Module 2 CE Impact Flashcards
Inventory Methods and Considerations
Red Flags
Purchasing from a source new to the trading partner
Receiving unsolicited sales offers from an unknown source (eg, receiving emails, telephone calls, or in-person sales calls from an unsolicited source)
An internet purchase from an unknown source that offers a product their usual source cannot provide or a better price
Purchasing from a source that a trading partner knows or has reason to believe has engaged in questionable business practices that could increase the risk of suspect product entering the supply chain, such as:
Previous business transactions where the trading partner sold or delivered illegitimate product
A trading partner with a history of problematic or potentially false transaction histories (eg, contains misspelled words or is incomplete)
A trading partner that is reluctant to provide a transaction history or does not do so in a timely manner
A trading partner that provides transaction information, a transaction statement, and/or transaction history that appears to be incomplete or questionable
Product that is generally in high demand in the US market
Product that is in higher demand because of its potential or perceived relationship to a public health or other emergency (eg, antiviral drugs)
Product that has a high sales volume or price
Product offered at a price that is “too good to be true”
Product that has been previously or is currently being counterfeited or diverted (eg, HIV, antipsychotic, or cancer drugs)
Product that has been previously or is currently the subject of a drug shortage (current and resolved drug shortages can be accessed at https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm)
Product that has been or is the subject of a public alert or announcement related to drug quality
Product that has been or is the subject of an FDA counterfeit or cargo theft
Drug Diversion
act of changing the intended course of a drug: at some point in the supply chain, it is passed along into the wrong hands.
Authenticating Trading Partners
check directly with the state licensing agency in the state in which the wholesaler is located, AND the pharmacy’s state (the state they are shipping into),
Check if license is current.
Specialty or biologic check manufacturer for authorized distributor
Drug Counterfeiting
act of selling a product that has packaging for one drug but contains a different drug, OTC product, or placebo.
Transaction Data
suspicious entries in transaction data may include duplicate serial numbers, unfamiliar names of manufacturers or wholesalers, or pharmacies who sold the drug to other trading partners. For some specialty or high-priced drugs, manufacturers will note which wholesalers they will sell to on their website. When these products show a different wholesaler in the transaction history, it is a sign that the drug may have been diverted or counterfeited.
Errors or evidence or suspicious produce contact supplier. Further investigation may be needed. If illegitimate FDA reporting.
Receive Product
Examine Outer Case, Examine Produce, Compare to Invoice,
Examine outer Case
Does the appearance of the package or container seem questionable? Does it have a label that contains misspellings or appears different from the standard label for color, font, images, or shrink wrap that has unexpected markings, etc.
Are there signs that it has been compromised or opened such as a broken seal, damage, appears to have been repaired, or otherwise altered?
Has the package or the transport container changed since the last shipment?
Are there shipping addresses, postmarks, or other materials indicating that the product came from an unexpected foreign entity or source?
Compare to Invoice
checking off each item received in the shipment. When C-II controlled substances are received, the amounts of each drug should be checked off on the purchaser’s copy of DEA Form 222. 222 then signed, dated, retained for at least 2 years. C-III through C-V substances also need to be detail checked off on the invoice or packing slip which is then signed and dated. Invoices and documentation for C-II must be separated from C-III through C-V, and both of these separated from non-controlled substance invoices and documentation.
Discrepancies immediately reported
Product Examinaton
Any missing information, such as the lot number or other lot identification, NDC, or strength of the drug
Package that contains foreign identification features (such as a different drug identification number where a National Drug Code (NDC) number would be expected)
Lot numbers and expiration dates on product that do not match the lot numbers and expiration dates of the outer container
Any altered product information, such as smudged print or print that is very difficult to read
A product name that is the product name for a foreign version of the drug
Misspelled words
Bubbling in the surface of a label
Lack of an “Rx only” symbol
Foreign language with little or no English provided
Foreign language that is used to describe the lot number
A product name that differs from the name that appears on the FDA-approved drug label or labeling
Missing security or anti-counterfeiting technologies normally featured on the FDA-approved product that are easily visible, such as holograms, color shifting inks, neckbands, or watermarks.
A finished dosage form that seems questionable (e.g., it has a different shape or color from the FDA-approved product, a different or unusual imprint, an unusual odor, or there are signs of poor quality like chips or cracks in tablet coatings or smeared or unclear ink imprints).
Suspect Product
(A) is potentially counterfeit, diverted, or stolen;
(B) is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
(C) is potentially the subject of a fraudulent transaction; or
(D) appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.
Put into inventory
Fridge - 36-46 Room 68-77 Freezer -13-14 Humidity 35-60% Remember first in first out
Illegitimate Product
(A) counterfeit, diverted, or stolen;
(B) intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
(C) is the subject of a fraudulent transaction; or
(D) appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.
If Suspect
Quarantine the product: Do not put products into active stock or dispense if there are any discrepancies that are not resolved. Do not destroy the product as FDA may want to obtain a sample for testing.
Perform an investigation: Contact the trading partner from which the product was purchased. You may also want to contact the manufacturer of the product to assist in verifying if the product is illegitimate.
If Illegitimate
Notify the appropriate agencies and trading partners: If the product is still suspect or illegitimate, notify the FDA. The FDA must be notified within 24 hours. If it is determined later that the product is legitimate, also notify the FDA. If the product is a controlled substance, also contact the DEA. The state board of pharmacy may also have requirements for notification.
Appropriately receive and act upon notifications from agencies or trading partners.: The FDA or other trading partners may contact the pharmacy or send a notification of suspicious or illegitimate products. If that specific product is on hand, quarantine the product and follow instructions for responding to the notification. If a product is eventually found to be legitimate, and notification to this effect is received, the product may be put back into active stock.
Document: Documentation of investigations and notifications of illegitimate products must be kept for at least 6 years after the conclusion of the investigation and final disposition of the product.
340B Drug Pricing
enables patients who are low-income, lack insurance, or live in a rural community to obtain medications at reduced prices. Hospitals that serve rural areas, children’s hospitals, or free-standing cancer hospitals can purchase drugs for their patients at significantly reduced rates. Manufacturers who participate in Medicaid are required to provide the needed medications at reduced rates to 340B-eligible institutions. The 340B covered entities must recertify their eligibility annually to remain in the 340B Drug Pricing Program.
A pharmacy that is a part of a 340B contract must meet specific regulations to maintain eligibility. Pharmacies must prove they meet the criteria to participate in 340B and must continually document that the discounted drugs are being dispensed or administered to the intended patients. Participants in the 340B program will be subject to audits that will review the procedures in place to ensure 340B is being managed appropriately.
Formularies
pre-determined lists of drugs available to be prescribed and dispensed within a hospital or healthcare system.
Consignment
specialty drugs that are high in price and infrequently used. The purchaser pays a fee as part of the consignment contract, but only pays the full price of the drug if it is dispensed to a patient.
State and Federal Vaccine Program
may be an ongoing contract in response to a high need in a geographical area or in a population the pharmacy serves, or it may be a part of a broad-scale public health initiative. Vaccines For Children A Medicaid-eligible child, who is not insured, who is administered a qualified pediatric vaccine by a FQHC or a rural health clinic, not insured with respect to the vaccine, A child who is Native American (per the Indian Health Care Improvement Act)
Hospital Formulary
created and maintained by the P&T committee. Creates list of what hospital will stock.
Pharmacy & Therapeutics Committee
evaluates potential changes to formularies, including adding medications that have been recently approved, adding medications that are requested by hospital staff, or removing medications that are no longer deemed valuable to the hospital or safe for patients.
General Inventory
inventory of all prescription products annually
Perpetual Inventory
process of documenting the addition or subtraction of each drug as it is occurring. The result is a continuously accurate real-time count of the drug in the pharmacy’s possession.
CII done this way
CS Inventory
Must be done upon Initial DEA Reg. And Q2 years some states require Q year.
non-controlled is moved into a controlled substance schedule, or a controlled is moved to a new schedule, an inventory of that specific drug must be performed the day the classification change.
CII by manual count. CIII-CV by estimated unless bottle is over 1,000 then manual.
ALL on premises.
Retained for 2 years
CS Inventory Requirement
The date the inventory was taken
An indication if the inventory is taken at the beginning of the day (before any prescriptions are filled) or the end of the day (after the pharmacy is closed)
The name of each controlled substance inventoried
The strength and dosage form (10 milligram tablet, 10mg/mL oral solution)
The number of dosage units or volume in the commercial container (e.g., 100 tablet bottle)
The number of commercial containers (e.g., four 100 tablet bottles)
The total count of the substance
Discrepancy accounted for
Form 41
reports breakage or spillage of CS
Signed by 2
CS Theft
Report to DEA Field office, state regulatory agency, and local law enforcement
Significant or recurring reported on form 106
Cycle stock
is the regular inventory that is needed to fulfill orders
