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"
In a cases where a PPI or MedGuide is not given when required, the drug product is __________________.
Misbranded
Where a PPI or a Medication Guide is not required, the prescription container label provides __________________________ for the patient.
"adequate directions for use"
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
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
(T/F) The prescriber can request that a PPI is to be withheld from a patient?
False
The _________________________ must provide PPIs to the pharmacy.
Manufacturer or distributor
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).
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
(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
(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.
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
The FDA requires a Medication Guide to be distributed with certain drug products that ____________________________________________________.
Pose a serious and significant public health concern
A Medication Guide is intended to help prevent_________________________________________.
Serious adverse effects and improve patient compliance (i.e., adherence)
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®)
A comprehensive list of available Medication Guides may be found at:
CDER website
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
(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.
The __________________________ must provide Medication Guides, or the means to produce Medication Guides, to the pharmacy.
Manufacturer or distributor
(T/F) A Medication Guide is equivalent to a PPI
True
Patient leaflets or written drug information other than a PPI or Medication Guide are referred to as______________________________.
consumer medication information (CMI)
Written drug information includes:
PPI or Medication Guide
consumer medication information (CMI)
Vaccine Information Statements (VISs)
A _________________ must be given to patients prior to most vaccines being administered to them.
Vaccine Information Statements (VISs)
What are the exceptions where a Vaccine Information Statements (VISs) does not need to be given?
Shingles
Though, strongly recommended
According to federal law, there is an exemption for controlled substances dispensed for administration to____________________________.
Institutionalized patients
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).
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
(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)
(T/F) The label exemption does not apply to legend drug products dispensed pursuant to prescriptions for administration to residents of a LTCF.
True
(T/F) Drug products stored in an emergency box in a Nebraska LTCF are subject to the label exemption.
True
(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
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
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.)
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
When can Non-legend drugs be administered to a patient in a LTCF?
Only pursuant to a valid order from a prescriber
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)
(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
(T/F) “child-resistant” means the same thing as "special packaging." ”; and the terms can be used interchangeably.
True
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
The strategy behind Child-resistant packaging is to:
Frustrate the child long enough so that he/she will go on to something else
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.
The child-resistant container statute addresses only drugs for____________________.
Oral use in humans
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
