871 Law Exam 1
What is DSHEA?
Dietary Supplement Health and Education Act: significantly altered the FDA's authority to regulate dietary supplements, so supplements more like food than a drug
What is the difference between a dietary supplement and a drug?
Dietary supplements can't make claims about a disease (doesn't include deficiencies)
What are the main types of inspection a pharmacy may experience?
Routine Inspection triggered by knowledge, suspicion or formal complaint Who can inspect: FDA, DEA, BoP
What are the recent additions to the specific patient population sections of the PI?
The three categories Pregnancy Lactation Female and Male of reproductive health
What evidence does a manufacturer or the FDA need to show for a dietary supplement to be added to or removed from the market?
To be added: must have evidence to support claim/claim isn't misleading, but doesn't have to be FDA reviewed, but has to notify within 30 days of marketing product FDA needs to provide evidence to disprove the dietary supplement is safe or effective for use, can remove for adulteration but must prove this too
What is special packaging?
packaging that is designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time
Special packaging definition
packaging that is designed or constructed to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time. Some drugs like NGT are exempt from this
State definition
defined as "any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico
New drug definition
drug that is not generally recognized as safe and effective for the condition(s) or in the dosage form it would be prescribed under; or a drug that has been recognized as safe and effective but has not been used in the condition(s) or in the dosage form for a sufficient amount of time.
Orphan drug definition
drug used for a condition that "affects less than 200,000 persons in the United States" or a condition that "affects more than 200,000 persons in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug.
Controlled substance definition
drug with dependence liability or the potential for abuse
Behind the counter definition
drugs available to patients without a prescription after consultation with a pharmacist.
OTC drug definition
drugs that are safe and effective for use without a prescriber's supervision for certain conditions.
What is tamper-evident packaging?
if something is breached or missing, we can see an issue with the product
Therapeutic equivalent definition
pharmaceutical equivalents likely to have the same clinical and safety profile: exact same thing having exact same effect
Who enforces the PPPA?
CPSC: Consumer Product Safety Commission
What can agents do?
Call in non controlled and controlled medications
What is agency?
"I give you power to go deal with patient X" Power of attorney or DEA signing forms, or someone calling for a prescriber Agency law allows a nurse or other authorized individual to call in a prescription, clarify a prescription, and complete other tasks on behalf of the prescriber
What happens if the FDA does not meet the required timeline for approval?
180 days to respond to company with a response If no response, company can take FDA to court but lengthy process and will make approval even longer so company assists FDA in any way and come to new timeframe discussion
What are REMS?
Risk evaluation and mitigation strategies: make sure benefits outweigh the risks Prevention strategies
How long are prescriptions valid in our state?
6 months if its a CIII, CIV or CV Everything else up to a year from date issued Refills: Controls - 5 ; CII - not refillable ; Everything else no rule
What information does the Orange Book and Purple Book provide, and what information is not covered in these publications?
A product RLD: bioequivalent and therefore therapeutically equivalent A can be substituted B product RLD: not bioequivalent and not therpaeutically equivalent to RLD B can not be substituted AA: products in conventional dosage forms not presenting bioequivalence problems BX: products for which the data are insufficient ot determine therapeutic equivalence AN: bioequivalent solutions and powders for aerosolization Orange book doesn't provide: pharmaceutical alternatives or substitutions Alternatives: same drug/API but different salt so like metoprolol tartrate and succinate, different esters, or are different dosage forms or strengths Alternative: AL - aluminum salt Substitution: changing drugs within a class so simvastatin to atorvastatin Not in orange book: substitution and alternative
What are the pregnancy categories, and when may they still be used?
A: Pregnant women studies with no risk ; but still only be used if necessary B: No pregnant women studies: animal prego studies with no risk ; but only use if necessary C: No pregnant women studies, animal prego studies with potential for fetal risk, only use if benefits outweigh risks D: risk to human fetus in some way, only use if benefits outweigh risks X: Risk to human fetus in some way, risks outweigh any benefit, don't use PCPs use these categories or prefer to use them when discussing whether to prescribe certain medications during pregnancy and lactation
What are warrants, the two types discussed, and how do they differ?
Administrative inspection warrant (AIW) - Search warrant - higher standards to get one
What is adulteration?
Adulteration: issues inside the product or issues with the product itself Criteria: Filthy, putrid, or decomposed - expired, degraded, precipitation, unclean container, dropping a tablet, expires on last day of the month Prepared, packed, or held under unsanitary conditions - bad temperatures, inappropriate environment, bad repack, wasn't tested right, wrong cGMP (manufacturer/compounding pharmacy) Not manufactured under good manufacturing practices remember pharmacies don't fall under cGMP while compounding (exam question related) Composed of deleterious substance in container - aka bad container Unsafe coloring agent Adulteration if coloring agent is used in product, misbranded if its not listed on label Doesn't meet official standards Misbranded too if doesn't say "not USP" Usually herbals, not usually RX and OTC products Mixed to reduce quality or substituted Ex: using wrong diluent Dilute to make it last longer Adulterated if used proper dilution and then dilute farther, adding an extra step to what the proper dilution of vanc/drug is Inspection refusals Adulterated and misbranded
When is a pharmacist responsible for making sure something is dispensed in special packaging?
All the time, ensure it is resistant unless waiver Can't reuse CRC (unless new cap/bottle is glass, but just don't do it)
What statements can manufacturers make about dietary supplements?
Benefit related to a classical nutrient deficiency disease and disclose prevalence of such disease Describes role of nutrient/dietary ingredient intended to affect the structure or fx in humans Characterizes the document mechanism by which a nutrient or dietary ingredient acts to maintain such fx or structure Describes general wellbeing from consumption of a nutrient or dietary ingredient
What does the PPPA require?
Child resistant 90% of adults should open container without difficulty 85% of children four and older (under 5) who haven't seen packaging or way to open it, should not be able to open within 5 minutes 89% of children four and older but under 5 still can't open packaging after an adult shows them how
What type of products does the Anti-Tamper Act cover?
Commercially sold products to consumers aka stuff on shelves a person can grab with their hands
What is the difference between compounding and manufacturing?
Compounding: does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling Compounding must be for an individual patient Be based on a valid rx from a physician or practitioner Compounded by pharmacist or licensed physician Manufacturing: is more of compounding on a larger scale, changing more parts instead of just mixing things together
What is the depth of recall, and what are the different depths?
Consumer level, retail level, wholesale level - depends on product's hazard and extent of distribution
What products require special packaging?
Controlled substances for oral (not topical, suppositories, etc) Rx drug for oral consumption OTC drugs approved after 2002 initially prescribed OTC oral meds (ASA, APAP, diphenhydramine etc) Sample packages for medications If a product needs CRC and doesn't have it and we dispense it: misbranded because drug is okay but labeling is not/container
What are potential concerns related to dietary supplements, and what actions can pharmacists take to mitigate the concerns?
Counsel on appropriate uses or steer towards products with proven track records such as those conforming to USP or NF
When can you refuse an inspection?
DEA without a warrant
Drug definition
Drug: an article recognized in the official compendium or any supplement of the official compendium (2) an article "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal (3) an article (other than food) intended to affect the structure or any function of the body in man or other animal USP: United States Pharmacopeia (USP) NF: National Formulary (NF) HPUS: Homeopathic Pharmacopeia of the United States (HPUS)
What are the different classes and types of devices?
Easy way to think of it: more complicated devices usually have more parts, hence class III devices will have more parts Class I: Not used for supporting or sustaining life without any potential unreasonable risk of illness or injury - general controls Stethoscope, scissors, elastic bandages, toothbrush Class II: more serious devices, with more special controls to include promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendation and other appropriate actions Syringes, tampons, condoms, pregnancy tests, powered wheel chairs, immunoassays Class III: supporting or sustaining human life or for which a use which is of substantial importance for human health Pacemakers, heart valves, breast implants, soft contact lenses Class I: 47% of devicesClass II: 43% of devices Class III: 10% of devices FDA approval: class I need to notify them, Class III similar premarket approval
What can be recalled, and when can the government require a recall?
Everything but drugs, if drug recall needs to happen, legal process and court stuff has to happen with FDA
Why are REMS used, who develops them, and who approves them?
FDA approves REMS, and for safety
What rights does a pharmacist have if given notice of inspection?
FDA: let them in, so none basically DEA: Notice of inspection can say no and make them get a warrant BoP: can't resist and have to let them in
What is the Anti-Tampering Act, and what crimes did it create?
Federal offense to tamper with consumer products such listed on a shelf but not rx medications; those crimes listed as: Tampering or attempting to tamper with a product Tainting a product Communicating false info that a product has been tainted Threatening to tamper with a product Conspiring to tamper
What are waivers, who can issue them, and how are they issued?
Information above Prescriber or patient needs to decide if there will be a waiver If packaging is not child resistant, pharmacist must repackage product into CRC like pharmacy bottle or ask if pt wants nonCRC
What are the different types of REMS, and what does each require?
Four strategies for REMS Patient friendly labeling like med guides Communication plans for disseminating info to healthcare practitioner about the risks of drugs Elements to assure safe use (ETASU) - activities or clinical interventions before product, could also do iPLEDGE Implementation system Reviews the ETASU measures
How does generic drug approval differ from new drug approval?
Goes through an ANDA Just show product is bioequivalent to already approved product
What labeling is required for dietary supplements?
Has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease
What steps are involved in the IND and NDA process?
IND - Investigational New Drug Submit to FDA, and at each trial phase Into effect 30 days after submission unless FDA says need more info NDA - New Drug Application - The NDA must detail all of the information obtained during the IND process, which can often be hundreds of thousands of pages of material FDA has 180 days to respond Abbreviated new drug application: ANDA - therapeutically equivalent product aka generic
What must a principal do for an agent to complete a task or communicate a prescription?
In agency law, the "principal" is the person who delegates authority to an agent. The "agent" is an individual completing tasks that require a legal authority to complete and that the individual does not have on their own
What was the point of revising the information required around pregnancy, lactation, and reproductive risk?
Make information about using a drug during pregnancy or reproductive age easier to understand Previous PCPs would make decisions on category of pregnancy not underlying risk
What does each part of the NDC number indicate?
Manufacturer - 5 digits Drug - 4 digits Package size - 2 digits
What information is required to be on a prescription label?
Must have: Name and address of dispenser Where the person physically gets the medications handed to them Serial number of rx/rx number Date of prescription Date written or date filled, either one federally Prescriber name Should have but federally doesn't have to: Patient name Direction for use Cautionary statements
What is the NDC number?
National Drug Code: identify the product and is part of the registration or approval process for a product FDA request for NDC on labeling but NDC NOT REQUIRED 10 digit code into three groups - 5-4-2 Manufacturer - 5 letters usually, can be 4 or 6 Drug - usually 4 but can be 3 Package size - 2 digits NDC example: Janssen's Invokana 300mg is 50458-141-30 If needed an 11 digit number, just add leading zeros
When are manufacturers responsible for making sure something is made or dispensed in special packaging?
Never unless stated on the bottle, box, etc.
What are the requirements for tamper-evident packaging?
One or more indicators or barriers to entry which if breached can be expected to provide evidence of tampering Distinctive by design - not easily replicated If not distinctive: package must have one or more indicators/barriers that use a specific characteristic Provide a visual indication of package integrity with a single container or secondary containers Designed to remain intact during handling/distribution Must seal capsules and list technology to seal the capsules - most use stiff, gelatin based solid capsules Specific labeling: listing all tamper evident features so that it can't be removed
What does each pregnancy category represent?
Only when necessary: A, B When benefit outweighs risk: C, D Never/no benefit could outweigh risk: X
What are the Orange Book and Purple Book
Orange Book: Approved Drug products with Therapeutic Equivalence Evaluations Compares all pharm equivalents to the RLD and provides ratings is they're therapeutic equivalents to the RLD To be interchangeable: must be pharm equivalent and therapeutic equivalent Purple book: interchangeable biological products
What are the different types of labeling?
Package Inserts (PI) Patient Package Inserts (PPI) Medication (MedGuide)
What information do the different types of labeling provide, and whom are they written for?
Package inserts: drug monograph/prescribing information, specified by law and reviewed by NDA with boxed warning, indications, dosages, contraindications, warnings, special population use, clinical pharmacology, etc - for healthcare professional use from human and possibly animal studies Can provide PI to patient but not needed Must have have PI on shelf at pharmacy or then its misbranded Patient Package Inserts: FDA approved labeling in patient language which must be dispensed with the drug or then misbranding Manufacturer supplies these with the product, and can present whenever dispensing and with first dose, and do usually after 30 days again Estrogen/BC require PPI - think of the huge BC package inserts Medication Guides: FDA approved with patient language which explains issues to specific drug or class Must present to patient at every Rx fill/nefill with outpatient FDA required in some situations: PPIs, Mood altering agents, SSRIs, opioids, amphetamines, NSAIDS
What are the requirements for a pharmacist to compound?
Parts listed above but: Compounding must be for an individual patient Be based on a valid rx from a physician or practitioner Compounded by pharmacist or licensed physician
What are the required clinical trial phases, and what are the characteristics of each phase?
Phase 1: Humans, healthy for PK, effects, adverse effects, mechanism, metabolism, and safety, less than 100 patients Phase 2: Humans of disease ; "effectiveness of drug for indication" and see short term SE and risks, less than 1000 patients Phase 3: overall benefit to risk relationship of drug, thousands of patients
What is the PPPA, and why was it enacted?
Poison Prevention Packaging Act - prevent accidental poisoning in children under five, so four and younger Consumer Product Safety Commission (CPSC) rules over this protection CRC: child resistant containers, not childproof
When does agency come into play?
Power of attorney, signing DEA forms, someone other than a prescriber calling in a prescription
What information is required in the pregnancy, lactation, and females and males of reproductive potential sections?
Pregnancy: summarizes risk of taking medication during pregnancy Lactation: summarizes the risks of using the drug during lactation, if the drug is contraindicated and provides clinical considerations to minimize infant exposure/SE F/M of reproductive potential: information relevant to pregnancy testing or contraception use before, during, or after therapy and any information about fertility effects of the drug, including potential infertility
What is the PDMA?
Prescription Drug Marketing Act - enacted because some people diverted rx drugs/samples from normal distribution channels To protect public health and from drug diversion by establishing distribution of rx and sample drug standards
What are the different sections of the PDMA, and what does each entail?
Reimportation: can't reimport a drug unless done by own manufacturer or by the FDA for a drug shortage/emergency use Bans the sale, purchase, trade/offer of a rx drug purchased at a reduced price (hospital buying or donated drug) - keeps fair economy and competitive pharmacy marketplace Prohibits sale, purchase, trade, of drug samples and coupons - pcp need to ask for samples in writing Retail pharmacies can't have rx drug samples at any time - but closed systems such as hospitals/clinics can Set up handling/records of drug samples Drug sample: unit of prescription drug intended to be sold - so OTC not a sample (OTC = Not a sample) Violators/Whistleblowers: records for PDMA must be for at least 3 years, whistleblowers receive money for snitching, wholesale distributors must be licensed
Who can prescribe medications, and what can they prescribe?
Scope is basically like education, the scope of what you cover and learn and specialty is a finer studying of that Big four: Physicians (MD/DO), Dentists (DDS/DMD), Veterinarians (DVM), Podiatrists (DPM) - they can prescribe everywhere Physicians (DO/MD): whole body scope Dentists (DDS/DMD) - Jaw and face scope Podiatrist (DPM) - feet, ankles, sometimes hands Veterinarians (DVM) - only animals Mid level practitioners Optometrist - eye meds PA and Nurse practitioners - extent of supervising practitioner's specialty Dermalogy PA for skin but Internal Med PA has bigger scope Some set to just a formulary
What causes an article to be adulterated or misbranded?
See above and practice Failure to follow cGMP can result in both misbranded and adulterated Verbal statements can be misbranding to a patient like saying you can take a higher dose than listen on an OTC ibuprofen bottle - if they have an OTC and use Rx dosing because of you, they'd need monitoring so don't misbrand them
How does the FDA regulate dietary supplements, and how does it differ from drugs?
Seen more as a food than a drug, doesn't need prior review FDA can't require premarket approval before dietary is on the market
What must happen if the government can't recall a product?
Seize it and legal process
What exceptions are there to information on prescription labels?
Should have but federally doesn't have to Patient name Direction for use Cautionary statements
What is an inspection?
Someone comes in to look around duh-Ron lol
Are pharmacists required to follow the USP information, or is the information in the chapters enforceable?
Standards for competent practice so based on state's law, but not required to follow all of USP Some are law: such as drug monographs that establish testing, labeling, storing, etc
What information does USP's publication provide?
Standards for different areas of practice, some are law and some are good practice
Territory definition
Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
What are the types of recalls, and when might they happen?
Types of recalls opposite of that of devices, so think of P2 schedule, our first class was the most important because therapeutics All recalls of drugs are voluntary by company, FDA can't issue a recall, but can ask, and if a recall needs to happen, FDA does legal process FDA can mandate a device, biological products, and foods Recall types Class I Recall: reasonable probability that use will cause serious consequences or death Ex: botulinum in food Class II Recall: situation in which use or exposure to can cause temporary or medically reversible adverse health consequences Ex: pregnancy from mislabeled BC package Class III Recall: not likely to cause adverse health consequences
What general information do the different USP chapters provide?
USP 795: mostly Beyond use dates (BUDs), proper potency and without contamination (like the rest of it duh) USP 797: sterile compounding standards USP 800: handling of hazardous drugs in healthcare for drugs that are toxic, carcinogenic, (anything with a "city" ending)
What is the USP?
United States Pharmacopeia: published by the United States Pharmacopeial Convention (USPC), which develops standards around different areas of practice related to drug products This covers USP 795, 797 and 800
How does the naming of products work?
United States adopted names is in charge of this. Ensures that the name does not infringe on a legitimate trademark and grants the authority to change established names if necessary.
What is required for an inspector to enter a pharmacy for an inspection?
Warrant means let them in! FDA: notice of inspection, no need for a warrant DEA: Notice of inspection or warrant BoP: can't resist and don't need a warrant
What products do not require special packaging?
What drugs MUST be in special packaging: NONE -b/c waivers etc Non oral drugs - nasal sprays, eye drops, topicals, topicals to mouth like mouthwash, inhalation Waivers for non CRC PCP can write waiver for a rx, but just that one rx, can't do blanket for waivers, but valid for that rx and x refills Patients can give verbal, blanket waivers for all rx for single pt, doesn't have to be in writing! But good idea to document as a pharmacist Emergency medications, mnemonic aids, steroids, and assortment SL Nitroglycerine, isosorbide dinitrite Erythromycin granules - not sure why, just in there Estrogen, contraceptives, and anything in a manufacturer memory aid (Z-pack, BC, prednisone) Cholestyramine in powder form Potassium unit dose forms Betamethasone tablets (Steroids) Prednisone tablets (steroids) Medroxyprogesterone acetate (BC/progestin) Methylprednisolone (steroids) Colestipol Mebendazole
Prescription drug definition
a drug intended for use by man which (A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug (B) is limited by an approved application under section 355 of this title to use under the professional supervision of a practitioner licensed by law to administer such drug prescription drugs must have the symbol or statement "Rx only," "Prescription only," or "Caution: Federal law prohibits dispensing without prescription" on the product label.
Dietary supplement definition
a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (a) a vitamin (b) a mineral (c) an herb or other botanical (d) an amino acid (e) a dietary substance for use by man to supplement the diet by increasing the total dietary intake (f) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause
Device definition
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory. Three classes with class three being most life supporting
Label definition
any printed, written, or graphic material on the actual product container. While, labeling is all labels and written, printed, or graphic material on the container, container wrapper, or accompanying the product.
Established name definition
applicable official name designated pursuant to section 358 of this title; or if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium...the common or usual name, if any, of such drug or of such ingredient...
Person definition
includes individual, partnership, corporation, and association
Pre-'38 drug definition
is a drug that was introduced before 1938 and was still on the market in 1962. These drugs were assumed to be safe for use and effective for their indication based on the longevity on the market. Villa had a question relating to this regarding morphine, so not all drugs on the market have gone through FDA process
New drug application (NDA) definition
is the application sent to the FDA once all clinical trials and data have been collected on a new drug to have the drug approved for marketing.
Abbreviated new drug application (ANDA) definition
is used by generic manufacturers to prove bioequivalence and proof of acceptable manufacturing practices and controls
What is misbranding?
issues outside of the product or issues with the words associated with the product Criteria: False or misleading labeling Missing info, unapproved info, needs labels, rx info, med guides, advertisements and all need FDA approval Manufacturer information Must list name and place of manufacturer, packer, or distributor NDC optional Quantity information Need tablet count, oz, etc Prominently displayed information on labels Can't hide information on label, have to be seen by "ordinary" individual Established names List all generic names active ingredients/inactive ingredients needed Generic name in half the size of brand name - subjective of size vs. font Adequate directions and warning in labeling Usually for otc bc person isn't a medical professional Directions for use, when to d/c a product warnings Official drug packaged as required Listing how to package or store (glass vial, light resistant packages, temp requirements, desiccant requirements) Labeled for deterioration Note on label how it deteriorates: precipitate, expiration dates If its missing an expiration date, its both adulterated (compromised most likely) and misbranded Misleading container or imitation Can't imitate something else and not be it Kleenex example, "I can't believe its not TYLENOL" aspirin product Dangerous to health as prescribed Based on standard recommended dosing, after clinical trials and received approval Ex: Vioxx Color additive and not labeled Can also be adulterated too if its a harmful dye/color thing Established name in advertising and other requirements List all the SE, generic names, API in advertisements Packaging in violation of the PPPA Packaged in CRP - child resistant packaging, or if got an exemption like a VERBAL or written statement from a patient (can be a blanket waiver), or waiver for a script from a PCP but thats not a blanket waiver Exemptions for emergency meds REMS not followed Risk evaluation and mitigation strategies Fails to bear product identifier Bear RX only or prescription only, or Federal law prohibits dispensing without a prescription
Pharmaceutical equivalent definition
products with the same active ingredient, same dosage form, and the same strength - everything the same, but might just look different or from different manufacturers, have different release mechanism, or expiration dates: exact same thing
Investigational new drug (IND) definition
the application sent to the FDA asking them for an exemption to the NDA requirements to investigate and conduct clinical trials on the new drug.
What makes something pharmacy compounding and not outsourcing?
the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug. If you don't follow the pharmacy compounding rules, you lose status and get bumped to stricter, more stringent rules as a punishment basically
What is the reference listed drug (RLD)?
the listed drug identified by the FDA as the drug product upon which an applicant relies in seeking approval of its ANDA
