical or mental disability or disease and for assisting those pharmacists in obtaining treatment



* Identify and describe activities that constitute the "active practice of pharmacy"

Ch 450.01(16)


1. interpreting Rx orders


2. Compounding, packaging, labeling, dispensing drugs and devices


3. Drug utilization review (DUR)


4. Proper storage of drugs and devices and maintaining related records


5. Provide info on drugs and devices


6. Drug product substitution (generic substitution)


7. Supervising non-pharmacist support personnel


8. Therapeutic alternate selection (in institutions only)


9. Drug regimen screening


10. Managing a pharmacy


11. Administering prescribed drug products, and under protocol, vaccines

* Describe the National Association of Boards of Pharmacy

- Represents state boards of pharmacy in all states, DC, Guam, Puerto Rico, Virgin Islands, New Zealand, some of Canada, Australia, and South Africa

* Describe the National Association of Boards of Pharmacy functions & authority

Mission: to assist its member boards and jurisdictions in developing, implementing, and enforcing uniform standards for the purpose of protecting the public health

* Describe the National Association of Boards of Pharmacy authority

- Oversees administration of standardized pharmacy exams


- Forum for development of policies and standards


- Develop model legislation and regulations


- Supervises license transfer between states


- Facilitates communication between states



Trying to standardize practice between states

Regulating pharmacy: who/where refers to...

Licenses



Regulating pharmacy: how pharmacy is practiced

Practice of pharmacy is mainly regulated by the states



Standards of practice


- rules and regulations


- reinforce standards


- professional judgement

Regulating pharmacy: federal level

Regulate drug product



Regulate participation in Federal programs


- e.g. Medicaid, Medicare, etc.

Structure of Pharmacy regulation: federal

1. 10th amendment: states have all powers not delegated to federal govt or prohibited by the US constitution


2. Police powers: allows states to enact laws promoting the health, safety, and welfare of people


3. Interstate commerce clause: US vs. Sullivan

Structure of Pharmacy regulation: state

1. Constitutional Law (won't talk about this)


2. Statutory Law


3. Administrative (Regulatory) Law

Wisconsin Pharmacy Practice Statute

Ch 450 : very vague... won't outline the practice in many details

Role of State Statutes

1. Outline practice of pharmacy


- Ch 450


2. Create and give authority to administrative agencies


- State Boards of Pharmacy (WI PEB)

State pharmacy practice acts

Statutes and regulations

NABP Involvement in Examinations

- North American Pharmacist Licensure Examination (NAPLEX)


- Multistate Pharmacy Jurisprudence Examination (MPJE)


- Foreign Pharmacy Graduate Equivalency Examination (FPGEE)

DSPS function

Function: licenses and regulates 132 different types of credentials in more than 58 professional fields (i.e. barbers, cosmetology, etc.)



Also, sets up Examining boards, credentialing boards, and councils

Reading:


General Duties of DSPS


General duties of examining boards and credentialing boards

WI Ch 440.03


WI Ch 440.035

PEB variances

Ch450.01(3m) talks about variances where pharmacy can come before the board and describe why they can't meet a certain standard and what they are going to do about it


- can be approved or denied by the board

PEB limits on pharmacy sales of non-prescription drugs

Ch 450.02(4): The board may not promulgate a rule which limits to a pharmacist the authority to sell or in any way interferes with the sale of nonnarcotic nonprescription drugs that are prepackaged for consumer use and labeled in compliance all applicable state and federal laws



- Think OTC drugs at gas stations