Chapter A
Devices: Class 1 controls:
- are intended for human use
salicyaltes
- reyes' syndrome
recall class 3:
- the use of , or exposure to a violative product is not likely to cause adverse health consequences
tikosyn
- for a-fib - tips program
approved drug:
- NDA has been approved by FDA - a drug that was used prior to the effective date of 1938 FDCA and not subject to NDA requirements -(1) Number of drugs in pre-1938 era is very small: aspirin, digitalis. (2) Due to labeling and use requirements, being as they existed in pre- 1938 era, these drugs are vulnerable to misbranding.
traceability
- applies to rx drugs for human use in finished dosage form - certain products are exempted like blood and blood components, radioactive drugs, imaging drugs , iv etc
1976 medical device amendment
- assures safety and effectiveness of medical devices and certain diagnostic lab products - upgraded regulatory authority over such devices by fda
Breach Notification:
- must notify individuals of a breach of their unsecured PHI within 60 calendar days after the breach is discovered -BAs are required to report any breaches of unsecured PHI to the cov ered entity and provide the identities of each affected individual. -d. For breaches affecting less than 500 individuals, covered entities must maintain a log of these breaches and notify HHS of these breaches annually. e. If more than 500 individuals are affected, the Secretary of HHS and prominent local media must be notified in addition to the affected indi viduals within 60 days after the breach is discovered.
xyrem
- narcolepsy - need med guide - only available at a centralized pharmacy
type 2
- new derivative of a chemical structure already approved in US new salt or ester
2012 fda safety and innovation act FDASIA
- reauthorized user fees for drug and medical devices and added user fees for generic drugs and bio similar bio products - fda can designate a new drug as a breakthrough therapy to expedite the development and review of the drug - gave fda new authority to address the globalization of the pharmaceutical supply chain and give funds to have more inspection of foreign facilities - fda was able to develop a unique device identification system for medical devices
Drug
- recognized by USP NF - for use in diagnosis, cure, mitigation, treatment, prevention of dz in man or animal - will affect the structure or any function of the body of man or animal - article intended for use as a component of the above
Phase 2:
- review of ingredients in each class of drugs based on panel's findings on public comment and new data - will publish what they find in federal register as a final monograph - have a period of time for any objections to the proposal
clozapine/Clozaril
- schizophrenia treatment - agranulocytosis - rems
Aspartame:
- state contains phenylalanine ___ mg per ____
state law preemption:
- state privacy laws that are more stringent than the federal privacy laws must be adhered to
Texas privacy laws Texas HIPAA
- they are more strict than federal -a. for commercial, financial, or professional gain, monetary fees, or dues, or on a cooperative, nonprofit, or pro bono basis, engages, in whole or in part, and with real or constructive knowledge, in the practice of assembling, collecting, analyzing, using, evaluating, storing, or transmitting protected health information; b. comes into possession of protected health information; c. obtains or stores protected health information; or d. is an employee, agent, or contractor of a person described by Paragraph a. b. or c. in so far as the employee, agent, or contractor creates, receives, obtains, maintains, uses, or transmits protected health information.
wintergreen oil-
- use other than as directed may be dangerous - keep away from children - has more than 5% methyl salicylate
isoproterenol inhalation prep
- warning don't exceed dose prescribed - contact doctor if hard to breathe
alcohol warning
- warning if consume 3 or more drinks/day -Internal analgesics and antipyretics including acetaminophen, aspirin, ibuprofen, naproxen, ketoprofen,
phenacetin
- warning kidney damage if take large act for long period of time
mineral oil
- warning to only take at bedtime and not be used in infants unless under pcp - don't use during pregnancy
k salt for oral ingesions
- warning- get stenosis with or without ulceration - only take when indicated -d/c if stomach pain , n,v, gi bleeding - use only when dietary supplements aren't practicable
1962 Kefauver harris amendments:
- was passed in response to thalidomide - required new drug products to be proven safe and effective for claimed use - increased safety requirements demanded ; more clinical investigations - increased and strengthened inspection authority of fda - established good manufacturing practices GMP
Medical device act of 1976
- was to provide the FDA with significant authority over the regulation of medical devices -The major purpose of the Act is to provide the public reasonable assurance of the safety of medical devices for human use. The purpose of including medi cal devices in the 1938 Food, Drug, and Cosmetic Act was to limit the number of fraudulent devices on the market. -
minimum necessary :
- when using and disclosing phi a pharmacy must make reasonable effort to limit phi to the minimum necessary to accomplish the intended purpose - this doesn't apply to providers for treatment or for transfers - doesn't apply to disclosures that the patient has signed an authorization - the minimum necessary standard does apply to disclosures for payment
medication guides:
- with meds that pose a serious public health concern and one or more of the following: a. patient labeling could help prevent serious adverse effects, b. the product has serious risks relevant to its benefits of which the patient should be aware of because such information could affect patients' de cisions to use, or continue to use the product c. patient adherence to directions is crucial to the drug's effectiveness. - important in REMS - written in standard format in language suitable for patients' - manufactures must get FDA approval before distributing med guides - for new and refill meds - FDA requires a Medication Guide to be provided at time of first dispensing, when there is a material change in a Medication Guide, when a REMS specifically requires a Medication Guide be reviewed with the patient prior to administration and when a patient re quests a Medication Guide. - list of drugs: a. b. c . d. e. f. g. h. i. j. k. l. Accutane® - (isotretinion) Antidepressants in Children and Teenagers Coumadin® (warfarin sodium) Extended-release and long-acting opiods Forteo® (teriparatide, rDNA origin) Lindane® shampoo and lotion Lotronex® (alosetron hydrochloride) Nolvadex® (tamoxifen) Non-Steroidal Anti-Inflammatory Drags (NSAIDs) Remicade® (infliximab) Trizivar® (abacavir sulfate, lamivudine, and zidovudine)
Lotronex- aldosterone hcl
- women with severe diarrhea predominant IBS and failed other therapy - part of rems -must have a medication guide
OTC pain reliever : acetaminophen
- write the ingredient acetaminophen on the display panel on container so that patient doesn't take too many products with acetaminophen - liver toxicity don't use more than recommended dose - limit alcohol - must have a warning to not take this with other drugs that have acetaminophen - tell doctor if on blood whining agents
patient rights: access
-(1) Patients have a right to inspect and obtain a copy of their PHI. (2) Pharmacies must comply within 30 days of request, but may extend the time by no more than 30 additional days with notification to the individual of the reason for the delay (3) Under certain limited circumstances, pharmacies may deny a patient's request to inspect or obtain a copy of their PHI.
2. new drug application
-An OTC drug that does not conform to an FDA OTC Monograph must go through pre-approval by FDA including filing of a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This is the same process that is used for prescription drugs.
Drugs covered under the Federal Poison Prevention Packaging Act and Exemp tions from the Act
-Aspirin: Any aspirin-containing preparation for human use in dosage form intended for oral administration. -Methyl salicylate (oil of wintergreen): Liquid preparations containing more than 5% by weight of methyl salicylate unless packaged in pressurized spray containers. -Controlled drugs: Any preparation for human use in a dosage form intended for oral administration that consists in whole or in part of any substance subject to control under the Federal Controlled Substance Act. -Methyl alcohol (methanol): Household substances in liquid form containing 4% or more by weight of methyl alcohol unless packaged in a pressurized spray container. -Prescription drugs: Any drug for human use that is in a dosage form for oral administration and that is required by federal law to be dispensed only by or upon an oral or written prescription of a practitioner licensed by law to ad minister such drugs - many more drugs! Page 32
label:
-Display of written, printed, or graphic matter on the immediate container.
extended release long acting opioids:
-Includes products such as Duragesic®, MS Contin®, Opana ER®, oxycontin - need drug sponsors or manufactures to provide education programs - needs a med guide
Medical device amendments of 1992
-Requires device distributors to maintain records and provide information to help the Food and Drug Administration or the manufacturer locate a patient in the event of a device recall or patient notification.
Compounding Quality Act as part of the Drug Product Quality and Security Act in late 2013.
-distinguish between pharmacies that are performing tradi tional compounding for specific patients based on individual prescriptions from pharmacies that are compounding large quantities of drugs that are not based on individual prescriptions. - made and outsourcing facility - allows them to do sterile compounding -also resolved the conflict between the 9th Circuit and the 5thCircuit as to whether or not the remaining portions of the compounding provisions in FDAMA (Section 503A) were still in ef fect.
HITECH act provisions :
-makes the Administrative, Physical, and Technical Safe guards of the HIPAA Security Rule directly applicable to Business Associ ates.
PDMA and texas laws / rules on drug samples
-manufacturers can provide rx samples upon written request of practitioner or a PA or APRN can signs for the request for samples and give them to its - will not allow a pharmacy to sell, purchase, trade, and possess rx drug samples unless the pharmacy meets the following conditions a) the pharmacy is owned by a charitable organization described in the Internal Revenue Code of 1986, or by a city, state or county government; (b) the pharmacy is a part of a health care entity which provides health care primarily to indigent or low income patients at no or reduced cost; (c) the samples are for dispensing or provision at no charge to patients of such health care entity; and (d) the samples are possessed in compliance with the federal Pre scription Drug Marketing Act of 1987. - if the pharmacy doesn't meet all of the exemptions of samples they must be disposed of asap -Pharmacies may possess and dispense prescription drugs which have been pro vided by the manufacturer as starter prescriptions or as replacement for outdated drugs. In addition, a pharmacy may possess and dis pense prescription drugs which have been provided by a manufacturer in replacement for such manufacturer's drugs that were dispensed pursuant to written starter prescriptions from prac titioners. The PDMA does not apply to OTC drugs; therefore a pharmacy may be in possession of sample OTC drugs.
HIPAA transactions and code set regulations:
1. Adopts standards for eight electronic transactions and code sets to be used for those transactions. 2. If a pharmacy conducts an electronic transaction with another covered en tity or business associate, the transaction must be conducted as a standard transaction utilizing the designated code sets. 3. Retail pharmacy drug claim standard is the National Council for Prescription Drug Programs (NCPDP) standard.
drugs for off label use
1. From time to time, a physician may prescribe an approved drug for a non- approved or "unlabeled" use (i.e., prescribes the drug outside of the limits of the package insert information). 2. Pharmacist's liability Presuming the prescription is labeled correctly and the pharmacist uses good professional judgment, the exposure to liability should be minimal. The physician has the primary liability. However, if something goes wrong, the pharmacist could have secondary liability. 3. Keep in mind "corresponding responsibility" relative to controlled substance prescriptions. 4. General negligence laws should be followed. 5. Manufacturers cannot promote an approved drug for an unapproved use in any manner through literature, detail persons, seminars, etc.
A drug is misbranded:
1. If the labeling is false or misleading in any particular way. 2. If it is a prescription drug and the manufacturer's labeling fails to contain the following information: a. The name and address of the manufacturer, packer, or distributor. b. An accurate statement of the quantity (i.e., Number: 100 tablets). c. The generic name of the drug, if any, and the proprietary name. d. A statement of the quantity of the ingredients (i.e., 0.25 mg per tablet). e. Adequate information for use. (intended for health care professionals) f. Adequate warnings against use where dangerous. g. Expiration date. h. Any other information required (e.g. certain products require "black boxed warnings" to alert health care professionals about essential information about the product). 3. When a pharmacist fills a prescription without authorization of the practitioner. 4. If it is an over-the-counter drug and fails to contain all required information. (See OTClabeling below.) 5. If it is a drug liable to deterioration unless it is packaged and labeled accordingly. 6. If the container is made, formed, or filled as to be misleading. 7. If the drug is an exact imitation of another drug or offered for sale under the name of another drug. 8. If it is dangerous to health when used in the dosage or manner suggested in the labeling. 9. If its packaging or labeling is in violation of the Poison Prevention Packaging Act (PPPA).
There are three basic forms of regulatory action FDA can impose:
1. Injunction or restraining order from a court - A civil procedure. 2. Seizure or embargo - A civil procedure. 3. Regulatory letter - Administrative action by FDA. - fda can't order a drug recall it has to be done by a manufacturer or distributor but they can order a recall on devices - fda can pursue criminal action in federal court for certain violations of the act
device
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related articles, including any component, part, or accessory, which is: a. Recognized in the USP or NF; -Intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease in man or other ani mals; or c. Intended to affect the structure or any function of the body of man or other animals and does not achieve its desired action by chemical means or by being metabolized by the body.
OTC drug labeling:
For over-the-counter drugs, the label and labeling are directed at the con sumer. Over-the-counter labeling helps assure that the drug will be safe for self-administration, so the labeling must contain adequate directions for use, dosage, and precautionary statements. This is different from prescription drug labeling (including the package label and package insert), which is di rected at the health professional. Prescription drug labeling must contain adequate information for use.
medical device
Instrument, apparatus, etc., intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal or intended to affect the structure or any function of the body of man or animal which does not achieve its intended purpose through chemical or biological action within or on the body.
Type 1 drug :
New molecular structure, different from existing drugs, that may be used for the same therapeutic purpose as similar drugs. Must not be currently marketed in the U.S.
Type P (priority) drug
The drug represents a major therapeutic gain because there are no other effective drugs available for treating a particular illness or because it has significant advantages compared to currently marketed drugs.
type 5
drug manufactured by a new company
type 4
new combo of two or more drugs
biosimilar
product is highly similar to the reference product notwithstanding minor differences in clinically inactive com ponents, and there are no clinically meaningful differences between the biologi cal product and the reference product in terms of safety, purity and potency of the product.
Amendment:
(1) Patients have a right to amend their PHI or records containing PHI that are maintained by a pharmacy. (2) Pharmacies must comply within 60 days of receiving a request, but may extend the time by no more than 30 additional days with notifica tion to the individual of the reason for the delay. (3) Under certain limited circumstances, pharmacies may deny a patient's request to amend their PHI, but must provide in writing the basis for the denial and allow the patient to submit a statement that explains the patient's disagreement with the denial.
accounting :
(1) Patients have a right to an accounting of disclosures of PHI made by the pharmacy in the six years prior to the date on which the account ing is requested. (2) Detailed requirements for this accounting can be found at §164.528(b)(2) of the HIPAA Privacy Rules. (3) Pharmacies do not have to provide an accounting of disclosures if the disclosure is: for treatment, payment or health care operations, made pursuant to an authorization, an incidental disclosure, for national se curity or intelligence purposes, to correctional facilities or law enforcement authorities, part of a limited data set, or if made prior to April 14, 2003. The HITECH Act eliminates the exemption for dis closures made for treatment, payment, or health care operations for covered entities that maintain electronic health records. However, the rule implementing this requirement has yet to be finalized. [See HITECH Act below.] (4) Disclosures to health oversight agencies such as state controlled sub stance agencies or boards of pharmacy are not considered part of health care operations and must be included in an accounting.
outsourcing facilities must
(a) Have a licensed pharmacist who provides direct oversight over the drugs compounded; (b) Compound only drugs from bulk ingredients that appear on a list developed by the Secretary. This list will be developed through a notice published in the Federal Register following a 60 day comment period, and must take into consideration clini cal need; (c) Register as an outsourcing facility. FDA will make available on their website a list of the name of each outsourcing facility along with the state where the facility is located, whether the facility compounds from bulk drug substances, and whether drugs compounded from bulk are sterile or non-sterile; (d) Report to the Secretary upon registering, and every 6 months thereafter, the drugs sold in the previous 6 months; (e) Be inspected by FDA according to a risk-based inspection schedule, and pay annual fees to support; (f) Report serious adverse event experiences within 15 days and conduct follow up investigation and reporting similar to cur rent drug manufacturers; (g) Label products with a statement identifying it as a compounded drug and other specified information about the drug.
Devices: Class 2 :
- Class II devices are those intended for human use and those for which controls alone (such as Class I) are insufficient to provide reasonable assurance of safety and efficacy. There is sufficient information about Class II devices to establish performance standards that provide such assurance (i.e., controls alone will not assure safety and efficacy, but controls in addition to a performance standard will). Examples: insulin syringes, thermometers, diagnostic reagents, tampons, blood pressure gauges, and electric heating pads.
Federal Hazardous Substances Act of 1966
- Intent and Purpose The intent was that all hazardous substances be regulated regardless of their packaging and wrapping. The purpose was to protect the consumer, especially children, from household and non-household substances. 1. Hazardous items that could not be labeled safely for household use were banned from interstate commerce. 2. The sale of toys and other children's articles containing hazardous substances was banned. D. Act deals primarily with household items such as bleach ,cleaning fluids, antifreeze, drain pipe cleaners, and muriatic acid. E. Sale of items in pharmacies The pharmacist should sell the products in the original manufacturer's container or label properly.
thalomid
- STEPS program need registration of all prescribers patients and pharmacists who prescribe receive or dispense this drug - need pregnancy testing for females - limit a 28 day supply - no phone rx or automatic refills
poison prevention packaging act of 1970
- The primary purpose of the Act was to extend to prescription and non prescription drugs special packaging requirements known as "child resistant con tainers." Other household substances are also included -Requirements - Packaging must meet a test by children. A package fails if more than 20% of the child test group can open the package AFTER DEMONSTRA TION and/or if more than 10% of the ADULTS tested cannot open the package. -A child-resistant container (CRC) made of plastic or any component made of plas tic CANNOT be reused according to the Act, since wear of the components may limit the package's ability to be child resistant. If you reuse a prescription con tainer (i.e., when refilling prescription), you violate PPPA (and TSBP rules). Unless specifically exempted, ALL drugs (over-the-counter or prescription) pro duced by a manufacturer must be sold in child-resistant containers meeting the requirements if the containers will be sold or dispensed to the consumer.
REMS: risk evaluation and mitigation strategies:
- a strategy to manage a known or potential serous risk associated with a drug / bio product - benefits of drug outweigh the risks -1. 2. 3. 4. 5. Special training, experience, or certification of health care practitioners pre scribing the drags; Special certification for pharmacies, practitioners, or health care settings that dispense the drag; The drag is dispensed to patients only in certain health care settings, such as hospitals; The drag is dispensed to patients with evidence or other documentation of safe use conditions, such as laboratory test results; Each patient using the drag is subject to certain monitoring;
Title 2: drug supply chain security act :
- a uniform electronic track and trace system for rx drugs as they move through the supply chain - preempts all state laws and regulations for tracing drugs through the supply chain and record keeping and pedigree requirements
1983 orphan drug act
- amended fdca to provide incentives for manufactures to deliver and market drugs or biologic products intended for a rare disease or medical contention occurring in the us - extends the patent lie of such drugs to enhance profitability
1988 prescription drug marketing act of 1987
- amended the federal food drug and cosmetic act to reduce the potential public health risks that result form diversion or rx drugs from legit commercial channels. - band sale trade purchase of drug samples - doesn't allow counterfeiting of drug coupons - will ban the reseal of rx drugs purchased by hospitals or health care facilities or donated to charity -(1) Bans reimportation of prescription drugs produced in U.S. (2) Bans sale, trade, or purchase of samples. (3) Mandates storage, handling, and record-keeping requirements for drug samples. (4) Prohibits, with certain exceptions, the resale of prescription drugs purchased by hospitals or health care facilities. 5. Establishes criminal and civil penalties for violations of the Act.
safe medical device act of 1990
- amends the federal food, drug and cosmetic act - requires a device user facility to report to the FDA when the facility becomes aware that a device probably caused the death of a facility's patient or serious illness or injury to a facility's patient - manufactures must have a device tracking method to tell patients if the device can cause adverse health events like for a implantable device, a life sustaining or life supporting device outside a device facility user , any other device designated by FDA - requires a manufacturer to conduct post market surveillance of any device introduced into interstate commerce after january 1, 1991 1. A permanent implant, the failure of which may cause serious, adverse health consequences or death, 2.Intended for a use in supporting or sustaining human life, or 3. Potentially presents a serious risk to human health.
toxic substance
- any substance which has the capacity to produce personal injury or illness to man through ingestion, inhalation, or absorption through any body surface
Tamper-Resistant Prescription Requirements
- as of april 1, 2008 all written rx for medicaid recipients must be on paper with at least one tamper resistant feature as outlined by cms - prescriptions must be on a specific paper 1. prevent unauthorized copying of a completed or blank prescription form; 2. prevent the erasure or modification of information written on the prescription by the prescriber; or 3. prevent the use of counterfeit prescription forms.
1992 prescription drug user fee act PDUFA
- authorized fda to assess fees on manufacturers seeking approval of drugs or biologics - sponsor of each drug must pay application fees, establishment fees for each facility, and product fees for each product.
Phase 1:
- by the advisory review panels - they had to review ingredients in non rx drugs and make sure they are safe and effective for self treatment - also would review claims and recommend appropriate labeling , indications, dosage instructions, and warnings about side effects and preventing misuse
hazardous substance:
- can cause injury or illness through handling and can cause potential danger especially to children if misused
recall class 2:
- can cause temporary or medially reversible adverse effects on health where the probability of serious ae on health is remote
1965- drug abuse control amendments
- controlled use of depressants, stimulants, and hallucinogens. - precursor to the federal controlled substances act of 1970
2009 biologics price competition and inventory act
- creates an abbreviated approval pathway for biological products that are shown to be biosimilar and interchangeable -
1997 FDA modernization act
- does allow manufactures to distribute literature containing unlabeled use information under certain conditions and recent court cases have challenged the fad's authority to restrict such info
Delivering prescriptions by US mail or common carrier :
- does not allow dangerous substances to be mailed - there are some exceptions - non controlled- can be mailed to the patient as long as no alcohol, poisons or flammable substances - toxic substances can be sent by manufacturer to pharmacist or physician - controlled substances may be mailed if - the rx container must be labeled in compliance with prescription labeling rules- the outer container must be free of markings that would indicate the nature of the contents - no markings of any kind may be placed on package to indicate nature of contents 3. mailing controlled substances toothed registrants: provided controlled substances are placed in a plain outer container or overwrapped in plain paper
1951 Durham-humphrey Amendments:
- drugs that can't be used safely without medical supervision must be dispensed with a prescription from a practitioner - provides which drugs must be dispensed on prescription only basis - created the otc and rx drug categories - provided how rx drugs should be dispensed: (a) Upon a written prescription issued by a licensed practitioner. (b) Upon an oral prescription by such practitioner which is promptly reduced to writing and filed by pharmacist. (c) By refilling a written or oral prescription if authorized by the practitioner either in the original prescription or by subsequent oral order. (d) By administration or dispensing directly by the practitioner. - Drugs dispensed on prescription are exempted from most of the manufacturer's labeling requirements discussed under "Misbranded Drugs" if the label of the prescription container has: (a) Name and address of dispenser (pharmacy). (b) Serial number (prescription number) of prescription. (c) Date of the prescription or filling. (d) Name of prescriber. (e) Name of patient. (f) Directions for use and cautionary statements, if any, contained in the prescription.
the fda OTC review
- established to evaluate the safety and effectiveness of OTC drug products marketed in us before may 11, 1972 - 3 phases - public - rule making process - will make standards for an otc therapeutic drug category
tax free alcohol
- ethanol having a proof of 190 degrees or more -3. Tax-free alcohol may be used for scientific, medicinal and mechanical pur poses, and in the treatment of patients. 4. Tax-free alcohol may not be used for beverage purposes or in any food product. 5. Tax-free alcohol may not be sold. 6. Tax-free alcohol may not be given to doctors for use in their private practice by hospitals even if the doctor has an office in the hospital. 7. Industrial Alcohol User Permit must be applied for and significant recordkeeping and storage requirements must be met. 8. If only small quantities will be used for compounding or for patient use (e.g. brandy at bedtime), it is often easier to purchase the alcohol from a licensed retail dealer. 9. A community pharmacy selling alcohol in the form of a beverage must obtain a retail dealer's stamp.
denatured alcohol
- ethyl alcohol with addition of denaturants like benzene and methyl alcohol
OTC drug approval :OTC monographs
- fda made otc monographs for 80 therapeutic classes - published in federal register - has active ingredients, label requirements for a class of drugs - after a final monograph is implemented companies can make and market otc products without getting fda approval - manufactures can petition to the fda to change a final monograph to include more ingredients or to modify a label - if drugs don't conform to a monograph they must go through a new drug approval process
restricted devices:
- fda will restrict the sale, distribution, or use of a device if there cannot be assurance of its safety and effectiveness. - cardiac pacemakers and heart valves require a practitioner's authorization
tysabri
- for MS - people developed a brain infection - TOUCH program - all patient's must do an MRI before start the drug - they must be evaluated every 3-6 months and every 6 months after
new drug
- has a new chemical substance for medical use b. It is an established drug offered in a new dosage form. c. It is an established drug offered with new medical claims. d. It is an established drug offered at new dosage levels. e. It is an established drug packed in a new or novel packaging material.
the food and drug administration modernization act of 1997
- helped clarify the distinction between manufacturing and compounding
sulfites:
- in warnings must tell that it can cause allergies
biological products
- include wide range products such as vaccines, blood and blood components, allergenic, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. - can be made of sugars, proteins, nucleic acids or complex combinations of these substances or cells and tissues - they are isolated from natural sources human, animal, microorganism - can treat a variety of medical conditions where no other treatment is available - approved for marketing under the public health service act
A drug is adulterated if:
- it contains filthy, putrid, or decomposed substances - it has been prepared, packed, or held under unsanitary conditions where it could be contaminated - the methods of manufacture do not conform with CGMPs - the container is composed of any poisonous or deleterious substance which may contaminate the drug - it has an unsafe color additive - if it purports to be a drug in an official compendium and its strength differs from or its quality or purity falls below the compendium standard unless the difference is plainly stated on the label - if it is not in compendium and its strength differs from or its quality falls below that which it represents - if it is mixed or packed with any substance which reduces its strength or quality or the drug has been substituted wholly or in part
2013 the drug quality and security act DQSA
- large scale compounding by pharmacies - establishment of a framework for uniform track and trace system for rx drugs throughout the supply chain
how patient package insert requirements affect the pharmacist
- manufacture must give pharmacist enough PPI to give to each patient - must provide one in spanish if it is requested - pharmacist must give PPI to patient upon dispensing the drug that requires a PPI - both new and refill meds - special rules for hospitals - give the PPI before the first dose and once every 30 days thereafter - dont need to give PPI to patient undergoing emergency treatment - failure to give a PPI makes the drug misbranded
recovery and reinvestment act of 2009
- modified hippa including expanding the reach of hippo to business associated and sending a nationwide security breach notification to those with electronic health info
NSAIDS:
- must write NSAID on the display of the container - must have a stomach bleeding warning - in people over 60 , prior ulcers, take a blood thinner, take more than one product with nsaid in it , when take alcohol, when take longer than directed - ask doctor before use if person at increased risk for stomach bleeding - stop use if signs of stomach bleeding occur
type 6
- new therapeutic indication for a drug already approved
sodium phosphates
- no more than 90 ml per otc container
highly toxic
- one in which a single oral dose of 50 mg or less / kg would kill half or more of the white rats that are given it
Patient package inserts PPI's. FDA requires pharmacist to provide PPI with
- oral contraceptives - estrogen and progesterone containing products
Compounding quality act
- passed due to outbreak of fungal meningitis due to contaminated injectable steroid in new england and 60 patients died - deleted advertising and promotion restrictions in compounding provisions of the FDCA that were unconstitutional
Fungal Meningitis Outbreak and Passage of the 2013 Compounding Quality Act
- patient got meningitis 19 days after epidural - 25 cases were later reported -This incident brought the issue of the distinction between pharmacy com pounding and pharmaceutical manufacturing to the forefront. -in response to this tragedy, Congress passed the Compounding Quality Act as part of the Drug Product Quality and Security Act in late 2013.
Business Associates:
- people other than those who work at a pharmacy who perform a function on behalf of the pharmacy that need phi - collection agencies, external auditors, outside attorneys
administrative requirements:
- pharmacies must establish polices and procedures to protect from accidental or intentional uses and disclosures of phi through the use of appropriate administrative , technical and physical safeguards to protect the privacy - must train all employees on these privacy policies and sanctions on violations
HIPPA 1996
- portability section made health insurance more portable and easier for people to continue health coverage when leaving a job - has an impact on how patient info is handled by health care entities like pharmacies
Devices Class 3:
- premarket approval -Class III devices are those intended for human use that are purported to be supportive or sustaining of human life or of substantial importance in preventing impairment of human health. Class III devices present a po tential unreasonable risk of illness or injury and are subject to premarket approval to provide reasonable assurance of safety and efficacy. Examples: pacemakers, intraocular lenses, replacement heart valves, insulin pumps, and breast implants
restrictions on use and disclosure of phi
- probates the sale of phi, except for tx, payment, health care operations, insurance, - must get authorization from patients for electorinic disclosure of phi except for treatment, payment, or health care and insurance
Pure food and drug act 1906
- prohibited interstate commerce of misbranded and adulterer foods drinks and drugs - purity standards only no efficacy requirements - administered by the department of agriculture
Omnibus budget reconciliation act of 1990 OBRA 90
- provides for expansion of medicare and medicaid programs which are funded by the federal government - has provisions that impact the practicing pharmacist - the requirements apply only to medicaid its but many states have expanded these requirements to apply to all patients receiving pharmaceutical services - services include mandatory prospective drug use review and patient counseling
distributing
- providing a drug to anyone other than the consumer/patient - different from dispensing - must have a wholesale distribution license and will pass DSCSA data without distribution
phase 3
- publication of drug monographs - monographs establish conditions under which certain otc drug products are recognized as safe and effective
advertising or promotion of prescription drugs:
- regulated by the fda - otc advertiising is regulated by the FTC federal trade commission - advertising by pharmacists- is considered reminder advertising under fda regulation :The only purpose of the advertising is to provide information on price, not information on the drug's safety, efficacy, or indications for use. 2. The advertising contains the proprietary name of the drug, if any; the generic name of the drug; the drug's strength; the dosage form; and the price charged for a specific quantity of the drug. 3. The advertising may include other information, such as the availability of professional or others types of services, as long as it is not misleading. 4. The price stated in the advertising shall include all charges to the consumer; mailing fees and delivery fees, if any, may be stated separately.
The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 (
- requires dietary supplement manufactures , packers, distributors to report serious adverse effects to the FDA. 3. The manufacturer, packer, or distributor whose name (pursuant to section 403(e)(1) of the FD&C Act) appears on the label of a dietary supplement marketed in the United States is required to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the United States. 4. Serious adverse event reports received through the address or phone number on the label of a dietary supplement, as well as all follow-up reports of new medical information received by the responsible person within one year after the initial report, must be submitted to FDA no later than 15 business days after the report is received by the responsible person.
interchangeability
- the biologic product is biosimilar to the us licensed reference biological product and can produce the same clinical result as the reference product in any given patient - won't have a risk in terms of safety and efficacy
biosimilarity
- the biological product is highly similar to the us licensed reference biological with minor differences in inactive components but no difference in safety, purity, potency of the product
Type S (Standard)
- the drug is similar to other drugs on the market
Recall classifications: Class 1:
- the use or exposure to the product will cause serious ae on health or death
accurate IPLEDGE:
- to prevent use during pregnancy - only wholesalers registered in Ipledge can obtain this drug from manufacture - only doctors registered in IPLEDGE can prescribe this - must counsel pt about pregnancy - patient must register with IPLEGE to get the drug - must complete an informed consent form, get counseling on drug, and comply with contraception - prescriptions must be picked up within 7 days of a pregnancy test - max of 30 days dispensed - blister packages may not be broken - no refills
Tracleer:
- to treat pulmonary hypertension - will treat liver toxicity - TAP program
what is a breach
- unauthorized acquisition, access, use or disclo sure of PHI that compromises its security or privacy. It does not include instances in which there has been an inadvertent disclosure from an authorized individual to another person authorized to access PHI within the same organization. A breach also does not include instances in which the covered entity or BA has a good faith belief that the PHI is not further acquired, accessed, retained, used, or disclosed.
wholesale licensing standards
- updates the standards for licensing of wholesale drug distributors originally found in the PDMA including facility requirements, record keeping, furnishing of a bond or other security, background checks of facility managers - the FDA will issue regulations further detailing these standards
prescription drugs:
-Drug which is habit-forming, toxic, or having a potential for harm or the New Drug Application (NDA) limits its use to under the supervision of a physician. -Previously, it was required that the label for human drugs contain the federal legend, i.e., "Caution: Federal law prohibits dispensing without a prescription." FDAMA changed the labeling requirement so that the label must now provide at minimum the symbol "Rx only." Since the previous legend does not include the "Rx only" symbol, it would not satisfy the new requirement. -Veterinary products are required to be labeled "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian." -Certain products in the same drug class may be either prescription or nonprescription depending on the product. For example,most insulin products are nonprescription, however certain newer insulin products such as Lantus® and Humalog® are prescription only products.
dietary supplement:
1. A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin; a min eral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredi ent above; 2. A product intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form; or if not intended for ingestion in such a form, is not represented as a conventional food and is not represented for use as a sole item of a meal or of the diet; and 3. A product labeled as a dietary supplement.
The Dietary Supplement and Health Education Act of 1994 (DSHEA)
1. Makes dietary supplement manufacturers responsible for determining that the dietary supplements they manufacture or distribute are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. 2. Dietary supplements do not need approval from FDA before they are mar keted. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, companies do not have to provide FDA with the evidence they rely on to substantiate safety or effectiveness before or after it markets its products. 3. Requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply. 4. Places the burden on the FDA to prove that a dietary supplement is unsafe before it can be removed from the market .5. Dietary supplements cannot make claims that they treat, prevent or cure a specific disease or condition. This would make them an unapproved drug. However, under DSHEA, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe the link between a food substance and disease or a health-related condition, the intended benefits of using the product, or the amount of a nutrient or dietary substance in a product. Different requirements generally apply to each type of claim. a. Structure/function claims may include that the product affects the normal structure or function of the body, and claims for common, minor symptoms often associated with life stages, but not claims to prevent, treat, cure, mitigate or diagnose a disease. FDA Final Rule 21 CFR §101.93(f) and (g). b. Products making such claims must include the following disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any dis ease." Manufacturers must also notify FDA within 30 days of marketing a product with such statements.
federal hazardous substances act of 1966 labeling requirements
1. Name and address of manufacturer. 2. Common name. 3. The signal word "danger." 4. The signal word(s) "warning" or "caution." 5. Statement of the hazardous properties. 6. Precautionary statements. 7. First aid instructions followed by "call a physician immediately." 8. The signal word "poison" and the skull and crossbones symbol on highly toxic substances when required by the regulation.
exemptions to child resistant containers requirement :
1. Patient/physician request. a. You can use non-child resistant containers at the request of the physician or patient. b. You can get a blanket request for all prescriptions from the patient BUT NOT FROM THE DOCTOR. It is good practice to verify this with the patient yearly. c. The law doesn't require a written request, but all requests should be documented. d. The pharmacist may initiate the request for a non-CRC container, but it must be the patient's decision. 2. Bulk containers shipped to manufacturers, wholesalers, pharmacies (not in tended for household use). 3. Drugs distributed to institutionalized patients, provided the drugs are adminis tered to patients by institution (hospital) employees. 4. One package size designed for elderly patients of an over-the-counter as long as it is labeled: "THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN."
filling and refilling otc drugs pursuant to a prescription
1. Prescribes will sometimes write "prescriptions" for OTC drugs for patients for a variety of reasons including for reimbursement purposes such as for flexible spending account qualification. 2. FDA OTC labeling requirements are not necessary for OTC drugs filled pur suant to a prescription since the prescription label satisfies the FDA labeling requirements. 3. If an OTC drug is filled as a prescription (that is, in a prescription bottle with a label), it is deemed a prescription drug and it must be labeled with the prescriber's directions foruse. Theprescriptionmustalsobevalidandindate.Oncetheprescriptionhas expired, the pharmacist cannot refill it, but nothing precludes a pharmacist from sell ing the same OTC product in its original packaging to the patient. 4. If an OTC prescription calls for a dosage different than that recommended dose on the OTC labeling, it must be filled as a prescription and refill instruc tions of the prescriber must be followed.
types of drugs covered under the FDCA
1. prescription - humans and animals 2. OTC (proprietary or patent) or Over-the-Counter 3. controlled substances
CGMPs for dietary supplements has requirements of:
1. the design and construction of physical plants that facilitate maintenance, 2. cleaning, 3. proper manufacturing operations, 4. quality control procedures, 5. testing final product or incoming and in-process materials, 6. handling consumer complaints, and 7. maintaining records.
National Drug Code
A. Facilitates automated processing of drug data by government agencies,drug manufacturers and wholesalers, third party administrators, etc. B. NDC is a 10-11 character number divided into 3 segments: 1. Labeler code - First 4 to 5 digits. (Assigned by FDA) 2. Drug product code - Next 4 digits. (Assigned by manufacturer) 3. Package code - Last 2 digits. (Assigned by manufacturer) Example: Valium®2mgRoche NDC: 0140 0004 01 RocheValium® 2mg 100 count C. Assignment of the NDC number does not necessarily mean the product has an approved NDA; nor is it a determination that a product is a drug; nor does it denote that a product is covered by or eligible for reimbursement by Medicare, Medicaid, or other payers. D. The NDC is not required to be on the manufacturer's label. E. The FDA maintains a list of NDC numbers for prescription drugs and insulin products called the National Drug Code Directory that can be accessed at http://www. fda. sov/cder/ndc/ F. The FDA has proposed a new rule which will, among other things, provide for a universal standard format for NDC numbers, allow FDA to assign the entire NDC number, and require drug repackagers to have their own NDC numbers.
Information on Medication Use During Pregnancy and Breastfeeding
A. In December 2014, FDA published a final rule that replaces the product letter categories (A,B,C, D and X) previously used to classify the risk of using pre scription drugs during pregnancy. B. the new labeling will start on June 30, 2015 and requires 3 things 1. pregnancy- provides information relevant to the use of the drug in pregnant women such as dosing and potential risks to the fetus- and tells if there is a registry that collects data on how pregnant women are affected when take the drug 2. lactation : info about using the drug while breastfeeding. how much drug will go into the breast milk 3. females and males of reproductive potential: includes info about pregnancy testing, contraception and fertility as it relates to the drug
FDA orange book:
A. Official name is "Approved Drug Products with Therapeutic Equivalence Evaluations." B. primary source to determine generic equivalency of drugs C. Uses two letter coding system to indicate equivalency with first letter being the key: 1. A = drug products that the FDA considers to be pharmaceutically equivalent and therapeutically equivalent. 2. B = drug products that the FDA considers NOT to be pharmaceutically equivalent and therapeutically equivalent. D. Products with no known or suspected bioequivalence issues: 1. AA - conventional dosage forms 2. AN - solutions and powders for aerosolization 3. AO - injectable oil solutions 4. AP - injectable aqueous solutions 5. AT - topical products E. Products with actual or potential bioequivalence problems where adequate sci entific evidence has established bioequivalence are given a rating of AB. F. The Orange Book can be searched electronically on the FDA's website.
FDA purple book:
A. Official name is "Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations". B. prima source to determine interchangbilty or biosimilarity of biological products
record keeping under FDCA
A. Purchase invoices are records of drug receipt. B. Prescriptions are records of drug disposition. C. Inventories furnish a record of drugs on hand. D. Sale of drugs to practitioners or other pharmacies should be evidenced by written memorandum (store invoice). E. Records are required to be maintained for 2 years as they are by TSBP, DPS, and DEA. Although FDA only requires records to be kept for 2 years, other laws, such as Medicare, Medicaid and HIPAA, have longer recordkeeping requirement
Violations of the FDCA
A. The adulteration or misbranding of any drug in interstate commerce. B. The introduction into interstate commerce of any drug that is adulterated or misbranded. C. The receipt in interstate commerce of any drug that is adulterated or misbranded and the delivery of it. D. The alteration, mutilation, removal, etc., of the labeling of a drug or the doing of any other act while the drug is held for sale which results in the drug being adulterated or misbranded. E. Failure to keep adequate records. F. Refusal to permit entry to FDA inspectors to inspect and verify records.
Labeling:
All labels and other written, printed, or graphic matter (1) upon the article or container or (2) accompanying such article (package insert). Labeling also includes the label on the product and any advertising; also representations made by a detail person (manufacturer's representative).
tamper evident packaging:
Manufacturers and packagers of OTC drugs (except dermatological, dentifrice, insulin, or lozenge products) for retail sale must package prod ucts in a tamper-evident package, if this product is accessible to the public while held for sale. A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. To reduce the likelihood of successful tamper ing and to increase the likelihood that consumers will discover if a product has been tampered with, the package is required to be distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture). In addition to the tamper-evident packaging requirement, any two-piece, hard gelatin capsule must be sealed using an acceptable tamper-evident technology. In order to alert consumers to the specific tamper-evident feature(s) used, each retail package of an OTC drug product is required to bear a statement that identifies all tamper-evident feature(s) and any capsule sealing technologies and is prominently placed on the package;
this label or statement can be presented by :
On a sticker attached to the unit package, vial, or container of the drug product. On a preprinted pharmacy prescription vial cap. On a separate sheet of paper. In a consumer medication information sheet. In the appropriate FDA-approved Medication guide.
approved use
The prescribing or administering of a drug within the limits of the required dosage and route of administration, therapeutic indications, precautions, warn ings, and contraindications, i.e., to prescribe or administer a drug within the limits of the package insert information.
repackaging of otc products:
The repackaging and resale of any OTC drug product, including repackaging by a pharmacist, is subject to the same CGMP and labeling requirements of a manufacturer.
OTC drug labels must contain the following:
a. A principal display panel, including a statement of identity of the product. b. The name and address of the manufacturer, packer, or distributor. c. Net quantity of contents. d. Cautions and warnings needed to protect user. e. Adequate directions for safe and effective use (for layperson). f. Content and format of OTC product labeling in "Drug Facts" panel for mat (see 21 CFR §201.66 for details and example). (1) Active ingredients (2) Purpose (3) Use(s) - indications (4) Warnings (5) Directions (6) Other information (7) Inactive ingredients (8) Questions ? followed by telephone number
controlled substances:
a. Are prescription (legend) drugs which have a high abuse potential with psychological or physical dependency liability. b. Additional controls which are regulated under the Federal Controlled Sub stances Act and administered by the DEA and individual states.
Phase 1: the panels classified ingredients in three categories as follows:
a. Category I: generally recognized as safe and effective for the claimed therapeutic indication; b. Category II: not generally recognized as safe and effective or unaccept able indications; c. Category HI: insufficient data available to permit final classification
more stringent training requirements:
a. Covered Entities must provide on-going training to their employees re garding state and federal law concerning PHI. b. The training must be customized to the Covered Entity's particular course of business and each employee's scope of employment. c. The Covered Entity must train a new employee no later than the 60th day after the employee is hired and the training must be repeated at least once every two years. d. All Covered Entities must maintain paper or electronic records document ing each employee's attendance at training programs.
provision of electronic health records EHR's
a. Covered Entities must provide patients with a copy of their EHRs in elec tronic format within 15 business days of receiving a written request. b. The Texas Health and Human Services Commission is required to recom mend a standard format for the release of EHRs that is consistent with federal law.
OTC drugs
a. Defined as drugs recognized among experts to be safe and effective for self-use (self-administration). b. Must be labeled with directions for the layperson that indicate their safe and effective use. c. An OTC drug may be approved for marketing by: (1) filing a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA); or (2) by marketing the product in compliance with the requirements of an OTC monograph which sets for the active ingredients, labeling, and other general requirements.
enforcement and penalties:
a. Enforced by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). b. If the entity did not know (or by exercise of reasonable diligence, would not have known) - at least $100 per violation, not to exceed $25,000 per calendar year for all violations of an identical requirement or prohibition. c. If a violation is due to reasonable cause and not to willful neglect - at least $1,000 per violation, not to exceed $100,000 per calendar year for all violations of an identical requirement or prohibition. d. If a violation is due to willful neglect and the failure to comply is cor rected within 30 days of when the entity knew or should have known that the failure to comply occurred, the entity is subject to a penalty of $10,000 per violation not to exceed $250,000 per calendar year for all violations of an identical requirement or prohibition. e. If a violation is due to willful neglect and the violation is not corrected within 30 days, the entity is subject to a penalty of at least $50,000 per violation, not to exceed $1.5 million per calendar year for all violations of an identical requirement or prohibition.
FDCA federal food drug and cosmetic act 1938
a. Extended coverage to cosmetics and devices. b. Required pre-distribution clearance for safety of new drugs - New Drug Application - but not efficacy or effectiveness; i.e., sulfanilamide trag edy involving diethylene glycol. c. Eliminated requirement to prove intent to defraud in drug misbranding cases. d. Provided for tolerance for unavoidable poisonous substances in foods. e. Created the FDA as we know it today. f. Authorized factory inspections by FDA. g. Added injunction procedures by FDA.
content labeling:
a. FDA requires content labeling for OTC drugs containing levels of cal cium, magnesium, sodium, or potassium that might be harmful to persons with certain underlying medical conditions. Under the rules, oral OTC drugs must state the exact amount of a particular ingredient in each dose if they contain: (1) 5 mg or more of sodium in a single dose [21 CFR 201.64(a)] (2) 20 mg or more of calcium in a single dose [21 CFR 201.70(a)] (3) 8 mg or more of magnesium in a single dose [21 CFR 201.71(a)] (4) 5 mg or more of potassium in a single dose [21 CFR 201.72(a)] b. The rules also require warnings to alert customers on restricted diets to consult with their physician before using oral products that contain maxi mum daily doses of: (1) more than 140 mg of sodium [21 CFR 201.64(c)] (2) more than 3.2 grams of calcium [21 CFR 201.70(c)] (3) more than 600 mg of magnesium [21 CFR 201.71 (c)] (4) more than 975 mg of potassium [21 CFR 201.72(c)]
privacy official and contact person
a. Pharmacies must designate a Privacy Official who is responsible for development and implementation of HIPAA-related policies and proce dures and compliance. b. Pharmacies must also designate a contact person to receive complaints. This person may also be the Privacy Official.
1984 drug price competition and patent restoration act
a. Purpose of the act was to reduce health care costs. b. Codifies FDA's authority to accept abbreviated new drug applications (ANDAs) for generic versions of "pioneer" drug products first approved after 1962. c. Speeds up approval of generic drugs by eliminating duplicate and unneces sary testing; no clinical testing necessary; bioequivalent to the pioneer drug. d. Requires FDA's involvement in the process to allow holders of patents of drugs or devices to obtain up to 5 years of patent life lost during FDA's regulatory review of a product
1997 FDA modernization act
a. Reauthorized user fees. b. Replaced prescription legend "Caution: Federal law prohibits dispensing without a prescription" with "Rx only." c. Eliminated requirement that certain substances be labeled, "Warning - May be habit forming." d. Clarified conditions under which a pharmacist may compound prescrip tion drugs (but see invalidation of this section under compounding vs. manufacturing).
what is a serious adverse event:
a. Results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or b. Requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in (1) above.
Penalties and enforcement of HITECH / HIPAA violation:
a. The HITECH Act makes the civil and criminal penalties for violations of HIPAA or the HITECH Act applicable to business associates in addition to covered entities. b. The penalties for violations of HIPAA or the HITECH Act now include a tiered penalty structure based on the organization's knowledge of the violation as outlined above. c.The HITECH Act also provides for enforcement by the State Attorneys General to enjoin further violations or obtain damages on behalf of the residents of the state in an amount equal to $100 per violation for a maxi mum of $25,000 per year.
breach notification requirements for all Texas businesses
a. The Texas Business and Commerce Code also requires that any busi ness that conducts business in Texas that handles PHI to provide notification to Texas residents if their PHI is wrongfully disclosed. b. This notification requirement is consistent with the requirement in the HITECH Act that subjects vendors of personal health records and their service providers to the same security breach notification requirements as HIPAA covered entities. c. Any business that fails to make the required notification is subject to state penalties not exceeding $250,000 for a single breach.
Ipecac syrup:
a. The following statement (boxed and in red letters) must appear: "For emergency use to cause vomiting in poisoning. Before using, call physi cian, the poison prevention center, or hospital emergency room immediately for advice." b. The following warning must appear: "Warning: Keep out of reach of children. Do not use in unconscious persons." c. The dosage of the medication must appear. The usual dosage is 1 table spoon (15 ml) in individuals over one year of age. d. May only be sold in 1 oz. (30 ml) containers. e. Note difference between fluid extract and syrup: fluid extract is 14 times as potent as syrup.
incidental disclosures:
a. Unintended "incidental" disclosures are not a violation of the Privacy Rule as long as reasonable safeguards are in place. b. Examples:salesrepresentativeorjanitorialservicememberaccidentally sees PHI during the normal course of their jobs; a customer overhears counseling that is performed in private area in a discreet manner.
Tax-free alcohol may be procured and used for authorized purposes by:
a. federal, state, and local government agencies, b. colleges and universities, c. laboratories used for scientific research, d. hospitals, sanitariums, blood banks, or pathological laboratories engaged exclusively in making analyses or tests for hospitals or sanitariums, e. charitable, non-profit clinics
Use and disclosure of protected health information PHI
a. its patient identifiable information b. Pharmacies may use and disclose PHI to provide treatment, for pay ment, and for health care operations without authorization from the patient. c. Pharmacies may also use and disclose PHI for certain governmental functions without authorization from the patient. This includes uses and disclosures for public health activities such as reporting adverse events to FDA, to health oversight agencies such as boards of pharmacies or state drug monitoring programs, and to law enforcement agencies. d. Other uses and disclosures, such as for marketing purposes, require a signed authorization from the patient. If the covered entity receives re muneration for the marketing, the authorization form must expressly inform the patient of such. Refill reminder programs and face-to-face communications regarding alternative drugs or health products are con sidered part of treatment and not marketing.
2007 food and drug administration amendment act FDAAA
a. reauthorized user fees for drug and medical device approvals b. reauthorized law that increases information about new and existing drug safety and efficacy in pediatrics and extends requirements to medical devices - established the reagan dual foundation which advanced the mission of the fda to modernize product development, accelerate innovation, and enhance product safety - established new conflict of interest policies for fda advisory committees. - expanded clinical trials registry beyond just for serious and life threatening diseases - enhanced fda authority foremost market safety of drugs - established rems - requires a toll free number for reporting ae due to a drug. the label should be referred to as side effects statement. - don't need this label if its for otc products and the package has a toll free number for reporting complaints to manufacturer. For prescription drugs, the statement must include: "Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088."
current good manufacturing practices CGMPs
apply to a pharmacy only if it is engaged in manufac turing, repackaging, and/or relabeling drugs beyond the usual conduct of dispens ing and selling at retail. - if a pharmacy will open and repackage a drug they will have to register with the FDA and comply with CGMPs
final distributor:
as any person who distributes a traced device intended for use by a single patient over the useful life of the device.
the tamper resistant requirement does not apply to
electronic prescriptions, pre scriptions transmitted to the pharmacy by telephone or fax, and orders for drugs in institutional settings (including hospitals and nursing homes) where drug orders are written into a medical record and then the order is given by medical staff directly to the pharmacy. The requirement also does not apply when a managed care entity pays for the prescription.
The only exceptions to having a distribution license and passing transaction data are as follows:
i) when the distribution is between two entities that are affiliated or under common ownership; (ii) when a dispenser is providing product to another dis penser on a patient specific basis; (iii) when a dispenser is distributing under emergency medi cal reasons; or (iv) when a dispenser is distributing "minimal quantities" to a licensed practitioner for office use.
cosmetic:
i) when the distribution is between two entities that are affiliated or under common ownership; (ii) when a dispenser is providing product to another dis penser on a patient specific basis; (iii) when a dispenser is distributing under emergency medi cal reasons; or (iv) when a dispenser is distributing "minimal quantities" to a licensed practitioner for office use.
a serious ae report
is a report that must be submitted to FDA on MedWatch Form 3500A when a manufacturer, packer, or distributor of a di etary supplement receives any report of a serious adverse event associated with the use of the dietary supplement in the United States.
type 3
new formulation of a drug already marketed in US
special warning for otc products in FDCA- fd&c yellow no. 5 tartrazine and no. 6-
should have a warning under precautions on the label saying it can cause an allergic reaction
FDCA - food drug and cosmetic act
will protect the public health by requiring that safe effective and properly labeled drugs and devices be introduced into body - will ensure that food and cosmetics are safe and properly labeled