Branches of Government PDF

Branches of Government - legislative, judician, executive legislative - make laws judicial - interpret laws executive - enforce law administrative - make laws, interpret, enforce laws types of laws in US - constitution, statutory law, administrative law, common law US constitution law - -supreme law...

Branches of Government - legislative, judician, executive legislative - make laws judicial - interpret laws executive - enforce law administrative - make laws, interpret, enforce laws types of laws in US - constitution, statutory law, administrative law, common law US constitution law - -supreme law of US -any federal or state law that conflicts is invalid -27 total amendments -first: freedom of sepech statutory law - a law made my legislatures (elected body of persons; Congresss) descriptive - statutory laws are ___, not perscriptive -intentionally vague statutes - organized in the following hierarchial order 1. federal statutes 2. state constitutions 3. state legislation 4. ordinances administrative law - The body of law created by administrative agencies (in the form of rules, regulations, orders, and decisions) in order to carry out their duties and responsibilities. -called regulations regulations - interpret and define statutes created by congress common law - -law made by courts -when two or more parties cannot settle a dispute or controversy among themselves, they are likely to ask the court to settle -duty of court is to apply the power law to the facts before it and resolve the matter through judicial opinions which are enforceable by law -necessary when courts are needed to help interpret the meaning of statutes stare decisis - Let the decision stand; decisions are based on precedents from previous cases -applies only to lower courts w/in the jurisdiction; courts will often carefully consider opinions from other jurisdictions -establishes continuity of decisions -expedite judicial decision making criminal law - defines the limitation of the relationship b/w an individual and society ex. murder civil law - pertains to the relationship among individuals in society -ex. money issues administrative law - assures adherence to regulations -ex. losing licenses statute of limitations - a law stating the amount of time someone has to initiate a lawsuit infraction - fine or imprisionment 5 days to 1 year imprisonment, community service, probation felony - >1 year to life imprisonment power of attorney - the grant of authority of another to act on your behalf MORE - state law or regulation can be ___ strict than federal law or regulations (this would not be a conflict), but it cannot be less strict (this would be a conflict) stricter - always follow the ___ law product - federal law focuses on the ___ in pharmacy practice - state law focuses on the ___ in pharmacy FDCA (Food, Drug, and Cosmetic Act) 1938 - -provides for the comprehensive regulation of all drugs introduced into interstate commerce -protects consumers from adulterated or misbranded foods, drugs, cosmetics, devices -no new drug may be marketed and sold unless it has been proven safe and effective for its intended use and approved by FDA state pharamacy laws - who regulates pharmacy practice? FDA - administers the FDCA -component of the department of health and human services (DHHS) adulteration - what happens when you drop a drug on the floor all drugs - the FDCA provides for the comprehenive regulation of ___ introduced into interstate commerce -it also protects consumers from adulterated or misbranded foods, drugs, cosmetics, or devices state pharmacy laws - who regulates pharmacy practice? Department of Health and Human Services - what is the FDA a component of? FDCA - the FDA administers the Wiley-Heyburn Act - Pure Food and Drug Act of 1906 -the primary forefunner of today's Food, Drug, and Cosmetic Act Adulteratin and Misbranding - the Pure Food and Drug Act of 1906 prohibited ___ and ___ of food and drugs in interstate commerce sulfanilamide tragedy - the Food, Drug, and Cosmetic Act of 1938 was prompted by the ___ -this act, with amendments, is the nucleus of today's FDCA SAFE - with the FDCA of 1938, no new drug coule be marketed until proven ___ for use (establishd the drug approval process) safety - the FDCA addressed ___ only; says nothing about efficacy Durham-Humphrey Amendment of 1951 - The amendment established two classes of drugs: 1. prescription 2. over the counter the amendment allowed for: 1. oral prescriptions 2. refills of prescription drugs -before package of this, drug manufacturers determined whether their products were prescription or OTC drugs establishing criteria - the durham-humphrey amendment resolved this situation by ___ for the classification of prescription drugs. All other drugs were considered nonprescription. Categorizing prescription drugs - -drugs unsafe for use except under the supervision of a practitioner because of the toxicity, the method of use, or collateral measures necessary to use the drug AND -drugs subject to the new drug application approval process DH Amendment 1951 - required that prescription drugs be dispensed: 1. upon the written prescription of a practitioner licensed by law to administer such drugs 2. upon the practitioner's oral prescription, to be promptly reduced to writing and filled by the pharmacist 3. by refilling a written or oral presentation if the refill was authorized by the prescriber either on the original prescription or orally, and then reduced to writing and filed by the pharmacist 4. by administration (dispensing) directly by the practitioner thalidomide disaster - The kefauver-harris amendment of 1962 was prompted by ___ Safe and Effective - this kefauver-harris amendment strengthened the new drug approval process by requiring that drugs be proven not only ___, but ___ -the efficacy requirement was made retroactive to all drugs marketed between 1938 and 1962 Orphan Drug Act of 1983 - pharmacetucial manufacturers urged congress to recognize that the NDA process was too expensive to develop drugs for diseases that affect relatively few people -congress passed this to provide tax and exclusive licensing incentives for manufacturers to develop drugs for the treatment of "rare diseases or conditions" rare disease or conditions - fewer than 200,000 americans Waxman-Hatch Amendment (1984) - Drug price competition and patent term restoration act -streamlined the generic approval process by requiring an Abbreviated New Drug Application (ANDA) instead of a New Drug Application (NDA), thus increasing access of generic drugs by the public innovator manufacturers - the drug price competition and patent term restoration act of 1984 is for ___ -established patent-term extensions or market exclusivity for 2-5 years, depending on when the regulatory review of the drug began and how much time it required patent term extensions - available only if the patent has not expired markety exclusivity - works independently of a drug's patent status. In general, for new chemical entities aproved under an NDA, the ___ provision prevents a generic drug application from being submitted for 5 years from the date of approval of the drug PDMA (prescription drug marketing act) of 1987 - enacted to minimize drug diversion the most significant amendments included: -banning reimportation -banning the sale of drug samples PDUFA (Prescription Drug User Fee Act 1992) - requires manufacturers to pay fees for review of NDAs basically an application fee Fees provide the FDA with resources to hire more reviewers an hopefully speed up NDA reviews DSHEA (Dietary Supplement Health and Education Act of 1994) - -legally created a category of dietary supplements -mandates the FDA regulate dietary supplements more as special foods than as drugs FDAMA (food and drug administation modernization act of 1997) - provisions include: 1. pharmacy compounding 2. expediting study and approval of fast track drugs 3. elimination of certain labeling requirements 4. dissemination of off-label treatment information 5. encouragement of pediatric studies pharmacy compounding - FDAMA clarified that the compounding of pharmaceutical products was approriately regulated by the states and exempted pharmacies from requirements for compliance with NDAs when compounding drugs for an identified individual patients expediting study and approval of fast tract drugs - FDAMA established requirements for deignation of a drug as a "fast track" product to facilitatie the development and expedite the review of drugs that treat a serious or life-threatening condition and demonstrate the potential to addresss unmet medical needs for such a condition Rx only - the FDAMA amended that "caution: federal law prohibits dispensing without a prescription" on the label of prescription products changed to "___" dissemination of off-label treatment infomation - FDAMA provided incentives for manufacturers to conduct research on new uses of drugs and to file supplemental NDAs for these uses by allowing manufacturers to disseminate limited information on unapproved uses of drugs while in the review process encouragement of pediatric studies - FDAMA encouraged drug manufacturers to preform pediatric studies by providing them with an additional 6 months of marketic exclusivity of the drug FDAAA (Food and Drug Administration Amendments Act 2007) - the law provides the FDA w/ significantly enahnced responsibilities and authority to regulate drug safety Food - An article used for food or drink in humans or animals, chewing gum, and substances used as components of food or drink cosmetic - article 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 the appearance. any component of the above articles is considered to be this as well diagnosis, cure, mitigation, treatment, or prevention - drugs are articles intended for use in the ___ of disease in man or other animals New Drug - a drug "not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use" -hasn't gone through drug approval process drug approval process - 1. submit investigational new drug application 2. conduct clinincal trials 3. submit new drug application name of drug, drug composition, methods of manufacture and quality control, information from preclinical investigations regarding pharmcology, pharmacokinetics, and toxicology, information about the experience and qualitifcations of the clinical investigators, complete outline of proposed clinical trails - IND applications must include purpose of IND - Protect the safety of humans who will participate in the clinical trials, ensure that the clinical trails are designed properly so as to prevent problems during hte NDA review 30 days - if the FDA does not reject the IND within ___ of submission, human clinical testing may begin Phase 1 clinical trials - subject: small number of healthy individuals purpose: determine effectiveness of the drug and to obtain information about adequate dosage, relative safety, and AE conducted by sponsoring company Phase 2 clinical trials - subjects: 100+ patients who actually have the disease the drug is intended to treat purpose: determine the effectiveness of the drug and to obtain information about adequate dosage, safety, and adverse effects conducted by: sponsoring company phase 3 clinical trials - subjects: hundreds or thousands of pts; often occur in actual clinical settings such as hospitals/doctors' offices purpose: to obtain data concerning the drug's effectiveness as compared to a control group that receives placebo. Most are double blinded. conducted by: independent investigators at remote and varied clinical sites informed consent - all three phases of clinical trials, the FDCA requires the investigators to secure the ___ of the patient for administration of an experimental drug. This requires that potential participants know the risks, possible benefits, and alternative courses of tx postmarketing surveillance - under the provision of this, the manufacturer must submit to the FDA 1. reports of serious AE 2. new information relating to the drug's safety and efficacy 3. information about current clinical studies 4. the quantiy of drugs distributed 5. information about labeling and advertising long term - ___ ae may not be discovered before approval phase 4 studies - 1. obtain dataa regarding the drug's safety and effectiveness 2. determine new uses for, or abuses of, the drug FDAAA - granted the agency authority to require phase 4 testing for any prescription drug widespread accesss - FDAMA modified the FDCA to state that an investigational new drug may be provided for ___ outside controlled clinical trials to treat patients with serious or immediately life-threatening disease for which no comparable or satisfactory therapy is available. FDA IND Treatment Approval - all of the folowwing apply: 1. used for a serious or immediately life-threatening disease or condition 2. no comparable or satisfactory alternative therapy available 3. drug under investigation for the disease or condition 4. sponsor is actively pursuing marketing approval of the drug 5. in case of serious diseases, there is sufficient evidence of safety and effectivenss for its use 6. in the case of immediately life-threatening diseases, there is a reasonable bias to conclude that the drug may be effective and would not expose patients to unreasonable and significant risk right to try - allows eligible patients to have access to investigational drugs pt has 1. been diagnosed with a life-threatening disease or condition, exhausted approved treatment options and unable to participate in a clinical trial 2. eligable drug is one that phase one has been completed and not FDA apporved for any other use -in May 2018, congressed passes a federal ___ law as an amendment to the FDCA -creates alt pathway to investigational drugs by removing the FDA from the process, allowing the patient to go straight to the manufacturer 21st century cares act - designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently Emergency Use Authorization (EUA) - mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies -est. 2004 -does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency EUA submission - include all safety data accumulated from phase 1 and 2 studies conducted w/ the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2 months (meaning that at least half the vaccine recipients in phase 3 clinical trials have at least 2 months of follow up) after the completion of the full vaccination regimen ANDA - need to demonstrate bioequivalence and acceptable manufacturing methods and controls type 1 chemical - new molecular entity type 6 chemical - new therapeutic indication for a drug already approved Type P - indicates that the drug represents a major therapeutic gain because there are no other effective drugs available for treating a particular illness of b/c it has significant advantages compared to currently marketed drugs -priority review type S - standard review -indicates that the drug is similar to other drugs on the marke NDC system - required for Rx and OTC drugs -11 digit code NOT - the NDC number does ___ have to appear on individual dosage units nor is there any federal law requiring that NDC numbers appear on prescription labels manufacturer code - first 5 numbers of NDC -manufacturer, packager, distributer product code - next 4 numbers on NDC -strength, dose form, formulation package code - last numbers on NDC package size and types imprint - the FDA requires manufactureres to ___ solid dosage forms, whether they are Rx or non-Rx products -must permit the ID of both the manufacturer and the specific drug product Good Manufacturing Practices (GMP) - set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product -ensures that the drug is safe and meets quality/purity requirements 2 years - manufacturers must be registered w/ the FDA and are normally inspected by the FDA for compliance with CGMP once every ___ adultering - refers to the composition of a drug misbranding - refers to the labeling of a product - is the labeling false or misleading? *if a drug is dispensed to a patient without adequate directions for use *if a prescription is refilled without an authorization from the prescriber *if drug is dispensed without the required patient package insert (PPI) or medication guide *if poison prevention act of 1970 pertaining to child resistant containers is violated medwatch - This is the FDA reporting service for adverse effects that occur from use of approved drugs. -report serious AE -potential and actual product use errors -product quality problems REMS - FDAAA granted the FDA another safety tool called ___, whereby the FDA can require a sponsor to establish special procedures directed at patient safety -require the manufacturer to submit periodic postmarket assessments of whether the drug's risks are being adequately managed -can require distribution of medguides, distribution of PPI, distribution of a communication plan aimed at health professionals Thalomid REMS - -indication: newly diagnosed multiple myeloma, leprosy, etc. -safety issues: severe birth defects/VTE -program requirements: prescribers and pharmacies must be registered, mandatory birth control iPLEDGE program - for isotretinoin -indication: acne -safety issuess: severe birth defects/depression/suicidal ideation/violence -program requirements: mandatory birth control, pregnancy tests class I product recall - there is a reasonable probability that the product will cause serious, adverse health consequences or death class II product recall - the product may cause temporary or medically reversible adverse health consequences, but the probability of serious health adverse effects is remote class III product recall - the product is not likely to cause adverse health consequences (mislabeling) label - refers to the written, printed, or graphic matter appearing on the immediate commercial container of a drug product labeling - the information printed on the label and outside the package of a drug product. It refers to all labels and other written, printed, or graphic matter either on the product, its container, wrapper, or accompanying the product -package insert, PPI, medguide sheet printed at pharmacy - not considered labeling. Not mandated or reviewed by FDA package insert - must be approved by the FDA before distribution boxed warnings - when the use of a drug may lead to death or serious injury, the FDA may require the warning of the special problem in the package insert to be placed w/in a prominently displayed box off-label - Any time that a drug is prescribed for an indication that is not FDA-approved and thus not listed in the drug's labeling, that use is considered ___ potentially dangerous - many ___ drugs must be dispensed with a PPI patient package insert - this is a documnet, provided by the manufacturer and written in lay language that is intended to educate the patient about the proper use and potential dangers inherent in the use of hte product accompanying it PPI requirements - -must be provided to the patient by anyone dispensing the drug. -must include one for each package that it intends will be distributed to the patient, and in turn, pharmacists must include one with each container dispensed, regardless of whether it is initially dispensed for a refill misbranding - failure to give a PPI to the patient is ___ PPI in acute/long-term care facilities - considered to have been given if given to the patient -before the first admin -every 30 days after serious and significant concern - in 1998, the FDA mandated the Medication Guide program for drugs posing a ___ MedGuides - required for a product if the FDA determines that one or more of the following circumstances exist -labeling could help prevent serious AE -serious risks relative to benefits that patient should be aware to decide whether to use/continue the med -patient adherence to directions is critical to the drug's effectiveness labeling - PPIs and MedGuides are federally mandated (for certain drugs) and are considered ___ -require FDA approval before dissemination consumer medication information (CMI) - written information provided by the pharmacy for all drugs -does not replace the PPI or MedGuide, it is not federally mandated and does not require FDA approval before distribution Mufacturer container label requirements - -name and address of the manufacturer, packager, distributer -established name of the drug -net quantitiy of the package -weight of each active ingredient contained in each dosage unit -Rx Only -Route of admin if not an oral dosage unit -special storage instructions, if approriate -manufacturer's control or lot number -expiration date established by the manufacturer brand name - does not need to be on the medication label Unit Dose packaging labeling requirements - -established name of the drug -quantity of the active ingredient in each dosage unit -expiration date -lot or control number -name of manufacturer, packer, distributer -any statements required by compendia if an official drug, or for unofficial drugs in any pertinent statement regarding special characteristics bar codes - the FDA does not require hospitals to use ___ NDC - the FDA ony requires the bar code to include the drug's ___ MedPaks - contain several solid dosage oral dosage forms with directions that specifically indicate the day and time that the contents are to be taken -usual info for unit dose packages is required, plus a serial number for the patient ___ in addition to the Rx serial numbers for each drug product Consumer Product Safety Commission (CPSC) - the poison prevention packaging act (PPPA) was administered by the ___ PPPA regulations - -requires the use of child-resistant containers for nearly all prescription drugs, nonprescription drugs, and hazardous household products CPSC - established testing protocols for child-resistant packaging. Test panels used to assess such packaging consists of 1. children under 5 2. adults 50-70 20% - a package will fail the child-resistant test if more than ___ of the children test panel can open the package in 10 minutes ONE - manufacturers may market ___ size of an OTC product for the elderly or handicapped in non-compliant packaging -must contain the statment: this package not for households with young children, or Package not child-resistant not - prescription drugs not intended for oral administration are ___ required to be dispensed with child-resistant packaging generic - established name of the drug Except - pharmacists must normally dispense oral prescription drugs in child-resistant packaging, ___ when the physician or patient requests noncompliant packaging -requests may be oral, but should ALWAYS be documented by the pharmacist tamper-evident packaging - FDA regulations written for the federal anti-tampering act requires that certain OTC drugs, cosmetics, and devices be manufactured in ___ Tempering - the improper interference with the product for the purpose of making objectionable or unauthorized changes tamper evident - Having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. -regulations do not require tamper-proof packaging b/c technology does not exist to eliminate the risk of tampering completely Federal Anti-Tampering Act Regulations - -variety of packaging methods may be used, as long as they meet requirements -labeling statement to alert the consumer to the tamper-evident features placed in a location where it still can be read if the package has been tampered -for two-peice hard gelatin capsules, 2 tamper-evident features must be used, unless the capsules are selaed then only 1 feature is required -allo ther products only require 1 tamper evident-feature Expiration Dating - dating required on manufacturer's containers Beyond Use Dating - dating of drug products that are dispensed by pharmacists may not - pharmacists ___ continue to dispense a drug product once its expiration date has passed. Most states require the pharamcist to remove any expired products from the working stock to an isolated area until the product cna either be destroyed or returned to the manufacturer shorter - the current guideline provided in the USP/NF is for re-packaged drug products to have the ___ of two potential dates: -6 months maximum -25% of the remaining time b/w the date of repackaging and the manufacturer's expiration date (divide remaining by 4, and add that time to the repackaging date) maximum of one year - there is no federal law concerning this type of beyond use date. Instead, some states have established their own guidelines, usually a ___ not longer, one year - multiple unit containers dispensed by pharmacists have a BUD ___ than the manufacturer's expiration date, or ___ from the date dispensed, whichever is less Med Pak - the expiration of the ___ should not exceed 60 days from the date from when it was prepared, or earlier if the manufacturer's expiration date of any drug in the package is actually earlier characteristics of non-prescription drugs - -Their benefits outweigh their risks -The potential for misuse and abuse is low -Consumers can use them for self-diagnosed conditions -They can be adequately labeled -Health practitioners are not needed for the safe and effective use of the product General labeling requirements for nonprescription drugs - -Name of the product -Name and address of the manufacturer, packer, or distributer -Net contents of the package -Established name of all active ingredients and certain inactive ingredients -Name of any habit-forming drug present -Cautions and warnings needed to protect the consumer -Adequate directions for use If any of the above information is missing, the nonprescription product is considered MISBRANDED Drug Facts in standard order - -active ingredients -purpose -uses -warnings -directions -other information -inactive ingredients pharmacist may refill nonprescription drugs w/o PA unless - -The dose requested is greater than the recommended dose on the label of the commercial OTC product -The prescriber has limited the number of refills on the original prescription -The drug is a Schedule V controlled substance where the number of refills must be designated by the prescriber -The individual state has set a time period limit for refills 15 business days - Dietary Supplement and Nonprescription Drug Consumer Act: -companies have to include contact information on their labels for consumers to reporting adverse events -the companies must also notify the FDA of any serious adverse event reports within ___ nonprescription drugs - label requirements for ___ for pregnancy and nursing mothers: -"if pregnant or breast-feeding, as a health professional before use" aspirin products - label requirements for ___ for pregnancy and nursing mothers -"it is especially important not to use this product during the last three months of pregnancy unless specifically directed to do so by a doctor" dietary supplement - a product that is intended for ingestion, is intended to supplement the diet, and contains any one or more of the following: -vitamin -mineral -herb or other botanical -amino acid -dietary substance for use by humans to supplement the diet by increasing the total dietary intake DSHEA (Dietary Supplement Health and Education Act of 1994) - -legally created a category and definition of dietary supplements -prohibited the FDA from regulating dietary supplements as drugs -mandated that the FDA regulate dietary supplements more as a special class of foods than as drugs -The FDA cannot require pre-market approval of dietary supplements as they do for drugs. -Dietary supplements may be marketed without their efficacy or safety proven. -The FDA would have to challenge products after they had been introduced onto the market if evidence surfaced that they are ineffective for the advertised or labeled use or are unsafe disease claims - not allowed on dietary supplements labeling per DSHEA -claims that explicitly or implicitly say that a product can be used to prevent, treat, cure, mitigate, or diagnose disease -these types of claims would subject the product to the drug requirement under FDCA structure/function claims - are allowed on dietary supplements labeling per DSHEA structure/function - when ___ is on label: -The following statement must appear: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." -The manufacturer must have substantiation that such a statement is truthful and not misleading. -The manufacturer must notify the FDA within 30 days of the marketing of the dietary supplement with such a statement. Medical Device Act of 1976 - amending the FDCA to establish a comprehensive system of device regulation that includes: -device classification -pre-market testing -standards of performance Class I medical device - requires the least amount of regulation b/c they post the least potential harm to consumers -general controls are adequate to ensure safety and effectiveness -ex. Needles, scissors, exam gloves, stethoscopes, toothbrushes Class II medical device - general controls are not adequate to ensure safety and effectiveness -products must meeet specific performance standards established by the FDA -ex. insulin syringes, infusion pumps, thermometers, diagnostic reagents, electric heating pads Class III medical device - require pre-market approval b/c they are life-supporting or life-sustaining or they prevent a potential risk of illness or injury -ex. pacemakers, contact lenses, replacement heart valves approval process for devices - -510(k) premarket notification -premarket approval -de novo pathway claims are made - the overriding factor in determining a product's status as drug or cosmetic may not be its ingredients, but what ___ for the product, especially on the label cosmetics - do not require premarketing approval from the FDA Generic Substitution Law - every state has enacted one; expanding the scope of pharmacy practice to allow pharmacists to sub a generically equivalent drug for the prescribed drug -apply only when a brnad name drug is prescribed -if the rx is written generically, the selection is not subject to the drug product selection law. In this situation, the pharmacist may dispense any product in the generic drug class using their professional judgement misbranding - labeling a substituted generic drug with a brand name drug would be considered what? bioequivalent - Pharmacists are responsible for ensuring that a substituted generic drug product is ___ to the prescribed brand product. pharmaceutical equivalents - Products that contain the same active ingredients and are identical in strength and are of the same dosage form bioequivalence - display comparable bioavailability (rate and extent of absorbption) at the site of action under similar conditions therapeutic equivalence - bioequivalence as termed in the Orange Book the orange boook - lists approved drug products that are pharmaceutical equivalents and rates them for therapeutic equivalence A rating - therapeutically equivalent AA, AN, AO, AP, AT - drugs with no known or suspected bioequivalence problems AB - actual or potential bioequivalence problems that have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence B rating - not therapeutically equivalent -drug products that hte FDA at this time, considers NOT to be therapeutically equivalent to other pharmaceutically equivalent products -may never have developed with the intention of making it bioequivalent to an innovator drug OBRA (Omnibus Budget Reconciliation Act) - requires prospective and retrospective DUR programs for Medicaid patients prospective DUR program - pharmacists are required to screen prescriptions for potential drug therapy problems b/c of: -therapeutic duplication -drug/disease CI -DDI -incorrect drug doseage -incorrection duration of therapy -allergy interactions -clinical abuse/misuse offer to counsel - OBRA 90 directs that in order to participate in the Medicaid program, states must enact requirements that pharmacists "___" Medicaid beneficiaries receiving Rx drugs ALL - although OBRA 90 only mandated the DUR, patient counseling, and patient medication record requirements for medicaid pts, most states have mandated these requirements for ___ patients state law - dictates who has the authority to prescribe and who may dispense drugs self-prescribing - is acceptable for some practitioners in some states, but some states have prohibited controlled substances pharmacist may refuse to fill - -the Rx is suspected to be forged or fictitious -the pharmacist will be violating a law if he/she fills it -drug is not in stock -pharmacist believes the drug will be harmful to the pt forged - written using the name and info of a legitimate prescriber fictitious - written creating information based on a nonexistent prescriber the pharmacy - once a Rx has been filled and dispensed, the prescription is legally owned by who? copy - if the prescriber or patient requests the actual prescription, the pharmacist should refuse but offer a ___ 10 years - MMA requires keeping medicare prescriptions for ___ 6 years - HIPAA requires keeping prescriptions for ___ 5 years - FDA can request prescriptions back to ___ 6 years - MS requires keeping prescriptions for ___ 2 years - controlled substance act requires keeping prescriptions for ___ -name of patient -Rx (serial number) -date when prescription is either written or dispensed -directions fur use -name of prescriber -name and address of pharmacy -any special precautionary statements that may be approriate - FDCA requires that every prescription bottle must be labeled with the ___ expiration date, lot number of drug, name of drug, manufacturer, strength, telephone number of pharmacy - not required on a prescription bottle pharmacy compounding - -medication is not commercially available -made for individual patients -cannot be sold in bulk for resale -cannot advertise specific drugs State boards of pharmacy - regulate pharmacy compounding pharmaceutical manufacturing - medication is commercially available -made in mass production -can be sold in bulk for resale -can advertise specific drugs (DTCA) FDA - regulates pharamceutical manufacturing the drug quality and security act - law that amended the FDCA to grant the FDA more authority to regulate and monitor the manufacturing of compounded drugs -created 503A and 503B 503A facilities - referred to by the FDA as a traditional compounding pharmacy that compounds in accordance to patient specific prescriptions and is required by the state boards of pharmacy to comply with USP nd guidelines 503B facilities - referred to by the FDA as an outsourcing facility that may product large batches with or without prescriptions to be sold to healthcare facilities as office use only or shipping out of state and is regulated by the FDA validates - every process in a 503B facility has to be ___ nonsterile - USP 795 sterile - USP 797 hazardous - USP 800 USP (United States Pharmacopeia) - -non-profit that sets standards for all drugs and compounding -does not do law enforcement FDA, state boards of pharmacy - enforce USP standards simple compopunding - ex. amoxicillin suspension -adding water and mixing -according the mannufacturer recommendations for BUD and stability data moderate compounding - ex. mixing two creams -stability isn't known or studied -BUD is uncertain due to lack of data complex compounding - ex. creating special transdermal dosage form -involves special training, equipment, facilities, procedures -probably won't see in community pharmacy USP 795 Requirements - -staff competency, training -potable water -designated area -cleanliness -plumbing -disposal containers -lighting -heating/cooling -formula records -recalls -pt complaints -designated expert -BOP rules/regulations -storage -documentation 6 months - 795 BUD for nonaqueous compounds - ___ or earliest expiration date of any ingredient 14 days - 795 BUD for water containing oral compounds (refrigerated) - ___ or earliest expiration date of any ingredient 30 days - 795 BUD for water-containing topical and semisolid compounds - ___ or earliest expiration date of any ingredient beyond use dates - assigned dates or timeframes after which a compounded sterile preparation (CSP) should not be used. -determined based on potential for microbial contamination, chemical degradation, or loss of potency -not expiration dates CSP category - factors that determine: -primarily based on environment/conditions of where compounded -level of garbing -environmental testing and monitoring -frequency of application of a sporicidal -based on BUD assignment CSP Category 1 - low risk level -revised: 24 hours refrigerated CSP category 3 - high risk level -revised: 24 h at room temp; 3 days refrigerated, 45 days frozen -old: BUDs may be older but can vary based on the specific conditions and requirements of hte CSP -sterility and endotoxin testing requirement 797 regulations (personnel and training) - -written testing -routine review/training -policies for testing/training -media fill tests 8 - ante area is ISO class ___ 7 - cleanroom is ISO class ___ 5 - work area (hood) is ISO Class ___ positive pressure - air flows out -for non-hazardous laminar flow hood - air blows towards you, clean if shut off, generally left on chemo hood (hazardous) - vertical air flow Buffer area - should not have sink/drain 797 requirements - need a spelled out quality assurance program -cleaning process spelled out in policies and procedures back to front - when cleaning in 797, go from ___, do not touch HEPA filter Personal Protective Equipment (PPE) - goal is to protect healthcare workers from exposure to hazardous drugs -2 pairs of gloves for chemo -chemo gowns for injectable chemo -cannot resuse gowns safety data sheets (SDS) - communicates the hazards of dangerous drugs and chemicals to anyone who compounds, stores, transports, or cleans these items -administered by OSHA OSHA (Occupational Safety and Health Administration) - administers SDS 30 years - SDS document must be kept on file for ___ BPCI Act (Biologics Price Competition and Innovation Act of 2009) - -allows for approval of biosimilars -subtitle of the affordable care act -FDA determines therpeutic equivalence -12 years marketing exclusivity to the reference product -first interchangeable biological product receives up to one year of exclusiviety over subsequent follow-on biologics biosimilar - a biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components, and has no clinically meaninful differences in terms of safety, purity, and potency (safety and effectiveness) from the reference product reference product - a biological product approved by the FDA under the Public Health Service Act based on a full complement of product-specific data, including nonclinical and clinical data generic biologic - is not approriate terminology b/c it implies an exact copy of the originator's product, which currently is impossible b/c of limitations in technology interchangeable product - a biosimilar product that meets additional requirements outlined by the Biologics Price Competition and Innovation Act. As part of fulfilling these additional requirements, info is needed ot show that this is expected to produce the same clinical result as the reference product in any given patient substituted - an interchangeable product may be ___ for the reference product by the pharmacist without the involvement of hte prescriber Zarxio - biosimilar for neupogen purple book - book with biological products and bio similar interchangeables