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Law chap 3
Terms in this set (74)
Establishes criteria for distinguishing prescription drugs from OTC drugs
What criteria makes a drug prescription only (3)
Toxicity, Collateral measures necessary for use, requires supervision of a practitioner for administration
Does the Durham Humphrey Amendment allow e-scripts
No, it could not have predicted those, but other laws were made to permit them.
What federal law allows e-scripts
Medicare part D
4 things required on label by durham Humphrey
Name and address of dispenser, serial number and date of prescription or of its filling, the name of the prescriber + patient, directions for use and cautionary statements (ex. Keep out of sunlight)
So why do we have to include expiration date and other stuff on labels?
3 ways a prescription drug can become an OTC drug
Manufacturer petitions FDA, or Manufacturer gets a SNDA approved, or the FDA independently adds or amends an OTC monograph
Is the USP BUD the same as the manufacturers expiration date?
What is "behind the counter"
a class of drugs which can only be sold from the pharmacy,
Does the FDA recognize "behind the counter"?
No but it seems to be changing its stance on that
Who determines the scope of authority for prescriptions (basically who gets to prescribe what)
The state government or state administrative agencies
Can a dentist prescribe oral contraceptive? Why?
No, because the dentist has exceeded the scope of their practice under state law.
A prescription may not be refilled unless
There is specific authorization either orally or in writing from a prescriber
Emergency contraception is approved for OTC for who
People 16 and older
Why can't it be used in all ages?
FDA commissioner approved the SNDA, but was overturned by the HHS secretary
Patient Package Inserts are required for
Estrogen containing drugs, DES (diethylstilbestrol), and oral contraceptives
What is a collaborative practice agreement
A written contractural agreement in the form of protocols and procedures that allows a pharmacist to initiate or adjust drug therapies in collaboration with a physician
Who can dispense prescription drugs according to the FDCA
It does not specify, this is left to the jurisdiction of states
Do labeling requirements of the Durham-Humphrey Amendment apply to physicians?
No they can basically pour tablets in sacks and give them to patients unless states intervene
What is CMI
Consumer medication information
What is the difference between a medguide and a cmi
Medguides are for drugs with a serious and significant concern to public
Are CMI required by the FDA?
No, the FDA wanted them to be required but congress intervened and allowed the private sector to develop their own standards for CMI
Are medguides required by the FDA?
Yep, for drugs posing a "serious and significant concern"
Has the private sector been effective at distributing CMI?
No they do not meet the "95% useful information" standard congress set up
How many patients actually receive CMI
89% of patients, the problem is the information is not always useful to patients, not that they aren't getting the info
Can drugs be prescribed and dispensed for off-label indications?
Does the pharmacist have a professional responsibility to confirm the off-label use with the prescriber?
Can a physician sell drugs to other physicians and pharmacies for off-label indications?
Nope, they are basically selling an illegal new drug at that point
Why did the FDA act to regulate pharmacy compounding
They were worried that some pharmacies were actually manufacturing, and also worried that compounding could jeopardize public health
What defines what differentiates compounding from manufacturing
Are compounded drugs new drugs?
No (because of FDAMA) BUT according to the FDCA it IS a new drug(this is a point of tension)
What about compounded drugs for animals
Not considered a new drug, but the FDA is trying to appeal this decision (Franck's lab)
Can the FDA inspect compounding pharmacies
Can the FDA inspect compounding pharmacies as manufacturing pharmacies
No, unless they are trying to verify that the pharmacy has crossed the line into manufacturing
Does the FDA need a warrant to do this
Can you compound something you can buy commercially anyway
The requirements in order for a pharmacist to substitute a generic drug for the prescribed drug are established by
Pharmaceutical equivalence means
drugs have same active ingredients in the same strength
Is pharmaceutical equivalence the same thing as bioequivalence?
Is therapeutic equivalence the same thing as bioequivalence?
Not EXACTLY but the fda assumes that bioequivalents are also therapeutically equivalent
What is bioequivalence
Products have comparable bioavailability (rate and extent of absorption) at the site of action under similar conditions
What is therapeutic equivalence
Two pharmaceutical equivalents that have the same clinical effect and safety
What is the orange book
Evaluates pharmaceutically equivalent products on the basis of bioequivalence
What does an "A" rating in the orange Book mean
They are therapeutically equivalent
What does a "B" rating in the Orange Book mean
They MIGHT not be considered therapeutically equivalent
What does an "AB" rating in the Orange Book mean
Has actual or potential bioequivalence problems, but evidence has now resolved those problems.
Can generics be assumed to be therapeutically equivalent?
Yes, as long as the generic was marketed after 1984 and approved under an ANDA since they would have had to demonstrate proof of bioequivalence for approval
What is a "narrow therapeutic index" NTI drug
Drug with less than 2 fold difference between median lethal dose and median effective dose or two-fold difference between minimum toxic concentrations and minimum effective concentrations
Why are NTIs relevant to this discussion
There is controversy as to whether or not the current parameters for bioequivalence are accurate enough for NTI drugs, so professional judgment is necessary even for A-rated drugs.
What was the Prescription Drug Marketing Act
Requires state licensing of wholesalers, bans reimportation of Rx drugs unless by manufacturer, bans sale or purchase of Rx samples, prohibits resale of Rx drugs
What is a drug sample
a unit of drug not intended to be sold and intended to promote the sale of the drug
How can a prescriber receive drug samples after the Prescription Drug Marketing Act?
Via written request through a proper form every time the prescriber wants samples
Can community pharmacies receive samples?
When can a hospital sell excess inventory to local pharmacies?
For emergency reasons to alleviate temporary shortage
Are secondary wholesalers legal?
What are pedigree requirements
A record of ownership for each drug that goes back to original manufacturer, likely using RFID (radio chips)
What is the point of pedigree requirements
To stop counterfeit drugs
Are pedigree requirements required of secondary wholesalers?
No, the FDA tried to pass this regulation but was struck down. However some states do have pedigree requirements.
When can a consumer import small amounts of a drug from a foreign country under FDA compassionate use
If the drug is not approved in the US, it is used for the treatment of serious condition for which no satisfactory treatment is available in the country, and if the consumer provides the name of their physician
Under what circumstances can you use tax-free alcohol
If you are a hospital pharmacy compounding medications for INPATIENTS (NOT outpatients NOT community pharmacy)
What is tax free alcohol
190-proof ethyl alcohol that s untaxed and used for scientific, mechanical or medicinal purposes
When can you reuse child-resistant containers
If they are glass or threaded plastic but it still needs a new closure
When can you dispense a non-child resistant container
At a patient's request, but only if the request is in writing and signed, or for certain drug products (like SL nitroglycerin), or for institutionalized patients
What is the poison prevention packaging act
Establishes standards for child resitant containers
Say a DS manufacturer made a TV ad that includes a pharmacy's name as a place to buy the DS. ("Now available at Walgreens!") The adverts contained false and misleading statements. Who is liable for false advertising?
BOTH the manufacturer and the pharmacy
What type of advertising has a strict liability standard
Product advertising (ex. "Buy Claritin and be Claritin Clear!")
Which type of advertising is exempt from liability standards
Price advertising (ex. "Walgreens is selling Claritin for $x.xx!")
Price advertising may not include
Information on a drug's safety, efficacy, or indication of use
Pharmaceutical Manufacturers Association v. FDA
The FDA wanted to require PPIs (patient package inserts) be provided to patients receiving estrogen-containing drugs. Pharmacy organizations were upset at needing to shoulder the burden of storing/distributing PPIs. The court found that the FDA does have statutory authority to require patient labeling in this case and that PPIs do not interfere with the right of the physician to exercise professional judgment.
Ramon v. Farr
Dr. Farr, a physician, performed a cervical block with Marcaine in Ms. Ramon during the delivery of her baby. The baby then had serious symptoms, including grand mal seizures, resulting in permanent physical and mental defect. Ramon sued Farr on behalf of her baby. Marcaine is not recommended by the manufacturer for cervical blocks. Because the doctor went against what the manufacturer suggests is appropriate for the use of Marcaine, Ramon felt that the doctor was negligent. The court sided with Farr, stating that "package inserts are not designed to establish a standard of medical practice" and also that there was no proof that Marcaine harmed the baby.
What should pharmacists take from this case
When dispensing off-label uses for drugs the pharmacist should use professional judgment. If there is a chance for risk to the patient, then you should call the prescriber and ask them to defend their decision (with evidence based medicine). Based on this response, the pharmacist can choose to not dispense the drug. The pharmacist also should document all of the intervention.
Pfizer Inc v Shalala
Pfizer had a drug called Procardia XL, a controlled release form of nifedipine that uses a oral osmotic pump release mechanism to release the drug slowly over time. Mylan released a generic form of Procardia XL that released the drug slowly using a different mechanism. The FDA accepted the ANDA for filing (did not approve the ANDA yet), but Pfizer was upset. The court ultimately denied Pfizer's claim due to being "transparently self serving" and contrary to the goal of expediting the production of low-cost generics.
Winn Dixie of Montgomery Inc v. Colburn
The pharmacist substituted what he thought was a generic equivalent to a prescribed drug, but it was not, and it harmed a patient. The patient was awarded damages of $130,000. Dixie felt that the judgment should be reversed because the judgment was excessive, and also the evidence was insufficient to support the award. The court found that it was within the right of the jury for Colburn to be awarded $130,000 due to the severity of harm the patient experienced due to the pharmacist's mistake. (The pharmacist asked the physician if he could substitute the drugs and was told no, but did it anyway, this resulted in a anaphylactic reaction to the medication that could have killed the patient)
Kennedy v Kentucky Board of Pharmacy
A hospital pharmacist was selling his excess inventory to a drug wholesaler. He was charged with unethical conduct, fined, and had his license suspended for a year. The pharmacist felt that the board erred with this conclusion. The court ultimately sided with Kennedy and remanded the case back to the board of pharmacy for dismissal of the charges. This was because, according to Kentucky law, Kennedy was neither a manufacturer or a wholesaler (the law even specifically states that pharmacists cannot be considered wholesalers in Kentucky) and thus there were no statues or regulations prohibiting him from selling excess drugs.
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