Law Test 2: Chapter 3

If you have a conscientious objection to sell of a product what should you tell patient?

-Direct patient to where they can get the product.

What are narrow therapeutic index drugs?

-Less than a twofold difference b/w the median lethal dose and the median effective dose -Careful patient monitoring

What are the ways that prescriptions can be taken?

-Written -Oral - must be reduced to written rx! -Electronic prescriptions - must maintain paper records even if prescription electronic

What are the arguments against a 3rd drug class?

FDA has concluded 3rd class limitation are uneccessary b/c a public need for such limitation has not been demonstrated

When are prescription drugs considered misbranded?

Misbranded if prior to dispensing label does not have symbol "Rx only"

What is failure of giving PPI considered?

misbranding

What do prescribers have the authority to prescribe?

-Within their scope of practice

What is AL view on collaborative practice?

- AL does not have a law for collaborative practice, but there is also no law that says we cannot do collaborative practice. Collaborative-like practice happens anyways, even though it is not legal and can be ruled against in court if something "bad" happens to patient.

What is the regulation on electronic prescriptions?

- At the time of Durham-Humphrey no means to transmit electronic/fax prescriptions. - Most states allow the use of fax and electronic transmission and have adopted laws to allow faxed and electronic prescriptions. - New DEA E-Prescriptions will be discussed later during this course - not legal if federal rules & regulations are followed.

What does the PPPA require?

- Child resistant containers for most OTC drugs - Most all prescription drugs - 80% of children < 5 years of age cannot open container whereas at least 90% of adults can must prove - Drug may be dispensed only 1 time in child-resistant container or vial b/c compromised effectiveness overtime. Dispense with new safety closure each time. - Patient can request non compliant containers - ask about their household - Best policy to have patient sign document rather than just verbal request - Pharmacy can dispense in reversible containers in the child-resistant mode

What is a beyond use date?

- Date after which the drug should not be used. - This cannot exceed the manufacturer's expiration date. - More affiliated with compounding (795/797/800)

Who gives authority to dispense prescription drugs?

- Each state

What is E-sign aka? What does it regulate?

- Electronic Signatures in Global and National Commerce Act -Allowed for e-signatures for interstate commerce -Preempts inconsistent state laws -Increased legitimacy and electronic records and electronic signatures

What does each letter of Orange Book rating indicate?

- First letter = A or B - Second letter = describes the dosage form or nature of the product

What are the exceptions to resale of drugs by hospitals and HC facilities?

- Hospital's purchases from a group purchasing organization or from other member hospitals for its own use - Sales or purchases to nonprofit affiliates - Sales or purchases among hospitals or health care entities under common contro - Sales or purchases for emergency medical reasons (ex. Temporary shortage) - Selling or dispensing prescription drugs pursuant to prescriptions

What interchanges are allowed and not allowed based on Orange Book ratings?

- Interchange b/w two A drugs allowed - Interchange b/w two B drugs or b/w an A and a B drug carries risk that products will not produce same effects

When may hospital pharmacies receive samples?

- MUST meet protocol and accounting - Request of licensed practitioner provided receipt contains: • Name & address of prescriber making request • Name & address of entity designated to receive drug • Name & address of person acknowledging delivery • Name & strength of drug • Quantity and lot # • Date of delivery

Who can be involved in malpractice cases?

- Malpractice case can involve professionals that are not HCPs b/c other professionals can be licensed (ex. Lawyer/attorney). - Malpractice claims are reserved for licensed professionals

How can prescription refill authorizations be given?

- May be written or oral

What are the exceptions to PPPA?

- Mfg. can produce 1 size of OTC product for elderly or handicapped. Popular size bottle, then mfg both type of lids. Example: Tylenol Arthritis - Must contain warnings: Contain statement "This Package for Households Without Young Children" or "Package Not Child-Resistant" - Institutionalized patient are exempt b/c employee's are administering

Are pharmacists required to place the same info on label as manufacturer? Why or why not?

- No -Impractical and the HCP must have some discretion

Why are unlabeled uses used by prescribers?

- Practitioners find promising uses for drugs much faster than regulatory system can approve - Manufacturers seek NDA approval for minimal # indications to expedite approval process and market sooner with intent to submit ANDA or SNDA later

What are the drugs exempt from PPPA?

- SL dose of nitroglycerin - SL and chewable forms of isosorbide dinitrate in strengths of 10mg or less - Sodium fluoride products containing not more than 264mg of sodium fluoride per package - Anhydrous cholestyramine in powder form - Methlprednisolone tablets containing not more than 84 mg of the drug per package - Mebendazole - Betamethasone - Potassium supplements - Erythromycin ethylsuccinate granules oral suspension & tablets - Colestipol - Aerosol containers - Pancrelipase preparations - Prednisone dose packs - OCPs - Medroxyprogesterone - Sucrase - Effervescent tablets ASA or APAP - Unflavored ASA or APAP powders

What expiration date should be put on the rx vial?

- Shall not be later than expiration date on mfg. container or 1 year from date drug is dispensed - whichever is earlier

What are Collaborative Practice Agreements?

- Think of this as a contract between a pharmacist and a prescriber that establishes protocols and procedures = written contractual agreement - Extent to which RPh can engage in drug therapy management is based on: state law, the collaborative agreement, and the practice setting - Authority can range from restrictive drug formulary to complete discretion to select any drug the pharmacist deems best

What does the 503A guidance document cover?

- Traditional compounding (everything except sterile) - Supposed to have a prescription for a designated patient prior to compounding - Must be an approved prescriber, writing a designated product, for a designated patient - All retail pharmacies must be compliant - USP 795 and Alabama code in AL

What are the arguments for 3rd drug class?

- Would allow FDA to switch more drugs to OTC that could not otherwise be switched b/c of safety concerns

What are A classifications and B classifications?

-A classification: considered therapeutically equivalent -B classification: not considered therapeutically equivalent

What do prescribers assume when they prescribe a medication for an unlabeled indication? What must a pharmacist do before dispensing?

-Additional liability, but not an FDA violation -Document discussion with prescriber about use for the drug in patient chart

Who didn't like the FDA idea of a behind the counter drug class?

-American Medical Association

What drugs is unlabeled use common in?

-Cancer and HIV treatments

What type of case is Winn Dixie vs. Colburn?

-Civil medical malpractice case -This case regards a damage reward for a patient that was injured because substitution of therapeutic equivalents occurred without authorization from the prescriber.

What mistake did the pharmacist make in the Winn Dixie vs. Colburn case?

-Dispensed Fiorinal No. 3 which contained codeine and Colburn was allergic -Did so even though prescriber said not too b/c trusted computer that it was equivalent

What are prescription drugs?

-Drugs that are unsafe for use except under the supervision of a practitioner bc of the toxicity, method of use or collateral measures -Limited by an approved application under section 505 to use under the professional supervision of a practitioner licensed by law to administer such drug.

What do FDCA regulations attempt to do?

-Eliminate/minimize risk in drug distribution system by a regulatory approach

Who enforce pharmacy compounding laws?

-FDA historically left enforcement issues to the state (ex. LTCF), but there are new guidance documents: 503A and 503B.

Is prescription drug importation from another country legal? What is FDA's action on this?

-General rule = No = illegal b/c FDA has not approved drug or manufacturer • Allowed if by original manufacturer or for emergency use • Personal importation allowed in small amounts if not approved in U.S. and used for treatment of serious condition for which there is not treatment in U.S. • There should be no unreasonable risk to patient if imported • Patient may transport 90 day supply from Canada (personal use exemption) b/c product there is subsidized and product here is unsubsidized. • Cannot be controlled • Cannot be a biological product/equivalent • FDA has historically not taken action for persons importing for personal use • Now individual states are seeking to import drugs because of their lower prices

If the FDA wants to take a drug off the market due to safety, then what can the manufacturer request?

-Increase restrictions on drug

Who does the Durham-Humphrey Amendment give prescriptive authority to?

-Legend drugs may be prescribed by practitioner licensed by law to administer such drug

What is an expiration date?

-Mfg. required to include on label of product -Identifies the time during which the drug may be expected to meet the requirements of the USP monograph for the drug -Pharmacists must put this date on the bottle, but it may not be the same as the mfg. date

What is did the Prescription Drug Marketing Act of 1987 do?

-More accountability with the products as a result of the act -Prohibits sale, purchase or trade of samples - Amends FDCA to: license wholesale distributors of prescription drugs, ban reimportation of Rx drugs, ban sale/trade/purchase of drug samples, mandate storage/handling/recordkeeping requirements for drug samples, ban trafficking in or counterfeiting of drug coupons, prohibit the resale of prescription drugs purchased by hospitals or HC facilities (with certain exceptions)

What type of injury did Mrs. Colburn suffer in the Winn Dixie vs. Colburn case? Was it life-threatening?

-Ms. Colburn experienced anaphylactic shock and was rushed to the emergency room. Even after treatment, she continued to feel side effects of the reaction including a severe headache that lasted several days. -Yes

What approval process are prescription drugs subject to?

-NDA

Do you have legal protection for a conscientious objection to an OTC product?

-No - none stated by ALBOP

When are prescription drugs dispensed?

-Only dispensed upon a written prescription of a practitioner licensed by law to admin such drug or up an oral prescription of such practitioner which is reduced to writing and filed by pharmacist

What does the 503B guidance document cover?

-Outsourcing facilities • Can do sterile compounding + traditional compounding (without registering under 503A) • Must be compliant with USP 797 and 800 as well as Alabama code in AL • Must be compliant with GMP and use safe packaging to ensure continues sterility during use - Must balance their need for batches and capacity for doing so • Includes pharmacies or manufacturers • Don't have to have designated patient assigned to them at outsourcing facility • Can opt out of being an outsourcing facility and not have to follow GMP = 3rd option

What is therapeutic equivalence?

-Pharmaceutical equivalents that can be expected to have the same clinical efec and safety

Who has the authority to dispense prescription drugs? How is their dispensing different?

-Pharmacists -Prescribers -Physicians (not held to same labeling standards by federal government unless state law is stricter)

What is the consumer medication information?

-Prints off and given with script - Accompany every new prescription (every time new Rx # given) - illegal if not given to patient - Must be written - Standard is that the information is useful -Government says the patient needs in order to take the prescription - Written in patient-friendly form - Want a trail that we have given it to them- so AWLAYS give it out. - Give it to patient's, so they can't bring you into a lawsuit.

What is the pharmacist's responsibility in generic substitution?

-Responsible for ensuring that substituted generic is bioequivalent to prescribed product

What is in place to control high risk drugs? Give examples.

-Risk Management Programs for Very High Risk Drugs -Risk Evaluation and Mitigation Strategies -Ex: Accutane and the iPLEDGE program, Thalidomide, Clozaril, Fosamax, Lotrenex, Plab B

What is a prescription drug sample?

-Sample is a unit of a drug intended not to be sold but rather to promote the sale of the drug -Starter pack is not considered sample

Why are there high risk drugs?

-Sometimes BBW, PPIs, and MedGuides and not enough

Who determines who can prescribe?

-States

What allows the FDA to switch Rx drugs to OTC?

-Subsection of the Durham-Humphrey Amendment authorizes the FDA to switch prescription drugs to OTC status by regulation when the conditions warrant

How does the pharmacist use toe beyond use date?

-Suitable beyond use date must be place on the prescription bottle by the pharmacist -The pharmacist should take into account the nature of the drug, the container in which it was packaged by the manufacturer, the characteristics of the dispense container, expected storage conditions, and other factors.

What was the Durham-Humphrey Amendment of 1951 aka?

-The Prescription Drug Amendment -Prior to this manufacturers determined if OTC or Rx and FDA could sue manufacturer if they disagreed with choice -Same ingredients could be deemed OTC by one company and Rx by the other

What is a concern with unlabeled uses?

-Unreasonable risk to patient -3rd party may not pay: must put correct diagnosis code or should be insurance fraud

Do you have legal protection for a conscientious objection to an Rx prodcut?

-Yes - statue from ALBP that protects you from refusing to dispense an Rx product, but going to change based on cases pending in other parts of the U.S.

Are pharmacist liable for dispensing a drug for an off label use?

-Yes if they pick the wrong diagnosis code

How is an Rx drug switched to an OTC drug?

1. Mfg. requests the switch & submits a supplemental application to NDA 2. Mfg. petition to FDA 3. FDA may add or amend an OTC monograph is they think something needs to change

What is a generic equivalent?

Active ingredients that are identical to those in the brand name product. Drugs are equivalent if they are the same strength and same dosage form. Therapeutic and generic equivalents are not the same.

Who has responsibility of enforcing PPPA?

Consumer Product Safety Commission

What is the drug information website for consumers?

Drugs@FDA • Info on Rx drugs, OTC drugs, and discontinued drugs • Can search by name or active ingredient • Obtain all labeling info including therapeutically equivalent drugs and approval history

Does FDA have to have warrant to inspect pharmacy?

FDA agents do not need warrant, can just show credentials and give notice of inspection (do not have to give reason)

What are the federal label requirements for prescription bottles by?

Federal information that must be listed: • Name and Address of the dispenser • Serial number and date of the prescription or of its filling • Name of the prescriber • Name of Patient (if stated) • Directions for use • Cautionary Statements -Retail Chain pharmacies will get the state with the most stringent label requirements and make their labels for all stores based on that law.

If you have a conscientious objection, then who do you need to let know?

Notification to employer of your objection + exactly what you would do in the situation (i.e. not even transfer prescriptions) IN WRITING

What is the danger with OTC drugs?

OTC's are safe for patients to purchase, but can be dangerous due to DIs with Rx drugs.

What are the OTC products kept behind the counter?

Sudafed, Plan B, Schedule V OTC's (in some states)

What must people engaged in wholesale distribution of drug be licensed by?

Persons engaged in wholesale distribution of prescription drugs must be licensed by the state.

When can pharmacist provide info on unlabeled uses?

Pharmacists may provide information about off-label use to other HCP it is okay as long as information if advisory or education, not promotional

What is bioequivalence?

Product displays comparable bioavailability [rate & extent of absorption' at site of action under similar conditions

What was the basis of appeal by Winn Dixie in the Winn Dixie vs. Colburn case?

The basis of appeal by Winn Dixie was that evidence was insufficient as well as the judgment was excessive. Winn Dixie argued that since Colburn suffered no permanent physical injury, the $130,000 award was out of proportion.

If a prescription product bears an expiration date of February 2015 - what is the last day that you can legally dispense the medication?

The last day of the month - you professional judgement

Can you be held liable if patient request brand and suffers injury b/c you did not dispense it?

Yes

What is an example of NTI drug?

carbamazepine, clonidine, digoxin, levothyroxine, lithium, minoxidil, phenytoin, theophylline, and warfarin

What is conscientious objection?

right to refuse to dispense prescriptions to which the pharmacist has moral or religious opposition

If a patient comes in with a script for Rx strength can you tell them to take the same strength OTC?

yes

What is the history of the way Plan B has been sold?

• 2001 - citizen petition to switch from Rx to OTC w/o age restrictions (denied) • 2003 - SNDA from Barr requesting switched w/o age restrictions (denied) • 2004 - another SNDA stating safe for girls 16 and over for switch to OTC - Denied because same ingredient could be marketed both Rx and OTC solely based on age, whether and how age distinctions could be enforced, and whether Rx and OTC could be marketed in a single package • 2006 - BTC by staffed pharmacist and purchaser must prove age of 18 and pharmacists should provide counseling and info to patient • 2009 - Supreme Court ordered it to be available to 17 years and older • 2011 - commissioner agreed with FDA experts that Plan B safe for all women of child-bearing age • Legal in the U.S. to be sold • Men and women can buy • You can't be required to carry it in your pharmacy as of right now and also can have right of conscientious objection if you do carry it.

What must be verified about persons who resale drugs of hospitals and health care facilities? Why?

• A need exists to verify records to insure public safety.

When can NTI drugs be switched with generics? What are the steps in switching?

• A-rated NTI drug switch: inform patient and alert them of changes watch for • B-rate NTI drug switch: do not switch without notifying prescriber and informing the patient

What is the orange book?

• Approved products are "pharmaceutical equivalents" - contain the same active ingredients and are identical in strength and are the same dosage form - rated in Orange Book for "therapeutic equivalence" -Codes for equivalence -Identifies Narrow therapeutic index drugs

What is the intent of the Poison Prevention Packaging Act (PPPA)?

• Intent to protect children from accidental poisoning with household substances

What was the drug that was compounded and killed a number of polo horses?

• Biodyl - mixture of vitamin B12, selenium and other minerals • The drug used in the compound for the horses was not legal in the United States.

What is the range of bioequivalence on normal drugs and NRI drugs?

• Bioequivalence standards allow range of 80-125% and NTI should be within range of 95-105%

What are the factors the FDA considers when taking action against your pharmacy regarding the compounding that is done there?

• Compounding in anticipation of receiving prescriptions (except for in very limited quantities) • Compounding drugs withdrawn or removed from market for safety reasons • Compounding from bulk ingredients not approved by FDA • Using drugs from a non FDA registered facility • Using non compendia standard components • Use of commercial scale mfg. or testing equipment • Compounding for 3rd party resale • Compounding a drug that is commercially available • Failing to comply with state law

What are patient package inserts?

• Contain drug's uses, risks, and precautions • Information not on product package nor adhered to bottle must be provided as leaflet from manufacturer to dispense with each package. Leaflet must be distributed with each prescription. • Distribute inpatient and outpatient

What triggered distribution of PPI?

• Contraceptives/estrogen containing drugs triggered this requirement b/c of women's unawareness of risks (first drug required with)

What are possible 3rd class drugs? What is the rationale?

• Drug sold only by a pharmacist • Rationale: Minimize possible injury to patient health by providing adequate Rph consultation

What did the Durham-Humphrey Amendment of 1951 do?

• Established 2 classes of drugs: prescription & OTC • Authorized oral prescriptions • Refills of prescription drugs are now allowed (oral or original script)

What are the generic substitution laws?

• Every state has its on generic substitution laws • "Mandatory" substitution states = RPh must dispense generic unless prescriber writes "dispense as written", "brand necessary", or a similar notation • "Permissive" substitution states = RPh may choose to substitute if the prescriber issues the script in a way that permits substitution • Without prescriber's permission substitution not allowed in most states even if consumer wants it • If written generic, then RPh can dispense any generic • Misbranding to label generic drug with brand-name

Is resale of drugs by hospitals and health care facilities allowed?

• General rule is that it is ILLEGAL - Created misbranding and adulteration problems b/c improper storage and repackaged, improperly labeled - Led to unfair schemes b/c sold for cheaper

What are Medication Guides? What are examples of drugs that require?

• Given out with drugs that pose a serious and significant concern in addition to CMI • Approximately 200 drugs that must receive MedGuides • Ex: FQs, NSAIDs

What document explains when MedGuides are required?

• Guidance document from FDA explaining when they will require MedGuide to be provided to a HCP for admin to the patient and when a MedGuide will be required as part of REMS

What are considered household substances?

• Household substance - any substance that is customarily produced for or used in the household and is designated as: - Hazardous substance - Economic poison - Food, drug or cosmetic - Household fuel when stored in portable container

When should supervisor/lawyer be called regarding inspections?

• If state BOP inspectors go from general convo (license, fridge, etc.) to specific convo (increase in control substances), then call supervisor for help b/c they could be looking for something that is criminal. - If FDA wants to inspect pharmacy.

What is the purpose of patient package inserts? What triggered their requirement?

• Initially limited to a certain number of drugs • Contraceptives, estrogen containing drugs triggered this requirement • FDA required PPIs on all drugs in 1980, then switched to requiring the CMI • For LIMITED products now

What drugs are dispensed with a PPI?

• Initially limited to a certain number of drugs • FDA required PPIs on all drugs in 1980, but opposed b/c of expense and burden on providers that would not achieve patient outcomes organizations proposed alternative means - Switched to requiring the CMI and PPI only required for limited products now

What must the pharmacist insure about the label?

• Label is not false or misleading • Drug dispensed is not an imitation drug • Drug is not sold under the name of another drug • Package & labeling conform to official compendia standards • Must be packaged & labeled appropriately if the drug subj. to deterioration • Packaged in conformance with Poison Prevention Packaging Act

Who provides MedGuides?

• Manufacturer must get FDA approval of MedGuide • Manufacturers must provide MedGuide for distributor or dispenser of product and they must provide to patient each time medication is dispensed • Other written info from pharmacy cannot replace

What information may states add in addition to federal labeling requirements?

• Name, initials or license number of dispensing pharmacist • Expiration date of drug • Drug name & Strength • Address of patient • Name of the manufacturer or distributor • Lot or control number • Specific state requirements will be discussed under State Law

What should a conscientious objection not get in the way of?

• No RPh belief should obstruct patient's right to lawful medication employers should have plan to get medication to patient with minimal inconvenience (ex. Another RPh on duty to dispense or referral of patient to nearby pharmacy)

What inspections are done under the FDCA?

• No routine inspection of pharmacies historically don't have funding, they believe state BOP has better means for regulating pharmacy • 503A and 503B have opened gates to FDA inspections • FDA inspectors may inspect facilities where drugs are held at reasonable times, within reasonable limits and in a reasonable manner (rare in community and hospital pharmacies, but increasing) • Pharmacies that do not mfg generally exempt (Can inspect pharmacies to determine whether it meets exemption or is engaging in mfg. If probable cause that pharmacy is mfg, ten FDA can extend search to pharmacy's records.)

Who can authorize a prescription refill?

• ONLY the PRESCRIBER can authorize a prescription, but another person may convey the message called a designated agent if state law permits. • Agent CANNOT personally authorize unless they have authority to prescribe - they can only transmit the message of the authorized prescriber.

Who may request the PPPA non compliant container for a patient?

• Patient can ask across the board. • Prescriber can ask for the prescription he/she is writing.

When is patient MedGuide required?

• Patient labeling required if FDA determines 1 or more of the following: 1. Patient labeling could help prevent serious ADEs 2. Product has serious risks relative to its benefits of which the patient should be aware to decide whether to use or continue to use the product 3. Patient adherence to directions is crucial to the drug's effectiveness

How is pharmacy compounding different from manufacturing?

• Pharmacies are exempt from registering as a manufacturer if they do not mfg drugs for sale other than in the regular course of their business of dispensing. • If a pharmacy is deemed a mfg. - must obtain a license from FDA and comply with CGMP and obtain IND application. • Pharmacy can prepare "very limited quantities" of drugs before receiving valid prescriptions provided this is consistent with prescriptions on file.

What is the pharmacists role in ensuring prescriptions came from a person with prescriptive authority?

• Pharmacist must dispense with good faith (check with prescriber if unsure of diagnosis and think that Rx may be outside prescriber's scope, make sure correct drug was prescribed) & KNOW the prescriptive authority of practitioners in their state (generally limited for NP, PA, or optometrists)

What is illegal to do with drug samples? What measures must reps take to ensure this doesn't happen?

• Rep has to account for how much product they leave in a physician's office • Illegal and unethical to sale samples - Illegal to have samples in retail pharmacies

What are regulations on pharmacies and advertising?

• Rx price advertising is considered to be reminder advertising; regulated by state law and administrative agencies generally [also 1st Amendment] • Cannot be false (FTC enforces strict liability) or misleading - Purpose should be to provide information on price • No info on safety, efficacy or indications should be included • Should contain drug name, strength, price for quantity -Include all charges in price

What does within the scope of practice mean?

• State practice acts defines practitioner's scope of practice to diagnose and treat, which, in turn, determines the practitioner's scope of prescriptive authority

Who decides the laws on conscientious objection?

• States can decide their own views on conscientious objection as of right now: some require RPh to dispense regardless of beliefs and some give RPh right to refuse

What was the trigger for the Prescription Drug Marketing Act of 1987?

• Trigger to change b/c of fraud in industry - samples were being sold to hospitals and pharmacies - No quality control of samples - Were combined into stock bottles, relabeled the bottles, and sold them to community and hospital pharmacies - Improperly stored, improperly labeled, and mixed with other lots

What can switch a drug from Rx to OTC?

• Will see some drugs OTC and Rx if switch occurs based on supplemental NDA for a specific manufacturer rather than based on a monograph for the drug • No regulations on who can petition to switch drug from Rx to OTC (ex. Nonsedating AH switched from Rx to OTC based on citizen petition approved by FDA)

What type of prescriptions does medicare part D permit?

•Medicare prescription drug law (part D) specifically permits e-prescribing and preempts any contrary state restriction

How must MedGuides be written?

•Must be written in non-technical language and uniform format and contain approved uses, when drug should not be used, serious ADEs, proper use, cautions, and other general info