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Fed Rx Laws 2011

Federal pharmacy laws of 2011

The FDA is part of what larger government department? DHHS (department of health and human services)
What are the 3 centers of the FDA? CDER, CBER, Center for food safety and applied nutrition
What can the FDA do? It's an administrative agency with extensive authority to make regulations/rules and provide guidance documents.
What are potential other agencies whose authority or rules can impact pharmacy practice? What can they impact? CMS, DEA [DOJ], OCR (office of Civil rights) for HIPAA, FTC (OTC advertising)
When was the Pure Food and Drug Act created? 1906
What is the purpose of the Pure Food and Drug Act? 3 key areas of focus Focus on PURITY and QUALITY by recognizing USP or NF (national formulary) standards. It also prohibited interstate sale of adulterated and misbranded drugs
What is the USP? Private org that establishes approved titles, definitions, descriptions for drugs. It makes standards for identity, quality, strength, purity, packaging, stability and labeling. It also published the USP (or NF)
When was the food drug and cosmetic act created? 1938
What is its primary focus? SAFETY
What did it do regarding the role of the FDA? Allowed them to oversee the manufacturing + quality of drugs, so BEFORE a drug can be marketed, manufacturer had to demonstrate SAFETY for proposed use.
What are "grandfathered drugs?" The pre-1938 marketed meds that did not have to demonstrate safety and efficacy because they were marketed before the food drug and cosmetic act.
What are the two major offenses this act recognized? 1) Misbranding 2) Adulteration
What is adulteration? When the quality or purity of the product is compromised; meaning its strength, quality or purity is not what's normally expected. The product may have been stored wrong, not manufactured under cGMP, or exposed to bad storage conditions
What is misbranding? 1) Product integrity is OK BUT 2)labeled incorrectly in a false or misleading way.
What conditions can make a product be considered misbranded? 1) Missing name or location of the manufacturer, packer, or distributor 2) No established name of active drug listed 3) It does not state Rx only if Rx drug 4)Breaks USP/NF rules.
Can a drug be a food as well? Yes, the definition of food, drug, device, and cosmetic are not mutually exclusive under the FDCA.
What is the FDCA definition of Food: article used for food or drink; gum; anything that can be used as component of above
What is a device under FDCA? 3 key conditions it must meet Instrument, implant, or related that is 1) recognized in USP/NF 2) used for diagnosis, cure, mitigation, Tx, prevention of disease in man/animal 3) indented to affect the STRUCTURE OR FUNCTION of human/animal W/O metabolism or chemical action.
What is a Drug under FDCA? 1) USE/NF/HPUS recognized 2) used in diagnosis, cure, mitigation, treatment, or prevention of disease 3) non-food particle that changes STRUCTURE OR FUNCTION 4) component of any above but not a device
When was the Durham-Humphrey amendment created? 1951
its purpose and what did it do? 1) Created Rx and OTC classes of drugs 2)Required Rx for "legend" drugs 3) Established dispensing guidelines for Rx drugs (oral scripts, refills of Rx)
What are BTC (behind the counter) drugs? 3rd class of meds sold only by pharmacist OR available only in a pharmacy. FDA traditionally did not see a need for this class of meds; now is considering it.
When was the Kefauver-harris amendment made? 1962
Its two key areas of focus? Focus on SAFETY AND EFFICACY
What drugs were impacted by the Kefauver-harris amendment? All new drugs post 1962 and NDAs approved post 1938 (post FDCA)
What did it establish? 1) GMP requirements for manufacturers 2) Made the FDA and NOT FTC responsible for Rx med advertising (OTC still under FTC)
What is the intent of cGMP, which is the minimum set of requirements for the methods, facilities, or controls used in teh manufacture, processing, packaging, or holding of a drug product. Ensure drug meets QUALITY and PURITY standards.
Does cGMP apply to pharmacies? No, manufacturers only. UNLESS you are TRANSFILLING oxygen tanks. then you need to adhere to cGMP.
Define: New Drug One that isn't recognized by experts as generally safe and effective
What categorization of drug can fit into this definition? 1) when it's a whole new chemical cmpd 2) old, established drug in a new dosage form, new therapeutic claims, or new dosage level, or for a different patient population.
More specifically: Fentanyl injc-->patch; cymbalta-->now for DM neuropathy; higher dose fluoxetine
Phase I trial? On small number of healthy patients to collect PK/pharmacology data to get safety
Phase II trial? Small number of pts with condition to collect safety/efficacy
Phase III trial? Large number of pts with condition for safety/efficacy/dosage/clinical/RCT
Phase IV: Post marketing surveillance
When did the Dietary supplement Health and education act (DSHEA) get created? 1994
What did it do? defined dietary supplements as foods rather than drugs and LIMITED fda's role in regulating them. EPIC FAIL of 1994. It also defined specific claims manufactures of dietary supplements can make.
What can be defined as a dietary supplement? Product that contains a "dietary ingredient" inteded to supplement a diet (...amino acid, concentrate, metabolite, constituent, extract or combo of above)
What are the requirements for a dietary supplement? 1) must be labeled as dietary supplement 2) Can't be presented as "conventional food" 3) Can't be represented for use as a sole item of a meal or of the diet (so it's A SUPPLEMENT; NOT A FULL MEAL OR MEANT TO STAND ALONE)
In adhering to cGMP, manufacturers of dietary supplements must do what in preparing to market product? Must evaluate purity, quality, strength, composition of products
What is the USP certification program? USP can test products and add the USP seal saying "dietary supplement verified"
What does that "deitary supplement verfied" seal mean? Voluntary program to test products to be verified independently for their dietary supplement claims (by USP)
What health claims can be made for Dietary supplements? Reduce risk of disease with supplement (Diets high in calcium may reduce the risk of osteoporosis)
What structure/function claims can be made? supplement can 1)Affects normal structure or function (calcium builds strong bones) 2) maintain normal structure or function "fiber maintains bowel regularity"
What MUST appear on all dietary supplement packs? statement saying "FDA has not evaluated the claim," and states "the dietary supplement is not intended to diagnose, treat, cure, or prevent ANY DISEASE"
Homeopathic drugs are recognized under what classification? the homeopathic pharmacopeia of the United states (HPUS)
Who regulates HPUS? FDCA
These products are presumed to be? What kind of safety/efficacy claims must they claim? They are presumed safe, and no proof of efficacy is required
Can they be Rx / OTC meds? Yes, can be either
Do they have to conform to cGMP? Yes! with the exception of 1) no assay 2) no expiration date
What is medicare? federal health insurance for those 65 and older (and for certain others with disability, regardless of age) like CKD for example
When was it established? What did it amend? Established in 1965 as an amendment to the SSA (social security act)
Medicare Part A is: Hospital coverage
Medicare part B: Physicians and other providers (optional coverage)
Medicare part C: Managed care plans (medicare choice, medicare advantage)
Medicare Part D: Drug plan (optional)
When was Medicare part D established? What act established part D? Medicare Modernazation act of 2003 (MMA)
What did the MMA further create in addition to the part D? MTM, required creation and implementation of e-prescribing
Regarding MTM, what did the plans have to provide? They had to have an MTM program, but they didn't specify who must deliver MTM services
ARe pharmacists recognized as medicare providers? Yes
Pharmacists need to be reimbursed for time spent counseling targeted patients including: multiple chronic conditions, multiple meds, high drug expenses
How did medicare regulate hospital pharmacy? Created basic requirements a hospital pharmacy must have
What are the requirements: 1) Must have a pharmacy directed by a registered pharmacist (or, in some cases, a drug storage area under pharmacist supervision. 2) It also said that adequate personnel must be employed and accurate records maintained.
When was medicaid established? 1965 amendment to SSA. Based qualification on income and assets.
Who administers medicaid programs? State administers, but medicaid is federally regulated and approved under CMS rules and regulations
Is a drug benefit plan Mandelbrot under medicaid? No, optional for the state to include/administer.
For whom are tamper resistant prescription pads required? For medicaid outpatient drug prescriptions that are hand written
What are the 3 requirements to be considered tamper resistant? 1) feature to prevent copying 2) feature to prevent erasing/modification of information written 3)feature to prevent use of counterfeit prescription forms
Does this apply to faxed/phoned in prescriptions at the pharmacy? No.
What is OBRA 90? The omnibus budget reconciliation act of 1990
What did it do? Established policy required drug use review (DUR) to ensure safe and effective drug therapy
What did it mean as far as pharmacists being able to bill for medicaid prescriptions? In order for a pharmacy to participate in a medicaid program, it had to follow the set of standards of practice for pharmacists established by OBRA 90.
What is a retrospective DUR? DUR board of physicians and pharmacists review med use trends and data over specified time periods and attemp to evaluate and improve medication use.
What is a prospective DUR? what are the 3 ways to do this. Solving drug therapy at the point of dispensing (checking scripts, counseling, documenting to avoid errors)
What federal regulations are placed upon LTC facilities? (3 key areas) 1) interdisciplinary care team must create a care plan for each resident 2) RPh must review meds monthly and report problems to PCP and director of nursing 3) Policies on drug admin, storage, prescribing, and record keeping
HIPAA information includes (3 key areas) patient's health status, health care or payment information
What must occur for each patient who walks into the pharmacy/hospital? Notice of Privacy practices must be provided to the patient
When can Protected Health Information (PHI) be used normally without explicit patient consent? Treatment, payment, or operations (TPO)
What if the PHI is not used for TPO, what must happen to allow use of PHI? Patient consent
When was the federal anti-tampering act created? 1982
What does it do? Makes it a federal offense to tamper with consumer products
What did it require regarding consumer products? Tamper-resistant packaging for certain OTC, cosmetic, and device products
When was the poison prevention packaging act created? 1970
Purpose of the PPPA? protect kids from accidental poisoning
What does it require? All NEW and REFILLED prescriptions MUST be dispensed in a tamper resistant closure
What are the exceptions NOT to dispense in a tamper resistant vial? 1) Prescriber can say no to ONE single prescription 2) Patient can request "blanket waiver" for all scripts or single one 3) When health professionals are responsible to admin the drug in institution/hospital.
What drugs are PPPA exempt=5 exemptions? 1) Sublingual nitro/isosorbide 2) Methylpred or pred in specific packs 3) UD forms of KCL supplements 4) Aerosol containers for inhaled therapy 5)OC/estrogen in dispenser packs
What is a RLD? Reference listed drug is the standard against which generic drug products are compared
What makes a product an equivalent? Same dose form and active ingredient with IDENTICAL strength
What is therapeutic equivalence? bioequivalence; same clinical effect and safety profile when admined
Orange Book Code A = (first letter) Therapeutically equivalent to RLD
Orange book code B - (first letter) Not therapeutically equivalent/insufficient data/still under review
Orange book code AA = second letter usually talks about dosage form drugs in conventional dosage forms, no bio equivalence problems
AB = established scientific Bioequivalence (actual or potential problems id and resolved)
What are Class I drug recalls? Reasonable probably of a SERIOUS, adverse health consequences or DEATH
Class II drug recalls? Temporary or medically reversible adverse effects. Remote probability of serious AE
Class III Not likely to cause adverse health effects
If a drug has an NDC, is it considered FDA approved? NO!! NDC is for ID purposes only.
What is the NDC? 11 digit number required with bar code on all Rx and OTC drugs and BIOLOGICAL PRODUCTS.
What prohibits the sale, purchase or trade of sample meds and restricts distribution to healthcare professioanls? The prescription drug marketing act of 1987 (my birth year!!)
Can RETAIL pharmacies receive samples? Not after that law (yay birth year!!)
In order for a prescriber to receive samples, what must he/she do? Written request for samples each time.
That is Tax paid alcohol? What kind of pharmacy uses it? Beverage liquor, regulated bby ATF, IRS used in community pharmacy
What is tax=free alcohol? Used only for medicinal, mechanical, and scientific purposes and in treatment of patients.
When was the Food and Drug FDA Amendments Act approved? FDAAA 2007
What did the FDAAA do? (4 things) 1) Created postmarketing safety initiatives to create REMS (medguides, PPI (patient pack inserts)) 2) DTC ad review 3) Tool-free ADR reporting and 4) created drug supply chain security through track and trace technology
What kind of information is federally required for select drugs (like SSRI) (comes from manufacturer) PPI or medication guide
What is pharmacy provided? Consumer medication information (CMI)
Is a PPI required only once? In a community pharmacy? In a hospital/LTC setting? Some meds require a PPI each time dispensing takes place in community pharmacy. In hospital setting, PPI is provided before the 1st dose and at least once every 30 days if therapy continues
When would a medguide be required? 1) Patient labeling could help prevent serious AE 2) product has serious risk relative to benefit 3) Patient adherence to directions is CRUCIAL
What are risk management programs? FDA programs for restricted distribution for high risk durgs
What are examples? iPLEDGE (tretinoin), CNR (clozaril national registry, and STEPS thalidomide (thalomid)
What kind of REMS are out there? (hint: two were already discussed) 1) Medguides and PPIs, 2) letters to healthcare providers 3) May required training dispenser/PCP, evidence of safe-use conditions 3) restricted distribution to certain settings (methadone clinics) 4) patient monitoring/registry
The side effect reporting statement with free phone number to report ADR must be placed where? 1) attached 2) preprinted vial cap 3) separate sheet 4) med information sheet 5) in FDA approved med guide
What is the medwatch program? Allows HCP to report SAEs, potential and actual product use errors, and product quality problems.
Where can one access a reporting shet? FDA website
What is the latest healthcare bill? Patient protection and affordable care act of 2010 and health care and education affordability reconciliation act
What are pharmacy related provisions in act related to doughnut hole? 1) Medicare coverage gab decreased $250 payment in 2010-->50% discount on brand name drugs in 2011 while in gap--->gone by 2020
Related to MTM? Plans MUST offer MTM services
RElated to OTCs? Change in FSA/HSA coverage of OTCs
Created by: farah.towfic


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