Law Exam 4 PDF

WEEK 14 -- PART 2 -- Prescription Records, Labels and Other Packaging Requirements When Dispensing Drugs and Devices Shall vs must!!! How can you send a CS to another pharmacy? - Federal rules - State Rules - UnfilledCS prescriptions (how do we get it over) -...

WEEK 14 -- PART 2 -- Prescription Records, Labels and Other Packaging Requirements When Dispensing Drugs and Devices Shall vs must!!! How can you send a CS to another pharmacy? - Federal rules - State Rules - UnfilledCS prescriptions (how do we get it over) - 2020 → we’re gonna do it this way (electronic or call the pharmacist and send a fax of wh at u got electronically - Big circle! But put over it - Ct says fax or electronic but DEA says electronic ONLY - Venn Diagram *** FROM CLASS*** - 2023 → DEA said nah. We want to make sure what comes to you electronically we KEEP it electronically (keep records) → CAN ONLY be sent to another pharmacy if you received it electronically!!!! - State says you need pharmacist name → additional requirement from state - Pre-emption! - A NO somewhere in that tree?? Sketch it out - Can do both? → do both - One or the other → federal over state law (cant do fax!) - Sometimes LESS flexible rule (hardest) - Summary of combined rules!! Practice of Pharmacy in Connecticut (Part III of the Pharmacy Practice Act) -- dispensing etc. - Practice of pharmacy without a license is prohibited [CGS 20-605] - Only a licensed pharmacist in compliance with laws & regulations may use the title "Pharmacist“ - Pharmacist certificate of license to be available for inspection [CGS 20-607] - The pharmacist’s license does not need to be displayed in Connecticut (Note that some other States may require a pharmacist’s license to be displayed) - Use of certificate of license or display document by unlicensed person prohibited [CGS 20-608] - pharmacist who permits someone else to use license is subject to $100 fine & disciplinary proceedings Hospital Use of Telepharmacy Connecticut hospitals are permitted to use electronic technology (“telepharmacy”) to allow pharmacist to supervise technician in dispensing of sterile products - Tech ratios apply - If technology malfunctions, there shall be no distribution of CSP prepared by technician unless pharmacist either: - Personally reviews and verifies that CSP process by tech was accurate; OR - when technology is restored, pharmacist uses it to confirm that tech took all proper steps - Orders must be verified by pharmacist before tech begins dispensing process - Hospital’s director of pharmacy is responsible - If using the technology, the hospital must do periodic quality assurance evaluations (at least once per calendar quarter) and make evaluations available for inspection to DPH and/or DCP Advertising Prescription Drugs Advertising Prices. If advertising price of legend drug sold at retail, advertisement must clearly state the period the advertised price will remain in effect (may not say that price is subject to change without notice) Price Requests. Pharmacist or person holding pharmacy license must disclose price of legend drug upon request of prospective purchaser - Pharmacist may ask prospective purchaser for the medication’s: - name - dose/strength - quantity - If a prospective purchaser does not know the name, dose/strength, and quantity -- and the information is necessary to give a price -- pharmacist may call the prescriber to obtain the information prior to disclosing the price Disclosure of Information About Drugs for Termination of Pregnancy [CGS 20-633l, effective June 13, 2023] “A pharmacist who is employed by a pharmacy that has been approved to dispense drugs for the termination of a pregnancy shall provide to any patient who is seeking any such drug a list of the pharmacies nearest to such patient that dispense such drug if the pharmacy does not have a supply of such drug.” Pharmacy must be approved to dispense drugs for termination of pregnancy - If patient is seeking drug to terminate pregnancy - And pharmacy does not have a supply of drug - Then pharmacy must provide patient a list of nearby pharmacies that have the drug. EMERGENCY REFILLS (NONCONTROLLED DRUGS); REFILLS FOR EXTENDED SUPPLY Emergency Refills – (Noncontrolled Only) -- DOES NOT cover “vacations” Allows refill of NONCONTROLLED prescription without prescriber authorization IF: - Unable to contact prescriber after reasonable effort - Failure to refill might result in interruption of therapeutic regimen or create patient suffering - Patient/representative is informed that prescription is being dispensed without authorization - Prescriber is informed at earliest reasonable time that authorization is required for future refills - Unauthorized refill quantity must not exceed 72-hour supply - Labeling NOT stated, but issue a label (no reimbursement from this) Refills for 90-Day Quantities Pharmacist may refill for greater quantity than initial quantity prescribed IF: - Refill is made after original quantity is dispensed - Refill does not exceed - 90-day supply or - total quantity prescribed - Prescriber has not prohibited change to initial or refill quantity - Drug is not a controlled drug - Pharmacist informs prescriber ASAP (and within 48 hours of refill) - Patient’s insurance plan/policy covers refill quantity dispensed without additional co-pay, - co-insurance, deductible or out-of-pocket expense from patient FLAVORING AGENTS Adding Flavoring Agents Flavoring agent may be added to a prescription product by a pharmacist - If prescriber, patient or patient’s agent requests it - If acting on behalf of a hospital Flavoring agent must - Be used according to GMP and in minimum quantity to produce its intended effect - Be recognized as safe (e.g., USP, 21 CFR 172) - Produce no effect other than flavoring - Not more than 5% of the total weight of the product Adding flavoring agents in accordance with this statute is exempt from the compounding requirements of CGS 20-633b and USP Chapters & WEEK 15 -- Substitutions of Drugs and Biological Products Substitution of Generics & Interchangeable Biological Products (IBPs) Record. Prescription record must document. - brand name of drug substituted or, if not brand, generic name and manufacturer - retail price of substituted drug at the time of dispensing Label. Container must be labeled with name of dispensed drug. - If no brand name, must use generic name along with name of drug manufacturer or distributor Signage. Pharmacy must post an easily seen sign - "THIS PHARMACY MAY BE ABLE TO SUBSTITUTE A LESS EXPENSIVE DRUG PRODUCT OR INTERCHANGEABLE BIOLOGICAL PRODUCT WHICH IS THERAPEUTICALLY EQUIVALENT TO THE ONE PRESCRIBED BY YOUR DOCTOR UNLESS YOU DO NOT APPROVE" Substitution of Generic Drugs & Interchangeable Biologic Products Unless purchaser instructs otherwise, may substitute generic drug or interchangeable biologic product (IBP) only if all of the following three conditions are met: 1. Generic drug or/IBP to be substituted exists in same strength, dose, dosage form, and is dispensed in same quantity 2. Generic product/IBP is therapeutically equivalent “Orange Book” (drugs) or “Purple Book” (IBPs) 3. There is a cost savings and it is passed on to the purchaser BUT NO SUBSTITUTION if: - Written Rx: specifies “Brand Medically Necessary” (BMN) or “No Substitution” (NS) - Telephoned (oral) Rx specifies BMN/NS: - BMN/NS in pharmacist’s handwriting (or in e-record) - Time prescription received - Name of person giving authorization to pharmacist - Electronic Rx: Prescriber must select DAW code on certified e-prescribing system (EHR) – EHR may not default to BMN/NS ALSO, SPECIAL SUBSTITUTION PROCEDURES for EPILEPSY/SEIZURES (per current ICD treatment code) Substitution of Generic Drugs & Interchangeable Biologic Products Special note about epilepsy/seizure drugs – Pharmacist to give notice to both patient & prescriber AND get prescriber’s written consent if filling Rx using different mfr/distributor - if (after reasonable efforts) pharmacist can’t get prescriber’s consent, pharmacist to use professional judgment about refilling the Rx as if it were an emergency refill (see CGS 20- 616(b)) Special Note about Medicaid Reimbursement – Medicaid provider contract will generally require generic substitution unless it is on a preferred dispensing list. If brand name is medically necessary, prescriber usually must obtain “prior authorization” for pharmacy to fill - If order/prescription transmitted orally and for Medicaid patient, written certification of no substitution/brand medically necessary in prescriber's handwriting within 10 days Pharmaceutical Equivalents vs. Therapeutic Equivalents Pharmaceutical Equivalent Therapeutic Equivalents - identical dosage forms - pharmaceutical equivalents with - identical route(s) of administration demonstrated bioequivalence - identical amounts - expected to have the same clinical effect - identical active drug ingredient (i.e., same and safety profile when administered to salt or ester of same therapeutic moiety) patients under the conditions specified in - identical compendial/applicable standard the labeling Differences may include: shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration date/time, and labeling (with certain limits) Bioequivalence To receive approval for an ANDA, the drug product must be bioequivalent to the Reference Listed Drug (RLD) or the Reference Standard (RS) chosen by the FDA - A generic drug is bioequivalent to the RLD/RS if: - “The rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the listed drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses.” FDA Draft Guidance (August 2021) on Bioequivalence Studies … for Drugs Submitted Under and ANDS FDA Equivalency Rating Codes (Orange Book) "A" rated products: bioequivalent and "therapeutically equivalent" to brand name/reference product - AA Conventional dosage forms - AN Solutions and powders for aerosolization - AO Injectable products with oil solvents - AP Injectable solutions - AT Topical Products (if same dosage form) "AB" rated products: Product meets "necessary bioequivalence" requirements and may be substituted because equivalency problem resolved by in vivo and/or in vitro evidence - AB1 & AB2 are not bioequivalent and are not interchangeable - Three-character codes generally are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading "B" rated products are not bioequivalent What can we sub ⇒ prinivil What do we put on record & What do we put on label CGS 20-617 CGS 20-619(i) & (j) ⇒ ONLY D (some pharmacy can put other drug) - Generic without brand THEN you say what its for  ⇒ A ONLY Substitution of “Interchangeable Biological Product” “Interchangeable Biological Product” (IBP) is a biological product that: - (A) is FDA licensed and meets the standards for interchangeability pursuant to 42 USC 262(k)(4), or - (B) is therapeutically equivalent to another biological product, as set forth in the most current FDA “Purple Book” (“Approved Drug Products with Therapeutic Equivalence Evaluations”) When substituting IBP, pharmacist (or pharmacist’s agent) must: - Inform patient (or patient’s representative) of substitution - Within 48 hours of dispensing (including refills unless product dispensed is same as prior filling), document name and manufacturer of specific product dispensed to patient - Within 72 hours of dispensing (including refills unless product dispensed is same as prior filling), notify prescriber of substitution, using one of the following: - Interoperable EMR - e-prescribing technology - PBM system - Pharmacy record - Facsimile, telephone or electronic transmission - If IBP is to be delivered to patient (e.g., mail order), patient may request that pharmacy deliver only if patient (or patient’s representative) is present to sign for the delivery © Biosimilar vs. Interchangeable Biosimilar product has “no clinically meaningful differences” from Interchangeable product is a biosimilar that has also shown it is expected reference product for safety, purity and potency as demonstrated to produce “same clinical result” through: - If administered more than once, manufacturer must evaluate - Pharmacokinetic studies (exposure) safety and efficacy of switching back and forth between reference - Pharmacodynamic studies (response) product and interchangeable product Biosimilars & FDA’s Purple Book Biologics Price Competition and Innovation Act of 2009 – 42 USC 262(k) - Part of Affordable Care Act - Created abbreviated licensure pathway for biologics shown to be “biosimilar” (or interchangeable) – Section 351(k) of Public Health Service Act Biological product = generally derived from a living organism (e.g., humans, animals, microorganisms, yeast) FDA approval for same indication(s) and conditions of use as reference product if biological product has: - Same MOA - Route(s) of Administration - Dosage form(s) - Strength(s) Example of biosimilars (but NOT interchangeable biological products): Neupogen (approved in 1991) and Zarxio (approved in 2015) Substitution with Different Dosage Form Pharmacist may substitute oral, tablet or liquid dosage form if: - prescriber is NOT reasonably available for consultation; and - prescribed drug does NOT use a unique delivery system technology; and - the form dispensed has the same strength, dose and dose schedule; and - the form dispensed is therapeutically equivalent to the drug prescribed. Pharmacist must inform patient (or patient's representative), and prescriber of the substitution at the earliest reasonable time PATIENT COUNSELING CHS 20-614 Offer to Counsel for All Patients Prior to (or simultaneous with) dispensing, pharmacist (or pharmacy employee) must offer that pharmacist will discuss or counsel patient on usage of drug - No need to make offer if: - Not “practicable” - Person picking up is not the patient - Pharmacist determines offer should be made in writing (if offer is in writing, then it should tell patient that discussion/counseling can be in person at the pharmacy or over the telephone) - Pharmacist is not required to counsel if patient refuses/declines or is unable - Pharmacist must document counseling (or refusal/inability to accept counseling) - Counseling records must be retained for same time as prescription records (i.e., 3 years) - Applies to all DCP-licensed pharmacy dispensing (does not apply to dispensing from a hospital pharmacy that operates under a DPH license) Pharmacist’s Duty to Counsel Medicaid Recipients Prior to or simultaneously with dispensing, pharmacist must offer in person to discuss the drugs to be dispensed and to counsel the client on their usage except when: - the person obtaining the prescription is other than the person named on the prescription form - or the pharmacist determines it is appropriate to make such offer in writing. - Any such written offer shall include an offer to communicate with the client either in person at the pharmacy or by telephone Medicaid patient counseling should include the following: - Name and description of medication - Dosage form, dose, route, duration - Special directions/precautions for preparation, administration and use of drug - Common severe side or adverse effects, interactions, and therapeutic contraindications or precautions - Self-monitoring techniques - Proper storage - Refill information  - Action to be taken if dose missed Pharmacist's Duty to Counsel Medicaid Recipients - Pharmacist not required to provide counseling or gather information when - patient refuses counseling, or - patient is unable to provide the information requested - Pharmacist shall document: - Whether counseling was provided - Refusal/inability of patient to - accept counseling - give information - Records to be kept for 3 years (same as for Rx's) Pharmacist’s Additional Duties with Medicaid Recipients Patient Profile – must make reasonable effort to obtain, record and maintain: - Demographic information (name, address, phone #, DOB/age, gender) - Patient history where significant (disease state(s), drug reactions, known allergies) - Comprehensive list of drugs and relevant devices dispensed within last 180 days - Pharmacist's comments relevant to drug therapy DUR of drugs dispensed in last 180 days for - Therapeutic duplication - Drug-disease state contraindication(s) - Drug-drug interaction(s) - Incorrect dosage or duration of therapy - Drug-allergy interaction(s) - Clinical abuse/misuse/inappropriate drug use Standards for DUR: American Hospital Formulary Service Drug Information, the United States Pharmacopoeia Drug Information, the American Medical Association Drug Evaluations and the peer-reviewed medical literature Miscellaneous Dispensing Requirements Relabeling & Dispensing of Parenterals Hospital or nursing home pharmacist may relabel and dispense non-controlled parenteral medication to another registered patient if: - The original medication order is discontinued - The medication is in an unopened, tamper-evident package - The medication is not expired - The original patient is not charged for the medication - Upon receipt of the medication by the facility from the licensed pharmacy, it is processed through the facility's pharmacy Concept – must not leave control of the pharmacy Compliance Packaging and “Redispensing”: Definitions and Requests “Compliance packaging” defined in CGS 20-571 as prepared at a pharmacy as a single package with separate compartments for solid oral dosage forms - May have different drugs is same compartment, but each compartment must identify drug name and strength (PA 24-73, Section 4(b)(4)] May be either reusable or nonreusable (disposable) - May be used to group different medications by prescribed time of administration (e.g., take at bedtime) - Pharmacist must verify that all drugs in a single compartment are “compatible” and that none are to be administered PRN - Cannot combine controlled substances with noncontrolled drugs or different controlled drugs in same compartment (but can combined same controlled substance with different dose in same compartment per prescription, e.g., diazepam 5mg & 10mg can be in the same compartment) - Must be tamper-evident - Must be “child-resistant” unless pharmacy obtains a waiver acknowledged by the patient - Entire package shall not contain more than a 90-day supply unless another federal or state law allows for a greater days’ supply - Must comply with all applicable USP chapters [specific chapters not enumerated in the law] Patient, patient’s representative, or prescriber may request compliance packaging - Pharmacist or “advanced pharmacy technician” can dispense single or multiple prescriptions for single patient in compliance packaging per request Compliance Packaging and “Redispensing”: SOPs Pharmacy that provides compliance packaging must have “dedicated” area for preparing it and “standard operating procedures” that address: - Inspections of compliance packaging integrity - Cleaning (of area and equipment) - Labeling (of compliance packaging) - Dispensing and redispensing - Proper hand hygiene - Quarantine - Handling of returned and “redispensed” drugs - Specifically which drugs are not compatible, are suitable to be dispensed/redispensed in compliance packaging, or require special consideration to be placed in compliance packaging Compliance Packaging and “Redispensing”: Returned Meds & Labels - Allows original dispensing pharmacy to accept medication already dispensed in compliance packaging for return and to then be “redispensed” when patient has a new or changed prescription - Any medication accepted from patient for redispensing must be returned to patient (return to pharmacy’s stock is expressly prohibited) unless another law provides otherwise (e.g., Medicaid program may require pharmacy to accept certain dispensed medications for return and credit to the Medicaid program) - If the medication(s) being returned to the pharmacy in its original compliance packaging has been deprescribed, discontinued, or inappropriate for inclusion in the new compliance  packaging, the drug(s) must be placed in a separate containers where each container is for a single drug type or dosage (e.g., Prozac 20mg in separate container from Prozac 10mg) that is labled with: - patient name, original RX number, drug name, dosage form, quantity redispensed, instructions for use (or disposal). - If drug is to be disposed, must also include “procedures for any lawfully available means for destroying such drug … at home” and nearest location where drugs are accepted for destruction (e.g., police station or retail pharmacy collector) - The opioid warning label required under CGS 20-636 may be affixed to the compliance packaging only once, and does not need to be placed on each comparmtnet if an opioid is dispensed/redispensed Compliance Packaging and “Redispensing”: Records A pharmacy that provides compliance packaging services must keep detailed records of all drugs dispensed to a patient in compliance packaging that include: - Patient’s name and address - The ID number of each compliance packaging used and date of dispensing - The initials of the pharmacist or advanced pharmacy technician who prepared the compliance packaging - The serial number of each prescription for each drug dispensed in compliance packaging - A visual description of each drug dispensed in compliance packaging For each original compliance packaging that a pharmacy accepts for return and redispensing, the record must include: - Patient’s name and address - The ID number of the original compliance packaging - The date the original compliance packaging was accepted for return - The name of the pharmacist or pharmacy technician who accepted the compliance packaging for return and redispensing - The name, formulation, and quantity of each drug accepted for return in the original compliance packaging and whether any drug was discontinued or deprescribed Records of compliance packaging and redispensing must be kept for at least 3 years. If DCP requests a copy of any of these records, the pharmacy must provide a copy (electronic, preferred; paper if unable to provide electronically) within 48 hours Special Circumstance for Hospital ED Dispensing Connecticut allows licensed practitioners to verbally authorize a hospital emergency department to dispense medications to a non-hospital patient if: - Not a controlled substance - Therapeutic needs of patient require that medication be initiated immediately - 24-hour supply - Services of a licensed pharmacy are not available within a 5-mile radius BUT NOTE: CGS 20-622 is outdated since its enactment in 1983: - CMS hospital CoPs do not permit verbal orders in the hospital when the practitioner is - available  - Hospital policies/protocols direct patients to the right setting of care, and those settings are now more available (24-hour pharmacies/urgent care centers) - Insurance will not reimburse this kind of dispensing by hospitals Do not confuse this with dispensing of “take-home” meds when a hospital discharges its own patient Sale of Nonlegend Drugs Sale of Nonlegend Drugs: Pharmacies, Non-pharmacies, Permit Revocation Generally, Connecticut allows the sale of nonlegend drugs and devices only by: - Licensed pharmacies - Businesses with a nonlegend drug permit from DCP - Nonlegend drug permit is good for one year (must be renewed annually) - Fee for nonlegend drug permit is in CGS 20-601 - Permit is “nontransferable” - Permit holder must notify DCP of any change in ownership, name, or location of the permit premises - Commission of Pharmacy may revoke or suspend a nonlegend drug permit for: - Violation of the Pharmacy Practice Act - Violation of the Retail Drug Control Act [CGS 21a-126 to 21a-134] - Violation of any regulation or federal law pertaining to the sale or offer of nonlegend drugs - Veterinary drugs – CGS 20-625 clarifies that nothing in the Pharmacy Practice Act prohibits a nonlegend drug permit holder from selling nonlegend veterinary drugs Sale of Non Legend Drugs: Pharmacies, Non-pharmacies, Vending Machines OTC drugs and devices may be sold in a vending machine - But DCP is working on regulations, and will not allow vending machine sales of OTCs until those regulations are adopted - 6, which makes former RCSA 20-576-31 obsolete] If selling by vending machine, each vending machine must be separately registered. - Only one non-legend permit is required per location (i.e., can have 2 or more vending machines in one location) Non-pharmacies must identify an individual who is responsible for vending machines. That individual must ensure that the vending machines: - Maintain proper temperature & humidity as required by the OTC manufacturer - Contain only OTCs that are in their original containers - Contain unexpired & unadulterated OTCs - Contain OTCs that are not subject to a recall - Contain only OTCs, sundries, and nonperishable items - Has a clear and conspicuous statement attached that discloses name, address and toll-free number for owner/operator of the vending machine - Do NOT offer any nonlegend drug or device that requires age verification, is subject to quantity limits, or any other sales restriction under federal or state law (e.g., no pseudoephedrine) - Contains packages with no more than a 5-day supply of OTC per manufacturer’s directions Fine for violation: Up to $1,000 Sale of Nonlegend (NL) Drugs in Vending Machines If adopted, the proposed regulations will: - Add to RCSA 20-576-1 definitions for: “adulterated”; “damaged product”; “misbranded”; “nonlegend device”; “nonlegend drug”; “nonlegend drug permitee”; “nonlegend product”; “service”; “vending machine”; “vending machine registrant”; and “wholesaler Nonlegend (NL) drug permittees may purchase NL DRUGS only from: - a wholesaler - another NL drug permittee - In other words, because not specifically mentioned, purchasing NL DRUGS direct from a manufacturer is prohibited - No similar restriction on NL DEVICES Sale of Nonlegend (NL) Drugs in Vending Machines NL drug permittee must have written policy for responding to recalls. Policy must include: - Process to review products and identify if any are subject to recall - Protocol to remove, return, destroy, or sequester recalled products NL drug permittee has 48 hours to electronically submit a copy of the recall policy upon DCP request - NL drug permittee must maintain record of: - All NL PRODUCTS for individual sale purchased from wholesaler or other NL drug permittee - All recall notices received - Each NL PRODUCT returned (by NL drug permittee), and the reason for the return such as recall, damage, or other reason - Records must be maintained for at least 3 years - PROHIBITED SALES: damaged, adulterated, misbranded, expired, or recalled products (if commercially known or “visually evident”) - NL drug permits and vending machine registrations: - May NOT be transferred to another person; - May not be transferred to another location without notice to DCP at least 30 days prior to the transfer Storage, Sale and Acquisition of Nonlegend (NL) Drugs in Vending Machines - Vending machine registrant must purchase only from wholesaler or another NL drug permittee and only NL PRODUCTS that are labeled for individual sale per FDA requirements [as drafted, may vendor may NOT purchase from manufacturer] - All products sold by a vending machine must be: - Stored per manufacturer recommendations (e.g., temperature conditions) - Sold only in manufacturer’s original packaging (package must be clearly labeled, original, unbroken, tamper-proof, and expiration-dated) - No expired products (vending machine registrant must remove products on or before manufacturer’s expiration date); no recalled products - NL drug permittee must have written policy to review expiration dating at least monthly - Policy must be made available to DCP within 48 hours of DCP reques  - Vending machine (VM) must be in “good working order.” If VM Registrant knows/learns VM is inoperable, must – within 24 hours -- affix signage to say “not in working order” and arrange for service to return to operation ASAP. - If not returned to operation within 7 calendar days, VM registrant must notify DCP and include specific information (e.g., registration #, CM serial #; VM location; date VM became inoperable; date CM registrant discovered inoperable CM; contents of CM; description of why VM is inoperable; whether any contents were damaged/compromised; date when VM is expected to return to service; contact name and phone number for company servicing CM) OTC Vending Machines: General Requirements and Servicing of - Vending Machines (VMs) must be: - ≥750 pounds OR physically affixed to the building - Protected from the elements (by internal systems, or by external enclosure) to be: weather-tight; week-ventilated; moisture-controlled; well-lit; protected from sunlight; and capable of maintaining storage conditions consistent with manufacturer’s recommendations for each OTC in VM at all times - “mechanically serviced” at least once a year - VM registrant must maintain record of service that includes date(s) serviced, company that provided service, and purpose of service. - Record of service must be either (1) affixed to interior of machine and visible form the exterior; OR (2) maintained electronically and available to DCP within one business day upon request OTC Vending Machines: If Damaged or Tampered With Vending Machine (VM) registrant must notify DCP within 24 hours of discovering any of the following events has occurred: - The VM has been tampered with - The VM has been damaged - The VM has had its contents forcible removed, stolen, or compromised Within 5 days of discovering such an event the VM registrant: - Must evaluate any OTCs remaining in the machine to determine if adulterated or damaged - Remove any adulterated or damaged product immediately - Must submit a written report to DCP. The report must include at least the written description of the event and the steps taken by VM registrant to resolve and prevent recurrence OTC Vending Machines: Relocation; DCP Inspection; Permanent Removal - Relocating vending machine (VM) inside registrant’s premises? - Provide written notice to DCP within 5 calendar days of relocating VM - Relocating VM to exterior location of registrant’s premises (or any location where climate/elements may impact the VM or OTCs)? - Request authorization from DCP at least 30 days in advance of relocating VM. Request submitted to DCP must be in writing and must describe - Reason for the request - The quality controls that will protect VM and OTCs contained in VM  - DCP may inspect all VMs and their contents. Inspection may include: verifying the owner, the registration and permit; the VM’s location is as stated on the registration; notices and signage on the VM; service records; protection from the elements; contained products are in tamper evident packaging, not expired, subject to recall, or damaged, and not prohibited for sale by vending machine - If permanently removing VM, registrant must: - Give DCP written notice at least 5 days before removal - Inform consumers of last date OTCs will be offered in VM by posting sign on VM at least 5 calendar days in advance - Remove all OTC products by 11:59pm of last [posted] day of operation. For as long as “removed” VM remains accessible to consumers, a sign must affixed to indicate that VM is no longer operational NONRESIDENT PHARMACIES Nonresident Pharmacy - Nonresident pharmacy = located outside of Connecticut & ships, mails or delivers legend drugs or devices into Connecticut - Must register with DCP before sending drugs or medical devices into Connecticut - Nonresident pharmacy requirements: - Valid license where physically located - Compliance with all home-state laws - Submit last inspection report to DCP with application - After registration, submit annual report (locations, officers, pharmacists) - any changes in name, ownership, management, officers/directors must be submitted go DCP within 10days [Effective 06/11/2018] Nonresident Pharmacy & Compounded Sterile Products (CSPs) - If nonresident pharmacy is dispensing sterile pharmaceuticals and sending them into Connecticut, must: - Comply with USP - If dispensing is not patient-specific, must also submit manufacturing license (state or federal) or FDA registration (e.g., FDCA 503B outsourcing facility) - Have 24/7 toll-free phone number - Disclose sterile compounding to DCP 10 days to provide DCP with notice of any disciplinary action, advisement, warning by state/federal agency or accrediting body - If any recall issued for drug/device: 24 hours to provide DCP names of Connecticut residents who received delivery Advertising by Nonresident Pharmacies Nonresident pharmacy may not advertise its services in Connecticut unless it has a certificate of registration from DCP - Prohibition is on both - Direct advertising - Advertising by a Connecticut resident on behalf of nonresident pharmacy PHARMACY REWARDS PROGRAMS Pharmacy Rewards Programs - Pharmacy rewards program is when a retailer offers store credits, discounts or other benefits in exchange for filling Rx’s with the retailer - To enroll consumer in a pharmacy rewards program, retailer must provide “plain language summary” of terms & conditions - If consumer participation requires HIPAA authorization, the authorization form must state: 1. Specific uses/disclosures of protected health information (PHI) is allowed 2. Whether PHI will be disclosed to 3rd parties, and if it will no longer be protected after disclosure 3. Which 3rd parties will have PHI 4. How authorization may be revoked 5. That consumer may have copy of signed authorization Week 17 -- Expanding Pharmacists’ Scope of Practice & Patient Care Services Spectrum of Pharmacist Prescribing Authority - Dependent prescribing (the “physician-extender” model because authority to prescribe is delegated by the authorized prescriber, and may be setting specific). - Patient-specific (most-restrictive) - Population-specific - Connecticut examples: APRN prescribing (through “collaboration agreement”) and PA prescribing (through “delegation agreement”) - Independent (autonomous) prescribing (the “statutory” or “scope of practice” model because prescribing authority is granted by law) - Statewide “protocol” - Connecticut example: pharmacist prescribing of naloxone - Unrestricted (but usually category specific) - Connecticut example: certain diabetic products Significant Hurdles to Pharmacist Prescribing Responsibilities and accountability - Who does diagnosis of patient? - Medical collaborator (physician, APRN) - Questionnaire - What about additional assessments? - Does pharmacist assess only response to medications for diagnosed condition or also other, undiagnosed conditions? - Coordination of care - Polypharmacy and medication reconciliation - Risk Management / Professional Liability - Reimbursement - Anti-kickback and anti-referral laws - Separation of functions (i.e., dispensing from prescribing) Hallmarks of Collaborative Practice Agreement - Enabled by statute/regulation, flexible by agreement - Formal relationship between pharmacist and medical provider (physician, APRN, other) - Voluntary collaboration of interdisciplinary team - May use: - Patient-specific protocol - Disease/condition of certain patient population - Contains appropriate communication processes for coordination of care Typical characteristics - Post-diagnosis initiation and monitoring of drug therapy - Usually addresses chronic disease states or conditions - Pharmacist’s expertise may address polypharmacy issues Other Key Elements of Collaborative Practice Statutory/regulatory elements - Healthcare provider participants (e.g., Only physician prescribers; all prescribers) - Structure of relationship (e.g., 1:1 physician/pharmacist, or groups of physicians/pharmacists) - Populations served (e.g., single patient/agreement; populations/per agreement) - Authorized services (e.g., initiate, modify, terminate/deprescribe drug therapy; test ordering & interpretation; administration of meds) - Requirements & restrictions (e.g., reporting; documentation; limitations; licensing body oversight) “Contractual” elements & safeguards - Pharmacist and physician determine (and document) scope of pharmacist services - List actual participants (prescriber/pharmacist) - Identify required training/competencies/continuing education - Identify specific patients or patient populations - Specify disease states, services, protocols/clinical guidelines, documentation processes - Specify term (period) of collaborative practice agreement (e.g., one year) - Address liability insurance issues Lecture 19 PHARMACISTS’ COLLABORATIVE PRACTICE IN CONNECTICUT CT’s Collaborative Drug Therapy Management by Pharmacists → collaborative agreement! A “qualified pharmacist” is authorized to manage a patient’s drug therapy and prescribed devices, order associated lab tests, and/or administer drugs (but NOT establish a port to administer parenteral drugs) under either: - A CDTM policy adopted by a care-giving institution (e.g., hospital, LTCF), or - Stops retail pharmacy from entering collab agreement with community physician. - Agreements are often specialized into different clinics- ie. diabetes clinic - a CDTM agreement with one or more prescribing practitioners (can include: practitioners from another US jurisdiction; any practitioner “who is authorized to issue a prescription within the scope of the individual's practice”); orPer the regulations, a CDTM AGREEMENT must include: 1. Types of prescriptive authority decisions pharmacist is allowed to make (initiate, modify, continue, discontinue or deprescribe) 2. Patients who are eligible for treatment 3. Types of diseases/drugs/drug categories involved 4. Procedures, decision criteria, plans and guidelines for therapeutic decisions (especially to initiate or modify drug therapy) 5. Required training 6. Plan for periodic review, feedback & quality assurance 7. Procedures for documenting prescribing decisions Per the 2022 change to CT’s statute, a CDTM agreement/policy may address issues and concerns arising during medication reconciliation or about polypharmacy and allow the qualified pharmacist to “initiate, modify, continue, discontinue or deprescribe drug therapy” ⇒ Pharmacist Collaborative Drug Therapy Management “‘Qualified pharmacist’ means a pharmacist who (A) is deemed competent under regulations adopted by the commissioner pursuant to subsection (e) of this section, and (B) has reviewed the latest edition of the ‘Pharmacists' Patient Care Process’ published by the Joint Commission of Pharmacy Practitioners. - (pharmD + license unless in institution that requires you to know other stuff + work experiences) - The regulations provide that, to qualify, a pharmacist must be one of the following: - BS with 10 years of experience, or PharmD - Certified by one of the following - Board of Pharmaceutical Specialties - Commission for Certification in Geriatric Pharmacy - Credentialed in disease state management by National Institute for Standards in Pharmacist Credentialing - In a pharmacy residency accredited by ASHP - Successfully completed disease state management certification program approved by ACPE Policy OR Agreement that states collaboration - On the other hand need to document what you're going to do with patient - Pt specific or population specific → OR by care plan, policy, protol - Pharmacist Collaborative Drug Therapy Management In addition to the CDTM agreement/policy, must have one of the following: - Patient-specific written protocol - Patient population-specific protocol - Collaborative drug therapy care plan - Each protocol and care plan must include (at a minimum): 1. Specific drug(s), therapeutic class(es), and/or devices to be managed by the pharmacist 2. Terms & conditions to initiate, modify, continue, discontinue, or deprescribe a drug therapy and/or the use of a device 3. Conditions/events upon which the pharmacist must notify the prescribing practitioner 4. Lab tests that may be ordered by pharmacist 5. A definition of the patient population included in the protocol/care plan 6. Drugs that may be administered by the pharmacist (if it is a patient-specific protocol) - A copy of the protocol must be filed in the patient’s medical record - Pharmacist’s activities must be documented in the patient’s record in accordance with prescriber’s/institution’s policies - If discontinuing or deprescribing, pharmacist must give notice to prescribing practitioner within 24 hours - All CDTM agreements, policies, protocols, and care plans must be available for inspection by DCP and DPH - Pharmacists under DCP and physicians under DPH - Prescribing practitioner must have provider-patient relationship with the patient - Patient does NOT need to consent to collaboration between pharmacist and prescribing practitioner Pharmacist Administration of Vaccines Pharmacist Administration of Vaccines* As of October 1, 2024, a licensed (and trained) pharmacist may order, prescribe, and administer: - any FDA approved/authorized vaccine that is on CDC’s age-appropriate immunization schedule to anyone 18+; or anyone 12-17 with consent of the minor’s parent/legal guardian/legal custodian (or who provides proof of “emancipation”) - any vaccine not on CDC’s Adult Immunization Schedule (if the vaccine’s administration instructions are available on the CDC’s website) to anyone 18+ - any vaccine pursuant to a “verbal or written” prescription by a “prescribing practitioner” for a specific patient - The pharmacist must make an effort to review the patient’s vaccination history Pharmacy Technician Administration of Vaccines - A registered and certified pharmacy technician may administer any of the vaccinations if the pharmacy manager is authorized to administer vaccinations and the pharmacy technician has been trained at the pharmacy and completes at ≥1 hour CE annually - Pharmacist not qualified to administer == not qualified to oversee other vaccinators - An “advanced pharmacy technician” (APhT) may administer only if the vaccine is on a CDC age-appropriate schedule, and only if the directly supervising pharmacist delegates the pharmacist’s administration authority to the APhT Regulations require that: - Administration must be conducted pursuant to an order of a licensed healthcare provider (established through written protocol per regulations) - Pharmacist must complete an approved training program (and annual continuing education) - Program must include pre-administration education and screening, vaccine storage and handling, subcutaneous and intramuscular injections, recordkeeping, vaccine safety, cardiopulmonary resuscitation, basic cardiac life support and adverse event reporting - Program must be accredited by National Centers for Disease Control Prevention, the Accreditation Council for Pharmacy Education (ACPE) or other appropriate national accrediting body - A system of control and reporting be established *NOTE: The federal PREP Act overrides these vaccination provisions until December 31, 2024 Protocol for Pharmacist Administration of Vaccines - Written protocol must address systems for control and reporting - At a minimum, written protocol must include: - Name of healthcare provider authorized to order or prescribe drugs - Name of pharmacist(s) authorized to administer vaccines - Types of vaccines to be administered - Procedures, decisions criteria and plan to be followed by administering pharmacist, - including when to refer patient to physician - Procedures for emergency situations - Recordkeeping/documentation procedures - Administering pharmacist’s name must be recorded Pharmacist Administration of Vaccines; RPh Responsibilities; Epinephrine; Techs Pharmacist Responsibilities - Pharmacist must make a reasonable effort to review the patient’s vaccination history to prevent inappropriate use of a requested vaccine. Pharmacist must administer vaccine in accordance with either the manufacturer’s package insert, or the orders of a prescribing practitioner. Pharmacists administering vaccines must comply with DCP’s regulations Epinephrine Administration - Pharmacists who have completed DCP-required training for administering vaccines are authorized to administer an “epinephrine cartridge injector” upon a reasonable belief that a patient is experiencing anaphylaxis, regardless of whether the patient has a prescription. Pharmacist (or pharmacist’s designee) must call 9-1-1 before or immediately after administering epinephrine, and document date, time and circumstances of the epinephrine administration. Documentation must be kept for 3 years. Administration of Vaccines by Pharmacy Technicians; Impact on Tech Ratios - Certified technicians only (and must be registered with DCP), may administer vaccines to patients at a pharmacy, but only if (A) managing pharmacist is authorized to administer vaccines, and (B) technician - (1) successfully completed hands-on vaccine administration training certified by ACPE, - (2) training at the pharmacy, - (3) at least one hour of annual CE, - (4) has been evaluated by the managing pharmacist, and - (5) administers vaccines at the direction of the pharmacist on duty at the pharmacy. - September 1 through March 31 (each flu season), certified technician authorized to administer vaccines who is used exclusively for administering vaccines does not count toward the pharmacist-to-technician ratios. Pharmacist Testing for COVID, Influenza, and HIV Pharmacist COVID & Influenza testing Testing. Allows licensed pharmacist to order and administer tests for COVID-19 and influenza, but only if pharmacist is employed by hospital or retail pharmacy. - For hospital-employed pharmacists: only requirement is that patient is 18+, or 12-17 with consent of parent/legal guardian/custodian or proof of emancipation. - For retail pharmacy-employed pharmacists: → not fully developed - (1) pharmacy must have DPH approved CLIA application for the tests; - (2) pharmacist must have completed DCP-required training; and - (3) patient is 18+, or 12-17 with consent of parent/legal guardian/custodian or proof of emancipation. - Use of advanced pharmacy technician (APhT): pharmacist may delegate authority to administer COVID or influenza test to APhT if: (A) APhT completes DCP-required training, and (B) APhT administers test under direct supervision of delegating pharmacist and in accordance with DCP regulations Reporting of Test Results. Pharmacist who orders and administers test must: - provide the test results to the patient (in writing), and any PCP identified by the patient - report the test results to municipality’s health director (where the patient resides) and DPH (as required under CGS 19a-215 and regs) - maintain a record of the test results for three years Pharmacist HIV-Related Testing ⇒ essential same thing Testing. Allows licensed pharmacist to order and administer HIV-related tests, but only if pharmacist is employed by hospital or retail pharmacy. - For hospital-employed pharmacists: only requirement is that patient is 18+, or 12-17 with consent of parent/legal guardian/custodian or proof of emancipation. - For retail pharmacy-employed pharmacists: - (1) pharmacy must have DPH approved CLIA application for the tests; - (2) pharmacist must have completed DCP-required training; and - (3) patient is 18+, or 12-17 with consent of parent/legal guardian/custodian or proof of emancipation. - Use of advanced pharmacy technician (APhT): pharmacist may delegate authority to administer COVID or influenza test to APhT if: (A) APhT completes DCP-required training, and (B) APhT administers test under direct supervision of delegating pharmacist and in accordance with DCP regulations Reporting of Test Results. Pharmacist who orders and administers test must: - provide the test results to the patient (in writing), and any PCP identified by the patient - report the test results to municipality’s health director (where the patient resides) and DPH (as required under CGS 19a-215 and regs) - maintain a record of the test results for three years Pharmacist Prescribing in Connecticut Pharmacist Prescribing of HIV-Related Prophylaxis NOTE: This is not “effective” until DCP adopts regulations - If pharmacist orders and administers HIV-related test, and the test result is negative, the pharmacist may prescribe HIV-related prophylaxis according to manufacturer’s insert if - pharmacist has completed DCP-required training - patient satisfies the package insert criteria - prescribing and dispensing complies with all applicable statutory and regulatory requirements - Pharmacist Prescribing of HIV-related Prophylaxis and DCP Access to Documentation. For any pharmacist prescribed HIV-related prophylaxis, DCP may request: - copy of the HIV test results - prescription information - any other documentation required by (yet-to-be) adopted regulations - All information submitted to DCP concerning the ordering and administration of COVID- 19, influenza, and HIV tests, and prescribing of HIV prophylaxis, by a pharmacist must be kept confidential by DCP, and is not subject to Freedom of Information (FOI) disclosure. Pharmacist Prescribing of Diabetes Devices, Glucagon & Insulin A pharmacist may immediately “prescribe and dispense” ≤30 day supply of any of the following diabetes products: - diabetic ketoacidosis device - insulin drug - glucagon - diabetes devices necessary to administer the insulin or glucagon BUT ONLY IF… 1. patient claims to have 300,000 controlled substance prescriptions over four years, and was one of the top prescribers in the nation of a type of fentanyl - Question in Ruan v. United States: Did the prescriber’s subjective intent matter? (Or was the sheer volume prescribed enough to hold the prescriber criminally liable) - UNANIMOUS Supreme Court said that the subjective (not objective) intent of the prescriber matters; that is, did the prescriber actually believe that the prescribing was for a legitimate medical purpose? Case #3 - Duty to Warn ⇒ The case of the common condition (scabies) Facts of the case: - Husband and wife saw physician for treatment of scabies - Pharmacy filled Lindane prescription in husband's name - Wife received different agent to treat scabies that was not effective - Physician told wife to use husband’s Lindane (no new prescription) - Wife used husband's prescription for Lindane for treatment - Wife was pregnant at the time of treatment, and their child was born with severe medical problems - Pharmacy did not disclose potential for birth defects when it dispensed the Lindane Allegations of the case: - Defendant pharmacy failed to adequately warn of the risks associated with Lindane, including possible birth defects if used by pregnant women Court found that the learned intermediary doctrine applied, and that pharmacy had no duty to warn about all of the risks of using Lindane Case #4 - Duty to Warn ⇒ The case of medication therapy management Facts of the case: - Patient with history of DVT and stroke had been on anticoagulation therapy for 6 years through local VA clinic - A clinical pharmacist (Ph.D.) at the clinic was responsible for managing the patient's anticoagulation therapy - In anticipation of tooth extractions scheduled for the patient, the clinical pharmacist adjusted the patient's doses of Coumadin and Lovenox - Within a month after the tooth extractions, patient's clotting times were outside of target range and patient suffered a massive stroke that led to near vegetative state Allegations of the case: - Clinical pharmacist failed to warn patient of abnormal clotting times and need to return to clinic for monitoring - Clinical pharmacist failed to conform to objective standard of care that would apply to a physician managing anticoagulation therapy Court found that pharmacist failed to meet the standard of care when she did not prescribe Lovenox after patient presented with low INR, but the cased needed to go to trial to determine whether it caused the patient’s stroke Case #5 - Duty to Warn ⇒ Pharmacist “Misinforms” Prescriber - RPh received Rx for total dose of 2mg colchicine to treat gout and called MD to say loading dose was improper - MD asked RPh for proper dosing and Rx was changed to 7.2 mg total dose - MD did not disclose to RPh that patient had renal insufficiency (an expert at trial testified that the dose should not have exceeded 3 mg for this patient) - Applying the learned intermediary doctrine, the court found that the hospital pharmacist was not liable Case #6 - Refusal to Fill ⇒ Self-determination vs. professional judgment - Plaintiffs (in Minnesota) became ill with COVID-19. Treating physician prescribed ivermectin & hydroxychloroquine. - Walmart and Hy-Vee pharmacists refused to fill the prescriptions (corporate policy and professional judgment) - Plaintiff’s sued alleging: - Violation of “common law right to self-determination” - Intentional infliction of emotional distress - Tortious interference with “contract” because refusal to fill impeded prescriber’s performance of obligations to provide “medical treatment to the best of [prescriber’s] knowledge, skills, ability, and experience.” - Case dismissed August 19, 2022 Case #7 - Refusal to Fill ⇒ Discrimination vs. religious beliefs - Prescription for emergency contraception sent to (Minnesota) pharmacy - Pharmacist declined to fill based on his religious “beliefs” that the emergency contraception prescribed was an abortifacient - Pharmacist did not provide any alternative for filling the prescription - 1999 Minnesota Board of Pharmacy newsletter described that pharmacist has an obligation to fill legitimate prescriptions, but noted an exception with prescriptions for emergency contraception. Pharmacist may refuse to fill, but must provide immediately available alternative staff or a pharmacy to dispense. - Patient finally located a pharmacy 50 miles away that would fill the prescription  - Patient sued, alleging discrimination in violation of the Minnesota Human Rights Act - Jury decided that there was no discrimination - BUT the jury also awarded $25,000 for emotional distress inflicted on plaintiff by pharmacist’s refusal to fill and failure to provide an alternative for immediate access to the emergency contraception Discussion Questions and Strategies to Protect Against Liability Do different settings give rise to different liabilities? - Dispensing - Compounding - Consulting - Administration of drugs - Collaborative Practice - What if I make a recommendation that is not accepted and there is an adverse outcome? - Working for the VA or Public Health Service What do I do with orders that don’t seem safe or ideal? - What should I document after contacting the prescriber? - Should I tell the patient? - patient self-determination vs. interference with the practitioner-patient relationship Is the pharmacist liable for what a pharmacy technician does? A Word About Professional Liability Insurance - Employer Insurance vs. Individual Insurance - Possible “gaps” in coverage - Second job - Volunteer work - Providing advice outside of your employment (family, friends, neighbors, acquaintances) - Coverage limits - Disciplinary actions and other administrative proceedings - Criminal defense - Claims that arise after you leave employment (claims-made policies) - May want to obtain “tail coverage” known as extended reporting period coverage - How much insurance? - Does coverage amount meet or exceed likely claims? - Does coverage amount provide protection of personal assets?