Jurisprudence Exam outline
what are some privacy regulations set by HHS
National Provider identifier standard Transactions and Code Sets Standard HIPAA privacy rule
what is an example of documentation of "significant difference:
No dye (X), patient allergy 6 mg dose, patient requires higher dose (only commercially available as 5mg) liquid, patient cannot swallow tablets (not commercially available as liquid)
What is OBRA 90
Omnibus Budget Reconciliation Act of 1990 US statuTe enacted to reduce the US federal budget deficit
when is a person CHARGED with a crime
Only if there is a statute prohibiting conduct
what act prohibits reimportation of prescription drugs and why
Prescription Drug Marketing Act (PDMA) to prevent counterfeiting
What act allowed the FDA to collect fees from drug manufacturers to fund the new drug approval process
Prescription Drug User Fee Act
Class II recall
Product may cause temporary or medically reversible adverse health effects but serious adverse effects are remote
What are the components of Title XIX of the social Security Act of 1932
Provides for healthcare costs of certain categories of indigent ACA broadened eligibility Dual eligible patients Eligibility determination covers all or part of several services medicaid: prescription drug coverage
Title V under HIPPA
Revenue Offsets includes provisions on company owned life insurance and the treatment of those who lose their US citizenship for income tax purposes
Pregnancy and lactation subsections must include what subheadings
Risk summary clinical considerations data
What prompted the Food Drug and Cosmetic Act (FD&C act) 1938
Sulfanilamide elixir tragedy of 1937 Safety
Changes to approved NDA are filed using what
Supplemental New Drug application
People use food primarily for what
Taste Aroma Nutritive value
prescriptive authority
The Durham-Humphrey Amendment provides that prescription drugs may be prescribed by a practitioner "licensed by law to administer such drug
what is the application required for biologics
Therapeutic Biologics Applications (BLA)
True or false?..Upon approval of the NDA, a manufacturer may legally distribute the drug into interstate commerce
True
What does the FDA consider Insanitary conditions?
Vermin in production area or adjacent area visible microbial contamination (bacteria, mold) non-microbial contamination (rust, dust, hairs, broken glass) in production area staff related -aseptic practices equipment and facilities conditions cleaning and disinfecting
What information is contained in the NDA
a complete evaluation of the drug's safety and efficacy Details of drug chemistry Pre-clinical and clinical trials Manufacturing processes Packaging and labeling
section 503B defines "outsourcing facility as what
a facility that is engaged in the compounding of STERILE drugs it is registered with the FDA as an outsourcing facility compliant with all of the requirements in section 503 B
What is an example of civil liability
a pharmacist sells a patient a drug they are allergic to and they had knowledge of the allergy but forgot and the patient got injured from ingesting the drug that they may sue the pharmacist for injury
What is a dietary supplement
a product (other than tobacco) intended to supplement the diet and contains one or more of specific dietary ingredients
What is food?
articles used for food or drink for man or other animals chewing gum articles used for components of any such article
How does the FDA ensure the quality of drug products
by carefully monitoring drug manufacturers' compliance with its CGMP regulations
How is eligibility determined under the social security act
by income and assets
Civil actions may be based on what kind of laws
common law (court) Statutory law (legislative) or both
What are misbranded Drugs
focuses on the representations made by the manufacturer on the label or labeling
What was the purpose of the Food and Drug Administration Amendments Act (FDAAA)
granted FDA authority to require a drug product sponsor to establish special procedures directed at patient safety, known as Risk Evaluation Mitigation Strategy (REMS)
package inserted are intended to be read by whom
healthcare professionals
USP expiration requirement for dispensed RX
manufacturer expiration date or 1 year from the date dispensed whichever is less
What is a required labeling by the FDA directed to the patient failure to do so is what
patient package insert (PPI) misbranding
what is NOT a mandated services to be covered under the social security act
pharmacy
How were the OTC classified under the efficacy Review
products were classified by rule making rather than case by case approval monograph of ingredients specified which classification the ingredients was placed
what is conscientious objection
refers to whether a pharmacist has a right to refuse to dispense prescriptions he or she has. moral or religious objection
PPI must include what
risks, uses, and precautions
FDA will only approve treatment with an IND only if......(FDAMA--widespread patient treatment)
serious or immediately life-threatening disease or condition no comparable or satisfactory alternative therapy is available clinical trials for the IND are for the disease or condition the sponsor is actively seeking approval for drug
How can an approved drug become "new drug"
the drug has a new intended use the dose, method or direction of administration change the drug contains a new substance the drug is a new combination of "approved" drugs
What is manufacturing
the production of FDA approved drug products pursuant to current good manufacturing practices (CGMP)
True or false...Manufacturing and compounding are Federal requirements
true
True or false..the exemptions of 503A do not extend to the provisions of 501(a)(2)(A)
true
how are biologics licensed
under PHSA
How is BPCIA regulated
under both the Public health service Act (PHSA) and FD&C
What is off label use
use that is not included in the FDA approved label unapproved or unlabeled use indications other than those approved by the FDA and thus not included in the approved labeling
Recall can be what
voluntary by manufacturer requires by FDA Mandated by the FDA
What drug classes were excluded from Part D formulary
weight loss or weight gain fertility promotion erectile dysfunction drugs used for cosmetic purposes of hair growth cough and cold drugs used to treat symptoms outpatient drugs for which the manufacture has testing or monitoring requirements vitamins and minerals (except: prenatal, Niacin, Fluoride preparation, and certain Vitamin D formulations)
All drugs under the following classes must be covered by the Medicare part D formulary
Antidepressant Antipsychotics Anticonvulsants antiretroviral Anti-neoplastic Immunosuppressant
What is Title IV under HIPAA and what is its purpose
Application and Enforcement of Group Health Plan requirements further defines health insurance reform including provisions for individuals with pre-existing conditions and those seeking continued coverage
What are categories of indigents that are covered by the Social Security Act
Blind disabled Aged Members of Families with Dependent children
Who leads the FDA and who appoints them
Commissioner appointed by the President with senate confirmation
who oversees the retrospective review
DUR review board of MD and RPh
FDA is the section of what department
Department of Heath and Human services
what is involved under the Retrospective Review
Develop ideal drug therapy criteria data review medication use over a particular period of time and compare to ideal drug therapy criteria identify areas of improvement in medication use
What is Title II: Section 202 u
Drug Supply Chain Security Act
How does the FDA address the inordinate amounts of compounded products
FDA has established a method to collaborate with the States through a Memorandum of Understanding (MOU)
What law prohibits Tampering with Consumer Products
Federal Anti-Tampering Act
What is the purpose of Medicare (Title XVIII)
Federal Government's effort to provide health care for the elderly (65 years of age or older) and disabled (regardless of age)
If a conflict exist between the State and Federal law, which one prevails
Federal law always prevails over state under the supremacy clause of the Constitution
Hospitals that wish to admit Medicare patient must comply with what
Federal requirements --Medicare: Conditions of Participation (COPS)
What does the first, middle and last digits of the NDC mean
First segment: assigned by the FDA and identifies the manufacture or distributor Second segment: identifies a specific strength, dosage form and formulation (i.e Lorazepam 100mg) Third segment: identifies package size and type of drug (i.e 100 capsules)
What is Title III under HIPAA
HIPAA Tax-related Health provisions includes tax-related provisions and guidelines for medical care
Any Federal or State statute or regulation that conflicts with the constitution is what
Invalid
How does FDA develop regulations
"Rulemaking authority: FDA develops regulations based on the laws set forth in the FD&C Act or other laws under which FDA operates
Prescription drugs labeling must meet what use requirements
"adequate information for use" are exempt from "adequate direction for use"
National Drug Code (NDC)
10 digit code that identifies the manufacturer, product, and package size of prescription and OTC medications universal product identifier for drugs that is utilized to report products to the FDA by drug establishments as required by the Drug Listing Act
When was the Kefauver Harris Amendment implemented how was it implemented
1968 the efficacy requirement was applied retroactively to all drugs marketed after 1938 (innovator and generics)
FDA will not consider the minimum quantity exceeded if a compounder holds for distribution no than how many days
30 days' supply based on history over the past year
what are the 3 provisions of the FD&C Act that certain drugs are exempted from under the 503 A
505: FDA approval prior to marketing (NDA) 501(a)(2)(B): cGMP requirements 502(f)(1): adequate directions for use labeling requirement
what are the 2 exempted FD &C provisions under 503 B for outsourcing facilities
505: FDA approval prior to marketing (NDA) 502(f)(1): adequate directions for use labeling requirements
What is ANDA
Abbreviate New Drug Application required for generic drugs
What drugs were excluded from Part D formulary prior to 2008 and what act added them back to the formulary
Barbiturates and Benzodiazepine Medicare Improvements for Patients and Providers Act (MIPPA) MIPPA allowed Part D plans to cover these drug as a supplemental benefit subject to certain restrictions
What is BPCIA what does it require
Biologics Price Competition and Innovation Act of ACA require pre-market approval of biologics by the FDA and are subject to FD&C Act requirements like new drugs by filling a specific application
Exemptions expiration date
CGMP requires drug products packaged since 9/29/79 to bear an expiration date which is supported by appropriate stability data, with limited exceptions OTC drug products which have no dosage limitation and which are stable for at least 3 years as demonstrated by appropriate data homeopathic drugs, while required to have a limited evaluation of stability, are also exempted allergenic extracts that are labeled "no US standard of potency"
What are the categories for the older labeling requirements for pregnancy warnings
Category A: no risk to fetus noted in well-controlled studies in pregnant women Category B: No adequate studies in pregnant women but animal studies have not demonstrated fetal risk Category C: assess benefit v risk to fetus before using --no adequate studies in pregnant women and animal studies show adverse effect category D: noted risk of fetal harm however potential benefits may outweigh potential risks Category X: risks outweigh benefits. Fetal risk noted in animal and or humans
What are the 3 categories that classified OTC meds during the efficacy review
Category I: generally recognized as safe, effective and not misbranded Category II: not generally recognized as safe and effective or that are misbranded Category III: insufficient data available to classify the ingredient
What are the consequences of violating the Fraud and abuse statute
Civil (fines) and Criminal (fines and/or prison) each prescription for reimbursement that is illegal submitted to Medicare or Medicaid would count as a separate false claim office of inspector General list--anybody on the list is not able to be involved with anything that has federal funding
What are some areas that physicians cannot refer medicare/Medicaid patients if a financial relationship exists
Clinical laboratory services Radiology Services (MIR, CT scan, Ultrasound) Radiation Therapy Services and supplies Outpatient prescription drugs inpatient and outpatient hospital services
what act amended the FD &C with respect to human drug compounding and drug supply chain security
Drug Quality and Security act
What is the Basic Framework of OBRA
Drug Utilization Review (DUR) Prospective Review Educational Program Retrospective Review demonstration projects rebates
what is the purpose of Title I: of DSQA
Drug compounding act exempts compounded drugs from new drug requirements, labeling requirements, ad track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements establishes annual registration requirement for any outsourcing facility
what are the six categories of drugs created by the national research council
Effective Probably effective (additional evidence required) Possibly effective (little evidence submitted) Ineffective (no acceptable evidence) Effective...but ( a better, safer, or more conveniently administered drug is available) ineffective as a combination
Durham-Humphre-Amendment 1951
Established 2 classes of drugs: RX (legend) and OTC (non-legend) authorized the FDA to classify drugs as prescription only vs OTC exempted prescription drugs from the "adequate directions for use" label requirement as long as they contained "caution Federal Law prohibits dispensing w/o a prescription" (RX only) authorized verbal prescriptions and refills of prescription drugs
The drug supply Chain security act requirements `
Establishes requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain establishes requirements for drug manufacturers, wholesalers, dispensers, and repackagers to ensure that all prior transaction information is provided in each transfer of ownership, in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, to provide within a reasonable time the applicable transaction documentation upon request by the Secretary or other appropriate federal or state official, to affix or imprint a product identifier on each package and homogenous case intended to be introduced in a transaction into commerce. Except from this requirement with respect to unique device identifiers any products required to have a standardized numerical identifier requires drug sponsors to ensure that each of its trading partners is authorized requires drug sponsors to have systems to investigate suspect products, handle illegitimate products, including through quarantine, disposal and appropriate notice to the Secretary and as necessary trading partners requires manufacturers, wholesale distributors, and repackagers to verify returned products before further distribution
What is the foundation, oversight and Nucleus of pharmacy law
FD&C act of 1938
What does non compliance with CGMP result in
FDA can consider any drug the company makes as "adulterated", recalls or seizure of the drug or litigation
What document lists the required label elements for the unit dose container
FDA compliance document
what is required by the FDA for individual patient access to investigation drugs
FDA must determine that there is sufficient evidence of safety and efficacy to support the drug's use the use of the drug will not interfere with clinical trials in support of approval
What is the FDA Oversight for New Drugs
FDA prohibits shipment of any new drug into interstate commerce without approval NDA, IND
FDA regulations and tampering
FDA require that certain OTC drugs, cosmetics and devices be manufactured in tamper-resistant packaging
What kind of health claims are allowed for foods by the FDA (FDAMA) example (Cheerios)
FDA will approve a health claim based on authoritative statement from certain scientific bodies FDA doesn't allow any degree of risk reduction like the Cheerios claimed must notify the FDA within 30 days if a healthy claim is made
What law repealed the habit forming requirement for unit dose substances and what is included
FDAMA (1997) the habit forming potential is included on the label with the corresponding Roman numeral denoting DEA Schedule (II-V)
What is included in the fraud and Abuse act
False claims
What kind of an offense is tampering with consumer products A product not packaged in a Tamper resistant container is What? adulterated, misbranded or both
Federal offense Adulterated and or misbranded
What is Title II under HIPAA and what is its purpose
HIPAA Adminsitrative Simplification directs the US department of Health ad Human services (HHS)to establish national standards for processing electronic healthcare transactions it requires healthcare organizations to implement secure electronic access to health data and to remain in compliance with privacy regulations set by HHS
What is Title I under HIPAA and what is its purpose
HIPAA health insurance reform protects health insurance coverage for individuals who lose or change jobs it prohibits group health plans from denying coverage to individuals with specific diseases and pre-existing conditions, and from setting lifetime coverage limits
What is HIPAA
Heath Insurance Portability and accountability Act (Public Law)
FDA possesses mandatory recall authority only with regard to what 4 products
Infant formula Medical devices Biologic products Tobacco products
what law allows private parties a cause of action against false and misleading adversing
Lanham Trademark Act
What was the conclusion of Madison (Plaintiff) vs Marshal
Marshal established the principle of judicial review (the power to declare a law unconstitutional) the ability of the Supreme Court to limit congressional power by declaring legislation unconstitutional
What are reimbursement rates under medicaid
Maximum allowable cost (MAC) Federal upper limits (FUL)--established reimbursement limits for multiple-sources drugs (drugs produced and marketed by more than one manufacturer)
FDA had no authority under FD&C act to review medical devices for safety and or efficacy before marketing until what amendment
Medical Device Amendment authorized the FDA to approve medical devices
what act allows for wholesale importation of prescription medications from Canada and how
Medicare Modernization Act (MMA) provided Secretary of HHS would approve (but the secretary has refused to acknowledge any certification)
What did the Pure Food and drug Act fail to authorize
Misbranding provision only prevented false claims regarding the drug's identity (strength, quality, purity) BUT NOT false or misleading efficacy claims did not give the FDA authority to ban unsafe drugs
does the congress have power to modify the constitution
NO, the congress does not have power to modify the constitution through regular legislation since the Supremacy Clause places the Constitution before the laws
What does the FD&C act authorize
New drug can't be marketed until proven SAFE for use under the conditions described on the label and approved by the FDA Expanded definition of misbranding and adulteration required that labels must contain adequate directions for use and warning about the habit-forming properties of certain drugs Expanded to cover cosmetics
Compared to Prescription drugs, how were OTC meds reviewed for efficacy under Kefauver Amendment
OTC's were not reviewed individually but the advisory review panels of qualified experts considered the drug by class
Examples of drugs that require package insert exemption
Oral Contraceptives estrogen containing products (DES) estrogen-progestogen oral contraceptives (exempt)
Where does the FDA publish patent information on approved drug products with Therapeutic Equivalence Evaluation (generics....
Orange Book
What are the 4 components of Medicare
Part A: hospitalization insurance Part B: Physician's services Part C--Medicare Advantage--allows a manned care place (PACE programs) Part D--Rx benefit implemented in 2006
What are Geographical requirements for Part D plans
Part D plans must ensure that beneficiaries have convenient access to a network pharmacy urban: 90% of beneficiaries within 2 miles of participating pharmacy Suburban: 90% of beneficiaries within 5 miles of participating pharmacy Rural: 70% of beneficiaries within 15 miles of participating pharmacy plans can use mail order --but not to replace requirements above plans must provide provisions for out of network (when necessary) plans must permit any pharmacy that meets the terms and conditions to participate (any willing provider)
Does medicaid cover prescription drugs
Prescription drug coverage is an optional service for medicaid
the package one size of a regulated drug in a non-child resistant label doesn't apply to what products
Prescription drugs (nearly all should be in child-resistant packaging if it is for household use) products intended for topical application (exempt from act) products in dosage forms not intended for oral administration (exempt from act) inpatient hospitals-households (exempt from act)
What is PHI
Protected Health Information it is individually identifiable protected health information under the Privacy rule (HIPAA)
what is the prescription drug marketing Act
Require states to license wholesale distributors of prescription drugs Ban the reimportation of prescription drugs, except by the manufacturer or for emergency use Ban the sale, trade, or purchase of drug samples Mandate storage, handling, and recordkeeping requirements for drug samples Ban the trafficking in or counterfeiting of drug coupons Prohibit the resale of prescription drugs purchased by hospitals or healthcare facilities, with certain exceptions
What are the 2 categories of foods created by the FDCA so that the FDA doesn't regulate these foods as drugs
Special dietary Foods Medical Foods
Prescriptive authority and scope of practice
State laws grant physicians broad treatment authority and thus the authority to prescribe almost any drug prescribers such as dentists, veterinarians, and podiatrists have much narrower treatment and prescriptive authority.
List the dietary ingredients
Vitamin, Mineral, herb or other botanical, amino acid dietary substance for use by man to supplement the diet by increasing the total dietary intake concentrate, metabolite, constituent, extract, or combination of any of the ingredients
What is the other name for the Drug Price Competition and Patent Term Restoration Act 1984
Waxman-Hatch Amendment
What are the requirements for off label advertising
Written information in the form of unabridged, peer-reviewed articles in scientific or medical journals that have not been influenced by the company can be disseminated. Prior to disseminating this information: the company must (1) have filed an application for approval for the use, (2) submit to the agency 60 days before dissemination of a copy of the information to be disseminated and (3) include with the disseminated information a disclosure that the use has not been approved, a copy of the official labeling for the product, any other products or treatments that have been approved for the use, the funding source for any studies relating to the use, and a bibliography of scientific publications regarding the use.
Can food ever be considered a drug?
Yes if a food is intended for use of diagnosis, cure, mitigation, treatment or prevention of disease
According to the US constitution, all legislative powers of the federal government are vested in what
a congress
Under section 503 A a compounded product should not be what
a copy of a commercially available drug (unless compounded only occasionally and not in inordinate amounts) on the do not compound list a drug that has been withdrawn from the market
What is considered to be a valid patient authorization under HIPAA a valid authorization must specify what
a description of the protected health information to be used and disclosed the person authorized to make the use or disclosure the person to whom the covered entity may make the disclosure an expiration date in some cases the purpose for which the information may be used or disclosed
How does the MDA (FDA) differentiate devices from drugs
a device does not achieve any of its principal intended purposes through chemical action within or on the human body/animal or dependent on metabolism it MUST be an an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article
Counterfeit drugs
a drug which or the container or labeling of which .... w/o authorization, bears any identifying mark, imprint, or device of a drug manufacturer, processor, packer or distributor other than the person who in fact manufactured, processed, packed or distributed such drug
What is civil liability goal?
a lawsuit in which one private party sues another private party alleging an injury goal: compensate the injured party for the damages caused by the wrongdoer
Recalls
a method of removing misbranded and or adulterated produced from the market to protect the public
How drug a manufacturer obtain approval of a new drug
a new drug application (NDA ) must be submitted
what is a package insert
a pamphlet that must accompany a drug product contains scientific and medical information needed for safe and effect use of the drug re-orgnizes information to make it easily accessible, and less complex Table of contents patient counseling section
PHI includes what
a patient's name, address, birth date and social security number an individual's physical or mental health condition any care provided to an individual information concerning the payment for the care provided to the individual that identifies the patient, or information for which there is a reasonable basis to believe could be used to identify the patient
what is an example of criminal liability
a pharmacist who sells a control substance without a prescription
if Medicare part D uses a formulary, it must have what
a pharmacy and Therapeutic (P&T) committee majority of the committee must be practicing pharmacists and physicians (must have at least 1 of each) the pharmacist and physician must have expertise in the care of the elderly and disabled no conflict of interest
What is the significant difference requirement
a prescriber must determine that the change made for an identified individual patient produces a significant difference from the commercial product the prescriber's determination must be documented on the prescription
What are the administrative requirements by HIPAA that covered entities must have in place
a privacy official responsible for developing and implementing policies and procedures training of all employees, including volunteers and trainees appropriate safeguards (administrative technical and physical) must be maintained a complaint process note: if PHI is disclosed in violation of its policies and procedures, a covered entity must mitigate, to the furthest extent actionable, any harmful effects
What is a Biologic
a product that replicate natural substances such as enzymes, antibodies, or hormones in our bodies
What are the 3 components required by OBRA under prospective review
a screen of prescriptions before dispensing patient counseling by the pharmacist pharmacist documentation of relevant information
Generally, an informed consent must contain what
a statement that the study involves research an explanation for the purposes of the research and the expected duration of the subject's participation a description of the procedures to be followed, and identification of any procedures which are experimental a description of any reasonably foreseeable risk or discomforts to the subject a description of any benefits to the subject or to others which may reasonably be expected from the research a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
Black Box Warning
a warning for drugs that may lead to death or serious injury required by the FDA warning of the special problem in the package insert within a prominently displayed box labeling requirement that FDA may require
What is fast track approval
accelerated approval for new drugs for serious or life-threatening illnesses
what is considered insanitary equipment and facilities
actionable microbial contamination in ISO 5 area or adjacent unsealed ceiling tiles ante room and buffer room door open at the same time HEPA filters not sealed around the perimeter to support frame construction in an area adjacent to compounding without adequate controls
What is the Food and Drug Administration (FDA)
administrative agency with the authority to oversee the safety of food, drug and cosmetics
What is the purpose of the physician anti-self referral law
aims to reduce the overuse of healthcare services and reduce costs to medicare/Medicaid prohibits physicians (dentists, podiatrists, chiropractors, optometrist) from referring Medicare/Medicaid patients to entities where the physician (or immediate family member) has a financial interest
What is the purpose of Permitted Use and Disclosure for certain healthcare operations without consent of the patient or authorization
allows a covered entity to use and disclosure protected health information with certain limits and protection for treatment, payment and health care operations activities
What is the physician Anti-self -referral violations include what
also known as Stark Law violations can result in significant fines and exclusions from Medicare and Medicaid programs
Individual patient access (parallel track policy) and investigational drugs
an individual patient acting through a physician may request an IND (in phases II or III) for treatment of a serious disease or condition
What is a device
an instrument, apparatus, machine, implant or other related article including any components, part or accessory which is -Recognized in the USP/NF -Intended for diagnosis, cure, treatment or prevention or affect the structure of human or animal body
what application does a drug sponsor NEED before conducting animal and clinical studies
an investigation New Drug (IND) application
what is required for an outsourcing facility
an outsourcing facility is NOT required to be a licensed pharmacy but compounding must be by or under the direct supervision of a licensed pharmacist and may or may not obtain prescription for identified individual patients
if a pharmacy is located within a state that signs the MOU, distribution of compounded products can be what percentage
as high as 30% of the total prescription orders dispensed/distributed by the pharmacy
why are drugs considered misbranded?
because FDA approves the exact wording of the label and labeling during the pre-market approval process
What are some biologics regulated by the FDA
blood and blood components gene therapy products human issues and cellular products used in transplantation vaccines allergy extracts
In general, before a covered entity can share PHI with another covered entity for approved reasons, which 3 requirements must be also met
both must have or have had a relationship with the patient (can be a past or present patient) the PHI requested must pertain to the relationship the discloser must disclose only the minimum information necessary for the health care operations at hand
how should compounding be performed
by or under the supervision of a licensed pharmacist pursuant to USP
How was the 503 B exemptions added to the FDCA
by the Drug Quality and Security Act
Outsourcing facilities are not exempted from what under 503 B
cGMP requirements and will be inspected by FDA according to a risk-based schedule
How big is the NDA
can be 100,000-200,000 pages of summary and data
What were the amendment to the FD &C act done by FDAMA
changes to labels and labeling caution federal law "without a prescription" was replaced with "Rx only" repealed "may be habit forming" labeling requirement streamline regulatory procedures to expedite approvals gave the FDA authority to approve use of investigational drugs outside of clinical trials (widespread patient treatment, individual patient access, fast track approval)
What are some examples of Business Association
claims processing datât processing software deleting quality assurance analysis billing services refill reminder services
what are the requirements of the medical device amendment
classification of devices based on function pre-market approval compliance with CGMP (record and reporting requirements)
What are some examples of activities that do not require authorization
communications about general health issues communications made for the treatment of the individual, face to face, case management or care coordination, to direct or recommend alternative treatment, therapies, healthcare providers or settings of care, about the health-related services offered by the pharmacy or a health plan
how do companies respond to the 483 form
companies are encouraged to respond to the FDA form 483 in writing with their corrective action plan and then implement the plan expeditiously
What is Phase IV
conducted after the drug has been marketed gathers additional information on the drug's effect in various populations gathers information regarding side effects associated with long term use
What is Phase III
conducted in a larger group of people compared to phase II continue to evaluate the drug's effectiveness further evaluate the drug's safety
What is Phase II
conducted to assess therapeutic effect (i.e subjects with disease) to determine if drug has biological effect conducted in a larger group of people compared to phase I aimed at determine the drug's efficacy and optimal dosing regimen further evaluates the drug's safety
Adulteration is defined as
containing poisonous, insanitary, ingredients or manufactured without adequate controls filthy, putrid or decomposed product prepared, packed or stored under unsanitary conditions that do not comply with CGMP containing a color additive which is unsafe strength, quality or purity differs from official compendium mixed with or ingredients substitute with another substance
What is the court's ruling regarding conscientious objection
courts have held that a pharmacist cannot obstruct a patient's legal right ro receive medications, and that state regulations requiring pharmacists to dispense are not unconstitutional
what does part D cover
covers prescription drugs for medically accepted indications, also includes biologics, insulin and medical supplies associated with administering insulin such as needles and alcohol swabs
Examples of health claims
cranberry tablets increase the acidity of the urine and help to maintain a healthy urinary tract helps maintain a healthy intestinal flora REDUCED risk (not prevent, treat, cure, diagnose, mitigate)
What was the purpose for the Waxman-Hatch Amendment
created a generic drug approval process Established the ANDA process Allowed for greater generic competition Enhanced protection for innovators provided certain non-patent exclusivities, including: orphan drug exclusivity unto 7 years
What is de-identified data
data that does not identify or provide information that could identify an individual has not restrictions to its use or disclosure
what is required of a drug sponsor for fast track approval
demonstrate the potential to address the unmet medical needs for the condition (fast track) demonstrate substantial improvement on a clinically significant endpoint compares to available therapy (Breakthrough Therapy) Approval will be conditioned on the completion of post marketing or phase IV clinical studies to verify the drugs clinical benefits
what does the 503 B describe
describes conditions under which an outsourcing facility (compound in bulk, not pt specific, CGMP) are entitled to exemptions from 2 provisions of the FDCA
What is the FD &C 503 A exemption
describes conditions under which compounding pharmacies (patient specific compounding) are entitled to exemptions from 3 provisions of the FDCA
What does adequate information for Use mean
directions for prescription drugs since they are intended to be administered under the supervision of a health care provider
the Physician Payment sunshine act
enacted under the ACA increase transparency around financial relationships between teaching hospitals, manufacturers of drugs, medical devise and biologics and physicians
What are the pharmacist's guidelines and Responsibilities under the PPPA
ensure packaging of required drugs is in child-resistant containers institutionalized patients are not required to receive child-resistant containers patient may provide a "blanket" waiver for child resistant packaging
What is the purpose of the Current Good Manufacturing Practices (CGMP)
ensure the drug is safe and meets quality and purity standards assure proper design, monitoring and control of manufacturing processes and facilities assures the identity, strength, quality and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations Manufacturers must be registered with the FDA and inspected once every 2 years by the FDA
what should be covered in the business associate contract or other arrangement that allowed by HIPPA to share PHI
establish specifically what the business associate has been engaged to do require the business associate to comply with HIPPA
Unit dose container label requirement
established drug name and quantity of active ingredient per dosage unit expiration date lot or control # required/pertinent info (i.e refrigerate, protect from light, shake well) Name and address of manufacturer, packer and distributor special characteristics 9i.e extended release, enteric coated, sublingual) Habit forming warning (Norman numeral and letter)
Prescription: commercial container label requirement
established product name identity (generic and proprietary names) Name and address of manufacturer, packer, and distributor active ingredients Names with some exceptions if not oral quantity--weights and measure (i.e 75 mg) Quantity--container (i.e 100 capsules) route of administration (except if oral) expiration date (unless exempted) Rx only or caution "Federal law prohibits dispensing w/o prescription)
The Drug Listing Act of 1972 applies to what drug establishments
establishments that are engaged in the manufacturing, preparation, propagation, compounding or processing of a drug in the distribution of the drug from the original place of manufacture to the person who makes final delivery or sale to the ultimate customer
What is needed before filling for a NDA
evidence that the drug is safe and effective obtained from animal and clinical studies the drug must be safe and effective in animal trials
Educational programs can be what
face-to face visits by experts symposiums attended by professionals involved in medication use written materials delivered to Health care professionals MD, Rph, or both can be audience of educational programs
what could result in fines under HIPAA violations who gives in the fines
falling victim to health care data breach failing to give patients acces to their PHI Office of Civil rights (OCR)
true or false..the overlap among common usage of the terms "treatment", "healthcare operations" and "Marketing" is avoidable
false
True or false..covered entities may condition treatment or coverage on the individual providing an authorization
false only with limited exceptions they may not condition ....
What was the purpose of FDAMA expediting approvals
fast track serious and life threatening drugs Encourage pediatric studies addressed off label use clinical trial database
What is phase I
first human use conducted in healthy volunteers conducted in a small group of people evaluates drug's safety, safe dosage range and side effects
What are medical foods
foods formulated for oral or enteral use under the supervision of a physician and that are intended for the specific dietary management of disease or condition for which distinctive nutritional requirements are established by medical evaluation foods formulated without the amino acid phenylalanine for phenylketonuria , folic acid, B6, B12, combination products for hyperhomocysteinemia)
What are special dietary Foods Examples
foods supplying a special dietary need that exists by reason of a physical, physiological, pathological, or other condition (disease, pregnancy, lactation, infancy, allergies, underweight, overweight, control intake of sodium) Infant formula, artificial sweetners, caloric supplements
The compounded drug product qualifies for the exemption if the drug product is compounded for what under section 503A FDCA
for an identified patient (no office use compounding) based on receipt of a valid prescription or in limited quantities before receipt of a valid prescription based on a history of receiving prescriptions by a licensed pharmacist in a state licensed pharmacy in compliance with USP, using drug with USP monographs or components of FDA approved drugs using bulk drug substances that are manufactured by FDA registered facilities and accompanied by a Certificate of Analysis (COA) following there interstate rules of the Memorandum of Understanding (MOU) between the FDA and the state where the pharmacy is located
Title II: Section 202 requires the Secretary to establish processes for what
for the exchange of transaction documentation, which shall include transaction information, transaction history, and transaction statements provide waivers of requirements, including for undue economic hardship or emergency medical reasons provide exceptions to requirements relating to product identifiers if a product is packaged without sufficient space to bear the information determine other products or transactions that should be exempt from the requirements of the act
What is the FDA 483 forms
form 483 notifies the company's management of objectionable conditions but it doesn't constitute a final Agency determination of whether any condition is in violation of the FDCA or any of its relevant regulations
staff related aseptic practices
handling beta-lactam, hazardous drugs or hormones without providing controls to prevent contamination of the production area improper gowning or failing to properly disinfect gloves, exposed skin during compounding moving too quickly while performing aseptic manipulations blocking first pass air
adminsitrative actions are called what
hearings
What is required in the Notice of Provision by HIPAA
how covered entity intends to use information legal duties of covered entity to protect PHI statement of patient right's and how to exercise statement that patients can complain to covered entity a person in covered entity to contact regarding HIPAA issues notice must be posted in a conspicuous place good faith effort to provide notice and obtain written acknowledgement
OTC container label requirement
identity, including established name name and address or manufacturer, packer, and distributor cautions and warning to protect the consumer adequate directions for use drug fact panel active ingredients including unit and quantity per unit purpose, uses, direction, inactive ingredients (alphabetically) telephone number for consumer questions
HIPPA and business associates requirement
if a covered entity engages a business associate to help carry out its health care activities and functions, the covered entity must have a written business associate contract or other arrangement with the business associate
When can a food item be considered a drug?
if a therapeutic or health claim is made for it under part B of the drug definition Part C of the drug definition specifically excludes foods (but all foods affect structure and function in some way)
How can a cosmetic become a drug Examples
if its manufacturer promotes it for a therapeutic purpose a product that might persuade an unthinking, ignorant or credulous consumer that the product would alter their appearance antidandruff shampoo, toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims or aromatherapy. these are both a cosmetic and a drug.
What is the Drug Efficacy study Implementation (DESI)
implemented in 1968 in response to 1962 Kefauver-Harris Amendment that required all drugs be effective and safe
What is tampering
improper interference with the product for the purpose of making objectionable or unauthorized changes
what is considered to be insanitary cleaning and disinfecting
improper selection of cleaning agents improper use of cleaning agents and supplies (dedicated supplies) no disinfection of equipment or supplies at each transition from areas of lower quality of air
What was the purpose of OBRA
improve quality of drug therapy to save money (primary goal) mandated changes in pharmacy practice going beyond oversight of drug distribution to include the detection and resolution of problems with drug therapy required Drug Utilization review (DUR) and patient counseling
how are clinical trials conducted
in a series called phases each seeking to answer a different research question
What is the ACA broadened eligibility
incomes at or below 138% FPL ($16,242 /year for an individual in 2015) -- states working on waivers
What is included in the "adequate information for use"
indications (i.e all purposes for which the drug is advertised) side effects , dosages, routes, methods, and frequency and duration of administration warning/precautions required to administer, prescribe, or dispense the drug safely
Female and Male reproductive potential subjection must include what
information about pregnancy testing, contraception and infertility
What are the services (all or parts) covered by the social security act
inpatient and outpatient hospitalization laboratory and X-ray skilled nursing facility care physician care home health care dental care
cosmetics are articles... Examples
intended to be introduced into or otherwise applied to the human body or any part for cleansing, beautifying, promoting attractiveness or altering the appearance intended for use as a component of any such articles skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants,
What does the term label mean
is a display of written, printed or graphic matter upon the immediate container of any article approved by the FDA narrower term than labeling i.e on the outside container or wrapper
What is a new drug?
is a drug not generally recognized by qualified experts as safe and effective for use as proposed by the drug's labeling
How did the National Research council deal with efficacy review of prescription drugs
it divided the task of evaluating each medication individually among 30 panels of experts within specific drug categories
What is a National Provider identifier standard and who is required to have it
it is a unique 10 digit national provider identifier number (NPI) that is required for each healthcare entity including individuals, employers, health plans and healthcare providers
What is the intention of the informed consent
it is intended to protect the human research subjects
what is the HIPAA privacy Rule
it is officially known as the Standards of Privacy of Individually Identifiable Health Information this rule establishes national standards to protect patient health information
when is the informed consent required in drug development
it is required for patient participation in phase I, II and III clinical trials (with some exceptions, such as emergencies) must be in WRITING
How was the 503 A exemption added
it was added to the FD &C act by FDAMA
how was the efficacy requirement by Kefauver-Harris amendment applied what was the downside
it was applied retroactively to all drugs marketed after 1938 (Innovator and generics, OTC) via DESI making the requirement retroactive for innovator and generics burdened the FDA (several thousands of drugs have been marketed between 1938-1962)
What are false claims
knowingly presenting or causing to be presented a false or fraudulent claim for payment or approval knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim
A drug is misbranded if ...
label or labeling is false or misleading label or labeling does not include required elements required label or labeling is not prominently displayed it is an imitation of another drug (i.e same shape, size, color or almost identical gross appearance, similar in effect to controlled substance
What is the FDA purple book
lists biologic products including biosimilars and interchangeable products
Who is responsible for determining if a dietary supplement is safe and that the claims about the product are substantiated by adequate evidence
manufacturer
what is required to manufacture an OTC product without child resistant packaging how to take advantage of this
manufacturer can market ONE size of OTC product for the elderly or handicapped in noncompliant containers provided that the package states "This package for Households Without Young Children" to take advantage, manufacture can distribute the same product in PPPA complaint package
what is an expiration date requirement
manufacturer is required to include the expiration date on the label of its product. This date identifies the time during which the drug may be expected to meet the requirements of the USP monograph for the drug.
what is the requirement for distribution of PPI
manufacturer must instruct the pharmacist to distribute the leaflet with each prescription (new and refill)
when is a black box warning required
may be required during the NDA review/approval process if risks are known or after approval based on post market surveillance
What does the term labeling mean
means all labels and other written, printed or graphic matter upon any article or any of its containers or wrappers or accompanying such article
what does adequate direction for use mean
means directions under which the layman can use a drug safely for the purposes for which it is intended
what are the requirements for medical foods
must be specially formulated, not naturally occurring and must provide nutritional requirements that would be impossible for the patient to meet through a normal diet
what is required by generic drug companies
must establish that the generic drug is effectively a duplicate of the branded, NDA drug, which is referred to as the Reference Listed Drug (RLD) it must show that the proposed generic drug has the same active ingredient, route of administration dosage form, strength and intended use as the RLD
what is the Educational programs requirement under OBRA
must provide for active and ongoing educational outreach programs on common drug therapy problems, using data provided by the State drug use review board
what matters can be considered significant to discuss with the patient during counseling
name and description of the medication dosage form, dosage, route of administration and duration of drug therapy special directions and precautions for preparation, administration and use by the patient common severe side effects, adverse effects or interactions and therapeutic contraindications that mat be encoded, including ways to prevent them and the action required if they do occur techniques for self-monitoring drug therapy proper storage prescription refill information actions to be taken in the event of a missed dose
FDA mandates what centers to have BUD
nursing homes intermediate care facilities skilled nursing homes
What is administrative liability
occurs when a statute or regulation has been violated or an act that requires investigation has been committed penalties: warnings, fines, license revocation, license suspension and probation
What is dual eligibility and how are they coved
patiens who have both Medicare and medicaid are covered by part D first for prescriptions Medicaid is always the payer of last resort
pharmacies that qualify for compounding exemptions are regulated by whom what regulations are not exempted
pharmacies that qualify for the exemptions are primarily regulated by the states, although some Federal requirements still apply (i.e no insanitary conditions)
What is the requirement for patient counseling
pharmacists must "offer to discuss" with each patient or caregiver matters that in the pharmacist's professional judgement are significant
What is the requirement for obtaining a waiver for child resistant packaging
pharmacists should obtain patient waiver for child-resistant packaging in writing from the patient or their agent provider MAY NOT provide a "blanket" waiver for child-resistant packaging for a patient
Meicare and hospital pharmacy requirement
pharmacy directed by a register pharmacist or drug storage area under competent supervision
under the prospective review, the review shall include screening for what
potential drug therapy problems due to therapeutic duplication drug-disease contradictions drug-drug interactions (including serious interactions with non-prescription or OTC drugs) incorrect drug dosage or duration of drug treatment drug allergy interactions clinical abuse/misuse
Class III recall
product unlikely to cause adverse health effects
What products are excluded from the office use requirement and holding distribution of compounded products under section 503A
products held in quarantine for testing
Pure Food and Drug Act
prohibited the adulteration and misbranding of foods and drugs in interstate commerce requires drugs to meet standards --USP/NF
What is the Anti-Kickback Statute
prohibits knowingly and willfully soliciting, receiving, offering or paying any remuneration (including kickback, bribe or rebate) in exchange for inducing referrals or for furnishing goods or services paid for by Medicare/Medicaid
what is the purpose of section 103 under drug compounding act
prohibits the resale of a compounded drug labeled "not for sale" or the intentional falsification of a prescription for a compounded drug note: deems a compounded drug to be misbranded if its advertising or promotion is false or misleading in any particular way
What are the 2 main goals of HIPPA what are the other goals
provide continuous health insurance coverage for workers who lose or change their job reduce administrative burdens and cost of healthcare by standardizing the electronic transmission of administrative and financial transactions combating abuse, fraud and waste in health insurance and healthcare delivery improving access to long term care services and health insurance
what is the purpose of tamper resistant packaging
provides visible evidence to a consumer that tampering occurred
drug compounding act requires the secretary to do what
publish a list of drugs presenting demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug , taking into account the risk and benefits to patients convene an advisory committee on compounding before creating the list
labeling for adequate direction for use must include
quantity or dosage for each intended use and for persons of different ages and physical conditions frequency of administration or application duration of use time of administration or use route of administration necessary preparations instructions (i.e shake well)
What is the requirement for approval of an investigation drug for immediate life-threatening disease
reasonable basis that the drug may be effective and would not expose the patient to unreasonable and significant risk
Class I recall
reasonable probability that product will cause serious adverse health effects or death
Drugs are articles... 21 U.S.C 321(g)(1)
recognized by the USP, official Homoeopathic Pharmacopoeia of the US or NF (A) intended for use in diagnosis, cure, mitigation, treatment or prevention of disease (B) Non-food intended to affect structure or function of human body/animals (C) intended for use as a component of A, B, or C
what does the ANDA refer to
refers to the previously approved NDA and relies on the safety and effectiveness data for the listed drug product (NDA product) f
The drug Listing Act requires establishments to do what
register with the FDA provide the FDA with a list of all their commercially marketed drug products
General controls for medical devices include what
registering facility with FDA listing products with the FDA following GMP maintain records and reports and pre-market notification in some cases (i.e Class III)
DSHEA authorizes the FDA to do what
regulate Dietary supplements as food rather than drugs or food additive cannot require pre-market approval for supplements MUST prove that a dietary supplement is unsafe before removing it from market
What is the new pregnancy warning system drugs approved on or after 6/30/15
replaces the former "letter category" risk levels requires labeling on pregnancy, lactation (including amount of drug in breastmilk and potential effects to child) and female and male reproductive potential
drug compounding act requires outsourcing facilities to do what
report biannually to HHS the drugs compounded in the facility submit adverse event reports be inspected (a risk-based inspection schedule)
older pregnancy warnings required what labeling requirements
require information regarding pregnancy and lactation
Kefauver -Harris Amendment
required drugs to be safe and EFFECTIVE established GMP requirement transferred oversight of drug advertising from FTC to FDA strengthened clinical trials by requiring informed consent of research subjects and adverse drug reaction reporting
Poison Prevention Packaging Act (PPPA) Requirements
requires "special packaging" of household products and drugs to protect children from serious injury or illness child-resistant packaging
what is the purpose of section 105 under drug compounding act
requires HHS to receive submissions from state boards of pharmacy describing any disciplinary actions taken against compounding pharmacies or any recall of a compounded drug, and expressing concerns that a compounding pharmacy may be violating the FDCA
What is criminal liability penalties, goal
requires a statute (law) prohibiting conduct Penalties: fine, prison or both depending on severity or penalties in the violated statute goal: deter an undesirable activity and punish/rehabilitate the wrongdoer
What is the Transaction and Code set standards
requires healthcare organizations to follow a standardized mechanism for electronic data interchange (EDI) in order to submit and process insurance claims
What do rebates require under OBRA
requires manufacturers to provide drugs to Medicaid at their "best price" the lowest price they sell to any consumer
Prospective Review (OBRA)
requires pharmacists to find out necessary information about the patients and their medications before dispensing occurs requires the active resolution of problems through a comprehensive review of a patient's prescription order a the point of dispensing
what is the function of section 107 under drug compounding act
requires the comptroller General (GAO) to report on pharmacy compounding and the adequacy of state and federal efforts to assure the safety of compounded drugs
what is the purpose of section 106 under drug compounding act
revises compounding pharmacy requirements to repeal prohibitions on adverting and promotion of compounded drugs by compounding pharmacies and repeal the requirements that prescriptions filled by a compounding primacy be unsolicited
How does the FDA determine compounded product are essentially copies?
same API API's with same, similar or easily substitutable strengths (within 10% of commercial product or fraction of multiple commercial product can be used) a compounded drug for a different route of administration when the commercially available product can be used by that route (even if off label) combinations of drugs--if same API as two or more commercially available products with same, similar or easily substitutable strengths
What is an unit-dose packaging
single dosage unit for direct administration used by hospitals and other institutions
What product is exempted from the cosmetic definition
soap
What regulations require expiration and BUD or dispensed Rx label
state laws USP standards
Exemptions to Child-proof containers!! know the strengths
sublingual Nitroglycerin sublingual and chewable ISDN 10mg or less oral contraceptives (estrogen or progesterone) Tablet Mebendazole in packages containing not more than 600 mg Powder Anhydrous cholestyramine all unit dose forms of K supplements ( individually wrapped effervescent tablets, vials of liquid K and powdered K) in unit dose packets containing not more than 50 mEq of K per unit dose Pancrelipase preparation in tablet, capsule or powder form Colestipol in powder form in packages containing not more than 5 grams Prednisone in tablet form, when dispensed in packages containing not more than 105 mg Methylprednisolone in tablet form in packages containing not more than 84 mg NaF products not more than 264 mg per package Betamethasone not more than 12.6 mg per package
what does the IND require
substantial information about the drug, its manufacturing and the experience and qualifications of clinical investigator
What is the requirement for approval of an investigational drug for serious disease
sufficient evidence of safety and effectiveness for the use
what kind of dietary supplements does the FDCA consider a drug what is the exception
supplements that contain any articles approved as a new drug unless prior to the articles approval, it was manufactured as a dietary supplement or food
the state government receives the authority to regulate pharmacy practice and the distribution of drug through what
the 10th amendment of the constitution (from the bill of rights) can also use police powers (allow to enact laws promoting health, safety and welfare of the public)
when is the 483 presented
the 483 form is presented at the conclusion of an inspection and discussed with the companies senior management
how did the FDA carry out the efficacy review of prescription drugs
the FDA commissioned the National Academy of Sciences-- National Research Council to study the drugs and submit recommendations to the FDA
What are sources of the US law
the US constitution Legislative: statutory law Administrative agencies (i.e FDA: interpret and define laws) Court: common law (developed via judicial opinions)
the benefit described by the physician for a compounded product must be what
the benefit described by the physician must be met by compounding the product
What is the supreme law of the United States
the constitution
What is BUD
the date after which the drug should not be used, and it must not exceed the manufacturer's expiration date.
What amendment allows for advertising
the first amendment
the US congress and Federal administrative agencies derive their authority to regulate drug distribution from what
the interstate commerce clause of the constitution
what is compounding
the production of a drug preparation that meets the unique needs of an individual patient when a commercially available drug does not meet those needs.
how does the Physician Anti-self referral act (stark law) differ from the Anti-Kicbak statute
the violation does not need to be knowingly and willfully
what is the goal of demonstration projects
to determine through scientific studies whether outcome of patient care improve and the costs decrease when Rph are paid to provide DUR services to patient, whether a drug is dispensed or not , the efficiency and cost -effectiveness of online computerized DUR cost-effectiveness of face to face consultation
what is considered to be marketing
to make communication about a product or service that encourages recipient of the communication to purchase or use the product or service
If a pharmacy is located within a state that doesn't sign the MOU, how is the distribution of compounded produced in the commerce restricted
to no more than 5% of the total prescription orders dispensed/distributed by the pharmacy
What is the function of HIPAA Privacy rule
to protect all individually identifiable health information that is held or transmitted by a covered entity or a business associate information can be held in any form, including digital, paper or oral
When did biologics got recognized to have generics
unlike drugs, generics were not recognized until the patient protection and affordable care Act (ACA) under the BPCIA
what is MedWatch
voluntary reporting system maintained by the FDA that allows healthcare professionals to report serious adverse events, including side effects, product use errors, quality problems, and therapeutic failures for some products (biologics, OTC, RX, food, cosmetics, devices, special nutritional products )
Does a patient have a right to waive counseling
yes counseling is for the benefit of the patient and has the right to waive it
