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169 Cards in this Set

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  • Back
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A body of principles that govern conduct - the observance of which can be enforced in courts, is known as?
-The Law
When we think to ourselves "what is legal?", we should be asking ourselves what question?
-What is best for the patient? (but is still legal)
What is nature of and the 4 roles of law?
-1. The fundamental notion of fairness
-2. Custom or history involved
-3. Command of a political entity
-4. Balance between conflicting social interests
What are the 4 legal systems in the US?
-1. Federal - DEA
-2. State - know that it is not legal for a state to pass a law that is less stringent than fed law
-3. County/municipal
-4. Administrative - w/in a state but specific to a particular profession - BOP
What should we know about the constitution of the US?
-It is the SUPREME LAW of the US
-It allows states to do certain things but does not mandate everything
A state or federal law that conflicts with the Constitution is what?
-Invalid
-Ex. Catholic Church being told they have to provide insurance for BCPs - this is unconstitutional. - Separation of church and state
What are the various court systems in the US?
-Federal courts
-State courts
-County/Municipal Courts
-Criminal Courts
-Civil courts
-Administrative courts
How are Administrative courts different than other types of US courts?
-If use the example of the BOP, the rules are staggered against the profession being overseen by that agency (pharmacy).
-Hearsay IS admissable here
-The court will allow anything they deem appropriate
-If the case is appealed and goes to another court, the BOP can tell the judge that they were correct - meaning we are not assumed innocent. We are presumed guilty
A Criminal case can cost you?
-Liberty (some money)
A Civil case can cost you?
-Money (some action)
An administrative case* can cost you?
-Your pharmacy license/priviledge (and money)
How do administrative agencies make regulations, generally speaking?
-by a process know as "notice and comment rulemaking"
Rules handed down by administrative agencies must be?
-Within the scope of the agency's authority
-Based on a statute that gives the agency authority
-Have a reasonable relationship to the public health, safety and welfare
Can things we do in our outside lives cause charges to be filed against us?
-Yes, our minimum standard of care is perfection so things we do can cost us our license if deemed to compromised that minimum standard
What does DEA stand for?
-Drug Enforcement Administration
Conduct that is against community standards (law) and morals, and which required an evil thought from inception is called?
-Moral Turpitude
What are examples of moral turpitude which could cause us to lose our license?
-Shoplifting
-Theft of property
-Theft of controlled substances
Violation of certain laws may result in what?
-Civil, criminal or administrative actions
If there is ever a conflict between Federal law and state law, which wins?
-Federal law - always
In Federal vs. State law, the supremacy clause of the constitution and preemption doctrine state that we must?
-Follow the stricter rule or regulation
What amendment gives states all powers not delegated to federal government or prohibited by the constitution?
-The 10th Amendment
-This means that state governments have the authority to regulate the practice of pharmacy and the distribution of drugs
What act protects consumers from adulteration and misbranding of foods, drugs, cosmetics and/or devices?
-The Federal Food, Drug and Cosmetic Act (FDCA) of 1938
There were many triggers of the FDCA, which led to the act in 1938. The first of these was directed at problems with the meat industry and risks to public health, such as unsanitary conditions. This act is?
-The Pure Food and Drug Act of 1906
-This act ONLY prohibited adulteration and misbranding!
-This act DID NOT prohibit false and misleading efficacy claims
-The basis was that people were dying from bad food
The 1912 amendment to the Pure Food and Drug Act of 1906 was added to prohibit false and fraudulent claims and was a result of which landmark case?
-US v. Johnson, 221 US 488
-This case was concerning a mfr that claimed a drug was effective against cancer when he knew this was not true.
-Here the court ruled that misbranding was only in regard to a drugs identity - purity; a listing of ingredients was not required
-The court held here that the misbranding provision in the law did not prevent false or misleading efficacy claims.
The last major occurrence which led to the FDCA of 1938 was a major trigger in which 107 people died and was called?
-The sulfanilamide elixer case of 1937
-Drug was mixed with diethylene glycol (antifreeze) - used today as an industrial solvent
-So many deaths triggered legislative result of FDCA of 1938
The 1938 Food, Drug and Cosmetic Act is triggered by?
-All of the issues that came before it - already discussed
-We must protect the food supply
What did the 1938 FDCA (during the WWII era) state?
-That a drug cannot be marketed until it is proven safe for use under the conditions described on the label and approved by the FDA
-This act also expanded the definition of adulterated/misbranded
-Added warnings, like habit forming properties of some drugs
-Included adequate instructions for use
-This act also applies to cosmetics and devices
Which drugs were exempt from the FDCA?
-Drugs marketed before 1938
What is the significance of Heckler v. Chaney in 1984?
-Condemned prisoners contended that drugs used for the execution of people in circumstances such as theirs (death penalty) were not approved by the FDA for this purpose and therefore were unlawful when used for execution by lethal injection.
-Occurred in Oklahoma and Texas
-argued unapproved use of an approved drug - violation of misbranding law
-They wanted those who used these drugs for execution to be prosecuted
How was the case of Heckler v. Chaney decided?
-It was decided on the basis of principles of administrative law.
-Product labeling is a guideline to appropriate use, but it doesn't define the universe of appropriate use.
-"off-label" uses generally do not violate the FDCA
-The FDCA regulates drug distribution but it DOES NOT regulate professional practice
What is the bottom-line from the Heckler v. Chaney case?
-Pharmacists should use their best judgment and their knowledge of the law to direct their behavior
The Durham-Humphrey Amendment (aka - Prescription Drug Amendment) of 1951 established what 2 classes of drugs?
-1. Prescription drugs
-2. OTC drugs
-It also established the statement "Caution: Federal Law prohibits dispensing w/o a prescription."
-It also established authorization of oral prescriptions and prescription refills
What should be noted about the Durham-Humphrey amendment with regard to directions for use?
-that when PharmD dispenses meds w/MD's instructions, the MD's directions actually meet the requirement for adequate directions for use
What did the Food Additive Amendment of 1958 address?
-Pre-market approval
-And anti-cancer provisions that prohibit food additives that might cause cancer
What did the Color Additive Amendment of 1960 address?
-The safety of color additives
What is the significance of the Kefauver-Harris Amendment (aka- Drug Efficacy Amendment) of 1962?
-It is a result of thalidomide and birth defects which were caused by the women taking it
-Added more strength to the FDCA by requiring that drugs be both safe and effective
-Efficacy requirement was retroactive back to all drugs marketed between 1938 and 1962
As a result of the Kefauver-Harris Amendment, the following changes were also made to the act...
-The FDA (not FTC) now had jurisdiction of drug advertising
-The new drug approval process was strengthened
-GMP (Good Manufacturing Practices) were now required
-More extensive controls were added to clinical investigations by requiring informed consent of research subjects and reporting of ADRs
What were the results of the Medical Device Amendment of 1976?
-Devices were classified according to function
-They must have pre-market approval
-They must meet performance standards
-Must use GMP requirements
-Reporting Requirements
What is the Orphan Drug Act of 1983?
-Provided tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the tx of rare diseases or conditions
-B/c NDA process was too expensive to warrant research for drugs to tx rare diseases that hardly anyone would use
What is the 1984 Drug Price Competition and Patent Term Restoration Act (aka Waxman-Hatch Amendment)?
-It streamlined generic approval
-Offered some patent extensions
-Incentives to develop new drugs
What was the 1987 Prescription Drug Marketing Act?
-Changed how drug companies and reps could operate
-Concerns were with drug samples
-Facilities (hospitals) could not sell drugs
-Prevention of diversion
What was the 1990 Safe Medical Devices Act?
-It increased FDA authority on certain issues post market
-It expedited pre-market approval
What was the 1992 Generic Drug Efficacy Act?
-A result of FDA staff accepting bribes
-Those who were convicted in related felonies now cannot participate in the approval process of drugs
What was the 1992 Prescription Drug User Fee Act (PDUFA)?
-The industry now had to pay significant fees for applications, supplements, etc
What was the 1990 Nutrition Labeling and Education Act (NLEA)?
-Mandated nutritional labeling on food
-authorized certain health claims as long as they were in compliance with FDA guidelines
What was the 1997 Food and Drug Administration Modernization Act (FDAMA)?
-It streamlined regulatory procedures to help the public
-It insured expedited availability of safe and effective drugs and devices - expedited drug approval process - but this didn't work out
What else did the 1997 FDAMA do?
-It required the FDA to define the scope of responsibilities/requirements - ie. increase FDA public accountability
-publication of compliance plans
What was the intent of the 1997 FDAMA?
-To decrease backlogs
-Insure timely review of apps
-Fast track certain apps - expedite
-Expand authority over OTCs
What is the Dietary Supplement Health and Education Act of 1994 (DSHEA)?
-Regulation of Dietary Supplements
-Treated more as a special type of FOOD rather than a drug
-Required no pre-market approval
Why do we have federal drug regulations?
-To protect the public
Who is the primary enforcer of the FDCA?
-The FDA
What was the 1990 Omnibus Budget Reconciliation Act (OBRA)?
-Required informed decision by patients
What are the different centers within the FDA? (5)
-1.Center for Biologics Evaluation and Research
-2. Center for Food Safety and applied Nutrition
-3. Center for Drug Evaluation and Research
-4. Center for Veterinary Medicine
-5. Center for Devices and Radiological Health
What is the definition of FOOD?
-1. Articles used for food or drink for man or other animals
-2. Chewing Gum
-3. Articles used for components of any such article
What is the definition of DRUG?
-Articles recognized in the Official US Pharmacopoeia, Official Homeopathic Pharmacopoeia of the US or the Official National Formulary
-Articles intended for use in the dx, cure, mitigation, tx, or prevention of the disease in man or other animals
-Articles other than food intended to affect the structure of any function of the body of man or other animals
What is the definition of a counterfeit drug?
-A drug not authorized to bear a trademark, trade name or other identifying marks
-It is NOT legal to sell counterfeit drugs to bad guys
What is the definition of a device?
-An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related device that is:
1.- Recognized in the National formulary
2. -Intended for use in the dx of diseases or other conditions, or in the cure, mitigation, tx or prevention of disease in man or other animals
-3. Intended to affect the structure of any function of the body or man or other animals
What else should we know about the definition of device?
-It should also not achieve any of its principal intended purposed through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.
-This is how it's different than a drug
What is the definition of a cosmetic?
-Articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwised applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance of
-Articles for use as a component of any such article above
Is SOAP considered a cosmetic by this definition?
-NO soap is NOT a cosmetic by this definition!
What is the Nutrition Labeling and Education Act (NLEA)?
-Can contain certain health and disease prevention claims
-Example: products that contain dietary fiber (oat cereals)
When can the FDA remove a dietary supplement from the market?
-only on the basis of public safety and then they must prove adulteration
-Example here is Ephedra products
What is adulteration?
-A significant risk of illness under the ordinary conditions of use
What is a label?
-Display of written, printed information upon the imediate container of any article
What is labeling?
-A broader application of the word label
-All labels and other written, printed or graphic material
What is a Compendia?
-Must be official to identify something is a drug and what the standards of use are
What are the 3 Compendia we should know - and where we can legally verify if something is a drug?
-1. USP - United States Pharmacopeial Convention
-2. USP/NF - official drug standards of the US
-3. HPUS - Homeopathic Pharmacopeia of the US
For a drug to NOT be considered adulterd or misbranded it must?
-meet all USP/NF standards
What is homeopathy?
-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
What are prohibited acts? (page 58 of text has a summary)
-From the FDCA Section 301
-All of these are regarding adulteration or misbranding in some way
-Know that anything having to do with adulteration or misbranding is a strict liability case
What are the 2 major offenses under the FDCA?
-1. Adulteration
-2. Misbranding
Nearly every violation of the FDCA constitutes?
-Punishment by the FDA
-The FDA may: initiate criminal proceedings, impose fines and/or impose imprisonment
To enforce prohibited acts the FDCA may:
-1. Initiate criminal proceedings
-2. Impose fines
-3. Imprisonment
What are the 3 classes of product recalls?
-I, II and III
-Remember the 1st one (class I) is the worst/most extreme and the last one is the least serious
What is a Class I product recall?
-reasonable probability that the product WILL cause serious adverse health consequences
What is a Class II product recall?
-The product MAY cause TEMPORARY or MEDICALLY REVERSIBLE adverse health consequences but the PROBABILITY of serious adverse consequences is REMOTE
What is a Class III product recall?
-The product is NOT LIKELY to cause adverse health consequences
Who is responsible for notifying sellers/pharmacies of recalls?
-the manufacturer
How do we usually receive notice of a product recall at our pharmacy?
-We receive product recalls via e-mail but if they are really important we will get them via certified mail
-Book says protocol is that sellers are responsible for contacting customers, if necessary
-Possible sample test question -> Which of the following product recalls is not likely to cause health consequences? - Class 3
-Recall notices may be delivered by letter, telegram, phone, sales reps, etc
What are FDA guidelines for protocol for notifying patients of product recalls?
-FDA guidelines require that written notices for class I, class II and some class III recalls be sent by 1st class mail with the envelope and letterhead conspicuously marked, preferably in red "URGENT:DRUG RECALL"
-Many pharmacy publications include current lists of recalled products
What is the pharmacist's responsibility with regard to recalls?
-The pharmacist is responsible for knowing which drug products have been recalled
-Furnishing a recalled product may violate the FDCA b/c it could be misbranded or adulterated and the pharmacist could not assert a good-faith defense and may be subject to civil liability in event of patient injury
What is the detailed definition of Adulteration?
-Started with food before but now adapted to meds
-Consists of filthy, putrid or decomposed substance
-prepared, packed or held in conditions where it may have been contaminated
-exposed to a container that may have been contaminated
-manufactured under conditions that do not conform to current GMPs
What does 501 (a)(2)(B) declare?
-That a drug is adulterated unless it is manufactured in accordance with CGMP
-CGMP inspections are performed by the FDA every 2 years
-CGMP applies to manufacturers and not pharmacies unless pharmacies are compounding
Can a defense be presented for Adulteration or misbranding violations?
-NO
-These are strict liability cases b/c they are SO wrong
-Intent or lack of knowledge is not a defense
- there is NO DEFENSE TO EITHER OF THESE CRIMES!
-ASSUMED GUILTY!
-You cannot present a defense!
What is the Federal Anti-tampering Act of 1982?
-Occurred b/c of product tampering with Tylenol in 1982
-Requirement now for tamper resistant packaging
What is the detailed definition of misbranding?
-If the labeling is false or misleading in any particular way
-think words/labels
What is the difference between adulteration and misbranding?
-respresentations made by the mfr on the label or labeling while adulteration deals with the drugs strength, purity and quality
Adequate directions for use means?
-Directions under which the layperson can use a drug safely and for the purpose for which it was intended
What are the prohibited acts that the FDCA, Section 301, contains a summary of? (2 major offenses)
- Adulteration -> nasty, putrid
-Misbranding ->
* something could be both of these
*See examples in book on this
Nearly every violation of the FDCA constitutes?
-Punishment by the FDA
-Initiation of criminal proceedings
-Imposition of fines
-Imprisonment
Why must a drug meet all USP/NF standards?
-If it doesn't it will be considered adultered or misbranded.
Sample exam question from class...Which of the following product recalls is NOT likely to cause health consequences?
-Class 3
Remember that 501 (a) (2) (B) specifically states that...
-A drug IS adulterated unless it is manufactured in accordance with CGMP
-CGMP inspections by the FDA should occur every 2 years
What is considered adequate information? at the manufacturer level (look at book to see what this is adequate information for)
-Drug Indication
-Side Effects
-Dosages
-Routes, methods, frequency and duration of administration
-Contraindications
-Other warnings
(Don't memorize list - just understand)
What else is considered adequate labeling? at the manufacturer level
-Quantity of dosage for each intended use, person (ages) and physical conditions
-Frequency of admin or application
-Duration of admin or application
-Time of admin or application
-Route or method of admin or application
-Preparation if any
What is an imitation drug?
-a drug is misbranded if it is an imitation of another drug - even if its "fake" marijuana - this is illegal
A prescription drug is?
-Not considered safe for the consumer unless the prescriber is involved
An OTC (Over-the-counter) drug is?
-Considered safe w/o a prescriber's intervention - it is safe and effective for self-medication by the consumer
What is non-prescription drug labeling?
-Considered to be user friendly (remember adequate information for use)
What is professional OTC labeling?
-Contains additional information not appropriate for consumer diagnosis or treatment.
What if a drug is both OTC and prescription?
- like Ibuprofen
-Look at the book, but this is usually due to the way the manufacturer marketed it
What must go on a Commercial container label?
-Name and address of the mfr, packer or distributor
-Established name of the product
-Ingredient info, including qty and proportion of each active
-Names of inactives
-statement of identity (generic and proprietary names)
-Qty in terms of wt or measure
-Net qty of the container
-Statement of the recommended or usual dosage or reference to the PI
-Symbol Rx Only or the legend: Caution: Federal law prohibits dispensing w/o a prescription
-Route of admin if not oral
-Identifying lot or control #
-Statement directed to the pharmacist specifying the type of container to be used in dispensing (i.e. dispense in tight, light-resistant container as defined in the National Formulary)
-Expiration date, unless exempted - if only mo and year, exp date is last day of the mo
Why is unit dose labeling different from other requirements?
-B/c it wouldn't be readable since the items are pre-packaged and pre-labeled for direct administration
Former test question...Which of the following is the supreme law of the land?
-The US Constitution
Former test question...ALBOP is which type of organization?
-Administrative Agency
Former test question...Intentional sale of a counterfeit drug by a pharmacy in Alabama can involve charges by?
-BOP and State of Alabama
-The FDA could possibly be involved - they don't have to but they could.
What is a package insert?
-Required/mandatory
-Pamphlet that must accompany the drug product and contains the essential scientific and medical information needed for the safe and effective use of the product by health care professionals.
What is a black box warning?
-indicates that this drug could possibly kill someone
-Exs include: Accutane, SSRIs, Spironolactone, stimulants
Pregnancy category A is?
-Adequate and well-controlled studies. Not demonstrated a risk
-Remember "A-OK"
Pregnancy category B is?
-Animal studies failed to demonstrate a risk but there are no adequate or well controlled studies in pregnant women
-Use only if clearly needed
Pregnancy category C is?
-Either animal studies show adverse effects on the fetus or there are no animal reproductive studies - or no adequate studies in pregnant women
-Use only if the potential benefit justifies the potential risk to the fetus
Pregnancy category D is?
-Positive evidence of fetal risk
-Drug can cause fetal harm
-Remember "D for Damage/Danger"
Pregnancy Category X?
-Fetal risk and the risk in pregnant women clearly outweighs any benefit
-Example - accutane or thalidomide
What is an NDC number?
-National Drug Code Number
-Today the number is an 11 digit number
-The first sequence of numbers represents the manufacturer and distributor
-The second sequence of numbers represents the strength, dosage form and formulation
-The third sequence of numbers represents the package size and type of drug
How is a new drug approved?
-A new drug cannot be introduced until it is approved by the FDA
-There are 4 phases of drug approval - see the following flashcards
What is an IND?
-The FDA must exempt a drug from the NDA requirement for the pursuit of clinical investigations. To receive this exemption, the mfr must apply for a Notice of Claimed Investigational Exemption for a New Drug - aka the IND or Investigational New Drug application
-If the IND is approved, the mfr may then conduct clinical studies of its investigational new drug
-Those seeking IND must submit: name of the drug, its composition, method of manufacture and quality control and info from preclinical (animal) testing regarding pharmacological, pharmcokinetic and toxicological evals
-If the FDA does not reject the IND w/in 30 days then human testing may begin in 3 phases
Know that the FDA may terminate the testing of an IND at any time if studies show?
-that the drug is too toxic under the agency's benefit/risk ratio criteria
-determination is final and not subject to appeal or judicial review
Phase I of new drug approval consists of?
-Small number of subjects
-Investigators examine the drugs for:
-Toxicity
-Metabolism
-Bioavailability
-Elimination
-Pharmacological actions
-Initial drug doses - low
The purpose of Phase I of IND is to?
-Determine adverse effects
Phase 2 of the new drug approval process consists of?
-testing on a limited number of patients that have the disease the drug is intended to treat
What is the purpose of Phase 2 IND?
-to determine the efficacy of the drug and the dosages at which the efficacy occurs
-If results are promising then it moves onto Phase 3
Phase 3 of the new drug approval process consists of?
-Testing on multiple patients - in clinical settings, hospitals, etc.
-Usually double-blinded
-Can have oral or verbal consent from the patient here b/c patient may be so ill that is the only way they can consent
-If results are favorable here, then the drug sponsor may submit a NDA to the FDA
-ONLY 1 in 10 Drugs MAKE IT THIS FAR!
All patients in trials/studies must provide?
-Consent - preferably written consent
Written consent is required in phases?
-1 and 2
-Phase 3 patients may provide verbal/oral consent if they are very sick
Phase 4 of new drug process consists of?
-clinical studies after the drug has been approved
What is DESI?
-Drug Efficacy Study Implementation
-Deals with generic drugs and approval by the FDA
Treating patients with investigational drugs is approved by the FDA only if?
-They are used for a serious or immediately life threatening disease or condition
-There is no other alternative
-Drug under investigation for disease or condition
-Sponsor is seeking approval
-Evidence of safetly and efficacy (in case of a serious disease)
-Reasonable basis to conclude the drug may be effective
How can an individual patient request use of an investigational drug?
-Through their physician from the manufacturer
Biologicals are highly regulated and derived from?
-live organisms - include viruses, therapeutic serums, toxins, antitoxins, vaccines, blood and blood components and derivatives applicable to the prevention, tx or cure of a disease or condition of humans.
-licensed under the PHSA - Public health Service act
What is Med Watch?
-A voluntary reporting system
-Reports adverse events
-Practioner's identity is confidential
-Pharmacies are now required to provide toll free numbers for patients to report events
What are the 3 classes of medical devices?
-Class I: have the least regulation b/c they poste the least potential for harm: Scissors, needles, examination gloves, stethoscopes and toothbrushes
-Class II: General controls are insufficient: insulin syringes, infusion pumps, thermometers, dx reagents, tampons, and electric heating pads
-Class III: Require premarket approval: anything not marketed before 1976 initially falls into this class unless the FDA detm that they are equiv to Class I or II; also pacemakers, soft contact lenses and replacement heart valves
*Be able to give examples from each class.
Scissors, Electric Heating Pads and replacement heart valves are medical devices in what classes?
-Scissors = Class I
-Electric Heating Pads = Class II
-Heart Valves = Class III
Can a cosmetic be misbranded or adulterated?
-Yes
-*Be able to provide and identify an example of each
Drug advertising and promotion...what amendment to the constitution protects free speech?
-The first amendment
What is DTC advertising?
-Direct to consumer advertising
-must include an adequate provision for the consumer to obtain full labeling info through a toll-free number, internet, print advertisement or health care provider.
-FDA
Look up Winn Dixie of Montgomery vs. Colburn case - lawsuit - liability/dispensing and pharmacist's responsibility
-Winn Dixie pharmacist substituted what he thought was a generic equiv drug
-Script was for Sedapap (Butalbital and Acetaminophen)
-Pharm looked up in computer and it showed that Fiorinal #3 was a generic equivalent - the computer was wrong!
-Fiorinal #3 is Butalbital, ASA, Caffeine and Codeine -> the patient is allergic to CODEINE! This is why the dr. prescribed the Sedapap for her Migraines in the first place
-the Pharm called the Dr. and the doctor specifically said do not substitute
-But the script showed the Dr's sig under generic substitution permitted
Winn Dixie didn't deny wrong-doing on the part of the pharm but did feel that the fine was too steep
-Pat suffered anaphylactic shock and thought she was going to die - still afraid to take scripts
-Important point here is that pharms may not legally substitute when prescribers specifically prohibit sub and pharmacists may not legally sub unless the drugs are generically equivalent
-Pharm did not make a generic sub but a therapeutic sub -> products in the same therapeutic class but are not generically equiv. - therapeutic sub w/o auth from Dr. is illegal
For the test...
-we might have an essay question to be able to explain our viewpoint on St. Vincent's or a Catholic organization being forced to provide insurance coverage for birth control - or something similar
FDCA Regulations attempt to?
-Eliminate/minimize risks in the drug distribution system
EXTREMELY IMPORTANT!!!
The Durham-Humphrey Amendment of 1951 did what?
-Was a prescription drug amendment from around WWII
-Established 2 classes of drugs (prescription and OTC)
-Authorized oral prescriptions
-Allowed refills of prescription drugs
Durham Humphrey Amendment to the FDCA in 1951 established?
-Precription drug class
-Thereby an OTC class
-Authorized oral prescriptions - over phone
-Authorized refills of scripts
What did the Durham Humphrey Act say about prescription drugs?
-That they are unsafe for use except under the supervision of a practitioner b/c of the toxicity, method of use or collateral measures
-Prescription drugs are also subject to the NDA approval process
Can a prescriber delegate someone he/she trusts to call in a prescription for him/her?
-Yes, the task of calling in a script can legally even be delegated to a stranger - this could possibly be a HIPPA violation, however
-Practitioner can delegate someone/anyone but ideally it should be someone he/she trusts - or he/she better have a lot of malpractice insuranced b/c mistakes can be costly
Does a prescription have to be written on a prescription pad?
-no, it could be on a napkin, scrap paper, etc.
How does Durham-Humphrey handle electronic scripts?
-At the time of DH (1951) there was no means to transmit electroic fax prescriptions but most states allow the use of fax and electronic transmission today
-Know that we must maintain records, even if the prescription is electronic (print out the hard copy)
How does DH handle E-Sign with Electronic scripts?
-E-Sign is electronic signatures in the Global and National Commerce Act - via Pres. Clinton
-This sort of developed over time and was added to DH
Does a prescriber have to be an MD?
- no - differs by state
What happened in the case of Nail vs. Publix?
-Patient had been taking 1 mg Coumadin 5x/day for 15+ mos for a pulmonary embolism after arthroscopic surgery
-Pt called Dr. for refill and nurse called in 5 mg Coumadin to the Publix in Homewood with the same sig: use as directed
-Pharmacist can't remember exactly how she counseled the patient but the patient did sign the waiver regarding counseling and the pharm said she always counsels with a dose change
-pt. was taking the 5 mg as she took the 1 mg so getting 25 mg Coumadin a day and ended up in Brookwood hospital - almost died
-Pharm should have verified with Dr.
-Bottom line here is that use as directed is NOT a good sig!
What shoudl be used instead of "use as directed" sig based on the Nail vs. Publix trial?
-Pharm could have called Dr. and explained the situation and asked for specific dosing instructions to be included with the script
-Lacey says for Zpak always use sig "take according to package insert"
-Remember that we do NOT have to dispense a drug if we are not sure
-Look at the patient's profile!
Should a pharmacist immediately surrender his/her license when involved in a case like this?
-No!
-Lacey says we should know that the second we call our insurance company that any communication between us and the patient will be cut off
-If we call the ins. co before we tried to contact the patient and make things right this could look bad for us in a court
-OUr number one concern is patient safety - we cannot put the pt in potential jeopardy
-Jury will look more favorably on fact that we tried to make things right.
Are pharmacists required to place the same info on a label as a mfr?
-No
-Would be impractical and the health care provider must have some discretion
What (federal requirements) must be on the prescription label from the pharmacy to the patient? (KNOW COLD!)
-Name and address of the dispenser
-The serial # and date of the script or of its filling
-Name of the prescriber
-Name of the patient - although this is optional (weird) if not stated in the prescription
-Directions for use
-Any cautionary statements
-Must bear, at minimum, the symbol "Rx only" - if not, it is considered MISBRANDED!
Do mis-spellings count as medication errors on labels?
-Yes!
In addition to the label requirements from the previous flashcard, the pharmacist must insure that?
-The label is not false/misleading
-Drug dispensed is not an imitation drug
-Drug is not sold under the name of another drug
-pkg and labeling conform to the official compendia standards
-Must be pkged and labeled appropriately if the drug is subject to deterioration
-Must be pkged in conformance with the Poison Prevention Pkging Act (see later card on this)
What additional information may states require on prescription labels?
-Name, initials or license number of the dispensing pharmacist
-Expiration date of the drug
-Drug name and strength
-Address of the patient
-Name of the mfr/distributor
-Lot or control #
What must we know about expiration or beyond use dating?
-Mfr is required to include the expiration date on the label of the product
-BUD = date after which the drug should not be used. This cannot exceed the mfr's expiration date
-RX vial - shall not be later than mfr container expiration date or 1 year from the date the drug is dispensed -> whichever is earlier
If a prescription product bears an expiration date of Feb 2012 - what is the last day that you can legally dispense the medication?
-Feb. 28, 2012
What should we as pharmacists be thinking about with regard to expiration dates of scripts?
-Would I take this drug?
-Then, would I let the patient take this drug?
How can the FDA switch prescription drugs to OTC status? (3 ways)
-1. Mfr. requests the switch and submits a supplemental application to the NDA
-2. Mfr. petitions the FDA as a result of consumer requests
-3. The FDA may add/amend an OTC monograph
What are some examples of former prescription drugs that are now avail. OTC?
-Prilosec
-Allegra
-Claritin
-Zyrtec
-Etc.
What is the possible 3rd class of drugs?
-Behind the counter drugs
-OTC but only with the intervention of a pharmacist
-Examples: Plan B; Sudafed
-Minimize possible injury to patient health
-Provides adequate consultation
-But there are arguments against it, too
How did the Durham-Humphrey act authorize prescription refills?
-must be specifically authorized by a prescriber
-May be written or oral
-authority to transmit may be delegated to an employee/agent if state law permits (see earlier)
-The agent cannot personally authorize unless they have prescriptive authority
What should we know about prescriptive authority?
-it's decided by individual states
-Via DH - legend drugs may be prescribed by a practitioner licensed by law to administer the drug (decided by state law)
-drugs prescribed should be within the scope of practice of the prescriber
-pharmacists must dispense with good faith
What would be a situation where a prescriber was writing a prescription outside of the scope of their authority?
-A dentist prescribing ADHD drugs
-etc
What is a collaborative practice agreement?
-Pharmacists don't have prescriptive authority in any state but most states allow pharms to initiate or adjust drug therapies in collaboration with a physician
-The collaborative agreement requires a written contractual agreement in the form of protocols and procedures
-The extent to which the pharm can engage in drug therapy mgmt is detm by state law
What should we know about Plan B emergency contraception?
-It falls into the possible 3rd class of drugs
-Sold in pharmacies staffed by a licensed pharmacist
-Personal id showing proof of age is required!
-2009 - supreme court changed age to purchase w/o prescription to 17 yo
-Behind pharmacy counter
-Currently there is a move to make this product avail w/o proof of age and through vending machines, etc.
What is conscientious objection and what does it have to do with PlanB?
-A pharmacist should notify the employer of his/her objections to dispensing particular drugs in advance
-Employer should develop processes so that the pharm is not placed in a situation where he/she would be required to dispense objectionable scripts
-Another pharm on duty could dispense or patient could go to an near by pharmacy
-No clear legal protection is stated here by our board of pharmacy
Is there a conflict with a moral stance if you do not sell Plan B but you do sell oral contraceptives?
-Possibly
-Technically Plan B is not an abortifacient
-It is emergency contraception which really doesn't differ from regular contraception
-I disagree b/c I think the emotional aspect of the whole thing is not addressed with Plan B
What should we remember about the authority to dispense prescription drugs?
-Authority is left for each state to decide
-Pharmacists can dispense only if the state law allows (I don't know why it wouldn't)
-Prescribers/physicians can legally dispense drugs
-However, the FDA labeling requirements only apply to pharmacists and not physicians ->but note that most state laws now require doctors to dispense w/the same laws as pharmacists
What should we know about patient pkg inserts? (Dr. Lacey said there will be at least 1 question on the exam about this)
-Initially PPIs were limited to a certain number of drugs
-Ex were contraceptives and estrogen containing drugs - due to the risks involved
-FDA changed PPI requirements to be included iwth all drugs in 1980
-Failure to do so is MISBRANDING!