PHP 308 Exam 2

new package insert requirements

-"highlights" section at the beginning -full prescribing information organized to give prominence to most important information -patient counseling information section

american recovery and reinvestment act (ARRA)

-"the stimulus" -package includes health info technology for economic and clinical health (HITECH) act -devotes >$31 billion in stimulus funds to streamline healthcare infrastructure and effect the adoption of electronic healthcare records -encompasses new medical privacy regulations that impact the healthcare industry with even greater magnitude than HIPAA

Nutrition labeling and education act of 1990

-Required nutritional labeling of almost all foods covered by the FDA with a specific layout and content that reflects consumers' dietary concerns for chronic disease prevention -health claim for food made by manufacturer that could result in the product being considered a drug -manufacturer must submit evidence to support the claim to obtain FDA approval

national drug code (NDC)

-11 digit 3 segment code -first segment identifies manufacturer/distributor (labeler code) -second segment identifies strength/dosage form/formulation (product code) -third segment identifies package characteristics/size -having a NDC does not denote FDA approval -on all Rx and OTC -in 2004 new regulations requiring bar code for certain drugs

old pregnancy labeling

-A= no demonstrated risk to fetus -B = no well controlled studies in pregnant women -C= no good studies or animal studies show adverse effect on fetus -D = positive evidence of fetal risk (phenobarbital, phenytoin) -X= risk outweighs benefit, demonstrated fetal risk (accutane, warfarin, thalidomide)

food additives amendment of 1958

-Anything that directly or indirectly becomes part of the food, is considered an additive - includes packaging components -components added to food receive premarket approval for safety -Delaney clause = bans food additives that are found to be carcinogenic

kafauver harris amendment of 1962

-Caused by Thalidomide drug for morning sickness that caused deformity in babies -drug efficacy act -ensures that drugs must be both safe and effective -adverse drug reporting

park doctrine

-Corporate officers of pharmaceutical companies can be prosecuted for corporate violations of the FDCA -is the affirmative duty of corporate officers to be aware of and correct violations -can be held personally responsible

durham humphrey amendment of 1951

-Created a distinction between "OTC" and "Legend Drugs" (prescription). -Legend Drugs can only be dispensed with a valid Prescription. -Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". -The emphasis on this act was to ensure safety through qualified medical supervision -does not include electronic prescriptions but states can permit them -RX = unsafe except under supervision of practitioner, toxicity/method of use requires supervision, collateral measures necessary to use the drug require supervision, subject to NDA approval process

NDA sponsors

-FDA amendment act amended FDCA to require that NDA sponsor must publish summary info about any post phase1 clinical trial on public registry -informed consent by patient is required in all 3 phases (in writing) -research subjects required to know risks, possible benefits and alternative courses of treatment -institutional review board (IRB) approval required -informed consent exceptions include in life threatening situation, military operations or public health emergencies

reimportation

-PDMA prohibits reimportation of Rx drugs in attempt to prevent counterfeiting -has instituted compassion use policy in CSA act to allow for limited personal importation from Canada (lower cost) -MMA allow wholesale importation of Rx medications from Canada provided that the secretary of HHS would approve

color additive amendments of 1960

-Required manufacturers to establish the safety of color additives in food drugs and cosmetics -must be suitable and safe

herbs/botanicals

-USP/NF has monographs for some botanical herbs -have had FDA or USP DI panel approved use -monograph describes portion of plant used, its botanical characteristics, appropriate assay for procedure for ingredients -does not include therapeutic use -must contain standard common name -must state that is has not been evaluated by FDA and that it is not intended to diagnose/treat/cure/prevent disease

Nutritional or Structure/function claims for DS

-benefit a classical nutrient deficiency disease -describes role of DS in affecting the structure/function of the body -characterizes the mechanism by which a DS act to maintain the structure/function -statements describe the general well-being from consumption of a nutrient or dietary ingredient -must state "this statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease -notify FDA within 30 days if it uses one of the permitted statements

technical safeguards for HIPAA

-access control -audit control -integrity control -transmission security -encryption

section 503A of title 1 quality compounding act

-all sterile compounding must comply with USP 797 and nonsterile USP 795 -exempt from cGMP requirements -no NDA required by FDA -must be dispensed pursuant to patient specific prescription, not for resale -

substance use disorder prevention that promotes opioid recovery treatment act (SUPPORT Act)

-allow pharmacies to deliver prescribed narcotic drugs in schedule 3-5 to a patient for the purpose of maintenance and detoxification to be administered by a practitioner through injection or implantation to patients

device

-any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent which is recognized in the USP/NF/HPUS -intended for use in diagnosis or disease, cure, mitigation, treatment or prevention of disease in man or animals -intended to affect the structure or any function of the body but are not food -(ex) pumps, cardiac pacemakers, monitors

covered entity

-anyone who provides treatment, payment, operations -health plans, health care clearinghouse, providers, insurance companies, health maintenance organizations, pharmacies, health care facilities -obligations= train employees, document policy/procedures, audit for compliance, notify entities of non-compliance, enforce policies (retraining, probation, termination), respond promptly to breach, submit documentation -any type of individually identifiable health information is any format is covered/ protected (PHI)

cosmetic

-articles intended to be rubbed, poured, sprinkled, sprayed on or applied to the human body for the purpose of cleansing, beautifying, promoting attractiveness or altering appearance -soap is excluded -do not require pre market approval -cannot contain unsafe color additives -do not have to conform to CGMP and do not require pre-market approval

removal of harm standard

-began in 2013 -impermissible use/disclosure of unsecured PHI presumed to require notification, unless CE/BA can demonstrate low probability that PHI has been compromised based on a risk assessment

optometrist with amplified therapeutic privileges

-can prescribe medications to treat conditions of the eye -includes oral steroids, narcotics and analgesics -Rx for oral NSAID/steroids should not exceed 7 day supply -Rx for controlled substance schedules 3-5 cant exceed 72 hour supply -may prescribe schedule 2 (hydrocodone) that doesn't exceed 72 hour supply -cannot prescribe anything that is injection

providers with prescriptive authority

-can prescribe: medical doctor, doctor of osteopathic medicine -limited scope: dentist, podiatrist, veterinarian, pharmacist, physician's assistant, nurse midwife, advanced practice RN

Food, drug and cosmetic act of 1938

-catalyzed by the tragedy of the elixir sulfanilamide incident -to be marketed proven safe under conditions on label and approved by FDA -adequate directions for use -warnings about habit forming -applies to medical devices and cosmetic products -concentrates on manufacturing of drugs, cosmetics and devices, not the practice of pharmacy

advanced practice RN scope of practice (RI)

-certified nurse practitioner has authority for prescription of legend medications and prescription controlled substances from schedule 2-5 -governing board of a hospital determines the scope of practice of nurse anesthetists -nurse midwife can prescribe all legend medications and controlled substances schedules 2-5 only

omnibus budget reconciliation act 1990 (OBRA 90)

-changed how we practice pharmacy -established public expectation of pharmacists to improve quality of drug therapy and increase likelihood of good outcomes -moves profession beyond distribution into medication therapy -law requires that the states must actually establish the standards in order to continue receiving federal funds for medicaid -most states chose to promulgate the regulations through the pharmacy practice act and apply OBRA provisions to all patients -primary goal to save money (appropriate use of pharmaceuticals-prior authorizations, quantity limits, step therapy), improve outcomes and manage cost -adopt the pharmacist care model (pharmacist patient care process) and medication therapy management -components of OBRA impacting RX = rebates, demonstration projects, drug use/utilization review

section 503B of title 1 quality compounding act

-compounder of sterile products may voluntarily register as an outsourcing facility -outsourcing facility= registered with FDA that has one geographic location engaged in the compounding of sterile drugs and complies with all section 503B requirements -must comply with cGMP requirements, permit FDA inspection according to risk based schedule, compliance with DQSA labeling requirements, reporting ADR and compounding information -prohibit sale or transfer of compounded products by an entity other than outsourcing facility -FDA must publish list of drugs with demonstrable difficulties for compounding, products withdrawn/removed from market, bulk drug substances for which there is a clinical need that may be used by outsourcing facilities -advantages: drug product properly compounded at a registered outsourcing facility will be exempt from meeting the adequate directions for use labeling requirements and not considered a new drug

2018 Farm Bill

-defines hemp as cannabis sativa L with a delta 9 THC concentration of not more than 0.3% by dry weight -removes hemp from the controlled substances act, paving way for legal cultivation, possession, sale and distribution of hemp -gives CBD producers to have greater incentive to use hemp as primary source for CBD rather than marijuana -FDA has not approved any OTC drugs containing CBD

methods of destruction

-destroy so that PHI cannot be read or reconstructed -no black markers -cross shred paper/hard copies -Degausser= wipes electronic disk/drives clean

OTC labels

-drug facts panel -adequate directions for use (normal dose, frequency, duration, administration, onset of symptoms, time factors, any required preparation for use)

counterfeit drug

-drug/container that without authorization has the trademark/name/imprint/device or any likeliness of a drug manufacturer/processor/packer/distributor other than the person who is in fact the manufacturer/processor/distributor of that drug -falsely represented to be the product of, or to have been packed/distributed by

narrow therapeutic index (NTI) drugs

-drugs with <2 fold difference between median lethal dose and median effect dose or 2 fold difference between minimum toxic concentrations and minimum effective concentrations -controversy exists as to whether FDA's statistical parameters for bioequivalence are accurate enough for certain NTI drugs -pharmacists should exercise professional judgment when called upon to substitute B rated NTI drugs -(ex) warfarin, levothyroxine, phenytoin, digoxin, carbamazepine

21st century cures act

-dsigned to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently -builds on FDA's ongoing work to incorporate the perspectives of patients into the development of drugs in FDA's decision making process -enhances FDA's ability to modernize clinical trial designs included use of real world evidence and clinical outcome assessments, which will speed the development and review of novel medical products -creates/amends pathway for serious or life threatening disease (affect small population or diseases with significant public health risk, create program for approval of antimicrobial resistant drugs, expand orphan drug program, reauthorize FDA voucher program for rare peds diseases)

HIPAA security rule (for covered entities)

-ensure confidentiality, integrrity, availability of all PHI they create, receive, maintain or transmit -identify and protect against reasonably anticipated threats to the security or integrity of all the PHI -protect against reasonably anticipated, impermissible uses or disclosures -ensure compliance by their workforce -when developing/implementing security rule consider size, complexity, capabilities, technical infrastructure, cost of security measures, likelihood/possibly impact of risks to PHI

health care clearinghouse

-entity that processes/facilitates nonstandard data elements of health info into standard data elements -(ex) billing service, community health management info system

FDA amendments act of 2007

-established FDA authority to order recalls -class 1 = reasonable probability that product will cause serious harm or death -class 2= may cause temporary or medically reversible consequences -class 3 = not likely to cause adverse health consequences -manufacturers responsible for notifying seller and for seller to notify consumers -pharmacists responsible for knowing of product recalls -recalls may be conducted on company's own initiative or by FDA request -FDA's role = oversee a company's strategy, assess adequacy of recall and classify it

breach risk assessment

-evaluate nature/extent of PHI involved, including types of identifiers and likelihood of re-identification of PHI -consider unauthorized person who impermissibly used the PHI or to whom the impermissible disclosure was made -consider whether the PHI was actually acquired/viewed or if only the opportunity existed for the info to be acquired/viewed -consider extent to which the risk to the PHI has been mitigated -pharmacy must evaluate all breaches and need to keep log of investigation and corrective actions

demonstration projects

-evaluate whether the DUR requirements would result in improved patient care and decreased cost

Hatch Waxman amendment

-evaluates pharmaceutically equivalent products on basis of bioequivalence -pharmaceutical equivalence = contain same active ingredients, identical in strength and dosage form -bioequivalent products = same clinical safety, same efficacy -pharmaceutical equivalents that are bioequivalent are considered by the FDA to be therapeutically equivalent

breach exceptions

-exceptions for inadvertent, harmless mistakes -unintentional acquisition/access/use of PHI if acquisition was made in good faith and within scope of authority -inadvertent disclosure of PHI by person authorized to access PHI at a covered entity or business associate to another authorized person -if covered entity/business associate has good faith belief that the unauthorized person to whom the impermissible disclosure was made would not have been able to retain the info

autonomous prescribing

-expand prescriptive authority for pharmacists -in Idaho/Oregon

medication dating

-expiration date = time during which the drug is expected to meet the requirements of the USP monograph -beyond use date= date after which the drug should not be used and must not exceed manufacturer's expiration date -repackaging= whichever is earlier, 1 year or the manufacturer's expiration date -return to stock= no drug returned to stock have expiration dates that exceed 6 months fro the date of dispensing of the original medication

"high in ____" food claim

-food has to contain >20% of the daily reference value or RDI per serving

"good source of ____" claim

-food would have to contain between 10-19% of the DRV or RDI per serving

drug use review (DUR)

-functions: retrospective review, educational programs, prospective DUR -all part of a continuous quality improvement process for all patients -retrospective DUR= review medication use data and compare to target criteria, may need to establish educational programs for providers not meeting target -educational programs= physician detailing (discuss best practices/payer's formulary), continuing education programs (specific to plan/disease categories identified by retro-DUR), letter campaigns (to physician to attempt to modify behavior) -prospective DUR= provide opportunity to evaluate the prescribed drug therapy before the Rx is dispensed -can use data generated from Pro-DUR to determine if drug use problems are being resolved or continuing -dosage/quantity limitations: behavioral health medications, narcotics, inhalers, triptans

medical device amendment of 1976

-goal to protect public against harmful or ineffective medical devices -medical device= any article intended to achieve its therapeutic goal through mechanisms other than chemical mechanisms -class 1= least potential harm (bed pan, enema kits) -class 2 = general controls alone are insufficient (tampons, insulin syringes) -class 3 = need pre market approval, is life supporting or sustaining (breast implants, pacemakers) -classified according to relative danger or requirement of premarketing approval -must meet cGMP

health information technology for economic and clinical health (HITECH) act

-goal: to protect privacy of PHI, reduce medical errors, reduce costs by improving administrative efficiency, improve coordination among providers, improve public health/emergency response system

black box warnings

-highlights if there is an adverse reaction so serious (fatal, life threatening) in proportion to potential benefit from the drug that is essential that it be considered in assessing the risks and benefits -if there is a serious adverse reaction that can be prevented or reduced in frequency or severity by appropriate use of the drug -if FDA approved the drug with restrictions to ensure safe used because they concluded that the drug can be safely used only if use is restricted

FDA

-housed under the department of health and human services (DHHS) -commissioner is appointed by president and confirmed by senate -secretary of DHHS has primary enforcement for administering the FDA -national headquarters= policy making and decisions -field force = works locally for inspection and information gathering -6 centers= biologics evaluation/research, food safety/applied nutrition, drug evaluation/research, vet medicine, devices/radiological health, tobacco products (only began in 2009 by Family smoking prevention and tobacco act)

Physician Payment Sunshine Act

-included in ACA -intent is to continue to monitor and reduce the impact manufacturers have on prescribers -mandate disclosure by drug manufacturers and group purchasing organization of non-trivial payments to physicians and teaching hospitals (gifts, entertainment, meals, travel, consulting fees) -must disclose $$ amounts to DHHS

qualified claims

-includes disclaimer and there is more evidence for claim than against it -"some evidence supports claim but is not conclusive" -"some evidence suggest but FDA determined that this evidence is limited/not conclusive" -"very limited and preliminary research as concluded by the FDA"

FDA enforcement authority

-injunction= cease illegal activities -criminal action = fines, imprisonment -seizure of adulterated or misbranded products -warning letters= first step to violators when action would serve the public interest -violations= imprisonment <1 year, fined <1000 -2nd offense or intent to defraud = imprisonment 3 years, 10000 fine

generic substitution

-innovator produces 1st generic version -30 month stay in ANDA process -part of the pharmacy practice act, where FDA does not have authority over substitution regulation (states) -labeling must accurately differentiate generic product from brand -mandatory regulation= must substitute a less expensive generic unless "dispense as written" -permissive regulation= pharmacist may choose to substitute if the prescriber issues Rx allowing substitution -some states require consumer consent or require cost saving

FDA inspections

-pharmacies exempt if they do not manufacture, prepare or compound drugs -FDA inspect pharmacies based on probable cause -FDA doesn't need a warrant

dietary supplements

-intended to supplement the diet, for ingestion and contains: vitamin, mineral, herb/botanical, amino acid -may include substance that increases the dietary intake of it or a concentrate, metabolite, constituent, extract or combination of ingredients -exempts DS from part C of drug definition -can only be removed by FDA if product is adulterated defined as presenting a significant or unreasonable risk of illness/injury under the conditions of use recommended in the labeling -manufactured under the current good manufacturing practices (cGMP)

federal anti-tampering act of 1982

-is a federal offense to tamper with consumer products -defined as improper interference with the product for the purpose of making objectionable or unauthorized changes -regulatory authority: FDA, FBI, department of agriculture -applies to OTC, cosmetics, drugs, devices -violation is misbranding/adulteration -label says "tamper evident"

HIPAA security requirements

-keep track of who accessed PHI, what they accessed and why -keep (un)successful logins/logouts, attempts to delete/modify logs, length of time on records

most common breaches

-keeping unsecured records -unencrypted data -hacking -loss/theft of devices -lack of employee training -gossiping/sharing PHI -employee dishonesty -improper disposal of records -unauthorized release of records -3rd party disclosure of PHI

misbranding

-label must not be false or misleading, including healthcare economic information -is the failure to provide info -label must include listing of active ingredients and quantity and listing of inactive ingredient in alpha order -must contain adequate directions for use and adequate warnings against use -label must have name/place of manufacturer, quantity of contents in terms of weight/measure/numerical count, adequate directions for use, adequate warnings against those pathological conditions or by children where it may be dangerous to health -item can be misbranded but not mislabeled, but mislabeling is always misbranding -misbranding if no PPI/MedGuide, no tamper evident packaging, dispensed in violation of poison prevention packaging act, does not bear imprint that allows identification where required for Rx/OTC products -if an Rx product is dispensed without written prescription of a practitioner

purple book

-lists biological products, including biosimilar/interchangeable, licensed by FDA under PHS act -includes date a product was licensed under and whether the FDA evaluated the biological product for reference product exclusivity

biologics patent protection

-manufacturers of innovator biologics granted 12 years exclusivity, with additional 6 months if in peds patients -biosimilar product applications may not be submitted for 4 years after approval of innovator -first interchangeable biosimilar is granted 1 year exclusivity

investigational drug

-may be used for treatment outside of phase 1-3 clinical trials -only for patients with serious or life threatening diseases for which no comparable or satisfactory alternative therapy is available -if the risk from the drug is no greater than the risk of disease in the situation

Rx label

-minimum info determined by Durham humphrey amendment -name/address of dispenser, serial #, date of prescription/filling, name of provider, name of patient, direction for use, cautionary statements

adulteration

-most provisions apply to manufacturers on both the facility and the product -drug is adulterated if its strength/quality/purity differ from compendia standards unless plainly stated on label or if it differs from the label itself -adulterated even if pure if its prepared/packed/held in conditions where it may have been contaminated -if it was exposed to a container that may have contaminated it (unsanitary) -if it was manufactured under conditions that do not conform to cGMP -if it contains any filthy/putrid/decomposed substances -if it contains an unapproved color additive -if its container is composed of a deleterious substance that may leach into the product -failure to manufacture product in a tamper evident container

minimum necessary requirement

-pharmacy can only disclose minimum amount of PHI necessary to accomplish the objective -limited data set= exclusion of direct patient identifiers -if can't comply with limited data set must justify its use

manufacturer package insert

-must accompany drug product -contain essential scientific and medical information needed for safe and effective use -cannot be false or misleading -highlight section in the beginning with most important information and includes all changes made within the last year -more prominence to important information and patient counseling info

patient package inserts (PPI)

-must be dispensed with potentially dangerous drugs -required to provide in drug package -info must be approved by FDA for informational use only -required for estrogen/progesterone products -must be dispensed with new Rx and refills

Rx to OTC switch

-must to be able to be labeled that patient can self diagnose, self treat, self manage, low potential for abuse/misuse, risk<benefit, supervision not warranted -switch done through manufacturer requests, citizen petition, FDA amends/add to OTC monograph

labels for dietary supplements

-name of DS -net quantity of contents -nutrition labelling -supplemental facts panel with ingredient list (active and inactive) -name/place of business of manufacturer -must state "dietary supplement" -doesn't need to state expiration date

RI Rx labels

-name of prescriber, name of patient, name/address of pharmacy, name of drug, quantity/strength, date of dispensing, prescription #, expiration date, full instruction for use

manufacturer label requirements

-name/address of manufacturer/packer/distributor -name of the drug product -quantity and proportion of each active ingredient -names of inactive ingredients in alphabetical order -statement of identity -quantity in terms of weight and strength -quantity of container (numerical count) -statement of recommended dose or reference package insert -Rx only if applicable -route of administration if not oral -lot/control # -type of container for pharmacy dispensing -expiration date -can put use on outer packaging if unit is too small, and RX must be on outside container

unqualified claims

-no disclaimer necessary if authorized by FDA by regulation

publicly conceived categories

-not FDA recognized -nutraceuticals -fortified or enhanced foods -probiotics

auto verification

-occurs when a medication is entered and released, bypassing the pharmacist verification step and is automatically verified in the EHR -computer prescriber order entry evaluates pre-specified medications based on their safety record for appropriate dosing, potential for drug interactions, patient allergies and adverse events -auto verification decreases pharmacist time for dispensing

off label indications

-off label prescribing and dispensing is legal -requires professional evaluation of the risk vs benefit

prohibited acts of section 301 of FDCA

-offenses violate section 301 regardless of person's intentions or knowledge -involve misbranding or adulteration -subject to strict liability = defendant is held liable for the offense or violation even where there is no criminal intent and where there may be no knowledge of the illegal act -applicable to pharmacies = receipt/delivery of an adulterated/misbranded drug, any act that causes drug to be counterfeit, alteration/mutilation of label

FDA's bad ad program

-outreach program designed to educate healthcare providers about their role in helping the agency to make sure that Rx drug advertising and promotion is truthful -administered by the office of prescription drug promotion (OPDP) in CDER -goal is to help raise awareness among healthcare providers about misleading Rx drug promotion and provide them with to report activity

customized patient med packs

-package may contain several solid oral dosage forms with directions that specifically indicate the day and time that the contents of each container are to be taken -label should contain all information on unit dose, serial # for med pack itself and separate identifying serial # for each of the prescription orders for each of the drug products contained in it

what is a drug (section 201 of FDCA)

-part A: articles recognized in the US pharmacopeia/national formulary (USP/NF) -part B: articles intended for use in diagnosis, cure, mitigation, treatment or prevention of disease -part C: articles other than food intended to affect the structure or function of the body -definition is intentionally broad to include almost anything with an intended therapeutic purpose or purpose of altering the structure or function of body, gives FDA more authority -if a drug is recognized in USP/NF/HPUS the drug must meet all standards of the compendia or it will be misbranded or adulterated -homeopathic pharmacopeia of US (HPUS) publishes standards for homeopathy products -USP/NF published by US pharmacopeial convention, is private but works with FDA and sets uniform standards

biologics price competition and innovation act of 2009 (BCPIA)

-part of ACA with intent to reduce cost of specialty products -created abbreviated licensure pathway for biologics shown to be biosimilar

administrative requirements for breach prevention

-perform/document risk assessments -develop/document policies / procedures regarding PHI -educate/train workforce on the importance of timely reporting of breach incidents and consequences in failing to do so -enact methods to monitor compliance -enforce sanctions for failure to comply -permit individuals to file complaints concerning policies/procedures -refrain from intimidating/retaliatory acts against personnel filing complaints -maintain log of breaches with burden of proof demonstrating that either all notifications were made or that the use/disclose of unsecured PHI did not constitute a breach -must maintain records for 6 years -make records available to HHS secretary upon request

right to try act

-permits eligible patients to have access to eligible investigational drugs -eligible patients= diagnosed with life threatening disease, has exhausted approved treatment options and is unable to participate in the clinical trial with the investigational drug, and has provided written consent -investigational drug= a phase 1 clinical trial has been completed, not approved by FDA, whose development/production is ongoing, has not been discontinued or placed on clinical hold by FDA

dietary supplement health and education act of 1994 (DSHEA)

-regulate supplement as a special category of food, not a drug -dietary supplements (DS) not approved by FDA but subject to adulteration and misbranding -must comply with cGMP -FTC (federal trade commission) regulates advertising -manufacturer responsible for determining if product is safe and accurately labeled -must file a petition of a new DS, require premarket notification but not evaluation for safety and efficacy -FDA may stop DS if not enough information is received in advance

notice provision

-pharmacy must provide notice of privacy practices -contains uses, disclosures, obligation to notify breach, statement on disclosure that require authorization, available upon request, how/where to complain -provided on first day of service -notice must be posted in prominent and visible location, and on pharmacy website -pharmacy must make good faith effort to distribute notice to patients and obtain written signed acknowledgment of receipt on first day of treatment , only required once for each patient -cannot refuse treatment if patient refuses to sign, must keep record of refusal

medicare catastrophic coverage act

-pre OBRA 90 -introduce DUR which became cornerstone of OBRA 90 to expand Medicare benefits to include outpatient drugs and limit enrollees' copayments for covered services -first bill to significantly expand Medicare benefits -was repealed

hormonal contraceptives

-prescribing of HC is being expanded to pharmacists -approved in CA, CO, HI, NH, OR, UT, MD, NM, TN, WA, WV, DC -to ensure timeliness in obtaining contraceptives CO, HI, OR, TN prohibit pharmacists from requiring the scheduling of an appointment and dispense as soon as possible

biosimilars

-product and reference utilize same mechanism of action for proposed condition of use -same condition of use -route of administration, dosage form and strength of the product and the reference are the same -the facility in which the product is manufactured meets standards designed to assure that the biologic is safe/pure/potent -interchangeable= expected to produce the same clinical result as the reference product in any given patient -prevent substitution of biosimilar/interchangeable product by writing "dispense as written" -some states require cost saving for substitution

health care finance administration (HCFA)

-promulgated regulations that expand the pharmacist's function in long term care to optimize drug therapy

poison prevention packaging act

-protect children from accidental poisonings due to household substances from OTC/RX -manufactured such that 80% of children <5 cannot open them -administered by consumer product safety commission -container may not be reused unless glass/threaded plastic and new safety closure is used -patients can make written request to not have this kind of container -manufacturer may market one size in noncompliant package to assist elderly/handicapped explicitly stating "package not child resistant"

patient's rights

-receive accounting of certain disclosures -view and obtain copies of their records -request amendment of medical records -request restriction on the use or sharing of their info, just because they are the insurance carrier doesn't mean they can have the info -receive notice of privacy -request to have medical records sent to another designate individual -request medical record copies -charge reasonable cost for producing records

drug supply chain security act of 2013 - title 2

-refers to manufacturing process of a drug with bulk ingredients to the distribution process incorporating wholesalers/repackagers/pharmacies, not the patient -prevent drug diversion -stop introduction of counterfeit drugs -adulteration and misbranded drugs -started with prescription drug marketing act= wholesalers licensed, ban samples, limit resale by hospitals, legitimate returns through wholesalers -granted FDA authority to require wholesalers that are not manufacturers and not authorized by manufacturer of the drug to maintain records that identify each prior sale/purchase/trade of drug -requires trading partners have systems in place to quarantine, investigate and notify FDA of suspect products -requires full system electronic, interoperable track and trace systems

pregnancy and lactation labeling rule (PLLR)

-removes pregnancy letter categories (A,B,C,D,X) -pregnancy= info relevant to use of drug during pregnancy, including dosing and risk to fetus -lactation= info for use during breastfeeding including amount of drug in breastmilk and potential effects on child -female/male reproductive potential (new)= info on pregnancy testing, contraception and infertility as related to the drug -labeling of OTC meds not affected by this new rule -must include subheadings on risk summary, clinical considerations and data -pregnancy label includes labor and delivery -lactation label includes nursing mothers

risk evaluation and mitigation strategy (REMS)

-required as a condition for approval of NDA or post-market when the FDA believes it necessary to ensure benefits outweigh risk -FDA can require a variety of procedures ranging from MedGuides to limiting the drug to specified settings for dispensing -include MedGuides, elements to ensure safe use, registry, limited distribution

MedGuide

-required for products that could help prevent serious adverse events, for products that has serious risks that could affect patient's decision to use or for patient adherence to directions that is crucial to effectiveness -manufacturers set criteria and receive FDA approval -given with new Rx and refills -(ex) accutane, antidepressants, avonex, advair, lindane, nolvadex, ziagen, etc

components of pro-DUR

-requires active resolution of problems through comprehensive review of patient's prescription at point of dispensing -components = screening, counseling, documentation -screening= pharmacist must detect potential drug use problems before Rx is dispensed -counseling= on name drug, intended use, expected action, route, dosage, dosage form, administration, severe side effects, self monitoring techniques, proper storage, potential drug interactions, refill info, what to do for missed dose -documentation= require pharmacy to obtain/record/maintain record of specified info about patient -profiling= must require in case of Medicaid beneficiaries the pharmacist make a reasonable effort to obtain/record/maintain patient profiles containing name/address/phone #/ DOB/gender/individual history/disease state/list of meds/pharmacist comments to individual drug therapy -must require offer to counsel, which may be made by ancillary personnel/pharmacist, and patient has right to waive

rebates

-requires manufacturers to provide drug products to Medicaid program at their best price -best price= lowest price at which they sell the product to any customer -Medicaid preferred drug list

dietary supplement and nonprescription drug consumer protection act of 2006

-requires manufacturers to report serious adverse events from OTC/DS -must submit within 15 days by mail/fax -must submit any subsequent medical information received within 1 year of the initial reported event -labels must contain supplier/distributor/packer's contact info/address/number if OTC approved under NDA/ANDA -must maintain records for 6 years

health insurance portability and accountability act (HIPAA)

-sections of privacy, security, breach -security= risk assessment, remediation, penetration testing, prevention, detection

administrative safeguards for HIPAA

-security management -assigned security personnel -information access management -workforce training and management -evaluation

prescription drug marketing act (PDMA)

-states require to license wholesale distributors of Rx drugs -bans reimportation of Rx drugs except by manufacturer or emergency use -bans sale/trade/purchase of Rx drug samples -prohibits resale of Rx drugs purchased by hospitals or health care facilities -bans trafficking in or counterfeit of drug coupons

special legal food categories

-supplying a special dietary need (infant formula, artificial sweeteners, caloric supplements) -medical foods (under supervision of physician, for specific management of a disease)

alcohol (190 proof ethyl alcohol)

-tax free -available to hospitals for medicinal, mechanical and scientific purposes and in treatment of patients

behind the counter meds

-third class of meds -nonprescription under condition of safe use -sold only by pharmacists - (ex) schedule V drugs or Plan B

breach

-treated as discovered on the first day on which such breach is known to the covered entity or by exercising reasonable diligence would have been known to the covered entity -must provide notification to affected individuals within 60 days of breach discovery -covered entity must maintain log and submit info annually to HHS no later than 60 days after end of each calendar year -if <500 affected individuals written notice by mail -if >500 affected individuals written notice by mail and notify HHS immediately and post on entity's website -entities that secure PHI according to government NIST standards are exempt from breach notification

PHI breach

-unauthorized acquisition, access, use or disclosure of unsecured protected health info, which compromises the security/privacy of such info -unsecure PHI = PHI that is not rendered unstable, unreadable or indecipherable to unauthorized individuals through encryption technologies or methods of physical destruction -disclosure must pose a significant risk of financial, reputational, or other harm to individual (no harm=no breach)

encryption

-use of algorithmic process to transfrom data into a form in which there is a low probability of assigning meaning without use of a confidential process/key

unit dose labeling

-used in hospitals/nursing homes -medication dispensed in a package that is ready to directly administer -label should contain generic/trade name, quantity of active drug, # dosage units, name/address of manufacturer, repackager's lot #, expiration date, storage requirements, controlled drug symbol if applicable, warning of habit forming if appropriate -all medications supplied to a hospital must be bar coded -expiration date should not exceed 25% of the time remaining between date of repackaging and original expiration date OR 12 months dating from the date drug was repackaged

orange book

-uses 2 letter rating system -rate drugs with therapeutic equivalence -pharmacists myst comply with state law when substituting B rated products and use professional judgment

biologics

-virus, therapeutic serum, toxin, antitoxin, vaccine, blood component, allergenic product, analogous product applicable tp the prevention, treatment or cure of a disease -need premarket approval and oversight -large complex molecules dependent on living systems so their manufacturing process is hard to replicate -important to control light, temperature, moisture and systems of manufacturing -they are defined by their manufacturing process -licensed under PHS act for the reference drug -regulated by CDER: monoclonal antibodies, proteins, immunomodulators, growth factors -biological license application (BLA) = must meet product and facility standards/inspection -biosimilar may be approved for indication without direct studies of biosimilar in that indication (extrapolation) -proper name = core name (shared with innovator and biosimilars) + random 4 letter suffix -also now include insulin and human growth hormone

MedWatch

-voluntary safety info and adverse event reporting program -goal to get safety info out to patients -moral obligation -MedWatch alerts= FDA enters info into database and broadcasts new safely info -pharmacies required to provide # to patients for reporting -reporting statement provided on sticker attached to container/package, preprinted vial cap, separate sheet, in info materials distributed, in MedGuide

de-identified health information

-when specific info has been removed to ensure that the info cannot be linked to the patient or be re-identified -once PHI is de-identified it is no longer covered under HIPAA

emergency prescription refill

-when you dispense a prescribed drug without practitioner authorization, if in the pharmacist's professional judgment, the prescription drug is essential to the maintenance of the patient's life or to the continuation of therapy -necessary during normal day to day operations when contact with the authorizing practitioner cannot be made -in RI: may dispense a one time emergency refill up to a 72 hour supply of the medication (as long as its not a schedule 2 drug)

penalties of breach

-willful neglect violations corrected within 30 days can result in 10000 fine with annual cap of 250000 -willful neglect not corrected within 30 days can be up to 50000 per violation and annual cal 1500000 -intentional violations/fraud can result in prison time -covered entity is responsible for violation even if it claims the violation is unknown, unless it is corrected within 30 days of discovery

disclaimer

sorry if these are wrong lol