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Extreme caution should always be used when handling or disposing of hazardous material. When near or in contact with any of these types of materials, you need to use personal protective wear as outlined in the ____________ for that specific product.
Safety Data Sheet (SDS)
Hazardous materials can be defined as...
any chemical or drug that poses potential harm to the person preparing or coming in contact with it
The ___________ has standards to protect employees who work with hazardous materials. This includes proper personal protective equipment (PPE) and procedures for dealing with different types of hazardous substances.
Occupational Safety and Health Administration (OSHA)
How should hazardous materials be stored?
Separate from other materials, often in a negative pressure room
Hazardous materials also need to be stored in a ___________ container that is labeled as __________ until it is disposed of safely.
leakproof; "hazardous drug waste"
Equipment available in your workplace to emergently help minimize exposure and injury could include...
an eyewash station, shower, or other emergent cleaning mechanisms.
Is PPE required for non-hazardous materials?
Non-hazardous waste may not pose a risk of potential harm to the individual but may pose a risk to _______ if not disposed of correctly, entering waterways, landing in solid landfills or destroyed by incineration
Non-hazardous waste can range from materials used to____________ to products that have...
prepare a compounded product; passed their intended expiration date
any medication, or ingredient used to make such medications, used for therapeutic treatment
Medicine like warfarin, tretinoin, finasteride, and methotrexate fall under the __________ pharmaceutical substance list. __________ pharmaceutical substances include drugs like amoxicillin, diphenhydramine, ranitidine, or atorvastatin. __________ pharmaceutical substances can be sent back to the manufacturer for reverse distribution.
hazardous; Non-hazardous; Expired
Vaccines, syringes, and needles must be disposed of in a ___________ to prevent an accidental needle stick.
____________ substances are medications that carry a high risk for abuse and misuse. These types of medications are highly regulated by the _______ and are categorized into __________ based on their level of potential abuse and misuse. Each pharmacy contains a __________, such as a vault or locked cabinet, where certain controlled medications are segregated to maintain accurate inventory and reduce the potential for diversion.
Controlled; DEA; schedules; designated area;
policy for movement of controlled substances
From the manufacturer to the pharmacy to the patient, each step in the life cycle of a controlled substance must be traceable to ensure proper handling and minimize any potential for diversion or unethical practices.
Schedule ___ prescriptions must be sent electronically from the practitioner to the pharmacy or handwritten on a secure prescription blank if the practitioner has a waiver on file (dependent on the jurisdiction).
Faxes are only acceptable for _______ or ________ patients.
hospice; long-term care
__________ emergency Schedule II prescriptions are limited to a __-hour supply or enough to cover the emergency period, depending on the jurisdiction. ________ emergency Schedule II prescriptions must be followed up with an electronic or hard copy per DEA regulations.
Telephonic; verbal; 72
To combat the current opioid crisis, some states limit the day's supply and amount of opioid(s) that can be prescribed to _____ morphine milliequivalents (MME) per day.
Anything above this amount would require a certain exemption and _____ code
What can be altered on a Schedule II prescription?
Nothing, even with confirmation from the practitioner
What should be done if the Schedule II prescription has an error?
Send a new one
The expiration date is based on your state's regulations, typically within ________ of the written date, as federal regulations do not suggest a specific time limit.
Remember, with regard to pharmacy regulations, pharmacies must follow both federal and state laws. However, when each is different (for example, the expiration of a Schedule II prescription), the ______ must be followed. Schedule IIs are typically limited to a ___-day supply maximum per state regulations.
stricter of the two; 30
Schedule III-V prescriptions can be handwritten, electronically sent, faxed, and even taken over the phone. These have a lesser risk for abuse compared to the Schedule II classification. These prescriptions are valid for ________ months from the date written and are limited to a __-day supply maximum per fill.
Schedule II prescriptions are not permitted to be written with any refills. If a patient's insurance has specific quantity limits or the patient does not want to fill the entire quantity of a Schedule II...
the remainder is forfeited and cannot be refilled
__________ patients are eligible to partially fill a Schedule II in increments, and such prescription expires ____ days from the written date. Schedule III-V prescriptions are limited to a maximum of ____ refills or ____ months.
Hospice; 60; five; six
Controlled substances cannot be filled early. Typically, a ________-day leeway period is acceptable; however, some insurances will reject the pharmacy claim until the actual day the refill is due
one to two
Schedule III-Vs can be transferred between pharmacies _____ time(s) only unless the pharmacies share an online, real-time database. In that case, the prescription can be transferred between the two locations until it expires or there are no refills remaining. By law Schedule II medications can be transferred _______.
All transfers must occur between ________. The prescription should be ________ by the original pharmacy and the current pharmacy should...
two pharmacists; voided; notate that it is a transferred prescription
Schedule III-V transfers are indicated by law for _______ purposes only. This means that if the prescription was never initially filled, it is _________
What should be included when transferring a prescription?
Original prescription date and dispensing date
Number of refills remaining
The name of the transferring pharmacist
The DEA number, name, and address of the transferring pharmacy
Schedule ___ drugs have the highest potential for abuse. They are not on the market because...
I; they are not acceptable medical treatments and lack therapeutic benefit
To find out if a prescription is valid, first divide __________. Then multiply __________.
Finally, multiply that product by the drug's __________.
the supply by the daily amount needed; the strength by the daily amount needed; MME conversion factor
The prescription is valid for dispensing if doesn't exceed the _________ or _________ limitations
MME/day; day supply
Here are a few of the most common opioids seen in pharmacy practice and their MME conversion factors:
Morphine = ____
Oxycodone = ____
Hydrocodone = ___
Codeine = ____
1; 1.5; 1; 0.15
The _______ enforces the controlled substance laws and regulations in the United States in an aim to minimize the potential for drug diversion or illegal practices.
DEA (Drug Enforcement Agency)
According to the ____________, handlers of all controlled substances need to maintain accurate and up-to-date records and inventory, keeping the pharmacy aligned with federal regulations. It can help prevent the ________ and _______ of meds.
Comprehensive Drug Abuse Prevention and Control Act of 1970/Controlled Substances Act of 1970; diversion; misuse
Categories for record keeping:
1) Schedule II
2) Schedule III-V
3) Non controlled substances
Pharmacies and practitioners must be registered with the ____ for prescribing and dispensing a controlled substance. Each is given a unique _______, which can be verified manually.
DEA; DEA number;
It is the responsibility of the pharmacist to verify a practitioner's DEA number as being active. In general, the DEA number consists of _____ letters followed by _____ numbers. The first letter identifies the type of _____ and the second letter is the first letter of the ________'s last name.
two; seven; DEA registrant; prescriber
1. Add the first, third, and fifth numbers together.
2. Add the second, fourth, and sixth numbers together.
3. Multiply the sum in the second step by 2.
4. Add the total from steps 1 and 3 together.
5. Verify that the second digit of the sum in step 4 is the same as the last digit of the prescriber's DEA number.
In addition, practitioners, as well as pharmacists, must check the __________ periodically to keep track of a patient's complete controlled substance history. This monitoring helps to cut down on polypharmacy, doctor shopping, and early fills.
Prescription Monitoring Program (PMP)
The ________ is responsible for regulating the safety and efficacy of medical devices, drugs, and biologics. They must approve each medication before it can be put on the market. It also regulates manufacturing, labeling, dispensing, and post-market surveillance.
Food and Drug Administration (FDA)
The FDA requires some medications to have a ________ warning on a medication's packaging. These warnings aim to alert healthcare providers and consumers of serious potential adverse effects or life-threatening risks. Opioid _________ contain this type of warning alerting the product's high risk of abuse, misuse, and addiction in addition to the potential for life-threatening respiratory depression.
black box; analgesics
The FDA has also put into effect the ______ program that requires adequate training be available for healthcare professionals who manage pain.
Opioid Analgesic Risk Evaluation and Mitigation (REMS)
Additionally, the FDA provides post-marketing surveillance of medications to monitor safety and efficacy concerns after a medication has come to market. In _______, the FDA required a _________ on opioid medications to guide providers on dose tapering prior to discontinuation due to reports of harm caused by abrupt discontinuation. _______ is the FDA's safety and adverse event reporting program.
2019; label change; Medwatch
For Schedule II drugs, after receiving an order, the _____ on duty must _______ each item and document the date each was received on copy three of the original order form that accompanies the order. Copy three of each order form must be maintained in the pharmacy for at least _____ years.
pharmacist; verify; two
There are no special requirements for ordering or receiving Schedule _____ drugs. Follow the rules for non-controlled drugs.
Controlled substances must be stored properly, as these medications are highly regulated. Schedule ___s must be kept under lock and key and in their own designated __________. This vault or cabinet must be equipped with a proper locking mechanism in addition to having ________ positioned on it at all times. Schedule _____s can either be dispersed throughout a pharmacy's non-control medication inventory or in their own area of the locked vault. Either way, _____ must be positioned on these medications as well. It is the preference of the _______ and pharmacy ______ on how they decide the Schedule III-V should be stored.
II; vault or cabinet; multiple cameras; III-V; cameras; pharmacist in charge; owner
Schedule II drugs must be ordered using a ______ form. This form is specific to Schedule II drugs, must be completed in triplicate, and can be handwritten or typed.
The three copies are retained by different stops in the supply chain to ensure consistency. The top copy is for the __________, the middle copy is sent to the ______, and the bottom copy is sent _____________________.
supplier of the Schedule II medications; DEA; back to the purchaser
Once filled out, the DEA 222 form is valid only for ___ days. A maximum of ____ different medications can be ordered on one form, and the form must be signed by the pharmacist who is registered with the DEA. The registrant pharmacist is typically the pharmacist in charge or the pharmacy manager.
Alternatively, a __________ can be used in place of a DEA 222 form for ordering Schedule II drugs. The pharmacy must meet specific electronic requirements to ensure digital security when using this alternative. It has largely replaced the use of paper DEA 222 forms due to convenience and ease of use.
Controlled Substance Ordering System (CSOS)
As of ______ 2019, the DEA has ruled in favor of a ______ copy DEA 222 form to replace the previous triplicate format. The previous triplicate format can be used in a transition period of up to ___ years following the ruling date. When the single form is being used, the purchaser must retain a copy and send the original to the _____. If a pharmacy or practitioner is the supplier, they must also send a copy by mail or email to the ______.
October; single; two; supplier; DEA
What must be on the pharmacy labeling of a controlled substance to be compliant with federal regulations?
Pharmacy name & address
Drug name, strength, dosage form, quantity, and number of fills (if CIII-V)
Directions for use & any applicable cautionary verbiage
What FDA warning must be present on the label?
"Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."
A prescription is only valid and able to be dispensed if it is written for a _________ under the usual scope of practice of the prescribing practitioner.
legitimate medical purpose
The medication must legally be dispensed to the patient or a _____________. If the controlled substance is dispensed to anyone else, it is not considered dispensing, but instead ________
member of their household; distribution
Typically, a valid form of ______ is recorded by the pharmacy upon pickup. This is to document the identity of the individual picking up the prescription and help limit diversion.
Although there is no federal quantity limit on controlled prescriptions, state law depending on jurisdiction typically limits Schedule II dispensing to a __-day supply and Schedule III-V to a __-day supply.
In the increased attempt to _______, some states are limiting narcotic Schedule II fills to a __-day supply for acute pain and __-day supply for chronic pain.
combat the opioid epidemic; 7; 30
________________ occurs when a pharmacy sends outdated, unusable drug product back to the drug manufacturer or other authorized distributor for processing or disposal. This may occur when drugs are returned by patients or the drugs are expired.
Outdated, damaged, or unwanted controlled substances may be _________ under the authorization of the DEA. To do so, the pharmacy or distributor must fill out a _____ form.
destroyed; DEA 41
A DEA 41 form must have...
Dates, location, and method of destruction
The NDC, name, strength, dosage form, and quantity of the medications being destroyed
Signatures of two witnesses of the destruction (should be employees)
___________ programs are a great way to safely dispose of unwanted prescription medications, regardless of being controlled or non-controlled. These programs occur a few times a year, typically at your local _______ or ________. These programs are beneficial as unwanted medications are _________ and disposed of correctly. In return, this inevitably makes the community a safer place since such unwanted medications do not end up in the wrong hands or our local waterways.
Take back; police station; university; voluntarily donated
In the event of lost or stolen controlled substances in Schedules II-V...
the DEA and local law enforcement must be notified immediately
In the event of lost or stolen controlled substances in Schedules II-V, the pharmacist must fill out a ________ form that details the medications involved in the theft. The original form is sent to the DEA and a copy should be retained for the pharmacy's records.
Spilling a small amount of a liquid or breaking a few tablets does not need to be reported. True or False?
True. Only a "significant" loss of controlled substances requires a DEA 106 form.
According to the ____________, the maximum amount that can be bought by an individual customer is _____ grams per day and 9 grams in a ___-day period. This refers to the base chemical, not the overall tablet strength of the product.
Combat Methamphetamine Epidemic Act of 2005 (CMEA); 3.6; 30
According to the CMEA, all products containing, ________, _____________, or ___________ must be kept ______________ to make sure all the required documentation is completed with the sale and to prevent theft.
ephedrine; pseudoephedrine; phenylpropanolamine; behind the pharmacy counter
An electronic or written _______ must be kept detailing the ________ of the person purchasing the product and the ________, _________, _____, and ______________ of the product.
logbook; personal information; quantity; strength; date; time of the sale
The ________ Program between the FDA and drug manufacturers helps limit inappropriate dispensing and protects patients.
Risk Evaluation and Mitigation Strategies (REMS);
Each drug has different criteria that must be met and this can include _____________, elements for _________ of the medication, a ___________ plan between healthcare providers and the patient, laboratory tests, etc.
patient education; safe use; communication
Isotretinoin can be very ________ if given to a pregnant woman. The ______ outlines the requirements to prevent disastrous effects. The law requires patients to have a _______ test and be counseled on safe use before being given a prescription. The patient also has a __-day time frame in which to fill his or her prescription and can only be given a __-day supply.
teratogenic; Isotretinoin Safety and Risk Management Act; blood; 7; 30
A patient comes to the pharmacy counter to purchase some Pseudoephedrine HCl 30 MG (24.6 MG base) tablets. Each box consists of 24 tablets. What is the maximum number of boxes he or she can legally buy from your pharmacy today?
3.6 gram daily limit per CMEA of 2005.
3.6 grams = 3,600 milligrams
3,600 milligrams / 24.6 base milligrams per tablet = 146 tablets
Each box contains 24 tablets, meaning this patient could legally purchase no more than 6 boxes from your pharmacy today.
In the event of a recall, the pharmacy MUST comply and the __________ and ________'s recommendations must be followed.
state BOP; Joint Comission;
During recalls, the pharmacist needs to ________ who might have been affected and reconcile the need for the recall. All recall records should be ________ in a similar manner as that for prescriptions.
contact all patients; maintained
The ____ can request a recall of any medical product available on the market. The _________ can also voluntarily recall a product due to a variety of safety concerns or product issues. These recalls are sent to ___________, which are then sent to the pharmacies who purchase and then supply to the public. If the recall is severe enough (Class __), it will require the pharmacy to personally reach out to any patients affected.
FDA; pharmaceutical manufacturer; distribution wholesalers; I
The most common reasons for a medication/device/supply/supplement recall include...
4) adverse effects
5) defective or hazardous medical devices
6) faulty components to medical supplies
Class __ is the most severe type of recall and involves medication that is likely to cause severe adverse effects or even death. This can also occur if one drug is labeled as another drug.
Class __ occurs when medication may cause temporary adverse health effects that are reversible or if there is a small risk of serious adverse effects.
Class ___ is the least severe type of recall. The medication in question is not likely to cause a patient to have adverse effects
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