Pennsylvania State Board of Pharmacy Exam 2024 Study Guide, Exams of Nursing

Download Pennsylvania State Board of Pharmacy Exam 2024 Study Guide and more Exams Nursing in PDF only on Docsity! PA PHARMACY LAW PG 77-98 - DR. GALLAGHER EXAM 2024 Composition of the State Board of Pharmacy (9) - correct answer✔✔ a. Commissioner of Professional and Occupational Affairs b. Director of Bureau of Consumer Protection c. *2* Public Representatives (appointed by the governor) d. *2* Independent Retail Pharmacist e. *2* Retail Chain Pharmacist f. *1* Acute Care Institutional Pharmacist State Board Requirements - correct answer✔✔ a. Executive Secretary must be a licensed Pharmacist and the Board Counsel must be an attorney b. members are appointed by the governor with approval by majority of Senate c. Pharmacist members must already hold a RPh license for at least 5 years d. Term is 6 years Purpose of the State Board of Pharmacy - correct answer✔✔ To protect the public health and safety Duties and Responsibilities of State Board of Pharmacy (9) - correct answer✔✔ 1. Regulate the Practice of Pharmacy 2. Determine the nature of pharmacist applicant exams (NAPLEX & MPJE) 3. Issue Licenses and Renewals 4. Employ appropriate consultants as necessary 5. Conducts Inspections - inspection report copies must be retained on pharmacy premise for 2 years 6. Conduct investigations of violations of the Pharmacy Act and Regulations 7. Conduct hearings regarding suspensions and revocations of licenses 8. Enforcement of laws and regulations pertaining to pharmacy 9. Promulgate (advocate) rules and regulations pursuant to the Pharmacy Act Reasons for Penalties - correct answer✔✔ 1. Procure a license through fraud, misrepresentation, or deceit (lying about CE credits) 2. Felony in connection with the practice of pharmacy of any offense involving moral turpitude (doesn't have to relate to pharmacy) 3. Impaired professional duties because of alcohol or controlled substances 4. Unfit to practice because of physical or mental diseases 5. Suspended or revoked licenses from another jurisdiction (a different state) 6. Violated pharmacy act or regulations 7. Compounded or dispensed drug which contains different amount than prescribed 8. Create danger to public health 9. Incompetences; malpractice, with or without injury 10. Guilty of grossly unprofessional conduct Guilty of grossly unprofessional conduct details - correct answer✔✔ 1. Willful Deceit 2. Improper Advertising 3. Public assertion or implication of professional superiority 4. Engaging in false, misleading, or deceptive advertising of drugs or devices 5. Payment or acceptance of compensation for recommending the services of another 6. Misbranding or adulteration of drug or device or sale of some *7.* Selling drugs marked as "sample" or "not for resale" 8. Displaying a license where not employed 9. Failure to have a pocket card available for inspection with practicing *10.* Acceptance and redistribution of a drug once it has left the pharmacy, unless it is in the original sealed container with the name, lost number and expiration date on the original manufacturer's label. (this law does not impact the business to refund the patient their money. that is up to the pharmacy) 11. Acceptance of employment as a pharmacist where medical professional are in a position to influence you c. Intern license is valid for up to a 6-year period Internship Credit - correct answer✔✔ Minimum of 1500 hours total required a. 500 of the 1500 hours must be served in a pharmacy b. An intern may earn up to 1000 hours by school c. Intern may not claim more than 50 hours a week d. Intern activities must be related to pharmacy practice: scrutinizing prescription/drug orders, compounding medications, filling prescriptions e. Must submit an "Intern Experience Reporting Form" f. Must send verification of hours to the State Board of Pharmacy via a verifiable delivery method that can be tracked and retain a second Original Copy for your own records Qualification of Pharmacist Preceptors - correct answer✔✔ 1. Preceptor must be registered in advance of internship 2. Preceptor must be full-time 3. Preceptor must be licensed in PA 4. Preceptor may not be register for more than 2 interns at a time 5. Change in preceptor necessitates submission of "Application to Change of Add a Pharmacist Preceptor" Qualification of Pharmacy - correct answer✔✔ 1. Must be Free of violations (fed/state/municipal) 2. Must compound and dispense a sufficient number of prescription 3. Must place an emphasis on activités connected with the distribution of articles and services pertaining to medical care including drugs, medicines, prescriptions, medical supplies and materials. Pharmacy Permit Requirements - correct answer✔✔ 1. A separate application/permit is required for each pharmacy a. each individual physical pharmacy location must possess its own permit b. a pharmacy serving the public on the premises of an institution must secure its own permit - institutional pharmacist are those pharmacies within health care facilities that are accredited by: the Joint Commission or The Commission of the American Osteopathic Association or Licensed by the Department of Welfare/Department of Health - only such institutional pharmacies are eligible for a pharmacy permit in PA Satellite Pharmacies Permit Requirements - correct answer✔✔ They are exempted. 1. Decentralized or Satellite Pharmacy are pharmacies within the same physical institutional that a. provided specialized services b. are dependent on a centrally located pharmacy for administrative control. Does a retail pharmacy in a hospital that serves the public need their own permit? - correct answer✔✔ Yes, only satellite pharmacies are covered under the general pharmacy of the hospital/institution. Pharmacist Manager - correct answer✔✔ 1. A separate pharmacist-manager for EACH pharmacy location needing a permit is required. T/F You can have one person act as the pharmacist manager for more than one store. - correct answer✔✔ FALSE. A person can only manage one pharmacy. Pharmacy Permit must bear: - correct answer✔✔ 1. Name and Address of the pharmacy 2. Name of owner 3. name of Pharmacist-manager (if it is not the same as the owner) If you quit and your name is not removed from the pharmacy permit.... - correct answer✔✔ .... you are still responsible. Sole Management is Required - correct answer✔✔ A pharmacist may be pharmacist-manager of only one licensed pharmacy at a time. Applicant Record (pharmacy permit) - correct answer✔✔ 1. Pharmacist-manager and Pharmacy Owner may not be guilty of any crimes concerning pharmacy 2. an applicant includes any director, officer of a company or individual owning greater than 10% of stock. (any person who owns more than 10% of the stock must have their name on the permit -- can me multiple people) Name of Business - correct answer✔✔ 1. Designation of "drugstore", "pharmacy", "apothecary", or "medicine" cannot be used if not a licensed pharmacy 2. Cannot use a "d/b/a" designation (doing business as) Pharmacist must personally supervise pharmacy - correct answer✔✔ 1. Every pharmacy must at all times when open, be under the constant direct and personal supervision and management of a pharmacist duly licensed in PA 2. 30 minutes lunch breaks are allowed and pharmacy may remain open for pharmacy related services, so long as the pharmacist remains in the pharmacy or within the immediate building ("physical structure that contains the pharmacy") a. A pharmacy related services include: - receipt of new written prescriptions - preparations of prescriptions for final verification - delivery of prescriptions already verified by a pharmacist Can a pharmacy intern or tech fill and deliver a prescription to the patient when the pharmacist is on break? - correct answer✔✔ NO, because the pharmacist did not complete the final verification for the prescription. An intern or a technician can not do this. Display of Registrations - correct answer✔✔ The following MUST be displayed: 1. Federal DEA Registration 2. Pennsylvania Pharmacy Permit 3. Pharmacist and Intern Licenses Renewal for Pharmacy Permit - correct answer✔✔ Every odd year for pharmacies (every 2 years) Period runs form September 1 - August 31 Pharmacy Closing - correct answer✔✔ 1. Return the Permit to the Board of Pharmacy 2. Notify the Board of the disposition of the files and prescription drugs - need permission of the Board before disposal, sale, or transfer of files or prescription drugs - if more than 30 days for the date of closing a. the sink must be connected properly to supply hot and cold water 2. Have restroom facilities for employees of the pharmacy a. provided reasonable close to, but outside of the prescription area Physical Set-Up Building Standards - etc - correct answer✔✔ 1. The pharmacy must be well lighted and ventilated 2. A television set may not be placed within the prescription area or so situation in the pharmacy that its viewing screen may be seen when looking at it from within the prescription area Equipment and Supplies - Inventory - correct answer✔✔ 1. Minimum at cost inventory of $5000 2. Pharmacies operating as central processing centers are exempted from inventory requirements 3. Outdated and otherwise adulterated and misbranded meds must be removed form active stock. Equipment and Supplies - Supplies - correct answer✔✔ 1. A pharmacy must contain additional equipment and supplies necessary to enable the pharmacy to properly prepare and dispense prescription within its scope of practice 2. A refrigerator used solely for store of drugs equipped with a thermometer or with a temperature monitoring device must be kept in the prescription area. Only for medicinal purposes. 3. Pharmacies operating as central processing centers are exempt. References Required in Pharmacy - correct answer✔✔ 1. Pharmacy Act and Board of Pharmacy Regulations - Blue and White Book (direct links to that on computer) 2. Federal and State Statutes and Regulations Pertaining to Pharmacy 3. Adequate and Updated Reference Library that: a. enables pharmacy to prepare and dispense properly appropriate to the type of pharmacy practice (technical, clinical, and professional aspects of practice) b. enables pharmacy to compound meds safely and effectively c. lists possible drug interactions and side effects d. lists therapeutic drug equivalents (substitution) - Orange Book) e. Lists therapeutic usage and dosage of meds f. provides guidelines for counseling Security - Arrangement of Pharmacy Area - correct answer✔✔ 1. must be under the constant and direct supervision of a pharmacist duly licensed in PA 2. Drugs and medical devices must be inaccessible to unauthorized personnel 3. Prescription are may not be used for storage of merchandise other than those used in preparation, dissension or delivery of drugs 4. No animals are allowed in the prescription area Security - Self-Contained Pharmacy - correct answer✔✔ Pharmacies located within retail establishments whose business hours differ shall adhere to the following standards: 1. The pharmacy must be able to be secretly sealed form the remainder of the store (floor to ceiling barrier) 2. Hours of the pharmacy must be posted at all points of access of the doors 3. Pharmacy must be closed whenever a licensed pharmacist is not present 4. A protocol for emergency access by non-pharmacist staff must be in place (including notification of pharmacist-manager) Security - Controlled Substances - correct answer✔✔ 1. Schedule II controlled substances must be: a. stored in a securely locked, substantially constructed cabinet; or b. dispersed throughout the stock of noncontrolled substances in a manner as to obstruct the theft or diversion of controlled substances 2. Schedule III-V may be stored: a. dispersed among stock of noncontrolled in a manner that obstructs theft Security - Hospitals - correct answer✔✔ Controlled substances must be stored in a separate locked space Security - LTCF - correct answer✔✔ 1. Controlled drug substances must be stored in separate locked permanently affixed compartments; OR 2. Double-locked medication carts Act 102 Significance - correct answer✔✔ 1. Expands scope of practice by allowing: a. Managing Drug Therapy in an institutional setting (Drug Therapy Management) b. Drugs Administration of Injectables, Biologicals, and Immunization 2. Also Expands Exposure to Liability a. Pharmacist who is part to a written agreement or protocol shall obtain professional liability insurance coverage (Pharmacist's Mutual) in the minimum amount of $1,000,000 per occurrence. * Need $1,000,000 insurance for immunization and managing drug therapy. Act 29 Significance - correct answer✔✔ Expanded Managing Drug Therapy to community settings by providing Collaborative Drug Therapy Management Duties of the Pharmacist - Interpret, Evaluate, and Implement Orders - correct answer✔✔ A pharmacist must: 1. Interpret, Evaluate, and Implement Medical Orders for Pharmacy Services and/or Prescription orders; including 2. Evaluate for safety and efficacy by conducting a Drug Utilization Review (DUR) or Drug Therapy Assessment, which evaluate: a. medication strength, dosage form, dosing schedule b. duration of therapy c. appropriate indication for use d. avoidance of therapeutic duplication e. avoidance of drug-drug interactions f. avoidance of drug-disease contraindications g. avoidance of drug allergy problems or adverse drug reactions h. proper utilization i. financial impact Other duties of a Pharmacist - correct answer✔✔ - Deliver, Dispense, or Distribute Prescription Medications - Preform Drug or Drug Related Research - Compound Products - Manage Drug Therapy 2. Currently, no educational registrations, licensing or certification requirements exist for technicians practicing in PA (exam question) Pharmacy Technicians - Permissible Functions - correct answer✔✔ 1. Carry containers of drugs in and around the pharmacy 2. Count Pills, tablets, or capsules and them in a containers. (Techs should not fill C2s, DEA says only Pharmacist can fill Controlled Substances) (if its in a locked cabinet only the pharmacist should have access) 3. Type or Print any labels 4. Maintain Records related to pharmacy practice 5. Assist the pharmacist in preparation and reconstitution of parenteral products and other medications a. supervising pharmacist must initial label of final product (pharmacist must do the final check and initial) 6. Enter prescription drug orders, or patient information into a profiles Pharmacy Technicians - Non-permissible Functions - correct answer✔✔ 1. Accept or transcribe an oral or telephone prescription order a. this includes refills and prescription transfers 2. Enter or be in a pharmacy without a pharmacist present 3. Preform any act within the practice of pharmacy, which requires professional judgement 4. Preform a duty until the tech has been trained and the duty is specified in a written protocol - Protocol must: a. be maintained on the premises b. specify the duties that a tech may preform c. be signed and dated by pharmacist-manager and the tech - protocol must be made available for Board of Pharmacy inspections 5. Provide Patient Counseling 6. Interact with other HCP regarding a patient's care 7. Dispense items, which require pharmacist intervention 8 Hand or have access to C2 controlled substances Interns - correct answer✔✔ Pharmaceutical activities by an intern must be performed under the direct, personal supervision of a licensed pharmacist. (pharmacist must be final check) Intern Activities - correct answer✔✔ 1. Verifying ingredients 2. Weighing ingredients 3. Compounding ingredients 4. Taking doctor calls Interns CANNOT - correct answer✔✔ 1. Enter or be in a pharmacy without a pharmacist on duty 2. Independently counsel a patient (technically an intern can not counsel patients unless a pharmacist is there) 3. Transfer Prescriptions (must be between 2 licensed pharmacists