Tennessee MPJE

FILLING Prescriptions of Deceased Providers

*A NEW prescription for a NON-CONTROLLED substance that has NOT been previously dispensed may be dispensed within 90 DAYS of the date on which the practitioner died *BUT DEA regulations prohibit filling or refilling prescriptions for controlled substances after prescriber has died

Exception to Narcotic Dependence

*A narcotic may NOT be prescribed/ordered for a narcotic dependent person EXCEPT: - Prescriber is registered as a Narcotic Treatment Program - Prescriber ADMINISTERS no more than 3 DAYS of therapy while arranging for admission to treatment - Buprenorphine by a prescriber with an "X" number - Hospital treating patient for some other condition or for patients with intractable pain

Temporary Absence of Pharmacist

*A pharmacist is permitted ONE temporary absence per day from the pharmacy practice site *The absence shall not exceed 1 hour per day *A sign must be posted at pharmacy stating "Pharmacist Not On Duty" *No prescriptions may be compounded or dispensed during pharmacist's time of absence *The prescription department must be secured by a physical barrier during the time of the pharmacist's absence to prevent unauthorized access

Internship Hours, Licensing Examination, and License Renewal

*A total of 1,700 internship hours are required for licensure •1,700 hours must be acquired in pharmacy programs structured by the college or school of pharmacy in which the student is enrolled *Licensing examinations •NAPLEX •MPJE *Reciprocity applicants must pass the TN MPJE

Substances/Drugs requiring poison-prevention packaging

*ALL oral controlled substances *Most oral Rx drugs - EXCEPTION: SL NTG, Isosorbide, Steroid or BC Dosepaks *Some oral OTC products - Any products with active ingredients that were previously available on by prescription - Aspirin (any Aspirin-containing preparation) - Methanol - Iron-containing drugs (> 250 mg/package elemental Fe) - Acetaminophen (> 1 g/package) - Diphenhydramine (> 66 mg/package) - Ibuprofen (> 1 g/package) - Loperamide (> 0.045 mg/package) - Mouthwash (> 3 g ethanol/package) - Naproxen (> 250 mg/package) - Lidocaine (> 5 mg/package) - Minoxidil (> 14 mg/package) - Dibucaine (>0.5mg/package) * Do not need to know the doses for 3 topicals (last 3)

Prescriptive Authority by Physician Assistants

*All hand-written, typed, or computer-generated prescription orders must be issued on TAMPER-RESISTANT prescription paper *A supervising physician may authorize a PA to order controlled substances in C-II to C-V as well as non-controlled drugs *A C-II or C-III OPIOID PRESCRIPTION must be limited to a maximum of a NON-REFILLABLE 30 DAY course of treatment (unless specific consult with supervising physician) *Any hand-written prescription must be LEGIBLE so it is comprehensible by the pharmacist

Podiatrist Prescriptive Authority

*All hand-written, typed, or computer-generated prescription orders must be issued on TAMPER-RESISTANT prescription paper *Any hand-written prescription must be LEGIBLE so it is comprehensible by the pharmacist

Optometrist Prescriptive Authority

*All hand-written, typed, or computer-generated prescription orders must be issued on TAMPER-RESISTANT prescription paper *Authorized to prescribe drugs rational to the diagnosis and treatment of conditions or diseases of the EYE OR EYELID *Authorized to prescribe ophthalmic lenses *Any hand-written prescription must be LEGIBLE so it is comprehensible by the pharmacist

Dentist Prescriptive Authority

*All hand-written, typed, or computer-generated prescription orders must be issued on TAMPER-RESISTANT prescription paper *Prescriptions from a dentist must be necessary or appropriate to the practice of dentistry *Any hand-written prescription must be LEGIBLE so it is comprehensible by the pharmacist

Physician Prescriptive Authority

*All hand-written, typed, or computer-generated prescription orders must be issued on TAMPER-RESISTANTprescription paper *Physician may prescribe controlled substances in the treatment of a person for INTRACTABLE PAIN to provide adequate pain treatment *Any hand-written prescription must be LEGIBLE so it is comprehensible by the pharmacist

Maintaining Records

*All records must be kept for 2 YEARS *Most may be kept at a central location (must notify DEA) EXCEPT the following (which must be kept at a registered location/pharmacy): - Paper prescriptions - Inventories - EXECUTED Order Forms (Form 222) *Records kept at a central location must be produced within 2 BUSINESS DAYS at the registered location upon written request from the DEA

Tennessee Board of Pharmacy Members

*Board consists of 7 members (one must be a consumer) *Consumer: - Must be a TN resident for at least 5 years - Currently reside in TN - Be a non-healthcare professional by education - Not have any ownership/financial interest in a healthcare business *At least 1 member should be 60 years of age or older *At least 1 member should be a racial minority *To be a board member a pharmacist must be licensed for at least 5 years and be actively engaged in the practice of pharmacy during his/her term in office Executive Director (not member of Board) shall be a pharmacist licensed in TN for at least 5 years Term of office is 6 YEARS with NO reappointment

Rubbing Alcohol

70% specially denatured ethyl alcohol

Pharmacy Technician

A NON-licensed and NON-certified individual trained and designated to assist pharmacists

Electronic Prescription

A controlled substance prescription that is transmitted as an electronic data file (NOT a fax) with a digital signature

Generic Equivalent

A drug product that has the SAME: - Active ingredients - Strength - Dosage form/route of administration - Established name Generic MAY DIFFER from brand in: - Size - Color - Shape - Scoring - Flavor - Excipients *Equivalence per "Orange Book" of rating "A" or "AB"

Investigational New Drug

A drug that has been tested on animals, and has shown it is safe and effective for the intended treatment

New Drug

A drug that is not generally accepted by experts as safe and effective for the intended use - New package material (e.g., glass to plastic) - New dosage form or method of administration - New combination of approved drugs - New intended use/indication - New dosage or strength - New patient population - New chemical entity

Automated Dispensing System

A mechanical system that dispenses controlled substances and maintains all transaction information *May be remotely located from the pharmacy, in which case the machine will have its own DEA registration

Long-Term Care Facility

A nursing home that provides health care to resident patients

Pharmacist

A pharmacist licensed by the state to dispense controlled substances AND an intern under the supervision of a pharmacist

Legibility of Prescriptions

A pharmacist may NOT fill a prescription unless it is COMPREHENSIBLE to the pharmacist A pharmacist may NOT fill an ILLEGIBLE prescription unless the pharmacist receives clarification from prescriber A pharmacist is NOT liable for any reasonable delay in providing a drug while trying to obtain clarification

Confidentiality of Patient Information

A pharmacist may disclose confidential patient information for the following purposes: - Prospective drug review to resolve DUR problems - Assist prescribers with patient drug history - Prevent abuse or misuse of drugs - Provide MTM or quality assurance programs - Very similar to Federal HIPAA law

Emergency REFILL of Prescriptions Without Authorization

A pharmacist may dispense a 72 HOUR supply of a drug without the prescriber's authorization IF: - It is a maintenance medication - Pharmacist cannot obtain prescriber's authorization - Health and welfare of the patient would be jeopardized without the drug *May NOT provide a controlled substance *If it is not possible to obtain the prescriber's authorization within 72 hours, ONE additional consecutive 72-hour supply may be dispensed *In the case of a government declared "DISASTER" a pharmacist may dispense up to a 20 day supply of refill non-controlled medication using information obtained from the prescription label or by oral authorization from the prescriber

Pharmacist's Refusal to Fill a Prescription

A pharmacist may refuse to fill a prescription if in the pharmacist's judgment it lacks therapeutic value or is not for a legitimate medical use

Continuing Education Requirements

A pharmacist shall complete at least 30 contact hours of continuing education during each 2-year license cycle. •At least 15 hours must be obtained through live programs •The 30-hr requirement is waived if the pharmacist was enrolled in: - An academic program pursuing a Doctor of Medicine degree - An academic program pursuing a Doctor of Dental Surgery degree - A graduate degree in a health-related science - An academic program leading to certification as a nurse practitioner or physician assistant - A pharmacy residency or fellowship program •Each pharmacist shall submit to the Board with the license renewal form a sworn statement indicating the pharmacist has completed the required continuing education (keep certificates of completion should the Board demand verification) - CE Monitor program through the NABP may eliminate certificates of completion •Any ACPE approved program will count toward the 30-hr requirement

Reporting Patients Attempting to Obtain CS Drugs Illegally

A pharmacist who knows that a person is knowingly attempting to obtain CS drugs shall report that person within 5 DAYS to local law enforcement

Central Fill Pharmacy

A pharmacy that fills controlled substances for a retail pharmacy AND returns the prescription to the retail pharmacy for delivery to the patient

Valid Prescription

A prescription issued for a legitimate medical purpose by a licensed individual practitioner in the usual course of professional practice *Must have a valid patient-practitioner relationship

Phase IV Clinical Trial

AFTER drug is approved the manufacturer will do post-market surveillance

Access to & Disclosure of Information

Access to the CS database shall be available at all times when dispensing controlled substances - All healthcare practitioners SHALL check the database the first time a patient is dispensed a controlled substance at that practice site and again at least once every 6 months for that patient. - A pharmacist SHALL check the database before dispensing a controlled substance if the pharmacist believes the prescription is fraudulent or inappropriate - Law enforcement personnel engaged in an investigation shall have access to the database *Pharmacists are not required to check the database if: -Patient is in hospice care -Quantity of drug does not exceed a 3-day treatment and does not allow any refill -The drug is prescribed for an inpatient of a hospital or nursing home

Label

Actual written/printed information placed upon the container (commercial container)

Pregnancy Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). Ex. Folic Acid, Levothyroxine, Magnesium Sulfate

Public Chapter #124

After January 1, 2021 ALL controlled substance prescriptions must be transmitted to the retail pharmacy electronically

Controlled Substance Registration

All licensees desiring to dispense any controlled substances must obtain a controlled substance registration from the Board of Pharmacy The state registration is IN ADDITION TO the pharmacy's DEA permit *This state registration is valid for two years, while the DEA registration is valid for three years (NOTE: Under 53-11-302 the state registration is valid for only 1 year - statute should prevail over a regulation)

Compassionate Use/Treatment INDA

Allows investigational drugs to be used to treat patients who are not enrolled in the clinical trial *Condition must be serious/life-threatening *No other effective treatment options available *Can use drugs in Phases I, II or III

Medicare Part C

Alternative to Part A, B, and D provided by managed care plans (HMOs) Plan is called "Medicare Advantage" Plans may or may not charge a monthly premium depending on the level of medical coverage provided

Dietary Supplement Health and Education Act of 1994

Amended the Food, Drug, and Cosmetic Act by creating a new type of product called "Dietary Supplements" FDA cannot require proof of safety or efficacy before marketing *Burden is on FDA to prove it is unsafe Manufacturer is prohibited from advertising that the product can diagnose, cure, or prevent any disease Can make "structure/function" claims (eg, helps you think better, helps digestive process, relieves aches/pains) Advertising is regulated by the FTC Pharmacists may display publications/articles/abstracts on dietary supplements, but material must be complete and not false or misleading AND must be physically separate from the actual product

Approved Use

An indication/use approved by the FDA pursuant to the NDA

Unapproved Use

An indication/use that has NOT been approved by the FDA *It is LEGAL for a prescriber to prescribe an APPROVED drug for an UNAPPROVED use (and the pharmacist may fill the prescription) *It is ILLEGAL for a manufacturer to promote or market an APPROVED drug for an UNAPPROVED use (EXCEPT for providing peer-reviewed scientific article(s) on the unapproved drug)

Mid-Level Practitioner

An individual practitioner other than a physician, dentist, veterinarian, or podiatrist

Individual Practitioner

An individual who is authorized to PRESCRIBE controlled substances

Prescription

An order for a controlled substance to be dispensed to a patient (for self-administration) *DOES NOT include an order for a controlled substance to be administered to an inpatient (drug order)

Pregnancy Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Ex. Metformin, HCTZ, Amoxicillin, Pantoprazole

Pregnancy Category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Ex. Tramadol, Trazodone, Prednisone, Amlodipine, Gabapentin

Schedule II Substances

High potential for abuse but currently accepted medical use in the US Abuse can lead to severe physical and psychological dependence Narcotics - codeine, meperidine, oxycodone, oxycodone/APAP, fentanyl, methadone, hydrocodone, hydrocodone/APAP (Vicodin/Lortabs), cocaine (FDA-approved), etc. Stimulants - amphetamine, methylphenidate, etc. Barbiturates (oral or injectable) - amobarbital, PENTObarbital, secobarbital

Institutional Practitioner

Hospitalist

Continuous Quality Improvement

Identifying quality related events and improving patient care

Destruction of CS Drugs in Hospital

If a controlled substance is dispensed to a patient, but is not totally used in the patient's therapy, the Excess drug shall be destroyed and a record of the destruction shall include: - Name of patient - Drug name, strength, dosage form, and quantity - Date and method of destruction - Identification of personnel witnessing the destruction - Destruction of records shall be maintained for at least 2 YEARS

Substitution of Drugs for Epilepsy Patients

If a patient's epilepsy is currently controlled on a specific drug, strength, or dosage form from a specific manufacturer, the pharmacist must notify the PATIENT AND PRESCRIBER prior to substituting another manufacturer's anti-epileptic drug *Pharmacist does NOT need to notify the patient or physician for inpatients of hospitals, nursing homes, or assisted living facilities

Reactivation of License

If inactive for 1-5 years it requires: *MPJE *All past-due CE *Internship (1-3 years = 160 hours; 3-5 years = 320 hours) If inactive for 5 years or more: Must do above PLUS pass NAPLEX *Licenses & Certificates must be renewed every 2 YEARS (renewed on or before the last day of the 2-year cycle)

Hazardous Sterile Products

If preparing cytotoxic drugs and hazardous substances: - Must have a dedicated Class II, Type A vertical flow hood or cabinet - Pharmacist interns and techs must ANNUALLY certify that they have reviewed appropriate texts

Partial Filling of C-II Prescriptions

Partial fills are allowed - Pharmacy must fill remaining balance within 72 HOURS - After 72 hours the balance is void and prescriber must be notified Two EXCEPTIONS to 72 hour limit: 1. Patient in LTC 2. Terminally Ill patient *Must indicate which exception by writing on the prescription *Pharmacist may partially fill for UP TO 60 DAYS from date of issuance of the prescription

Patient Registration

Patients are NOT required to register *Warning on CS ("Caution: Federal law prohibits transfer to another person") *Patients may bring CS into the US obtained from another country provided: - Drugs obtained legally - Patient declares the CS to customs for personal use - No more than 50 dosage units were obtained

Medication Guides

Program established for drugs that posed a serious and significant concern to health Requires manufacturers to submit proposed Med-Guides to the FDA for approval before use and to supply pharmacies with ample supplies Med-Guides must provide information on: - Proper use and when product should not be used - Serious adverse reactions that may occur *Required with each NEW and REFILL prescription

Pure Food and Drug Act of 1906

Prohibited adulteration and misbranding of food and drugs in interstate commerce

Medicare Part D

Provides coverage for OUTPATIENT RX DRUGS Voluntary program administered through private insurance companies with various monthly premiums based on co-payments/deductibles and drugs covered Requires insurance companies to provide MTM services to patients taking multiple drugs that will exceed an annual cost determined by HHS

Sale of Listed Chemicals

Pseudoephedrine - No more than 3.6 g of pseudoephedrine base may be sold to the same purchaser in a single calendar day OR - No more than 9.0 g in a 30-day period *Pseudoephedrine must be kept behind the counter or in a locked case to prevent direct access by customers *Purchaser must show a valid ID and sign a written or electronic logbook with name, address, date, and time *Sale pursuant to a prescription are not controlled or limited •Every seller of listed chemicals must train employees on the requirements and limits for sales of listed chemicals •Seller must submit a "self-certification" confirming the training to the DEA for each person •Seller must update the self-certification annually -The law does not preempt a state from passing a more stringent law, unless it is in conflict with the Federal law (Tennessee has more stringent rules)

Class I Drug Recall

Reasonable probability that the product will cause serious adverse health consequences *MOST SEVERE

Narcotic Treatment Program Registration (Category VII)

Registration is valid for ONE YEAR *No coincident activities

Manufacturer Registration (Category I)

Registration valid for ONE YEAR *May also do research and distribution of controlled substances

Distributor (Wholesaler) Registration (Category II)

Registration valid for ONE YEAR *NO coincident activities

Reverse Distributor Registration(Category III)

Registration valid for ONE YEAR *NO coincident activities

Dispenser Registration (Category IV)

Registration valid for THREE YEARS *Includes pharmacies and prescribers May also do research and instructional activities May perform central fill activities *If the pharmacy qualifies as "on-line" they must obtain a MODIFICATION to authorize dispensing via internet

Food and Drug Administration Modernization Act of 1997

Renewed PDUFA Changed the legend on Rx drug container from "Caution: Federal Law Prohibits Dispensing Without a Prescription" to "Rx Only" Created a fast-track approval process for drugs intended for serious illnesses Allowed manufacturers to provide prescribers with scientific peer-reviewed articles on UNAPPROVED uses for APPROVED drugs Clarified that pharmacists were allowed to COMPOUND a drug for a patient pursuant to a prescription and to compound limited quantities of a drug in anticipation of receiving a prescription Encouraged drug manufacturers to perform pediatric trials on drugs that might be useful/beneficial for pediatric patients

Food and Drug Administration Amendments Act of 2007

Renewed PDUFA Permitted FDA to order a drug recall Permitted the FDA to order Phase IV surveillance on Rx drugs Permitted FDA to require REMS for drugs that may pose an increased risk to patients

Technician to Pharmacist Ratio

STANDARD RATIO is 2 TECHS : 1 PHARMACIST *Ratio may be increased to 4 techs : 1 pharmacist IF TWO of the technicians are certified *PIC may request from the Board an even higher ratio based on technician experience and workload

Storage of Schedule II Controlled Substances

Schedule II controlled substances shall be stored in a substantially constructed cabinet, safe, or other structure with a double-locked security system

What Schedule is gabapentin in TN?

Schedule V

Central Fill Pharmacies

TN permits a pharmacy to utilize the services of a central-fill pharmacy under the following conditions: *BOTH pharmacies shall: - Hold a TN pharmacy permit - Share a common database or be able to access information necessary to fill a prescription order - Maintain a policy and procedure manual *If BOTH pharmacies are not owned by the same entity, then the pharmacies shall enter into a WRITTEN contract

Electronic Prescriptions

TN permits electronic transmission of prescriptions either DIRECTLY from a prescriber to a pharmacy or through a prescription intermediary - The electronic prescription order may be kept as a computer image or printed as a hard copy - A pharmacy is PROHIBITED from providing a prescriber with electronic equipment or software in exchange for transmitting prescription orders to the pharmacy - It is permissible for a pharmacy to transmit a prescription to another pharmacy by electronic transmission - The pharmacist shall not restrict a patient's freedom-of-choice of a pharmacy

Prescription Transfers

Transfers ARE authorizations to dispense - Transferee must record entire prescription history and information on the transferor pharmacy - If the drug is a controlled substance, transfer is permitted only ONE TIME - Transferor pharmacy must CANCEL the prescription and the transferee must inform the patient that the prescription has been canceled at the original pharmacy

Maintenance Treatment

Treatment in excess of 21 DAYS

Short-Term Detoxification

Treatment not to exceed 30 DAYS

Long-Term Detoxification

Treatment of MORE THAN 30 DAYS but LESS THAN 180

Certified Nurse Practitioner Prescriptive Authority

*CNP must be issued a CERTIFICATE OF FITNESS to prescribe prescription drugs *CNP must have a list of legend drugs that CNP is authorized to prescribe *CNP's can be authorized to order any medication (C-II to C-V and non-controlled) EXCEPT medications used for abortion *Any C-II or C-III OPIOID prescription shall be limited to a maximum of a NON-REFILLABLE 30 DAY course of treatment (unless specific consult with supervising physician) *All hand-written, typed, or computer-generated prescription orders must be issued on TAMPER-RESISTANT prescription paper *All prescriptions written by a CNP must bear name, address, and telephone number of supervising physician AND the CNP *Any hand-written prescription must be LEGIBLE so it is comprehensible by the pharmacist

Emergency Kits

*Contains drugs for IMMEDIATE/EMERGENCY use *Expiration date shall be marked on the exterior of the kit, and the date shall be the earliest expiration date of any drug within the kit *When the kit is opened, the pharmacy shall be notified and the kit shall be restocked and resealed ASAP

Sterile Product Preparation Policy and Procedure Manual

*Every sterile product compounding pharmacy shall have a policy and procedure manual - Must include compliance with all applicable USP standards - Must address a response to adverse events, outbreaks, and other public health threats associated with the compounded sterile products - The policy and procedure manual must be reviewed and updated each year *Every sterile compounded product shall have a label with the information required by the Regulation

Invoices/Prescriptions/Returns/Loss

*For EVERY record you need the following elements: - Drug/dosage form/strength/quantity - Date the drug entered or left the pharmacy - Name/address/DEA number of supplier (if purchased) - Name/address/DEA number (if any) of purchaser (if sold)

C-II Prescriptions

*Generally must be written and signed -Electronic transmission is permitted (and in the future may be REQUIRED) with the use of DEA approved encryption/decryption software EXCEPTIONS: *Facsimile *Emergency Oral Prescriptions

Home Care Kits

*Home care kits are to be kept in the home of the patient for use by healthcare professionals *Contains drugs which are not immediately available from other sources *Drugs in kit are for EMERGENCY use ONLY *When the kit is opened, the pharmacy shall be notified and the kit shall be restocked and resealed ASAP

Termination of Business

*If a pharmacy terminates business: - PIC must notify Board in writing of *The disposition of the drugs Records of the pharmacy AND *Date of closing If a pharmacy is being sold to another pharmacy or selling its drugs to another pharmacy, than the PIC of each pharmacy shall jointly inventory all controlled substances and mail a copy of the inventory to the Board within 30 days of the sale

REFILLING Prescriptions of Deceased Providers

*If a prescription for a NON-CONTROLLED substance has valid refills, the refills may be provided for up to 180 days fromt the date on which the practitioner died *BUT DEA regulations prohibit filling or refilling prescriptions for controlled substances after prescriber has died

Inventory Requirements

*Must be kept for 2 YEARS *Must count ALL CS drugs in stock/inventory - Take EXACT count of C-II drugs - May estimate opened containers of C-III to C-V if the container holds LESS than 1,000 tabs/caps (If more you must take an exact count) *May taken inventory on ANY DAY within 2 years of last inventory, but must take either before opening or after closing for business on the day of inventory *Must maintain in typewritten or printed form, and may be taken with tape recorder if promptly transcribed *If a drug is added tot he list of CS drugs, and was NOT a CS drug before, must inventory on the day it becomes a CS drug (e.g., Tramadol) *If a drug moved from one schedule to another, no inventory is required (e.g., Lortab) *Pharmacy is NOT required to maintain a perpetual inventory

Pharmacist in Charge (PIC)

*Must maintain a current list of pharmacy technicians working *PIC may be in charge of only ONE pharmacy unless the Board determines it is the public's interest *A PIC shall be on duty at LEAST 50% of the hours a pharmacy is open OR 40 hours per week (whichever is LESS)

Application for permit to operate a pharmacy, outsourcing facility, or oxygen supplier

*No pharmacy, outsourcing facility, or oxygen supplier may operate until a license has been obtained *A new license must be obtained if there is a change in name, location, or ownership

Patient Counseling (OBRA 90)

*OFFER to counsel shall be made with all new and refill prescriptions •Must be done by pharmacist. (NOTE: under 1140-02-.01(13)(d) an intern under the supervision of a pharmacist may provide counseling - a conflict!) •Shall be done with all new retail prescriptions unless the patient refuses *Required for outpatients of hospitals and when medications are dispensed to patients upon discharge from a hospital *Counseling is NOT required for inpatients Counseling Shall Cover: •Name and description of drug •The dosage form, dose, router of administration, and duration of therapy •Special directions for preparation, administration, and use by the patient •Common side effects or adverse effects and therapeutic contraindications •Techniques used for self-monitoring •Proper storage •Prescription refill information •Action to be taken in the event of a missed dose *Patient profiles shall be maintained for all retail/outpatients (pharmacist can not force patients to provide information) •Name, Address, phone number •DOB, gender •Medical & drug history •Pharmacist's comments *Drug regimen review shall be performed before dispensing each new or refill retail/outpatient prescription *Pharmaceutical care shall be implemented with all prescriptions to achieve desired therapeutic outcomes

Prescription Drug Marketing Act of 1987

*ONLY APPLIES TO PRESCRIPTION DRUGS Requires states to license drug wholesalers *Established a PEDIGREE - paper/electronic trail of drug as it moves from manufacturer to wholesaler (Currently tracked using RFID chips) Bans sale of Rx drug SAMPLES *Requires practitioners to request and sign for Rx drug samples in writing, and drug companies must keep the records for at least 3 YEARS Bans reimportation of Rx drugs manufactured in the US once the drugs are exported *Can reimport by original manufacturer for returns

Transfer of UNFILLED CII-V Prescriptions

-Normally unfilled controlled substance prescriptions may not be transferred/forwarded to another retail pharmacy. -The exception to the normal rule is if the unfilled prescription is electronic then the prescription may be transferred/forwarded to another retail pharmacy, even if it is a SCH II prescription

Prescription Regulations

*On new prescriptions the pharmacist must place the date of dispensing, initials, and quantity of drug dispensed if different from the amount ordered *Prescription must be maintained in the pharmacy for 2 YEARS from date of last dispensing *Outpatient prescriptions must be serially numbered and filed numerically *If the prescriber authorizes "PRN" or "at will" refills, such refills may only be provided according to the dosage directions and only for a maximum of ONE YEAR from the date of issuance (unless prescriber's authorization is terminated sooner) *Record of refills may be kept on a computer, but daily hard-copy log or book must be created, signed, and dated *Refill record documentation must be maintained for at least 2 YEARS

Inventories by PIC

*Outgoing PIC and Incoming PIC should conduct a joint inventory of all CS drugs (if outgoing PIC is not available, the incoming PIC shall do the inventory alone) *Inventory has to include the name and address of the pharmacy *Has to include the name, strength, dosage form, and quantity of each controlled substance on hand *Has to have the date of the inventory, and whether it was taken at open or close of business *The inventory must be signed by pharmacist or pharmacists conducting the inventory *The inventory must be maintained at the pharmacy for at least 2 YEARS

Records and Reports of Registrants

*Pharmacies must keep records of EVERY CS dosage unit that enters the pharmacy and EVERY CS dosage unit that leaves the pharmacy *Prescribers do NOT need to keep records relative to CS drugs they prescribe or administer (EXCEPTION: Must keep records of CS drugs they sell to patients with either a direct charge or a charge that is included in the office visit; or PRESCRIBE or USE in MAINTENANCE or DETOXIFICATION of a patient

Requirements for TN Controlled Substance Registration

*Pharmacies that dispense controlled substances in TN must ANNUALLY obtain a registration issued by the Board of Pharmacy (*remember DEA registration = 3 years) *A separate registration is required for each principal place of business - Registration may be suspended or revoked if the pharmacy: - Furnished false information in the application - Is convicted of a felony under state or federal law relating to a controlled substance - Has its federal DEA permit suspended or revoked

Indication Placed on Prescription Label

*Pharmacist shall include the indication on the prescription label if: - It is requested by the prescriber or patient AND - Prescriber or patient provides the pharmacist with the indication for the drug *NOT REQUIRED of patient is in a hospital or nursing home

Distribution of CS Drugs in Hospital

*Pharmacist shall review prescription orders before a drug is dispensed unless pharmacist is unavailable •The prescription orders shall be maintained for at least 2 YEARS from the date of issuance *Drugs may be stored in secured medication carts *Certain drugs may be kept as "floorstock" pursuant to policies of the institution *Distribution may include: - Emergency kits - Floorstock - Automated dispensing devices - Medication Carts - After-hours pharmacy access

Absence of Pharmacist in Hospital

*Pharmacists must be on call 24/7 *Policy must be in place for authorized personnel to obtain necessary drugs when the pharmacy is closed - Access via locked cabinet or automated dispensing machine - The PIC shall develop an inventory of drugs to be included in such locked cabinets or dispensing machines - Drugs in cabinets shall be prepackaged in amounts not to exceed 72 HOURS or medication treatment (unless "unit of use") - Drugs should be inventoried at least ONCE PER MONTH - A record shall be made of any drugs taken from the locked cabinet, a record must be made •The record shall be verified by a pharmacist ASAP •The record shall be used to replenish the drugs used •The record shall be kept for at least 2 YEARS *IF a necessary drug is not available in the cabinet then an authorized individual (shift nursing supervisor) accompanied by another authorized employee may have access to the pharmacy to remove the drug *Quantity removed shall NOT exceed the immediate dose needed plus ONE additional dose *If drugs are removed from the pharmacy, a record shall be made •Date and time of removal of drug •Patient identification •Drug identification •Signatures of the authorized personnel •The record shall be kept for at least 2 YEARS

Lost/Stolen Form 222

*Pharmacy can prepare another form 222 *Include a statement with: - serial number of lost or stolen Form 222 - date of lost or stolen Form 222 - statement that the drugs covered by the first order were NOT received

Controlled Substance Record Keeping

*Pharmacy must keep inventories and records of C-II drugs separate from all other records *For C-III to C-V drugs the records must be kept separately or readily available Ex: 1. Three separate files (C-II, C-III-V, Non CS) 2. Two files (C-II-V, Non-CS) 3. Two files (C-II, C-III to C-V and Non-CS) *If C-III to C-V is mixed with EITHER C-II or Non-CS then a red stamp "C" must be placed in the lower right corner on the C-III to C-V hard copies *EXCEPTION: If the pharmacy has a computer system adequate to retrieve those prescriptions prescriptions for sch II do not have to be kept separate; but inventories and records for sch II must be separated

Multiple C-II Prescriptions

*Prescriber may issue multiple prescriptions for the same patient and drug on the same day IF: - Legitimate medical purpose - Maximum of 90 DAYS therapy - Each prescription is dated as of the date actually issued - Prescriber must give written instructions on prescriptions indicating earliest date to fill each prescription

C-III and C-IV Prescriptions

*Prescriptions may be written, oral, or facsimile *May be REFILLED 5 TIMES within 6 MONTHS from the date of issuance *May be partially filled up to 6 MONTHS from date of issuance

Refills of C-III and C-IV Prescriptions

*Record of refills may be kept on the back of the prescription or in computer *Must have daily printout of refills and the printout must be signed by EACH pharmacist who refilled a prescription that day

Immediate Methamphetamine Precursors

*TN is STRICTER than federal law *May ONLY be sold from a LICENSED pharmacy *May not sell: - More than 3.6 g per day - More than 5.76 Gm PSE base in any consecutive 30-day period - More than 28.8 Gm PSE base in any one-year period *EXEMPT formulations: - Liquids, gel-caps, etc. *No quantity limits if prescribed by a licensed provider other than pharmacists *Purchaser must be 18 years of age, present valid government issued photo ID, and pharmacist must record the type of ID presented (not necessary with a valid prescription) - If less than 18 years of age, must have a prescription from a MD, APNP, PA, etc. or a pharmacist *Pharmacist or intern must ask purchaser the reason for buying the drug, and if in doubt as to a legitimate purpose, pharmacist should refuse to sell *Must maintain an electronic record of all sales, and record may be kept as pharmacist-created prescription *Before completing a sale, Pharmacist must electronically submit required information to the National Precursor Log Exchange (NPLEx) - If a stop sale alert is issued by NPLEx, do not sell unless you are in fear of imminent bodily harm - These requirements do NOT apply if the patient has a valid prescription - If NPLEx is not available, then use the TN Methamphetamine Information System (TMIS)

Facsimile Precriptions

*TN permits facsimile transmission of prescriptions, and the fax serves as the original prescription order *A pharmacist is PROHIBITED from providing a fax machine to a prescriber *The prescription must be dispensed only by the pharmacy to which it was faxed *It is permissible for a pharmacy to transmit a prescription to another pharmacy by facsimile

Automated Dispensing Devices

*The lot number of each drug must be posted or listed on the automated device *Drugs with different lot numbers may NOT be mixed *After drugs with a lot number are used, the cassette must be cleaned before refilling with the drug from a different lot number

Change in PIC

*The pharmacy permit holder must notify the Board IMMEDIATELY of: - Change in PIC or disability of PIC exceeding 30 days *The notice to the Board shall contain: - Name and signature of outgoing PIC - Effective date of the appointment of the new PIC - Name and signature of the new PIC - Name and address of the pharmacy site *If a PIC's disability lasts more than 30 days, a temporary PIC must be hired and the temporary PIC must conduct an inventory of all CS drugs - When the disabled PIC returns another inventory of CS drugs must be performed

Exceptions to Generic Substitutions

*The prescriber shall permit generic substitution UNLESS: - With anti-epileptic drugs, the pharmacist has not previously notified the patient AND physician of a generic substitution - A generic equivalent is not available - Prescriber determines a medical necessity for the brand name drug

Pharmacy Intern Responsibilties

*Under the supervision of a pharmacist: - Provide patient counseling and drug information - Initial prescription orders - Open and close a pharmacy practice site - Wear an identification badge with title

DEA Form 222

*Written forms are triplicate in books of 7 or 14 *Forms are preprinted with pharmacy's name, address and DEA number *Unexecuted forms may be kept at a central location (EXECUTED forms must be kept at the pharmacy) *Executed forms must be kept for 2 YEARS

Label & Labeling

- "Label" = noun - "Labeling" = verb

Tamper-Proof Prescription Pads/Paper

- All prescriptions written in TN shall be on TAMPER-RESISTANT paper that meets TennCare, Medicare, and Medicaid requirements - A pharmacist is prohibited from filling a prescription from a TN prescriber unless it is issued on tamper-resistant paper, except for emergency drug supplies - Does not apply to hospitalized patients *Tamper-resistant paper is NOT required IF: - Patient never had the opportunity to handle the written order - Prescription is transmitted verbally, electronically, or via facsimile - Prescription is written by a veterinarian - Order is for an inpatient in a hospital - Out-of-state prescriptions

Drug

- Articles recognized in official compendium - Articles intended to infect the structure or function of human body or animals - Articles intended to cure, treat, or prevent disease in man or animals

Risk Evaluation and Mitigation Strategies (REMS)

- Black Box Warnings - Med-Guides - Education for prescribers, dispensers, and patients - Manufacturing standards to prevent abuse of opioids

Security Provisions

- C-I drugs MUST be locked in a cabinet/safe - C-II to C-V may be locked up OR Dispersed through the stock of non-controlled drugs - Pharmacies may NOT hire a pharmacist/intern or tech who has been convicted of a felony relating to controlled substances or had a DEA registration revoked or surrendered for cause - A registrant must notify within ONE business day of discovery, IN WRITING, the DEA of any theft or significant loss of any CS drugs AND file a written or electronic DEA FORM 106

Information Required on Prescriptions

- Date issued by prescriber - Full name and address of patient - Drug/dosage form/strength/quantity - Directions for use - Name/address/DEA number of prescriber - "X" number of prescriber if for Buprenorphine for maintenance or detoxification of narcotic addiction *Prescription MAY be prepared by an agent of the prescriber, but a written Rx must be SIGNED by prescriber *Corresponding liability on pharmacist to assure all required information is contained on the Rx

Compounding Prohibitions

- May not sell the product to another pharmacy, prescriber, hospital, or anyone other than a patient with a prescription (EXCEPT if registered under Quality Drug and Security Act) - May not duplicate a commercially available product - May not compound a drug that was withdrawn from the market for safety reasons - May not use commercial grade equipment

Third Class of Drug

Drugs that do NOT require a prescription but may only be sold by a pharmacist or kept behind a counter - C-V OTC - Robitussin AC *Only stores with an FDA DEA number can sell this even though it is OTC - Pseudoephedrine

Technician Responsibilities

- Must REGISTER with the Board (DO NOT NEED TO BE LICENSED OR CERTIFIED, BUT MUST REGISTER) - Probationary employees up to first 90 days and students in technician training program are exempt *Registered Pharmacy Technicians may, under the supervision of a pharmacist, assist with the preparation of dispensing of prescriptions EXCEPT those tasks that must be performed by a pharmacist or intern. •Performing final verification of prescriptions •Initialing of prescriptions noting appropriate comments •Providing patient counseling and/or drug information to patients, care givers, and healthcare providers •Supervision of compounding •Daily opening and closing of pharmacy site CERTIFIED pharmacy techs may also: •Receive new or transferred oral prescriptions •Receive and transfer oral prescription orders between pharmacy practice sites (DEA seems to allow only a pharmacist to do a transfer for controlled substances) •Verify the contents of unit dose carts and automated dispensing systems prepared by other registered technicians REGISTERED Technicians under supervision: •Shall register with the Board unless they are probationary employees or participating in a rotation under a technician training program •May compound drugs under supervision of pharmacist •Must wear identification badge with title •Shall maintain registration certificate at the pharmacy and possess at all times proof of registration and certification, if applicable. •Must notify the Board of any change in employer or address

TN: Use of Buprenorphine products

- Must be for an FDA approved use •Detoxification •Maintenance •Pain - Buprenorphine without naloxone is only permitted for •Pregnant patients •Nursing mothers •Patients with history of sensitivity to naloxone •If drug is administered directly by a healthcare provider

OTC C-V Sale

- Must be made by a pharmacist (or intern under supervision) - Purchaser must be at least 18 YEARS of age - Quantity is limited to 4 oz in a 48-hour period - A BOUND BOOK is maintained for all record keeping

Obtaining Patient Informaiton

- Name, address, telephone, DOB, and gender - History includes disease states, allergies, and a list of medications the patient is taking - Pharmacist comments relative to the drug therapy - Patient may refuse to provide information

Offer to Counsel

- Offer can be made by ANY agent of the pharmacist but only a pharmacist should do the counseling - Patient has the right to refuse counseling - If the prescription is delivered outside of the pharmacy, then a toll-free number must be provided - Offer is not required for inpatients (drug orders)

Practice of Pharmacy

- Patient oriented health services - Interpreting and evaluating prescription orders - Compounding - Drug selection, evaluation, and utilization review - Patient counseling and education *Tennessee: Collaborative Practice Act of 2014 allows pharmacists to prescribe drugs, order laboratory tests, and provide patient care services

Peer Review

- Pharmacists are encouraged to participate in peer review to improve quality of care & reduce medication errors - Pharmacists are immune from liability when supplying information in peer review activities, and are presumed to be acting in good faith.

Prescription Labels for Controlled Substances

- Pharmacy name and address - Serial number of Rx - Date of INITIAL filling - Name of patient - Name of prescriber - Directions for Use - No requirement for pharmacist's initials *If filled by a central fill pharmacy, must identify the central fill pharmacy by name OR DEA number

Handling of Form 222

- Pharmacy/purchaser sends copies 1 & 2 to supplier and keeps copy 3 - Supplier writes on copies 1 & 2 the quantities actually sent to the pharmacy/purchaser *Supplier has 60 DAYS to compete a partial order *Purchaser may cancel in writing the entire order or the balance of order - Supplier keeps copy 1 and sends copy 2 to DEA - Purchaser writes on copy 3 the actual quantity received and the date of receipt Copy 1 (brown) - Supplier Copy 2 (green) - DEA Copy 3 (blue) - Purchaser

Hospital and Alternative/Parenteral Pharmacy Personnel

- Shall have PIC - Shall have Sufficient number of pharmacists - May hire a consultant pharmacist for: •Consultation of drug selection, safe drug use, and drug therapy assessment •Evaluation of patient drug therapy and communication with prescribers •Counseling of patients •Providing in-service educational programs -Supportive personnel: •Pharmacy interns •Pharmacy technicians •Other supportive personnel as may be required

Prospective Drug Use Review

- Therapeutic duplication - Drug-Drug interactions - Drug-disease contraindications - Drug-allergy interactions - Incorrect dosage or duration of therapy - Clinical abuse/misuse

Substances excluded or exempted from schedule

-A manufacturer may apply to DEA to exempt any non-narcotic substance •Butalbital with acetaminophen (fioricet) •Bronkolixir (phenobarbital) •Anabolic steroids that have no potential for abuse -A manufacturer may apply to DEA to exempt any chemical preparation

Execution of Form 222

-Executed in triplicate simultaneously in indelible ink or typewritten - Only one drug per line - In bottom block must indicate the number of lines used - Enter name/address/DEA number of supplier - Enter date ordered - No erasure/changes/alteration is permitted - Signed by an authorized individual of pharmacy

Corrections / Additions / Changes to CS Prescriptions by a pharmacist

-Must obtain permission from prescriber to make any changes, if significant -With SCH III-V may change/add any information including the prescriber's signature with the permission of the prescriber -With SCH II prescriptions, may NEVER add prescriber's signature -With SCH II prescriptions state law may prohibit certain changes, but it appears that the DEA will permit any change except adding the prescriber's signature

Four Aspects of Healthcare Information Covered by HIPAA

1. Uniform electronic transaction and code sets *Allows efficient electronic billing of Rx claims *Enforced by CMS 2. National Provider Identifier number (NPI) 3. Security *Protects confidentiality, integrity, and availability of patient's health information 4. Privacy *Enforced by the Office of Civil Rights in HHS *Includes ANY health information that could be identified with a particular patient *Pharmacists may only disclose PHI for TREATMENT, PAYMENT, or HEALTH CARE OPERATIONS *Pharmacists must disclose PHI to the patient upon request

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Any healthcare provider that submits ELECTRONIC claims must follow HIPAA Covers 4 aspects of healthcare information Pharmacy must develop policies and procedures to implement HIPAA privacy standards Pharmacist must provide ONE Notice of Privacy Practices (plus any changes or amendments) PHI may be shared with "business associates" who are under contract with the pharmacy to provide services

Compounding Pharmacies

Any pharmacy involved in STERILE compounding MUST: - Comply with USP-797 - Must report to the Board on a QUARTERLY basis the QUANTITY of sterile compounded products DISPENSED

Board Suspension/Revocation

Board may suspend, revoke or otherwise discipline or refuse to issue a permit or license if the applicant: - Is CONVICTED of ANY crime - Is ADDICTED to the use of drugs or alcohol - Is INCAPABLE to a degree that creates a danger to the public - Is GUILTY of dishonorable, immoral, unethical, or unprofessional conduct - Is DISCIPLINED by a Board in another state

Exemption from Narcotic Treatment Program Registration

Buprenorphine used for narcotic maintenance or detoxification *Prescriber (MD, DO, PA, NP) must obtain an "X-number" from the DEA and include BOTH DEA and X number on prescription *In 2016, new regulations permitted prescribers to complete an 8-hour course and obtain an "active waiver" to treat up to 100 patients in the first year. With additional credentialing, physicians may treat up to 275 patients at any one time.

Schedule VII Drugs

Butyl Nitrate

Separate Prescription for C-II Drugs

C-II drugs must be ordered on a separate prescription form with no non-scheduled drugs on the same form *A pharmacist, intern, or technician may create a separate prescription form for any non-controlled drugs ordered on a prescription form with a C-II drug - The new prescription shall serve as original prescription for non-scheduled drug - The new prescription may be created by hand, photocopy, or scanning

Schedule I Substances

High potential for abuse and no currently acceptable medical use in the US Heroin Crack cocaine (non-FDA approved) LSD Marijuana/THC (non-FDA approved) GHB (non-FDA approved) Methaqualone (Qualude) *cocaine is a legal CII, but not crack cocaine; dronabinol is a legal CII, but not marijuana

Mailing of CS Prescriptions

CS Prescriptions may be sent by: - USPS - Common carrier service (FedEx, UPS, etc.) - These drugs may be ANY CS including narcotics - The outer package must NOT indicate that the package contains CS prescriptions

Scheduling of Controlled Substances/ "dangerous drugs"

Controlled by the commissioner of public health If a drug is added, deleted, or rescheduled by the DEA, TN shall similarly control the drug Alcoholic beverages are NOT included as controlled substances

Unused Drugs and Related Materials

Drugs shall be returned to the pharmacy if they are: •Discontinued for the patient's use •Outdated •Defective or deteriorated •If it has warn, illegible, or missing labels All returned drugs must be destroyed unless: •The drugs are in unit dose packaging or in unopened commercial packages AND •The pharmacist believes the drugs meet standards for product integrity

Medicare Part A

Covers a portion of HOSPITAL charges including inpatient drug therapy Provided at no cost to the patient/beneficiary

Medicare Part B

Covers a portion of PHYSICIAN charges and some outpatient diagnostic/treatment services and some drugs that a patient cannot self-administer Voluntary program that costs ~$115/month

Administrative Inspectionsm

DEA agents have the right to inspect any pharmacy with a DEA permit *Purpose is to COPY, inspect, or verify records *Agents may make a physical inventory of CS drugs *Agents are NOT permitted to inspect financial, sales, or pricing data without written consent of the manager in charge *To gain access the DEA agent must show: - Credentials - Notice of Inspection - Provide an administrative inspection warrant (or obtain informed consent from the manager)

Prescriber DEA Number Validation

DEA number contains two letters and seven numbers First letter: A, B, F, or G - MD/DO/DVM/DDS/Podiatrist M - Mid-level practitioner Second letter - first letter of prescriber's last name Add number 1, 3, and 5 Add numbers 2, 4, and 6 and multiply sum by 2 Add the two results together and the last number should match the 7th number in DEA number *If a prescriber dies or retires the registration TERMINATES and any unfilled new prescription and any remaining refills on prescriptions become void

Administrative warrants

DEA obtains the AIW from a judge or federal magistrate *No "probable cause" is needed for an AIW No AIW is needed IF: - It is the initial inspection to obtain a DEA permit - Informed consent provided by the manager/owner - Emergency situation presenting imminent danger to health or safety - Inspection of conveyances where there is reasonable cause to obtain a warrant *Must be executed during regular business hours

TN Controlled Substance Monitoring Program- Controlled Substance Monitoring Database

Dispensing responsibility to consult database •If the pharmacist is aware that a person may be attempting to obtain a Controlled Substance illegally or for medically inappropriate purposes, the pharmacist must consult the database before dispensing EXCEPTIONS to the responsibility to consult database •Patient is currently receiving hospice care •Patients in a particular medical specialty have shown a low potential for abuse •The drug is prescribed/dispensed as a non-refillable treatment for a surgical procedure that occurred in a hospital •The quantity of drug prescribed/dispensed does not exceed an amount adequate for a 7-day treatment period and does not allow for any refills

Tennessee Charitable Clinic Pharmacies- Donor Patient Form

Donor Patient Form shall include: •Name of patient •Name of institutional facility •Name of drug, quantity, prescription #, date of prescription, and name of pharmacy where drug was originally dispensed •Name of charitable clinic pharmacy •Date drug was donated •Authorization to donate the drug •Signature line of donor patient

Phase II Clinical Trial

Drug is tested in a LIMITED number of SICK people to establish its EFFICACY and SAFETY

Phase I Clinical Trial

Drug is tested in a SMALL number of HEALTHY people to establish SAFETY

Phase III Clinical Trial

Drug is tested on a LARGE number of SICK people to establish EFFICACY and SAFETY

Drugs Dispensed from the Emergency Room

Drugs dispensed (not administered) in the ER must be dispensed by a physician or nurse/PA under direction of the physician *If the physician does not personally dispense the drugs, then drugs packaged in containers from the pharmacy shall be used and the quantity dispensed shall not exceed 12 HOURS of therapy

Reference Texts

Each Pharmacy shall have an adequate reference library Reference texts may be accessed in printed or electronic forms Reference texts shall include a current copy of Tennessee Pharmacy Laws as issued by the Board

Electronic Transmission Requirements

Electronic Transmissions shall include: - Telephone number of prescriber - Time and date of transmission - Name of pharmacy to which it was sent - Prescribers electronic signature - Identification of agent if a prescriber's agent transmits the prescription

Orphan Drug Act of 1983

Encouraged drug manufacturers to develop and market Rx drugs for conditions affecting < 200,000 patients in the US Manufacturer is given 7 years market exclusivity, NDA filing fee is waived, and given tax credits

Protected Health Information (PHI)

Enforced by the OFFICE OF CIVIL RIGHTS in HHS •Includes any health information that could be identified with a particular patient •Pharmacists may only disclose PHI for Treatment, Payment, or Health Care Operations (TPO) •Pharmacists must disclose PHI to the patient if patient requests •Pharmacy must develop policies and procedures to implement the HIPAA privacy standards •A pharmacist must provide patient with one NOTICE OF PRIVACY PRACTICES (plus any later changes or amendments) -How pharmacy will use the information, and its legal duties -A statement of patient's rights, and the name and telephone number of the person a patient may contact if problems occur -Must be posted and available upon request •Pharmacies must train employees on HIPAA requirements, and document such training •HITECH was passed in 2009 to strengthen disclosure issues -Required that any disclosures of PHI be limited to the minimum amount necessary -Notification to patient if unsecured PHI is breached

Drug Enforcement Administration (DEA)

Enforces the CSA President/Executive branch --> DOJ --> FBI --> DEA

Anabolic Steroids

Entire list of scheduled steroids

Durham-Humphrey Amendment of 1951

Established Rx vs. OTC drugs Required a prescription before a pharmacist could sell/dispense an Rx drug *Selling without a prescription = MISBRANDING *Refilling without authorization = MISBRANDING

Tax-Free Alcohol

Ethyl alcohol that is used for: - Laboratory testing for inpatients and outpatients - Scientific and mechanical purposes - Educational and research purposes - Government purposes - In-patient medications

Taxed Alcohol

Ethyl alcohol that is used for: - Laboratory testing in PRIVATE outpatients of physicians - Any beverage use

Quotas

Every C-I or C-II is subject to an annual manufacturing quota *Manufacturers of C-I or C-II drugs must apply ANNUALLY for a manufacturing quota for the following year based on estimated needs for medical use, scientific research, industrial use, exports, and maintenance of reserve stock *In 2017, 2018, and 2019 the DEA lowered manufacturing quotas for opioids in general and significantly for hydrocodone products which had been moved from Sch III to Sch II and for fentanyl products.

Tennessee Charitable Clinic Pharmacies- Patient Waiver Form

Every indigent patient receiving drugs from charitable clinic pharmacy shall execute a waiver form which includes the following: •Name of indigent patient •Name of drug, quantity, prescription #, and date of prescription •Name of charitable clinic pharmacy dispensing the drug •A waiver releasing the institutional facility and donor patient •Signature of indigent patient

TN Controlled Substance Monitoring Program- Electronic Access

Every pharmacy dispensing controlled substances must have electronic access to the database at all times when providing controlled substance prescriptions

Outsourcing Facility

Facility engaged in the compounding of sterile drugs and that has registered with the FDA

Labeling

Federal definition: Written/printed information placed upon the container PLUS any other written/printed information packaged with the container Tennessee definition: The act of placing a label on the prescription bottle

Medicare

Federal program to provide health INSURANCE to those at least 65 years of age and those who are disabled Administered by CMS No economic/means test for qualification

Alcohol

Federal: 95% ethyl alcohol *If not it is MISBRANDED and ADULTERATED Tennessee: Any RUBBING alcohol including isopropyl or denatured ethanol

Investigational New Drug Application (INDA)

Filed with the FDA BEFORE testing the drug on humans *If FDA does NOT reject the INDA within 30 DAYS, trials in humans can begin

Abbreviated New Drug Application (ANDA)

Generic manufacturer must prove BIOEQUIVALENCE to the brand name drug to be able to use the trial results from the brand name drug for approval

Promotional Labeling

Information such as advertising that does not accompany the container (e.g., advertisements) *Must give fair balance of risk vs benefit

Drug Price Competition and Patent Term Restoration Act of 1984

Innovator of drug is given at least 5 years of exclusive marketing or remainder of patent life, whichever is LONGER (patent life = 20 years from date of filing) Generic companies could gain approval through an ANDA (need to show bioequivalence) If an innovator drug is on market for an approved use and is then approved for a NEW use, the innovator is granted 3 YEARS of market exclusivity *But generic can still sell/promote for the prior approved use

Food

Intended for use as a food or drink

Drug

Intended for use in diagnosis, treatment or prevention of disease

Device

Intended to affect the structure or function of the body

Cosmetic

Intended to be applied to the body for cleansing, beautifying, or promoting attractiveness

Failure to Identify or Correct

Involves drug allergy/age/disease/gender contraindications; over or under utilization; therapeutic duplication; clinical abuse or misuse

Error

Involves the wrong drug, dose, or dosage form; wrong patient; incorrect labeling

Medicaid

Jointly funded FEDERAL and STATE program to provide health INSURANCE to the indigent The programs are administered at the STATE level but must follow FEDERAL guidelines - Covers most types of medical/dental care - Coverage determined by the STATE but must comply with a federal minimum Qualification based upon income and assets Pharmacists must follow OBRA 90

Outpatient Prescription Labels

Labels shall include: - Name, address, and telephone number of pharmacy - Serial number of prescription - Name of prescriber - Name of patient - Name of drug - Directions for use - Date of original dispensing or date of refilling -Advisory/cautionary labels - Expiration date

Anabolic Steroids

Lawful UNLESS prescribed for: - Enhancing athletic performance - Increasing muscle mass or strength

Schedule V Substances

Low potential for abuse Currently accepted medical use in the US Abuse may lead to limited physical or psychological dependence Narcotics diluted or mixed with non-controlled drug: - No more than 200 mg codeine/100 mL - No more than 2.5 mg diphenoxylate with not LESS than 25 mcg of atropine (Lomotil) - Promethazine with Codeine cough syrup - Robitussin AC (and generic equivalents) Pregabalin (Lyrica) •Pregabalin (Lyrica) •Lacosamide (Vimpat) •Epidiolex (cannabidiol)

Non-Prescription/OTC/Proprietary/Patent Drugs

Manufacturers are able to provide adequate DIRECTIONS for use so a patient can take safely without medical supervision Labeling must provide complete information ("Drug Facts Panel," directions for use, warnings, active and inactive ingredients, telephone number for questions) Advertising is regulated by the FTC

Schedule VI Drugs

Marijuana THC Synthetic THC equivalents •This Schedule does not exist under the Federal C.S. Act •The term "Marihuana" does not include a cannabidiol product approved by the FDA as a prescription medication or CANNABIS OIL WITH LESS THAN 0.6% THC

Transferring C-III and C-IV Prescriptions

May be transferred ONE time only between pharmacies that do NOT share a common database (pharmacies with a common database can "transfer" to maximum number of refills authorized by prescriber) - Rx must be voided in the transferring pharmacy - Transfer must be communicated between two LICENSED pharmacists - Both pharmacists must record the information on the other pharmacy *Keep records for 2 YEARS from the date of the last refill

Manufacturing

Must be licensed and inspected by the FDA to manufacture, repackage, or re-label drugs Must use current good manufacturing practices (CGMP) Applies to prescription and OTC drugs Each drug product must be approved by the FDA prior to sale/shipment

Isopropyl Rubbing Alcohol

Must indicate percent concentration *Usually sold in pharmacies

Schedule II Amphetamine

NO CII amphetamine product may be prescribed for the purpose of weight loss or gain - Such a prescription would would be invalid -Intent was to also include Methylphenidate

C-V Prescriptions

No limits on the number or timing of refills No partial filling after 6 MONTHS from date of issuance May be sold OTC if no federal or state law prohibits OTC sale

TN Sterile Product Registration

No pharmacy may compound or manufacture any sterile product without first obtaining a sterile compounding MODIFIER registration from the Board of Pharmacy

(TN) Who is prohibited from writing a prescription for a drug to cause abortion?

Nurse practitioners & Physician assistants

Sale of Non-Rx Drugs

OTC insulin may be dispensed under the supervision of a pharmacist and must be stored in an area not accessible by the general public A pharmacist may create a prescription for NON-PRESCRIPTION drug sales to allow maintenance of patient profiles with ALL DRUGS a patient is taking

TN Generic Substitution Law

Only applies if: - Prescription is written for a brand name drug AND - An FDA-approved generic version of the brand name drug is available *If the prescriber does NOT want to permit substitution, the prescriber must indicate specifically that the pharmacist is to dispense the brand name drug

OMNIBUS Budget Reconcilliation Act of 1990 (OBRA 90)

Only applies to NEW Medicaid prescriptions *States have expanded requirements to all Rxs Requires pharmacists to do three things: - Prospective drug use review on each NEW prescription - Offer to counsel patients on each NEW prescription - Obtain and maintain patient information (patient profile/patient history)

Damaged or Outdated Drugs

Owner or PIC shall inspect prescription stock regularly and immediately return or destroy all outdated, defective, or deteriorated drugs No damaged prescription drugs may be surrendered to an insurance or salvage company without prior approval of the Board No prescription drug that has been damaged by heat, smoke, water etc. or that is outdated may be kept in stock or dispensed

Loss/Theft of Prescription Drugs

PIC shall immediately report to the Board any robbery, theft, burglary, fire or disaster resulting in a loss of or damage to prescription drugs or controlled substances PIC must list all drugs and amounts lost or damaged

Refilling of CII prescriptions

PROHIBITED

Emergency Oral C-II Prescription

Permitted in an EMERGENCY situation permitted that: 1. Immediate administration is necessary 2. No alternative drug that is not C-II will work 3. Prescriber cannot provide a written prescription - Quantity must be limited to the emergency period - All information must appear on the prescription (EXCEPT signature of prescriber) - Pharmacists must verify authenticity of prescriber - WITHIN 7 DAYS, the prescriber must deliver or have postmarked a signed, written prescription with "Authorization for Emergency Dispensing" and the date of oral order on the face of the prescription - If prescription is not provided in a timely manner, the pharmacist must notify the DEA

Facsimile of C-II Prescriptions

Permitted in three circumstances: 1. Narcotic pain therapy drug for INJECTION therapy 2. C-II for a LTC resident 3. C-II for a patient enrolled in HOSPICE care program licensed by the state or certified by Medicare (Prescriber must note on Rx "Hospice Patient")

Compounder

Person involved in maintenance or detoxification of narcotic addicts who also mixes/prepares the narcotic drug used in treatment *DIFFERENT from Federal/State definition

Prescription/Legend/Non-Proprietary Drug

Product that CANNOT be taken safely without medical supervision Manufacturer must provide adequate INFORMATION for use to prescribers and dispensers The Rx label must provide adequate DIRECTIONS for use to the patient Advertising is regulated by the FDA

Dietary Supplement

Products that are NOT drugs/foods/cosmetics Must be intended for ORAL ingestion (no injectables or topicals) Must contain: - A vitamin - A mineral - An amino acid - An herb or botanical Must be labeled "Dietary Supplement" Must have 'Supplemental Facts' label Must be manufactured using CGMP

Distributing Controlled Substances

Pharmacies are allowed to distribute to another registrant a limited amount of controlled substance(s) - If the drug is C-II a Form 222 must be used - The distributing pharmacy must make a record of sale - The total number of dosage units distributed must NOT EXCEED 5% of the total number of dosage units dispensed AND distributed in the calendar year *Returns to manufacturer/wholesaler/reverse distributor do NOT count toward the 5% rule *Distributions to an automated dispensing machine owned by the pharmacy DO NOT count toward the 5% rule

Bulk or Group Purchasing of Drugs by Pharmacies

Pharmacies are permitted to form a consortium or group to make bulk purchases of drugs for resale

Controlled Substance Drug Disposal

Pharmacies may modify their DEA registration to allow the pharmacy to accept the return for destruction of CS drugs from patients or caregivers Returns may be in person or by mail Pharmacies MUST have an ON-SITE method of destruction to destroy returned drugs These are never counted or entered into inventory

Quality Drug and Security Act

Pharmacies may register as HUMAN DRUG COMPOUNDING OUTSOURCING FACILITIES in order to sell products to physicians, hospitals, or other pharmacies *Pharmacies MUST be inspected by the FDA

Pharmacist Requirements for Generic Substitution

Pharmacist Shall: - Notify prescriber if a generic equivalent has become available since last dispensing the product AND - Substitute the least expensive generic drug IN STOCK for the brand name drug if authorized by the prescriber *Pharmacist shall also notify the patient of the substitution by noting on the prescription label the generic drug provided

Sterile Product Preparation Personnel

Pharmacist in charge must: •Establish policies and procedures manual and quality assurance procedures •Document competency in aseptic techniques of all staff •Provide sterile products on a 24-hr basis •Maintain records of training and competency evaluations Pharmacist, Interns, and Techs must: •Obtain ongoing training in aseptic technique •Use proper aseptic technique in all sterile preparations

Pharmacist & Intern Responsibilities

Pharmacists SHALL: - Respect confidentiality of patient information - Report to the Board any known violations of laws or rules - Provide patient counseling and drug information to patients - Notify the Board in writing of any change in address or practice site - Conspicuously display license and registration - If convicted of any crime including DWI, report the conviction to the Board within 10 days of the conviction becoming final - Initial prescription orders with appropriate comments - Supervision of compounding - Daily opening and closing of a pharmacy practice site - Shall wear an identification badge with title Pharmacists SHALL NOT: - Use adulterated, misbranded, or non-FDA approved drugs - Participate in any "kickback" or referral-fee transactions - Work under conditions that interfere with the exercise of professional judgement or ethical conduct - Compound or dispense from secret formula or coded prescriptions - Induce the transfer of a prescription absent the exercise of professional judgment

Tennessee Charitable Clinic Pharmacies- Pharmacist Responsibilities

Pharmacists at charitable clinic pharmacies shall ensure that: •The only drugs accepted are in sealed and tamper-evident packaging including single-unit doses •The donor patient executed a donation form •Donor patient's name and any identifying marks have been removed from the package •The drug name, strength, lot #, and expiration date is on the drug package or label •If drug information is not on the package the pharmacist shall destroy the drugs •That no expired, misbranded, recalled, or deteriorated drugs are utilized •That no controlled substances are accepted or dispensed •Assure that the institution transferring the drugs has a contract with the charitable clinic pharmacy that is approved by the Board

Drug Quality and Security Act of 2013

Pharmacists may register with the FDA as HUMAN DRUG COMPOUNDING OUTSOURCING FACILITIES Must be inspected by the FDA May sell compounded products to hospitals, doctors, other pharmacies, etc. without a prescription for a specific patient

Collaborative Pharmacy Practice Agreements

Pharmacists working JOINTLY & VOLUNTARILY under a written agreement with one or more physicians to provide patient care services - Any patient care services provided by a pharmacist shall be DOCUMENTED - Individual doctor or medical group may employ pharmacists to provide patient care services, but no pharmacy may employ a prescriber for the purpose of creating a collaborative practice agreement - Written agreement must be renewed at least every 2 YEARS

Pharmacy Standards

Pharmacy must have: - A retail pharmacy must have a private consultation area - Must be at least 180 sq. ft. - Hot/cold running water and refrigeration unit in immediate area - All licenses and certifications must be conspicuously displayed in the pharamcy

Electronic Form 222

Pharmacy/purchaser must obtain a DIGITAL SIGNATURE from the DEA *May include C-III to C-V drugs AND Non-CS drugs on electronic Form 222 (WRITTEN Form 222 is for C-II ONLY) *When drugs are received the purchaser must electronically LINK the receipt record to the original electronic record - Must include date of receipt and quantity received

Schedule IV Substances

Potential for abuse but lower than C-I and C-II Currently accepted medical use in the US Abuse can lead to limited/moderate physical dependence or high psychological dependence Benzodiazepines - alprazolam, diazepam, lorazepam PHENObarbital (*Pentobarbital = C-II) Pentazocine (Talwin) -tramadol -zolpidem (Ambien) -suvorexant (Belsomra) -butorphanol (Stadol)

Schedule III Substances

Potential for abuse but lower than C-I and C-II Currently accepted medical use in the US Abuse can lead to limited/moderate physical dependence or high psychological dependence Narcotics diluted or mixed with non-controlled: - No more than 1.8 g codeine per 100 mL - Codeine with APAP up to 60 mg/dose unit Buprenorphine Barbiturates (suppositories) - secobarbital Butalbital with Aspirin (Fiornal) Dronabinol (THC in FDA approved form) Anabolic steroids (testosterone gel)

Compounding

Preparation of a drug pursuant to a prescription order, or in anticipation of a prescription order *FEDERAL definition - a person involved in maintenance or detox of narcotic addicts who also mixes/prepares the narcotic drugs used in the treatment

Compounding

Preparation of a drug pursuant to a prescription order, or in anticipation of a prescription order *Must used FDA approved ingredients

Prescription Copies

Prescription copies provided to patients shall have in RED letters the words "Copy for Information Only" *A copy is NOT authorization to dispense a drug (it is for informational purposes only)

Distribution of Drug Samples by Pharmaceutical Reps

Prescription drug samples may be provided to prescribers only upon WRITTEN request by the prescriber (from the Federal Prescription Drug Marketing Act)

Prescription Returns

Prescription drugs returned by patients MUST be for DESTRUCTION and not for re-use UNLESS: - The drug is in unit dose packages or an unopened commercial container AND - The drug meets the standards for product integrity •If Controlled Substances are accepted for return, pharmacy must modify its DEA registration to include drug disposal

Prescription Drug User Fee Act of 1992

Required a fee with every new NDA or supplemental NDA Law must be renewed every 5 years

Patient Package Inserts (PPI)

Required by the FDA to warn/educate patients on the risk of certain drugs (Isoproterenol, birth control, estrogens) *Patients must be given the PPI with NEW and REFILL prescriptions *Hospitalized patients must be given PPI prior to FIRST DOSE and every 30 DAYS thereafter *Failure to provide PPI is MISBRANDING *No additional drugs were added after 1980

Food, Drug, and Cosmetic Act of 1938

Required drugs to be proven SAFE before shipment or marketing in interstate commerce Required labels to provide adequate DIRECTIONS for use Allows FDA to inspect any facility where drugs are manufactured or stored *Only need credentials and Notice of Inspection Enforced by the FDA

Electronic Transmission of Controlled Substances

Requirements: - Prescriber must use approved encryption software - Prescriber must obtain and use a digital signature - Pharmacy must use approved decryption software *If all requirements are met, the prescriber may transmit electronically C-II to C-V prescriptions *Direct electronic transmission of a controlled substance prescription from a retail pharmacy to a central-fill pharmacy WITHOUT encryption software is PERMISSIBLE

Kefauver-Harris Amendment of 1963

Requires drugs to be proven both SAFE and EFFECTIVE before marketing in interstate commerce Transferred Rx advertising to the FDA Established CGMP

Poison Prevention Packaging Act of 1970

Requires that certain dangerous "household substances" be packaged in child-proof containers - 80% of children under 5 years cannot open container - 90% of adults can open container Plastic child-proof containers may be used only ONCE *Must dispense in new plastic container with new plastic cap on each refill EXCEPTION: Glass container Patient can request a single or blanket waiver Prescriber can request a single waiver ONLY (no blanket) EXCEPTION: - One size of an OTC product that states "Package for households without young children" IF manufacturer also supplies the substance in packages that are child-proof - Oral or written waivers by prescriber or patient - Rx drugs for patients in hospitals or nursing homes where the drug will be ADMINISTERED

Pharmacy Security

Security must include: - Keys or access codes to gain access to the pharmacy area or to prevent unauthorized access *ONLY pharmacists practicing at the pharmacy may have the keys or access codes *The PIC shall place a key or access code in a sealed, signed envelope in a safe/locked container OUTSIDE the pharmacy *Individuals other than pharmacists, interns, and technicians are only permitted in the pharmacy during hours that a pharmacist is on duty (Example: no cleaning at night)

Separate Registrations

Separate locations require separate registrations - Each outlet of a pharmacy retail chain (e.g., Walgreens) - Separate hospital pharmacies in separate hospitals even under common ownership (e.g., HCA) - Automated dispensing cabinets located at a nursing home must have separate registration from the retail pharmacy operating the machine *EXCEPTION: separate registration is NOT required for multiple pharmacies within a hospital (e.g, satellite vs. central pharmacy)

MTM/Medication Therapy Management

Services to optimize patient outcomes (under Medicare Part D)

Medication Therapy Management (MTM)

Services to optimize patient outcomes in patients taking multiple drugs that will exceed an annual cost determined by the Department of Health and Human Services (HHS) *Provided under Medicare Part D

TN Prohibited Acts

Similar to federal law in most cases

TN Together- Ending the Opioid Crisis

Slide 169

Pregnancy Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. Ex. Warfarin, Atorvastatin (Statins), Methotrexate, Finasteride

New Drug Application (NDA)

Submitted to the FDA after Phase III trials completed Includes proposed label, package insert and manufacturing process

DEA REgistration

The CSA has created a CLOSED SYSTEM in which everyone handling the drug is registered (EXCEPT the patient)

Dispenser Registration Rules

The EMPLOYER is registered NOT the employee (e.g., Walgreens not the individual pharmacist) Prescribers who are employees of a hospital (residents and hospitalists) may use the hospitals DEA if: - Licensed by the state to prescribe - Hospital assigns an internal code that is used as a suffix to the hospital's DEA number - Hospital maintains a list of suffix numbers and makes them available to pharmacies - Prescriber PRINTS or STAMPS his/her name on any prescription IN ADDITION TO signing

Sale of Pharmacy to Another Pharmacy

The PIC of each pharmacy shall jointly inventory CS drugs and MAIL a copy of the inventory to the Board within 30 DAYS of the sale

Monthly Inspections

The PIC shall assure that all drugs kept at nursing stations, surgery rooms, delivery rooms, emergency rooms, and any other areas of the facility are inspected monthly •Records of such inspections shall be dated, signed and maintained for at least 2 YEARS

TN Food, Drug, & Cosmetics Acts

The State Board of Pharmacy enforces this law and promulgates regulations for its enforcement

TN Prescription Safety Act of 2016 (TN Controlled Substances Monitoring Act)

The database includes information on ALL controlled substance prescriptions (C-II to C-IV and C-V with abuse potential) dispensed in TN *Reporting is NOT required for: - Drugs ADMINISTERED directly to a patient - Drugs ADMINISTERED at a licensed narcotic treatment program *Report all required prescription data by the close of business the following day - Provides specific procedures for law enforcement to access the database, thus there should be no need for a pharmacy to allow law enforcement access to the pharmacy's prescription information

Unapproved Drug

The drug/dosage form/strength has NOT been approved by the FDA *Illegal to ship in interstate commerce (EXCEPT for drugs in clinical trials) *Illegal to prescribe, possess or dispense

Approved Drug

The drug/dosage form/strength/indication(s) have been approved by the FDA pursuant to the NDA *Drugs may be shipped in interstate commerce

Class III Drug Recall

The product is not likely to cause adverse health consequences Ex. Technical violation

Class II Drug Recall

The product may cause temporary or reversible adverse health consequences, but probability of serious adverse consequences is remote

Pregnancy Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Ex. Lisinopril, Alprazolam (BZDs), Losartan

Tennessee Charitable Clinic Pharmacies- Purpose

To develop a prescription drug redispensing program that authorized charitable clinic pharmacies to redispense drugs that would otherwise be destroyed to indigent patients •Drugs are generally obtained from long-term care facilities

Proof

Two times the percentage of ethyl alcohol Ex. 100 Proof = 50% ethyl alcohol

Alcohol

Under Federal Law: 'contained with filth' = 'adulterated' TN: 'alcohol' is defined as ANY RUBBING alcohol including isopropyl or denatured ethanol *Federal definition: 95% ethyl alcohol

National Drug Code Number (NDC)

Unique 11 digit number assigned to a drug product First 5 - manufacturer/distributor Next 4 - strength, dosage form, and formulation Last 2 - package size *NDC does NOT indicate FDA approval

Prescriptions

Valid prescriptions for CS must be issued for a legitimate medical purpose by a prescriber acting in the usual course of practice Pharmacist responsibility: - Electronic transmission is PERMITTED IF both prescriber and pharmacy have approved encryption software - Not valid to write a CS prescription "For Office Use" (Must use Form 222 to "order") - Legal for prescriber to write CS prescription for his/herself if it is for a legitimate medical purpose -Not valid to write a CS prescription for maintenance or detoxification treatment EXCEPT for Buprenorphine

Informed Consent

WRITTEN consent REQUIRED in Phase I and II ORAL consent PERMITTED in Phase III

Tennessee Board of Pharmacy

Within the Tennessee Department of Health The Board shall employ investigators who are pharmacists The Board must require each pharmacy to maintain a copy of TN pharmacy statutes & Board rules/guidelines (as long as you have internet access)

Sterile Products Preparation Attire

•All pharmacist, interns, and technicians shall wear applicable outer garments and use respiratory precautions as set out in USP section 797

TN Controlled Substance Monitoring Program- Access to Database

•All prescribers and dispensers who provide direct patient care shall be registered in the database -New licensees have 30 days to register •Prescribers and dispensers of controlled substances shall have access to the database -Law enforcement personnel shall have access to the database, and therefore should not need to obtain records from a pharmacy

Sterile Products Preparation Quality Assurance

•All sterile compounding pharmacies shall have an ongoing quality assurance program - The Q&A program shall follow USP standards - The Q&A program shall require a gap analysis (comparison of actual product to desired product)

Standards for Sterile Product Preparation

•All sterile products shall be prepared in compliance with USP standards (especially section 797) •Any pharmacy compounding sterile products shall submit to the Board each quarter a listing of the quantity of sterile products compounded and dispensed *The pharmacy must keep information for 2 YEARS on: •The name and strength of all products compounded •Sources and lot numbers of the components •Total number of dosage units compounded over the past two years •Name of the person who prepared and the of the pharmacist who approved each drug product •Name of the practitioner or patient receiving the drug product •Results of all sampling/testing conducted for quality control

Comprehensive Addiction & Recovery Act of 2016 (CARA)

•Amends the Controlled Substances Act to allow the partial fill of Sch II prescriptions for up to 30 days from the date of issuance of the prescription. DEA has not yet promulgated regulations to implement this provision •Allows APNP's and PA's to obtain "X" numbers and prescribe buprenorphine for narcotic detoxification and maintenance

Automated Dispensing Systems

•At the time of removal of any drug from the device, it shall automatically make a record to be retained by the pharmacy for 2 years and indicate date and time of removal, identification of drug, identification of patient, and identification of the person removing the drug •The facility may provide off-campus automated dispensing systems for care provided by the institution - Each automated dispensing system should be registered with the Board of Pharmacy - The filling/stocking of all drugs shall be completed by a pharmacist or pharmacy technician under the supervision of a pharmacist. - Prepackaged cartridges may be prepared at the pharmacy for loading into the remote system if verified by the pharmacist and verified using bar-coding or other technologies

TN Controlled Substance Monitoring Program- Submission of Information

•Each dispenser shall submit to the database the information required by the statute on all Schedule II to V drugs demonstrating a potential for abuse •The information shall be submitted by the close of business on the following day •No reporting is required for a drug administered directly to a patient or from any DEA registered narcotic program

Quality-related event

•Errors involving - Wrong drug, dose, or dosage form - Wrong patient - Incorrect labeling • Failure to identify or correct the following: - Drug allergy/age/disease/gender contra indications - Incorrect duration of therapy or dose - Over or under utilization - Therapeutic duplication - Clinical abuse or misuse •Wholesale Distribution - "Wholesale Distribution" does NOT include sales or transfers of drugs from one licensed pharmacy to another

Prescription Requirements under TN CS Act

•In an emergency a Schedule II drug may be dispensed upon an oral prescription of a practitioner BUT... Tennessee has no specific definition of "emergency" nor quantity limitations, thus pharmacists must follow the federal DEA regulations (which are stricter)defining an emergency and limiting the quantity of Schedule II drugs provided •NO PRESCRIPTION FOR ANY OPIOIDS OR BENZODIAZAPINES MAY BE DISPENSED IN QUANTITIES GREATER THAN A 30-DAY SUPPLY

Sales of Needles, Syringes, and OTC Insulin

•Needles and syringes must be kept behind the pharmacy counter and sold by a pharmacist or an intern/technician supervised by a pharmacist •Needles and/or syringes may only be sold on proof of medical need (is including not wanting to get a disease) •OTC insulins must be kept in an area that is not accessible to the public, and may only be sold by a pharmacist or an intern/technician under the supervision of a pharmacist

Practice of Pharmacy

•Patient oriented health services •Interpreting & evaluating prescription orders •Compounding •Drug selection, evaluation, & utilization review •Patient counseling & education •See Collaborative Practice Act of 2014 which allows pharmacists to prescribe drugs, order laboratory tests, and provide patient care services under a written agreement

TN Controlled Substance Monitoring Program- Identification of Patients

•Patient shall provide a social security number as a patient identifier: - If patient refuses to provide SS#, patient's drivers license number or telephone number shall be used as the patient identifier - If patient has none of the above, use the number "000-00-0000" as the patient identifier If a patient refuses to provide any identification, use the number "999-99-9999" - If patient is a child who does not have an SS#, use the parent's patient identification number

TN Collaborative Pharmacy Practice

•Physicians, APNP's, and PA's may engage in collaborative pharmacy practice agreements with pharmacists pursuant to a written agreement filed with the licensing boards. The agreement must also be signed by the patient or patient's representative. •A collaborative practice agreement may involve a hospital or a retail setting, but in a retail setting it must include a formulary of the drugs or category of drugs and services authorized. •The pharmacist must hold an active license and have at least $1M in liability insurance. - The pharmacist must hold a Dr. of pharmacy degree or have been in active practice for at least 2000 hours within the preceding 24-month period. A collaborative practice agreement: •Must be reviewed and updated at least every 2 years •Must include a plan of care prepared by the prescriber •May not permit pharmacists prescribing of a controlled substance except in a hospital or hospice setting. •Pharmacists are "strongly encouraged" to complete 10 hours of continuing education biennially in topics related to the clinical practice of pharmacy •Pharmacists who hold a current DEA license must complete at least 2 hours of CE biennially on topics related to controlled substance prescribing and treatment guidelines on opioids and chronic pain

Patient identification requirement for dispensing certain CII to CIV drugs for greater than a seven-day supply

•Unless the patient is personally known by the pharmacist/intern/tech, the patient must produce a valid government-issued identification or insurance card if prescription is for an opioid, a benzodiazepine, zolpidem, barbiturate, or carisoprodol for greater than a seven-day supply - If the patient is a minor or is homeless, a pharmacist shall use professional judgment as to whether to dispense the prescription without seeing a valid ID •The law allows the prescription to be picked up by another individual on behalf of the patient •Does NOT apply to inpatients or to outpatients if Rx is given directly to the hospital pharmacy •Does NOT apply if the patient receives the drug by a home delivery directly from the pharmacy