Introduction to Laws & Rules for Pharmacy Interns (Florida)

Law and the Pharmacy Intern Introduction to Laws & Rules: IPPE Considerations Kim Burns, RPh JD Objectives Discuss various federal and state laws and rules impacting Discuss pharmacy practice Recognize Recognize how the selected laws and rules apply to IPPEs...

Law and the Pharmacy Intern Introduction to Laws & Rules: IPPE Considerations Kim Burns, RPh JD Objectives Discuss various federal and state laws and rules impacting Discuss pharmacy practice Recognize Recognize how the selected laws and rules apply to IPPEs Locate common pharmacy practice related laws, rules, and Locate guidance documents Summarize basic requirements from sections of select laws, rules, Summarize and/or guidance documents that may be relevant to IPPEs Examples of Federal Laws and Rules Impacting Pharmacy Practice Federal Food Drug and Cosmetic Act (FDCA) FDA Federal Controlled Substances Act (CSA) DEA Poison Prevention Packaging Act (PPPA) CPSC Health Insurance Portability & Accountability Act (HIPAA) HHS OCR Omnibus Reconciliation Act of 1990 (OBRA 90)  FDCA FDA enforces the law – strict liability law Major topics covered include (but not limited to): RX & OTC drug approval & requirements Provides for the comprehensive regulation of (manufacturing, label/labeling, distribution) covered products introduced into interstate Track and Trace; obtaining products from approved commerce channels Intent of the law is to protect consumers from Compounding (503a and 503b pharmacies) adulterated or misbranded products (e.g. foods, Therapeutic equivalence of drugs and drugs, dietary supplements, cosmetics, and/or Interchangeability of biosimilars devices) Recalls No new drug may be marketed and sold unless it Medical Devices has been proven both safe and effective for its MedWatch Program intended use and approved by the federal Food and Repackaging Drug Administration (FDA) Patient Package Inserts, Medication Guides, REMS Oriented towards manufacturers; controls the Beyond Use Dating products RPh’s dispense NDC Codes Pharmacies/pharmacists must still be concerned with the law/specific sections apply Manufacturer marketing/advertising of Prescription Drugs  “Drug Facts” Label for OTC Drugs Consumer/user friendly labeling required Statement of identity of product; name/address of manufacturer, packer, or distributor; qty of contents; cautions and warnings; adequate directions for use; drug facts panel; normal dose for intended purposes; frequency of use; administration information; required prep for use Drug Facts Panel: Allows patient/family member to read and use as labeled (example from FDA.gov) 5  RX Drug Requirements – Commercial Container Label  Prescription drugs are labeled for the health care professional, not the patient. Requirements on commercial labels include:  Name and address of manufacturer, packer, or distributor  Established name of drug product  Ingredient information, including the quantity and proportion of each active ingredient  The quantity in terms of weight or measure  The net quantity of the container  A statement of the recommended or usual dosage, or reference to the package insert  The symbol “RX Only” or the legend: “Caution: Federal law prohibits dispensing without a prescription”  The route of administration, if it is not for oral use  An identifying lot or control number  Info on type of container to be used in dispensing the drug  The expiration date, unless exempted 6  Misbranding and/or Adulteration 2 major violations under the FDCA: Violations can occur at all points – e.g. manufacturing, distribution/repackaging, storage, pharmacy/pharmacist level  False/ Misleading Labeling Missing Dispense Man/Pkgr RX w/out /Dist or valid RX qty on package Doesn’t Missing meet FDA packaging required requirement Misbranding s (PPPA statement and tamper s/warning evident law) s Dangerous Imitation label/lacks of info on another dangers Failure to drug have adequate direction for use  Filthy/ Putrid/ Decomposed Prepared/ Lacks packed/ Tamper Evident held in Packaging unsanitary conditions Product or Drugs container may mixed/packed & reduced Adulteration be contaminated quality or cause harm Strength/ quality/ purity fall cGMPs below violated standards or labeling Unsafe color additive Misbranding and/or Adulteration A product can be rendered misbranded, adulterated, or BOTH!! Pharmacist can be found for misbranding and/or adulteration of a product Dispensing RX without authorization (misbranding; need valid RX to be exempt from manufacturer labeling) Misfilling of RX (misbranding; if wrong strength involved also adulteration) Drug dispensed without required PPI/MedGuide (misbranding) False/misleading advertising of a compounded product (misbranding) Counting a medication on a tray with residue from another medication (adulterated) Storing medication in improper temperature (adulteration) Not dispensing a product in a child-resistant container (misbranding) Violation of Tamper Evident Packaging requirement (adulteration and misbranding) 10  MedGuides and PPIs FDA Regulated Part of manufacturing labeling FDA approved drug information directed towards patient about dispensed medication (risks/warnings/what to do…) Pharmacists must provide with dispensed prescription with each new/refill prescription Amended requirements for hospital setting PPIs required for specific products/classes: e.g. birth control / estrogen products MedGuides – list of classes/products available on FDA website: https://www.fda.gov/drugs/drug-safety- and-availability/medication-guides Examples include Coumadin; SSRIs Consumer Medication Information (CMI) if not a substitute!!! Pharmacy Container and Label Packaging (vial or container) must meet various requirements FDA, USP, PPPA Poison Prevention Packaging Act Special packaging (child-safety/adult-friendly) CPSC Guidance Document – resource for practice https://www.cpsc.gov/s3fs-public/384.pdf Pharmacy label must comply with multiple federal and state laws and rules CPSC Guidance Document Important for law class and practice!!  Poison Prevention Packaging Act (PPPA) Delegates authority to the Designed to protect Consumer Products Safety Poison Prevention children from accidental Commission (CPSC) to Packaging Act of 1970 poisonings with household regulate, enforce, and (PPPA) substances, including ensure compliance with prescription drugs requirements Need new bottle/vial and cap Requires prescription and with each prescription filled OTC drugs to have child (can re-use glass container with resistant containers (test new cap) must be passed to be considered child-resistant; (RXs packaged for 80% under 5 can’t; 90% LTCF/hospitals exempt if the adults can) facility personnel will administer the medications 14 to the patient)  Examples of Pharmacy Exemptions from PPPA Requirements OTC products marketed specifically for elderly or disabled individuals with proper notation that the packaging is not child-resistant A manufacturer is allowed to make one package size in non child resistant container Exceptions/exemptions for certain drugs dispensed in special containers or for certain uses For example - sublingual nitro should not be packaged in child resistant containers (see lists in resource document) If requested by physician or patient to not receive child resistant container Requests – not required to be in writing, but prudent to try! 15 Compounding v. Outsourcing v. Manufacturing FDCA and FDA Regulated 503a and 503b https://www.fda.gov/drugs/human-drug- compounding/fdc-act-provisions-apply- human-drug-compounding FDA Guidance Documents https://www.fda.gov/regulatory- information/search-fda-guidance-documents State Laws/Rules Regulate USP Chapters 795 (non-sterile) & 797 (sterile)  Compounding FDA has numerous resources and guidance available, for example: Anticipatory compounding Drugs that are essential copies Links available at: https://www.fda.gov/drugs/guidance- compliance-regulatory- information/human-drug-compounding  Generic Substitution and Biosimilar Interchangeability State law controls circumstances around substitution (e.g. how to determine, documentation requirements, notification, how patient and/or prescriber to request brand, prescription details) FDA provides guidance in helping determine substitution of products (many states adopt Orange and Purple Book as law or require it to be used in professional judgment determination) FDA Orange book as guidance for generic substitution of traditional medications 2 letter coding system – FOCUS ON FIRST LETTER 1st letter is A or B. (A = therapeutically equivalent to reference product or B = not therapeutically equivalent) Biosimilars and Purple Book – “Interchangeable” FDA rating required of a biosimilar to be interchanged with reference product without intervention Orange and Purple Book available online from FDA  National Drug Codes National Drug Codes Unique 10 digit, 3 segment number (4-4-2; 5-3-2; 5-4-1) to report/identify product; 11 digit used for billing to comply w/HIPAA Ex: 60575-4112-1 becomes 6055-4112-01 to meet HIPAA requirements FDA proposing 12-digit NDCs in the future First segment identifies the manufacturer, the next identifies the drug (Strength/dosage form), and the last identifies the package size On OTC and RX drug labels and labeling Used to ID drugs; used a lot by insurance companies to process claims 19 HIPAA Company/organization/facility will have policies and safeguards in place to protect PHI under HIPAA Notice of privacy Security measures Training CSA Controlled Substances Laws/Rules/Guidance specific to CS Narcotic and non-narcotic CS Dependence/Abuse/Diversion concerns Closed system of distribution Registration and Record Keeping Requirements A primary goal is to prevent diversion while allowing patients with a legitimate medical need to obtain the FDA approved medications States have their own laws/rules too If additional or stricter requirements, follow!!! https://deadiversion.usdoj.gov/ DEA Pharmacist’s Manual DEA Guidance for pharmacists on how to comply with many provisions of the CSA Very important document for law class and practice!!! Available at: https://www.deadiversion.usdoj.gov/GDP/( DEA-DC-046R1)(EO- DEA154R1)_Pharmacist%27s_Manual_DEA. pdf 14 Sections and 14 Appendices CS – Common Practice Issues CII – written or ERx; no refills; emergency verbal prescriptions allowed under strict criteria; issuance of multiple prescriptions permitted; partial fills permitted under limited situations CIII-V – expire in 6 months; up to 5 refills permitted; verbal/written/faxed/ERx CS RX required to have specific information on it by prescriber and pharmacy must address if anything is missing/incorrect Corresponding Responsibility of pharmacists – HUGE TOPIC in past decade Dispensed RXs – must keep 2 or 3 files (CII/CIII-V/NONCS or CII/CIII-V with NON CS but CS must be easily retrievable) Security requirements for storing CS DEA 222 Forms – now only in Single Sheet Format or CSOS Inventory requirements PSE limits (3.6g/day; 9g/month) OTPs and DATA – Methadone in community practice v. Buprenorphine products See DEA Pharmacist’s Manual for Sections and topics!! OBRA 90 States required to adopt federal standards as minimum Some states adopted stricter rules and/or additional requirements 3 Components of Prospective Drug Use Review under OBRA 90 mandate: 1. A screen of prescriptions before dispensing Pharmacists are to detect potential problems by looking for such problems as therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect doses and durations, allergy interactions, abuse/misuse Further action should be taken if potential problem(s) detected 2. Patient counseling by the pharmacist – see next slide 3. Pharmacist documentation of relevant information OBRA requires a reasonable effort to keep written record of patients information including: Name/address/telephone number/birth date/gender of patient Significant individual history (allergies, diseases) Pharmacist comments relevant to drug therapy OBRA 90 Patient Counseling Standards Pharmacists (or delegate if allowed by state) must offer to discuss with each patient or caregiver matters that are significant, including: Name/description of medicine Dosage form/dosage/route/duration of therapy Special directions and precautions Common side effects/interactions Self monitoring/proper storage Refill information How to deal with missed doses Professional judgment to be used by RPh Waiver of counseling is allowed by patients, but it must be a knowing and voluntary refusal States may vary on offer/mandate; who can offer; intern involvement; who can counsel, etc. (state can be and often are stricter than federal )  Common State Laws and Rules Impacting Pharmacy Practice Pharmacy Practice Act State Board of State Controlled State Food and Pharmacy Rules Substance Laws Drug Laws and State Board of and Regulations and Rules Rules Pharmacy State Laws and State Generic Rules impacting State Mid-level Substitution State PDMPs Hospitals and Prescriber Rules Laws and Rules LTCFs *State Pharmacy Act and Board Rules generally available on State Board website; other state laws/rules may be too, or located on other state agency sites FL Board of Pharmacy Website Each State Defines the Practice of Pharmacy: Florida Example “Practice of the profession of pharmacy” includes compounding, dispensing, and consulting concerning contents, therapeutic values, and uses of any medicinal drug; consulting concerning therapeutic values and interactions of patent or proprietary preparations, whether pursuant to prescriptions or in the absence and entirely independent of such prescriptions or orders; and conducting other pharmaceutical services. For purposes of this subsection, the term “other pharmaceutical services” means monitoring the patient’s drug therapy and assisting the patient in the management of his or her drug therapy, and includes reviewing, and making recommendations regarding, the patient’s drug therapy and health care status in communication with the patient’s prescribing health care provider as licensed under chapter 458, chapter 459, chapter 461, or chapter 466, or a similar statutory provision in another jurisdiction, or such provider’s agent or such other persons as specifically authorized by the patient; and initiating, modifying, or discontinuing drug therapy for a chronic health condition under a collaborative pharmacy practice agreement. This subsection may not be interpreted to permit an alteration of a prescriber’s directions, the diagnosis or treatment of any disease, the initiation of any drug therapy, the practice of medicine, or the practice of osteopathic medicine, unless otherwise permitted by law or specifically authorized by s. 465.1865 or s. 465.1895. The term “practice of the profession of pharmacy” also includes any other act, service, operation, research, or transaction incidental to, or forming a part of, any of the foregoing acts, requiring, involving, or employing the science or art of any branch of the pharmaceutical profession, study, or training, and shall expressly permit a pharmacist to transmit information from persons authorized to prescribe medicinal drugs to their patients. The practice of the profession of pharmacy also includes the administration of vaccines to adults pursuant to s. 465.189; the testing or screening for and treatment of minor, nonchronic health conditions pursuant to s. 465.1895; and the preparation of prepackaged drug products in facilities holding Class III institutional pharmacy permits. The term also includes the ordering and evaluating of any laboratory or clinical testing; conducting patient assessments; and modifying, discontinuing, or administering medicinal drugs pursuant to s. 465.0125 by a consultant pharmacist. FS 465.003(22) Many of the Terms then have Additional Details… “Dispense” means the transfer of possession of one or more doses of a medicinal drug by a pharmacist to the ultimate consumer or her or his agent. As an element of dispensing, the pharmacist shall, prior to the actual physical transfer, interpret and assess the prescription order for potential adverse reactions, interactions, and dosage regimen she or he deems appropriate in the exercise of her or his professional judgment, and the pharmacist shall certify that the medicinal drug called for by the prescription is ready for transfer. The pharmacist shall also provide counseling on proper drug usage, either orally or in writing, if in the exercise of her or his professional judgment counseling is necessary. The actual sales transaction and delivery of such drug shall not be considered dispensing. The administration shall not be considered dispensing. (FS 465.003(13)) State Pharmacy Practice Act Passed by legislature to regulate the practice of pharmacy in the state Creates Board of Pharmacy to pass rules and regulations related to the practice of pharmacy and enforce the State Pharmacy Act Act gives broad authority to BOARD but also has a lot of practice related topics within Examples of topics often found in State Pharmacy Practice Acts Licensure Requirements (FL has FS 456 that applies to all health professions) Disciplinary actions / unprofessional conduct (FS 456 and 465) Documentation and record keeping requirements Defines scope of practice and authority of licensees Emergency Refills Transfers of prescriptions Return of unused medications Regulates areas not seen in federal law, or may regulate same areas and have stricter or additional requirements  Ex: Florida Pharmacy Act creates Multiple Categories of “Pharmacies” “Pharmacy” includes a community pharmacy, an institutional pharmacy, a nuclear pharmacy, a special pharmacy, and an Internet pharmacy. FS 465.003 (20)(a) 1. The term “community pharmacy” includes every location where medicinal drugs are compounded, dispensed, stored, or sold or where prescriptions are filled or dispensed on an outpatient basis. 2. The term “institutional pharmacy” includes every location in a hospital, clinic, nursing home, dispensary, sanitarium, extended care facility, or other facility, hereinafter referred to as “health care institutions,” where medicinal drugs are compounded, dispensed, stored, or sold. 3. The term “nuclear pharmacy” includes every location where radioactive drugs and chemicals within the classification of medicinal drugs are compounded, dispensed, stored, or sold. The term “nuclear pharmacy” does not include hospitals licensed under chapter 395 or the nuclear medicine facilities of such hospitals. 4. The term “special pharmacy” includes every location where medicinal drugs are compounded, dispensed, stored, or sold if such locations are not otherwise defined in this subsection. 5. The term “Internet pharmacy” includes locations not otherwise licensed or issued a permit under this chapter, within or outside this state, which use the Internet to communicate with or obtain information from consumers in this state and use such communication or information to fill or refill prescriptions or to dispense, distribute, or otherwise engage in the practice of pharmacy in this state. Any act described in this definition constitutes the practice of the profession of pharmacy. Then…. The Florida Pharmacy Act and Board Rules will have additional details/requirements for each type  Board enforces Pharmacy Act State Board Passes detailed rules/regulations to implement Pharmacy Act; of offers guidance on certain topics Pharmacy Board members include pharmacists Rules and Provides specific details on many day-to-day practice Regulations activities and pharmacy matters Licensure / continuing education requirements Required information on pharmacy label and filed prescriptions Scope of practice for pharmacy personnel Practice standards (expiration of RXs/Refills/CII RX) Sales of needles w/out RX Advertising of medications/prices PDR, Counseling, Patient Profile requirements Compounding; immunizations; drug therapy management Refusing to dispense medications Security, recordkeeping, documentation requirements Additional State Materials w/ Pharmacy Practice Requirements State CS Laws and Rules State Food and Drug Laws and Rules Generic Substitution Laws and Rules State Health Dept. Rules Hospital and/or LTCF Rules PDMPs; Midlevel Prescribing Dos and Don’ts for Interns (State Specific Issues) Topic Florida1 Required License Yes Limits to Enter Interns must maintain proof of current licensure such that it is readily retrievable upon request by state (DOH/Board) and Remain in or public; pharmacy may display license or a notice that it is available to view Pharmacy Interns must be identified by clearly visible identification badge or monogrammed smock showing their name and that they are a pharmacy intern Activities that Intern may not perform any acts related to the filling, compounding, or dispensing of medications unless it is done MAY be under the direct immediate personal supervision of a licensed pharmacist Delegated to In all pharmacies, pharmacist has the professional/personal responsibility for any delegated acts Intern by RPh Receiving verbal prescriptions Supervising and being responsible for CS inventory Interpreting and identifying prescription contents Engaging in consultation w/ a practitioner regarding interpretation of a prescription and data in a patient profile Engaging in professional communication with practitioner, nurses, or other health professionals Advising or consulting with a patient, both as to prescriptions and patient profile record Tasks listed as permitted by Techs (e.g. data entry, labeling of preparations and prescriptions, retrieval of prescription/patient files, counting/weighing/measuring prescription medications, initiating communication to confirm patient/prescription information, initiating communication with a prescriber/their agent to clarify or obtain info missing or illegible on prescriptions, accepting an authorization to refill an existing prescription that has no refills; preforming any other mechanical/technical tasks which do not constitute the practice of pharmacy Pharmacist Only Conducting the final verification of a completed prescription and assuming the complete responsibility for its Functions preparation and accuracy Engaging in final determination of prospective drug review / not allowing intern to independently override clinical alerts 1. See FL Pharmacy Act/Board Rules; https://floridaspharmacy.gov/resources/ Dos and Don’ts for Interns (State Specific Issues) Topic Pennsylvania1 Intern License/Registration Required Yes Limits to Enter and Remain in Only allowed to enter and be in pharmacy when open w/ licensed RPh on duty (pharmacy still Pharmacy considered open when RPh takes approved break on premises) Can only perform delegated functions under direct immediate personal supervision of a RPh Activities that MAY be Delegated to Procedures which require professional skill and training Intern by RPh Assisting the pharmacist in compounding Preparing and reconstituting parenteral products and other medications Receiving and transcribing verbal prescription orders from prescriber/prescribers' office Administration of immunizations (if intern is licensed specifically for this activity) Sale of hypodermic needles from the pharmacy Offering counseling to patients/caregivers for new retail/outpatient prescriptions Creating, obtaining, recording, and maintaining patient profiles Computer/data entry of RXs and patient information Preparing prescription medications and packaging of them for final verification by RPh Maintaining records related to the practice of pharmacy Making a notation on RX or patient profile when pt refuses to accept counseling or provide requested pt information Activities that Cannot be Delegated to Final review and verification of prepared prescriptions, prescription labels, drug orders, Intern by RPh compounded products prior to dispensing final product Performing PDRs for RXs or drug orders Participation in Drug Therapy Management Counseling patients 1. Pennsylvania Pharmacy Act and Pennsylvania Board of Pharmacy Rules. Available at: https://www.dos.pa.gov/ProfessionalLicensing/BoardsCommissions/Pharmacy/Pages/Board-Laws-and-Regulations.aspx FL Board Rule: 64B16-27.1001 Practice of Pharmacy Provides a lot from List Ready to try some Real Examples? Example 1 Under the Florida Pharmacy Act (Chapter 465) List at least 2 examples of why a pharmacist, pharmacy intern, or pharmacy technician may be denied a license to practice in Florida, or if they are currently licensed how that could be disciplined Example 2 Under the Florida Pharmacy Act Mrs. Smith comes into the pharmacy Friday night and is out of her blood pressure medication. You look up her profile and see she has no refills remaining. You attempt to contact the prescriber, and there is no answer and there is no one on call covering them. How could you/your pharmacist assist Mrs. Smith in this scenario? Example 3 Under Florida Administrative Code, Chapter 64B16, Board of Pharmacy (Board Rules) List what activities or tasks a pharmacy technician can and can’t do (Hint: Refer to Chapter 64B16-27 Pharmacy Practice) Example 4 Under Florida Administrative Code, Chapter 64B16, Board of Pharmacy (Board Rules) A patient brings in a new written prescription for Lasix 20mg for a one-month supply written last week by the prescriber. It has on the prescription “Refills- 11”. The patient asks what this means. What should the reply be? (Hint: Refer to Chapter 64B16-27 Pharmacy Practice) Additional Examples? Depending on class time remaining, we may do additional examples Watch for future announcements for any potential additional materials Summary Interns have to be licensed by state Pharmacies / pharmacists are required to comply with various federal and state laws, rules, guidance How to locate and access these are important Interns must also comply with the same laws when involved in any aspect of the practice of pharmacy Only perform under direct immediate supervision of RPh Interns are limited in activities that can and can’t be performed Rules dictate many specific activities Pharmacist discretion for any activities that can be performed Preceptors should guide you; but if you aren’t sure – ASK!! Any Questions?????????