PHP316 Exam #1
Prescription drugs must contain:
"Adequate information for use" and the drug's indications, side effects, dosages, routes, methods, frequency, and duration of administration, contraindications, and other warnings.
Stare Decisis
"To abide by decided cases" A court's establishment of a certain rule of law based on a particular set of facts becomes a precedent that all lower courts in that jurisdiction must follow.
The 2006 CPG (Compliance Policy Guide) signified the beginning of what the agency termed...
"Unapproved Drugs Initiative"
When asking "What is legal?" think...
"What is best for the patient?"
Cosmetic
(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance (2) articles intended for use as a component of any such articles; except that term shall not include soap
Therapeutic Equivalence
Pharmaceutical equivalents that can be expected to have the same clinical effect and safety.
Purple Book
Lists biological products, including any biosimilar and interchangeable biological products licensed by the FDA under the PHSA.
Prescription Drug User Fee Act of 1992 (PDUFA)
- Requires manufacturers seeking NDAs to pay fees for applications and supplements when the FDA must review clinical studies. - Must be reauthorized every 5 years.
Risk Evaluation and Mitigation Strategy (REMS)
- Intent is to manage known or potential serious risks of the product. - FDA requires a drug product sponsor to establish special procedures directed at patient safety. - Requires manufacturer to to submit periodic postmarket assessments of whether the drug's risks are being adequately managed.
Drug (4 part definition)
(A) articles recognized in the U.S. Pharmacopoeia, the official Homeopathic Pharmacopoeia, or official National Formulary, or any supplement to any of them (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals (C) articles, other than food, intended to affect the structure or any function of the body of man or other animals (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C)
Child Resistant Containers
- 80% of children <5 cannot open. - 90% adults can open. - Only glass or threaded plastic containers can be reused.
The Dietary Supplement and Nonprescription Drug Consumer Protection Act
- Adds two adverse events reporting systems: one for nonprescription drugs and the other for dietary supplements. - Via Medwatch.
Guidance Documents
- Clarify laws or regulations, explain how compliance with laws may be achieved, and outline review and enforcement approaches. - Not legally binding, nor legally enforceable.
Pedigree
- Contains information on each transaction changing the ownership of the drug.
The Federal Register
- Daily publication. - Lists various federal actions including proposed regulations, final regulations, and various government notices.
Dietary Supplement Health and Education Act of 1994 (DSHEA)
- Defined dietary supplements and permitted manufacturers to make certain claims that otherwise would've been illegal under FDCA. - Exempts dietary supplements from part (C) of the drug definition because it allows them to make structure/function claims.
Unqualified Health Claims
- Do not require a disclaimer. - Allowed if FDA found that the dietary supplement met the significant scientific agreement test.
Phase III of Human Clinical Trials
- Drug is tested for safety and efficacy in hundreds or even thousands of patients. - Often occur in actual clinical settings such as physician's offices and hospitals.
Durham-Humphrey Amendment of 1961
- Established prescription and OTC drugs. - Provided that the labels of prescription drugs need not contain "adequate directions for use" so long as they contain the legend "Caution: Federal law prohibits dispensing without a prescription". - Also authorizes oral prescriptions and refills of prescription drugs. - Provides that prescription drugs may be prescribed by a practitioner "licensed by law to administer such drug".
Prescription Drug Marketing Act of 1987
- Establishes sales restrictions and recordkeeping requirements for prescription drug samples. - Prohibits hospitals from reselling their pharmaceutical purchases to other businesses. - Requires state licensing of drug wholesalers.
Courts often can reach decision in law only after considerable reasoning based on several factors including:
- Fundamental notions of fairness - Custom or history involved - Command of a political entity - Best balance between conflicting societal interests
The product is an imitation drug if it is...
- Identical in size, shape, and color. - Similar or virtually identical in gross appearance. - Similar in effect to controlled substances.
Delaney Clause
- Included in Food Additives Amendment of 1958. - Prohibits the approval of any food additive that might cause cancer.
Drug Efficacy Study Implementation (DESI)
- Initiated in response to Kefauver-Harris Amendments require drugs to be both efficacious and safe. - FDA regarded generic drugs as new drugs and required generic manufacturers to prove efficacy.
Phase II of Human Clinical Trials
- Limited number of patients who actually have the disease for which the drug is an intended treatment. - Purpose = to determine the efficacy of the drug and the dosages at which the efficacy occurs.
Patient Package Inserts (PPIs)
- Manufacturers must include a PPI for each package that it intends will be distributed to the patient. - Pharmacists must include a PPI with each container dispensed (new or refill).
National Association of Boards of Pharmacy (NABP)
- National organization that brings state boards of pharmacy together. - Oversees the NAPLEX.
Food and Drug Administration Modernization Act of 1997 (FDAMA)
- Passed to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices. - Creates a fast-track approval process for drugs intended for serious or life-threatening diseases.
Food, Drug, and Cosmetic Act of 1938
- Provided that no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA. - Required that labels must contain adequate directions for use and warnings about the habit-forming properties of certain drugs. - Exempted drugs marketed before 1938.
"Adequate" labeling of a drug must include:
- Quantity or dosage for each intended use and for persons of different ages or physical conditions. - Frequency of administration or application. - Duration of administration or application. - Time of administration or application. - Route or method of administration or application. - Preparation necessary for use.
FDA Safety and Innovation Act of 2012 (FDASIA)
- Reauthorized PDUFA. - Added new user fees for generic drugs and biosimilars.
Food and Drug Administration Amendments Act of 2007 (FDAAA)
- Reauthorized and amended many drug and medical device provisions that were set to expire. - Provided FDA with new funding and significantly more authority over drug safety. - Requires that pharmacies provide patients with notification of a toll-free number so they can report AEs.
Section 505(b)(2) NDAs
- Replaced and expanded "paper" NDAs. - Allowed a manufacturer to rely (at least in part) on published safety and efficacy data. - Manufacturer could be granted 3-5 years market exclusivity.
Qualified Health Claims
- Require a disclaimer. - Made when the claim does not meet the significant scientific agreement test and the claim would be misleading without the disclaimer. - Allowed only when there is more evidence for the claim than against it.
Kefauver-Harris Amendment of 1962
- Required that drugs not only be proven safe, but also be effective. - Was made retroactive to all drugs marketed between 1938 and 1962. - Transferred jurisdiction of prescription drug advertising from the Federal Trade Commission (FTC) to the FDA. - Established GMP requirements. - Required informed consent of research subjects and reporting of ADRs during clinical trials.
The Generic Drug Enforcement Act of 1992
- Resulted from scandal of FDA staff accepting bribes. - Authorized the FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies.
Code of Federal Regulations (CFR)
- Revised annually. - Compilation of final regulations. - Divided and indexed by subject matter. - 50 titles (which are further subdivided).
Phase I of Human Clinical Trials
- Small number of subjects. - Examine the drug's toxicity, metabolism, bioavailability, elimination, and other pharmacological actions. - Doses of drug are initially low then are gradually increased. - Purpose = to determine safety and detect adverse effects, not to determine efficacy.
Waxman-Hatch Amendment
- Streamline the generic drug approval process while giving patent extensions to innovator drugs. - Provides market exclusivity for an innovator manufacturer that develops a new chemical entity or a new use for a previously approved drug. (In general, prevents a generic drug application from being submitted for five years from the date of approval of the drug).
An approved drug may become a new drug if:
- The drug contains a new substance. - There is a new combination of approved drugs. - The proportion of ingredients in combination has changed. - There is a new intended use for the drug. - The dosage, method, or duration of administration or application is changed.
What limits the extent of government regulation?
- U.S. Constitution - State constitutions - Human condition
Four types of market failures relevant to drug use:
1. Public goods 2. Externalities 3. Natural monopolies 4. Information asymmetry
Only about ____ in _____ drugs demonstrates enough merit to make it through clinical trials to the NDA submission.
1 in 10
MedWatch Number
1-800-FDA-1088. Must be provided to patients with each new and refill prescription via a sticker, a pre-printed cap, on a separate sheet of paper, in a MedGuide.
Postmarketing surveillance is necessary for two reasons:
1. An investigational drug is tested in a relatively small number of patients compared with the number of patients who may use the drug after it is marketed. 2. Long-term AEs may not be discoverable before approval.
Two purposes of stare decisis?
1. Establishing continuity of decisions 2. Expediting judicial decision making
Most states require that for the applicant to practice pharmacy, he/she must meet criteria:
1. Graduation from pharmacy school/ 2. Completion of specified internship requirements. 3. Attainment of a specified age. 4. A passing score on the licensure examination. 5. Demonstration of good moral character.
The FDA will approve an investigational drug for treatment if:
1. It is to be used for a serious or immediately life-threatening disease or condition. 2. There is no comparable or satisfactory alternative therapy available. 3. The drug is under investigation for the disease or condition. 4. The sponsor is actively pursuing marketing approval of the drug. 5. In the case of serious diseases, there is sufficient evidence of safety and effectiveness for the use. 6. In the case of immediately life-threatening diseases, there is a reasonable basis to conclude that the drug may be effective and would not expose patients to unreasonable and significant risk.
Three Concerns with DSHEA
1. Law allows the marketing of unsafe dietary supplements and it prevents the FDA from acting aggressively enough to protect the public. 2. Lack of consumer information about the dangers of taking many dietary supplements with certain OTC and prescription medications. 3. Dietary supplements lack quality standards for strength and purity because manufacturers are not required to register themselves or their products with the FDA prior to marketing them.
Three ways in which a drug can be switched from prescription to OTC:
1. Manufacturer may request a switch by submitting an sNDA. 2. Manufacturer may petition the FDA. 3. FDA may add or amend an OTC monograph.
Two parts of the patient information program:
1. MedGuides - required that the manufacturer provide MedGuides for a few specifically designated drugs that pose a "serious and significant" concern to public health. 2. Useful written information (Consumer Medication Information of CMI) be given to the patient for every drug each time a new prescription is dispensed.
In order to be valid, a regulation must generally meet three legal tests:
1. Must be within the scope of the agency's authority 2. Must be based on a statute that gives the agency the authority to promulgate the regulation 3. Must bear a reasonable relationship to the public health, safety, and welfare
What should the pharmacist take into account when determining BUD?
1. Nature of the drug 2. Container in which it was packaged by the manufacturer 3. Characteristics of the dispensed container 4. Expected storage conditions
Two pathways into impaired pharmacist rehabilitation programs:
1. Pharmacist voluntarily enters into a rehab program without BOP involvement or knowledge. 2. Pursuant to a BOP hearing.
What determines if the FDA is going to approve an NDA?
1. Proof of the drug's safety and efficacy 2. The proposed manufacturing process 3. Benefit/risk ratio
Fees reduce FDA response time in 3 ways:
1. The fees allow the FDA to hire hundreds of extra reviewers 2. High fees discourage sponsors from submitting applications until they have a high probability of success 3. Fees fund upgraded information technology systems to improve efficiency
Two controversies of PTRA:
1. The law allows a generic drug to statistically vary in its rate and extent of absorption by plus or minus 20% from the parent and still be considered bioequivalent. (Could result in AEs). 2. Whether a generic drug product could be prescribed and dispensed for an indication that the innovator drug product has been granted exclusivity.
Objectives of pharmacy licensure:
1. To increase the quality of healthcare 2. To reduce the cost of healthcare 3. To inhibit the criminal abuse of drugs
In 2012, PhRMA (Pharmaceutical Research and Manufacturers of America) determined that it takes an estimated ________ years for a potential drug to go from lab to patients, at an average cost of ____________.
10 - 15 years; $1.2 billion
The PDUFA of 1992 was generally credited as having reduced the FDA review time for NDAs from a median approval time of ____________ (before the act) to ____________ (in 1995).
23 months to 15 months
If the FDA does not reject the IND request within ___________ of submission, clinical testing on humans may begin.
30 days
Institutional Review Board (IRB)
A committee designated by the institution charged with reviewing any research projects involving human subjects.
Adulteration
A drug may be adulterated, even if it's pure, if it is: - Prepared, packed, or held in conditions where it may have been contaminated. - Exposed to a container that may have contaminated it. - Manufactured under conditions that do not conform to cGMP. - Contains an unsafe color additive. Or if: - A drug that is subject to compendia standards has a different strength, quality, or purity that listed in the compendia. - If not a compendia drug, has a different strength, quality, or purity than listed on the label.
"New Drug"
A drug that is not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the drug's labeling. Even if the drug is recognized, it must have been used for a material extent of time under the conditions recommended on the labeling.
"Paper" New Drug Applications
A generic drug manufacturer would not have to duplicate the actual research establishing the safety and efficacy of the innovator drug, as a full NDA would require.
Dietary Supplement
A product that is intended for ingestion, is intended to supplement the diet, and contains any one or more of the following: vitamins, minerals, herbs or other botanicals, amino acids, a dietary substance intended to increase total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of those.
Current Good Manufacturing Practices (cGMP)
A set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product.
National Drug Code (NDC) Number
A unique, 10-digit, 3-segment number. Either 4-4-2, 5-3-2, or 5-4-1.
Sample
A unit of drug intended not to be sold but rather to promote the sale of the drug.
What organization accredits pharmacy schools in the U.S.?
ACPE - American Council on Pharmaceutical Education
Verified Internet Pharmacy Practice Sites (VIPPS)
Accreditation process for internet pharmacies. Any pharmacy that has been accredited will display the VIPPS seal.
Drug Supply Chain Security Act (Title II of DQSA)
Added "track and trace" (pedigree) requirements for all entities in the chain of distribution of pharmaceutical products.
"Professional labeling"
Additional labeling specifically for the healthcare professional. Provides information for conditions not appropriate for lay diagnosis or treatment.
Supplemental New Drug Application (sNDA)
After NDA approval, any changes a manufacturer may wish to make in the production or labeling of the drug are usually made by means of an sNDA. (3 varieties)
Interstate Commerce Clause of the Constitution
Allows U.S. Congress and federal administrative agencies to derive their authority to regulate drug distribution.
Collaborative Agreement
Allows pharmacists to initiate or adjust drug therapies in collaboration with a physician.
Change Being Effected (CBE) Supplement
Allows the sponsor to implement the change before the FDA approves it.
Unit Dose Packaging
When a single dosage unit of a drug is prepackaged and prelabeled for direct administration.
"Authorized Generic"
An innovator manufacturer producing a generic version of its brand-name product just as their patent is about to expire or be successfully challenged by a generic competitor.
Fourteenth Amendment
Applies the Bill of Rights (i.e. freedom of speech, freedom of religion, right to due process) to state constitutions.
Class III Drug Recall
Applies to products that are not likely to cause adverse health consequences.
If a biological product contains a drug, it will be classified...
As either a biological or a drug depending on its primary mode of action.
What does the first section of an NDC number identify? Who assigns it?
Assigned by the FDA to identify manufacturer or distributor.
Category III Ingredients
Available data insufficient to permit classification.
Section 707 of the FDCA
Because the FDA is an administrative agency, it has rule-making authority.
Which branch of the FDA most directly affects pharmacy practice?
CDER - Center for Drug Evaluation and Research
_________________ and ________________________ require that prescription labels be printed in labels other than English.
California and New York.
De novo
Case will be conducted as an entirely new trial and no heed will be considered to previous hearing findings.
What is the old system regarding pregnancy and drugs?
Category A,B,C,D,X
Patient Protection and Affordable Care Act of 2010 (ACA)
Changed a lot of the healthcare system and added provisions to the FDCA both directly and indirectly affecting other law related to pharmacy practice.
Alberty Food Products Co. v. United States
Conclusion: Merely stating the proper way to take a drug is not adequate. The labeling must be complete enough to inform the consumer that the drug should be used for the consumer's particular ailment.
Office of the Inspector General (OIG)
Conducted a study to assess the accuracy, truthfulness, education value, and quality of prescription drug advertisements in leading medical journals. Concluded that most advertisements potentially violated FDA regulations.
Amendment of the Pure Food and Drug Act in 1912
Congress amended the law to prohibit false and fraudulent efficacy claims.
Informed Consent
Consent of the patient confirming that they know the risks, possible benefits, and alternate courses of treatment.
First Letter A
Considered therapeutically equivalent to a reference drug product.
United States v. Article of Drug -- Decholin
Court established that the FDA must prove two issues to change the status of a drug from OTC to prescription: 1. that the toxicity and method of use require practitioner supervision 2. the collateral measures necessary to use the drug require supervision
Griffiths v. Superior Court
Court ruled that the Board was justified in determining that three different misdemeanor convictions by a pharmacist in a five-year period constitutes unprofessional conduct.
Administrative Agencies
Created by a legislature to implement desired changes in policies or to administer a body of substantive law when the legislature itself cannot perform these functions.
Biologics Price Competition and Innovation Act (BPCIA)
Creates a regulatory framework to facilitate the approval of generic biologics; grants the FDA the authority to determine whether a biosimilar is therapeutically equivalent to a reference biologic and thus can be interchanged in the same manner as generic drug products.
A pharmacist's wrongful act may subject the pharmacist to a ______________, _________________, or _________________ action, or perhaps all three at the same time.
Criminal, civil, and administrative.
Plea Bargain
Defendant agrees to plead guilty to a lesser offense instead of risking the results of a jury trial and being found guilty of a greater offense.
Homeopathic Pharmacopoeia of the United States (HPUS)
Defines homeopathy as the "art and science of healing the sick by using substances capable of causing the same symptoms, syndromes, and conditions when administered to healthy people".
The FDA is a component of the _______________.
Department of Health and Human Services
Wholesale Distribution
Distribution to anyone other than the consumer. (Wholesalers must be licensed in the state in which they are located).
What is another name for the Kefauver-Harris Amendment?
Drug Efficacy Amendment.
What is another name for the Waxman-Hatch Amendment?
Drug Price Competition and Patent Term Restoration Act of 1984
Orphan Drugs
Drugs that are sufficiently safe and effective to be marketed, but the number of patients who need them is so small that it is not commercially feasible for a manufacturer to market them.
Poison Prevention Packaging Act (PPPA) of 1970
Enacted with the intent of protecting children from accidental poisonings with "household substances".
Executive Branch
Enforces the laws.
"Park Doctrine"
Established based on United States v. Dotterweich and United States v. Park, and established that corporate officials can be personally prosecuted without proof that they acted intentionally or with negligence or even if they had no knowledge of the offense.
Administrative agencies are housed in the ___________________ branch of government.
Executive.
Externality
Exists when the production or assumption of a good affects someone who does not fully consent to the effect and when the costs of a good are not fully incorporated into the consumer price. (ex: persons who purchase goods produced in a factory do not think of the lung pollution/damage experienced by those who live close to the factory)
"Outsourcing Facility"
Facility registered with the FDA that has one geographic location engaged in the compounding of sterile drugs and complies with all of 503(b).
Misbranding
Focuses on representations made by the manufacturer on the label or labeling. - A drug's labeling shall not be false or misleading.
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 a disease or condition for which distinctive nutritional requirements are established by medical evaluation. Must be specially formulated, not naturally occurring.
Abbreviated New Drug Application (ANDA)
For generic drugs. Proof of efficacy not required, but rather proof of bioequivalence and proof of acceptable manufacturing methods and controls.
Class II Medical Devices
General controls alone are insufficient to ensure safety and effectiveness. (Ex: insulin syringes, infusion pumps, thermometers, tampons).
GRASE
Generally Recognized by experts As Safe and Effective.
Category I Ingredients
Generally recognized as safe, effective, and not misbranded.
Proof in a criminal trial?
Government must prove its case "beyond a reasonable doubt".
Example of natural monopoly in drugs?
Government regulation ensures that there is an incentive to develop new drugs by initially providing an exclusive right to market them.
What types of pharmacies can receive samples?
Hospital, healthcare entities, NOT community.
What does the second segment of an NDC number identify? Who assigns?
Identifies a specific strength, dosage form, or formulation for a particular firm. Supplied by the firm.
What does the third segment of an NDC number identify? Who assigns?
Identifies package size and type of drug. Supplied by the firm.
Special Dietary Foods
Include, but are not limited to, those supplying a special dietary need that exists by reason of a physical, physiological, pathological, or other condition (i.e. disease, pregnancy, lactation, underweight, overweight). Ex: infant formulas, artificial sweeteners, and caloric supplements.
Labeling
Includes the label and all other written or graphic manner that accompanies the drug, such as the package insert.
Mill principle
Individuals in a free society are permitted to act in ways that they deem best for themselves -- as long as their actions do not interfere with another individual's right of action.
Judicial Branch
Interprets the laws.
Information Asymmetry
Leads to market failure when the consumer is uninformed about the true value of a good.
Orange Book
Lists thousands of currently marketed multi source drug products that the FDA has approved as safe and effective. - Rates pharmaceutical equivalents for therapeutic equivalence. - Not a mandate, merely a guide. - Pharmacists should reference before substituting a brand with a generic. - Rates using a two letter coding system (i.e. AA, AB, AO, etc.)
Drug Quality and Security Act of 2013 (DQSA)...what are the two titles?
Made of two titles: Title I = Compounding Quality Act Title II = Drug Supply Chain Security Act
Direct Regulation
Makes decisions for people rather than helping them make decisions on their own.
Legislative Branch
Makes the laws.
Nutrition Labeling and Education Act of 1990 (NLEA)
Mandates nutrition labeling on food products and authorizes health claims on product labeling.
Investigation New Drug Application (IND)
Must be approved if manufacturers want to ship their drug for clinical purposes (to ultimately complete an NDA). Can be submitted once the applicant has determined that the drug has potential merit and would be reasonably safe to test in humans (has already been tested on animals and in the lab).
Class III Medical Devices
Must have pre-market approval because they are life-supporting or life-sustaining or they present a potential unreasonable risk of illness or injury. (Ex: pacemakers, soft contact lenses, heart valves). All devices initially fall in Class III.
When there are marketed unapproved identical or similar drug products, none of which have NDAs and one manufacturer obtains an NDA, the other products generally...
Must obtain NDA approval within one year, or risk enforcement action.
What prompted the Compounding Quality Act of DQSA?
New England Compounding Center.
Does a patient have a constitutional right to obtain an unapproved drug for treatment?
No.
First Letter B
Not considered to be therapeutically equivalent for various reasons.
Category II Ingredients
Not generally recognized as safe or effective. Are misbranded.
Natural Monopoly
Occurs when the fixed costs of providing a good are high relative to the variable costs, so the average cost declines over the time that the good is provided. (ex: utilities that supply electricity, water, and natural gas because the cost of laying the infrastructure exceeds the cost of supplying the good later on)
Rite Aid Corp. v. Board of Pharmacy
Offense: BOPs typically made up of all independent pharmacists. Charge: Rite Aid challenged the composition of the board and contended that the statute was unconstitutional because it did not require a chain pharmacist. Conclusion: Court rejected arguments and stated that there was no evidence of bias in selection of board members.
United States v. Baxter Healthcare Corporation
Offense: Baxter reconstituted, packaged, freezed, and distributed antibiotic drugs. Charge: FDA ruled that this reconstitution makes the drugs new drugs. Conclusion: Court found that the reconstitution did indeed make the drugs new drugs because the procedure raised concerns about the safety and efficacy of the final product.
Hoffman LaRoche, Inc. v. Weinberger
Offense: FDA continued to allow drugs to be marketed while their ANDA was in the pipeline. Charge: FDA cannot allow the marketing of drugs unless their ANDA or NDAs are approved. Conclusion: U.S. District Court agreed with the charge.
Burroughs Wellcome Co. v. Schweiker
Offense: FDA created "paper" new drug applications. Charge: Innovator drug companies felt this was unfair. Conclusion: FDA prevailed.
Pearson v. Shalala
Offense: FDA did not approve health claims made by four dietary supplement companies. Charge: The manufacturers argued that requiring premarket approval of health claims violates the First Amendment & that the FDA lacks sufficient criteria for explaining why a health claim does not meet the "significant scientific agreement" standard. Conclusion: Court ruled that complete suppression of health claims, unless they are false or misleading, is too restrictive when disclaimers on the label would accomplish FDA's objective.
Cutler v. Kennedy
Offense: FDA let Category III ingredients be on the market. Charge: A group of consumer's contested the FDA's policy and demanded that the FDA remove all Category III products from the market. Conclusion: Court sided with consumers and said that FDA did not have authority to continue the practice. However, did not require FDA to remove current Category III products on the market.
National Nutritional Foods Association v. Mathews
Offense: FDA tried to classify Vitamins A and D in high doses as drugs on the basis of a lack of nutritional value and potential toxicity. Charge: FDA cannot do that. Conclusion: Court held the nutritional value and toxicity were not relevant to the statutory definition of a drug.
United States v. Park
Offense: Food products held under unsanitary conditions, president of company contended that he delegated the responsibility for sanitation to employees and could not be expected to oversee all corporate operations personally. Charge: President was held responsible. Conclusion: Court found the defendant liable under FDCA and stated that he had a responsibility to seek out and correct violations.
Schlieter v. Carlos
Offense: Hospital did not supply patient with PPI prior to administration of estrogen (Premarin). Hospital argued that it had a right to rely on the treating physician to provide the PPI if the physician so wished. Charge: Patient charged hospital with negligence. Conclusion: Court stated that an institution could no truly on the prescribing physician to provide the PPI. The intent of the regulation is that the patient be given the PPPI, not the physician.
Blais v. Rhode Island Department of Health
Offense: Inadvertent dispensing error. Charge: License revoked by DOH. Conclusion: Revocation of pharmacist's license was not justified.
United States v. Johnson
Offense: Manufacturer claimed on label that drug was effective against cancer, knowing the representation was false. Charge: Misbranding. Conclusion: Supreme Court ruled that the misbranding provision in the law prevented false statements only as to the drug's identity (i.e. strength, quality, purity) not as to the efficacy of the drug.
United States v. Undetermined Quantities of an Article of Drug Labeled as Exachol
Offense: Manufacturer of a product called Exachol distributed literature proclaiming that the product was useful in the prevention and treatment of coronary disease. Charge: FDA charged that the product was a drug on the basis of therapeutic claims. Conclusion: Supreme Court ruled that it was inconsistent for the FDA to single out Exachol as a drug while failing to take action against other such products.
United States v. Articles of Drug (Midwest Pharmaceuticals)
Offense: Midwest distributed a drug containing caffeine, ephedrine, and phenylpropanolamine. Advertisements contained pictures that looked exactly like well-known amphetamine-type controlled substances. Charge: FDA charged that it is an imitation drug. Conclusion: Court ruled for FDA that a product is an imitation.
North Carolina Board of Pharmacy v. Rules Review Commission
Offense: NC Board of Pharmacy proposed a regulation limiting the number of continuous hours a pharmacist may work to 12 hours and requiring pharmacists to be given one 30-minute and one 15-minute break if working longer than 6 hours. Charge: Board lacked statutory authority to regulate pharmacists' working conditions because it is a function of NC Department of Labor. Conclusion: NC Supreme Court ended up reversing the appellate court decision and ruling that the board did have authority to because there is a relationship between continuous hours of work and accuracy in filling prescriptions.
Rite Aid of New Jersey, Inc. v. Board of Pharmacy
Offense: NJ Board of Pharmacy required that pharmacies maintain patient-profile record systems. Charge: Regulation charged as invalid because the law made no mention of patient medication records. Conclusion: Court found that the law was valid because it furthered the objective of the state law requiring pharmacists to keep records to protect the public.
Huock v. Iowa Board of Pharmacy Examiners
Offense: Pharmacist compounded OTC nasal spray for patient, but patient's nose got worse so he contacted the BOP. Charge: Patient filed complaint. Conclusion: Board found that the pharmacist had unlawfully manufactured and dispensed a compounded drug without a prescription. Board upheld that OTC compounded drugs require a prescription.
Schram v. Department of Professional Regulation
Offense: Pharmacist had lost license in Michigan and Florida subsequently revoked his license in that state, too. Charge: Florida BOP did not try hard enough to contact him and let him know because they sent the revocation letter to his old address. Conclusion: Court agreed that the board had not exercised due diligence, a requirement for notice of an administrative action. So, the revocation was vacated.
Pennsylvania State BOP v. Cohen
Offense: Pharmacist sold empty gelatin capsules, along with lactose and quinine hydrochloride, which are used for the manufacturing of illicit drugs. Charge: Board suspended his license on basis of unprofessional conduct. Conclusion: Court ruled in favor of pharmacist saying he did not break any rules and could not be expected to guess what is illegal.
United States v. Sullivan
Offense: Sullivan (GA pharmacist) purchased a drug wholesale from a pharmaceutical manufacturer in Illinois and then distributed the drug without a prescription and without the labeling required under the FDCA. Charge: Sullivan claimed that the federal FDCA did not apply to transactions between his pharmacy and his customers because these were entirely intrastate transactions. Conclusion: Supreme Court held that the Act extends even to intrastate transactions because its intent is to protect the public.
United States v. Dotterweich
Offense: Wrongful acts in a relabeling company. Charge: President of a repackaging and relabeling company was convicted of adulteration and misbranding (even though there was no evidence he knew of the wrongful acts). Conclusion: Court upheld and concluded that it is better to place the burden on those in a position to discover the violations than on an innocent and helpless public.
Young v. Board of Pharmacy
Offense: pharmacist had not kept accurate dispensing records. Charge: Charged with "unprofessional conduct". Conclusion: Supreme Court of New Mexico ruled that accurate record keeping should not be a test of a person's professional character, and that the punishment had been excessive.
Examples of public goods in the drug industry?
Orphan drugs and vaccines.
Example of an externality in drug therapy?
Overuse of antibiotics.
Package Insert
Pamphlet that must accompany the drug product and contains the essential scientific and medical information needed for safe and effective use of the drug by healthcare professionals. (Cannot be promotional, false, or misleading).
________________________ may make a blanket request that are their medications be dispensed in non-compliant packaging; ___________________ may not, except for refills of the prescription.
Patients; prescribers.
Medicare Prescription Drug Law (Part D)
Permits e-prescribing and and preempts any contrary state restriction.
_______________________ equivalents that are ______________________________ are assumed by the FDA to be _____________________________ equivalent.
Pharmaceutical; bioequivalent; therapeutically.
Proof in a civil trial?
Plaintiff must establish proof by a "preponderance of evidence". (Burden of proof much lower than in a criminal trial).
What is the Durham-Humphrey Amendment of 1961 also referred to as?
Prescription Drug Amendment
Class II Drug Recall
Product may cause temporary or medically reversible adverse health consequences, but the probability of serious consequences is remote.
Biologics (or Biologicals)
Products derived from living organisms, and include viruses, therapeutic serums, toxins, antitoxins, vaccines, blood and blood components, and derivatives applicable to the prevention, treatment, or cure of a disease or condition of humans. Must be approved by FDA but are licensed under PHSA.
Pure Food and Drug Act of 1906
Prohibited the adulteration and misbranding of foods and drugs in interstate commerce.
Pharmacy Laws
Provide the rules and structural framework for practicing pharmacy, within which pharmacists exercise strategy and good professional judgment.
Orphan Drug Act of 1983
Provided tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of "rare diseases or conditions" (those affecting <200,000 Americans).
What two acts are biologics governed under?
Public Health Service Act (PHSA) and FDCA.
Class I Drug Recall
Reasonable probability that the product will cause serious adverse health consequences or death.
Section 510(g)
Recognizes that the traditional compounding by pharmacists, which is regulated by state law, is not manufacturing.
Label
Refers to information on the immediate container of any article.
Common Law
Refers to law developed from judicial opinions.
Class I Medical Devices
Require the least regulation because they pose the least potential harm to users. (Ex: needles, scissors, toothbrushes).
Standard Numerical Identifies (SNIs)
Required at the package level (the smallest unit sold by the manufacturer to a dispenser).
Medical Device Amendments of 1976
Required classification of devices according to their function, premarket approval, establishment of performance standards, conformance with GMP regulations, adherence to record and reporting requirements.
Color Additive Amendments of 1960
Required manufacturers to establish the safety of color additives in food, drugs, and cosmetics.
Food Additives Amendment of 1958
Required that components added to food products receive premarket approval for safety.
United States v. Generic Drug Corporation
Ruled that a generic drug is a new drug and thus is subject to FDA approval.
Cosmetics regulations?
Sections 601 to 603 of the FDCA and 21 C.F.R. parts 700 to 740 regulate cosmetics.
USP-NF
Serves as the official compendium for drug standards in the U.S.
Supremacy Clause of the Constitution
States that federal law always prevails over state law. (Most conflicts occur when state law is less strict than federal law).
Compounding Quality Act (Title I of DQSA)
Strengthened FDA oversight over pharmacies engaged in large-scale compounding and shipping of sterile products to other licensed entities.
What was the catalyst for the new Food, Drug, and Cosmetic Act of 1938?
Sulfanilamide elixir tragedy of 1937 which killed 107 people as a result of using diethylene glycol in humans (it's toxic!).
What prompted the Kefauver-Harris Amendment of 1962?
Thalidomide causing birth defects.
What prompted the Pure Food and Drug Act of 1906 and brought attention to unsanitary and poorly labeled foods?
The Jungle by Upton Sinclair
Which stage of a bill is most important to its success or failure?
The committee stage.
"Beyond-use Date"
The date after which the drug should not be used (and it must not exceed the manufacturer's expiration date).
Zarxio
The first FDA approved biosimilar product (2015).
The Board of Pharmacy protects ________________ not ______________________________.
The public, not the profession.
Public Goods
Those necessary and beneficial commodities that private entities will not supply because there is no incentive for a private entity to provide them. (ex: national defense programs and lighthouses)
What is the new system regarding pregnancy and drugs?
Three subsections that labeling must include to describe risks: Pregnancy, Lactation, and Females and Males of Reproductive Potential.
All FDA regulations are contained in _____________ of the CFR.
Title 21.
What is the purpose of an NDC?
To identify the product (NOT to indicate that a drug has received an approved NDA).
"de minimis" violations
Very minor or trifling violations.
Narrow Therapeutic Index or Narrow Therapeutic Ratio (NTI or NTR) Drugs
Where there is less than a two-fold difference between the MTC and the MEC.
Consumer Medication Information (CMI)
Written information, other than a PPI or MedGuide, that a pharmacy distributes to a patient.