Law exam 1 Flashcards
Branches of government
legislative: makes the laws
Judicial: interprets the law
Executive: enforces the law
Checks and Balances
Makes sure that all three of the branches have equal power so not one is more powerful than the other
market failures
Public goods: manufacturers will not produce what they will not get incentives for such as orphan drugs and vaccines
Externalities: one issue affecting one party more than another example antibiotic resistance
Natural monopolies: one group of manufacturers might have a tendency to produce more of the drugs thus they will get more money
Information asymmetry: information not being known in full amount by a certain group than another
Public goods:
manufacturers will not produce what they will not get incentives for such as orphan drugs and vaccines
Externalities
one issue affecting one party more than another example antibiotic resistance
Natural monopolies
one group of manufacturers might have a tendency to produce more of the drugs thus they will get more money
Information asymmetry
information not being known in full amount by a certain group than another
doctors know more than patients
Why regulate drugs
Market failures
Best interest of patient
Highly regulated profession
Limits on the law
Minor violations
Sources of Law
Federal vs State
- Federal law over state law
- There is a discrepancy when the state is less strict
Constitution
3 branches
What does each branch do
Administrative agencies
- Examples: statutory,
Criminal vs Civil vs Administrative
civil: private vs private
Criminal: federal vs private
Administrative: agency vs private
Code of Federal Regulations
compilation of final regulations divided and indexed by subject matter
Federal Register
daily publication of proposed and final regulations and notices
State
Branches
Agencies
idk rn
State vs. Federal
What to follow- federal over state if ever an option
Court cases/Trial Procedure
Plaintiff tries to state their point and warrant that the defendant’s point has not merit
Notwithstanding can allow the judge to override the verdict if the jury came to the wrong one
A witness can face penalty if they do not show up in court
Defendant can issue a plea of bargain so that they not be arrested
FDCA
1- A drug has to be proven safe and effective for use before it is marketed and sold
2- has to be proven by the Food and Drug Administration (FDA)
3- forms the nucleus for today’s laws
Durham Humphrey
Rx & OTC
Oral prescriptions
1- Labels must have directions for use and warnings about the habit-forming properties of drugs.
2- This applies to cosmetics and devices as well.
3- Drugs on the market at this time were not safe for use except under medical supervision.
1- Established two classes of drugs
prescription and over-the-counter
2- Labels of prescription drugs do not need to contain “adequate directions for use” as long as they have “Caution: Federal law prohibits dispensing without a prescription”
1- The label for “adequate directions of use” is satisfied by a pharmacist putting the label of directions from the prescriber
2- Authorizes oral prescriptions (giving prescriptions by word of mouth) and refills of prescription drugs
Food Additive
requires the Food and Drug Administration (FDA) to ban food additives that are found to cause or induce cancer in humans or animals as indicated by testing.
Color Additive
- cannot be used to hide impurities of food
1- Requires manufacturers to establish the safety of color additives in foods, drugs, and cosmetics.
2- The FDA can approve a color for one use but not the others (e.g. external use only)
Kefauver Harris
Established that drugs need to be not only safe but effective and need to be tested in pregnancy subjects too
Established pregnancy warnings
1- required drugs to be proven not only safe but also effective.
2- Place control of prescription drug advertising from the Federal Trade Commission to the FDA
established
3- Good Manufacturing Practices (GMP)
added more extensive controls for clinical investigations, informed consent, and reporting of adverse drug reactions
Medical Device
- made sure that they were effective to implement chemical and biological effect for medical benefit
1-The FDA could not review medical devices for safety and efficacy before marketing
2- Congress amended the FDCA to provide more extensive regulation and administrative authority regarding the safety and efficacy of medical devices.
1- Classification of devices according to their function
2- premarket approval
3- Establishment of performance standards
4- Conformance with GMP regulations
5- Adherence to record and reporting requirements
Orphan Drug Act
- created incentives for manufacturers to create orphan drugs for rare diseases
1- Pharm. companies told Congress that the NDA process was too expensive to make drugs for diseases that affected a few people.
2- Congress provides tax and exclusive licensing incentives for companies to develop and market these drugs– so this is the Orphan Drug Act :)
what is an orphan drug?
drugs for “rare diseases or conditions” (defined as those affecting fewer than 200,000 Americans.)
PDMA - prescription drug marketing act
1- Prescription drug samples will have sales restrictions and record-keeping requirements
2- Prohibits hospitals and other healthcare entities from reselling their drugs
3- Other businesses require state licensing of drug wholesalers.
4- A secondary distribution system for prescription drugs was threatening public health and safety and creating an unfair form of competition.
Safe Medical Device Act
- makes sure that medical devices are safe
1- Made the FDA have additional authority for post-marketing requirements and premarket notification
2- also allowed for approval while speeding up the premarket device approval process.
Generic Drug Enforcement Act
- made it so that generic drugs are used instead of brands because they are cheaper
1- Occurred when some FDA staff accepted bribes from generic drug industry workers to facilitate the approval process of certain generic drug products.
2- The FDA banned individuals or firms from participating in the drug approval process if convicted of related felonies.
3- Impose severe civil penalties for any false statements, bribes, failures to disclose material facts and other related offenses.
PDUFA - prescription drug user fee act
- allowed the FDA to collect user fees from an ultimate user of drugs
1- The FDA and Congress took the approach that private industry should handle part of the costs for new drug approval rather than the taxpayers.
2- Requires manufacturers to pay fees for applications and supplements when the FDA must review clinical studies.
3- Fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and hopefully speed up the NDA review.
Food Drug Administration Modernization Act
- expedited important drugs such cancer, reproductive etc
1- Due to FDA criticism, the FDA was not efficiently administrating its statutory responsibilities, and the FDCA was too burdensome a regulatory system for drug approval.
2- FDAMA passed to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices.
1- The intent is to eliminate backlogs in the approval process and ensure timely review of applications.
2- Creates fast fast-track approval process for drugs intended for serious or life-threatening diseases
3- Establish a database of information on clinical trials, authorize scientific panels to review clinical investigations, and expand the rights of manufacturers to disseminate unlabeled use information.
4- Expands the FDA’s authority over OTC drugs and establishes ingredient labeling requirements for inactive ingredients.
Drug Quality and Security Act
- drugs are now under surveillance to make sure that they are not being abused or harmful in any way
1- clarifies and strengthens FDA oversight over pharmacies engaged in the large-scale compounding and shipping of sterile products to other licensed entities.
2- The law also removed uncertainty regarding when a product compounded by a pharmacy is exempt from CGMP, labeling, and the new drug approval process.
3- title 1 also called the Compounding Quality Act
1- adds “track and trace” requirements for all entities in the chain of distribution of pharmaceutical products.
2- Requires manufacturers to provide transaction information to purchasers, who in turn must provide transaction information to subsequent purchasers.
3- The law also mandates an electronic, exchangeable product tracing system by 2023, strengthens wholesaler and third-party logistics licensure requirements, and requires manufacturers to serialize drugs by 2017.
4- Title II known as the Drug Supply Chain Security Act,
Food and Drug Administration Amendment Act
- safe and effective drugs
1- FDA’s broader use of the fees generated from PDUFA, substantially increased fees
2- In response to postmarket problems with certain drug products (i.e. Vioxx), the law provides the FDA with increased responsibilities and authority to regulate drug safety, label changes related to safety, clinical trial data reporting, and registries, requiring postmarket clinical studies to assess risk
3- requires companies to implement risk evaluation and mitigation strategies (REMS).
FDA Safety and Innovation Act
1- enables the FDA to inspect foreign drug manufacturers more regularly and requires the agency to target problematic manufacturing sites.
ACA
allowed every one to have affordable insurance
Created insurance option for poor, elderly and less for fortunate people
Drug
article recognized in compendia
Article the mitigates, treats and prevents disease
FDA
food drug administration
All drug approvals go through them
Device
- excludes articles that elicit their effect through chemical and or biological effect
Cosmetic
alters appearance, for cleansing
Food
any nutritious substance that people or animals eat or drink or that plants absorb in order to maintain life and growth.
Combination Product
therapeutic and diagnostic products that combine drugs, devices, and/or biological products.
Food Vs Drug vs supplement
- DSs are used to replace food and can be vitamins, amino acids, minerals, herbs etc
Label & labeling
The term labeling includes labels.
Labeling is defined as written or printed or graphic matter “accompanying” the article.
Courts have defined accompanying.
If the written, printed, or graphic matter is not labeled, it is advertising.
Official Compendia
USP
- Published by the USPC
- Sets uniform standards
- USPC works closely with the FDA but is private.
HPUS
- Publishes standards for homeopathy products by the HPCUS, a private organization
- Role and legal authority of HPUS
Pursuant to FDCA, if a drug is recognized in USP or HPUS, the drug product must meet all standards of the compendia.
Violations of FDCA
Adulteration
Misbranded
Violation of FDCA is subject to strict liability
- Good faith excuse applicable
Most prohibited acts involve misbranding or adulteration.
Adulteration
Adulteration provisions focus on both the facility and the product. A pure drug may be considered adulterated based on the facility.
A drug is adulterated if its strength, quality, or purity differs from compendia standards unless plainly stated on the label.
A drug is adulterated if its strength, quality, or purity differs from the label.
A product is adulterated unless manufacturer complies to CGMP.
CGMP is an exhaustive set of standards directed at manufacturers.
The failure to manufacture a product in a tamper-resistant container when required by law is adulteration and also misbranding.
Pill falls on the floor
Misbranded
Labeling must not be false or misleading, including healthcare economic information.
Labeling must include a listing of active ingredients and quantity and a listing of inactive ingredients in alpha order.
Labeling must contain “adequate directions for use” and “adequate warnings against use” by children and others for whom use might be dangerous.
If a drug cannot be labeled with “adequate directions for use,” it must contain “adequate information for use.”
It is misbranding if a drug imitates another drug.
The package promises hair growth and does not do that at all
Impact of adulteration and misbranding on pharmacy
- impacts the trustworthiness of pharmacy to hold to its word and deliver what it says that it would
Recalls
1- drug poses lethal effect
2- the drug has ADR
3- drug labeling violation
The FDAAA established the FDA authority to order drug recalls for certain products, but not drugs.
Three classes of recalls
Manufacturers are responsible for notifying sellers; sellers are responsible for notifying consumers, if necessary
Pharmacists responsible for knowing of product recalls
Product Tampering
Is illegal
Must be evident by the packaging and manufacture must provide product tamper evident packaging to ensure that the product is not tampered before getting to ultimate user
Label
Commercial Container label 77
Unit Dose Label 77
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Package insert
Black Box Warning
Pregnancy Warning
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Black Box Warning
- highest level of warning that can be given
Required in labeling when use of a drug may lead to death or serious injury
Required for many prescription drugs
Pregnancy Warning
- placed with package to warn against drugs affecting pregnancy, lactation, reproduction, etc
The labeling system prior to June 30, 2015, required that drugs potentially risky during pregnancy be placed into one of five categories: A, B, C, D, and X.
A- no harm
X- harm
A 2014 regulation replaces the above system.
For drugs approved after June 30, 2015, labeling will require the inclusion of three subsections to describe risks: “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential.”
Drugs approved prior to June 30, 2015, will be gradually phased into the new labeling standards.
NDC
National Drug Code Number
Manufacture, product, package
10-digit three segment code (4-4-2, 5-3-2, or 5-4-1)
The first segment identifies the manufacturer or distributor;
the second identifies strength, dosage for, and formulation;
the third identifies package size and type of drug.
Billings and claims submissions require an 11-digit NDC number.
New Drug Approval
formulation/ early formulation: extracting the molecule or chemically creating it
Preclinical trials: testing the molecule in rodents
Apply for the IND to test it in humans
phase I: test the safety
Phase II: test the efficacy
Phase III: test the safety and efficacy
New Drug Application (NDA) Process
IND Investigational New Drug Application
The sponsor must receive an approved Notice of Claimed Investigational Exemption for a New Drug to ship the drug in interstate commerce to conduct phase 1, 2, and 3 clinical studies.
The FDA may terminate testing at any time under risk–benefit criteria; the decision is not subject to an appeal or judicial review.
The FDAAA requires NDA sponsors to publish summary information regarding phase 1 trials on a public registry.
The FDA has 180 days to act on a completed NDA, but delays are common.
Approval is based on proof of safety and efficacy, the manufacturing process, and risk–benefit ratio.
The applicant may judicially appeal a rejected NDA, but success is very unlikely.
Definition of New Drug
one that has not been previously recognized in the pharmacopeia
Has new substance
is defined as a drug that is not generally recognized by qualified experts as safe and effective (GRASE) for use under the conditions recommended in the drug’s labeling and has been used for a material extent and time for conditions recommended in labeling.
Approved Drug as a new drug
- when it passes all the clinical trials and is approved by the FDA
An approved drug can become a new drug under certain conditions:
- Addition of new substance
- New combination of approved drugs
- Change in proportion of ingredients
- New intended use
- Dosage, method, or duration of administration or application is changed
Informed consent for New drug approval
- should be received from the subjects of the study
Informed consent is required in all three phases of the clinical trial
Research subjects are required to know the risks, possible benefits, and alternative courses of treatment
Institutional Review Board (IRB) approval required in some settings
NDA- new drug application
- is applied for after all of the trials to be approved by the FDA as a new drug
The FDA has 180 days to act on a completed NDA, but delays are common.
Approval is based on proof of safety and efficacy, the manufacturing process, and risk–benefit ratio.
Applicant may judicially appeal a rejected NDA, but success is very unlikely.
FDA Rating and Classification
- rating drugs based off of therapeutic ability and not just by name
A priority classification system rates new drugs by chemical type and therapeutic potential; this determines how quickly the drug will move through the IND/NDA process.
A number designates chemical type, and a letter (S, P, or O) designates therapeutic potential.
Phases in Clinical Trial
I: Safety
II: efficacy
III: safety and efficacy
Risk Evaluation and Mitigation Strategy (REMS)
The FDAAA granted the FDA authority to require REMS as a condition for approval of an NDA or postmarket when the FDA believes it necessary to ensure benefits outweigh risks.
Under REMS authority, the FDA can require a variety of procedures ranging from Medication Guides to limiting the drug to specified settings for dispensing.
Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)
- generics were created to compete with the production of brands
Statutorily created the ANDA, expediting generic approval
Concessions to innovator drug companies included:
- Patent extensions
- Market exclusivity
OTC Review
- Reviewing OTC for acceptable use by the public
The OTC drug review process approves drugs on the basis of therapeutic category and conformance to a monograph rather than on a drug-by-drug basis like prescription drugs.
Biologics
- medicinal entities from biological organisms
Products derived from living organisms
Licensure by PHSA, but subject to FDCA and FDA requirements
The Biologics Price Competition and Innovation Act created a regulatory framework in 2010 for biosimilars or “follow-on” biologics.
The FDA Purple Book lists biological products, including any biosimilar and interchangeable biological products.
Medwatch
- health care professionals keeping an eye on how the drug is doing in their patient and reporting any ADR to the FDA
Voluntary reporting system to allow healthcare professionals to report any serious adverse events, product use errors, and product quality issues
The FDA emphasizes the importance of reporting by healthcare professionals.
The FDAAA requires pharmacies to provide patients with the MedWatch number and a statement about reporting side effects.
Medical Devices
- excludes articles that are used to implement a chemical effect on a patient
Cosmetics
- used to cleanse and or alter appearance
The definition of cosmetic generally includes topical articles intended for cleansing, beautifying, or altering appearance.
A cosmetic can become a drug if the seller makes a health or structure/function claim.
“Ignorant, unthinking consumer” standard likely applied
Some products can be both cosmetics and drugs.
No premarket approval, nor conformance with CGMP
Manufacturers must substantiate product safety.
The FDA may remove if misbranded, adulterated, or a health hazard.
Must be labeled with list of ingredients in descending order of predominance and appropriated warnings
Biosimilars
- drugs that are very similar to the reference but pose more side effects
Drug Advertising
- done to sell drugs on the market
The FDA regulates Rx drug advertising, and FTC regulates OTC drug advertising.
The First Amendment restricts government regulation of commercial advertising.
Any regulation will be evaluated pursuant to the four factors established by the U.S. Supreme Court.
Sunshine Act
- for physicians to advertise drugs
Off Label
- using a drug for anything other than the accepted use from the FDA
Direct-to-Consumer Advertising
marketing targeted directly toward a consumer
Lanham Trademark
Prohibits use of any false description or representation
Allows for private cause of action and recovery of monetary damages
Durham Humphrey- these are the things that it did:
RX vs OTC
Written vs oral vs electronic
Labeling requirements
Exempts the pharmacy label on dispensed drugs from Section502, except for certain provisions
Specifies the minimum information that a dispensed Rx label must contain
Expiration or beyond-use dating on dispensed Rx label required pursuant to state laws
Establishes criteria for distinguishing prescription drugs from OTC drugs
Legally establishes oral prescriptions and refills
Although the amendment did not contemplate electronic prescriptions, other federal and state laws permit them.
State standardization of Rx Label
name, address, DOB of patient
Prescribers name, address, phone # and DEA #
Expiration date
- need to be on label
Expiration or beyond-use dating on dispensed Rx label required pursuant to state laws
BUD- Beyond Use Date
- needs to be on the label
Expiration or beyond-use dating on dispensed Rx label required pursuant to state laws
Rx to OTC
these are the way it can be done:
Manufacturer SNDA
Manufacturer petition FDA
FDA add or amend
Three methods:
- SNDA: product-specific switch
- Petition: product-specific switch
- Adding or amending an OTC drug monograph: affects all products in the class
Third Class of Drug
behind-the-counter drugs
Intended to be only sold in a pharmacy
Pseudoephedrine
Naloxone
Emergency contraceptives
Refers to creating a class of drugs that can only be sold from the pharmacy department
Rationale based on the fact that more dangerous drugs are being switched and would allow even more to be switched
Historic opposition to the FDA appears to be shifting
Prescription refill authorization
Distinguish authorization of refill from transmittal authority
who decides on Prescriptive authority
- federal allows state to decide
Federal law leaves it up to the states to determine who may prescribe independently or in collaborative practice.
Scope of authority as determined by the state for prescribers who are not MDs or DOs is important for pharmacists to know.
Emergency contraception
- initially, Plan B was for Rx only and now it is moved to OTC
Plan B approved in 1999 as Rx only
Citizen Petition in 2001 requesting switch to OTC status without age restriction followed by SNDA requesting the same in 2003
After initial rejection of Barr’s SNDA, the FDA finally approved the drug in 2006 as OTC in women 18 and older and only sold behind the counter of pharmacies.
FDA denied Citizen Petition in 2006 prompting Tummino lawsuit, where judge found FDA abused its discretion
Judge ordered age reduced to 17 and FDA to reconsider petition
In 2011, Teva submitted SNDA for drug as OTC without age or point-of-sale restriction.
FDA Commissioner approved SNDA to eliminate age restriction in 2011; overturned by secretary of DHHS
The FDA again denied the Citizen Petition leading to another Tummino decision in 2013 where the court reversed the FDA’s decision and ordered the FDA to make Plan B OTC without restrictions.
The FDA ultimately declined to appeal and approved Plan B One-Step as an OTC drug without restriction.
Conscientious objection
- an RPh can refuse to give medication if it goes against their ethical beliefs
Refers to whether a pharmacist has a right to refuse to dispense prescriptions when a moral or religious objection exists
States have passed laws or regulations addressing this issue.
Courts have held that a pharmacist cannot obstruct a patient’s legal right to receive medications. State regulations requiring pharmacists to dispense except in certain situations have been upheld.
Collaborative practice agreement
- RPh & MD agree to collaborate together
Authority granted to pharmacists in most states
Authority to dispense
MD- under certain cases if the state allows
RPh- most of the time
Depends on state law
The FDA does not believe D-H dispensing standards apply to prescribers; however, most states regulate prescriber dispensing in some manner.
Medications may only be dispensed by a physician, pharmacist, or registered nurse. The act of administering medication involves giving the client a single dose of prescribed medication. All personnel who are licensed to do so may administer medications.
Package insert
includes details and directions that health care providers need to prescribe a drug properly, including approved uses for the drug, contraindications, potential adverse reactions, available formulations and dosage, and how to administer the drug.
Patient package insert
- both must be included as a black box warning and or pregnancy warning in the package to be given
Although the FDA originally had wanted PPIs required for most drugs, it applies to very few, including estrogen-containing drugs, DES, and oral contraceptives.
Duty of manufacturers and pharmacists to distribute to patients
Law applies to institutional pharmacy as well as community.
Medication guide
- can be given with the package to educate ultimate user on how to take medication
Required for drugs FDA has determined as posing “serious and significant concerns”
Required for new and refill prescriptions
Generally required for outpatients not under direct supervision of healthcare professional with some exceptions
Content of MedGuide must be approved by FDA
Every new MedGuide approved since 2007 has been in conjunction with a REMS.
FDA proposing a single page information document
Information sheet
- like a med. guide, should be included with the package in order to educate patient on what they are taking
REMS- risk evaluation mitigation: risk vs benefit of
The FDAAA granted the FDA authority to require REMS as a condition for approval of an NDA or postmarket when the FDA believes it necessary to ensure benefits outweigh risks.
Under REMS authority, the FDA can require a variety of procedures ranging from Medication Guides to limiting the drug to specified settings for dispensing.
DRUG INFORMATION ROUNDS- FDA
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Approved Drugs for Off Label Indications
Quetiapine (Seroquel) for Insomnia. …
Drug products commonly prescribed for off-label uses
Off-label prescribing and dispensing is legal under FDCA.
Off-label prescribing and dispensing requires professional evaluation of risk vs. benefit.
Courts generally regard labeling as evidence toward the standard of care and not as prima facie establishing the standard of care.
FDAMA 503A
applies to human drug compounding by a licensed pharmacist within a state-licensed pharmacy or federal facility, or by a licensed physician, that is not registered with FDA as an outsourcing facility. Section 503B applies to human drug compounding within an outsourcing facility.
New Drug
not recognized in the pharmacopeia
DQSA
- a nation wide security system that is used to monitor how drugs are being used for medicinal purposes
Compliance Guides
- given like a med. guide or package insert
Other Compounding issues
USP Compounding Requirements: 503, 797, 795
503:
- compounds to accommodate patient-specific prescriptions and is required by the state boards of pharmacy to comply with USP 797 Guidelines. 503A pharmacies are not permitted to distribute for office use, nor are they permitted to compound large batches of product.
797:
- sterile compounds
795
- nonsterile compounds
Patent Issue
Orange Book and Generic Substitution
A. State Substitution Laws
B. 503A: where RPh can compound ???
C. Orange Book ????
- A_
- B_
- Range 80-125
- Authorized generic
State generic substitution laws
- Every state permits pharmacists to substitute generically in some manner.
- State laws differ considerably.
- Labeling must accurately differentiate generic products from brands.
503A
FDAMA (Section503A) 1997
- Defined compounding and delineated nine activities that might cross the line from compounding to manufacturing; added other requirements regarding compounding
- Stripped FDA of authority to consider compounded drugs as “new drugs”
NTI- narrow therapeutic index drugs
Examples
FDA Stance
Drugs with less than a two-fold difference between the median lethal dose and median effective dose or a two-fold difference between minimum toxic concentrations and minimum effective concentrations
Controversy exists as to whether the FDA’s statistical parameters for bioequivalence are accurate enough for certain NTI drugs; the FDA drafted new guidelines.
Pharmacists should exercise particular professional judgment when called upon to substitute B-rated NTI drugs.
PDMA
Drug Samples
Registration of wholesalers
PDMA generally prohibits reimportation of Rx drugs
Drug Chain Security
Importation of Prescription Drugs for Personal Use
PDMA generally prohibits reimportation of Rx drugs
Many stakeholders wish to obtain Rx drugs from Canada and other countries because of lower costs.
The FDA has instituted a “compassionate use policy.”
The CSA also allows for limited personal importation.
The MMA allows wholesale importation of Rx medications from Canada, provided the secretary of DHHS would approve.
The Homeland Security Act permits limited personal importation from Canada.
The FDA will enforce the no importation law against businesses (Rx Depot case).
FDA Inspections
can be done at any time during business hours
Can be required even whiteout probable cause if the inspector has an AIW
The FDA can inspect a pharmacy to determine if the pharmacy is compounding or manufacturing.
It can extend the search if probable cause exists that the pharmacy is manufacturing.
The FDA may search without a warrant.
Use of alcohol in pharmacy
Tax Free- can be used in hospital
Tax paid- can be found in the pharmacy
Can use both in the pharmacy
Tax-paid alcohol
- Used in compounding in community pharmacies
- Obtainable from outlets that sell liquor at retail
Tax-free alcohol (190 proof ethyl alcohol)
- Available to hospitals for medicinal, mechanical, and scientific purposes and in the treatment of patients. May be used only for inpatients.
- Charity clinics may use medicines for outpatients if they do not charge.
Poison Prevention Packaging Act
used to prevent accidental child poisoning of a household drug
Household Substances-
Exceptions:
- Drug requires it
- patient requests it
- MD requests it
- Institutionalized patients
- OTC-labeled requires it
- Certain drug products such as SL nitroglycerin and SL and chewable isosorbide dinitrate
- For manufacturer: may market one size in a noncompliant package with the appropriate statement
Intent of act to protect children from accidental poisonings due to “household substances”
Administered by the Consumer Product Safety Commission
The law establishes the standards for child-resistant containers.
Container may not be reused unless glass or threaded plastic and then only with new closure.
Drug Advertising
- done to promote drugs on the market
Price advertising
- Considered reminder advertising and thus exempt from Section502(n), provided that certain conditions are met
Product advertising
- Subject to strict liability standard
Closed System
described the CS regulatory system of the U.S
Highly regulated and kept on tight security in the U.S
Schedules
used to organize drugs of abuse by their potential to be abused
I-V
I has no medical reason to be used
Placement into one of five schedules depending on abuse potential and degree to which drug may cause physical or psychological dependence
Examples of schedules
I- LSD, Ecstasy, heroin, methaqualone, unapproved GHB
II- Hydrocodone, cocaine, amphetamine, methamphetamine, amobarbital, glutethimide, secobarbital, and pentobarbital
III- anabolic steroids, dronabinol, ketamine, paregoric, and GHB approved by the FDA
IV- dextropropoxyphene; alprazolam, chloral hydrate, barbital, benzodiazepines; diethylpropion, phentermine; tramadol
V- Includes antitussives containing codeine and antidiarrheals, lyrica
Authority to schedule
attorney general
must request a scientific and medical evaluation of the drug and recommendation from the secretary of DHHS
Manufacturing label & packaging
Labels and labeling of commercial containers of controlled substances must contain the identification symbol of the schedule.
The symbol must be prominently located.
- both need to include the schedule of abuse sticker and what schedule it is
Adequate directions
Dose and dosage form
Registration
Who needs to be registered all of these people need to be registered except
- Manufacturer
- Distributor
- Dispenser
- Conducting research
Prescriber- no they do not
What about the ultimate user- no they do not
Anyone who manufactures, distributes, or dispenses controlled substances (among others) must register with the DEA.
Manufacturers and distributors must register annually; dispensers must register every 3 years.
Exemptions from registration include agents or employees of registrants, common carriers, ultimate users, prescribers, and dispensers in the service of the U.S. government, and law enforcement officers.
Separate Registration
for distributors that are handling CSs
Each principal place of business where CSs are administered, dispensed, or stored requires separate registration.
Application for Registration
224- use this to register as a distributor/ as a pharmacy
May not engage in activity where registration is required until registration is granted and certificate of registration issued
Current registrants should receive a registration form approximately 65 days before expiration. A second notice will be sent electronically if required.
The dispenser registration form is DEA Form 224, which is available online.
Transfer vs termination of registration
if a person ceases legal existence (whether by death or retirement) they need to contact the DEA and they will terminate the person’s name in the system
Transfer: *Any modifications must be approved by the DEA.
*If registrant dies or ceases legal existence, the DEA must be notified, and the registration terminated.
*Registrations cannot be assigned or terminated without DEA approval.
*If the registrant wishes to transfer business, a proposal must be submitted to the DEA at least 14 days prior to the transfer with required information.
Security requirements
Safe/Vault
Alarm
all of these need to be implemented so that a CS is kept safe away from the public
Intersperse the CS through the other meds or keep it in a locked vault so that a robber cannot do a clean sweep
All applicants and registrants must provide effective controls and procedures to guard against theft and diversion.
The DEA considers several factors when evaluating the overall security system of a registrant or applicant.
Individual practitioners must securely lock CSs in a substantially constructed cabinet.
Pharmacies and institutional practitioners may do the same or disperse them throughout the stock of noncontrolled substances.
May not employ any person whose application for registration has been denied or revoked
Penalties
Negligent record keeping
- prescribers and practitioners will be fined for the penalty of not. complying to record-keeping mandates
Section841 establishes penalties for drug traffickers and applies to practitioners who prescribe and/or dispense outside of the ordinary course of professional practice.
Section842 establishes penalties for practitioners for not conforming to the requirements of the CSA, such as recordkeeping.
The standard was changed from strict liability to negligence.
Form 222 violations are subject to fines of up to tens of thousands of dollars and up to four years in prison.
Knowingly or intentionally possessing a CS other than by a valid Rx could result in up to one year in prison and a fine of up to $1,000.
The purpose of the law is to make it a federal crime if robbery results in $500 or greater replacement cost of CSs, or a person suffers “significant” injury or interstate commerce is involved in the planning or execution of the crime.
Penalties can result in up to 20 years of imprisonment, $25,000 fine, or both. If a weapon is used, the penalties are higher. If death results, the penalty is higher yet.
Pharmacy Inspection
4th amendment protects against being searched or no good reason
No deny an inspection so far as they only have a search warrant but if they have an AIW, you cannot deny it, especially during business hours
Constitutional issues
- The Fourth Amendment protects individuals from unreasonable searches and seizures.
- Requires the issuance of a search warrant based on probable cause
- The exclusionary rule provides that any evidence obtained in violations of the Fourth Amendment will not be admissible.
Search Warrant
can be denied by a pharmacy if the PIC wants to
Consent required
AIW
Valid Public Interest
cannot deny inspection of someone with this
Against probable cause
In the interest of the public
4
Constitutional rights
4
OTP- opioid treatment programs
DATA- can do narcotic treatment programs through office and use Subutex/suboxone
Methadone- can be used as a treatment for this
Subutex/Suboxone
DEA Numbers- needed for someone to do an OTP,
Qualified Physician- can do OTP
What about mid level practitioners- yes they can do it too
Controlled Substance Registrant Protection Act
protects ultimate users that have a CS
- if they lose more than $500 of CS and or significantly hurt, then charges pressed against the person who committed the crime
Chemical Diversion and Trafficking Act
imposes criminal liability on any person who knowingly or intentionally imports or exports a listed chemical, or reasonably believes that a listed chemical will be used to produce illegal drugs.
Anabolic Steroid Act
cannot be given for any athletic performance at all
Example: testosterone
Combat Meth Act- removed OTC drugs that could be used to create meth.
Daily: can only get 3.6g of pseudoephedrine a day
Monthly- 9 g a month, 7.5 g a month for mail orders. 3.6 g = 3600 mg, 3600mg/30 days = 120 tablets a month
Record-Keeping Requirements- need to keep record of
Self Certification- need to provide ID so that you can the drug
Mailing of Prescriptions
can be done otherwise there would be no mail order!
the mail package needs to be within compliance of US postal laws
Must be sealed and individually labeled
cannot reveal that there are drugs inside
Prescription
given for legitimate medical reason
Prescriber has valid DEA #
Prescribe
(of a medical practitioner) advise and authorize the use of (a medicine or treatment) for someone, especially in writing.
DEA #
specific to prescriber
IPs can start with A but now B or F
Mid level start with M — PAs, NPs and also pharmacists if they can
Issue of Rx
for valid reason
Correcting Written prescription
can be done by an RPh as long as they do not change anything about patient, prescriber or the medication except if it is a change from brand to generic
Purpose of Rx
- for legitimate medical reason
Corresponding Responsibility
- on the RPh and prescriber that the Rx is for the right reason and written according to the FDA policy
Pain
can give CS for pain
Pain is a legitimate medical reason that a CS can be given
CII Rules
oral
written
fax
emergency
Oral- can be given that way under emergency situations
Written- can be given that way
Fax- can be given that way
Emergency
For prescriber
need the CS for immediate treatment
No other medication option even amongst other CS
Cannot give written Rx prior to dispensing
For RPh
give the exact amount of the medication for treatment, no more or less
Rx complies with the law except without a signature
Made a good-faith effort tp verify the Rx
Refills & fills
cannot be done without valid Rx
established by the D-H amendment
no refills for CII but refills for Schedule III and IV controlled substances cannot be filled or refilled more than 5 times or more than 6 months after the date the prescription, V & VI rules are silent
In regard to a controlled substance in Schedule II or III, no prescription shall be filled for more than a thirty–day supply of such substance upon any single filling; provided, however, that with regard to dextro amphetamine sulphate and methyl phenidate hydrochloride, a prescription may be filled for up to 60
provided further, that subject to regulations of the department and the board of pharmacy, prescriptions for implantable infusion pumps consisting of Schedule II or Schedule III controlled substances may be filled for a maximum of 90 days.
Partial Fill- both under 2016 CARA Law
Retail- can be done within 30 days of the original Rx
LTC- can be done within 60 days of the Rx
Can be done within emergencies
Unable to supply refills if
if not over 18, do not provide valid ID, gives false Rx
Rx of Multiple CII
needs to be written on separate sheets of papers, directions on the Rx, not in different color ink
refills for CIII, IV and V
III and IV - can be refilled:
Refills 5
6 months
V do not apply to 5 monthly refills and 6 month expiration
Oral - can be given
Fax - can be given
Written - can be given
Label - needs to include
Partial fill- does it not match the regular guidelines below?
II, III, IV, V- put these stickers as part of the label to indicate the schedule
Pharmacy name and address
Serial Number
Name of patient
Name of drug
Directions for use and cautions
Aux Sticker II, III, and IV NOT V
E-prescribing
Can be done
Transfer of III, IV and V- can be transferred, CII cannot because there are no refills
Process in
Process out
Central Fill
one pharmacy processes, and one fills
They are both under contract agreement to have this relationship
Internet Pharmacy
can be done for any drug
Under the Ryan Haight act, needs to be for a legitimate reason
PDMP- prescription drug monitoring program
every state has one
Purpose is to monitor the distribution of drugs through the U.S for state to determine possible diversions
LTC
Record keeping
Non-RX V- 279
Distribution
Time
Inventory requirements
- Initial- of RPh
- Biennial- every 2 years
- Exact count II and bottles greater than 1000
Best practice exact count of all
Non-RX V- 279
Only by RPh
Book
Distribution
- 5% RULE
- If a distribute gives more than 5% of the total CSs dispensed throughout the year, then they will have to register as a pharmacy
222: Dispense
224: register as a pharmacy
41: dispose
106: report theft or loss
forms
41- use to dispose and or destroy a CII
106- use to report loss or theft of CII within 1 day of discovering this situation
222- used to dispense and distribute CII
224 - application for registration
222
222- use to dispense and distribute CII
Copy 1
Copy 2
Copy 3
Partial fill 222
CSOS- can be used instead of 222
Lost
Stolen
Power of Attorney
someone other than registrant to sign a 222
verify DEA #
Add together the first, third, and fifth digits.
Add together the second, fourth, and sixth digits. Multiply the sum by 2.
Add together the totals from Step 1 and Step 2.
Verify that the last digit of the result of Step 3
matches the check digit of the DEA number.
