last thing for law lol- study guide Flashcards
Prescribe
- IPs need DEA and are authorized by state or exempt
- delegation of prescriptive authority
- those allowed to dispense CSs: RPh or pharmacist employed by registered pharmacy or institutional practioner
- Ancillary and IPs can dispense if their state allows
- Rx can only be given by IP who is authorized to by the state, is registered or exempt from registration under 21 CFR 1306.03
prescription
- medication order for ultimate user
- Rx does not include orders for medication dispensed for immediate administration (like hospital charts)
-prohibition for Rx for office use
DEA #
–Nine digits composed of letters and numbers
two alphabet letters followed by seven numbers
–Initially, the registration number started with the letter A.
All registration numbers starting with A have been assigned
DEA started with B now F, started G (?)
- Mid-level practitioners (and pharmacists) begin with M.
- Distributors begin with either P or R
- The second letter is usually, but not always, the first letter of the registrant’s last name
- The next six positions are a computer-generated number unique to the registrant
- The last and 9th position is a computer-calculated
To check the validity of a DEA registration number:
an RPh
–adds the first, third, and fifth digits
–adds the sum of the second, fourth, and sixth digits, multiplied by 2, to the first sum
–determines whether the rightmost digit of this sum corresponds with the ninth check digit
Disclaimer
– In reality, many forgers are familiar with the procedure to verify a DEA registration number and can invent a number that would be plausible.
–Therefore, pharmacists cannot rely solely on this check to determine the validity of a controlled substance prescription.
Issue of Rx
–Date of issuance required: no predating or postdating
– name and address of patient
–drug name
– drug strength
–dosage form
–quantity prescribed
–directions for use
–name, address, and registration number of practitioner & DEA #
–Before filing, must contain the written or typed name or initials of a dispensing pharmacist, the date dispensed, and the units or volume dispensed
– everything in permanent ink
–Corresponding responsibility of pharmacist and prescriber that a CS Rx complies with all requirements
correcting written Rx
For C-III, C-IV, and C-V Rxs:
– The pharmacist may add or change any information after consultation with the practitioner
cannot change:
- patient’s name
- name of CS (except generic substitution)
- prescriber’s signature
For C-II Rxs:
- corrections can be made if state law or policy permits.
Purpose of CS Prescription
- for a legitimate medical purpose in the usual course of professional practice.
- Corresponding responsibility upon the pharmacist
- Knowingly prescribing or dispensing a CS Rx not for a legitimate medical purpose violates the law.
- When suspicious a pharmacist should investigate.
- Legitimate medical purpose: acting in accordance with accepted standards of medical practice.
Examples of invalid prescriptions include:
- Narcotic Rxs for the purpose of maintaining or detoxifying an addict
- Rxs written for fictitious patients
- Rxs written without a good-faith medical examination
- Rxs written when there is no medical reason
- A facially valid Rx is not necessarily a valid Rx.
- Pharmacists will more likely face enforcement action in situations where there is blatant or glaring misconduct as opposed to isolated prescriptions.
CII Rules
Oral
Written
Fax
Emergency
Refills
Partial Fill
Retail
LTC
Unable to supply (?)
Multiple CII
Oral: can be given in emergency situations
Written: written and signed by a prescriber
Fax: faxed RPh serves as original for narcotic infusion, LTCFs, Hospice patients
Emergency: dispensed upon oral order
- immediate administration of CII is necessary for the proper treatment of the intended ultimate user;
- no alternative treatment is available, including administration of other CSs
- not possible for the prescriber to give a written Rx prior to the dispensing.
Refills: no refills without a new Rx
Partial Fill:
—- Retail:
- 2016 CARA Law permits that there can be a partial refill within 30 days of the Rx
- CARA also allows partial refills upon emergency Rx
LTC:
- can be given up to 60 days from the date of issuance if the record is kept
Unable to supply (?)
Multiple CII:
- Each Rx must be on a separate blank.
- The total quantity prescribed does not exceed 90-day supply.
- The practitioner determines a legitimate medical purpose to do this.
- The practitioner writes instructions on each Rx
- Multiple Rxs do not create undue risk of diversion.
- Permissible under state law
CIII, IV and V
III and IV
Refills 5
6 months
V do not apply to 5 monthly refills and 6-month expiration
Oral
Fax
Written
Refills
CIII, IV, and V
III and IV
–Refills 5
– 6 months
can get up to 5 refills within 6 months of the original Rx
- V does not apply to 5 refills and 6-month expiration
- refills cannot exceed the quantity originally authorized
Oral:
- for III & IV the practitioner may orally authorize additional refills if the original was written for less than five and authorization is recorded on hard copy or in an automated system.
Fax:
Written
–May be dispensed pursuant to written, faxed (considered original), electronic, or oral order (need to be reduced to writing)
look above for Refills
Label
Partial fill
II, III, IV, V
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
Partial fill
allowed if
- recorded in the same manner as the refill
- The total quantity dispensed does not exceed the total prescribed.
- No dispensing after 6 months from the date of issuance
must have:
II, III, IV, V
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
- The label must include the date of filling if a C-II drug
- date of initial filling if in another schedule.
- Refills should be labeled with both the date of initial filing and the date of dispensing.
- Labels must cautionary statement prohibiting the ultimate user from transferring the drug.
- Labeling requirements are not applicable if prescribed for administration to an institutionalized patient, provided that restrictions and requirements are met.
E-prescribing
prescriber requirements
pharmacy requirements
Prescribers must:
- Undergo identity proofing
- Digitally sign using two of three possible factors for authentication
- An agent can enter Rx information but cannot have access to authentication factors and sign.
Pharmacy requirements:
- The pharmacy or ASP must digitally sign,
- The pharmacy must archive the Rx.
- If Rx transmission fails, the regulation establishes that certain requirements must be followed.
- May make changes to Rx after receipt
- Must back up daily and keep records for two years
- All application systems must be approved by a third-party audit or certified by a DEA-approved entity.
Transfer of III, IV and V
CIII
- You cannot transfer a CII because they do not have refills
- CIII-V can be transferred once if state law allows and requirements are followed by both pharmacies
- Rx information sharing among pharmacies participating in common-electronic record systems is not subject to the transfer Rx requirements
Central Fill
- Pharmacies that fill Rxs for other retail pharmacies pursuant to a contractual arrangement
- May fill both new and refill Rxs
- Any Rx dispensed for another pharmacy must be transported to that pharmacy for furnishing to the patient.
- The label must indicate which pharmacy the drug was dispensed.
- Cannot accept Rxs directly from patients or practitioners or deliver Rx directly to patients or practitioners
- Corresponding responsibility doctrine applies to pharmacists at both facilities.
Internet Prescriptions
- Rogue internet pharmacy businesses are those that sell Rx medications to customers either without requiring Rxs or by issuing Rxs pursuant to online surveys.
- The Ryan Haight Act law valid Rx: issued for a legitimate medical purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient - online pharmacies must comply
- Although the act only applies to CS Rxs, most states consider any Rx not dispensed pursuant to a legitimate physician–patient relationship as invalid.
PDMP- State Electronic Drug Rx Monitoring Programs
- All states have a PDMP.
- Requires a pharmacy to electronically state a record of the CS Rx dispensed.
- Enables states to determine possible diversion and abuse situations
- Most PMPs allow or mandate practitioners to request patient-specific information.
- Many states share data between PDMPs.
Long-Term Care (LTC) Pharmacy
- Not registered with DEA
- DEA is concerned about excess supplies of CSs and so permits automated dispensing systems, partial filling, and voluntary collection receptacles by registered “collectors”
Record keeping
Time
Inventory requirements
Initial
Biennial
Exact count II and bottles greater than 1000
Best practice exact count of all
- Every registrant must keep a complete and accurate record of all CSs.
- Three types of records are involved:
Inventory
Drugs received
Drugs dispersed
Negligent recordkeeping is a violation of the CSA.
Time: every 2 years
Inventory requirements
Initial and Biennial - Prior to beginning business and subsequently every two years, an inventory must be conducted containing a complete and accurate record of all CSs “on hand” (in possession of or under the control of the registrant)
- Inventory may be taken at the beginning or end of the business day; records must be written, typed, or printed.
- Newly scheduled drugs must be inventoried on the date of scheduling.
- The exact count must be made of C-I or C-II drugs.
- The estimated count is permissible for other schedules unless the container holds more than 1,000 units.
Non-RX V- 279
Distributions from a Pharmacy to Another Practitioner
5% rule
The total number of dosage units distributed to another registrant must not exceed 5% of total units of CSs distributed and dispensed in one year.
Forms
41
222
106
41: disposal & destruction of CII from ultimate users and LTFCs
222: distributing CII
106: reporting a theft or loss of CII, notify DEA within 1 day of discovery of theft or loss
form 222
Copy 1
Copy 2
Copy 3
Partial fill 222 (?)
CSOS
Lost
Stolen
Each form is in triplicate titled Copy 1, Copy 2, Copy 3. just have 1 form now
Electronic CSOS can be used instead of 222, The purchaser can order any drug, The registrant must obtain a digital certificate for each DEA-registered location.
Power of Attorney (POA)
Required to allow person other than one who signed registration to execute Form 222
Lost or Stolen Forms
- the purchaser must execute another together with a statement noting the serial number of the lost form, the date of the lost form, and that the CSs were not received.
- Must maintain together Copy 3 of the second order form and lost order form with a statement
- The copy of the statement must be sent with Copies 1 and 2 to the supplier.
- If forms are stolen or lost other than in transmission, must notify DEA and provide serial #s of missing forms; if found, DEA must be notified immediately
Closed System
allows for controlled substances to be traced from initial manufacture to final dispensing to the patient.
created by federal controlled substance act
Schedules
Placement into one of five schedules depending on abuse potential and degree to which drug may cause physical or psychological dependence
Examples of CS
CI: hallucinogenics, some opiates, methaqualone, and unapproved GHB
CII: opium and many other opiates (including products containing hydrocodone); cocaine; stimulants such as amphetamine and methamphetamine; depressants such as amobarbital, glutethimide, secobarbital, and pentobarbital
CIII: stimulants, anabolic steroids, dronabinol, ketamine, paregoric, and GHB approved by the FDA
CIV: dextropropoxyphene; depressants such as alprazolam, chloral hydrate, barbital, benzodiazepines; stimulants such as diethylpropion, phentermine; tramadol
CV: antitussives containing codeine and antidiarrheals containing an opiate
Authority to schedule
- in the attorney general who requests a scientific and medical evaluation of the drug and recommendation from the secretary of DHHS
- The recommendation of the secretary regarding scientific and medical issues is binding on AG, except when AG finds the drug must be placed in C-I to avoid an imminent hazard to public safety.
Manufacturer Labeling and Packaging
- Labels and labeling of commercial containers of controlled substances must contain the identification symbol of the schedule.
- The symbol must be prominently located.
Registration
Who needs to be registered
who is exempt
- Manufacturer - register annually
- Distributor - register annually
- Dispenser - register every 3 years
- reverse distributing
- conducting research
- conducting narcotic treatment programs
- conducting chemical analysis
- importing
- exporting
exemptions:
- agents or employees of registrants
- common carriers
- ultimate users
- prescribers
- dispensers in the service of the U.S. government
- law enforcement officers
separate registration
Each principal place of business where CSs are administered, dispensed, or stored requires a separate registration.
Application for Registration
what form do you use
- register before participating in an activity requiring registration
- 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 (used to register with the DEA), which is available online.
Transfer vs termination of registration
- Any modifications must be approved by the DEA.
- If the registrant dies or ceases legal existence, the DEA must be notified, and the registration is terminated.
- Registrations cannot be assigned or terminated without DEA approval.
Security requirements
Store CSs in a locked cabinet
Intersperse them throughout the other drugs to prevent a quick sweep
penalties for practitioners
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.
Pharmacy Inspection
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.
Administrative Inspection Warrant (AIW)
- No consent required
- Probable cause requirement
- Valid public interest
- Contrast to probable cause for search warrant (SW, which requires probable cause that you are doing something illegal)
- AIW created by Supreme Court as alternative to SW
- AIW may only be served during regular business hours.
Opioid Treatment Programs (OTPs)v
- Congress first authorized narcotic treatment programs (now OTPs) in 1974.
- Only LAAM, methadone (CII- a retail pharmacy can hold this for severe pain, cannot use for cough), buprenorphine, and buprenorphine containing products are authorized drugs for treatment of opioid addiction.
- Practitioners wanting to conduct maintenance or detox treatment must be registered by the DEA.
methadone:
- Used for severe pain outside of narcotic treatment programs
- Not legal to prescribe or dispense as an antitussive
- The APhA lawsuit established that the FDA could not restrict the distribution of methadone.
- Manufacturers voluntarily restricted 40 mg methadone tablets to OTPs. So, retail pharmacist usually have 5 or 10mgs
DATA
- Enacted in 2000 with the intent of allowing addicts to be treated for addiction in office-based settings (outside of OTPs)
The only permitted drugs are buprenorphine SL (Subutex) and buprenorphine-naloxone (Suboxone) tablets.
- Treatment must be by a “qualifying physician.”
- The qualifying physician may apply to treat up to 275 patients and must obtain a special DEA number (“X”).
- A recent amendment now allows mid-level prescribers to prescribe under DATA if state law allows.
Controlled Substance Registrant Protection Act
- a federal crime if robbery results in $500 or greater replacement cost of CSs, or 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.
Chemical Diversion and Trafficking Act
regulate precursor chemicals, essential chemicals, tableting machines, and encapsulating machines by imposing record-keeping and import/export reporting requirements on transactions involving these materials.
Anabolic Steroids (CIII) Act of 2004
- Amends prior anabolic steroid (Testosterone etc) legislation enacted to prevent misuse in order to enhance athletic performance
- Maintains anabolic steroids as schedule III
- Adds several steroids to the act
- Provides for automatic scheduling of certain salts, esters, and ethers of anabolic steroids without the need to prove muscle growth
- Physicians and prescribers cannot give for athletic performance
Combat Meth Act
know the math for pseudoephedrine!
- Places restrictions on OTC drugs used to manufacture methamphetamine including pseudoephedrine
- The law limits sale to no more than 3.6 g of ephedrine, PSE, or PPA base to a single purchaser per day.
- No consumer may purchase more than 9 g within a 30-day period or 7.5 g within a 30-day period by mail order.
- The products must be stored behind the counter or in a locked cabinet where customers do not have direct access.
- Sales must be recorded with required information.
Limits pseudoephedrine age: no age requirement, each employee undergoes training that is certified to attorney general
pseudoephedrine is 30mgs
Know basic info: 3.6g per day
3.6 grams is 3600 mg
3600/30mg is 120 tablets
Ask about pseudoephedrine base not hydrochloride or sulfate
US Postal Laws
CSs may be mailed, provided they meet the packaging standards established by the U.S. Postal Service.
Can you mail drugs: yes
Can mail CII-CV drug
If you were not able to mail, there would be thing as mail order pharmacy
Lable must not say that there are drugs inside
FDCA
Federal Food, Drug, and Cosmetic Act (FDCA) is a set of United States (US) laws that authorize the Food and Drug Administration (FDA) to oversee and regulate the production, sale, and distribution of food, drugs, medical devices, and cosmetics.
Durham Humphrey
explicitly defined two specific categories for medications, legend (prescription) and over-the-counter (OTC), oral refills
Food additive
manufacturers to provide safety assessments for all new food additives.
Color Additive
brought all colors, natural and synthetic, under the Food, Drug, and Cosmetic Act. Color additives may not be used to deceive consumers or to conceal blemishes or inferiorities in food products.
Kefauver Harris
required that manufacturers prove the effectiveness of drug products before they go on the market, and afterwards report any serious side effects. required that evidence of effectiveness be based on adequate and well-controlled clinical studies conducted by qualified experts.
Medical Device
consolidated and expanded ex- isting Federal authority over medical devices into a system of regulating the safety and effectiveness of medical devices in proportion to the degree of risk that they pose.
Orphan Drug Act
a law passed by Congress in 1983 that incentivizes the development of drugs to treat rare diseases
PDMA - Prescription Drug Marketing Act of 1987
1) to ensure that drug products purchased by consumers are safe and effective,
(2) to avoid the unacceptable risk to American consumers from counterfeit, adulterated, misbranded, subpotent, or expired drugs.
Safe Medical Device Act
provided FDA with two additional postmarketing activities, Postmarket Surveillance for the monitoring of products after their clearance to market and Device Tracking for maintaining traceability of certain devices to the user level.
Generic Drug Enforcement Act
enacted response to what Congress concluded was a corrupt approval process for generic drugs through abbreviated new drug applications (ANDAs).
an Act to Promote, Require and Ensure the Production of an Adequate Supply, Distribution, Use and Acceptance of Drugs and Medicines Identified by their Generic Names.
PDUFA
Prescription Drug User Fee Act (PDUFA)
created by Congress in 1992
authorizes the FDA to collect user fees from persons who submit specific human drug applications for review or who are named in approved applications as the sponsor of certain prescription drug products.
FD Administration Modernization Act
modifies the mission of the FDA to include a goal of speeding research, innovation and access to care. The legislation allows fast track review for the most important drugs.
Drug Quality and Security Act
outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States.
Food and Drug Administration Amendment Act
reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA
Food and Drug Administration Safety and Innovation Act
gives FDA new authorities to help ensure the safety, effectiveness and quality of drugs in the United States
ACA
“Affordable Care Act” (ACA) is the name for the comprehensive health care reform law (passed in 2010) and its amendments. The law addresses health insurance coverage, health care costs, and preventive care.
FDA
Overview
Drug
Device
Cosmetic
Food
Combination Product
Food Vs Drug vs supplement
Overview: Housed under the Department of Health and Human Services (DHHS), Authority for administering the FDCA, FDA secretary appointed by president with confirmation of Senate
Drug:
- Articles recognized in the USP or homeopathic pharmacopeia
- Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease (Part B)
- Articles other than food intended to affect the structure or function of the body (Part C)
- The definition is intentionally broad to include almost anything with an intended therapeutic purpose or purpose of altering the structure or function of the body
Device:
- excludes articles that achieve their purpose through chemical action and metabolism.
- Whether a device containing drugs is a drug or device is dependent on various factors.
Cosmetic:
- 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.
Food
- broad definition
Food vs. drug vs. supplement:
- Created a new special category of food called “dietary supplements” (DSs)
- DSs do not require premarket approval
- DS defined as a vitamin, mineral, herb, or other botanical, amino acid, or substance used to supplement the diet by increasing total dietary intake
Label
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 labeling, 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.
Approved Drug as a new drug
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
Informed consent required in all three phases
Research subjects required to know risks, possible benefits, and alternative courses of treatment
Institutional Review Board (IRB) approval required in some settings
new drug definition
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.
FDA rating
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.
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.
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)
Statutorily created the ANDA, expediting generic approval
Concessions to innovator drug companies included:
Patent extensions
Market exclusivity
OTC review
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
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 biosimiliar and interchangeable biological products.
Medwatch
- 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.
Biosimilars
biologic medical product that is almost an identical copy of an original product that is manufactured by a different company.
Drug Advertising and Promotion
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.
Prescription Drug Advertising: Manufacturer to Professionals
Section502(n) requires all advertisements to contain “true statement” and “brief summary.”
Reminder advertising is exempt.
True statement is not met if advertising is false or misleading, does not present a fair balance, and fails to reveal material facts.
Advertising includes ads in journals and other periodicals, broadcast media, and telephone communications.
Brochures, booklets, mailings, bulletins, calendars, and other information distributed to healthcare professionals by a manufacturer is labeling.
Prescription Drug Advertising: Manufacturer to Professionals(1 of 2)
Journal advertising
- Actively scrutinized by the FDA after early studies showed considerable violation
Industry-supported educational programs
Concerns that programs are independent and objective
Factors distinguishing independent from promotional
programs published in guidance document
The court decision requires that the guidance document be used as a “safe harbor.”
PhRMA has published self-policing guidelines.
Prescription Drug Advertising: Manufacturer to Professionals(2 of 2)
Physician Payment Sunshine Act
FDA Bad Ad Program
Prescription Drug Advertising: Manufacturer to Consumer (DTC)(1 of 2)
Significant congressional and public controversy
No specific laws and regulations, thus Section502(n) applies
Because compliance with Section502(n) is impractical, FDA allows manufacturers to apply the “adequate provision” requirement.
The consumer must be offered full labeling information from one or all of four sources.
Prescription Drug Advertising: Manufacturer to Consumer (DTC) (2 of 2)
For DTC print advertising, FDA encourages manufacturers to present key risk information in user-friendly ways.
Reminder and help-seeking ads are exempt from requirements.
The GAO report noted FDA weaknesses in regulating DTC ads.
The FDAAA has provided FDA with authority to require prereview of ads.
sunshine act
requires manufacturers of drugs, medical devices, and biologicals that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals.
off label
the practice of prescribing a drug for a different purpose than what the FDA approved
lanham trademark
Prohibits use of any false description or representation
Allows for private cause of action and recovery of monetary damages
Durham-Humphrey Amendment(1 of 2)
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.
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
State standardization of Rx Label
Patient package inserts (PPIs)
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.
Switching Prescription Drugs to OTC
what are the 3 methods
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 Drugs/Behind-the-Counter/Nonprescription Under Conditions of Safe Use
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 of the FDA appears to be shifting
Prescription refill authorization
Prescriptive authority
Emergency contraception
Conscientious objection
Collaborative practice agreement
Authority to dispense
Prescription refill authorization
- Distinguish authorization of refill from transmittal authority
Prescriptive authority
- 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:
- Citizen Petition in 2001 requesting switch to OTC status without age restriction followed by SNDA requesting the same in 2003
- Plan B approved in 1999 as Rx only
- 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
Collaborative practice agreement
- Authority granted to pharmacists in most states
Authority to dispense
- 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.
Package insert
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
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”
Orange Book and Generic Substitution
State generic substitution laws
Every state permits pharmacists to substitute generically in some manner.
State laws differ considerably.
Labeling must accurately differentiate generic product from brand.
Evaluates pharmaceutically equivalent products on the basis of bioequivalence
Pharmaceutical equivalence—products contain same active ingredients and are identical in strength and dosage form
Bioequivalent pharmaceutical equivalents are generally presumed therapeutically equivalent—having the same clinical safety and efficacy.
The Orange Book uses a two-letter rating system; some products use two letters and a number.
Pharmacists must comply with state law when substituting and exercise professional judgment substituting B-rated products.
Narrow Therapeutic Index (NTI) Drugs
Drugs with less than a two-fold difference between median lethal dose and median effective dose or 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.
Pedigrees Under PDMA
The FDA granted authority to require secondary wholesalers to maintain pedigrees of drugs.
The 1999 regulation to implement was enjoined on the grounds it would likely cause irreparable harm to secondary wholesalers and violate the equal protection clause.
The FDAAA in 2007 mandated that the FDA develop track and trace standards and SNIs, but fell short of developing a true federal pedigree program until the DSCSA of 2013.
Drug Supply Chain Security Act(DSCSA 2013)
Established timeline for trading partners toward implementation of a track and trace system
A full system electronic track and trace system must be in place by November 2023.
Applies to transactions where prescription drugs change ownership with some important exceptions
Establishes uniform national licensing standards for wholesalers and 3PL providers
Numerous opportunities for diversion and introduction of counterfeit drug products
Federal efforts to protect the security of the drug supply chain include the Prescription Drug Marketing Act of 1987 and the Drug Supply Chain Security Act of 2013.
Use of Alcohol in Pharmacy Practice
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 treatment of patients. May be used only for inpatients.
- Charity clinics may use for medicines for outpatients if they do not charge.
Poison Prevention Packaging Act
definition
exemptions
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.
exemptions:
- Prescriber requests- only good for that prescription
- Patient requests- good for all the drugs that the patient requests for, does not have to be in writing
- Institutionalized patients
- Certain drug products such as SL nitroglycerin and SL and chewable isosorbide dinitrate
- For manufacturer: may market one size in noncompliant package with appropriate statement
Drug Advertising by Pharmacies
Price advertising
- Considered reminder advertising and thus exempt from Section502(n), provided that certain conditions are met
Product advertising
- Subject to the strict liability standard
Market failures
Public goods
Externalities
Natural monopolies
Information asymmetry
Public Goods
Necessary and beneficial commodities that private entities will not supply because there is no incentive
Examples: orphan drugs; vaccines
Externality
When the production or consumption of a good affects someone who does not fully consent to the effect
When the costs of the good are not fully incorporated in the price of the good
Example: indiscriminate use of antibiotics
the government puts hormones into our chickens but we did not consent to those hormones
Monopoly
When the fixed costs of providing a good are high, relative to the variable costs of producing the good
Example: patents and market exclusivity for new drugs
information asymmetry
When the consumer is uninformed about the true value of a good
Examples: prescription only drugs; written consumer information for certain drugs, the doctor knows more than the patients
why regulate drugs
Market failures
Best interest of patient
Highly regulated profession
Limits on the law
Certain human relationships
De minimis violations
Protecting individual freedoms while preventing harm to others
State court likely unless:
Federal issue is involved
Parties are from different states
Civil Court Procedures: Parties
Plaintiff: person bringing the action
Defendant: person action is brought against
Plaintiff’s name appears first in title of case
Plaintiff must prove “standing”
The challenged conduct has caused the plaintiff injury.
There is a legally protectable interest.
Civil Court Procedures:Statute of Limitations
Limits the period of time in which a case can be filed
Civil Court Procedures:Summons, Complaint, and Answer
Summons: issued by court notifying defendant of suit and commanding defendant to file an answer
Complaint: contains all material facts of case and remedy requested
Answer: admitting to or denying allegations
Default judgment if answer not filed
Civil Court Procedures:Discovery
Pretrial process in which each side must give the other all facts, evidence, and names of witnesses upon which it will rely
Deposition: out-of-court testimony by a witness under oath
Civil Court Procedures: Jury Selection
Voir dire examination: the questioning by each side of potential jurors
The jury’s role is to determine questions of fact.
The judge must determine questions of law.
Witnesses
May be subject to subpoena, an order to appear in court
Failure to appear may result in contempt of court.
Expert witnesses
Called when the factual subject matter is beyond the scope of jurors
Civil Court Procedures:The Trial
Motion for summary judgment: one party attempts to convince the judge that the claims of the other side have no merit, even if correct.
Motion for directed verdict: after the introduction of evidence, one party alleges that the other lacks sufficient evidence.
Objections: attempt to restrict the introduction of evidence or testimony; might constitute issues of law for appeal
After all evidence is presented, the judge instructs the jury as to the applicable law.
Civil Court Procedures:Verdict and Appeal
Judgment notwithstanding the verdict (NOV): the judge may rule contrary to the jury if the jury clearly reached the wrong verdict.
A mistrial may be granted if a major error or violation of law or procedure occurred during the trial.
Either party may appeal the final verdict based on an error of law.
For an appeal, attorneys submit a “brief” to the court, citing the legal principles and precedent involved and why the lower court erred.
Criminal Court Procedures
A defendant can be either indicted or arrested.
Indictments are issued by a grand jury when it determines that enough evidence exists for an arrest and trial.
If arrested, the judge must determine at a preliminary hearing if there is enough probable cause for an arrest; if so, the defendant must enter a plea at an arraignment.
The parties may agree to a “plea bargain,” in which the defendant agrees to a lesser charge rather than face a trial.
Burden of proof is “beyond a reasonable doubt,” rather than a “preponderance of the evidence” as in a civil trial.
Case Citations
State and federal appellate court decisions are often reported and have citations.
From the citation, one can tell the names of the parties, which court decided the case, and the volume and page number where the case can be found.
Federal Register
daily publication of proposed and final regulations and notices
Code of Federal Regulations (CFR)
compilation of final regulations divided and indexed by subject matter
Law Made by Administrative Agencies:Legislative Function
Promulgate regulations
Regulations interpret, define, and add detail to statutes.
Regulations enacted via notice and comment rulemaking
Validity tests of a regulation:
Within scope of board’s authority
Based on statutory authority
Reasonable relationship to public health, safety, and welfare
Law Made by Administrative Agencies: Judicial Function
Render decisions pursuant to “hearings” resembling court proceedings
Decisions subject to judicial review
The court will review record to determine if decision was based on substantial evidence.
De novo: If substantial evidence is lacking, court will conduct an entirely new trial.
drugs on PPI
contraceptives
orange book
Evaluates pharmaceutically equivalent products on the basis of bioequivalence
Pharmaceutical equivalence—products contain same active ingredients and are identical in strength and dosage form
Bioequivalent pharmaceutical equivalents are generally presumed therapeutically equivalent—having the same clinical safety and efficacy.
The Orange Book uses a two-letter rating system; some products use two letters and a number.
Pharmacists must comply with state law when substituting and exercise professional judgment when substituting B-rated products.
med guides
Required for drugs FDA has determined as posing “serious and significant concerns”
Required for new and refilled prescriptions
Generally required for outpatients, not under the direct supervision of healthcare professionals with some exceptions
The content of MedGuide must be approved by the FDA
Every new MedGuide approved since 2007 has been in conjunction with a REMS.
FDA proposing a single-page information document
drug information rounds
Drug Info Rounds is a series of educational videos for healthcare professionals brought to you by the FDA’s Center for Drug Evaluation and Research (CDER), Office of Communications (OCOMM), Division of Drug Information (DDI)
approved drugs for off-label indications
Drug products commonly prescribed for off-label uses
Off-label prescribing and dispensing is legal under FDCA.
Off-label prescribing and dispensing requires a 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.
Other Compounding issues
Dietary supplements
OTC drugs
Manufacturer patent issues
USP Compounding Requirements
Section503A:
-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”
FDA 1992 compliance guide
- Published by FDA over concern that some pharmacies were crossing the line from compounding to manufacturing and were not compounding properly
