PHP316 Pharmacy Law Final Exam
What is the BUD for a non-aqueous formulation?
no later than time remaining until earliest expiration date of an active pharmaceutical ingredient, or 6 months, whichever is earlier
What is the limit of refilling C-V Rxs?
no limit federally
What is the federal sale limit for nonprescription C-V sales (provided states aren't stricter)?
no more than 8oz (240mL) of an opium-containing product or 4-oz (120mL) of any other CS may be dispensed to same purchaser within a 48-hour period
Do individual pharmacists have to be registered with the DEA?
no, as long as their pharmacy is registered (or employer is registered) and they AREN'T in collaborative practice agreements
Does patient preference to not have safety caps have to be in writing?
no, but it should be
Can C-I drugs be manufacturered, prescribed, or dispensed?
no, except as approved by DEA for investigational purposes
A CE may exempt what parts of its operation from HIPAA requirements?
non-healthcare (e.g. walmart lawncare section does not have to comply with HIPAA)
What are FDA guidance documents?
non-legally binding/non-enforceable documents that explain compliance and should be followed
What kind of pharmacist error is a breach of duty as a matter of law?
nonjudgemental error in filling (misfilling)
Without the prescriber's permission, either express or tacit, substitution is _____ _____ in most states, even if the consumer wishes a substitute.
not allowed
If lost forms are found, what must a purchaser do?
notify DEA immediately
What must be noted on each 222?
number of last line completed
What did the Patient Protection and Affordable Care Act (2010) do?
obamacare
What is "duty" for pharmacists?
objective reasonable standard requiring a degree of care that a reasonable, prudent pharmacist would use under similar circumstances
If a manufacturer obtains NDA approval for an unapproved marketed drug, all marketed drugs in the same class must do what?
obtain NDA approval within one year
Is treatment of pain a legitimate medical purpose?
of freaking course
What specific office under the DHHS enforces HIPAA?
office for civil rights (OCR)
When calling somebody to the counter to pick up their Rx, what is it ok to say and what is it not ok to say?
ok to say patient name, not ok to say name of drug or anything out
Newly scheduled drugs must be inventoried when?
on date of scheduling
When must the complete inventory of CS be taken upon transfer of a business?
on date of transfer (w/222)
When is a breach treated as "discovered"?
on first day on which such breach is known to the CE
On what basis can the FDA remove a DS from market?
on the basis of public safety if it can prove the product is adulterated
How are pharmacist decisions requiring professional judgement judged?
on the basis of reasonableness
When must the "notice of privacy provisions" be provided to the patient?
on the day the pharmacy first provides service
How many times must patients acknowledge a pharmacy's "notice of privacy practices"?
once
How does the Ryan Haight Act law define a valid Rx?
one that has been issued for a legitimate medical purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient
What did the Riff decision do for pharmacist's?
opened the door to expanded legal responsibility for pharmacist's but not widely (foundational case)
What is stare decisis?
opinions are binding on lower courts in the same jurisdiction and serve as precedent
What is a CS prescription?
order for medication dispensed to or for an ultimate user
What are some examples of class III medical devices?
pacemakers, contacts, and heart valve
What is "accompanying" as defined by the courts?
part of an integrated distribution program with a common origin and destination that explains the drug
What are pharmacists allowed to do in ambulatory settings in regards to C-II Rxs?
partial fill if "unable to supply" full quantity
It's important to differentiate _____ ______ from _____.
partial fills; refills
Compounding involves _____ _____ medication.
patient specific
PHI may be provided to who provided professional judgement is applied?
patient's agent (e.g. family member)
What are HIPAA's privacy requirements concerned with?
patient's right and how/when the patient's info may be used
Most PMPs allow practitioners to request what?
patient-specific information
What is "pure" comparative negligence?
permits recovery against a defendant no matter how much at fault the plaintiff was
Why is the FDA definition of a drug intentionally broad?
to include almost anything with an intended therapeutic purpose or purpose of altering structure / function of the body so that the FDA can regulate it
What is the purpose of punitive damages?
to punish or make an example of the defendant
What is the purpose of ADS?
to reduce stock of excess CS in LTCF
What must be marked on a Rx for partial filling to a LTCF or terminally ill patients (up to 60 days from date of issuance)?
"terminally ill or hospice patient"
Negligent recordkeeping can result in fines up to ____ per offense.
$10,000
Pharmacies must do what in regards to recordkeeping for CS electronic transmission Rxs?
back up daily and keep records for 2 years
According to the MPPA, sellers can now capture information by ____ ____ reader.
bar code
What are two frequently used affirmative defenses?
contributory negligence and statute of limitations
All applicants and registrants must provide effective ____ and ____ to guard against theft and diversion.
controls; procedures
Whose responsibility is it to make sure that a CS Rx complies with all requirements?
corresponding responsibility of pharmacist and prescriber
What do manufacturer coincidental activities include?
distributing its own products, chemical analysis, and preclinical research
There exists a controversy whether delivery to a patient's prescriber is _____ or _____.
distributing; dispensing
Wholesalers must register as _____.
distributors
What is strict liability?
do not need intent to be liable
What does an rating that starts with A mean?
drug considered therapeutically equivalent to reference drug product
For hospice patients receiving NARCOTIC C-II drugs, what kind of C-II Rx serves as the original?
faxed
Actual damages can be a result of what secondary to negligence?
loss of income, medical expenses, pain and suffering
Is a facially valid Rx always a valid Rx?
no (must have legitimate physician-patient relationship)
What is the BUD for water-containing oral formulations?
no later than 14 days at controlled cold temp
What is the BUD for water-containing topical/dermal liquid, mucosal liquid, or semisolid?
no later than 30 days
What must the original paper Rx have written on it for central filling Rxs?
"CENTRAL FILL"
What must an inventory record include?
"a complete and accurate record of all CS on hand on the date the inventory is taken"
What is the definition of "minimum necessary"?
"limited data set", meaning the exclusion of direct patient identifiers
What must a pharmacy provide a notice of?
"notice of privacy practices"
Treatment for opioid addiction under DATA must be by whom?
"qualifying physician" (doesn't include NP or PA)
What must an herb have to get a monograph?
-FDA approved use OR -USP DI panel recognized use
What are the requirements for HD set out by USP <800>?
-HD storage and prep in areas separate from non-HDs -administer HD with closed-system transfer devices -sterile HD need CII BSCs or CACls for PEC -non-sterile HD need externally vented C1 BSC and containment ventilated enclosures (CVEs) -must occur in negative pressure environment -negative pressure rooms for HD compounding cannot be used for non-HD compounding
List 11 NTIs.
-carbamazepine -cyclosporine -digoxin -ethosuximide -levothyroxine -lithium -phenytoin -procainamide -tacrolimus -theophylline -warfarin
What are special dietary foods?
-those supplying a special dietary need that exists by reason of a physical, physiological, pathological, or other, condition -infant formulas, artificial sweeteners, caloric supplements
What is misbranding?
-when labeling is false/misleading, including healthcare economic information -if drug imitates another drug
What are some controversies involving generic drug labeling?
-whether FDA can approve an ANDA for a generic when lableling will not include one or more of indications contained on the innovator drug product's labeling -whether generic drug manufacturers should be required to change labeling to reflect a known adverse effect
What is consumer medication information (CMI)?
-written patient information about prescription -not mandated, but recommended by FDA guidance
What is the strength limit of difenoxin and atropine in C-V drugs?
.5mg/dosage unit and not less than 25mg atropine/dosage unit
No more than ____ days medication can be administered to one patient whom a doctor is helping with withdrawal at one time.
1
How many years of exclusivity does a biologic reference product get?
12
What are two titles under the Drug Quality and Security Act (2013)?
1. Compounding Quality Act 2. Drug Supply Chain Security Act
What are three specific HIPAA rules enforced by the OCR?
1. HIPAA privacy rule 2. HIPAA security rule 3. patient safety rule
What two acts allow foods to contain health claims if approved by FDA regulation or "significant scientific agreement"?
1. Nutritional Labeling & Education Act (1990) 2. FDAMA
A qualifying physician may not treat more than ____ patients.
100 (starts at max of 30 for first year and then increases to 100 thereafter)
HIPAA penalties can range from ____ per violation for ______ violations up to ______ per violation for ____ neglect violations
100; unintentional; 50000; wilfull
According to the CMEA, no consumer may purchase more than ______ of ephedrine, PSE, or PPA base within a ____ day period or _____ within a ____ day period by mail order.
9g; 30; 7.5g; 30
A generic company filing a successful paragraph IV ANDA enjoys a ______-day exclusivity period.
180
When did congress first authorize opioid treatment programs (OTPs)?
1974
Knowingly or intentionally possessing a CS other than by a valid Rx could result in up to ____ year in prison or a fine of up to _____.
1; $1,000
What US code establishes penalties for drug traffickers?
841
What is the FDA definition of a drug, as define by the FDCA?
A: articles recognized in USP-NF or HPUS B: articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease C: articles other than food intended to affect the structure or function of the body
What is the 2 letter rating system used by the Orange Book?
A____ and B____
What act is HITECH a part of?
American Recovery and Reinvestment Act
If mixing CIII-CV records with regular Rx drugs, what must be on CS records?
C
What does the Ryan Haight Act apply to, but what is important to remember in regards to this?
CS Rxs; most states consider any Rx not dispensed pursuant to a legitimate physician-patient relationship as invalid
What does form 41 not apply to?
CS collected from ultimate users or LTCFs
What are the US postal laws regarding CS?
CS may be mailed, provided they met packaging standards established by the US postal service
The Supreme Court has held that marijuana buying cooperatives violate what law?
CSA
What is the DEAs authority concerning CS inspections?
DEA can inspect any place where CS records are kept/persons are registered
Any modifications of registrations must be approved by who?
DEA
What may pharmacists obtain in many states that allow collaborative practice agreements?
DEA registration
Why do some stores run out of CIIs (like amphetamine) by the end of the year?
DEA sets annual manufacturing and procurement quotas for C-I and C-II
The FDA is housed under what department?
DHHS
What is another name for the Kefauver Harris Amendment (1962)?
Drug Efficacy Amendment
What statutorily created the ANDA for all generic drugs?
Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman)
If the computerized system suffers downtime, what must pharmacies have?
auxiliary system for documenting refills
Who can recall devices?
FDA
Who has primary enforcement for administering the FDCA?
FDA
Who is the first NDC segment assigned by?
FDA
Biologics are under the authority of what organization?
FDA (via FDCA)
The Dietary Supplement Health & Education Act only permits DS manufacturers to make health claims if...?
FDA approves claim by regulation or by significant scientific agreement test
How does a biosimilar become an interchangeable product?
FDA determination
Why did the FDA remove Ephedra and Ephedrine Alkaloid?
FDA received long-term adverse event reports
What did the Rx Depot case reveal?
FDA will enforce the "no importation" law against businesses
Name some federal agencies that deal with pharmacy.
FDA, CDC, NIH, EPA, DEA, OIG
Some hospital pharmacies are not under the jurisdiction of the _____, but instead under _____ jurisdiction.
FDA; state
What are primary engineering controls (PEC)?
HEPA filter and unidirectional airflow
What is another name for the Drug Price Competition and Patent Term Restoration Act?
Hatch-Waxman
Purchasers of ephedrine, PSE, or PPA base must show ____.
ID
What are the only authorized drugs used for treatment of opioid addiction?
LAAM, methadone, buprenorphine SL (subutex), buprenorphine-naloxone (suboxone)
What act made is so that device manufacturers have to follow cGMPs?
Medical Device Amendments
_____ enabled states to obtain federal grant support for PMP programs?
NASPER
May the registrant correct/change any info or errors on 222s?
NO
When is the delegation of prescriptive authority to an IPs agent/employee legal?
ONLY IF agent/employee also has prescriptive authority
What act generally prevents reimportation of Rx drugs?
PDMA
What is "unsecured" PHI?
PHI that is not rendered unusable, unreadable, or indecipherable to unauthorized individuals through encryption technologies or methods of physical destruction approved by secretary of DHHS
Biologics are licensed under what act?
PHSA
What makes somebody a PR?
POA for a patient
What is required to prove actual cause?
expert witnesses
Discharge medication orders may only be dispensed pursuant to ____.
Rx
Oral C-II Rx must be immediately reduced to writing in what steps?
Rx has to have necessary info --> verify physician if unknown to pharmacist --> get hard copy within 7 days --> has to have "authorization for emergency dispensing" written on it --> hard copy must be post marked within 7 day period --> upon receipt of hard copy must attach oral Rx --> if prescriber fails to deliver hard copy Rx, DEA must be notified or else the prescription is void
What are exemptions from registration with the DEA?
agents or employees of registrants, common carriers, ultimate users, prescribers/dispensers in the service of the US government, and law enforcement officers
Where are guidelines for non-sterile compounding located?
USP <795>
What documents specify beyond use dates (BUD)?
USP monographs and standard recipes
What publication has monographs for some botanical herbs?
USP/NF
What is the United States Pharmacopeia / National Formulary (USP/NF)?
USPC publication that sets out uniform standards and drug monographs
Are drug tolerance and physical dependence as a consequence of opioid use normal and natural?
YES
What type of clinic creates a special concern for pharmacists?
alleged pain clinics
What are unqualified health claims?
can be put on without disclaimer because it met the significant scientific agreement test
The lower the ISO number, the _____ larger-sized pariculate matter per cubic meter is allowed.
fewer
Prescription bulk drug labels are meant for whom?
pharmacists
What causes will sever the defendant's responsibility?
unforeseeable superseding causes
What does HIPAA attempt to do/target?
•standardizes transaction and code sets (connectivity of all datasets) •national provider identities (standard national ID) •security of health info (confidentiality, integrity, and availability) •privacy of health info
Refusal of a AIW inspection carries a fine of up to _____ and up to ____ year imprisonment, or both.
$25,000, 1
Form 222 violations are subject to fines of up to ____ and up to ____ years in prison.
$30,000; 4
Which act is the nucleus of today's drug laws?
(federal) FDCA
What must be included on new patient package inserts (PPI)?
-"highlights" section at beginning -table of contents -"full prescribing information" organized to give prominence to most important information -"patient counseling information" section
What is a buffer room?
-ISO Class 7 or cleaner area where the primary engineering control is physically located -activities that occur in this area include the preparation and staging of components and supplies used when compounding CSP
What does the compounding record include but is not limited to?
-actual lot numbers of ingredients used in prep -expiration dates of ingredients -name of person who prepared it and date prepared -beyond use date
What are the required elements in Rx drug labeling?
-adequate information for use -name/address of manufacturer -name of drug -ingredient information, quantity, proportion -inactive ingredients -statement of generic/proprietary name identity -recommended dosage -"Rx only" -route of administration, if not for oral use -lot/control number -statement directed to pharmacist specifying type of container to be used in dispensing drug -expiration date unless exempted
USP Chapter <800> applies to who?
-all healthcare workers who handle HD -all entities that store, prepare, transport, or administer HD
What are collaborative practice agreements?
-arrangement between physician/practice and a pharmacist saying that a pharmacist can initiate/adjust patient's drug therapy -legal in most states
What did the Generic Drug Enforcement Act (1992) do?
-banned individuals/firms from participating in drug approval process if convicted of related felonies -imposed severe civil penalties for any false statements, bribes, failure to disclose material facts, and other offenses
What are some controversies for generics and healthcare practitioners?
-bioequivalence of generics to parent and each other (vary +/- 20%) -whether a drug without market exclusivity for a particular indication could be prescribed and dispensed for that indication
What are the requirements for a 503B facility?
-complies with cGMP -permits FDA inspection according to risk based schedule -prohibit the sale or transfer of compounded products by an entity other than the outsourcing facility -compliance with the DQSA labeling requirements -reporting of ADR and compounding information
Where is tax paid alcohol used?
-compounding in community pharmacies -obtainable from outlets that sell liquor at retail
What does it mean when a drug is adulterated?
-contains in whole or in part any filthy, putrid, or decomposed substances -has been prepared, packaged, or held under unsanitary conditions where it may have been contaminated -manufactured under conditions that do not meet standard cGMPs -contains an unapproved color additive -contains a drug recognized in official compendia, but its strength, purity, or quality is lower than the official standards. -container is composed of a deleterious substance that may enter (leach) into the product container.
How does one clean/disinfect sterile compounding facilities?
-dedicated mops, buckets, and disinfecting agents -cleaning should be done from cleanest to dirtiest areas -area to area, within area ceiling-->wall-->floor, within PEC in direction of airflow source --> exit -daily cleaning of work surfaces, counters, floor, storage and shelving, and ceiling
What did the Dietary Supplement Health and Education Act (1994) do?
-defined dietary supplements -forced FDA to regulate dietary supplements more as food than drugs
What are the principles of interpretation when the courts must interpret statutory law?
-determining legislative intent -ordinary meaning of words -due process rights of the individual
What did the Medical Device Amendments (1976) do?
-established criteria for classifying devices into one of three categories -required classification of devices according to function, premarket approval of certain devices, performance standards, conformance with cGMP regulations, and adherence to record/reporting requirements
What did the Durham-Humphrey Act (1951) do?
-establishes criteria for distinguishing Rx and OTC drugs -legally establishes refills and oral prescriptions -established that labels of Rx drugs need not contain "adequate directions for use" as long as they contain the legend, "caution: federal law prohibits dispensing without a prescription," and a pharmacist's label -required expiration or BUD on dispensed Rx label pursuant to state laws
What are medical foods?
-foods formulated for oral or enteral use under supervision of a physician and that are intended for specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation -provide nutritional requirements impossible for patient to meet through normal diet
Describe a low risk CSP.
-for facilities that compound sterile products without a buffer ISO Class 7 area -non-HD substances -administration must be started no later than 12 hours from preparation or as recommended by manufacturer
What did the Safe Medical Devices Act (1990) do?
-gave FDA additional authority related to post-marketing requirements and premarket notification/approval for devices -expedited premarket device approval process
What are the requirements for class II medical devices?
-general controls are insufficient alone to ensure safety/efficacy -must meet specific performance standards established by FDA before marketing is permitted
What does it mean when products are therapeutically equivalent?
-generic is pharmaceutically equivalent and bioequivalent -generic is pharmaceutically equivalent and expected to have same clinical effect and safety
What does simple non-sterile compounding involve?
-have USP monograph or appear in peer reviewed journals with specification of all components, procedures, equipment, and stability data -reconstituting or manipulating commercial products with addition of more ingredients
What did FDAMA (1997) accomplish?
-increased FDA public accountability -creates fast-track process for drugs intended for serious/life-threatening diseases -mandated priority review for breakthrough technologies in medical devices -established 503a facilities (clarifies compounding laws), and stated that compounded drugs are NOT new drugs -replaced "caution: federal law....without a prescription" statement with "Rx only" -warning of "may be habit forming" eliminated from drug labels -expands manufacturer rights to disseminate unlabeled use information -expands FDA authority over OTC drugs and establishes ingredient-labeling requirements for inactive ingredients
What are some ways the FDA can enforce its regulations?
-injunction -criminal action -seizure of products -warning letters -fines
What are some controversial innovator drug manufacturer practices under the Drug Price Competition and Patent Term Restoration Act (1984)?
-innovator company producing "authorized generics" -30-month stay in ANDA approval awarded when patent holder sues for patent infringement against a paragraph IV ANDA -innovator manufacturer filing of secondary patents, often for product changes and attempt to shift market share to new product (product hopping) -exclusion payments (pay-for-delay agreements)
What are some available PEC?
-laminar airflow workbench -compounding aseptic isolator for non-HD materials -biological safety cabinet (BSC) class II
What are the requirements for class I medical devices?
-least potential harm to users -general controls: manufacturers register facility and list their products with FDA, provide premarket notification, maintain records/reports, and adhere to cGMP
What does the Homeland Security Act permit?
-limits personal importation from Canada for people transporting drugs on their person in a quantity not to exceed a 90-day supply -no controls or biologicals
What must be included in drug labeling?
-list of active ingredients -quantity and listing of inactive ingredients in alpha order -"adequate directions for use" and "adequate warnings against use" by children and other for whom use might be dangerous (OTC drug) -if drug cannot be labeled with "adequate directions for use", must contain "adequate information for use" (Rx drug)
What did FDAAA (2007) do?
-mandated development of "track and trace" (pedigree) standards and SNIs (standardized numerical identifier) for ALL "trading partners" (not just secondary wholesalers now) -allowed FDA broader use of fees from PDUFU -established that FDA could mandate labeling changes related to safety post-market, require clinical trial data reporting/registries, require post-market clinical studies -require companies to implement REMS -require pharmacists to provide patients with medwatch number and statement about reporting side effects -gave FDA authority to issue recalls (but not to drugs)
What did the Nutrition Labeling & Education Act (1990) do?
-mandated nutrition labeling on food products -authorized health claims on product labeling as long as they are made in compliance with FDA regulations
Where is tax free alcohol used (190 proof ethyl alcohol)?
-medicinal, mechanical, scientific, and treatment purposes for inpatients in hospitals -charity clinic may use for outpatients if they do not charge
Describe medium risk CSPs.
-multiple doses of sterile products combined or pooled to administer to multiple patients or one patient on multiple occasions -more than 3 commercially available sterile products are used for compound -More complex compounding process (parenteral nutrition)
What were some concessions given to innovator drug manufacturers in the PTRA?
-patent-term extensions (longer than initial 20 years started at the beginning of drug development) -market exclusivity for an innovator manufacturer that develops a new chemical entity or new use for a previously approved drug (5 years) -generic manufacturer must make patent certification relevant to reference drug
What is described in an herb monograph?
-portion of plant used -botanical characteristics -appropriate assay for procedure for ingredients
What are several reasons for the vast number of marketed unapproved drugs?
-pre-1938 drugs -FDA has yet to remove drugs lacking efficacy after DESI -lax FDA policies on generics approvals prior to 1984 -unscrupulous manufacturers
Describe high risk CSPs.
-prepared from non-sterile ingredients -compounded using non-sterile device prior to terminal sterilization -contain non-sterile water that are stored for more than 6 hours before sterilization -exposed to conditions worse than ISO class 5 air quality for longer than 1 hour -containing bulk ingredients whose chemical purity and content strength are not verified by labeling and documentation from suppliers or by direct determination -contain or are compounded from sterile contents commercially manufactured products or CSPs without antimicrobial preservatives -prepared by compounding personnel who are improperly garbed or gloved -pre‐sterilization procedures for high risk CSPs such as weighing and mixing shall be completed in no worse than ISO Class 8 environment -must be terminally sterilized before administration to patients
What are exemptions to the Poison Prevention Packaging Act?
-prescriber requests (one medication) -patient requests (blanket request for all meds) -institutionalized patients -certain drug products such as SL nitroglycerin and SL/chewable isosorbide dinitrate -manufacturer may market one size with noncompliant package with an appropriate statement
What are implications of the Dietary Supplement Health and Education Act for pharmacists?
-product selection -education of patients as opposed to promotion of products -restrictions regarding display of DS publications
What did the Virginia decision not bar states from doing?
-prohibiting false/misleading advertising -advertising professional superiority -from making it illegal for pharmacies to offer discounts or rebates
What is the rationale for federal drug regulation?
-protection of public against adulterated and misbranded drug products -necessity of balanced direct regulation with indirect regulation
What did the FDA Safety and Innovation Act (2012) do?
-reauthorized PDUFA -added new user fees for generics and biosimilars -provisions reducing drug counterfeiting -allowed FDA to inspect foreign drug manufacturers -mandated that FDA issue guidance documents on prescription drug promotion through social media
What are some prohibited acts as they relate to pharmacists?
-receipt or subsequent delivery of an adulterated/misbranded drug -doing of any act which causes a drug to be counterfeit -alternation, mutilation, etc. of the labeling
What did the Compounding Quality Act (2013) do?
-reinstated 503A and thus stripped FDA of new drug authority over compounded drugs -clarified/strengthened FDA oversight over pharmacies engaged in large-scale compounding of sterile products to other licensed entities -entities compounding sterile products may voluntarily register with FDA as "outsourcing facilities" + comply with cGMP and have their products exempt from misbranding provisions (503b facilities)
How do administrative agencies carry out judicial function?
-render decisions pursuant to "hearings" resembling court proceedings -these decisions are subject to judicial review
What can the FDA do if it determines that a device presents unreasonable risk of substantial harm?
-require firms to notify healthcare professionals -recall product -require manufacturer to repair/replace/ refund the purchase price of devices
What does complex non-sterile compounding involve?
-require special training, equipment, facilities, or procedures -includes transdermal or modified release preparations
What are medguides?
-required for drugs FDA has determined as posing "serious and significant concerns" -required for new and refill prescriptions -required for outpatients not under direct supervision of healthcare professional with some exceptions -every new medguide approved since 2007 has been in conjunction with a REMS
What did the Drug Supply Chain Security Act (2013) do?
-required manufacturer serialization of drugs by 2017 -required by 2015 that manufacturers provide transaction info to purchasers, who in turn must provide transaction data to subsequent purchasers (track and trace) -established timeline for trading partners toward implementation of electronic track and trace system (nov 2023) -established uniform national licensing standards for wholesalers and 3PL providers
What did the Prescription Drug Marketing Act (1987) do?
-required state licensing of wholesaler in the state they are located -instated pedigree requirement for secondary wholesalers -banned reimportation of Rx drugs except by manufacturer -banned sale, trade, or purchase of Rx drug samples -prevented community pharmacies from receiving drug samples -prohibited resale of Rx drugs purchased by hospitals or healthcare facilities (unless pursuant to a prescription)
What did the Kefauver-Harris Amendment (1962) do?
-required that new drugs be proved safe AND effective -efficacy requirements made retroactive to all drugs marketed between 1938-1962 -transferred jurisdiction of prescription advertising from FTC to FDA -established cGMP requirements -added more extensive controls for clinical investigations by requiring informed consent of research subjects and reporting of adverse drug reactions
Describe immediate use CSPs.
-reserved for emergent use or situations in which adhering to low‐risk compounding procedures would add additional risk due to delays in patient care -do not need to be compounded in ISO class 5 as long as aseptic technique is followed -no batching or storage -no HD -no more than one hour elapses from time compounding to commencement of administration
What does moderate non-sterile compounding involve?
-special calculations or procedures required to measure quantities -stability data may not be available
What must be submitted in an ANDA?
-sponsor does not have to conduct clinical studies to establish safety/efficacy -submit sufficient information that generic contains same active ingredient, route of administration, dosage form, and strength as pioneer drug -establish bioequivalence and acceptable manufacturing methods and control procedures
What did the Drug Price Competition and Patent Term Restoration Act (1984) do?
-streamlined generic drug approval process while giving patent extensions -made generic drugs more readily available to public -provided incentives for manufacturers to develop new drugs -statutorily created the ANDA
What is track-and-trace, and what is the reason behind it?
-transaction data from very beginning of product life all the way to the pharmacy including every single location that pill or bottle went along the way -prevent counterfeit drug distribution
What must be included on nonprescription drug labeling?
-user friendly format -pharmacological category -principle intended use -cautions and warnings -adequate directions for use -"drug facts" panel
What are the two ways paper Rxs may be filed?
1. In three separate files: One file for schedule II drug prescriptions; a second file for the prescriptions of schedule III, IV, and V drugs; and a third file for noncontrolled drug prescriptions 2. In two separate files: One file for schedule II drug prescriptions, and a second file for schedule III, IV, and V prescriptions, together with all prescriptions for noncontrolled drugs.
What are three methods to switch prescription drugs to OTC?
1. SNDA - product specific switch 2. petition - product-specific switch 3. adding or amending an OTC drug monograph - affects all products in class
The DSHEA permits what four types of nutritional support statements on DS?
1. benefitting a classical nutrient deficiency disease 2. describing role of DS in affecting structure/function of the body 3. characterizing the mechanism by which a DS acts to maintain the structure/function 4. statements of general well-being
What are six centers in the FDA?
1. drug evaluation and research 2. biologics evaluation and research 3. devices and radiological health 4. tobacco products 5. veterinary medicine 6. food safety and applied nutrition
The FDA will not take action if a hospital pharmacy distributes compounded drug products without first receiving patient-specific prescriptions/orders provided that...?
1. drug products distributed only to healthcare facilities owned and controlled by same entity that controls pharmacy 2. drug products only administered to patients within healthcare facility pursuant to a patient specific prescription/order 3. drug products compounded in accordance to all other provisions of section 503A
What are the four elements of negligence?
1. duty 2. breach of duty 3. causation 4. damages
What rules apply in determining the dollar value of compensation when the harm has no real value (e.g. pain and suffering)?
1. eggshell plaintiff 2. plaintiff required to mitigate damages by seeking timely medical assistance or some other mechanism (if they are able to) 3. most states place caps/ceilings on liability awards
What are 4 risk factors to assess when a breach is made?
1. evaluate nature and extent of PHI involved (including likelihood of re-identification) 2. consider unauthorized person who impermissibly used PHI and to whom impermissible disclosure was made 2. consider whether PHI was actually acquired or viewed or if only the opportunity existed for such 4. consider extent to which risk for PHI has been mitigated
What are four offices in the FDA?
1. foods and veterinary medicine 2. global policy 3. medical products and tobacco 4. operations
What parts of the three branches of US government actually make laws?
1. legislative = legislature 2. executive = administrative agencies 3. judicial = courts
What must be included in compounding documentation?
1. master formulation (recipe) 2. compounding record (batch record)
What 18 PHI items are considered as identifiable?
1. names 2. geographic subdivisions such as street address, city, county, zip code 3. dates of birth, admission, discharge, death, ages over 89 4. telephone numbers 5. fax numbers 6. electronic mail addresses 7. social security numbers 8. medical record numbers 9. health plan beneficiary numbers 10. account numbers 11. certificate/license numbers 12. vehicle identifiers and serial numbers/license plate numbers 13. device identifiers and serial numbers 14. web universal resource locators 15. internet protocol address numbers 16. biometric identifiers (finger and voice prints) 17. full-face photographic images and comparable images 18. any other unique identifying numbers, characteristics, or codes
What are the two main branches of the FDA?
1. national headquarters (policy making decisions) 2. extensive field force (local inspection and information acquisition)
Name four items addressed in the Food, Drug, and Cosmetic Act (1938).
1. no new drug could be marketed until proven safe for use 2. required labels must contain adequate directions for use and warnings about habit-forming properties of certain drugs, cosmetics, and devices 3. exempted drugs marketed before 1938 from requirement that new drugs be proven safe before marketing 4. batch certification of safety/efficacy of insulin and penicillin
What are two steps to in proof of causation?
1. plaintiff must prove defendant's conduct was a substantial factor in the harm that occurred (actual cause) 2. plaintiff must fix liability with the party or parties whose misconduct most directly caused the damage (proximate causation)
What three subsections does the new pregnancy labeling (2014) have to include?
1. pregnancy 2. lactation 3. females and males of reproductive potential
What are three main criticisms of the Dietary Supplement Health and Education Act?
1. prevents FDA from acting aggressively enough to protect public against unsafe DS 2. lack of consumer information about dangers of taking DS with OTC or Rx meds 3. lack quality standards for strength and purity
What 6 factors does the DEA list to be considered in determining whether a loss is significant?
1. quantity lost in relation to the type of business 2. specific drugs lost or stolen 3. whether the loss can be attributed to individuals or unique activities 4. whether losses are random or fit a pattern 5. local trend 6. other indicators of diversion
What are two legal special food categories?
1. special dietary foods 2. medical foods
What options of CS destruction does the DEA allow?
1. transfer to registrant authorized to possess substance 2. delivery to DEA agent or nearest DEA field office 3. destruction in presence of DEA agent or authorized person 4. other means authorized by DEA
When is a "breach" not a breach?
1. when acquisition, access, use, or disclosure is unintentional and in good faith, and does not result in further use or disclosure 2. when the unauthorized person to whom the PHI has been disclosed would not reasonably have been able to retain it 3. when the disclosure is inadvertent between two authorized individuals at the same facility if the information is not further used or disclosed
What are three validity tests for a regulation?
1. within scope of board's authority 2. based on statutory authority 3. reasonable relationship to public health, safety, and welfare
What is the strength limit of codeine or dihydrocodeine in C-III drugs?
1.8g/100mL; 90mg/dosage unit
How long does the President have to return a bill to congress?
10 days
How many numbered lines are on each 222, and how many items are allowed per line?
10 lines; 1 item per line
What number do all healthcare providers covered by HIPAA have to use?
10-digit NPI number
What is the National Drug Code number?
10-digit three segment code that identifies a drug
What is the strength limit of dihydrocodeine, ethylmorphine, or opium in C-V drugs?
100mg/100mL
When reporting a theft/significant loss to the DEA, the registrant must complete what form?
106 (available online)
Where does state authority to regulate drugs come from?
10th amendment and inherent police powers
Billings and claims submissions require an ____-digit NDC number.
11 (add a 0 at the beginning of one of the sections)
What did the Virginia decision establish?
1st amendment applies to commercial speech and to recipients of the speech
Within what time period must centrally kept records be able to be delivered to a registered location per DEA request?
2 business days
How long must records of refills for C-III and C-IV Rxs be maintained?
2 years
For how long must the original and transferred prescription be kept?
2 years from date of last refill
What is the strength limit of diphenoxylate and atropine in C-V drugs?
2.5mg/dosage unit and not less than 25mcg atropine/dosage unit
How can congress override a veto?
2/3rds vote
The Controlled Substance Registrant Act imposes what penalties?
20 years imprisonment, $25000 fine, or both
Orphan drugs are used to treat diseases that affect fewer than _______ Americans.
200,000
When was the Drug Addiction Treatment Act (DATA) enacted and what was its intent?
2000; intent of allowing addicts to be treated for addiction in office-based settings (outside of OTPs)
What is the strength limit of codeine in C-V drugs?
200mg/100mL
Dispensers use what form to order and return C-I and C-II?
222
Distribution of C-I and C-II drugs between registrants always requires a ____ following proper procedure.
222
On what form must C-II products be recorded during the complete CS inventory on the date of a business transfer?
222
What forms do pharmacies use to register with the DEA as dispensers?
224
What is the dispenser registration form?
224
What forms must be completed to work with narcotics?
224a, 225a, anything with "a" suffix
What is the manufacturer, distributor, importer, exporter, or research registrant form?
225
How many biosimilars are on the market, and how many of them have been deemed interchangeable?
3 biosimilar, none interchangeable
What are the exceptions allowing treatment of addicts outside licensed addiction programs or DATA?
3 days rule from office supply to relieve symptoms until prescriber can refer patient to treatment center
CMEA and MPPA limit sales to no more than _____ of ephedrine, PSE (pseudoephedrine), or PPA (phenylpropanolamine) base to a _____ purchaser per _____.
3.6g; single; day
PHI must be provided to a patient, their PR, or patient's agent (if allowed by professional judgement) within how many days?
30 days (with 30 day extension providing patient with written explanation for delay)
What are the strength limits of dihydrocodeinone/ethylmorphine in C-III drugs?
300mg/100mL; 15mg/dosage unit
The initial dose of methadone for OTPs cannot exceed ____, and total dose cannot exceed ___.
30mg; 40mg
What did manufacturers voluntarily restrict distribution of to just OTPs?
40mg methadone tablets
What is the form for breakage or spillage?
41
What amendment protects individuals from unreasonable searches and seizures?
4th
How are controlled substances classified?
5 schedules based on: 1. abuse potential 2. degree to which drug may cause physical or psychological dependence
How long does a patient's PHI remain protected after death?
50 years
What are the strength limits of opium in C-III drugs?
500mg/100mL or 100g; 25mg/dosage unit
What are the strength limits of morphine in C-III drugs?
50mg/100mL or 100g
How long must breach records be maintained?
6
What is the limit of refilling C-III and C-IV Rxs??
6 months after date of issuance or five times, whichever comes first
Suppliers must complete partial order fills pursuant to 222 form within ___ days.
60
In LTCF or for terminally ill patients, pharmacists may partially fill C-II Rx for up to ____ days from date of issuance, provided _____ requirements are met.
60; recordkeeping
When should current registrants receive a registration form (for renewal)?
65 days before expiration
Non specially-DATA registered physicians can help somebody who is in withdrawal for ____ hours max.
72
What US code is applicable to practitioners who prescribe and/or dispense outside of ordinary course of professional practice?
841
What US code establishes penalties for practitioners for not conforming to the requirement of the CSA (e.g. recordkeeping)?
842
?????
?????
What are the old pregnancy risk categories?
A - adequate, well-controlled studies that have not demonstrated risk to fetus B - animals studies failed to demonstrate risk to fetus, but there is no adequate, well-controlled studies in pregnant woman C - either animal studies have shown an adverse effect on the fetus or there are no animal reproductive studies, and there are no adequate well-controlled studies in pregnant women D - positive evidence of fetal risk exists based upon data from investigational or marketing experience or studies in humans; however, potential benefits from the drug may be acceptable despite potential risks X - studies in animals or humans have demonstrated fetal risk, and that risk in pregnant women clearly outweighs any benefit
Generic drugs marketed after 1984 and approved under an ANDA should all have an ____ rating because of what act?
A; PTRA
What established that the FDA could not restrict distribution of methadone?
APhA lawsuit
What schedule substance is marijuana under federal law?
C-I
CSOS certificates are required for electronic ordering of what CS?
C-I and C-II
What drugs need an exact count?
C-I and C-II
"azalam" usually indicates what CS schedule?
C-IV
What FDA center most affects pharamcy?
CDER
Who must comply with HIPAA?
CE and BA of CE
What are the security requirements for CE mandated by HIPAA?
CE must develop physical, technical, and organizational procedure safeguards in order to protect health info from being improperly accessed, altered, deleted, or transmitted
CHAPTER 1
CHAPTER 1
CHAPTER 4
CHAPTER 4
CHAPTER 5
CHAPTER 5
CHAPTER 6
CHAPTER 6
CHAPTER 8
CHAPTER 8
CHAPTERS 2 + 3
CHAPTERS 2 + 3
What drugs allow an estimated count?
CIII-CV
What is one type of non FDA-reviewed written information that patients may receive with their prescription?
CMI
If an invoice contains both CS and nonCS, what is required?
CS must be identified in a manner so as to be readily retrievable
Who must the DEA registrant name on their CSOS application?
CSOS coordinator
Who enforces HIPAA?
DHHS
If more than 500 individuals are affected by a breach, what must be done?
DHHS and media notified within 60 days of discovery IN ADDITION TO individual notification
Records of breaches have to be made available to ______ _____ upon request.
DHHS secretary
What are some state agencies that deal with pharmacy?
DOH, BOP, local government bodies
What did the Pharmanex, Inc. v Shalala case establish?
DSs cannot be specially manufactured to concentrate the natural drug ingredient
What act established FDA authority to order recalls for certain products, but not drugs?
FDAAA
What act removed requirements that distributors must submit adverse events reporting to FDA or device manufacturers?
FDAMA, but it stated that distributors had to maintain record of adverse events
What was the outcome of United States v Sullivan?
FDCA has jurisdiction in transactions between pharmacist and patient, even if its within state lines
What act gave the FDA the authority to regulate tobacco products?
Family Smoking Prevention and Tobacco Act (2009)
What are three classes of recalls?
I - reasonable probability that product will cause serious adverse health consequences or death II - product may cause temporary or medically reversible adverse health consequences, but probability of serious consequences in remote III - products not likely to cause health consequences
What are the four types of patent certifications made in an ANDA?
I. NDA holder did not file information on patent to FDA II. patent already expired III. date the patent will expire IV. patent is invalid and will not be infringed upon by manufacture, use, or sale of applicant's generic drug (more complicated than the other three)
IPs need not keep records of CS they administer unless ... ?
IP regularly engages in dispensing/administering and charges patients
What is the ante room?
ISO class 8 or cleaner area where personnel handle hygiene and garbing procedures, staging of components, order entry, CSP labeling, and other high-particulate-generating activities
Are electronic logbooks required by the MPPA?
NO, but it is hoped that they will become the standard and that pharmacies will participate in common electronic logbooks
What is professional OTC labeling?
OTC drug labeling published by manufacturers for certain indications intended specifically for the healthcare professional and not the consumer
What Rx information sharing is not subject to transfer Rx requirements?
Rx information sharing among pharmacies participating in common-electronic record system
IPs in the armed service or public health must include what in place of a registration number?
Rx service ID number
Acceptable records of dispersal include what?
Rxs, record books, form 222, invoices, records of disposal, theft or loss, etc.
What does HITECH require between a CE and a BA?
a contract that authorizes and defines the use of PHI shared between parties
What is proximate cause?
a determination of the extent to which the defendant should be held liable for the conduct
PHI may be provided to who besides the patient?
a patient's PR
The pharmacy that installs the ADS must maintain what?
a separate DEA registration at LTCF location
Distributors are required to design and operate what kind of system?
able to detect suspicious orders of CSs and inform DEA upon discovery
How does the FDA recruit for committees that advise on guidelines?
academic institutions and openings
What can central filling pharmacies NOT do?
accept Rx directly from patients/practitioner OR delivery Rx directly to patient/practitioner
What must be kept regarding detoxification?
accurate records
What does "breach of PHI" mean?
acquisition, access, use, or disclosure of PHI in an unpermitted manner which compromises the security or privacy of the PHI REMOVED "SIGNIFICANT HARM" STANDARD
What is a "legitimate medical purpose in the usual course of professional practice"?
acting in accordance with accepted standards of medical practice
What are manufacturer coincidental activities?
activities it can legally perform
It's important to distinguish ____ from _____.
addiction; dependence
It's important to ascertain whether taper-down dosages are for detoxification of ______ or withdrawal due to ______ ______.
addiction; physical dependence
What are the required elements in OTC drug labeling?
adequate directions for use + this picture
IPs may do what in regards to CIII-CV drugs?
administer or dispense without a Rx
IPs who are agents or employees of another IP may do what in regards to CS?
administer/dispense CS, but not prescribe
IPs who are agents or employees of a hospital or other institution may do what in regards to CS?
administer/dispense/prescribe CS, providing that all requirements are met
IPs may ____ or ____ CS without an Rx.
administer; dispense
Physicians helping somebody with withdrawal can ____ drugs in their office, but not _____ these drugs to patient.
administer; prescribe
What type of entity is the FDA?
administrative agency
What happens if a drug does not meet all compendium standards in the USP-NF or HPUS?
adulterated (and misbranded??)
If the written, printed, or graphic matter pertaining to a drug is not labeling, what is it?
advertising
What must be done after a breach is discovered?
affected individuals notified within 60 days
What is the Park Doctrine?
affirmative duty of corporate officers to be aware of and correct violations in their company, as they are responsible for the actions of the company even if they are unaware of their goings-on
In what case would an administrative hearing be applicable?
agency v. private party
What is notice and comment rulemaking?
agency writes up initial regulations --> posts for comment in fed. reg. --> holds open public meeting to discuss --> takes comments into consideration --> posts final regulation draft with an effective date in fed. reg. / CFR
According to the latest federal register notice, what are LTCF nurses allowed to be?
agent of prescriber provided there is a formal, witnessed agreement
What is a covered entity (CE)?
all providers of health care, health plans, and health insurance agencies, as well as clearinghouses of medical info that conduct financial or administrative transactions electronically
What did 2014 DEA regulations allow for in regards to return of CS to pharmacies for disposal?
allowed authorized entities, including pharmacists, to collect CS from ultimate users provided they register as a "collector"
What was the Anabolic Steroids Act of 2004 enacted to do?
amend prior anabolic steroid legislation that was enacted to prevent misuse in order to enhanced athletic performance
What did Health Information Technology for Economic and Clinical Health (HITECH) 2009 do?
amended several parts of HIPAA and appropriated 20$ billion to develop a nationwide HIT infrastructure
What did the Johnson case prompt?
amendment of PFDA to prohibit false and fraudulent efficacy claims
What is a tort?
an injury or wrong to one person for which the person who caused the injury is legally responsible
What did the Secure and Responsible Drug Disposal Act of 2010 allow?
an ultimate user to deliver to CS to another person for disposal
How often is the Orange Book updated?
annually
How often must manufacturers and distributors of CS register with the DEA?
annually
What are secondary engineering controls (SEC)?
ante room and buffer room
A purchaser can order ____ CS drug from a CSOS.
any
Medical device manufacturers and device-user facilities have to report what about their products?
any deaths or serious injuries related to their products
What does the exclusionary rule state?
any evidence obtained in violations of the 4th amendment will not be admissible
What is a device?
any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or related article / component that is A: recognized in USP/NF or HPUS B: intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals C: intended to affect the structure or any function of the body of humans/animals but is not food
How does congress oversee administrative agencies?
appointment confirmations and appropriations to agencies
The Delaney Clause of the Food Additives Amendment (1958) prohibits what?
approval of food additives that may cause cancer
What is the role of the president in the legislative process?
approve or veto bill
A pharmacy may manufacture and distribute what to other practitioners?
aqueous/oleaginous solution or solid dosage forms of a narcotic not exceeding 20% narcotic concentration
What is a cosmetic?
articles intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body for the purpose of cleansing, beautifying, promoting attractiveness, or altering appearances
What does the definition of a device exclude?
articles that achieve their purpose through chemical action and metabolism (drugs)
How are ADS medications dispensed?
as single dose by Rx
When can the inventory be taken?
at beginning or end of business day
The label of a centrally filled dispensed drug must indicate what?
at which pharmacy the drug was dispensed
Who has scheduling authority?
attorney general (under section 811 of CSA)
It is coincidental activity of dispensers to conduct research with schedule II-V CS if ______.
authorized
Who must sign and date a 222?
authorized person (last person to sign registration form for registrant certification OR someone with POA)
Because the DEA is concerned about excesss supplies of CS in LTCF, what does it permit?
automated dispensing systems (ADS), partial filling, and voluntary collection receptacles by registered "collectors"
What is the ARCOS?
automated, comprehensive drug reporting system which monitors flow of DEA CS from point of manufacture through commercial distribution channels to point of sale/distribution at dispensing/retail level
For recording refills of C-III and C-IV Rxs, where must a pharmacist record them if using a non-automated system?
back of Rx or other readily retrievable document
Why do the FDA and DEA work together on certain CS violations?
because CS are still under the FDCA (still drugs)
Why are affirmative defenses called such?
because defendant has to bring them up (aren't automatically applied)
When does one clean ISO class 5 PEC?
beginning of each shift, before each batch, every 30 minutes when compounding, after spills, and when surface contamination is known/suspected
Subutex is intended for _____ treatment and likely will be administered by _____.
beginning; prescriber
Ephedrine, PSA, or PPA base products must be stored how?
behind counter or in locked cabinet where customers do not have direct access
What is an unofficial third class of drugs?
behind-the-counter drugs that can only be sold from the pharmacy department
What is a criminal case based on?
being charged with a crime as prohibited by a statue and subject to penalties specified by statute
How will pharmacists use PHI?
billing for services, treatment recommendations, notice regarding benefits, validation of audit findings, verification of health charges, fraud/waste/abuse detection, assessing Rx utilization trends, P&T support
What does interchangeability mean?
biologic can be expected to produce same clinical result as the reference product in any given patient
What does biosimilar mean?
biological product is "highly similar" to reference product with no clinically meaningful differences in terms of safety or efficacy
In lieu of printout for maintaining record of recording refills of C-III and C-IV Rxs, pharmacist may maintain what?
bound logbook or separate refill file
What is the patient's rights in regards to PHI disclosures?
can request and receive report of disclosures over past 6 years, EXCEPT FOR TPO
What does "non-retrievable" mean?
cannot be transformed to physical or chemical condition or state as a CS or CS analogue
What are the 6 criteria used to identify a hazardous drug?
carcinogenicity, teratogenicity, reproductive toxicity, genotoxicity, organ toxicity at low doses, and drugs that mimic existing drugs in structure/toxicity
What is the "discovery rule" modification to the statute of limitations?
cause of action does not accrue until the date on which the patient discovers the injury (even if injury is discovered years after medication was dispensed)
What is the standard for practitioners conforming to the requirements of the CSA?
changed from strict liability to NEGLIGENCE
What is the ISO goal for compounding sterile products?
class 5
How is bioequivalence established?
clinical trials done by manufacturer or if FDA can conclude it from other studies/facts submitted by company
What are some examples of narcotics?
codeine, hydrocodone, oxycodone, methadone, hydromorphone, morphine, fentanyl
What are some examples of CEs?
college health services, pharmacies, hospitals, LTCF
What is injunction?
command to cease activities
What products cannot be compounded?
commercially available products, unless there is a shortage
What type of law is contributory negligence?
common law
What is marketing defined as?
communication about a product or service that encourages the recipient to purchase or use the product or service
What are exceptions to marketing?
communications: •about general health issues •for treatment of the individual •face to face •for case management or care coordination •to direct or recommend alternative treatments, providers, or settings •about the health-related services offered by the pharmacy or health plan
What is the purpose of actual damages?
compensation
What is the purpose of negligence and malpractice laws?
compensation and deterrence
What is contributory negligence?
complete bar to recovery if plaintiff could have avoided consequences of defendant's negligence by ordinary care
Every registrant must keep a _____ and _____ record of all CS.
complete; accurate
What are state legislatures generally modeled after?
congress
What is the "knowingly" standard?
conscious disregard for the obvious
What must a food manufacturer submit to obtain FDA approval of its drug claim?
considerable evidence to support the claim
CE have ____ latitude to develop their own security measures provided ....
considerable; they achieve HIPAA objectives and standards
Who administered the Poison Prevention Packaging Act?
consumer product safety commission
What does pharmaceutical equivalence mean?
contain same active ingredients and are identical in strength and dosage form
There is a ______ responsibility upon the pharmacist for making sure a CS Rx is for a ____ medical purpose.
corresponding; legitimate
IPs must contain CS records administered in .... ?
course of maintenance or detoxification of treatment of addiction
What was the verdict in North Dakota BOP v Snyder's Drug Stores?
court ruled that the state statute that prevented Snyder's from opening a pharmacy where the majority owners were not pharmacists was unconstitutional
What happens during judicial review of administrative agency judicial functions?
court will review record to determine if decision was based on substantial evidence, and if substantial evidence lacking, court will conduct entirely new trial
What did the Dietary Supplement Health and Education Act (1994) do?
created new special category of drugs called dietary supplements (DS)
What are some reasonable policies and procedures for PHI disposal?
cross-shredding (not strip-shredding), burning, purging electronic media consistent with NIST, contracting with disposal vendor
What should original CS Rx labelling include if of a C-II?
date of filling
What should original CS Rx labelling include if of another schedule?
date of initial filling
Labeling of refills for CIII-CV drugs should include what two things?
date of initial filling and date of dispensing
What must the pharmacy record on the invoice or form 222 for records of receipt?
date of receipt
What is a judicial opinion?
decisions of the court that are enforceable as law
What is the "eggshell" rule?
defendant must accept whatever underlying condition the plaintiff had before the defendant's negligent act (e.g. if patient has condition that made them more susceptible to harm because of the pharmacist's negligent act, the pharmacist must still compensate them even if a regular person without that underlying condition would not have been harmed by the pharmacist's act of negligence)
What was the Baker case?
defendant pharmacy advertised computer system that could detect drug interactions, then tech ignored the computer notification and pharmacist filled prescription without becoming aware that patient was also using a drug which could interact with the newly prescribed drug --> patient suffered stroke and died
What is the International Organization for Standardization?
defines max acceptable particulate matter and size of matter allowable per cubic meter within air of area
Who is authorized to dispense medications?
depends on state
If state inspectors do not have a warrant, is consent required?
depends on state law
What are the procedures when one receives an adulterated product?
destroy or quarantine and send back to manufacturer
Why can't settlements establish precedent?
details are sealed
What are the objectives in a criminal case?
deter, punish, rehabilitate
What is proximate cause usually based on?
determination of foreseeability
Who defines scope of authority?
determined by the state for prescribers who are not MDs or DOs
When may the AG deny a practitioner-applicant a registration?
determined not to be in the public interest
What are DS manufacturers responsible for?
determining if their product is safe and only making truthful / non-misleading claims substantiated by adequate evidence
What is the pharmacist's role under the CSA?
determining the legitimacy of Rx for pain rather than therapeutic appropriateness of using opioids
What must pharmacies do to implement HIPAA privacy standards?
develop policies that do so, including identifying a privacy officer
What is a CSOS certificate?
digital identity issued by the DEA's CSOS certification authority that allows for electronic ordering for CS (digital equivalent of ID info on 222)
What is now required of BA?
directly responsible/accountable to maintain and protect PHI in same manner as covered entities and are subject to HIPAA enforcement authority
In what order does personnel garbing take place in sterile compounding facilities?
dirtiest to cleanest article of clothing
What is the objective in an administrative hearing?
disciplinary determination that may include warning, fines, licensure revocation/suspension, or probation
What must DS labels contain?
disclaimer
IPs must keep records of CS they _____, but not of those they ____.
dispense; prescribe
What is detoxification?
dispensing an opioid agonist in decreasing doses incident to withdrawal
What is maintenance (treatment)?
dispensing of opioid agonist for period in excess of 21 days
If recording refills of C-III and C-IV Rxs using an automated system, how must a pharmacist provide online retrieval?
display OR hard-copy printout of original Rx information/up-to-date refill history
What must the defendant do in the case of negligence?
disprove the four elements of negligence, prove the affirmative defense, or both
What does a rating that starts with B mean?
drug not considered therapeutically equivalent, quality standards are inadequate, insufficient data to determine therapeutic equivalence, drug product still under review
What does the second NDC segment identify?
drug strength, dosage form, formulation
What were medical devices classified as before the Medical Device Amendments (1976)?
drugs
What did the old pregnancy labeling have to include?
drugs potential risk during pregnancy be placed into one of five categories (A, B, C, D, X)
What are narrow therapeutic index drugs (NTI)?
drugs with less than a two-fold difference between MTC and MEC
An AIW may only be served when?
during regular business hours
Foreseeability plays an important role in what elements of negligence?
duty and (proximate) causation
Separate registrations are required for .... ?
each principal place of business where CS are prescribed, administered, dispensed, or stored
What is the difference between probably cause for a search warrant (SW) and probable cause for a AIW?
easier qualifications to satisfy than search warrant
How is the BUD on patient labels (multiple-use containers) determined?
either the expiration date on the manufacturer's container or one year from the date the drug is dispensed (whichever is earlier)
How is the BUD date on unit-dose labels determined?
either the expiration date on the original bulk container or one year from the date of repackaging (whichever is earlier)
What is protected health information (PHI) under HIPAA?
electronic and hard-copy health info that: •relates to past, present, or future physical or mental health, provision of care, or payment for care •could identify the patient
What can be used instead of form 222?
electronic order system [controlled substance ordering system (CSOS)]
According to the MPPA, what are the three means that a seller can collect a purchaser's signature?
electronic, bound paper book (not regular notepad) where signature is adjacent to unique ID number or printed sticker linking signature to logbook info, or signing printed document at time of sale that displays required logbook info
What is NOT a CE?
elementary/middle/high school with vaccination records
What is the justification for respondeat superior?
employer has an obligation to hire and train competent employees
What is well established under tort law?
employer is liable for the negligent acts of its employees
What is vicarious liability under the "respondeat superior" doctrine?
employer of an employee (pharmacist) who commits a negligent act that harms a patient is liable for the act, as is the pharmacist
What is the particular purpose of HIPAA?
ensure privacy and security of health info + ensure health insurance for those changing jobs?
Agents can do what in regards to CS electronic transmission Rxs?
enter Rx info
What equal characteristics must biosimilar products have?
equal MOA, route of administration, dosage form, and strength
What type of standard are pharmacists held to for mechanical-type acts (not requiring professional judgement)?
error-free
What is HIPAA's intent in targeting transaction and code sets?
establish uniform standards for electronic claims and data transmission to improve efficiency and lower costs
What did the Poison Prevention Packaging Act do?
established standards for child-resistant containers (like safety caps)
What kinds of drugs are required to be distributed with PPIs?
estrogens, oral contraceptives, DES
How often must PDUFA be reauthorized?
every 5 years
Who do federal laws apply to?
everybody
Courts generally regard labeling as what related to standards of care?
evidence toward, but not prima facie establishing, standard of care
What are DEA inspectors allowed to do?
examine/copy all records, inspect within reasonable limits, and take inventory of all CS
What is a 503A pharmacy?
exempt from misbranding, cGMP, and new drug requirements if certain standards are met (prescription is for individual patient, limited quantity, etc.)
When suspicions exist about a CS Rx, what should a pharmacist do?
exercise professional judgement and investigate
What is required to prove breach of duty for judgemental errors?
expert witnesses testimony that there was a standard of care and that the pharmacist violated that standard
What do adulteration provisions focus on?
facility and product
What is a reverse distributor?
facility licensed by DEA that will take expired or non-returnable CS, destroy them, and give you a certificate that says they have been destroyed
What reasons would a lower court have for deviating from precedent set out by stare decisis?
factual distinctions and changing times/circumstances
What act is considered adulteration and misbranding?
failure to manufacture OTC product in tamper-evident packaging/container when required by law
For LTCF patients, what kind of C-II Rx can serve as the original?
faxed
For narcotic compounded drugs for direct administration by infusion, what kind of C-II Rx can serve as the original?
faxed
What are most non-routine board or DEA inspections triggered by?
fear of imminent danger to public health/safety/welfare, complaint by public, or belief that violation has occurred or will occur
Where do you find federal regulations?
fed. reg. and CFR
What is the difference between the fed. reg. and the CFR?
fed. reg. is a daily publication of proposed/final regulations and notices, while CFR is an annually published compilation of final regulations divided and indexed by subject matter
Why is state legislative history generally harder to determine than federal legislative history?
fewer written records of committee hearings & reports
Pharmacists should exercise professional judgement in regards to what with DATA?
filling prescriptions for DATA purposes
What is USP <797>?
first set of enforceable sterile compounding standards issued by USP
Who is copy 2 for?
for DEA (green)
If purchasing CS through a CSOS, the registrant must obtain a digital certificate where?
for each DEA-registered location
In what situations may investigational drugs be used for treatment outside of the clinical trials?
for patients with serious or life-threatening disease for which no comparable or satisfactory alternative therapy is available
Who is copy 3 for?
for purchaser (blue)
Marketing of PHI is different from PHI ____ ____.
for sale
Who is copy 1 for?
for supplier (brown)
Are misbranding and mislabeling interchangeable?
for the most part
Historically, what was the DEA's stance on return of CS to pharmacy/LTCF for disposal?
forbidden
Distributions from a pharmacy to another practitioner require what for C-II products?
form 222
Acceptable records of receipt for C-I and C-II include?
form 222 (not just invoice)
What must compounding personnel be trained in?
garbing, aseptic technique, maintaining iso class 5 environment, cleaning and disinfection
What do most state biosimilar laws allow?
generally permit substitution, provided the prescriber has either authorized or not prohibited substitution, and that the prescriber is notified of the substitution
What are the patent considerations of an ANDA?
generic manufacturer must make one of four types of patent certifications
Labeling must accurately differentiate between _____ and ______.
generic; brand
Every state permits pharmacists to substitute ______ in some manner, but state laws differ ________.
generically; considerably
If the patient's name, name of CS (except for generic sub) or prescriber's signature need to be changed on a CIII-CV prescription, what can you do?
get new prescription from prescriber
Pharmacies must make a ____-____ effort to distribute its "notice of privacy practices" to patients and obtain .... ?
good-faith; a written, signed acknowledgement of receipt
What is direct regulation?
government makes decisions for people rather than helping them make it for themselves
In what case would a criminal case be applicable?
government v private party
Drugs approved before June 30, 2015 will be ______ _______ ______ the new pregnancy labeling standards.
gradually phased into
What must non-compounding support personnel who perform cleaning procedures be trained in?
hand hygiene, garbing, and cleaning/disinfection
What are qualified health claims?
has to have "not approved by FDA" disclaimer because it did not meet the significant scientific agreement test (this sounds weird but it's right i swear i checked it ~15 times)
Agents cannot do what in regards to CS electronic transmission Rxs?
have access to authentication factors OR sign
States laws must bear a reasonable relationship to public ______, ______, and ______.
health, safety, welfare
If a weapon is used, penalties are _____, and if death results, the penalty is _____ yet.
higher; higher
What is the difference between hospice and LTCF faxed C-II prescription requirements?
hospice can only have narcotic C-II Rx faxed (not all C-IIs are narcotics)
PPI distribution laws apply to _____ pharmacy, not just _____ pharmacy.
hospital; community
What does the definition of institutional practitioner include?
hospitals (not pharmacies)
Law Abbreviation Hell
https://quizlet.com/192223204/law-abbreviation-hell-flash-cards/
CONTROLLED SUBSTANCE CHART
https://sakai.uri.edu/access/content/group/93e1613e-1954-442a-acac-a92737aeda3e/Resources/Federally%20Controlled%20Substances.pdf
Labels and labeling of commercial containers of CS must contain an ____ ____ of the schedule.
identification symbol
What is an interchangeable biologic product?
if FDA deems biosimilar therapeutically equivalent to reference product
What is the doctrine of negligence per se?
if a pharmacist violates a statute or regulation, the violation in itself could establish negligence
What is the exemption for estimated count drugs?
if container hold more than 1000 units
When may containers be reused, according to the PPPA?
if containers are glass or threaded plastic, and only with a new closure (NEW CAP REQUIRED EVERY TIME)
Pharmacies are exempt from standard manufacturing definition when?
if engaged in ordinary course of pharmacy practice
When will the FDA not regulate a product as a medical device?
if intended for general wellness, has low risk, and makes no references to diseases/conditions
If you see a methadone prescription come to a pharmacy, when can you fill it?
if it says it's for pain (if you suspect its for something else DO NOT FILL)
When can a patient request PHI not be disclosed to their health plan?
if its purpose is for payment/operations, or if patient paid in cash
When may the FDA remove cosmetics from the market?
if misbranded, adulterated, or a health hazard
What are the implications for a drug if it is recognized in USP/NF or HPUS?
if must meet all standards of the compendia
When may individual patients acting through a physician request an investigational drug?
if physician determines patient has no comparable or satisfactory alternative and the risk from the investigational drug is no greater than the risk of the disease
When are labeling requirements for CS not applicable?
if prescribed for administration to institutionalized patients (provided that restrictions and requirements are met)
When can a cosmetic become a drug?
if seller makes a health or structure/function claim
When must a distributor report previously shipped orders as suspicious?
if the distributor subsequently decides to cease distributions to a customer as a result of conducting "due diligence"
When would a pharmacist not be subject to penalties?
if the pharmacist sells the drug in good faith and on request furnishes the FDA with information about the source of supply
In what cases does a defendant receive punitive damages?
if there is evidence of the defendant's wanton and reckless disregard of the plaintiff's rights, or morally culpable conduct
What is the FDA inspection authority?
if they have probable cause that pharmacy is manufacturing (no warrant required)
When is a CE exempt from breach notification?
if they secure PHI according to government NIST standards (encryption/destruction)
What is standard for cosmetic safety?
ignorant/uninformed consumer could use it and won't be hurt
What is the FDA's compassionate use policy?
importation of small amounts of drugs, but only if they are approved in the US and are used for the treatment of a serious condition for which no satisfactory treatment is available in this country
What is the general purpose of the Health Insurance Portability and Accountability Act of 1996 (HIPAA)?
improve efficiency and effectiveness of the healthcare system
If BA is acting as an agent of the Ce, the BA's date of discovery is _____ to the CE.
imputed
Where must a pharmacy's "notice of privacy practices" be posted?
in a prominent and visible location
How are 222s issued?
in mailing envelopes containing 7 forms
What does on-hand mean?
in possession of or under control of registrant
For what reasons would the drug approval process be expedited?
in the case of drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs for the condition AND have an effect on a clinical endpoint predictive of clinical efficacy
Manufacturing excludes the activities of practitioners ____ to dispensing.
incidental
If the prescription is for GHB, what are additional requirements?
include medical need of patient written on prescription
Midlevel practitioners may register as dispensers provided their state law authorizes what?
independent or collaborative prescriptive authority
Who are CSOS certificates issued to?
individuals
What can a DEA inspector not do without consent of an owner/PIC?
inspect financial, sales (other than shipping), or shipping data
What does an audit procedure involved?
inspecting records received, drugs dispensed, and drugs destroyed --> comparing these numbers with inventory
What are some examples of class II medical devices?
insulin syringes, pumps, thermometers, tampons, electric heating pads
What acts carry more severe penalties (e.g. prison)?
intentional acts or acts involving fraud
Commission of any of the listed offenses in Section 301 of the FDCA violates the FDCA, regardless of the person's ______ or ______.
intentions; knowledge
Under what presumption has the Supreme Court held that federal agents can seize medical marijuana?
interstate commerce
Where does federal authority to regulate drugs come from?
interstate commerce clause
What records CANNOT be kept centrally?
inventory records and executed order forms
What are three types of records involved with CS?
inventory, drugs received, drugs dispersed
Distributions from a pharmacy to another practitioner require what for CIII-CV drugs?
invoice containing all required info (not a prescription)
Acceptable records of receipt for CIII-CV include?
invoices
The FDCA excludes an article as a DS in what situation?
it was approved as a drug prior to being marketed as a DS
Why should USP standards be followed?
joint commission requires USP adherence, and its the group that accredits hospitals and allows them to bill medicare/medicaid, so it's kind of a big deal
What is common law?
judicial opinions
How do courts make laws?
judicial opinions (common law)
What is a judgement notwithstanding the verdict?
jury has rendered a verdict that was wrong so losing party asks judge to rule contrary to jury
What is a label?
labeling present on the immediate container or wrapper of any article
What is evidence that a product is a drug?
labeling, advertising, and nature of product
The term _____ includes _____.
labeling, labels
What is the path a bill takes to become a law?
legislator sponsors bill --> bill sent to appropriate congressional committee in either house or senate --> house/senate committee holds hearings, conducts investigations, and determines whether bill will go to house/senate floor --> once bill is approved by either house/senate, the process is repeated in the other wing of congress
Who creates administrative agencies?
legislature
A CS Rx must be for a ______ medical purpose in the usual course of ______ practice.
legitimate; professional
Conflicts generally exist when state law is ____ strict than federal law.
less
What are the CSP risk categories based on?
likelihood of contaminating a compounded sterile preparation (CSP) with microorganisms, spores, endotoxins or other foreign material
What is the "statute of repose" seen in many states?
limits length of time after the defendant's alleged negligent action during which the discovery rule can postpone the accrual (and expiration) of the statute of limitations
What must be included on cosmetics labeling?
list of ingredients in descending order of predominance and appropriate warning
CE must maintain a _____ of breaches and submit information ____ to DHHS no later than ___ days after the end of each calendar year.
log; annually; 60
How must executed 222 forms be preserved?
maintained separately from all other records and retained for 2 years, with copy 3 kept at registered location
What is the purpose of the Controlled Substance Registrant Protection Act?
make it federal crime if robbery results in 500$ or greater replacement costs of CS, person suffers "significant" injury, or interstate commerce in involved in the planning/execution of crime
What power does the 10th amendment give the states?
make laws that are not specified by federal government, as long as they do not supersede federal law
What are the requirements for destroying CII?
make product non-retrievable
What did the Federal Anti-Tampering Act (1982) do?
makes it a federal offense to tamper with consumer products
If not an outsourcing facility (503B) or a 503A pharmacy, the FDA will classify an entity as a _____.
manufacturer
Who assigns the second and third NDC segments?
manufacturer
Whose responsibility it is to dispense medguides to patients for drugs requiring medguides?
manufacturer and dispenser
What is the learned intermediary doctrine?
manufacturer of prescription meds is released of its duty to warn users of the risks associated with its products by warning the prescribing physician of the proper use and risks of the manufacturer's product
What does the first NDC segment identify?
manufacturer/distributor
Pharmacies that relabel or repackage must conform to same labeling standards as _____.
manufacturers
What are the reporting requirements on manufacturers and distributors?
manufacturers and distributors must report quarterly to the DEA certain CS, with some states requiring reporting to state as well
In the event of a recall, who is responsible for notifying who?
manufacturers responsible for notifying seller, and seller for notifying consumers if necessary
Who must register with the DEA?
manufacturing, distributing, reverse distributing, dispensing, conducting research, conducting narcotic treatment programs, conducting chemical analysis, importing, or exporting CS
If filing CIII-CV with nonCS, what must you do to the CIII-CV scripts?
mark with a red C unless done electronically
Financial remuneration related to communications constitutes as _____.
marketing
What can a pharmacist do to correct errors or omissions on CIII-CV Rxs?
may add/change any information after consultation with practitioner + documentation EXCEPT patient's name, name of CS (except generic sub), or prescriber's signature
What are the allowed responsibilities of employees/agents of IPs?
may communicate prescriptions to a pharmacist or prepare the Rx for signature of IP
What are emergency filling procedures for a C-II?
may dispense C-II on oral or signed faxed authorization of IP, limited to amount necessary to treat emergency
What may a pharmacy include is in disclosure of PHI if complying with a "limited data set" is not possible?
may include minimum necessary and be prepared to justify its use
What is an ADS?
mechanical system that stores, packages, counts, labels, and dispenses medications while maintaining transaction info
What are two types of FDA-reviewed written information that patients may receive with their prescription?
medguides and PPIs
What office of the FDA is most related to pharmacists?
medical products and tobacco
What should pharmacists familiarize themselves with in order to ascertain the legitimacy of opioid Rxs in pain treatment?
medical standards of practice for diagnosing and treating pain
What kinds of institutional medication records are distinguished from prescriptions?
medication or chart orders
Compounded drugs are exempt from new drug provisions provided the pharmacy...?
meets all conditions established in FDAMA
Pharmacists in collaborative practice agreements are considered _____ practitioners.
midlevel
What type of environment is needed for sterile compounding?
minimizes any potential for contamination of product they're creating
What do medication and chart orders need to contain?
minimum info necessary to provide acceptable disperal record
Promotion of off-label use by pharmacists and sales persons is ______.
misbranding
What is it called if a drug doesn't have a label or it has an incorrect label?
misbranding and mislabeling
If a medication has a brand name label, but you dispense the generic, what is that considered?
misbranding and mislabelling
What did United States v Johnson hold?
misbranding provisions did not prevent false/misleading efficacy claims
What is compounding?
mixing, altering, or assembling a drug and other ingredients
How does one differentiate between a drug and a biologic?
mode of action
What are some examples of opioids?
morphine, heroin, methadone, buprenorphine, oxycodone, hydrocodone
What are the requirements for a pharmacist to dispense CS?
must be acting in usual course of professional practice AND be registered individually or EMPLOYED by a registered pharmacy/institutional practitioner
What are the requirements for class III medical devices?
must have premarket approval because they are life-supporting / life-sustaining or present potential unreasonable risk of illness/injury
When distributing from a pharmacy to another practitioner, what is the dosage unit limit?
must not exceed 5% of total units of CS distributed and dispensed in one year
Who developed USP Chapter <800>?
national institute for occupational safety and health (NIOSH)
What is a narcotic?
natural or synthetic opium/ opiates/derivatives
What are some examples of class I medical devices?
needles, scissors, gloves, stethoscopes, toothbrushes, and examination gloves
Malpractice is _____ and a type of ____.
negligence; tort
The FDA has the authority to reclassify devices based on what?
new safety and efficacy information
Central filling pharmacies may fill both ____ and ____ Rxs.
new; refill
According to federal courts, can the government take action against physicians who reccomend medical marijuana?
no
According to federal courts, does a patient have a right to obtain marijuana?
no
Are LTCF registered with the DEA?
no
Are all CII drugs narcotics?
no
Are all scheduled drugs narcotics?
no
Are errors, alterations, or erasures generally permitted on 222s?
no
Are expert witnesses generally required for misfilling?
no
Are regular doctors allowed to treat addiction?
no
Can PHI be de-identified with a black marker?
no
Can a pharmacy refuse treatment if a patient refuses to sign an acknowledgement of its "notice of privacy practices"?
no
Can a pharmacy's right to compound override a manufacturer's patent rights?
no
Can a prescriber write a prescription for a CS for office use?
no
Can a refill quantity exceed quantity originally authorized?
no
Can an individual sue someone under HIPAA?
no
Can community pharmacies receive samples according to PDMA?
no
Can registrations be assigned or terminated without DEA approval?
no
Do DSs require premarket approval?
no
Do IPs include pharmacists, pharmacies, or institutional practitioners?
no
Do Rx include orders for medications dispensed for immediate administration (i.e. hospital chart orders)?
no
Do all states allow substitution with B rated products?
no
Do practitioners need a DEA number if they aren't dealing with controlled substances?
no
Do settlements establish precedent?
no
Does an inspector with an administrative inspection warrant (AIW) require owner/pic consent?
no
Does having a NDC denote FDA approval?
no
Does the DEA consider a LTCF an agent of prescriber for the purpose of an emergency kit?
no
Does the FDA have to follow committee recommendations?
no
Does the federal government give a time frame in which the C-II prescription needs to be filled?
no
Does the federal government limit C-II quantity ordered?
no
If DEA agents have a warrant, can you refuse inspection?
no
If an acknowledgement of notice is signed by a patient's agent is not their PR, does it have legal binding?
no
Is de-identified information considered PHI?
no
Is methadone legal to prescribe or dispense as an antitussive?
no
May pharmacies, institutional practitioners, or IPs employ a person whose application for registration has been denied or revoked?
no
Must cosmetics obtain premarket approval or conformance with cGMP?
no
Will courts readily find the existence of pharmacist duty to a person other than the patient?
no
Without a prescription, can you advise about an OTC drug for a non-OTC indication?
no
is it legal to prescribe a narcotic for addiction detoxification?
no
Is there recovery for malpractice if no harm was done?
no (law does not deal with hypothetical cases)
Are pharmacies responsible for incidental uses and disclosures of PHI?
no, provided they applied "reasonable safeguards" to protect the PHI
Can complete barring of recovery based on contributory negligence still be used today?
not in most jurisdictions; replaced by comparative negligence
In what situations is misbranding not the same as mislabeling?
not putting OTC product in tamper-evident packaging & forgetting ppi
By what process are regulations enacted?
notice and comment rulemaking
If a registrant dies or ceases legal existence, the DEA must be ____ and registration ____.
notified; terminated
What must a purchaser do if forms are stolen or lost other than in transmission?
notify DEA and provide serial #'s of missing forms
If registrants do not receive registration forms by 45 days before expiration, what must they do?
notify DEA and request forms
What are distributor/manufacturer suspicious order monitoring programs required to report?
orders of unusual size, frequency, or those that substantially deviate from a normal ordering pattern
What is a 503B facility?
outsourcing facility that has one geographic location engaged in compounding of sterile drugs
What does the third NDC segment identify?
package size and type of drug
Pharmacists should seek a collaborative practice relationship with what kind of physicians?
pain
It's important to determine whether the purpose of opioid treatment is legally for _____ or illegally for _____.
pain; addiction
The pharmaceutical care model is ____ oriented, not _____ oriented.
patient; physician
When necessary and appropriate, pharmacists should interview both ____ and ____ regarding ____ and _____.
patient; prescriber; pain; treatment
The Abigail Alliance decision declared what?
patients do not have constitutional right to investigational new drugs
What is indirect regulation?
people regulating their own decisions with gov providing accurate/useful information through labeling
POA is ___ DEA registrant.
per
What are the requirements for multiple C-II Rxs for the same drug and patient on the same day?
permitted provided: •each Rx is on separate blank •total quantity prescribed does not exceed 90 day supply •practitioner determines legitimate medical purpose to do this •practitioner writes instructions on each Rx (other than first) as to earliest date each Rx may be dispensed ("do not fill until ____") •multiple Rxs do not create undue risk of diversions •its permissible under state law
What is a OTP compounder?
person who engage in maintenance or detoxification and mixes, prepares, packages, or changes dosage form of a narcotic drug
Acknowledgement may be signed by a patient's ______ ______ (___), but NOT by an ____ who is not a ____.
personal representative (PR); agent; PR
What is a business associate (BA) of a CE?
persons or entities that perform functions requiring access and use of PHI on behalf of covered entities
What are the training program requirements for pharmacies as mandated by HIPAA?
pharmacies must train all members of their pharmacy department workforce about HIPAA policies and procedures within a reasonable time after being hired
What does "central filling" of Rxs mean?
pharmacies that fill Rxs for other retail pharmacies pursuant to contractual agreement
What have courts upheld in relation to a pharmacist's conscientious objection?
pharmacist cannot obstruct a patient's legal right to receive medications, but that state regulations requiring pharmacists to dispense violate first amendment rights
What was the United States v. Hayes case about?
pharmacist challenged "corresponding responsibility" doctrine saying it posed "unfair" burdens on pharmacists --> court said suck it up
What was Ryan's v. Dan's Food Store Inc about?
pharmacist contended he was wrongfully discharged for questioning the validity of controlled substance prescriptions; court, however, found the discharge to be valid because the discharge was based on the pharmacist's behavior of being suspicious of most of the patients with controlled substance prescriptions and of being rude to those patients
What was the resulting common law from the Hooks SuperX case?
pharmacist have duty to provide expanded patient services based on: 1. relationship 2. foreseeability 3. public policy
What is permissive generic substitution?
pharmacist may choose to substitute if prescriber issues the prescription in a way that permits substitution
What is the foreseeability factor in expanded pharmacist duty?
pharmacist only expected to warn of foreseeable risks, not all risks
In regards to central filling pharmacies, the corresponding responsibility doctrine applies to what pharmacist?
pharmacists at both facilities
What is mandatory generic substitution?
pharmacists must substitute a less expensive generic drug unless dispenser writes "dispense as written"
Who is responsible for LTCF emergency kits?
pharmacy (control and and accountability)
What really are the only standardized datasets under HIPAA?
pharmacy datasets
What was the Vermont & 100th Medical Arts Pharmacy v. State BOP about?
pharmacy filled 10,000 prescriptions written by a small group of physicians for four controlled substances and then argued that he did not know the prescriptions were not valid
What was the decision in the Happel v. Wal-Mart case?
pharmacy has NO duty to warn either patient or physician about adverse effects EXCEPT WHEN: 1. it has patient-specific information about drug allergies 2. it knows that the drug being prescribed is contraindicated 3. there are special instruction by the manufacturer to warn
What is the "minimum necessary requirement" for pharmacies according to HIPAA?
pharmacy may only disclose the minimum amount of PHI necessary to accomplish objective
What do state PMPs require?
pharmacy to electronically transmit to the state a record of CS Rx dispensed
What was the decision in the Baker v. Arbor Drugs case?
pharmacy will be held liable when it voluntarily assumes a function that it was under no legal obligation to assume and a patient relies on that function to their detriment
From what phases can investigational drugs be used outside of clinical trials for?
phase 3
Drug expedition is conditional upon the manufacturer agreeing to what?
phase 4 testing
What was the United States v. Lawson case about?
physician operated diet clinic and created fictitious medical records for patients; pharmacist initially contacted physician to ascertain validity of prescriptions, but subsequently dispensed drugs without question
What does the definition of practitioner include?
physician, dentist, veterinarian, scientific investigator, pharmacy, pharmacist, hospital, or others licensed by their jurisdiction to be involved with CS
Who are considered "individual practitioners" (IPs)?
physicians, dentists, veterinarians, or others licensed to dispense by the state
What is a summary judgement?
plaintiff argues case has no merit even if all facts are correct
What is meant by "modified" comparative negligence?
plaintiff is permitted to recover whatever percentage of the damages corresponds with the defendant's percentage of fault, provided the plaintiff is less than 50% / 51% at fault (depending on state)
What are the stipulations of the doctrine of negligence per se?
plaintiff must be within the class the statute or regulation seeks to protect AND the harm must be of the type it seeks to protect
What is the statute of limitations?
plaintiff must bring claim within a specified period of time after cause of action accrues
ARCOS monitors wholesale from what point?
point of obtaining wholesale drug and sending out to different pharmacies
How do states enforce law?
police powers and 10th amendment
What is required to allow a person other than the one who signed the registration to execute a 222?
power of attorney (POA)
What is scope of practice?
practitioners authority to perform actions in their field of practice, as determined by state
What is the burden of proof in a civil case?
preponderance of evidence
What is the process of using a LTCF emergency kit?
prescriber must issue prescription to pharmacy, and pharmacist must authorize nurse to dispense from kit
Only a _____ can authorize a refill; however, authorized ______ of the prescriber can transmit the prescriber's refill authorization.
prescriber; agents
What are the prescriber requirements for CS electronic transmission Rxs?
prescribers must... •undergo identify proofing •digitally sign using 2 of three possible factors for identification
You can put a ______ label on an _____ drug, but you can't put an _____ label on a _____ drug.
prescription; OTC; OTC, prescription
What is the general rule for dispensing C-II drugs?
prescriptions must be written and signed by prescriber
Who appointments the FDA commissioner?
president
What is a pocket veto?
president doesn't sign veto but congress adjourns before 10 days
There is a _____ of interstate commerce in federal regulation of CS.
presumption
When must an inventory be conducted containing a complete and accurate record of all CS "on hand"?
prior to beginning business and subsequently q2years
The USPC works closely with the FDA, but is _____.
private
What HPCUS is a _____ organization.
private
What does the FDA require to inspect a pharmacy/hospital to determine if the entity is compounding or manufacturing?
probable cause
What is required to obtain an AIW?
probable cause with root in a valid public interest
What does it mean to manufacture?
produce, prepare, compound, process, package, repackage, label, or relabel a drug
Cosmetic manufacturers must substantiate _____ _____.
product safety
What are biologics?
products derived from living organisms
What does bioequivalence mean?
products display comparable bioavailability (rate and extent of absorption) at the site of action under similar conditions
What should pharmacists exercise when called upon to substitute B-rated NTI drugs?
professional judgment
What did the Pure Food & Drug Act (1906) do?
prohibited the adulteration and misbranding of foods and drugs in interstate commerce
How must the identification symbol of the schedule on commercial labeling of CS be located?
prominently
How do administrative agencies make laws?
promulgate regulations that interpret, define, and add detail to statutes
How does the FDA have rulemaking authority?
promulgation of regulations
If a registrant wants to transfer their business, what must they do?
proposal submitted to DEA at least 14 days prior to transfer with required info
How are biologics and biosimilars named?
proprietary name that includes FDA-designated suffix
What are the objectives of HITECH?
protect PHI privacy, reduce medical errors, reduce costs by improving administrative efficiency, improve coordination among providers, and improve public health and emergency response system
What was the purpose of the Poison Prevention Packaging Act?
protect children from accidental poisonings due to "household substances"
What must the plaintiff do in the case of negligence?
prove the four elements of negligence with preponderance of evidence AND disprove the defendant's affirmative defense
What must a pharmacy's policies and procedures that implement HIPAA privacy standards do?
provide for imposition of sanctions against any worker who violates privacy rules or pharmacy's policies/procedures
What does FDAAA require pharmacies to do regarding medwatch?
provide patients with medwatch number and statement about reporting side effects
What did the Orphan Drug Act (1983) do?
provided tax and exclusive licensing incentives for manufacturers to develop and market orphan drugs and biologicals
What is the public policy concerns factor in expanded pharmacist duty?
public policy favors recognition of expanded pharmacist duty in the cases of: 1. preventing intentional and unintentional drug abuse 2. not jeopardizing physician-patient relationship 3. avoiding unnecessary health costs
What is the Homeopathic Pharmacopeia of the United States?
publication by HPCUS that sets standards for homeopathy products
What information can the seller enter into electronic logbooks?
purchaser's name, address, date of sale, time of sale
What is the name of the book that lists biosimilars and interchangeable products?
purple book
How can CIII-CV drugs be dispensed?
pursuant to written, faxed, electronic, or oral order
How often must dispenser of CS register with the DEA?
q3years
Some states have stricter laws about general C-II drug prescriptions, such as .... ?
quantity limits, time limits, security Rx forms
_____ of drugs prescribed and _____ of Rxs alone are not indicators of improper prescribing.
quantity; frequency
What is considered as a basis for appeal?
question of law
What is the Orange Book?
rates pharmaceutically equivalent drugs on the basis of therapeutic equivalence using a two-letter coding system
Upon receipt of an order pursuant to 222 form, a purchaser must do what?
record number of containers received of each item AND date received
Return of CSs to suppliers by practitioners is exempt from the definition of distributing provided what?
recordkeeping requirements are met: •date of transactions •name/form/quantity of substance •name/address/registration number of person making distribution •name/address/registration number of supplier or manufacturer
Oral orders for CIII-CV drugs must be promptly _____ ___ _____.
reduced to writing
What is the exception to financial remuneration related to communication constituting as marketing?
refill reminders
What is form 106?
registrant fills out in case of CS theft/significant loss
What is form 41?
registrant fills out in case of requesting CS disposal/destruction
What are the requirements regarding theft/loss?
registrant must notify DEA within one day of discovery of any "theft or significant loss" of CS
What must be done for disposal or destruction of CS?
registrant must request DEA form 41 (available online) and complete it
Registrants may not engage in activity where registration is required until ... ?
registration is granted and certificate of registration is issued (state and federal)
For IPs exempt from registration, what must they include on their prescription?
registration number of institution and special internal code number
How does the FDA interpret FDCA?
regulations and guidance documents
What did the Biologics Price Competition and Innovation Act create?
regulatory framework for biosimilars or "follow on" biologics
What are important determinants of duty?
relationship and foreseeability
CS labeling should be easily identifiable without pharmacists having to do what?
remove bottle from shelf (aka symbol has to be BIG)
The Dietary Supplement and Nonprescription Drug Consumer Protection Act requires manufacturers to do what?
report serious AEs
What must the attorney general (AG) have to make a scheduling declaration?
request scientific/medical evaluation of a drug AND recommendation from secretary of DHHS
How are 222s obtained?
requesting in writing from nearest DEA office
What did the Food Additives Amendment (1958) do?
required components added to food products to receive premarket approval for safety
What is DEA form 222?
required for any distribution of C-I and C-II drugs (including reverse distribution)
What did the Prescription Drug User Fee Act (1992) do?
required manufacturers seeking NDAs to pay fees for applications and supplements, not the public
What did the Color Additive Amendments (1960) do?
required manufacturers to establish safety for color additives in foods, drugs, and cosmetics
CS labels must include all _____ information PLUS what?
required; cautionary statement prohibiting the ultimate user from transferring the drug
What is sterile compounding?
requires maintenance of sterility (free of contamination)
What is a veto?
return bill with reasons for dissaproving
Under the Food, Drug, and Cosmetics Act (1938), the FDA had no authority to do what?
review medical devices for safety and efficacy
Off-label prescribing and dispensing requires professional evaluation of ______ v ______.
risk; benefit
The FDA prioritizes enforcement of marketed unapproved drugs with highest priority to drugs that present _____ risks.
safety
The 4th amendment requires the issuance of a ____ _____ based on ____ ____.
search warrant; probable cause
Who does the FDA commissioner report to?
secretary of DHHS
Who has the actual authority for administering the FDCA?
secretary of DHHS
How must IPs store CS?
securely lock in a substantially constructed cabinet
How must pharmacies or institutional practitioners store CS?
securely lock in a substantially constructed cabinet or disperse throughout stock of nonCS
According to the MPPA, sellers must annually engage in ____-_____.
self-certification
What are "rogue internet pharmacies"?
sell Rx medications to customers either without requiring Rxs or by issuing Rxs pursuant to online surveys
Who confirms the FDA commissioner?
senate
How are 222 forms labeled?
serially numbered and issued with name, address, and registration number of registrants, authorized activity, and schedules registrant is authorized to handle
What kind of resolution is common in negligence cases?
settlements
What is methadone used for outside of narcotic treatment programs?
severe pain
What are three levels of non-sterile compounding?
simple, moderate, and complex
All three copies of form 222 must be executed ______.
simultaneously
What can "unable to supply" be broadly interpreted as?
situations beyond out of stock (patient can't afford or pharmacists is suspicious about validity)
What is excluded from the definition of cosmetics?
soap
Why do drugs that are both OTC and prescription exist?
some indications can be labeled with "adequate directions for use" (OTC), while some cannot (Rx)
A qualifying physician under DATA must obtain what?
special DEA number for "medication assisted treatment of addiction" (DEA number starts with X)
Labels for herbs must contain what?
standard common names as listed in the Herbs of Commerce (reference source)
How can HIPAA be used in civil breach-of-privacy lawsuits?
standard of care
What part of HIPAA is enforced by the CMS?
standards transactions
Guidance documents incorporate advice from who?
standing advisory committees of outside experts
Who can bring HIPAA violations to court?
state AG
IPs and ancillary personnel may dispense CS if permitted by ____ ____.
state law
The DEA generally has a close relationship with _____ _____ _____.
state pharmacy boards
What is a DEA inspector required to do prior to inspection?
state purpose of inspection AND present owner/PIC with credentials and a written notice of inspection (NOI)
The inspector must obtain what from PIC/owner?
statement of informed consent
Who defines prescriptive authority?
states
What do state PMPs enable?
states to determine possible diversion and abuse situations
How do legislatures make laws?
statutes (statutory law)
What type of law is comparative negligence?
statutory
What is the BUD for CSPs determined by?
sterility limits and chemical stability
What are section 505(b)(2) NDAs used to file for?
streamlined drug approval process for certain drugs and generic approvals that do not want to go through full NDA or ANDA (can rely on published safety and efficacy data and/or the FDA's findings for a previously approved drug)
Violation of the FDCA is subject to ______ ______, but ____ ____ can be an applicable excuse as long as the violator cooperates with FDA investigation.
strict liability; good faith
Many states have ______ laws concerning sale of ephedrine, PSA, or PPA base products.
stricter
How does a manufacturer obtain a license to sell a biologic?
submit biological license application (BLA) that includes evaluation of purity, safety, and potency
What is the FDA biosimilar substitution law?
substitution allowed when FDA determines product is interchangeable
What are the only permitted drugs to be used under DATA in office-based settings?
subutex and suboxone
What was the catalyst for the Food, Drug, and Cosmetic Act (1938)?
sulfanilamide poisonings
What is the nature of a product dependent on?
supplier's intended use, NOT the buyer's
What allows federal law to preempt state law when they conflict?
supremacy clause
Who created the AIW as an alternative to the SW?
supreme court
How does one check a suspicious DEA number?
take sum of 1st, 3rd, and 5th digits take sum of 2nd, 4rd, and 6th digits, multiplied by 2 add sums of step 1 and step 2 determine if right most digit of this sum corresponds with ninth check digit
What is PKI?
technology that allows for secure online communication, providing --> •confidentiality •authentication •integrity •non-repudiation for a electronic ordering system
What are some examples of BA?
temp agency, people who remove PHI trash, cleaning services, accounting services
What drug was the catalyst for the Kefauver-Harris Amendment (1962)?
thalidomide
What must a pharmacy document about worker training?
that each worker has completed it
Transfer of business can occur unless ... ?
the DEA notifies otherwise
PHI must be provided to who if they request it?
the patient
Who bears the burden of proof?
the plaintiff
What does OTC drug review approve drugs based on?
therapeutic category and conformance to a monograph (rather than on a drug-by-drug basis like prescription drugs)
What is NOT described in an herb monograph?
therapeutic use
Unpermitted use or disclosure of PHI is presumed to be a breach UNLESS ... ?
there is a low probability that PHI has been compromised
Contrary to the DSHEA, in Pearson v. Shalala, the courts held that DS manufacturers could make health claims not approved by the FDA provided...?
they are not false or misleading, and they are accompanied by a disclaimer
All CS electronic transmission application systems must be approved by ____-____ ____ or certified by a ____-approved entity.
third-party audit; DEA
How many unapproved drugs does the FDA estimate are on the market today?
thousands
What are the three parts of the CSA?
title 1 - rehabilitation for drug dealers title 2 - registration/distribution of CS title - import/export of CS
What does it mean to distribute?
to deliver a DS
What does the Controlled Substance Act allow?
total combined quantity of 50 dosage units of controlled substance that must be transported personally across the border
What is a 503A pharmacy?
traditional pharmacy that compounds for specific patients pursuant to prescriptions (no cGMP required)
As opposed to disposal or destruction, what can a registrant also do with CS?
transfer to a reverse distributor using form 222 (send to distributor) for C-II or invoices for CIII-CV (send to distributor)
Any Rx dispensed by central filling pharmacies for another pharmacy given to the patient how?
transported to pharmacy that originally took prescription for furnishing to patient
The use and disclosure of PHI may be made for what purposes?
treatment, payment, and operations (TPO)
Each 222 form is in ____ titled ... ?
triplicate; copy 1, copy 2, copy 3
What is the PKI process?
trusted certification authority (CA) issues digital certificates to subscribers after validating their identify and authority, who then use these certificates to digitally sign CS orders that are placed using CSOS-enabled ordering software
What is HIPAA's intent in targeting national provider identities?
uniformity, simplicity, reduced cost
What kind of airflow must be present in a PEC?
unilateral with sufficient velocity to sweep particles away from compounding area
What is negligence?
unintentional act that causes harm, as contrasted from intentional torts
What is a drug sample?
unit of drug not intended to be sold, but instead intended to promote sale of drug
Why were people dying prior to the enactment of the Pure Food & Drug Act (1906)?
unsanitary and poorly labeled foods/drugs
Breach of PHI requirements apply to _____ PHI.
unsecured
Drugs in ADS are pharmacy stock ____ dispensed.
until
What amount of ephedrine, PSE, or PPA sold does not have to be recorded?
up to 60mg
For Rx information among pharmacies participating in common-electronic record systems, CS Rxs may be transmitted up to how many times?
up to max # of refills provided
When may the AG suspend or revoke a registration to manufacture, distribute, or dispense?
upon finding that the applicant materially falsified an application, has been convicted of a felony, or has had a state license/registration suspended, revoked, or denied
What are DSs?
vitamin, mineral, herb, other botanical, amino acid, or substance used to supplement the diet by increasing total dietary intake
What is medwatch?
voluntary reporting system to allow healthcare professionals to report any serious adverse events, product use errors, and product quality issues
PIC/owner consent must be ______ and not _____, and may be _____ at any time during the inspection.
voluntary; coerced; withdrawn
When do common and statutory law merge?
when courts have to interpret meaning/application of statutes
When is the only time post-dating is allowed by DEA for CS?
when there are multiple C-II Rxs for same drug and patient on same day
When will pharmacists be more likely to face enforcement action?
when there is blatant/glaring misconduct as opposed to isolated prescriptions
To what transactions does the Drug Supply Chain Security Act apply to?
where prescription drugs change ownership
What is conscientious objection as it relates to pharmacists?
whether pharmacist has right to refuse to dispense prescriptions when a moral or religious objection exists
What does the Medicare Modernization Act allow?
wholesale importation of Rx meds from Canada provided Secretary of DHHS would approve
If pharmacists in ambulatory setting partially fill a C-II Rx, when must the balance be filled?
within 72 hours after partial filling
Where do state laws apply?
within the state they were enacted
What is a yet-to-be-finalized rule regarding patients and disclosures?
would allow patients to request and receive all disclosures over three years
The use of PHI for marketing purposes requires what?
written patient authorization
What is labeling?
written, printed, or graphic matter "accompanying" a drug article
Inventory records must be ... ?
written, typed, or printed
Are HD products received and stored separately from non-HD?
yes
Are LTCF emergency kits permitted?
yes
Are bioequivalent products generally presumed to be therapeutically equivalent?
yes
Are pharmacists responsible for knowing of product recalls and notifying patients of recalls?
yes
Are there exceptions allowing treatment of addicts outside licensed addiction programs or DATA?
yes
Are unit dose labeling subject to different information requirements than regular commercial labels?
yes
Are you able to just sign for C-V drugs in some states?
yes
Can a PIC/owner grant limited consent?
yes
Can blanket authorization of disposal/destruction be allowed for hospitals?
yes
Can certain devices be available by prescription only?
yes
Can interchangeable products be substituted for reference products without intervention of the healthcare provider who prescribed the reference product?
yes
Can pharmacists and sales people disseminate requested scientific information to doctors in the absence of promotion?
yes
Can summary judgements be appealed in appellate courts?
yes
Can you transfer CS Rx to central fill pharmacies electronically?
yes
Do DS manufacturers have to conform to cGMPs?
yes
Do all prescription drugs marketed in the US have to have a NDC?
yes
Do investigational drugs need to be included on the HD list if they meet one of the NIOSH criteria?
yes
Do some states allow warrantless searches of pharmacies?
yes
Do the Color Additive Amendments contain a Delaney Clause?
yes
Does every state have its own laws?
yes
Does every state now permit pharmacists to substitute generically in some manner?
yes
Has the DEA published examples of suspicious CS Rx situations?
yes
If CE and BA use firewalls to safeguard PHI and they have a breach, do AI have to be notified?
yes
Is 224 available online?
yes
Is knowingly prescribing or dispensing a CS Rx not for a legitimate medical purpose illegal?
yes
Is negligent recordkeeping a violation of the CSA?
yes
Is off-label prescribing and dispensing legal under the FDCA?
yes
Is price advertising (reminder advertising) by pharmacies exempt from 502, provided certain conditions are met?
yes
Is product advertising by pharmacies subject to strict liability standard?
yes
Is there a difference between authorization of a refill and transmittal authority?
yes
May pharmacies make changes to CS electronic transmission Rxs after receipt?
yes
Must a pharmacy's "notice of privacy practices" be made available upon any request to any person?
yes
Must a pharmacy's "notice of privacy practices" be posted on its website, if it has one?
yes
Must a registrant allow the DEA to inspect records kept at a central location without a warrant?
yes
Must medication and chart orders from an institution be readily retrievable?
yes
Is actual cause often difficult to prove in drug cases?
yes (drug is gone from system)
Can political subdivisions within a state (municipalities) write their own statutes?
yes (ordinances)
Is the NDC number of the product optional for a registrant on a 222?
yes (supplier must enter it)
Can a physician titrate a patient with dependence off their medication?
yes!
When reporting previously shipped orders to a DEA, does a manufacturer/distributor have to report even if previous orders are not of unusual size, frequency, or pattern?
yes, as far back as records go
Can you fax CS Rxs to central fill pharmacies?
yes, as long as retail pharmacy maintains original hard copy and central fill pharmacy maintains faxed prescription
Do all states allow pharmacies to advertise drug prices?
yes, because of the virginia decision
If there is no buffer area, can sterile compounding still occur?
yes, but air in PEC must still be ISO class 5, and only low risk compounds can be made
Is enrollment in CSOS optional?
yes, but it is the only system that can be used to electronically order C-I and C-II
Can a supplier refuse an electronic order via CSOS?
yes, but must notify purchaser and give a reason why
Can a prescriber purchase CS from a pharmacy for patient office use?
yes, but the pharmacy must be registered as a DISTRIBUTOR
Does an employer have a right to sue its employee (pharmacist) for contribution if the plaintiff sues the employer and not the pharmacist?
yes, but this rarely happens
Do preliminary motions such as summary judgements establish precedent?
yes, even if the case ultimately gets settled out of court
Is the recommendation of the DHHS secretary regarding scientific and medical issues binding on the AG?
yes, except when AG finds drug must be placed in C-I to avoid imminent hazard to public safety
Does the DEA allow ADS?
yes, if state allowed (2005)
Are IPs authorized to prescribe (or issue medication orders) in their state?
yes, if they are registered with DEA or exempt from registration
Do practitioners need more than one registration when prescribing CS from multiple offices?
yes; must check to make sure you're using correct DEA number for each office when filling prescription
Can CS Rx information (except C-II) be transferred?
yes; only one-time between pharmacies if state allows AND requirements are followed by both transferring pharmacy and receiving pharmacies
What are some recent 2017 DATA updates?
•NP and PA who have completed 24 hours of required training may seek to obtain a DATA 2000 waiver for up to 30 patients •physicians who have prescribed buprenorphine to 100 patients for at least one year can now apply to increase their patient limits to 275 by practicing in a qualified practice setting OR holding additional credentials
What are C-II drugs?
•accepted medical use with severe restriction •high potential for abuse •abuse may lead to severe physical/psychological dependence
Scheduling decisions are based on what factors?
•actual or relative potential for abuse •scientific evidence of its pharmacologic effect, if known •state of current scientific knowledge regarding drug •history and current pattern of abuse •scope, duration, and significance of abuse •risk to public health •physiological or psychic dependence liability •whether the substance is an immediate precursor of a substance already controlled
What CS are tracked by ARCOS?
•all C-I and C-II (manufacturers and distributors) •C-III narcotics and gamma hydroxybutryic acid (manufacturers and distributors) •selected C-III and C-IV psychotropic drugs (manufacturers only)
What are some examples of C-V drugs?
•antitussives containing codeine •antidiarrheals containing an opiate •anticonvulsants (lyrica, gabapentin)
What are some practical considerations during an inspection?
•be cordial and cooperative •if inspection is not routine, PIC should contact owner and attorney (if necessary) •ask politely for ID and why they are here •never lie •generally best to say as little as possible •document what is said and done •do not sign anything not understood
What is the proposed single copy form 222?
•books of triplicate order forms would be replaced by a single sheet tamper resistant form •purchaser would send original completed form to supplier after making and retaining and copy •supplier would then send original completed form to DEA after making and retaining a copy
What are some examples of C-III drugs?
•certain stimulants •anabolic steroids •dronabinol •ketamine •paregoric •GHB approved by FDA
What are the important exceptions to the "minimum necessary requirement"?
•communications to patient •communications regarding the treatment of patient with other providers involved in their treatment •when authorized by patient •when required by DHHS for compliance and enforcement purposes
What are defenses to negligence?
•contributory negligence/ comparative negligence (its replacement) •statute of limitations
What can a pharmacist do to correct errors or omissions on C-II Rxs?
•corrections can be made if state law/policy permits •(DEA used to maintain that addition or changes could be made as with other CS rx, but this position has flip-flopped in recent years)
What does the Federal Controlled Substances Act (CSA) do?
•creates closed system via registration •establishes national uniformity (not really) •enforced by DEA
What are the recordkeeping requirements for partially filling to LTCF or terminally ill patients (up to 60 days from date of issuance)?
•date •quantity dispensed •remaining quantity authorized to be dispensed •identification of dispensing pharmacist
What are the information requirements of CS prescriptions?
•date of issuance (no predating/postdating) •full name/address of patient •drug name/strength/dosage form/quantity prescribed •directions for use •name/address/registration number of practitioner •must contain written/typed name or initial of dispensing pharmacist (before filing)
What are important PHI considerations for pharmacy students?
•de-identify all presentations involving patients unless specific patient authorization given •do not discuss patients in public areas •secure patient charts, computers, and electronic files containing identifiers
What is required in breach letter notifications?
•description of what happened •date of breach •date of discovery •specific types of PHI involves (do not include actually PHI) •steps the AI should take to protect themselves •description of what CE is doing to investigate, mitigate, and protect against future breaches •contact procedures for victims to ask questions (toll-free number, email, website, and postal address)
C-V products can be sold without an Rx (in some states) provided ... ?
•dispensing done by pharmacist (or intern if supervised by pharmacist) •purchaser is at least 18 •purchaser furnishes suitable ID •sale recorded in bound record book with all required information •does not conflict with state, local, or federal laws
What are the exceptions to C-II prescription being written and signed by prescribers?
•emergency situations •narcotic compounded drug for direct administration by infusions •LTCF patients •hospice patients •electronic (pursuant to requirements discussed later)
What must a purchaser do if an unfilled order form is lost?
•execute another together with a statement noting the serial number of the lost form, date of lost form, and that CS were not received •maintain together copy 3 of second order form and lost order form with statement •send copy of statement with copies 1 + 2 to supplier
What are some examples of C-I drugs?
•hallucinogenics •some opiates •methaqualone •gamma hydroxybutyric acid (GHB) not approved by FDA •bath salts
What must be contained in a pharmacy's posted "notice of privacy practices"?
•how pharmacy intends to use/disclose info •pharmacy's obligation to notify patient of breach of unsecured PHI •statement that individual can restrict certain disclosures of PHI to a health plan when the individual pays for the treatment out of pocket in full •descriptions of the legal duties of the pharmacy to protect the confidentiality of PHI •statement regarding uses and disclosures that require authorization •statement of patient's rights and a brief explanation of how the patient may exercise those rights •statement that patients may complain to the pharmacy of DHHS and that explains the method for filing a complaint •person in the company whom a patient may contact with privacy concerns
When may a practitioner orally authorize additional refills for CIII-CIV Rxs?
•if original was written for less than five refills AND •if authorization is recorded on hard copy or in automated system AND •if refill quantity does not exceed quantity originally authorized
What must CE and BA (of CE) do in regards to PHI disposal?
•implement reasonable safeguards to protect PHI that is disposed, including training workforce members who dispose of pHI •develop and implement reasonable policies and procedures for disposal
What is the difference between the lawsuits of Lemmon Company v State Board of Medical Examiners AND Zogenix v Patrick?
•in lemmon vs. state board, the company challenged a NJ regulation that prevented amphetamines from being used to treat obesity and that the regulation was inconsistent with federal law, to which the court replied it was consistent because it was related to controlling traffic in CS •in zogenix vs patrick, the court blocked a state order banning prescribing/dispensing of FDA-approved C-II xohydro ER because federal law preempted state's attempts to reach own conclusions about the safety/efficacy of a drug
What are the exceptions to when a warrant is not required for an inspection?
•initial inspection upon pharmacy opening •records are ordered pursuant to administrative subpoena •owner has given informed consent •situation presents imminent danger to public health/safety •exceptional/emergency situation where warrant would be impractical because of lack of time •search made incident to lawful arrest •inspection is limited to areas of commercial premises open to the public •when evidence is in "plain view"
What are US postal packaging standards for CS?
•inner container of parcel is marked/sealed and is placed into plainer outer container or securely wrapped in plain paper (can't have anything on outside that indicates its contents are a CS) •if inner container has prescription medications, it's also labeled to show name + address of pharmacy, practitioner, or other person dispensing prescriptions
What must IPs who are agents/employees of a hospital or other institution have to prescribe CS?
•institution must have assigned them a specific internal code number as a suffix to the institution's DEA number •log is maintained
What are general recordkeeping requirements for CS?
•kept for 2 years on site with exceptions •certain records (financial/shipping) may be kept at central location with notification to DEA •C-I and C-II records must be maintained separately •CIII-CV need not be maintained separately provided they are readily retrievable
What are C-III drugs?
•lesser potential for abuse than C-II •abuse may lead to moderate/low physical dependence or high psychological dependence •includes C-II drugs in combo with a noncontrolled ingredient, in smaller doses, or in less abusable form
What are C-V drugs?
•low potential for abuse relative to C-IV drugs •abuse may lead to limited physical or psychological dependence relative to C-IV drugs
What are C-IV drugs?
•lower potential for abuse than C-III drugs •abuse may lead to limited physical or psychological dependence
In what ways may a patient's written acknowledgement of a pharmacy's "notice of privacy practices" be extended?
•mail notice to patient with acknowledgement form that patient could sign and return •pharmacy could attempt to obtain acknowledgement directly •PR can act for patient (someone authorized by state law such as parent of minor/child, legal guardian, POA)
What does the Anabolic Steroids Act of 2004 do?
•maintains anabolic steroids as C-III •adds several steroids to previous act (~59 now) •provides for automatic scheduling of certain salts, esters, and ethers of anabolic steroids without need to prove muscle growth
What must a NOI contain?
•name of owner/PIC •name and address of business •date and time of inspection •statement that NOI was given
What is the required information on all records of receipt?
•name of substance •dosage form •strength of substance •number of dosage units or volume of container •number of commercial containers •date of receipt •name/address/registration number of supplier
What is the info required on an invoice for distributing CIII-CV drugs from a pharmacy to another practitioner?
•name of substance •dosage form •strength of substance •number of dosage units or volume of container •number of commercial containers distributed •date distributed •name/address/registration number of person to whom containers were distributed
What information is required in the bound record book when making nonprescription sales of C-Vs?
•name/address of the purchaser •name/quantity of CS •date of each purchase •name/initials of pharmacist
Dispenser research of C-I drugs requires what info be provided in the necessary application?
•name/qualifications of investigator •institutional affiliation •description of project •copies of IND and description of security precautions (for clinical research)
What are some examples of invalid prescriptions?
•narcotic Rxs written for purpose of maintaining or detoxifying an addict •Rxs written for fictitious patients •Rxs written without a good-faith medical examination •Rxs written when there is no medical reason
What are some examples of C-IV drugs?
•narcotics (dextropropoxyphene) •depressants (alprazolam, chloral hydrate, barbital, benzodiazepines) •stimulants (diethylpropion, phentermine, tramadol)
What are C-I drugs?
•no accepted medical use •high potential for abuse •lack accepted safety information
What are some examples of C-II drugs?
•opium •opiates •opium products containing hydrocodone •cocaine •stimulants (amphetamine, methamphetamine) •depressants (amobarbital, glutethimide, secobarbital, and pentobarbital)
How can state warrantless search statutes be constitutional?
•pervasively regulated industry •government's interest is in protecting public •statute limits time and scope of inspections
What is the relationship factor in expanded pharmacist duty?
•pharmacist-patient relationship is independent •patient relies on pharmacist because of knowledge and expertise
What was the historical position of courts on pharmacists' legal duty?
•pharmacists had no legal duty to warn a patient of adverse effects of a drug, and only had a duty to accurately dispense Rx as written •did not include model of patient-centered pharmaceutical care
What are the pharmacy requirements for CS electronic transmission Rxs?
•pharmacy or ASP must digitally sign and archive Rx •if Rx transmission fails, regulation establishes certain requirements must be followed
What is the scheduling authority of the AG?
•place an unscheduled drug into a schedule •place a scheduled drug into a different schedule •remove a drug from scheduling
What did the Combat Methamphetamine Epidemic Act (CMEA) of 2005 and Methamphetamine Production Prevention Act (MPPA) of 2008 do?
•placed restrictions on OTC drugs used to manufacture meth (including pseudoephedrine) •made new category of CSA (scheduled listed chemical products - SLCP)
What was the Hooks SuperX case?
•plaintiff injured back and during his course of treatment became addicted to propoxyphene •over several years plaintiff had propoxyphene prescriptions filled at an outrageous quantity and rate by the defendant pharmacy, more than anyone could consider normal •physician refused to furnish more prescriptions and plaintiff eventually when to rehab for drug addition •plaintiff sued pharmacy under theory that pharmacy breached duty of care by failing to stop filling prescriptions even though the pharmacist knew the plaintiff was consuming drugs so quickly it pose a threat to his health •defendant moved to dismiss case because they had "no such duty", court denied •defendant appealed, and indiana court of appeals concluded that no duty existed because it would undermine physician-patient relationships •plaintiff appealed? so FINALLY indiana supreme court decided to expand pharmacist duties based on three relevant factors that supported the imposition of expanded duty
Practitioners registered to dispense are exempt from the definition of distributing when they dispense CS to other practitioners for the purpose of general dispensing these medications to patients when they comply with what conditions?
•practitioner to whom drug is distributed is registered to dispense •distribution recorded with info of distributing and receiving practitioners •form 222 is executed if drug is C-I or C-II •total number of dosage units distributed does not exceed 5% of the total units of CS substances distributed/dispensed in one year
What acts can a LTCF nurse acting as a prescriber agent perform?
•prepare written Rxs for doctor signature •transmit fax for doctor that has been signed by prescriber (including C-IIs) •NO TRANSMITTING C-II UNLESS SIGNED FAX •can convey oral CIII-V prescriptions , but NOT CII even in an emergency
Sales involving ephedrine, PSA, or PPA base products must be recorded with what required information UNLESS LESS THAN 60mg of PSE?
•product name •quantity sold •purchaser's name •address of purchaser •date and time of sale •signature of purchaser (electronic, paper bound book, or signing printed document at time of sale)
What is other permissible use of disclosure of PHI?
•public health activities •judicial and administrative proceedings •law enforcement purposes •serious threats to health or safety •as required by law
What five factors are considered when determining if a registration is not in the public interest?
•recommendation of appropriate state licensing board •applicant's experience •applicant's conviction record with respect to CS •applicant's compliance with applicable state, federal, or local laws •any other conduct by applicant that may threaten public health/safety
Partial filling of CIII-CV Rxs is permitted provided .... ?
•recorded in same manner as refill •total quantity dispensed does not exceed total prescribed •no dispensing after six months from date of issuance
What must be done upon discontinuance of a business without transfer of that business?
•registrant must return certificate of registration to DEA for cancellation •registrant must return any unexecuted form 222s •CS must be disposed of pursuant to regulations
What were the reasons for traditional rule of law in pharmacy?
•relationship •physician is primary provider, not pharmacist (pharmacist would interfere with physician-patient relationship) •foreseeability (only physician has requisite patient info) •social policy (unfair burden on pharmacists)
What is comparative negligence?
•same principles as contributory negligence, but replaces the complete bar to recovery •reduces a plaintiff's recovery by the percentage that corresponds with the percentage of fault attributed to the plaintiff
What are other other requirements of written CS Rxs?
•signed on day of issuance •written in ink/indelible pencil or typed •manually signed by prescriber (e.g. fax or printed prescriptions must be manually signed) •must have stamped, typed, or hand printed name of prescriber in addition to their manual signature
What does the definition of dispense include?
•to deliver a CS pursuant to the lawful order of a practitioner •includes prescribing, administering, and dispensing
What are the exceptions of the "track and trace" requirements of the DSCSA for pharmacies?
•transfer from one pharmacy to another to fulfill a specific patient (filling a prescription) •distribution in a minimal quantity by a pharmacy to a practitioner for office use •distribution pursuant to a sale or merger of a pharmacy •distribution of drug/device combination products •distribution for emergency medical reasons •product returns
What was the Riff v Morgan Pharmacy case?
•woman given cafergot (ergotamine) suppositories for migraines, without being told to limit use of suppositories to 2 per headache or 5 per week (directions said to use every 4 hours) •pharmacist filled prescriptions as written •patient used too many suppositories and had toxic reaction, and sued pharmacy and physician •pharmacy argued that the limits of the pharmacist's responsibility to patient are to process medication orders accurately •court disagreed, and said that pharmacist is a member of the healthcare team, and as such must "play a brother's role with regard to others on the team"
What are CS III-V Rx transfer requirements for the receiving pharmacist?
•write "transfer" on the face of the transferred prescription •reduce to writing all information required on a CIII, CIV, or CV prescription including: -date of issuance of original prescription, original number of refills authorized, date of original dispensing, number of refills remaining, dates/locations of previous refills, transferring pharmacy's name/address/DEA number/prescription number, name of transferor pharmacist, pharmacy name/addresses/DEA number/prescription number from which prescription was originally filled
What are CS III-V Rx transfer requirements for the transferring pharmacist?
•write "void" on face of invalidated prescription •record on back of invalidated prescription the name/address/DEA number of pharmacy to which prescription was transferred and name of receiving pharmacist •record date of transfer and their name
How must an individual be informed of a breach of their PHI?
•written notice by 1st class mail or email if permitted by individual, and sent to next kin or PR if affected individual (AI) is deceased, unless contact info not available •urgent situations require additional notice (phone + email)
