• Shuffle
    Toggle On
    Toggle Off
  • Alphabetize
    Toggle On
    Toggle Off
  • Front First
    Toggle On
    Toggle Off
  • Both Sides
    Toggle On
    Toggle Off
  • Read
    Toggle On
    Toggle Off
Reading...
Front

Card Range To Study

through

image

Play button

image

Play button

image

Progress

1/241

Click to flip

Use LEFT and RIGHT arrow keys to navigate between flashcards;

Use UP and DOWN arrow keys to flip the card;

H to show hint;

A reads text to speech;

241 Cards in this Set

  • Front
  • Back

What are Ethics?
Rules promulgated by a profession and imposed on all members.
-> Enforced by profession
-> A means to self-regulate
-> What "ought to be" whereas law is what must be
-> May not be covered by laws/regulations
T/F

If you act legally you will always be acting ethically.
False
Is it possible to act legally, but not ethically?
Yes
Is it possible to act ethically but not legally?
Yes
T/F

If you act ethically you will always be acting legally.
False
In the Walgreens-Lilly example, did any involved party violate the LAW?
No
But it was UNETHICAL
Agencies are typically part of what component of the Government?
Executive
The president and governors are part of which branch of the government?
Executive
What is the function of the Executive branch?
To enforce laws
What is the purpose of the Legislative branch?
To make the laws
What is the function of the Judicial Branch of the government?
To interpret the law and choose idiots to be the president
What is the "4th Branch" of the government and what does it do?
The administrative agencies. Although they are in the executive branch officially, they can interpret and make law in addition to enforce it because they have the technical knowledge to do so, whereas the legislature and certainly our president/dictator do not.
Name 3 sources of US Law
Constitution/Bill of Rights
Statues (Congress)
Rules/Regulations (Agencies)
Where does the Federal Government get the authority to regulate drug distribution?
Interstate commerce laws of constitution, applies to interstate and intrastate transactions and in effect controls manufacturers and controlled substances.
Where do states get the authority to regulate?
10th Ammendment. If the Fed doesn't do it, the states do.

Police powers - States may promote health, safety and welfare of its people.
If a state and federal law conflict then what prevails?
Federal
If state and federal laws are not in conflict but are different, what happens?
Stricter law prevails.
FDA is an example of what?
Federal Administrative Agency
DEA is an example of what?
Federal Administrative Agency
CMS is an example of what?
Federal Administrative Agency
Illinois department of Financial and Professional Regulation (state board) is an example of what?
State Administrative Agency
_____________ are considered Gov't experts in their field.
Administrative agencies
In court, you vs. an agency, who is probably gonna win?
The Agency.
In criminal cases, who is the plaintiff (prosecuting?)
The government
In civil cases, who is the plaintiff (bringing an action)?
An individual
Describe Criminal Law
Act or violation of a duty owed to society for which the breaching offender is punished by the government.
Describe Civil Law
Concerns private rights and parties.
Describe Stare Decisis
"To abide by decided cases"
--> Law based on certain set of facts
--> Applied to lower courts in individual jurisdictions
--> Factual differences or changing times/circumstances may alter stare decisis
1906 What Law?
Pure Food and Drug act
1938 What Law?
FDCA
1951 What Law?
Durham Humphrey Amendment
1962 What Law?
Kefauver Harris Amendment
1976 What Law?
Medical Device Amendment
1983 What Law?
Orphan Drug Act
1984 What Law?
Drug Price competition and Patent Term restoration act
1987 What Law?
Prescription Drug Marketing Act
1990 What Law (FDCA Timeline)
Nutrition Labeling and Education Act of 1990
1994 What Law?
Dietary Supplement Health and Education Act
1997 What Law?
Food and Drug Administration Modernization act
What prompted FDAC 1906?
Public concern over unsanitary practices in drug and food industries
What did PFDA 1906 do?
Prohibited adulteration and misbranding of food and drugs in interstate commerce.
--> Prohibited false statements regarding drug identity, including strength, quality and purity.
What did PFDA 1906 NOT do?
-->Did not require label to list ingredients, directions for use or provide warnings.
-->Ban unsafe drugs
-->Prohibit false or misleading efficacy claims
Describe the Sulfanilamide Elixir Tragedy
In 1937, S.E. Massengill Co. produced product that had 40 grains per ounce in a solution of diethylene glycol. 107 people died. PFDA 1906 did not grant authority to ban unsafe drugs so FDA removed based on concept of misbranding (Did not contain alcohol)
Which ammendment to the FDCA made it pretty much what it is today?
FDCA 1938 of 1938.
Main concepts of FDCA 1938
No new drug can be marketed until proven safe for use under conditions marked on label and approved by FDA.
Label's must contain adequate directions for use and warnings about habit forming properties.
What does the FDAC 1938 not do?
It doesn't cover drugs marketed before 1938.
Describe what the Durham-Humphrey Amendment 1951 did?
1. Established Rx and OTC
2. Drug labels do not have to have adequate directions for use if Rx Only
3. Authorized oral Rx's and refills for legend Rx drugs
Which act prohibits adulteration and misbranding of drugs?
Pure food and drug act of 1906
Which act requires the drug to be proven safe for use and FDA approval?
FDAC 1938
Which law stated "Labels must contain adequate directions for use and warnings about potential habit-forming properties?
FDAC 1938
Which act established the Rx and OTC categories?
Durham-humphrey 1951
Which act stated that labels did not need adequate directions for use as long as they had "Caution: Federal law prohibits dispensing without a presciption."
Durham-humphrey 1951
Which act authorized oral prescriptions and refills for legend prescriptions?
Durham-humphrey 1951
What happened in 1961 that influenced Drug laws significantly?
Thaidomide Tragedy
Sold as tranquilizer.
In 1960, 29K patients in US involved in testing, FDA withheld approval pending additional safety info. Confirmed as teratogen in 1961 (Phocomelia)
Which law was in response to the Thalidomide tragedy?
Kefauver-Harris Amendment 1962
Outline Kefauver Harris Amendment 1961
1. Requires to be proven safe and effective (Efficacy requirement made retroactive for all drugs between 1938 and 1962)
2. Transferred advertising control to FDA from FTC.
3. Established GMP for manufacturers
4. More extensive controls for clinical investigations - required informed consent and reporting of ADRs
Which Act required that drugs be proven BOTH safe and effective?
Kefauver-Harris Amendment 1961
Which Act transferred jurisdiciton of Rx advertising from the FTC to the FDA?
Kefauver-Harris Amendement 1961
Which act Established the Good Manufacturing Practices?
Kefauver-Harris Amendment 1961
Which Act required more extensive controls for clinical investigators (informed consent / reporting of ADRs)?
Kefauver-Harris Amendment 1961
What is the Medical Device Amendment of 1976 entail?
Empowered FDA to approve devices for safety and efficacy prior to marketing.
What prompted the Medical Device Amendment?
Safety concerns iwth Dalkin Shield --> Malfunction caused sterility...
Describe the Orphan Drug Act 1983
Those manufacturers producing drugs for rare diseases or conditions affecting less than 200k OR producing drugs for more than 200k with no hopes of a profit will get:
A: Tax incentives
B: Limited exclusive license
What act established incentives for manufacturers to develop drugs for rare diseases?
Orphan Drug act of 1983
What Act empowered the FDA to approve medical devices before marketing?
Medical Device Amendment 1976
Describe the Drug Price Competition and Patent-term restoration act 1984
1.Streamlined generic drug approval process
2.Gave patent extensions to certain brand name (innovator) drug manufacturers
3.Gave incentives to develop new drugs.
Which act streamlined the generic drug approval process?
Drug Price Competition and Patent-term restoration act of 1984
Which act gave patent extensions to certain brand name manufacturers?
Drug price competition and patent-term restoration act of 1984
Which act gave incentives to develop new drugs?
Drug price competition and patent-term restoration act of 1984
Describe the Prescription Drug Marketing act 1987
1.Required states to license WDD
2.Required rug pedigrees in certain situations
3.Banned the reimportation of drugs except by manufacturer or for emergency use
4.Banned the sale, trade or purchase of drug samples
5.Mandated the storage, handling and recordkeeping requirements of drug samples.
Which act required states to license WDD?
Prescription Drug Marketing Act 1987
Which act required drug pedigrees in certain situations?
Prescription Drug Marketing Act 1987
Which act banned the reimportation of prescription drugs except by the manufacturer or for emergency use?
Prescription Drug Marketing Act 1987
Which act banned the sale, trade or purchase of drug samples?
Prescription Drug Marketing Act 1987
Which act mandated the storage, handling and recordkeeping of drug samples?
Prescription Drug Marketing Act 1987
Describe the Nutrition Labeling and Education act of 1990
Mandated nutrition labeling on food products and authorized health claims in compliance with FDA rules
Which act mandated nutrition labelign on food products?
NLEA (Nutrition Labeling and Education Act)
Which act authorized health claims (in compliance with FDA rules) on food?
NLEA
What did the Prescription Drug User Fee Act of 1992 do?
Charged manufactuerers fees for drug approval
What is DSHEA?
Dietary Supplement Health and Education Act of 1994
1-Defined dietary supplements
2-In response to manu complaints that NLEA was to restrictive
3-Allowed certain claims previously not allowed by NLEA
4-Required FDA to prove unsafe before it can be removed from market
Which act required that Dietary supplements be proven unsafe by the FDA before it can be removed from the market?
DSHEA
What did FDAMA (Food and Drug Administration Modernization Act) of 1997 do?
1. Streamlined Drug approval process
2. Eliminated approval backlog
3. Fast track drugs for life-threatening diseases
4. Expanded rights of manufacturers to disseminate unlabeled use information
5. Created databank for clinical trials
6. Expanded FDA's authority over otc's
Which Act created a fast track for approval of drugs for life-threatening diseases?
FDAMA
Which Act created databank for clinical trials?
FDAMA
Which act greatly expanded the FDAs authority over OTCs?
FDAMA
If a drug does not meet _____ standards, then it is considered misbranded or adulterated.
USP/NF
A drug that claims to be _________ recognized but is not is misbranded or adulterated.
USP/NF
What is the USP?
Independent, private organization that works closely with FDA to establish approved titles, definitions, descriptions and standards for identity, quality, strength, purity, packaging, stability and labeling of drugs.
What is in the NF monographs?
Inactive ingredient information.
What happens if a dietary supplement's claims are not approved by the FDA?
The FDA can deem it a drug.
Does the FDA approve many dietary supplement claims?
No - 11 so far....
In terms of claims, what does DSHEA allow dietary supplements to say?
Aside from health claims, DSHEA specifically allows nutritional support claims.
1. Product will benefit a classical nutrient defiency with disclosure of US prevalence.
2.Role of affecting structure or function of body
3.MOA in maintaining structure or function
4.Descriptions of General Well-being due to consumption (ie energizer, relaxant, muscle enhancement)
Appropriate or not for dietary supplement?
Cranberry tablets increase the acidity of urine and help to maintain a healthy urinary tract.
Appropraite
Appropraite or not for dietary supplements?
Cranberry tablets prevent UTIs
Inappropriate
Appropriate or not for dietary supplements?
Helps maintain healthy intestinal flora
Appropriate
Appropriate or not for Dietary Supplement
Prevents diarrhea assocaited with antibiotic use
Inappropriate
FOR CLAIMS MADE ON DIETARY SUPPLEMENTS, WHAT MUST ALSO BE ON THE LABEL?
"This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.
What requirements exist on health claims approved by FDA for dietary supplements under DSHEA?
1. Must describe relationship between product and disease
2. FDA approval contingent upon "significant scientific agreement" regarding the claim.
What are some criticisms of DSHEA?
1. NO PREMARKET APPROVAL REQUIRED
2. Dangerous products are marketed with potential interactions and lack of quality standards.
Labeling is directed towards _______________.
HCPs, not patients
Is detailing considered a form of labeling since it is information targeting HCPs?
NO- Labeling accompanies the product. Detailing is a form of advertising
What are the Container Label Requirements
1.Mfr Name/Address
2.Established product name
3.Active ingredients, qty and proportion
4.Inactive ingredients if not for oral use
5.Statement of identity
6.Strength
7.Net quantity
8.Refer to package insert for dosing or dosing information
9.Rx Only
10.Route of admin (if not PO)
11.Lot
12.Dispensing container directions (may be elsewhere if limited space)
13.Expiration date
What are the Package Insert Requirements
1.Description (names)
2.Clinical Pharmacology
3.Indications/Usage
4.Contraindications
5.Warnings
6.Precautions
7.Adverse reactions
8.Drug abuse/dependence
9.Overdosage
10.Dosage/Administration
11.How supplied
12.Most recent revision date
What must Label on OTC drugs contain?
1. Statement of identity/category
2.Mfr name/address
3.Package qty
4.Cautions/warnings
5.Adequate directions for sue
6.Drug Facts panel (active ingredients, purpose, use warnings, directions, other info, inactive, phone number for questions?, normal doses for each intended use and doses for individuals of different ages and conditions, frequency/duration, meals, onset of sx timing, route or method of admin, preparation)
What do most FDCA violations consist of?
Adulteration
Misbranding
Both
When FDCA violations such as adulteration or misbranding occur, how lenient is the law?
NOT AT ALL
STRICT LIABILITY- INTENT AND KNOWLEDGE NOT A FACTOR
What is Adulteration?
Focused on a flaw in the product.
Product flaw may be related to what the label purports the product to be
What is misbranding?
Focused on flaw in labeling or other representation
Who does adulteration typically apply to?
Manufacturers
Compounding Pharmacies
Repackaging pharmacies
If a substance is subject to compendial standards, any variation in strength, quality or purity from the USP/NF unless stated on the label constitutes what?
Adulteration
If a drug is not subject to compendial standards but the contents differ in strength, quality or purity from the label, what does this constitute?
Adulteration
A drug is considered adulterated unless it is manufacturered in a manner in accordance with ________.
CGMP (Current Good Manufacturing Process)
Describe the Registration requirements for CGMP for manufacturers?
Must register with the FDA and are inspected for compliance with CGMP once every 2 years.
Describe the Federal Anti-Tampering Act
-Response to 1982 Tylenol Poisonings
-Requires that tamper-resistant packaging be used for select OTC productss and cosmetics, particularly PO.
-->Must have indicator or barrier to limit access
-->Package must indicate how a consumer can tell if package has been tampered with
-->Violation may be adulteration, misbranding or both
Violation of the Federal Anti-Tampering act consitutes what?
May be adulteration, misbranding or BOTH
Basic definition of Misbranded
Mislabeled drugs that are sold, dispensed or distributed in violation of the labeling requirements of the FDCA.
Labeling must conform with requirements and not be false or misleading
Insulin and Antibiotics not being batch certified is an example of what?
Misbranding
Improper refills is an example of what?
Misbranding
Outdated drug is an example of what?
Adulterated and Misbranded
What would be some examples of Adulteration only occuring?
1.Contaminated product
2.Cotnainer is contaminated
3.Product is held under conditions where it may have become contaminated
State some examples where a drug has been MISBRANDED ONLY
1.Dispensing w/o Rx or without refill authorization
2.Dispensing wrong drug (possibly also adulteration)
3.Improper directions for use
Purchase invoices are records of _______.
Receipt
Prescriptions are records of __________.
Disposition
Inventories are records of _____________.
Drugs on hand
FDCA requires records be maintained for ________.
2 years
Who can enforce FDCA?
1. FDA (Seize adulterated drug, pull licenses, injunctions, criminally prosecute)
2. IDPR can discipline
3. Patient can sue for damages caused by adulterated or misbranded product.
Does the FDA have the statutory authority to order a recall?
No, but it can ask real nicely by threatening the manufacturer with an injunction to cease distribution or seizure.
Who's responsibility in a recall is it to notify sellers of record?
MFR
Class I Recall
SERIOUS, ADVERSE HEALTH CONSEQUENCES
Class II Recall
Temporary or medically reversible adverse health consequences, probability of adverse consequences is remote
Class III Recall
Not likely to cause adverse health consequences
Describe Class I Devices
Needles, scissors, examination gloves, stethoscopes, toothbrushes, ice bags - pose least potential harm: General controls
Describe Class II devices
Tampons, contact lens solution, syringes, condoms, infusion pumps, thermometers, electric heating pads) - General controls + Perofrmance
Describe Class III Devices
IUDs, pacemakers, heart valves, artificial hips, soft contact lenses) General controls + Performance standards + premarketing approval and MFR must demonstrate efficacy and safety
Is soap cosmetics?
No
Define Cosmetics
Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced to, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering appearance.
Do cosmetics require premarketing approval?
No
Labeling requirements for Cosmetics
Ingredients
When can the FDA remove cosmetics from the market
If:
Adulterated
Misbranded
Health Hazard
Who regulates Rx Advertising?
FDA
Who regulates OTC Advertising?
FTC
Define Rx Drugs
Unsafe for use except under the supervision of a prescriber due to toxicity, method of use and collateral measures necessary for use.
How was what FDA must demonstrate to convert OTC to Rx established and what must they demonstrate?
US v. Article of Drug-Decholin
1.Harm using the drug without prescriber supervision
2.Harm in postponing effective treatment if use of the drug is inappropriate
Which act described the Prescription Label (vial label) requirements?
Durham-Humphrey Act 1951
List Prescription Label (Vial label) requirements
1.Name, address of Dispenser
2.Serial #
3.Date of filling
4.Prescriber name
5.Directions for use
6.Cautionary statements
7.Name/Strength of drug
8.Name/initials of RPh
9.Expiration/Beyond use date
10.Patient address
11.Mfr name/distributor name
12.Lot number
Which act authorizes FDA to switch Rx drugs to OTC?
Durham-Humphrey Act 1951
3 Ways Rx--> OTC switch can occur
1. MFR requests switch via SNDA
2. MFR may petition FDA
3. OTC drug review process (Most common) - Advisory review panel recommends a switch to the FDA
Criteria for switch from Rx to OTC
1.Effective for intended use and must have appropraite margin of safety
2.Condition must be self-limiting and Sx recognizable by public
3.Easily administered
4.Note - Just because on MFR switches to OTC, doesn't mean other MFR's products switch
What is the "Third Class of Drugs"
Restricts sale of certain drugs to RPh only.
Exists with certain C5 drugs
Plan B (18 and older w/o Rx)
Basic limitation on Cheratussin AC sale from RPh without Rx
No more than 120ml q 48 h w/o Rx
Has has independent prescriptive authority?
MD, DO, DDS, DPM, DVM
Who has limited or dependent prescriptive authority?
NP, PA, OD, RPh
What is collaborative practice?
Allows RPh to prescribe via agreement with traditional prescriber
Which drugs require PPI provision by RPh?
1. Estrogen containing
2. Progesterone containing
3. OCPs
4. Oral diethylstilbestrol (DES)
5. Intrauterine Devices (IUDs)
PPI timing requirements
Must receive PPI with every dispensing in community or prior to first dose and every 30 days in institutional settings
Which drugs require MedGuides?
Accutane
Lariam
Lindane Lotion/Shampoo
NSAIDs
Antidepressants
Warfarin
What is the deal with MedGuides?
Separate from PPI, FDA requires written patient information provided by the MFR and approved by the FDA when:
1. Labeling would help prevent serious adverse reactions
2.Product has serious risk of which patient should be aware
3.Patient adherence to directions is crucial for effectiveness
Why is off-label uses of drugs necessary?
MFR seeks approval for minimal number of indications to expedite approval process with intent to submit ANDA or SNDA to have additional indications later.
CLINICAL PRACTICE IS FAR AHEAD OF DRUG APPROVAL PROCESS
Is off label prescribing and dispensing legal?
Yes, per the FDA
Pharmacies are exempt from manufacturer requirements if they _____________________
do not manufacture, prepare, propagate, compound or process drugs or devices for sale OTHER THAN IN THE REGULAR COURSE OF BUSINESS

Meaning... if they do it in the regular course of business they are ok.
Why do pharmacies NOT want to be considered manufacturers by the FDA?
Because doing so would require the entity to obtain a license from the FDA and conform to CGMP requirements.
What must pharmacies that repackage OTC products or in any way change the container, wrapper, or labeling for resale do?
Register as manufacturers
What are the viewpoints on the following question?

"Is a compounded drug considered a new drug?"
FDA: Yes!
5th Circuit US court: No!
Name some things that may get a pharmacy in trouble with the FDA in terms of compounding...
1. Compounding in anticipation of receiving prescriptions, except in small quantities
2.Compounding drugs withdrawn from the market for safety reasons
3.Compounding from non-FDA approved bulk ingredients
4.Using commercial scale equipment
5.Compounding for 3rd parties for resale (OK if MD uses, but doesn't resell it!)
6.Compounding commercially available products (OK with slight variation and medical need for such variation)
Orange Book
First Letter "A"
Therapeutically equivalent to reference drug product
Orange Book
First letter "B"
Not considered therapeutically equivalent to reference drug product
Why would a number be added on to the orange book coding system?
If more than one reference drug exists (i.e. Nifedepine)
Why will generic drugs approved after 1984 via ANDA all have an A rating?
Patent Term Restoration Act of 1984 requires proof of bioequivalence for approval
T/F

FDCA mandates use of orange book.
False
T/F

Many states mandate the use of orange book when determining when an RPh can substitute with the generic.
True (Illinois)
Under the Prescription Marketing Act of 1987, the presence of ___________ in a retail pharmacy will be considered evidence that the drug was acquired ILLEGALLY.
Drug Sample
Under what conditions can a pharmacy in a hospital or health care entity accept samples?
1. Must be at request of licensed practitioner
2. Must have a receipt documenting the transaction in detail
What law allows non-profit organizations to purchase drugs at much lower prices?
What restrictions exist?
Prescription Marketing Act 1987
PROHIBITS SALE, PURCHASE OR TRADE (OR OFFERS TO DO SO) OF RX DRUGS THAT WERE PURCHASED BY A HOSPITAL, HEALTH CARE ENTITY OR CHARITABLE ORGANIZATION (exceptions: sale to patients w/ Rx, sales among hospitals or nonprofits under common control or affiliates or in emergency shortage situations)
Which act allows MFRs to reimport Rx drugs?
Presciption marketing act 1987
Which act BANS reimportation of drugs AVAILABLE in the US?
Prescription Drug Marketing Act 1987
Can medications made with tax-exempt 95% ethanol be sold to outpatient?
No
Can Walgreens by Tax-free 190 proof alcohol?
No
Who enforces the Poison Prevention Packaging Act (PPPA)?
CPSC (Consumer Product safety commission)
Describe recent changes on iron tablets brought upon via PPPA
Products w/ >30mg elemental Fe must be packaged in unit dose containers.
Containers that contain more than 250mg elemental Iron must be child resistant.
Official name of the CSA 1970 (Controlled Substance Act)
Federal Comprehensive Drug Abuse Prevention and Control Act
Who enforces the CSA?
DEA
How does the state regulate controlled substances? (As long as they don't conflict with federal law)
Via its police powers
Who enforces the Illinois Controlled substances act? (NOT ON TEST)
Illinois Department of Professional and Financial Regulation
What authority does the Attorney General of the US have as far as controlled substances?
Sole authority to:
1.Classify a drug as a controlled substance
2.Reschedule a controlled substance
3.Remove controls over a controlled substance
Who really has the authority to assign, change or remove controlled substances from the schedules.
The Secretary of the US department of Health and Human services provides the Attorney general the info and a recommendation, which the attorney general MUST follow.
What factors determine the Controlled status of a drug?
1. Potential for abuse
2. Pharmacological effect
3. History and current pattern of abuse
4. Scope, duration and signficance of abuse
5. Risk to public health
6. Physiological or psychological dependence liability
Define a Narcotic Controlled Substance
1. A natural or synthetic opium or opiate and any derivative, such as poppy straw.
2. Coca leaves
3. Cocaine
4. Ecgonine
Can (CI)'s be prescribed?
NO
Describe Schedule 1 Controlled Substances
1. High potential for abuse
2. Have no currently accepted medicinal use in Tx in the US - Cannot be prescribed
3. Lack accepted info on the safety of their use, even under medical supervision
4. Examples: pot, LSD, heroin
5. GHB: Schedule 1 if not FDA-approved, Schedule 3 if approved
6. Conflict: State medical marijuana laws do not change (C1) status, federal offence even if not a state offense
Describe Schedule II Controlled Substances
1. High potential for abuse
2. Accepted medical use or a currently accepted use with severe restrictions.
3. Abuse of the substance may lead to severe physical or psychological dependence
4. Examples: Morphine, codeine, methylphenidate
Describe Schedule III Controlled Substances
1. Less abuse potential than C2,C3
2. Accepted medical use
3. Abuse may lead to moderate to low physical dependence or high psychological dependence
4. T3, Ketamine, anabolic steroids, paregoric
Describe the codeine amount restrictions for Schedule 3
No more than:
*1.8g codeine per 100ml or 90mg per dosage unit
Describe the dihydrocodeinone/ethylmorphine restrictions for schedule 3
No more than 300mg per 100ml or not more than 15mg per dosage form with one or more active, non-narcotic ingredients
Describe the opium restrictions for schedule 3
No more than 500mg opium per 100ml or per 100g or not mroe than 25mg per dosage unit.
Describe the morphine requirements for schedule 3
Must not contain more than 50mg morphine per 100ml with one or more active, non-narcotic ingredients
Describe Schedule 4 Controlled Substances
1. Low potential for abuse relative to Schedule 3
2. Accepted use
3. Abuse may lead to limited physical dependence.
Examples: Alprazolam, Diazepam, phentermine, pentazocrine
Describe Schedule 5 Controlled Substances
1. Low abuse potential
2. Accepted medical use
3. Abuse may lead to limited physical dependence or psychological dependence relative to C4
Examples: Mostly antitussives with codeine and antidiarrheals with an opiate
Describe Manufacturing Labeling requirement for controlled substances.
Must designate C1 -> C5
How often do MFR/Distributors of controlled substances have to register?
Yearly
How often do Dispensers of Controlled substances have to register?
Every 3 years
Under what title do individual practitioners register in order to prescribe controlled substances?
As Dispensers
Agents/employees of individual practitioners may do what with regard to controlled substances?
Dispense or adminsiter, NOT prescribe
When can an individual engage in activities for which CS registration is required?
Only after their application is granted and the Certificate of Registration is issued
If a CS registered individual does not receive their re-registration materials, can they continue to do activities that require registration?
No!
Affirmative duty to register!
Who can deny, suspend or revoke a DEA registration?
The attorney General
If a person has had their application for registration denied or revoked cannot do what?
Be employed in an environment where they would have access to controlled substances
DEA Agents have a _____________ for inspection unless a warrant is presented.
Consent requirement
Does the State board of pharmacy need a warrant to inspect controlled substances?
Nope
Who enforces the Narcotic Addict Treatment Act of 1974?
The FDA
OTP
Opioid treatment program
Methadone dispensing requirements
If for severe pain, Retail pharmacies can dispense.
If for detox or maintenance, only OTP's can dispense
Significance of DATA (drug Addiction treatment Act)
Allowed office based Tx of opioid addiction by qualified physicians who may prescribe and dispense C3,C4,C5 opioids approved by FDA for said treatment.

Subutex/Suboxone only
What law made it a federal offense for robbing a pharmacy?
Controlled Substance Registrant Protection Act of 1984
What law made anabolic steroids for human use Scheudle 3?
Anabolic Steroids Control Act 1990
Can Prescribers order CS's "for office use"
Nope
What is a Prescription under the CSA?
1. An order
2. Dispensed to an ultimate user
3. NOT for immediate admin (inpatients)
4. Prescribers cannot write on Rx "for office use"
Why authorizes prescribers to prescribe CS's (not register)?
The state
Can Oral CS prescriptions be communicated to pharmacist by prescriber's agent/employee?
Yes
Can written CS prescriptions be prepared by prescriber's employee/agent for signature?
Yes, just as long as they don't sign
Who is allowed to dispense controlled substances?
Pharmacists (techs/interns if allowed by state under supervision of RPh)
Individual Practitioners
FOR A SCRIPT TO BE VALID FOR CONTROLLED SUBSTANCES, IT MUST HAVE WHAT?
1. BE DATED AS OF AND SIGNED ON THE DATE OF ISSUANCE (NO PRE-DATING OR POST-DATING ALLOWED)
2. HAVE FULL NAME AND ADDRESS OF PATIENT
3. CONTAIN DRUG NAME STRENGTH, DF, QTY AND SIG
4. CONTAIN NAME, ADDRESS AND DEA NUMBER OF PRESCRIBER
5. IF COMMUNICATED ORALLY, NO SIGNATURE REQUIRED, RPH MAY WRITE IN NAME OF PRESCRIBER.

E-RX'S NOT YET ALLOWED, BUT COMING
Who is responsible for the proper prescribing and dispensing of a controlled substance?
The pharmacist and physician

RPh must ensure script is valid
For an emergency C2 oral Rx, what do you do if the physician fails to get the Rx to you within 7 days?
Contact DEA office or else Rx is invalid
When are faxed C2 prescriptions allowed and the faxed copy to serve as the original?
1.Rx is for C2 Narcotic tobe compounded for direct administration via non-PO route
2.Prescription is for a C2 for a patient in a long term care facility
3.Prescription is for a C2 narcotic enrolled in hospice certified by Medicare or licensed by the state. Prescriber or agent must note that patient is hospice patient.
Describe procedure for PFL on C2 Medications
If OOS or RPh wants to verify or patient doesn't want entire amount, pharmacist must note qty dispensed on face and balance must be filled within 72 hours after partial. If unable to fill within 72 hours, must notify prescriber. No further qty may be supplied within 72 hours without a new prescription
Describe Procedure for LTCF C2 Partial fills
May be written for terminally ill and dispensed in partial qty's to include individual dosage units. For each filling, must record transaction. Cannot exceed 60 days from issuance date.
MUST RECORD THAT PATIENT IS TERMINALLY ILL OR A LTCF PATIENT
Requirement for Written or Faxed C3-C5 Rx's
Must have signature of practitioner
How many times can CS be transferred?
Once, unless within a chain, then up to maximum refills.
Describe inventory requirements for C3-C5
Exact count on closed bottles, exact on bottles >1000 and estimated count on all other opens.
Must occur initially at opening then every 2 years (biennially) thereafter
Can CS inventories be electronic?
No, must be in written form.
Describe inventory schedule for CS that have been re-scheduled.
Inventory on effective date of schedling or rescheduling, then on regular biennial inventory date.
Are CS inventory records sent to the DEA?
No, hold 'em
For C3 - C5, what serves as records of receipt?
Invoices
For C1 - C2, what serves as records of receipt
DEA Form 222
Who must sign DEA Form 222
The person who signed the most recent DEA registration, or by a person designated in a power of attorney previously submitted to the DEA
Who gets the DEA Form 222 Triplicates?
1. DEA
2. Wholesaler
3. Pharmacy
What do you do if used or unused DEA 222 Forms are lost or stolen?
Contact DEA
In order to sell an MD a bottle of Oxycontin, what must be done?
They must fill out a 222 form.
For disposal or destruction of controlled substances, what must be done?
Request must be sent to DEA on form 41, then DEA will instruct on how to proceed.
What did Congress use that was developed by the pharmacy profession in developing OBRA 90?
"Pharmaceutical Care Model"
What is the Pharmaceutical Care model?
Pharmacists responsible for producing good therapeutic outcomes and improving patients' quality of life