MPJE Federal
Prescribing authority: CNM
"within scope of practice" certified nurse midwife, formulary
Prescribing authority: DO
"within scope of practice" no restrictions
Prescribing authority: MD
"within scope of practice" no restrictions
Prescribing authority: PA/RNP
"within scope of practice" no restrictions
Cosmetic
(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap. SOAP IS NOT A COSMETIC unless perfumed medicated cosmetic is now a drug
Drug
(i) articles recognized in the USP, NF, HPUS (ii) articles INTENDED for use in the diagnosis, cure, mitigation, treatment, prevention of disease in man or other animals (iii) articles other than food intended to affect the structure or any function of the body of man or other animals (iv) articles intended for use as a component of any article specified in clause i, ii, iii
Prescribing authority: DVM
*animals only* no NRT yes to all others including oral contraceptives *sometimes used in animals*
Prescribing authority: OD
*eye only* no CII C-3 only all legend within scope of practice no OC, NRT, anxiety, weight loss
Prescribing authority: DPM
*foot only* controls and legends: yes no oral contraceptives, no NRT, no weight loss yes anxiety
Prescribing authority: DDS
*mouth only* controls and legends: yes no oral contraceptives, no weight loss yes NRT, anxiety
All prescriptions for controlled substances must contain`
- full name and address of the patient -name and address and DEA number of prescriber
Controlled Substance Registration
- individual practitioner (authorized prescriber) registered to prescribe CS - individual practitioner who dispenses CS - is prescriber is an agent or employee of a hospital, he can prescribe under the hospitals registration number with an internal control number added to the hospitals DEA number - a pharmacy (pharmacists working in a registered pharmacy do not need their own DEA) -Manufactuering CS I-V -Distributing CS I-V - Reverse Distributing of CS -Dispensing CII-V -Conducting research with CI -Conducting research with CII-V -conducting a narcotic treatment program using any narcotic drug in CII-V
Emergency CII Rx
- may be oral - quantity prescribed and dispensed is adequate to treat during emergency - is prescriber is not known, pharmacist must make reasonable effort to determine authority - prescriber must have written Rx delivered to pharmacist within 7 days (if mailed, postmarked within 7 days)
DQSA: Section 503b outsourcing facilities
- voluntary process for compounding pharmacies to register with the FDA - engaged in the process of compounding *sterile* drugs -outsourcing facility not required to be a licensed pharmacy - *may or may not obtain prescriptions for identified individual patients* - comfort to GMP that are different from manufacturers
DQSA and FFDCA Section 503A Final Guidance for Compounding Pharmacies
-Drug must be compounded for identified, individual patient pursuant to a prescription or a notation that says a compounded product is required - Drug must be compounded pursuant to a prescription or before receiving a prescription if there is a history of compounder receiving past orders - Drug must be compounded in compliance with USP chapters on compounding, using bulk substances that comply with applicable USP or NF monograph: guidance provides compounded drugs should only contain bulk drug substances that are components of FDA-approved drugs or are subject of a USP or NF monograph -Drug must be compounded using bulk drug substances manufactured by registered entity - Drug must be compounded using bulk drug substances accompanied by valid certificates of analysis for each substance - If drug compounded using ingredients other than bulk drug substances, they must comply with applicable USP or NF monographs - drug being compounded cannot have been withdrawal or removed from the market by FDA because drug or its components are unsafe or ineffective - FDA has created a list that should be checked regularly 21 CFR 216.24 -Compounder cannot regularly compound "inordinate" amounts of drugs that are essentially drugs that are commercially available - compounder cannot compound drugs that FDA has identified as presenting difficulties for compounding that "reasonably" demonstrate a negative effect on drugs safety or efficacy - compounder is generally prohibited from distributing more than 5% of its prescriptions out of state - exempt from cGMP, certain labeling provisions, new drug applications/abbreviated drug applications if compounder complies with 10 conditions (identified patient, valid prescription, limited quantities) *compounding pharmacies regulated by the state BOP*
Dispensing outside of an opioid treatment program
-if dispensing methadone for an opioid treatment program, must have separate registration - pharmacy may dispense methadone for pain - pharmacy may dispense buprenorphine for addiction treatment without having a registration (prescriber must have a special DEA number with an X to replace the first character
4 aspects of healthcare information for HIPAA
1. Uniform electronic transaction and code sets: allows efficient electronic billing of rx claims, enforced by CMS 2. National provider identifier numbers for all providers 3. security: protects confidentiality, integrity and availability of patients health information 4. privacy
Pure Food and Drug Act
1906 Prohibits the adulteration and misbranding of foods and drugs in interstate commerce standards of purity and quality were defined by USP and NF unless manufacturers declared their own standards on product labels authorized seizures and criminal penalties for violations followed publication of "The Jungle" by Upton Sinclair
Sherley Amendement
1912 to the FDC Act defined misbranded: label contains any statement, design or device regarding the curative or therapeutic effect of such article or any of the ingredients or substances contained therein which was false and fraudulent
Food, Drug, & Cosmetic Act
1938 drugs required to be proven SAFE before shipment or marketing in interstate commerce. FDA must approve as safe prior to marketing "limit interstate commerce in drugs to those that are safe and effective" originally enacted as the Pure Food and Drug Act of 1906 requires labels to provide adequate directions for use FDA enforcement as a result of sulfanilamide elixir tragedy 1937 - massengill used diethylene glycol (antifreeze) as liquid vehicle, 107 deaths Many amendments but this is a current act that we operate under (durham-humphrey, kefauver-harris, dietary supplement health and education act, drug quality and security act)
Durham-Humphrey Amendment
1951 established prescription versus OTC drugs (before this only narcotics were dispensed on prescription only) legend drugs "caution: federal law prohibits dispensing without a prescription" served as an exemption from the FDCA requirement that the label of a drug contains adequate directions for use by the consumer now drugs have labeling which is directed at the prescriber and the parhamcist
Kefauver-Harris Amendment
1963 required drugs to be proven both safe and effective prior to marketing in interstate commerce drugs marketed prior to 1938 grandfathered in as long as label remained the same (never proven safe but on the market so long that they were considered safe) as a result of thalidomide induced birth defects 1962 - application at FDA, on market in Europe, used for N/V associated with pregnancy, birth defects caused FDA withheld marketing approval Rx advertising under the control of FDA, drugs can be marketed only for approved use, physicians may prescribe and pharmacists may dispense drugs for unapproved uses established CGMP requirements requires informed consent from patients participating in clinical trials FDA established DESI (Drug Efficacy Study Implmentation) review for drugs approved between 1938-1962 to determine if drugs safe AND effective
Poison Preventing Packaging Act
1970 enforced by the consumer product safety commission certain dangerous "household substances" must be packaged in childproof containers child proof containers required for all oral controlled substances, most oral rx drugs, some oral OTC products, and three topical Rx products plastic childproof containers may be used only once unless the container is glass the patient may request a non-safety closure (may be oral and may be a blanket request) the prescriber may direct a non-safety closure (blanket request not permitted) except: -SL nitroglycerin -SL isosorbide dinitrate in 10mg or less -sodium fluoride products containing nmt 264mg sodium fluoride/package -anhydrous cholestyramine in powder form - methylprednisolone tabs containing nmt 84mg/package - mebendazole tabs containing nmt 600mg/package - betamethasone tabs containing nmt 1.6mg/package - unit dose potassium supplements - erythromycin ethylsuccinate granules for oral suspension in packages containing nmt 8gm - colestipol in powder form up to 5gm/packet - preparations in aerosol containers for inhalation - pancrelipase preparations - prednisone tabs containing nmt 105mg/package - medroxyprogesterone acetate tablets - sucrose preparations in a solution of glycerol and water
Orphan Drug Act
1983 designed to encourage drug manufacturers to develop and market Rx drugs for conditions affecting <200,000 manufacturers given 7 years of exclusive marketing, waiver of NDA filing fee and tax credits
Drug Price Competition and Patent Term Restoration Act
1984 aka Waxman-Hatch Amendment designed to help BOTH major pharmaceutical companies and generic manufacturers - generic manufacturers can work on their copes of the brand name while patent still in force innovator of drug given at least 5 years of exclusive marketing or remainder of patent life (up to 20 years from the date the application is filed), whichever is longer ANDA - generic companies could use innovators data on safety and efficacy, requires two bioavailability studies If drug approved for a new use, 3 years of exclusive marketing for new use
Prescription Drug Marketing Act
1987 Only applies to prescription drugs requires states to license drug wholesalers (drug pedigree/product tracing established) bans the sale, trade or purchase of Rx drug samples in community pharmacies, hospital pharmacies may serve as custodian of samples for in-hospital physicians, mandatory storage, record keeping, handling of samples bans the reimportation of rx drugs manufactured in the US once the drugs are exported except when reimported by the manufacturer or for emergency medical care with permission of secretary of the department of health and human services prohibits the resale of Rx drugs purchased by hospitals or HMOs at preferential prices except for limited situations
OMNIBUS Budget Reconciliation Act
1990 required manufacturers to pay a rebate to the states based on volume of a drug sold only applied to new medicaid prescriptions (states have expanded to all rx) required pharmacists to 1. perform prospective drug use review on each new prescription 2. offer to counsel patients on each new prescription (not required for inpatient drug orders) 3. obtain and maintain patient information (patient may refuse to provide)
Prescription Drug User Fee Act
1992 fee required with every NDA (new drug application) or supplemental NDA filed with the FDA law requires renewal every 5 years
Dietary Supplement Health and Education Act
1994 (DSHEA) created the product "dietary supplement" manufacturer prohibited from advertising that the product can diagnose, cure or prevent any disease, may make structure/function claims without premarket approval; health claims need premarket approval allows non-drug structure/function claims - can change a non-drug to a drug through FDA process may not be represented as conventional food or the sole item of a meal or diet advertising regulated by FTC (federal trade commission) must have supplement facts label if an ingredient was never sold in the US before October 1994, its deemed a "new dietary ingredient" NDI and must submit safety data to the FDA before marketing the product as of 2010, GMP required manufacturer must report serious adverse events to the FDA manufacturer can apply for USP verification to confirm quality of the product and the manufacturing process
Health Insurance Portability & Accountability Act (HIPAA)
1996 any healthcare provider that submits electronic claims must follow clarifies what PHI is and how it is used pharmacy must develop policies and procedures to implement privacy standards pharmacist must make available "notice of privacy practices" - how the pharmacy intends to use the information, intends to disclose the information, description of the pharmacy's legal duties to protect information, statement of patients rights and a brief explanation of how the patient can exercise those rights pharmacies must train employees on HIPAA requirements and document training HITECH 2009 to strengthen disclosure issues (notification of breaches, minimum necessary) authorization is not required for refill reminders, disease management programs consent to release PHI not required for response to court order, subpeona, discovery or other lawful process, post marketing surveillance, reporting of ADEs, report to a public health authority to report child abuse, neglect All healthcare providers, including pharmacists, must have a NPI number
Food & Drug Administration Modernization Act
1997 "legend" -> "Rx only" "caution: federal law prohibits dispensing without prescription" fast track approval for drugs for serious conditions, post-marketing required manufacturers can provide prescribers with scientific peer reviewed articles on unapproved uses for approved drugs compounding for prescription, limited batching permitted permitted manufacturers to provide prescribers with economic data on drug encouraged manufacturers to perform pediatric clinical trials
Food Drug Administration Amendments Act
2007 FDA may require submission of any DTC television ad 45 days prior to broadcast FDA may make recommendations sponsor does not have to accept them
Food & Drug Administration Amendments Act
2007 Renewed the Prescription Drug User Fee Act for 5 years permitted FDA to order a drug recall permitted FDA to order Phase IV on Rx drugs permitted FDA to require Risk Evaluation & Mitigation Strategies (REMS)
Drug Quality and Security Act
2013 created outsourcing facilities pharmacies may register with FDA as "human drug compounding outsourcing facilities" outsourcing facility not required to be a licensed pharmacy, but must be supervised by a pharmacist voluntary, for facilities engaging in compounding sterile drugs must comply with cGMP standards an outsourcing facility may or may not obtain prescriptions for identified individual patients can compound drugs based on non-patient specific purchase orders third party logistics provider licensing: third party logistic providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license inspected by FDA, registered for $15,000 may sell compounded products to hospitals, doctors, other pharmacies without a prescription twice-yearly report regarding drugs compounded and adverse events development of a drug tracking system: placing unique product identifiers on individual drug packages and providing product and transaction information at each sale with lot level information; hope to enhance detection and notification of illegitimate products in the drug supply chain and facilitate more efficient recalls drug tracking system will enhance the FDAs ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, harmful, improves detection and removal of potentially dangerous drugs from the supply chain may not compound drugs that were withdrawn or removed from the market for safety reasons or drugs that appear on FDAs current list of drugs with demonstratable difficulties may not compound identical or nearly identical to commercially available products: same active ingredient(s), route of administration, dosage form, dosage strength, excipients UNLESS the drug appears on the FDAs drug shortage list at the time of compounding, distribution, dispensing or there is a change in the approved bulk substance that produces a clinical difference **outsourcing facilities must be registered in MD as wholesale distributors** as a result of New England Compounding Center tragedy
Behind the counter ephedrine/pseudoephedrine or phenylpropanolamine products
3.6 grams/day 9 grams/month stored so that customers do not have direct access, seller maintains logbook and enters name of product and quantity sold, seller maintains logbook for at least 2 years, purchaser presents official picture ID and signs logbook, entering name address and date/time of sale COMBAT Methamphetamine Epidemic Act 2005: requires vendors of scheduled listed products to self-certify annually that staff has been trained
Definition of child proof container
80% of children under 5 cannot open container, 90% of adults can open container
New Drug
A drug that is not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the drug's labeling, or conditions under which it is prescribed and recommended not GRAS or GRAE (generally recognized as safe/effective)
Food
Articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article
Corresponding Responsibility Doctrine
Both prescriber and pharmacist have a corresponding responsibility for dispensing of controlled substances for a legitimate medical purpose
Pharmacy CS security
CII may be dispersed throughout the general inventory or may be secured in a locked cabinet
FDA Drug Recalls
Class I: reasonable probability that the product will cause serious adverse health consequences Class II: product may cause temporary or reversible adverse health consequences, but probability of serious adverse consequences is remote Class III: the product is not likely to cause adverse health consequences
DEA inspections
DEA may enter a pharmacy and inspect anytime: - may examine and *copy* all records and reports -may inspect premises within reasonable limits - may take an inventory of CS DEA must obtain signed consent or administrative inspection warrant
Abbreviated New Drug Application (ANDA)
Different company submits to market GENERIC drug after innovator company patent expires. New drug requires proof of similar pharmacokinetic properties, bioavailability, clinical activity.
DEA
Drug Enforcement Administration enforces the controlled substances act under the FBI within the Justice Department within the executive branch of government
Schedule II
High potential for abuse has currently accepted medicinal use in tx in the US, or currently accepted medicinal use with severe restrictions use may lead to severe physical or psychological dependence
Label versus labeling
Label: display of written, printed, or graphic matter upon the immediate container of any article Labeling: all labels and other written, printed or graphic matters (i) upon any article or any of its containers or wrappers or (ii)accompanying such article
Risk Evaluation & Mitigation Strategies (REMS)
Med-guides, BBW, may require prescribers to have special training or experience, may require patients to enroll in registry and testing, may limit the practice settings from which drug may be dispensed
Section 505(a) of FDCA
No person shall introduce into interstate commerce any "new drug" unless an application has been approved by the FDA. section (b): New Drug Application (NDA) subsection (j): Abbreviated New Drug Application (ANDA) for generic drugs
USP 795
Non-sterile compounding categories of compounding: -simple: reconstituting, manipulating -moderate: special procedures or calculations (morphine suppositories) -complex: special training, environment, facilities, equipment, procedures BUD and stability criteria
USP 795 Stability Criteria and Beyond Use Dating
Nonaqueous formulations: - BUD not later than the time remaining until the earliest expiration date of any ingredient or 6 months, whichever is earlier water-containing oral formulations: - BUD 14 days refridgeration water-containing topical/dermal and mucosal liquid and semisolid formulations: BUD 30 days
Veterinary Drugs
OTC if adequate directions for lay use can be written on label Rx drugs must bear the legend: "caution: federal law restricts the drug to use by or on the order of a licensed veterinarian" prescription only veterinary products may be dispensed only by a pharmacist or licensed veterinarian to client a prescription only human drug may be OTC for veterinary use but since it is still rx for humans, a pharmacist may not sell it without a prescription OTC drugs for human use may not be sold for veterinary use without a prescription because they do not bear adequate directions for use in animals
State Substitution Laws
Permissive: allow the pharmacist to substitute a generic (38 states including MD) mandatory: require a pharmacist to substitute a generic (12 states) some states do not allow automatic substitution of NTI drugs
Direct to Consumer Prescription Drug Advertising
Prescription drugs: FDA regulates labeling and advertising OTC Drugs (and dietary supplements): FDA regulates labeling, FTC regulates advertising must have brief summary for product specific ads
Biosimilars
Products that are highly similar to an already approved biological product. not automatically substitutable biologics: viruses, vaccines, proteins ... purple book
Bioequivalent Drug Products
Refers to products that are pharmaceutically equivalent or alternative products that provide the same results of drug delivery with the same pharmacokinetic properties.
Ryan Haight Online Consumer Protection Act of 2008
Regulates online pharmacies dispensing CDS (non-CDS internet pharmacies regulated by state boards) obtain modified DEA registration notify DEA and all state boards of pharmacy of DEA #s of all practitioners/pharmacies and all site addresses disclose on webpage information about pharmacy and pharmacist report to DEA monthly count of CDS dispensed include the statement: "this online pharmacy will only dispense a controlled substance to a person who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner. This includes at least one prior in-person medical evaluation or medical evaluation via telemedicine in accordance with applicable requirements of section 309"
Phase I Clinical Trial
Small trials with healthy subjects, purpose is to determine pharmacokinetics and maximum tolerated dose primarily to determine SAFETY 20-40 subjects primarily healthy males: concern over birth defects, females regularly participate but with safeguards volunteers and informed consent, reviewed and approved by IRB
Phase II Clinical Trial
Testing of drug on patients to assess efficacy and safety The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety 100-200 subjects with the disease to be treated by the compound volunteers/informed consent
Phase III Clinical Trial
Testing of drug on patients to assess efficacy, effectiveness and safety (usually multi-center trials on a much larger patient groups). The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. volunteers/informed consent 1,000-3,000
Controlled Substances Act: Titles
Title I: establishes rehabilitation programs for drug abusers Title II: provides for registration and distribution of controlled substances Title III: importation and exportation of controlled substances
DEA definitions: Automated Dispensing System
a mechanical system that dispenses controlled substances and maintains all transaction information (may be remotely located from the pharmacy, in which case the machine will have its own DEA registration)
DEA definitions: compounder
a person involved in maintenance or detoxification of narcotic addicts who also mixes/prepares the narcotic drugs used in the treatment
DEA definitions: central fill pharmacy
a pharmacy that fills controlled substance prescriptions for a retail pharmacy AND returns the prescription to the retail pharmacy for delivery to the patient
DEA definitions: valid prescription
a prescription issued for a legitimate medical purpose by a licensed individual practitioner in the usual course of professional practice; valid patient-practitioner relationship
Food Additive
a substance added to food products that causes desired changes in the products any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food example: sweet N low, packaging made of materials that will leech into the food
Rx drugs covered under the Poison Prevention Packaging Act of 1970
all except exempted (sublingual nitroglycerin or isosorbide, steroid, birth control pack) topical lidocaine (over 5mg), dibucaine (over 0.5mg), minoxidil (over 14mg) all oral controlled substances
Medicare Part C
an alternative to parts A, B, D provided by managed care plans (HMOs) these plans are called "medicare advantage"
DEA definitions: individual practitioner
an individual authorized to prescribe controlled substances
DEA definitions: Mid-level practitioner
an individual practitioner other than a physician, dentist, vet, podiatrist
Device
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article including any component, part or accessory which is (i) recognized in USP,NF (ii) intended fir use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals (iii) intended to affect the structure or any function of the body of man or other animals and which does not achieve its primary intended purpose through chemical action within or on the body and which is not dependent on being metabolized for the achievement of its primary intended purposes
OTC oral drugs covered under the Poison Prevention Packaging Act of 1970
any products with active ingredients that were previously available only by prescription aspirin (any) acetaminophen and ibuprofen in packages of 1gm or more naproxen 250mg or more iron containing drugs 250mg or more Benadryl in 66mg or more Loperamide in packages of more than 0.045mg
New England Compounding Center (NECC) Meningitis Outbreak of 2013
compounded large amounts of sterile steroid for spinal injection and shipped to thousands of states, contaminated with fungus
FDA Violations in compounding
compounding of drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving valid presciptions compounding drugs that were withdrawn or removed from market for safety reasons compounding from bulk active ingredients that are not components of FRDA approved drugs without an FDA sanctioned investigational new drug application receiving, storing or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substance has been made in an FDA registered facility receiving, storing or using drug components not guaranteed or otherwise determined to meet official compendia requirements using commercial scale manufacturing or testing equipment for compounding drug products compounding drugs for third parties who resell to individual patients or offering compounded drug products at wholesale compounding drug products that are commercially available (same active pharmaceutical ingredients, same, similar or easily substitutable dosage strength, same route of administration
Counterfeit Drug
container or labeling bears trademark, trade name, or other identifying mark, imprint, or device or any likeness thereof of a drug manufacturer, processor, packer, or distributor (other than the actual ones) without authorization and thus is falsely representing itself is deliberately and fraudulently mislabeled concerning identity and/or source may include products with correct ingredients or with wrong ingredients, without active ingredients, with insufficient ingredient and fake packaging secondary wholesalers are often the conduit for introduction of counterfeit medications into the legitimate supply chain its not illegal to be an unauthorized or secondary wholesaler, must be registered
Prescription Drug Label Requirements
date prescription is filled name and address of dispenser (pharmacy) the serial number of the Rx name of prescriber name and strength of the drug or device name of the patient any directions for use expiration date; the lesser of: 1 year from the date of dispensing, month and year of when the drugs/devices actually expire, appropriate expiration date for repackaged drugs or devices, a shorter period as determined by the pharmacist any appropriate special handling/cautionary statements if a pharmacist substitutes a drug or device product for a generic, the label shall include the name of the manufactuer or distributor of the drug or device dispensed
Pharmaceutical Equivalent
drug products that contain identical amounts of the same active ingredients in the same dosage form and same route of administration and identical in strength or concentration
Pharmaceutical Alternative
drug products that contain the same ACTIVE INGREDIENTS but not necessarily in the same salt form, strength, or dosage form
PHI under HIPAA
enforced by the Office of civil rights in HHS pharmacists may only disclose PHI for Treatment, Payment or Health Care Operations (TPO) pharmacist must disclose PHI to the patient if patient requests
Unit dose labeling
established name of drug quantity of active ingredient in each dose expiration date lot or control number name/address of manufacturer or packer or distributor any statement required by compendia
Medicare
federal program to provide health insurance to those at least 65 years of age and those who are disabled Administered by the Centers for Medicare and Medicaid services (CMS) No economic/means test for qualification 4 parts
OBRA 90
for pharmacists that provide prescription services to medical assistance recipients shall *offer* to discuss with each *medical assistance recipient or caregiver* who presents a prescription order for *outpatient drugs*, other than for a refill: common side effects, not necessary severe offer face-to-face communication with pharmacist or at least two: sign posted, a notation affixed to or writen on the bag in which the prescription is to be dispensed, notation on prescription container or communication via telephone ' must make a reasonable effort to obtain, record, maintain name address, telephone number, date of birth, gender, individual history when significant, comprehensive list of meds, pharmacist comments - *maintain patient profiles in reference to compounding* does not apply to refills outpatient prescriptions only this law was written for medicaid patients
Medicare Part A
hospital charges, including inpatient drug therapy
HIPAA's provisions for the notice of privacy practices
identifies how the pharmacy will use the information and its legal duties a statement of patients rights and the name and number of person a patient may contact if problems occur must be posted and available upon request
Exceptions to the Poison Prevention Packaging Act of 1970
if OTC label states "this package for household without young children" and the package is child proof if either the patient (blanket request ok) or prescriber (no blanket request) requests orally or in writing non-safety packaging of an oral prescription drug rx drugs for patients in hospitals or nursing homes where the drug will be administered
when does the minimum necessary requirement not apply?
if for treatment purposes
Outsourcing drug label under the DQSA
if fr"this is a compounded drug" or reasonable comparable alternative statement name, address, phone number of the applicable outsourcing facility lot or batch number established name of drug dosage form and strength statement of quantity or volume
DEA Part 1301: Registration for Dispensers
includes pharmacies and prescribers registration valid for 3 years may modify registration to include being a "collector" from non-registrants separate locations require separate registrations (each outlet of a pharmacy retail chain, separate hospital pharmacies in separate hospitals even if under common ownership, separate registrations not required for multiple pharmacies within a hospital) Automated dispensing (nursing home) separate registration from the retail pharmacy pharmacy registered not pharmacist
Medicaid
jointly funded by federal and state program to provide insurance to the indigent programs administered at the state level but must follow federal guidelines, coverage determined by state qualification is based on income and assets pharmacists must follow OBRA 90
definition of misbranding
label or labeling false or misleading label fails to state the name and place of business of manufacturer, packer or distributor and an accurate statement of quantity legend drugs: the label does not state the generic "established" name or that of ingredients, in type not less than one half the size of the trade or brand name not labeled and packed by compendia standards the package of the drug is misleading in the way it is filled or formed or is imitative of another drug, the container is so made, formed or filled as to be misleading the drug is subject to deteriorate, unless it's label bears appropriate precautionary statements and its packaged in such a form and manner the drug or device is health-endangering if used in the manner or with the frequency or duration prescribed, recommended or suggested in the labeling the drug contains a color additive and is not labeled in accordance with color additive requirements the manufacturer is not registered with the FDA under section 510 and the drug was not listed as a manufacturer by the manufacturer if the drug was imported by a company not registered under section 801(s) not included in a list required by section 510(j) not packed according to the Poison Prevention Packaging Act of 1970 Omission of information by the manufacturer, packer, distributor from advertisements and other descriptive printed matter issued or caused to be issued a true statement of the established name, printed prominently and in type at least half as large as that used for any trade or brand name thereof, the formula showing quantitatively each ingredient of such drug to the extent required for labels and such other information in brief summary related to side effects, contraindications, effectiveness not adequate directions for use on its label and adequate warnings against use by children or those in conditions where use might be dangerous not adequate warnings against unsafe dosage and methods or duration of use if any word, statement, or other information required to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use In the case of published direct-to-consumer advertisements, the following statement printed in conspicuous text: "You are encouraged to report negative side effects of prescription drugs to the FDA." if the responsible person for a drug is in violation of a requirement relating to postmarketing studies and clinical trials or related to labeling if it is a drug and fails to bear the product identifier as required by section 582 the labeling does not include adequate directions for use MARYLAND: -contains any quantity of a narcotic or hypnotic substance unless the label states the name, quantity or proportion and immediately to the side states "Warning - may be habit forming" -improperly dispensed -anytime before it is dispensed, it does not contain the statement "caution: federal law prohibits dispensing without a prescription" or "caution: state law prohibits dispensing without a prescription"
Schedule V
low potential for abuse abuse may lead to limited physical dependence or psychological dependence
Schedule IV
low potential for abuse has currently accepted medicinal use in US abuse may lead to limited physical or psychological dependence
Office Use and Veterinary Compounding
may provide to an ophthalmologist office for office use without a patient-specific prescription: compound antibiotics for emergency treatment of bacterial endophthalmitis or viral retinitis, anti-vascular endothelial growth factor agents for the emergency treatment of neovascular glaucoma, wet macular degeneration or macular edema office must inform the pharmacy of the identity of any patient to whom the drugs are administered
DEA Part 1301: Registration for prescribers in a hospital
may use hospital DEA if licensed by the state to prescribe, hospital assigns a unique internal code number to the employee and its used as a suffix to the DEA of the hospital, lists of suffix numbers available to pharmacies, prescriber prints or stamps his/her name on any prescription in addition to signing
Official Compendium
means the official US Pharmacopoeia (USP), official homeopathic pharmacopeia of the US (HPUS), official National Formulary (NF)
Dietary supplements
must be intended for oral ingestion not drugs/food/cosmetics/food additives means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, herb or other botanical, amino acid, a dietary substance for use by man to supplement the diety by increasing total dietary intake or a concentrate, metabolite, constituent, extract, a combination of any aforementioned ingredients must be labeled as a "dietary supplement", name and quantity, for herbs or other botanicals must identify the part of the plant used must be manufactured using CGMP (since 2010) labeling does not include certain publications: reprinted in entirety, used in connection with sales, pamphlet: not false or misleading, no promotion of particular manufacturer or brand, displayed with other items for a balanced view, physically separated from products, no appended information permissible statements: benefit related to classical nutrient deficiency, role of dietary supplement intended to affect structure/function, documented mechanism to maintain structure/function, describe general well being from DS - must include "this statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, cure or prevent any disease." FDA has burden of proof for adulteration/misbranding of dietary supplements
Sterile Compounding for 503(A) pharmacies
must have identifiable patient for each prescription utilize beyond use dates aseptic compounding physical requirements: clean room, anteroom, positive/negative air pressure equipment: laminar airflow workstations, isolators, biological safety cabinets attire, staff training, quality assurance
Prescription drug labeling for the commercial container
name and address of the manufacturer, packer or distributor established name of drug ingredient information, including quantity names of inactive ingredients if not for oral use statement of identity (generic and proprietary names) quantity of drug (milligrams) net quantity of container (100 tablets) statement of recommended or usual dose or reference to package insert "Rx only" or "caution: federal law prohibits dispensing without prescription" route of administration if not for oral use lot or control number statement to the pharmacist about the type of container if applicable expiration date
Physician dispensing label requirements
name and strength of the drug or device date dispensed expiration date that is the lesser of: 1 year from date of dispensing, month/year when the drug/device expires, shorter period as determined by the prescriber any appropriate special handling instructions regarding proper storage of the drug or device labels on all containers/devices board of pharmacy has authority over physician dispensing label should include identical information to the labels found in a pharmacy
Beyond Use Dating, Non-sterile
non-preserved aqueous dosage forms: 14 days preserved aqueous dosage forms: 35 days nonaqeous dosage forms: 90 days solid dosage forms: 180 days
DTM contracts
not required for the management of patients in an institutional facility or in a group model health maintenance organization protocol needed: for a particular therapeutic or diagnostic intervention
DEA Part 1301: Registration for patients
patients do not register! warning notice on all CII-IV: "caution: federal law prohibits transfer of this drug to any person other than the patient for whom it was prescribed" patients may bring controlled substances into the US obtained in another country for personal use provided drugs were legally obtained in the foreign country, patient declares to customs for personal use, no more than 50 dosage units that were obtained abroad
Therapeutic Equivalent
pharmaceutical equivalents that produce the same clinical effects in patients and safety profile generics, generic equivalent deemed by FDA to be therapeutically equivalent if approved as safe and effective, pharmaceutical equivalents, bioequivalent, adequately labeled, manufactured in compliance with GMP regulations
Medicare Part B
physicians visits and outpatient diagnostic/treatment services, medications that a patient can't self administer, durable medical devices
Schedule III
potential for abuse has currently accepted medicinal use in treatment in the US abuse may lead to moderate or low physical dependence or high psychological dependence
definition of adulteration
prepared, packed, held under unsanitary conditions consists of filthy, putrid, decomposed substance manufactured without good manufacturing practices container composed of poisonous or deleterious substances that may leach into the contents contains an unsafe color additive varies from an official compendial standard unless its variations are plainly stated on the label new unsafe animal drug or an animal feed containing such a drug class III device without premarket approval or a banned device OTC drug not packaged in tamper-resistant packaging mixed with or substituted with another ingredient to reduce quality or strength refusal of inspection a device that does not comport with performance standards with compounding, no need to adhere to cGMPs unless it is an outsourcing facility if it is a new animal drug which is unsafe or if it is an animal feed hearing or contaminating a new animal drug, and such animal feed is unsafe doesnt meet compendium standards
Pharmacists role in regard to dietary supplements
professional responsibility, knowledge: if you dont know, find out must have knowledge of the products carried in the pharmacy
Off label use
relates to misbranding a manufacturer is allowed to promote its product only for its FDA approved use including: detail personal communications with prescribers, advertising "a physician may legally prescribe a drug for an off label use and a pharmacist may fill the prescripiton" figures prominently into False Claims Act: off label promotion by manufacturers to doctors increased prescibing in medicaid and medicare, manufacturers run the risk of being debarred from participating in federal programs (Medicare and Medicaid) sales representatives can give prescribers copies of "peer-reviewed scientific or medical journal articles or reference publications" -- journal should be published by an organization having an editorial board with expertise, not a special supplement, peer-reviewed -- scientific or medical reference publication should not be primarily distributed by a manufacturer but available in bookstores, should not be written, edited or excerpted for or at the request of a manufacturer, should not be edited or significantly influenced by a manufacturer
Non-sterile compounding for 503(A) Pharmacies
simple, moderate, complex non-sterile compounding -> purified water
Labeling of OTCs
statement of identity, accurate statement of the general pharmacological category or principal intended action name and address of manufacturer, packer or distributor, net quantity of contents of the package, cautions and warnings, adequate directions for use (indications, side effects, dosages, routes, methods, frequency and duration of administration, contraindications, other warnings and precautions, any required preparation) drug facts panel: active ingredients, dosage units, quantity per dosage unit, purpose, indications, warnings, directions, inactive ingredients
USP 797
sterile compounding CSP microbial contamination levels: - low risk: single-volume transfers of sterile dosage forms from ampuls, bottles, bags, vials using sterile syringes with sterile needles - medium risk: multiple individual or small doses of sterile products are combined or pooled to prepare a CSP that will be administered either to multiple patients to one patient on multiple occasions - high risk: non sterile ingredients, including manufactured products not intended for sterile routes of administration are incorporated or a non sterile device is employed before terminal sterilization
Orange Book and evaluation codes
the common name for the FDA's Approved Drug Products with Therapeutic Equivalence states use as the basis for generic substitution "A": no known or suspected bioequivalence problems, actual or potential bioequivalence problems have been resolved with adequate in vivo or in vitro evidence supporting bioequivalence "B": actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence
DEA Part 1301: Registration
the controlled substances act created a closed system in which everyone handling the drugs is registered (except the patient, who is given a written notice not to transfer the drug to anyone else)
Compounding
the preparation, mixing, assembling, packaging or labeling of a drug or device as the result of a practitioner's prescription where there is an established physician, patient, pharmacist relationship
New Drug Application (NDA)
the process through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States Assess chemistry, pharmacology, dosage formulation, other ingredients, clinical trials results, PK, proposed labeling advisory committee at FDA evaluates FDA uses benefit/risk evaluation: adverse reaction and other safety data, seriousness of disease, availability and adequacy of other remedies
DEA definitions: maintenance treatment
treatment >21 days
DEA definitions: long term detoxification
treatment >30 days but <180 days
DEA definitions: short term detoxification
treatment NTE 30 days
Medicare Part D
voluntary program administered through private insurance companies requires insurance companies to provide coverage for MTM services to patients taking multiple drugs that will exceed an annual cost determined by HHS
Is tobacco regulated by the FDA?
yes, an official definition exists
