DR C Chapter 1
PPIs are currently required for ?
1. Oral Contraceptives 2. Estrogen containing products
Content and format of OTC product labeling in "Drug Facts" panel format including:
1. Active Ingredient 2. Purpose 3. Use-Indication 4. Warnings 5. Directions 6. Other Info 7. Inactive ingredients (in alphabetical order) 8. Questions"? (OPTIONAL) followed by telephone #
Compounding pharmacies that aren't registered as an outsourcing facility are considered what ?
503a facility
Florida hasn't entered in an MOU with FDA this means what ?
503a pharmacies in Florida may not distribute compounded drug products out of state in quantities that exceed 5% of the total prescription orders dispensed or distributed by such pharmacy.
Transaction data should be maintained for how much time by each supply chain partner ?
6 years !
If pharmacist counts med on a tray with residue of another medication ?
Adulterated
Any product that implies FDA approval when in fact it is not counts as what ?
Misbranding !
Aspartame
Must contain warning in "precautions" section of labeling to the following effect: "Phenylketonurics: contains phenylalanine ____ mg per dosage unit
An NDC number is required for what ?
Required for a drug manufacturer to list their product with the FDA. FDA suggests they be included on the drug's label, although not technically required. The fact that a med has an NDC number doesn't automatically mean that they've been approved by the FDA. It just means they're listed.
Kefauver-Harris Amendment of 1962
Required new drugs to be proven safe and effective for their claimed use. Prior to this amendment, new drugs only had to be safe. Increased safety requirements for drugs and established good manufacturing practices (GMPs) for manufacturing drugs Gave FDA jurisdiction over prescription drug advertising
REMS
Strategy to manage a known or potential serious risk associated with a drug or biological product
Isoproterenol inhalation preparations
warning not to exceed dose prescribed and to contact physician if difficulty breathing persists
Standard NDC for billing and claims submissions ?
1 1 digit NDC #. Accomplished by inserting a leading 0 into one of the segments. 1st segment if its 4 #s. 2nd segment if its 3 numbers. Beginning of 3rd segment if it only has one #.
What is misbranding ? These labeling requirements are intended for the manufacturer's container. Not the labeling that goes in a regular pharmacy vial.
1. False or misleading labeling in any particular way 2. Labels fails to contain following info: a. Name and Address of manufacturer, packer, or distributor b. brand and/or generic name of drug or drug product c. Net quantity d. Weight of active ingredient per dosage unit e. FEDERAL LEGEND RX ONLY f. If not taken orally, specific routes of administration g. Special storage instructions if appropriate h. Lot number (manufacturer's control number) i. Expiration date j. Adequate information for use aka the package insert in rx drugs. Also includes BBW to alert healthcare professionals
Outsourcing facilities must ...
1. Have a licensed pharmacist that provides direct oversight over the drugs compounded 2. Register as an outsourcing facility. 3. Report to secretary of HHS upon registering and every 6 MONTHS thereafter (drugs sold in the last 6 months) 4. Be inspected by the FDA 5. Report serious adverse event experiences within 15 days and conduct follow up investigations 6. Label products with the statement identifying them as a compounded drug
Adulteration is what ?
1. It contains any filthy, putrid, or decomposed substance 2.Prepared or held under insanitary conditions 3. Methods of manufacture don't conform to current cGMPs 4. Manufactured, packed, processed or held in any establishment that delays, denies or refuses permit entry or inspection 5. Container is composed of any poisonous or deletrious substance 6. Contains unsafe color additive 7. It belongs to compendium and the strentgth differs from its quality or purity falls below the compendium standard 8. Not compendium but strengths differs from what it represents 9. Mixed or packaged w. any substance that reduces its strength or quality
OTC pain relievers- APAP-
1. Must have "acetaminophen" prominently displayed 2. Must warn about liver toxicity 3. Must warn not to use with other products containing APAP and to talk to a dr or rph before taking warfarin
OTC pain relievers (NSAIDs)
1. Must include term "NSAID" prominently on label 2. Must contain "stomach bleeding" warning
Outsourcing facility that meets act's requirements are exempt from what ?
1. Pre market approval requirements for new drugs 2. Adequate directions for use 3. Drug track and trace provisions
Exemptions to childproof requirement:
1. Request of pt or dr 2. bulk containers not intended for household use 3. Drugs distributed to institutionalized pts 4. Prescription drugs packaged for residents of LTCFs and other institutionalized settings if the staff will adm meds to pts 5. One package size OTC drugs designed for the elderly 6. Specific prescription and non-prescription drug exemptions: 1. oral contraceptives, conjugated estrogens, norethidrone in manufacturers package 2. Medroxyprogesterone acetate tablets 3. SL Nitroglycerin and SL/Chewable isosorbide dinitrate of 10mg or less 4. ASA and APAP effervescent tabs 5. Pottassium supplements in unit-dose packaging 6. sodium fluoride containing no more than 264 mg per pack 7.Anhydrous cholestyramine and colestipol packs 8. erythromycin ethylsuccinate granules for oral suspension and oral suspensions containing no more than 8 g of erythromycin 9. erythromycin ethylsuccinate tabs in packages containing no more than 16 g of erythromycin 10. Prednisone tabs containing no more than 105 mg per package 11. Methylprednisolone tabs containing no more than 84 mg per package 12. Mebendazole tabs containing no more than 600 mg per package 13. Betamethasone tabs containing no more than 12.6 mg 14. Preparations in aerosol containers intended for inhalation 15. Pancrelipase preparations 16. Sucrose preparations in a solution of glycerol and water 17. HRT that rely solely of one or more progestogen or estrogen substances
Patient Package Insert (PPI)
1. Supplied by manufacturer and written for a layperson 2. Required to be given to patients in the community setting when new and refill prescriptions for certain products are dispensed.
CMS Requirements
1. Tamper Resistant Prescription- all written Rx meet certain tamper resistant requirements to prevent unauthorized copying to prevent counterfeiting. Should have recognized features to prevent unauthorized copying, prevent the erasure or modification of information, and prevent the use of counterfeit prescription forms.
If a product is illegitimate pharmacies must notify the FDA using what form ?
3911
Interstate distribution of compounded drugs from a 503A pharmacy is limited to
5% of total prescription orders dispensed or distributed by such pharmacy. Unless compounder is located in a state that has entered into a memorandum of understanding w FDA addressing inordinate amounts of compounded drugs in interstate commerce and providing for appropriate investigation and complaints by the state.
Repackaging of OTC products ...
A Pharmacist that repackages OTC products would be subject to CGMPs and would have to provide tamper-evident packaging if offered for sale to public
Which community pharmacy are the only ones that can have samples ?
A community pharmacy that's affiliated to a healthcare entity. If no affiliation exists, then they may not have drug samples.
NDC number
A unique 10 character number that identifies a particular drug manufacturer or packager, product, and package size a. First 4 to 5 digits = labeler code b. Next 3 to 4 digits = specific drug, strength, dosage form c. Last 1 to 2 digits = package size
Misbranding in OTC Products is if it fails to contain any of the following:
A. Principal display panel, including statement of identity of the product B. Name and address of the manufacturer, packer or distributor C. Net quantity of contents D. Cautions and warnings to protect the consumer E. Adequate directions for safe and effective use (layman terms)
The Orange Book uses 2-letter code system to indicate whether or not a generic drug is therapeutically equivalent to the branded drug. A is what ? B is what ?
A= FDA considers product both pharmaceutically and therapeutically equivalent B= NOT pharmaceutically and therapeutically equivalent, hence no substitution.
If the misfilled medication is the wrong strength it would also be what ?
ADULTERATED
If pharmaicst stores inventory in a room or refrigerator where the temp is NOT adequately controlled, the product is what ?
Adulterated
If pharmacist stores a specific product incorrectly, such as stocking med on a pharmacy shelf instead of in the refrigerator as required ?
Adulterated !
An expired drug product in a manufacturer's bottle is what ?
Adulterated ! Because after the expiration date, the strength can't be assured.
If prescription is filled using an expired product, it is what ?
Adulterated and Misbranded. Misbranded if the pharmacist placed a BUD that is after the expiration date of the drug.
Manufacturers should obtain what in order to distribute medguides ?
Approval by FDA. They must also provide sufficient quantities for pharmacies.
FDA Orange Book
Approved Drug Products with Therapeutic Equivalence Evaluations Primary source for determining generic equivalency of drugs.
Outsourcing facilities may not compound a drug product that includes a bulk drug substance unless
Bulk drug substance appears on a list identifying bulk drug substances for which there's a clinical need. The drug compounded from suck bulk drug appears on FDAs drug shortage list at the time of compounding, distribution, dispensing.
Device Classification
Class I devices: low risk, least regulatory controls. Ej. Floss Class II: higher risk than I, Ej, Syringes Class III: Highest risk, Highest Regulatory Controls, Pose significant risk for injury/illness. Ej. Heart Valves
Drug and Device Recall Classifications
Class I: Serious adverse affects or death Class II: Temporary or medically reversible adverse effects on health Class III: Not likely to cause adverse effects is remote
What permit is needed in Florida to handle samples ?
Complimentary Distributor Permit from the division of drugs, devices, and cosmetics of the department of business and professional regulation is required to hold, distribute, and dispose of prescription drug samples.
Poison Prevention Packaging Act of 1970 is enforced by who ?
Consumer Product Safety Commission NOT THE FDA
What's a 503b facility ?
Defined as an outsourcing facility. Are permitted to compound sterile products without receiving patient specific prescriptions or medication orders.
Additional OTC requirements: Tamper-evident packaging is required for all OTC products except which products ?
Dermatological Dentrifice Insulin Lozenge products
Other criteria that leads to misbranding :
Drug liable to deterioration unless it is packaged or labeled accordingly Container is made, formed, or filled as to be misleading Drug is exact imitation of another drug or offered for sale under the same name of another drug Dangerous to health when used in the dosage or manner suggested in labeling Packaged or labeled in violation of the poison prevention packaging act
Pharmaceutical Equivalents ?
Drug products in identical dosage forms and route of administration that contain identical amounts of the identical active drug ingredient.
OTC products are regulated by WHO ?
Federal Trade Commission (FTC)
ipecac syrup
Following statement boxed and in red letters "FOR EMERGENCY USE TO CAUSE VOMITING IN POISONING" Before use call physician, poison prevention center or hospital emergency room immediately for advice Keep out the reach of children and not to be used in an unconscious person The dosage should appear MAY ONLY BE SOLD IN 1 OUNCE OR 30 ML CONTAINERS
A pharmacy that compounds products may advertise that they provide compounding services ....
However if they make any therapeutic claims regarding those products they would be subject to FDAs rules on advertising
What is a starter pack ?
Human prescription drugs that are generally distributed without charge by manufacturers or distributors to pharmacies to be placed in stock and sold at retail. THEY ARE NOT INTENDED TO BE A FREE SAMPLE TO THE CONSUMER.
What is the only way a pharmacist can break open a commercial OTC product and sell the lesser quantity by placing it in a vial and labeling it ?
If Patient has a prescription for the smaller quantity and OTC drug is filled as a prescription
How should medication guides be written ?
In a standard format and in a language suitable for patients
Alcohol warning
Internal analgesics & antipyretics including: ASA, APAP, IBU, naproxen, ketoprofen, etc. are req' to warn consumers to consult Dr before taking these drugs if they consume >3 alcoholic beverages per day
When a pharmacist doesn't comply with PPPA (poison prevention packaging act) what happens ?
It's considered misbranding
FDA Purple Book
Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations Lists biological products that are considered biosimiliars and provides interchangeability evaluations
If a REMS drug is dispensed without regards to the criteria established by REMS it is what ?
MISBRANDED
If a med is filled with the wrong strength ?
MISBRANDED and ADULTERATED
Misfilling a prescription with the wrong drug, strength, or directions for use is what ?
MISBRANDING
Dispensing a medication WITHOUT authorization ... adulteration or misbranding ?
MISBRANDING - Because prescription drug product is exempt from the manufacturer's labeling requirements when it is dispensed pursuant to a valid rx
503A pharmacies
May only compound products pursuant to an individual prescription or medication order. They are permitted to do limited anticipatory compounding.
Failure to provide PPI is classified as what ?
Misbranded !
If a pharmacist fails to dispense a medication in a child resistant container when required it is what ?
Misbranded !
Failure to provide MedGuides is considered what ?
Misbranding
The advertising or promotion of a compounded drug that is false or misleading would be considered what ?
Misbranding
What is to be generically equivalent ?
Must be pharmaceutically and therapeutically equivalent to the reference drug product.
Sulfites
Must contain allergy warning
Phenactin (acetophenetidin)
Must contain warning about possible kidney damage when taken in larger amounts over an extended period of time
FD&C Yellow No. 5 (tartrazine) and No. 6
Must disclose presence and provide warning in "precautions" section of label that may cause allergic reaction in certain susceptible persons
Transaction Information includes what ?
Name Strength Dosage form NDC # Container size # of containers Date of transaction Name and Address of person from who's ownership is being transferred and to whom the ownership is transferred
FDA requires medication guides for who ?
New and refill prescriptions dispensed in the community setting when: a. patient labeling could prevent serious adverse events b. Product has serious risks relative to benefits c. patient adherence to directions is crucial
Is consumer medication information (CMI) equivalent or sustutitable for FDA regulated and mandated PPIs and Medguides ?
No bro
Can community pharmacies have samples ?
No. Unless it's a community pharmacy that is part of a healthcare entity such as a community pharmacy owned by a hospital.
When an OTC product is filled as prescription ...
OTC labeling requirements don't need to be followed. The prescription drug labeling requirements would apply and would include the prescriber's directions for use. Any instructions for refills would apply as would BUD.
NDC numbers shouldn't appear where ?
On non-drug products. If a dietary supplement or device has an NDC number it is considered misbranded.
Mineral Oil
Only to be taken at HS and not to be used in infants unless under advice of a physician. Label can't encourage use during pregnancy.
PPIs for Hospitalized Patients ?
PPI must be provided to a patient prior to the 1st administration of the drug and every 30 days thereafter
Transaction statement includes what ?
Paper or electronic statement by the seller that the seller is authorized, received the product from an authorized person, received transaction information, and history from the prior owner. Didn't knowingly ship a suspect of illegitimate product. Didn't provide false transaction information.
Transaction History includes what ?
Paper or electronic statement that includes prior transaction information for each prior transaction back to the manufacturer
Drug Compounding Quality Act (DCQA)
Passed in response to an outbreak of fungal meningitis in over 20 states in the fall of 2012. Makes the distinction between 503a and 503b facilities
Prescription drugs: Side Effects Statement:
Pharmacies and Pharmacists are required to distribute a SE statement to patients when dispensing all new and refill prescriptions in the outpatient setting Must read: Call ur dr for medical advice about SE. You may report SE to FDA at 1-800-FDA-1088 SE statement is distributed on a sticker attached to pharmacy container, vial cap, separate sheet of paper, or within CMI or Medguides
Who gets samples ?
Practitioners Request of a licensed practitioner to an institutional pharmacy or pharmacies of other healthcare facility.
Prescription Drug Marketing Act of 1987
Prevents re-importation of prescription drugs and insulin products produced in the US. Bans sale, trade, or purchase of prescription drug samples.
An interchangeable med is what ?
Product that has been shown to be biosimiliar to the reference product and it is expected to produce the same clinical result as the reference product in any given patient Only biological products that have been designated "interchangeable" may be substituted for the original reference product by a pharmacist. If it's only biosimiliar then physician intervention is needed.
Rating of AB what does it mean ?
Products w potential or actual bioequivalence problems but for which adequate scientific evidence has established bioequivalence are given a rating of AB
Advertising and promotion of prescription drugs ?
Regulated by FDA
Poison Prevention Packaging Act of 1970
Requires use of child-resistant containers for all prescription and the following OTC drugs : 1. ASA for human use for PO adm 2. Methyl Salicylate (oil of winter green) - Liq preparations containing more than 5% by weight of methyl salicylate unless packaged in pressurized spray containers. 3. Controlled Drugs 4. Methyl Alcohol (methanol) >4% 5. Iron containing drugs except animal feeds used as vehicles for the administration of drugs, non-injectable animal/human drugs providing iron for therapeutic or prophylactic purposes which contain elemental iron equivalent to 250 mg. 6. Dietary supplements containing iron- except preparations in which iron is used for colorant, dietary supplements that contain an equivalent of 250 mg or more of elemental iron in a single package 7. APAP in oral dosage form and containing > 1 gm of APAP in a single package 8. Diphenhydramine- oral dosage forms containing more than 66 mg in single package 9. Ibuprofen- oral dosage forms containing > 1 gm in single package 10. Loperamide- "" > 0.045 mg of Loperamide in single package 11. Lidocaine- Products containing > 5 mg of Lidocaine in single package (includes sprays, patches, creams etc) 12. Dibucaine- products containing >0.5mg 13. Naproxen- oral dosage forms containing > 250 mg in single package 14. Ketoprofen- oral dosage forms containing > 50 mg 15. Fluoride- Products containing > 50 mg elemental fluoride and > 0.5% fluoride in single package 16. Minoxidil- Preparations containing > 14 mg in single package 17. Imidazolines- Products containing > 0.08 mg in single package. Includes oxymetazoline, naphazoline, tetrahydrozoline 18. ANY DRUG SWITCHED FROM RX TO OTC STATUS
potassium salt preparations for oral ingestions
Requires warning regarding nonspecific small bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric coated thiazides with potassium salts
Starter Packs aren't what ?
SAMPLE
Only Interchangeable product up till this moment ?
Semglee, can be substituted by pharmacist to Lantus (glargine)
OTC Drugs for Minor Sore Throats - Any OTC product label that states "For the temporary relief of minor sore throats" must include this warning
Severe or persistent sore throat or sore throat accompanied by high fever, HA, N/V may be serious. Consult physician promptly. Don't use for more than 2 days or adm to children less than 3 y/o unless directed by physician
Salicylates
Special warnings for use in children including warning regarding Reyes syndrome. Retail containers of 11/14 grain (pediatric) ASA CANNOT be sold in containers holding more than 36 tabs
Who regulates 503A facilities?
States and are subject to USP Chapter <797> quality standards for sterile compounding
Who is the only person that can make a blanket request for all of their prescriptions to be filled in non-childproof containers ?
THE PATIENT IS THE ONLY PERSON THAT CAN MAKE THAT REQUEST. Not legally required in writing but it is good practice to have it in writing to avoid lawsuits bby. A prescriber can make the request for the patient but would need to do so with every request. Not a blanket request.
Advertising of Prescription Drug Prices
The advertising of prescription drug prices is considered reminder under FDA regulations. However such advertising is exempt from FDA advertising regulations provided that the following conditions are met: purpose of advertising is to provide info on pricing not safety, efficacy, or indications advertising contains propietary name of the drug, generic, strength, dosage form, price charged It may contain any info as long as it isnt misleading price of advertising shall include all charges to the consumer
Therapeutically equivalent ?
They can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling
Under drug supply chain security act, manufacturers are required to provide "transaction data" for each product sold. What does transaction data include ?
Transaction Information Transaction History Transaction Statement
OTC Products Containing Iron in Solid Oral Dosage Form
Warning: Accidental OD of iron containing products is a leading cause of fatal poisoning in children under 6. Keep product out of the reach of children. In case of OD call dr or poison center immediately This requirement is also for dietary supplements containing iron
OTC drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient
Warning: This product doesn't protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner
FDA proposed an 11 digit NDC ?
Yes , but proposed change has not been adopted.
Some meds, drug classes that require med guides :
a. accutane b. antidepressants in children/ teens c. coumadin d. epogen e. forteo f. lindane g. lotronex (alosetron) h. nolvadex (tamoxifen) i. NSAIDS j. remicade (infliximab) k. Trizivar l. opioids m. Benzos
What does biosimilar mean?
biological product is "highly similar" to reference product with no clinically meaningful differences in terms of safety or efficacy (purity or potency)
OTC Products not packaged properly would be considered what ?
misbranded and adulterated
Winter green oil (methyl salicylate)
more the 5% must include warning that any use other than directed may be dangerous and kept out of the reach of children
Special Warning Requirements for OTC products...
next...
sodium phosphate
no more than 90 ml per OTC container
Who regulates 503b facilities ?
primarily regulated by FDA and are subject to FDA's Current Good Manufacturing Practices
Durham-Humphrey Amendment of 1951
• Created a distinction between "OTC" and "Legend Drugs". • Legend Drugs can only be dispensed with a valid Prescription.. • Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". • Most people refer to Legend drugs simply as "Prescription Drugs". Authorized verbal Rx and Prescription Refills
