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Controlled Drugs & Substances Act
(CDSA) and Narcotics Safety and
Awareness Act (NSAA) Questions with
key solutions.
CDSA - CORRECT ANSWER -Controlled Drug and Substances Act
- Federal Law
- It applies to the handling of controlled substances in Canada
- Export, import, and distribution of all controlled substances in Canada
NSAA - CORRECT ANSWER -Narcotic Safety and Awareness Act
- provincial act
- affects the dispensing in Ontario of monitored drugs
What is an Act? - CORRECT ANSWER -outlines what may or may not be done
What is a Regulation? - CORRECT ANSWER -gives more details about how the
act is going to be achieved
What is a Schedule? - CORRECT ANSWER -list of information
What are the 2 acts that make up the federal legislation for controlled substances? -
CORRECT ANSWER -Controlled Drugs and Substances Act
Food and Drugs Act
What regulations fall under the CDSA? - CORRECT ANSWER -Narcotic Control
Regulations Benzodiazepines and other targeted substance regulations
What regulations fall under the food and drugs act? - CORRECT ANSWER -
Food and Drugs regulation
What are the 3 major drug classifications for controlled substances? - CORRECT
ANSWER -Narcotics
Controlled Drugs Benzodiazepines and other targeted substances
What are controlled substances? - CORRECT ANSWER -- Refers to a
substance which can alter mental processes and that may produce harm to one's health and to society when disturbed or used without supervision
What are controlled drugs? - CORRECT ANSWER -- Refers only to the items
listed in schedule G to the FDA regulations
What is the definition of a narcotic? - CORRECT ANSWER -- A narcotic is any
substance, or anything that contains a substance included in the schedule to the Narcotic Control Regulations (NCR) *Most strictly regulated
- Easily identified since the manufacturers stock bottles must be labeled with an "N" symbol adjacent to the trade name
What classifies as a narcotic drug? - CORRECT ANSWER -- Containing only a
single narcotic ingredient (codeine tablets)
- All narcotics in an injectable form for parenteral use
- All narcotic compounds containing more than 1 narcotic drug
- All narcotic compounds containing less than 2 other non-narcotic ingredients
- All products containing methadone, hydrocodone, oxycodone, or pentazocine
What are the basic rules to narcotic drug prescriptions? - CORRECT ANSWER --
Require a written or faxed prescription from the prescriber
- Cannot be ordered verbally
- Narcotic drug prescriptions cannot be refilled. These drugs may be prescribed as part fills and dispensed in divided portions.
- For part fills, the total quantity to be dispensed must be indicated as well as the part-fill quantity
- Transfers of narcotic drugs are not permitted, including part-fills
What must the narcotic receipt/hard copy show? - CORRECT ANSWER -- Name
and address of patient
- Name, strength, quantity of drug
- Manufacturer of drug
- Directions for use
- Name and address of prescriber
- Identification number
- Price charged
- Date of dispensing
- Signature of the person dispensing the drug, and the person receiving a. verbal prescription
- Must include information that a prescriber must provide for these prescriptions
- Products must not be visible to the public
- If they can see it - they may be influenced to buy it What are the main differences between narcotic drugs vs narcotic preparations? -
CORRECT ANSWER -Narcotic drug - contains 1 or more narcotic ingredients
- Less than 2 non-narcotic ingredients
- Containing methadone, hydrocodone, oxycodone Narcotic preparation - only one narcotic drug
- 2 or more non-narcotic ingredients
- Not for injection
- Does not contain methadone, hydrocodone, oxycodone What are the guidelines regarding quantity authorized on narcotic prescriptions? -
CORRECT ANSWER -stated amount of the prescription to be given must be an
actual numerical value or a value that can be calculated
- must contact doctor if unsure about anything What steps must pharmacists take when dispensing a narcotic prescription? What are
the general guidelines? - CORRECT ANSWER -- Verbal prescriptions for
narcotic preparations can be accepted by a pharmacist or registered pharmacy student
- All reasonable precautions must be taken to ensure validity of a prescription for a narcotic
- pharmacists are expected to verify the prescription if the prescriber is not known to the pharmacist
- Must ensure that the prescription is authentic and appropriate
- Verbal prescription narcotic may be dispensed upon receipt of a verbal order from a person that the pharmacist has taken reasonable precautions to ensure it was a real practitioner that prescribed What rules must a physician "in a notice" must follow? What does this mean? -
CORRECT ANSWER -- A term used to indicate that a practitioner or other HCP
has a restriction on their practice with respect to controlled substances
- A practitioner or pharmacist named in a notice:
- Is listed in a letter sent to all pharmacies indicating restrictions for some or all controlled substances
- Is not allowed to prescribe some or all controlled substances
- Is not allowed to order some or all substances for their pharmacy
- Not allowed to be a manager
What is Double Doctoring? - CORRECT ANSWER -- Anyone who obtains a
controlled substance from a practitioner must disclose if they have received a prescription for any controlled substances within the 30 days of another practitioner
- Onus on the patient to share this information
- Intentional abuse or diversion of controlled substances cannot be assumed, but when identified, provides further opportunity for pharmacist intervention and patient education and support
Are refills allowed on narcotic prescriptions? - CORRECT ANSWER -no - not
permitted How does a physician allow for repeated dispensing on a narcotic prescription? -
CORRECT ANSWER -- To allow repeated dispensing of a narcotic, the
practitioner must authorize a larger total quantity that is stated on the initial prescription to be dispensed in smaller portions or part-fills
- A practitioner may also indicate an interval, although not legally required, between dispensing of the divided portions
- If there is no interval on the prescription, the pharmacist could use professional judgement to monitor the patient's adherence to drug therapy
- It is important to note that the interval becomes part of the prescription and must be followed
What is the difference between a part-fill and a refill? - CORRECT ANSWER -
Part-fill: have a total quantity authorized which is divided into smaller portions that is dispensed to the patient over time Ex) prescription for 120 tablets to be dispensed in part-fills of 30 tabs Refill: smaller authorized quantity that is multiplied and dispensed repeatedly Ex) prescription for 30 tablets with 3 repeats, so dispensed 4 times to give a total of 120 tablets
What is methadone? - CORRECT ANSWER -- Methadone is more strictly
regulated than other narcotics with respect to who can prescribe it and how it is dispensed
- Methadone is a narcotic that is prescribed as treatment for opioid dependence and pain
What is a practitioner with exemption? - CORRECT ANSWER -- Not all
practitioners are allowed to prescribe methadone
- Regulations refer to a practitioner with an exemptions, which they must get from the office of controlled substances -Exemptions can apply to either MMT or pain
- Practitioner who wishes to provide methadone must have separate exemptions
- Exemptions have an expiry date attached
What are the 2 reasons for the prescribing of methadone? - CORRECT
ANSWER -- For addiction treatment or methadone maintenance treatment (MMT)
What steps does Health Canada recommend to limit loss and theft of narcotic products?
- CORRECT ANSWER -- Immediately after receiving a shipment, verify shipping container for tampering
- Immediately verify the quantities in the shipment and document any discrepancies
- Complete a physical check of the products for tampering
- Ensure contents are recorded in register and place in secure location
- Document any discrepancies on the Health Canada Loss and Theft form within 10 days of its discovery
- Report loss to the OCP, local police, and licensed dealer
What must pharmacies do with inventory records? - CORRECT ANSWER --
Have systems and procedures in place when these medications are ordered and received
- Once received, the medications are under the pharmacist's control
- Reconcile shipments as soon as they are received
What is an emergency supply for narcotics? - CORRECT ANSWER -- When
there are times that a pharmacy does not have sufficient supply of a narcotic medication for this patients needs
- A pharmacist may purchase an emergency supply from another pharmacist
What must the written order of a narcotic emergency supply include? - CORRECT
ANSWER -- Name and address of ordering pharmacy
- Name of medication -Quantity requested -Signature of ordering pharmacist
- Written order can be delivered in person or faxed
- Can only purchase enough to fill the prescription you have on hand at the time of the request
- Must record the purchase
What does a loss refer to? - CORRECT ANSWER -"loss" refers to any activity
that would lead to a loss of narcotics, including:
- Theft
- Forgeries
- Expired drugs
- Miscounts
- Damaged drugs
- Mishandled drugs
Where should losses be reported to? - CORRECT ANSWER --Police
(immediately)
- Office of Controlled substances, Health Canada (within 10 days)
What are the 2 forms of reporting loss? - CORRECT ANSWER -§ Loss and theft
report form § Forgery report form
What identifying factors can help identify a forged prescription? - CORRECT
ANSWER -Are the patient and prescriber known to you?
- Does the patient live or work nearby? (Why are they here?)
- Do the quantities/directions differ from the norm
- Can you verify prescribers address, phone/fax number? ·-Does the prescription look original, or has it been photocopied?
How do you report a forgery? - CORRECT ANSWER -Reporting a forgery is the
same as reporting a loss except:
- A forgery must be reported even if the prescription was not filled
- The Forgery Reporting Form requires details, including if filled or not
What is a prescription forgery? - CORRECT ANSWER -- A forged prescription is
a loss of the controlled substance
- It is the responsibility of the pharmacist to use their professional judgement when determining the authenticity of such prescriptions
What systems are in place for securing narcotic prescriptions? - CORRECT
ANSWER -- Verifying prescriptions
- Ensuring safe storage
- Monitoring of use and inventory levels
- Security systems and video surveillance of storage area
- Reconciliations
What is narcotic reconciliation? What all does it include? - CORRECT
ANSWER -Narcotic reconciliation is one of the tools to monitor the inventory of
controlled substances to protect from diversion and theft
- Counting inventory is not sufficient as it only tells what is on hand at the time
- Inventory must be used as a point of comparison to allow for reconciliations and detect any discrepancies
- It is a detailed audit that validates current inventory on hand
- Used to assess losses, overages, and identify problems in dispensing process or inventory control
What must be completed to do narcotic reconciliation? - CORRECT ANSWER --
Starting inventory
- Add purchases (including from other pharmacies for emergency use)
- Deduct sales (Rx dispensed)
- Inventory should be on hand is the physical count
What are the rules around controlled drug refills? - CORRECT ANSWER -
Controlled drugs in part 1 can be refilled if:
- The practitioner indicates this on a written prescription at a the time it is issued
- The written prescription must have the number of refills and dates for, or the intervals between refills If prescription is verbally, no refills are permitted but part fills are allowed Controlled drugs in part 2 and 3 can be refilled if:
- The practitioner directs refills on either written or verbal prescriptions at the time it is issued
- The practitioner must indicate the number of refills and the dates for, or the intervals between, the refills
How long must controlled drug records be kept for? - CORRECT ANSWER -
Records are to be kept for at least 2 years according to these regulations In Ontario, patient records are to be kept for 10 years since the date of last service was provided
What is done for the loss, theft and forgery of controlled prescriptions? - CORRECT
ANSWER -Pharmacists must take responsibility for the safety and security of the
controlled drug inventory as for narcotics
- Same reporting for narcotics What are some examples of benzodiazepines and other targeted substances? -
CORRECT ANSWER -o Alprazolam
o Diazepam o Lorazepam
How to identify benzodiazepines? - CORRECT ANSWER -Have a T/C in a
square on bottle
What are the prescription regulations for benzodiazepines? - CORRECT
ANSWER -o Can be faxed, verbal, written
o Only valid for one year from date prescribed
Are refills allowed for benzodiazepines? - CORRECT ANSWER -o Refills are
permitted o No interval is required, but practitioner can put one and must be honoured o Refills are valid for only one year from the day first prescribed
What are the rules for transferring benzodiazepine prescriptions? - CORRECT
ANSWER -- May be transferred from one pharmacy to another, except where a
prescription has already been transferred
- Prescriptions may be transferred once and cannot be transferred any further
- The date the prescription was authorized is also required when the transferring pharmacy when it is providing the legally required information to allow the transfer
Who is responsible for the ordering of controlled substances? - CORRECT
ANSWER -- In Ontario, only authorized persons may order controlled substances
- Designated manager is responsible for purchasing, receiving, storing, distributing, and disposing of medications in the pharmacy, including controlled substances
- The designated manger is identified by OCP as a narcotic signer
What is the narcotic signer? - CORRECT ANSWER -- Term used in Ontario to
identify a pharmacist that is permitted to order controlled substances from licensed dealers on behalf of the pharmacy
- Only a pharmacists is designated as a narcotic signer by the pharmacy owner or designated manager has the authority to order controlled substances
- Not everyone employed at the pharmacy can be a signer
How can controlled substances be ordered? - CORRECT ANSWER -- Writing
(fax)
- By a remote input device
- Verbally over the phone
- Pharmacies must purchase medications only from reputable sources
- Narcotics can only be sold at licensed dealers (wholesalers) that have a license and are regulated by Health Canada
What is the signed receipt for, for controlled substances? - CORRECT
ANSWER -- Receipt must be returned to the licensed dealer within 5 business days
- Pharmacist verifies what they are signing for is what was received
- The pharmacist who signed and returned the order to the licensed dealer has taken responsibility for the order delivered to the pharmacy
- If the signed receipt is not returned within 5 business days, the licensed dealer cannot supply any further quantity of the substances by that pharmacist until the receipt is returned
What are the regulations of the destruction of controlled substances? - CORRECT
ANSWER -- The regulations to the CDSA require that pharmacists:
o Take all steps necessary to protect the security of these drugs in their possession o Ensure that these drugs are accounted for, through inventory counts and reconciliation
- Is a provincial legislation affecting the prescribing and dispensing of monitored drugs in Ontario
- The act was created to help control inappropriate prescribing and dispensing, inappropriate use or misuse, and diversion of monitored drugs
Why is the Ontario's narcotics safety and awareness act important? - CORRECT
ANSWER -- Narcotics related deaths
- Drug abuse and addiction
- Pharmacy theft of prescription narcotics
- Risk to the health and safety of Ontarians and pharmacy staff
What is a monitored drug? - CORRECT ANSWER -- Any controlled substance
listed in a schedule in the CDSA
- Other drugs not listed in CDSA that the ministry of Health wishes the track
- Any other drug as listed in the ministry of health
What is the Narcotic Monitoring System? - CORRECT ANSWER -- Information
on prescribing and dispensing activities is collected in a provincial database, Narcotic Monitoring System (NMS)
- The NMS acts as a central database to allow for drug utilization reviews of monitored drugs
- Documentation requirements for both prescribers and dispensers/pharmacies
What are the prescription requirements for monitored drugs? - CORRECT
ANSWER -- Patient identification number (health card)
- Type of ID shown
- Prescriber registration number
- Patient name
- Date
- Name and address of prescriber
- Name, strength, quantity of monitored drug
- Directions for use What requirements must be met for a pharmacy to submit a prescription to NMS? -
CORRECT ANSWER -- Prescriber registration number and regulatory body
where registered
- Patient ID number and type of ID used
- Name of the patient
- Birth date and gender of patient
- Date dispensed
- DIN
- Quantity of monitored drug dispensed
- Length of therapy (in days)
- Prescription number
- Pharmacist registration number (OCP number)
- Pharmacy ID
What are the acceptable forms of ID for receiving a monitored drug? - CORRECT
ANSWER -- Healthcare of Driver's license
- Ontario Photo card
- Birth certificate
- Valid passport
- Certificate of Canadian citizenship Is the dispenser/pharmacist required to check ID for narcotic prescriptions? -
CORRECT ANSWER -not required to check the patients ID, but should use
professional judgement to determine when it needs to be used for verification purposes
What may NMS identify? - CORRECT ANSWER -An alert is used to the
pharmacy at the time the prescription is being dispensed if a concern is identified through a DUR May identify:
- Duplicate prescriptions from different prescribers (double doctoring)
- Duplicate prescriptions from multiple pharmacies (polypharmacy)
- Alerts to help identify possible concerns with inappropriate use of monitored drugs but must be considered along with other information obtained while providing patient care
What is a Data integrity check/DUR? - CORRECT ANSWER -The data integrity
check will ensure that the information submitted is complete
- If the patient ID number is missing, NMS will not review the data
- Drug utilization reviews (DUR) are based on analysis of the current dispensing record and previous dispensing records to identify potential drug therapy concerns
Is patient consent required for information regarding to NMS? - CORRECT
ANSWER -Not required when submitting information to the NMS
- Patients cannot choose to withdraw from the requirements of this act, and patients must comply with the information required by the NMS to receive a prescribed monitored drug
- Provides a complete account of all prescriptions for monitored drugs dispensed in Ontario
- Supports ongoing improvements in the way these drugs are prescribed, dispensed, and used What are the exemptions to providing information to NMS? (do not have to monitor) -
CORRECT ANSWER -Hospital in-patients where monitored drugs are provided
as patients treatment in hospital
- Once they are out of hospital, they are subject to NMs
