law time!

slideshow from school

Food and Drug Administration (FDA)

• primarily federal law dealing with food, drug, cosmetic and medical device safety

• mandated that drugs be labeled with adequate directions for safe use

• introduced the concept of premarket approval for new drugs- manufactures had to demonstrate safety to the FDA before marketing the drug

Durham-Humphery amendment of 1951

• established 2 classes of drugs

  • prescription (or legend drugs)

  • over the counter (OTC)

• you will be expected to know which products require a prescription, including those that differ depending on product/strength

Kefauver-harris amendments of 1962

• required new drugs to be proven safe and effective for their claimed use

• increased safety requirements for drugs and established good manufacturing practices (GMPs) for manufacturing drugs

• led to a review of all drugs approved between 1938 and 1962, with many being found ineffective and removed from the market

prescrption drug marketing act (PMDA) of 1987

• bans the sale, trade, and purchase of prescrption drug samples

• mandates the storage, handling and record keeping requirements for prescription drug samples

  • a community pharmacy that is not affiliated with a healthcase entitiy may not be in possesion of prescrption drug samples

• prohibits (with certain exceptions), the resale of prescription drugs purchased by hospitals or healthcare facilites

drug compounding quality act (DCQA)

• permits outsourcing facilities (503B facilities) to compound sterile products without receiving a patient-specific prespcriton or medication orders

  • the new york board of pharmacy licenses outsourcing facilities

• outsourcing facilities that meet requirments are exempt from the premarket approval requirments for new drugs, adequate directions for use requirments and drug track-and-tract provesions

• compounding pharmacies that are not registered as “outsourcing facilities” are reffered to as 503A pharmacies

  • may compound pursuant to an individual prescription or medication order

  • premitted to do some limited anticipatory compounding

  • interstate distribution of coumpounded drugs limited to 5% of total prescriptions unless the compounder is located in a state that has entered into a memorandum of understanding with the FDA

drug supply chain security act (DSCSA) (Track&trace)

• sets national standards for the licensure of wholesale drug distributors and third-party logistics providers

• provides for a unfiorm national framework for an electronic track-and-trace system for prescrption drugs as they move through the supply chain

  • manufactures are required to provide “transactions data”

  • wholesales are required to recieve transaction data upon purchase and subsequently provide transaction dates to buyers

  • pharmacies are required to recieve transaction data and pass this information long if they further distribute the product

• “transaction data” includes transaction information, transaction history and a transcation statment

• the transacction information required to exchanged includes the product intentifier at the package level for each package included in the transaction

• pharmacies must have systems and processes for:

  • verification of product at the package level

  • promptly responding with the transcation information and transaction statment for a product upon request in the event of a recall or investigative purposes

• pharmacies must investigate and properly handle suspect and illegitimate products

prohibited acts under FDCA: adulteration

think “drug”

• contains any filthy, putrid or decomposed substances

• has been prepared or held under insaintaitry conditions where it may have been contaminated

• methods of manufacture do not conform to cGMPs

• has been manufactured, processed, packed, or held in any establishment and the owner, operator or agent of such establishment delays, denies or limits an inspection

• container is composed of Anu poisonous or deleterious substance that may contaminate the drug

• contains an unsafe color additive

• strength differs from or quality or purity fall below the compendium standards or what the drug product represents

• mixed or packed with any substance that reduces it strength or quality, or the drug has been substituted in whole or in part

prohibited acts under FDCA: misbranding

think “label”

• labeling is false or misleading in any particular way

• labeling fails to contain required information

• container is made, formed, or filed as to be misleading

• drug is an exact imitation of another drug or offered for sale under the name of another drug

• is dangerous to health when used in the dosage or manner suggested in the labeling

• is packaged or labeled in violation of the poison prevention packaging act

adulteration and misbranding as applied to pharmacies

• dispensing a prescription without authorization causes the drug to be misbranded even if its labeled correctly by the pharmacy

• misfiling a rx with the wrong drug, strength or direction is misbranding

• if a misfiled rx involves the wrong strength of the drug prescribed, it would also be adultered

• if a drug is subject to a REMS and it is prescribed without meeting the requirements of the rems, its misbranded

• an expired drug product in a manufactured bottle is adulterated; if a rx is fulled using an expired product, it may also be misbranded if the pharmacy put an BUD that is after the drug’s expiration date

• if a pharmacist counts a medication on a tray that has residue from another medication, the product would be adulterated

• a pharmacist stores inventory in a room or fridge w temp not adequately controlled, the products will be adulterated

• a pharmacist stores a specific product incorrectly (fridge item on a shelf), the product is adulterated

• if a pharmacist fails to dispense a medication in a child-resistance container, it would be misbranding

drug approval process

• after completion of animal studies, a drug manufacturer can file an investigational new drug (IND) application w the FDA

• clinical studies can begin after the IND application has been approved by the FDA and the clinical trials have been reviewed by an institutional review board

• 3 phases:

  • phase 1: small trial, see how the drug works (ADME)

  • phase 2: larger trial, is the drug effective

  • phase 3: largest trial about saftey and treatment

• after completion of clinical stuides, the drug-sponsor may submit a new drug application (NDA) to seek approval to market the drug

• postmarket studies → after FDA approvla for additonal drug uses

• abbreviated new drug application (ANDA): approval for generics

OTC requirements

• approves drugs on the basis of therapeutic category and conformance to a monograph rather than on a drug-by-drug basks like rx drugs

• monograph = reciepe book that defines

  • active ingredient allowed

    • ingredients that are generally recoginized as safe and effective (GRASE)

  • strengths/dosage limits

  • labeling requirments

  • formulations

• monographs are created through an advisory review panel (appointed by the FDA) and public comment

• new otc products that conform to the monograph may be marketed without FDA approval

• tamper-evident packaging

  • manufactueres nad packacgers of OTC drugs for sale at retail outlet smust package OTC products in tamper-evident packaging

  • otc products not packaged in tamper-resistant packaging would be consdiered adultered and misbranded

  • exceptions: detmatologics, dentificries, insulins and lozenges

advertising & promotion of prescription drugs

• the FDA regulates rx drug advertizing

• the FTC regulates OTC drug advertising

patient package inserts

• supplied by the manufacture and written for a layperson

• required to be given to patients in the community setting when new and refill res for certain products are dispensed

• required for

  • oral contraceptives

  • estrogen-containing products

medication guides

• similar to PPI programs, but w amended requirements for institutionalized patients

• FDA requires med guides for all new and refill rx’s dispensed in the community setting when

  • patient labeling could prevent seirous adverse effectts

  • product has serious risks realtive to benefits

  • patient adherenece to directions is crucial

• fda maintains a serchable med guide database on its website

• failure to proide a med guide when dispensing a drug that requires one would be misbranding

Rx drugs: side effects statement

• pharmacies and pharmacists are required to distribute a side effect statement to patients when dispensing all new and refill rx in outpatient setting

  • “xall your doctor for medical advice…”

• can be distributed on a stucer attached to pharmacy container or prepinted on a vial cap, sperate sheet of paper or found within CMI or medguides

risk evaluation and mitigation strategies (REMS)

• REMS are strategies to ma nage a known or potential serious risk associated with a drug, drug class or biological product

• a REMS can include a med guide, PPI, a communication plan, elects to ensure safe use and an implementation system

  • special training, experience, or certificaiton of professionals prescribing the drug

  • special certification for pharmacies that disepense the drug

  • dispensiing drugs to patients only in certain helthcare settings

  • evidence or other documentation of safe use conditions

  • monitoring patients using the drug

  • enrolling each patient using the drug in a registry

national drug code (NDC)

• national drug products are identified by a NDC numver

• 10-digit code

• first segment is manufactures or distrubuter

• second is strength, dosage form and formulation

• third is size and type of package

orange book

• evaluates pharmaceutically equivalent products on the basis of bioequivalence

• pharmaceutical equivalence: products contain same active ingredients and are identical in strength and dosage form

• bioequivivalent pharmaceutical equivalents: are generally presumed therapeutically equivelenat- having the same clinical safety and efficacy

orange book and generic substitution

two letter rating system

• a: drug product FDA considers to be pharmaceutically equivalent and therapeutically equivalent

• b: drug products FDA consider NOT to be pharmaceutically and therapeutically equivalent

purple book

• the FDA purple book lists biological products that are considered biosmilars and provides interchangeably evaluations for these products

• “biosimilar” or biosimularity” means that the biological product is highly similar to the refrence product, not withstanding minor differences in clinicallu inactive components, and there are not clinically meaniningful differences between the biological product and the refrence product in terms of saftery, purity and potency

• only biological products that have been designated “interchangable” mayb be subsitutied for the original refrence product by a pharmacist

medical devices

• the FDA classifies medical devices based on the risk associated with the device

  • class I: devices are deemed to be low risk and subject to the least regulatory control (dental floss)

  • class II: devices are higher risk and require greater regulatory control (syringes)

  • class III: highest risk devices- post a significant risk of illness or injury require premarket approval by the FDA (heart valves)

• class I and II devices are exempt from premarket approval and GMPs, but still must comply with other regulatory requirments unless they are exempt

poison prevention packaging act

• administered by consumer product safety commission (CPSC)

• requires child-resistant containers for all rx drugs and specific nonprescription drugs, drug classes, preparations or dietary supplements

• exemptions:

  • the request of patient or physican

    • BUT! only pt can blanket request for all future rx’s, physican can only request on individual rx

  • bulk containers not intended for household use

  • one package size of OTC drugs designed for the eldery

  • specific exceptions:

    • oral contraceptives, conjungated estrogens, norethidrone in manufactures dispenser packaging

    • medroxyprogesterone tablets

    • sublingual nitroglycerin and sublingual and chewable isosorbide dinitrate 10mg or less

    • aspirin and acetaminophen in effervescent tablets or granules

    • potassium supplments in unit dose packaging

    • sodium flouride containign not more than 264mg of SF per package

    • anhydrous cholestryamine and colespitpoo packets

    • erythromycin granuales for suspension, and oral suspensions in packages containing no mpore than 8g of erythromycin

    • prednisone tablets containing no more than 84mg per package

    • mebendazole tablets containig no more than 600mg per package

    • betamethasone tablets containing no more than 12.6mg per package

    • preperations in aerosol containers for inhalation

    • pancrelipase preperations

    • sucrose peperations in a solution of glycerol and water

    • hormone replacement therapy products that rely soley upon the activity of one or more progestogen or estrogen substances

    • colesvelam in power form in packages not containing more than 3.75g of the drug

    • sevelamer carbonate in powder form in packages containing not more than 2.4g of the drug

centers for medicare and medicaid services requirements

• tamper resistant prescriptions

  • CMS requires that all written rx’s meet certain tamper-resistent requriments to prevent unauthorizied copying and to prevent counterfeting

• pharmacy services at long term health care facilities

  • new york uses the term “residential healthcare facility” (RHCF) to refer to most long-term care facilities, including nursing homes

  • requires a consultant pharmacist to preform a medication regimen review for all long-term care patients every 30 days

  • each resident’s therapy must be free from unnecessary dsrugs

  • when used PRN, psuchotropic drugs must be limited to 14 days unless the practioner documents the rationale for extending an order

  • to reduce medication waste, pharmacies may not dispense more thn a 14 day cycle of brand name medication to medicare part D LTCF residents, with limited exceptions

  • pharmacies must ensure routine and emergency drugs are provided in a timely manner to all residents

delivery rx’s by mail

• prescriptions containing non-controlled substances may be mailed by a pharmacy to the ultimate user, provided that the medications are not alcoholic beverages, poisons, or flammable substances

• controlled substances may be mailed to patients under the following requirements:

  • the rx container must be labeled in compliance with rx labeling rules

  • the outer wrapper or container in which the rx is place must be free of markings that would indcate the nature of the contents

  • no markings of any kind may be plasced on the package tot indicate the nature of the contents

privacy (HIPAA)

• enforced by the office of civil rights

• most pharmacies are a “covered entity” under HIPAA and must be in compliance with these requirments

• notes and acknowledgments:

  • pharmacies must provde patients with a “notice of privacy practice” and make a good faith effort ot obtain written acknowledgment of receipt of the notice from the patient

  • the notice must be provided upon first service delivery to the patient

  • the HIPAA privacy rule requires mandatory provesions in the notice

use and disclosure of protected health information (PHI)

• protected health information (PHI) is the HIPAA term for patient identifiable information

• pharmacies may use and disclose PHI to provide treatment, for payment, and for healthcare operations without authorization from the patient

• pharmacies may also use and disclose PHI for certain governmental functions without authorizations from the patient

• other uses and disclosures, such as for marketing purposes, require a signed authorization from the patient

minimum necessary standard

• when using and disclosing PHI, a pharmacy must make reasonable efforts to limit PHI to the minimum necessary to accomplish the intended purpose

• does not apply to disclosures to healthcare providers for treatment purposes (prescrption transfers or med recs)

• does not apply to disclosures for which the patient has signed an authorization

• does not apply to disclosures for payment

incidental disclosures

• unintended “incidental” disclosures are not a violation of the privacy rule as long as reasonable safeguards are in place

• examples

  • sales representavies or janitoral service members accidentally see PHI during the normal course of their jobs

  • a customer overhears counseling that is preformed in a private area in a discreet manner

  • PHI must properly disposbed of by pharmacies

HITECH

• the HITECH act amended HIPAA to strengthen many of its provisions

• added a breach notification requirement

• covered entities (pharmacies) must notify individuals of a breach of their “unsecured” PHI within 60 days

• a “breach” is defined as unauthorized acquisition, access, use, or disclosure of PHI that compromises its security or privacy

  • does not include instances in whcih there has been an indvertent discolusure from an authorizaied indvidual to another person authorized to access PHI within the same organization

  • does not include instances in which the covered entitiy has a good faith belief that the PHI is not further accquired, accessed, retained, used or disclosed

• for breaches affecting fewer than 500 individuals, covered entities must maintain a log of these breaches and notify HHS of these breaches annually

• if more than 500 individuals are affected, the secretary of HHS and prominent local media must be notified in addition to the affect individuals within 60 days

schedule II drugs (CII)

• high potential for abuse

• have currently accepted medical use in treatment in the US or currently accepted medical usw with severe restrictions

• abuse of the drug or other substances may lead to severe physical or psychological dependence (addiction)

• note: under New York law, anabolic steroids are CII, stricter than federal law

schedule IV drugs (CIV)

• low potential for abuse relatives to schedule III drugs

• have currently accepted medical use and treatment in the US

• abuse may lead to limited physical or psychological dependence (addiction) relative to schedule III drugs

• in NY, although benzo are CIV drugs under federal law, they are subject to many of the same restrictions as CII substances in regard to their requirments for insurance and dispensing

schedule V drugs (CV)

• low potential to abuse relative to schedule IV drugs

• have currently accepted medical use and treatment in the US

• abuse of the drug or other substance may lead to limited physical or psychological dependence (addiction) relative to schedule IV drugs

concentration limits

• codeine

  • schedule V limit = 200mg/100mL

  • schedule III limit = 1.8g/100mL and 90mg per dosage unit

• dihydrocodeine

  • schedule V = 100mg/100mL

  • schedule III limit = 1.8mg/100mL and 90mg per dosage unit

• ethylmorphine

  • V = 100mg/100mL

  • III = 500mg/100mL and 25mg per dosage unit

• opium

  • V = 100mg/100mL

  • III = 500mg/100mL and 25mg per dosage unit

• morphine

  • V = 100mg/100mL

  • III = 50mg/100mL

a compounded narcotic prescription will never be a schedule IV drug

compounding

a pharmacy may compound narcotic controlled substances to a rx. however, DEA limits the compounding of “aqueous of oleaginous solutions or solid dosage forms” to no more than a 20% concentration.

DEA registration (part 1)

• federal law requires registration with DEA prior to conducting activity with controlled substances

  • manufacturing, distrubiting, dispensing, conducting research, conducting narcotic treatment programs, conducting chemical analusos, iporting anf exporting of controlled substances

• dispenser registration must be renewed every 3 years

  • pharmacies are degistered as dispensers

• the bureau of narcotic enforcement (BNE) is the division of the new york department of health with controlled substance regulation

• the CSA specifically allows the following persons to possess controlled substances without registration:

  • an agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substances if such agent or empolyee is acting in the usual course of his buisness of employment

    • under this exception, pharmacist employed by a registered pharmacy or insitution do not need to be individually registered

  • a common or contract carrier or warehouseman or an employee thereof whose possession of the controlled substance is in the usual course of buisness

  • an ultimate user who possesses such substance for a lawful purpose

DEA registration (part2)

• IPs who are agents or employees of a hospital or or other institution may administer, dispense, and prescribe controlled substances under the registration of the hospital or institution provided certain conditions are met:

  • done in the usual course of professional practice

  • individual practioner is authorizaied or permitted to do so by the judication in which they are practicing (verified by employer)

  • the practioners is acting within the scope of their employment

• the insitution assigns a specific internal code number to the IP as a suffix to the institutions DEA number

• seperate DEA registration is required for seperate locations

  • DEA will sometimes issue a campus registration that may include multiple buildings on a case-by-case basis

• it is not necessary for practioners to maintain more than one registration when prescribring for more than one office, provided the practioner only prescribes conterolled substances and doesnt administer, dispense, or store them in more than one office

• a pharmacy does not have to register with the DEA as a distributer as long as the total quantities of controlled substances distributed during a calender year in which the pharmacy is registered do not exceed 5% of the total quantity of all controlled substances dispensed and distributed during that same calendar year

• to check the validity of a DEA registration number, a pharmacist

  • adds the first, third, and fifth digits

  • adds the second, fourth, and sixth digits and multiples this number by 2

  • adds sums from step 1 and step 2

  • the last number of the final sum matches the last digit in the DEA number

applications for DEA registration

form 224 (new) & form 224a (renewal)

• dispensers: pharmacies, hospitals/clinics, practitioners, and teaching institutions

form 225 (new) & form 225a (renewal)

• manufacturers, distributors, researches, analytical labatories, importers and exporters

form 363 (new) & form 363a (renewal)

• narcotic treatment facilities

New York controlled substance licensing

• New York licenses many of the same entities and individuals dealing with controlled substances as the DEA with a few exceptions

• new york controlled substance licenses are issues by the new york bureau of narcotic enforment (BNE)

• note: hospital pharmacies are required to have a new york controlled substance license as an institutional dispenser, but community pharmacies do not unless they are using an automated dispensing system to provided controlled substances to RHCFs

• each prescriber must also register with the BNE in order to prescribe controlled substances

• the registration must by renewed every 2 years

ordering, transferring, and dispensing of controlled substances

• DEA form 222 is required for each transfer of Schedule I or II drugs, except dispensing to the ultimate user

  • single item ordered on each number line

  • the number of lines completed must be notated on the form

  • the name and address of the suppliers from whom the controlled substances are being ordered must be entered

  • the form must be signed by the registrant or by the person authorized to execute DEA form 222 by a power of attorney

• DEA form 222 purchaser and supplier responsabilities

  • the purchaser filling out DEA form 222 must make a copy of the original form for its records and submit the original form to the supplier

  • the supplier may only fill an order from the original form and not from a copy; the supplier must record the number of containers furnished for each ordered item and the date the products were delivered or shipped

  • a supplier may provide a partial quality for the requested amount, but the remaining quantitiy must be sent within 60 days or the order becomes void

  • when the product has been received, the purchaser must record the number of containers recieved and the date recived for reach item on the copy of the DEA from 222 they made when ordering the product

• unaccepted and defectives forms

  • forms that are not complete, legible, properly prepared, or signed will not be accepted

  • forms that show any alteration, erasure, or changes will not be accepted

  • if a DEA form 222 cannot be filled for any reason, the supplier must return the original DEA form 222 to the purcbaser with a statment explaining the reason the order could not be filled

• if a completed order form is lost, thw purchaser must prepare another DEA form 222 along with a statment containing the serial number and date of the lost form; it must state the goods covered by the first order were not recieved becasue the form was lost

electronic ordering of schedule II controlled substances

• DEA allows electronic ordering of schedule II controlled substances through the controlled substance ordering system (CSOS)

• CSOS allows electronic orders based on digital signing certificates issued by the DEA certification authority that are valid until the expiration of the DEA registration for the facility (3 years)

ordering schedule III-V controlled substances

• CIII-CV controlled substances can be ordered through normal ordering processes from a wholesaler or manufacturer, but must be documented with an invoice provided by the wholesaler or manufacturer

• invoice must include specific items

  • name of controlled substances

  • dosage form and strength

  • number of units per container

  • quantity recieved (containers)

  • date of shipment or delivery

  • name, address, and DEA number of the registrant from where the controlled substances was recvied

  • new york law also requires the BNE registry number of the supplier

security and theft or loss of controlled substances

• controlled substances shall at all times be properly safeguarded and securely kept at the address of file with the DEA

• New York specifies that access to controlled substances be limited to the minimum number of employees required to efficiently handle the manufacture, distribution, custody, dispensing, or administration or other handling of such substances

• storage in the pharmacy

  • pharmacies may store controlled substances in a secure cabinet that is locked

  • pharmaciers may store controlled substances by dispersal throughout the non-controlled stock to deter theft

  • pharmacies may not store all controlled substances on a single unsecured shelf

• theft or signifiacnt loss:

  • must be reported in writing to the DEA within 1 business day fo discovery

  • DEA also recommends notifying the police

  • musst complete DEA form 106 using the online theft and reporting system within 45 days of discovery

  • NYS also requires promput notification to the BNE using the department of health’s loss of controlled substances form (DOH-2094). it is recommened to submit within 1 business day of the incident

disposal, waste & returns

• registrants may dispose of a controlled substance in one of the following manners:

  • destroying the substance using an on-site method of destruction that meets the DEA’s non-retrievable standard

  • delivering the substance to a reverse distriubtor;s registered location

  • delivering returns or recalled substances at the registered location to the registered person form hwo the substance was obtained, the registered manufacturer, or another registrant authorized by the manufacturer

  • request assistance from the special agent in charge of the administration in the area where the registrant is located

• onsite destruction of controlled substances in a community pharmacy

  • must be done using DEA form 41, which requires the name and NDC number of the drug, the strength, dosage form, package size and the quanitity of the controlled substances destroyed

  • it also requires recording the method by which the drugs were destroyed and 2 signatures of employees who witnessed the destruction

  • the method of destruction shall be sufficient to render allcontrolled substances as non-retrievable

• transfer to a registered reverse distributor

  • involved transferring controlled substance from one DEA registerant (the pharmacy) to another (the reverse distributor)

  • no DEA form 41 is required becasue its considered a transfer

  • instead, the transfer must be documented with an invoice for CIII-CV drugs and DEA form 222 for CII drugs (same porcess for ordering)

• returns of controlled substabces inventory to supplier

  • unused controlled substances may also be returned to the supplied

  • such returns require appropriate documentation

    • CII = DEA form 222

    • CIII-V = invoice with requied elements

• disposal of controlled substances collected from ultiamate users

  • DEA allows pharmacies to modify their DEA registrations to serve as “authorized collector” of controlled substances from ultimate users

  • under the new york drug take back, groups of 10 or more pharmacies that are under common owndership are required to provide a drug take back program with either collection receptacles or mail back envelopes

  • any other community pharmacy may voluntarily participate in the drug take back program

  • authorized collectors may allow ultimate users to deposit CII-V obtained legally into collection receptacles at the registered location

inventory

under New York law, all records (including prescriptions), unless otherwise specified, must be kept for at least 5 years from the date of transaction at the site of activity. this also applies to transaction and investor record required to be kept by manufacturers, distributors, importers, exporters, institutional dispensers, etc.

inventory records

• an initial inventory is required on the first day the pharmacy is open for business

• pharmacies may take and maintain records of a controlled substance inventory every 2 years

• new scheduled drugs or drugs move from one schedule to another must be inventoried on the day scheduled or moved

• inventory records must be maintained for 5 years

• separate records must be kept for all controlled substances dispensed or returns to an automated dispensing system

• inventory counts:

  • an EXACT count is required for all CII drugs

  • an estimated count is allowed for CIII-V unless the container holds >1,000 tabs/caps