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Where a PPI or a Medication Guide is required, the combination of a prescription container label and either a PPI or a Medication Guide fulfills the _______________________________.
Food, Drug and Cosmetic Act (FDCA) requirement that "adequate directions for use"
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In a cases where a PPI or MedGuide is not given when required, the drug product is __________________.
Misbranded
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Where a PPI or a Medication Guide is not required, the prescription container label provides __________________________ for the patient.
"adequate directions for use"
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According to federal law, a PPI must be distributed with each and every filling to patients with drug products containing:
- Estrogenic substances (e.g., Premarin or conjugated estrogens)
- Oral contraceptives, including those oral contraceptives containing only a progestin
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When the drug product is being administered to a bed patient in a hospital (i.e., an inpatient) or a resident of a long-term care facility (LTCF), the PPI must be provided:
- Before the first dose is administered
- AND
- Every thirty days thereafter as long as the therapy continues
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(T/F) The prescriber can request that a PPI is to be withheld from a patient?
False
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The _________________________ must provide PPIs to the pharmacy.
Manufacturer or distributor
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The labeling for some ________________________ requires two PPIs to be given to the patient.
- Oral contraceptives
- (i.e., the long or detailed form and the short or brief summary form).
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When in doubt about whether to provide a PPI or MedGuide, the pharmacist should____________________________________________.
review the manufacturer's or distributor's labeling for each drug product
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(T/F) The pharmacists has the option to distribute consumer medication information (CMI) produced by commercial vendors as a substitute when a PPI is required for a particular drug.
False
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(T/F) The distributing a PPI to patients is required with progestational drug products that are not approved as an oral contraceptive (e.g., Provera® or medroxyprogesterone acetate).
- False, not required
- However, use professional judgment in deciding whether or not to provide the PPI to a patient.
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Does a PPI have to be provided to a patient with a compounded drug product containing an estrogenic substance?
- No. That is because a compounded drug product is not an FDA-approved drug
- However, counseling would be wise
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The FDA requires a Medication Guide to be distributed with certain drug products that ____________________________________________________.
Pose a serious and significant public health concern
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A Medication Guide is intended to help prevent_________________________________________.
Serious adverse effects and improve patient compliance (i.e., adherence)
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When must a MedGuide be distributed?
- With:
- Isotretinoin, warfarin (e.g., Coumadin®)
- Quinine (i.e., Qualaquin®)
- Varenicline (i.e., Chantix®)
- Antidepressants ("to all patients of all ages")
- NSAIDs ("even OTC NSAIDs if you dispense them as a prescription")
- Fentanyl transdermal system (e.g., Duragesic®)
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A comprehensive list of available Medication Guides may be found at:
CDER website
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A Medication Guide must be distributed with each and every filling of a prescription (i.e., all new and refill prescriptions) for Isotrentoin, Quinine, Varencycline, Antidepressants, NSAIDs and Fentanyl transdermal drug products for_____________, but not ___________.
- Outpatients
- Hospital inpatients or residents of a LTCF
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(T/F) A prescriber can request that a Medication Guide is to be withheld from a patient.
- True
- Such a request can be overridden by the patient.
- It would be wise to have such a request in writing.
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The __________________________ must provide Medication Guides, or the means to produce Medication Guides, to the pharmacy.
Manufacturer or distributor
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(T/F) A Medication Guide is equivalent to a PPI
True
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Patient leaflets or written drug information other than a PPI or Medication Guide are referred to as______________________________.
consumer medication information (CMI)
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Written drug information includes:
- PPI or Medication Guide
- consumer medication information (CMI)
- Vaccine Information Statements (VISs)
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A _________________ must be given to patients prior to most vaccines being administered to them.
Vaccine Information Statements (VISs)
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What are the exceptions where a Vaccine Information Statements (VISs) does not need to be given?
- Shingles
- Though, strongly recommended
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According to federal law, there is an exemption for controlled substances dispensed for administration to____________________________.
Institutionalized patients
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An institutionalized patient is defined as one who is a bed patient in a hospital (i.e., an inpatient), and does not include __________________________________.
A resident in a long-term care facility (LTCF).
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The label exemption is applicable to controlled substances administered to a hospital inpatient provided that:
- Dispensed at 1x:
- < 7-day supply of a Schedule II controlled substance
- OR
- < 34-day supply or 100 dosage units (whichever is less) of a Schedule III, IV, or V
- AND
- Controlled substance is not in the possession of the ultimate user prior to administration
- AND
- Institution maintains appropriate safeguards, records, control, dispensing, and storage
- AND
- Adequate to identify the supplier, product, patient, directions for use and cautionary statements
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(T/F) The label exemption is not applicable to all drugs administered to hospital inpatients via a unit dose system, from ward stock (e.g., a drug room, Pyxis medication management system, etc.), crash carts (e.g., a code blue bag, drawer, or cart), etc.
False, it is applicable (not shouldn’t be in the statement)
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(T/F) The label exemption does not apply to legend drug products dispensed pursuant to prescriptions for administration to residents of a LTCF.
True
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(T/F) Drug products stored in an emergency box in a Nebraska LTCF are subject to the label exemption.
True
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(T/F) A LTCF in Nebraska cannot have any legend drug product on the premises, unless it is labeled for a specific patient as outlined in this lesson or it is stored in an emergency box as allowed by Nebraska statute.
True
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A LTCF in Nebraska cannot have any ________________ on the premises, unless it is labeled for a specific patient or it is stored in ____________________ as allowed by Nebraska statute.
- legend drug product
- An emergency box
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A LTCF in Nebraska can __________________________on the premises for administration to multiple patients.
have nonlegend drug products (e.g., acetaminophen, aspirin, milk of magnesia, etc.)
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In a LTCF, _________________________ do not have to be labeled for a specific patient, but can be administered to a patient only pursuant to a valid order from a prescriber.
Nonlegend drug products
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When can Non-legend drugs be administered to a patient in a LTCF?
Only pursuant to a valid order from a prescriber
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The ___________________________________ requires that hazardous household products (which include medications) must be sold in child-resistant packaging (with a few exceptions).
Poison Prevention Packaging Act of 1970 (PPPA)
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(T/F) “child-resistant” means the same thing as “child-proof”; and the terms can be used interchangeably.
False, Child-resistant is the correct term
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(T/F) “child-resistant” means the same thing as "special packaging." ”; and the terms can be used interchangeably.
True
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A container can be considered child-resistant if _____________________________________________________________.
80% of children under 5 years of age CANNOT open it and 90% of adults CAN open it
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The strategy behind Child-resistant packaging is to:
Frustrate the child long enough so that he/she will go on to something else
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When should you include a warning on the label: "Keep all medication out of the reach of children" on a prescription?
- If it is in conventional (i.e., easy-to-open, flip-top, standard) packaging
- Best practice = even if it is on a CRC
- What are the categories of medication that require child-resistant containers?
- In general, it includes most OTC drugs and most legend drugs
- All legend drugs and controlled substances must be dispensed in child-resistant containers except those specifically exempted by law
- This is true of most OTC products as well.
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The child-resistant container statute addresses only drugs for____________________.
Oral use in humans
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If you are dispensing a prescription for an animal, do you need to use a child-resistant container by law?
- No
- but a lot of pharmacists do as a precaution – this is a good risk management strategy
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Are ophthalmics or topicals required to be CRCs?
No.
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