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Jurisprudence Part 2 > CDSA & NSAA > Flashcards

CDSA & NSAA Flashcards

1
Q

What does CDSA stand for and what is it?

A

Controlled Drugs and Substances Act –> federal law that applies to the handling of controlled substances in Canada

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2
Q

What does NSAA stand for and what is it?

A

Narcotics Safety and Awareness Act –> provincial law that affects the dispensing in Ontario of monitored drugs

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3
Q

What is legislation made up of? (define the three main parts)

A

Act –> outlines what may or may not be done

Regulations –> detailed rules about how the act is to be achieved (can be changed more easily)

Schedule –> a list of information in an act

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4
Q

What are the two main acts for controlled substances in Canada?

A
  1. CDSA

2. FDA

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5
Q

What are the 3 major classifications for controlled substances?

A
  1. Narcotics
  2. Controlled Drugs
  3. Benzodiazepines and other targeted substances
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6
Q

What are the three main regulations for controlled substances and which acts do they come from?

A
  1. Narcotic Control Regulations (CDSA)
  2. Benzodiazepines and Other Targeted Substances Regulations (CDSA)
  3. Food and Drug Regulations Part G (FDA)
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7
Q

Why was the CDSA developed by the federal government?

A

To control the import, export and distribution of all controlled substances in Canada

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8
Q

What does the term ‘controlled substance’ mean?

A

Substance which has the ability to alter mental processes and that may produce harm to one’s health and to society when distributed or used without supervision

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9
Q

What is a controlled drug?

A

Controlled drug refers only to the items listed in Schedule G to the FDA regulations

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10
Q

What is the purpose of the Controlled substances Schedules 1-8 and how does this compare to NAPRA?

A

The schedules are for law enforcement; talks about penalties for manufacturing, possession and trafficking of controlled substances

NOT the same as the National Drug Schedules by NAPRA

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11
Q

Define Narcotic, how strictly are they regulated and how can you tell what a narcotic is?

A

Narcotic = Any substance included in the schedule to the Narcotic Control Regulation (NCR)

They are the most strictly regulated drugs and are marked with an N on the manufacturer label.

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12
Q

What are the two classifications of narcotics?

A
  1. Narcotic Drugs: Schedule N (written prescription, straight or reportable narcotics)
  2. Narcotic Preparations: verbal prescription narcotics and exempted codeine preparations
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13
Q

What do Narcotic drugs include?

A
  • product containing a single narcotic ingredient
  • narcotics in injectable form for parenteral use
  • narcotic compounds containing more than one narcotic ingredient
  • narcotic compounds containing less than 2 other non-narcotic ingredients
  • products containing methadone, hydrocodone, oxycodone, or pentazocine
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14
Q

What are qualities of a narcotic prescription?

A
  • cannot be ordered verbally
  • cannot be refilled
  • may be prescribed as part fills (total quantity dispensed and part fill quantity must be indicated)
  • transfers are not permitted
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15
Q

What are the dispensing requirements for narcotics that is different from the general requirements from the DPRA?

A

Prescribers must record on the prescription for a narcotic:

  • registration/license number
  • patient identification number
  • type of patient identification provided
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16
Q

Define Narcotic Preparation

A

ALL of the following requirements:

  • only one narcotic drug plus two or more non-narcotic medicinal ingredients in therapeutic doses
  • not intended for injection
  • not containing methadone, hydrocodone, oxycodone, or pentazocine
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17
Q

What are the qualities of a prescription for narcotic preparations?

A
  • may be verbal, written or faxed
  • may be accepted verbally by registered pharmacy students and interns under the direct supervision of a pharmacist
  • may not be accepted verbally by technicians
  • require the same dispensing information as narcotic drugs
  • cannot be refilled
  • cannot be transferred
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18
Q

Is Tylenol No. 2 a narcotic?

A

No it is a narcotic preparation –> one single narcotic ingredient (codeine is not on the list) and two non-narcotic medicinal ingredients

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19
Q

Define Codeine preparations

A
  • contains codeine up to a maximum of 8mg per solid oral dosage form or 20mg/30mL of liquid

AND

  • 2 or more active non-narcotic ingredients
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20
Q

What is the label that must be on the outside of a codeine preparation?

A

“This preparation contains codeine and should not be administered to children except on advice of physician, dentist or nurse practitioner”

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21
Q

What Schedule do non-prescription codeine products fall under and what are their conditions for sale?

A

NAPRA Drug Schedule II

  • must be sold from an area of the pharmacy where there is no opportunity for self selection
  • pharmacist intervention required to determine need and potential for harm
  • cannot be visible to the public
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22
Q

Define Advertisement and how does this apply to narcotics?

A

Any means of promoting directly or indirectly, the sale of a narcotic

  • pharmacies are not permitted to advertised
  • cannot advertise the sale of exempted codeine products through promotional print or web-based materials
  • products must not be visible to the public
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23
Q

Define narcotic prescription

A

An authorization given by a practitioner that a stated amount of the narcotic be dispensed for the person named in the prescription

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24
Q

When must the practitioner confirm an authorized quantity?

A

If:

  • prescription indicates “as needed” dosing
  • prescription has a flexible dosage (1-2 tabs tid for example)
  • prescription has interval between doses

AKA if the amount cannot exactly be calculated

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25
Q

What does it mean to be put “in a notice”?

A

The practitioner or pharmacist named in a notice has had their ability to order controlled substances revoked by the Office of Controlled Substances, Health Canada.

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26
Q

What does it mean if a pharmacist is ‘in a notice’?

A
  • they are listed in a letter sent to all pharmacies indicating restrictions for all or some controlled substances
  • they are not allowed to order some or all controlled substances to their pharmacy
  • they are not allowed to be a designated manager
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27
Q

What does the term ‘double doctoring’ mean and what does the CDSA do to prevent this?

A

Double doctoring: receiving multiple narcotic prescriptions from different practitioners

The patient must disclose if they have received a prescription for or have obtained any controlled substances within the preceding 30 days from another practitioner –> the onus is on the patient

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28
Q

What should a pharmacist do if there is no interval indicated on the prescription?

A

Use professional judgement to monitor patient adherence to the drug therapy

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29
Q

With respect to who can prescribe and how it is dispensed, what is the most strictly regulated narcotic?

A

Methadone –> for pain and opioid dependence

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30
Q

Who can prescribe methadone and what are the two types of exemptions for prescribing?

A

Practitioner ‘with exemption’ is allowed to prescribe methadone

Two types of exemptions:

  • for addiction treatment or methadone maintenance treatment (MMT)
  • OR for pain
  • *these exemptions have an expiry date and must be reapplied for when they run out
  • **As of May 19, 2018, practitioners no longer require a Section 56 exemption from Health Canada prior to prescribing methadone as per changes to the Narcotic Control Regulations (NCR).
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31
Q

Who can a pharmacist sell or provide methadone to?

A
  1. A licensed dealer
  2. Another pharmacist
  3. A hospital employee (practicing in a hospital, practitioner of medicine, dentistry, veterinary medicine or a nurse practitioner)
  4. A person exempted under s.56 of the CDSA with respect to methadone (no longer applicable)
  5. A person from whom the pharmacist has received a written order from a practitioner (exempted under s.56 of the CDSA with respect to methadone no longer applicable)
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32
Q

What are the dispensing requirements for methadone?

A

Owner or DM of a pharmacy that dispenses methadone must provide OCP with the following within 7 days:

  • notice of intention to dispense methadone
  • if accepting new patients
  • names of pharmacists trained to dispense methadone
  • hours of operation of the pharmacy
  • any changes in this status
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33
Q

What information is required to be kept in a record with respect to received narcotic drugs?

A
  • name of narcotic
  • quantity received
  • date received
  • name and address of licensed dealer
34
Q

How is the recorded information for received narcotics stored?

A
  • in a register
  • readily retrievable
  • kept in chronological order
  • kept for a minimum of 2 years
35
Q

What should pharmacies do to minimize loss and theft on receiving shipments of narcotics?

A
  1. Verify shipping container for tampering
  2. Verify the quantities in the shipment - document discrepancies
  3. Complete physical check of products for tampering
  4. Record contents in the register and place in secure location
  5. Document discrepancies on Health Canada Loss and Theft form within 10 days
  6. Report loss to OCP, local police and licensed dealer
36
Q

Why is it the sales record, along with the dispensing record, required for narcotic prescriptions?

A

This will make a consolidated list of all higher risk prescriptions and may be used to identify trends or patterns in prescribing or dispensing

37
Q

What is required on the written order for purchasing an emergency supply of narcotics?

A
  • name and address of ordering pharmacy
  • name of medication
  • quantity requested
  • signature of ordering pharmacist

***the amount purchased can only be enough to fill the prescription on hand at the time of the request

38
Q

What does the selling pharmacy have to do when supplying another pharmacy with an ‘emergency supply’ of narcotics?

A

Document the sale in their sales report, even if the product sold is not reportable like Tylenol No.2

39
Q

Who should loss of narcotics be reported to and what are the two forms for reporting loss?

A

Loss should be reported to the police (immediately for theft and forgery) and the Office of Controlled Substances (OCS), Health Canada (within 10 days of discovery)

Two types of forms for reporting loss:

  1. Loss and Theft report form
  2. Forgery report form
40
Q

What is the difference between reporting forgery and loss?

A

Forgery is considered to be a loss of narcotics

BUT

Forgery must be reported even if the prescription was not filled

41
Q

Who is responsible for protecting the narcotics in the practice site against loss or theft and how do they do it?

A

Pharmacists

  • verify prescriptions
  • ensure safe storage
  • monitor use and inventory levels
  • security systems and video surveillance of the storage area
  • reconciliations
42
Q

What is reconciliation of narcotics?

A

A tool that is used to monitor the inventory of controlled substances –> detailed audit of the inventory versus the expected inventory (drugs purchased and dispensed compared with current inventory)

43
Q

What does the frequency of reconciliation depend on?

A
  • volume of prescriptions for controlled substances dispensed
  • number of staff having access to this inventory
  • number of temporary or relief pharmacists
  • whether or not there have been problems in the past

***full reconciliation should be completed at least once every 6 months

44
Q

What information is required to be disclosed to the OCS within 10 days of permanent pharmacy closure?

A
  • names of drugs and exact quantities
  • where the controlled substances were transferred
  • date of pharmacy closure
45
Q

What are the three subdivisions of controlled drugs and what do they include?

A
  1. Straight controlled drugs and all combinations with more than 1 controlled drug
  2. Most barbiturates and others as listed
  3. Anabolic steroids and derivatives
46
Q

What is a controlled drug preparation?

A

All combinations containing:
1 controlled drug in either part 1, 2, or 3
AND
1 or more non-controlled ingredient in therapeutic doses

47
Q

Can a controlled drug be prescribed verbally?

A

Yes

48
Q

Can controlled drugs be transferred?

A

No

49
Q

Can controlled drugs be refilled?

A

Yes controlled drugs in part 2, or 3 can be refilled if:

  • practitioner directs refills on either written or verbal prescriptions
  • practitioner indicates the number of refills and the dates for, or intervals between the refills
50
Q

How are dispensing records for controlled and narcotic prescriptions kept?

A

Filed separately from all of the other prescriptions, usually together

Need to be filed in order by date and number sequence

51
Q

What must be included on the purchase record of narcotics?

A
  • name and quantity of the controlled drug
  • name and address of licensed dealer
  • date received
  • must be kept in chronological order and for a minimum of 2 years
52
Q

What subsections of controlled drugs require that sales records are kept for them?

A

Part 1 –> sales requirements are the same as narcotics

Part 2 and 3 –> sales records not required

53
Q

What is an important note for prescriptions for benzos?

A

Prescriptions are only valid for one year from the date prescribed, other than that the prescription requirements are the same as controlled drugs

54
Q

What are the requirements for refills for benzodiazapines?

A
  • refills are permitted
  • intervals are not required but if they are indicated, they must be followed
  • refills are only valid for one year after the practitioner issues the prescription
55
Q

Can prescriptions for benzos be transferred?

A

Yes but ONLY once

56
Q

Where can the prescription records for benzos go?

A

Can be filed with the narcotics and controlled drugs but can also be filed with the regular prescriptions –> as long as it is done consistently

57
Q

What is the difference between purchase records for benzos and narcotics?

A

A purchase record is required but unlike with the other targeted substances, there is not requirement for recording sales other than sales to other pharmacies

58
Q

Is there a quantity restriction on purchasing an emergency supply of benzos from other pharmacies?

A

NO but:

  • pharmacies should not be using other pharmacies as wholesalers
  • purchasing pharmacy must record the purchase
  • selling pharmacy must keep track of the sale
59
Q

Who is responsible for purchasing, receiving, storing, distributing and disposing of medications in the pharmacy?

A

The designated manager (DM) –> this is why pharmacists who are ‘in a notice’ cannot be a DM

60
Q

What is a narcotic signer?

A

This identifies a pharmacist who is permitted to order controlled substances from licensed dealers on behalf of the pharmacy

***this is a designation given by the owner or DM

61
Q

Who regulates licensed dealers of narcotics?

A

Health Canada –> they must obtain a license

62
Q

When does the signed receipt need to be returned to the licensed narcotic dealer and what happens if this is not done?

A

Within 5 (business) days

If no receipt has been returned, the dealer cannot supply more narcotics until the receipt has been returned

63
Q

What is the responsibility of the narcotic signer?

A
  • check to make sure that what is on the receipt is actually what was delivered to the pharmacy
  • the entire order is now the responsibility of the signer
64
Q

Are damage, expired, unused or wasted controlled substances still considered part of a pharmacy’s inventory?

A

Yes

65
Q

How do you get permission to destroy narcotics?

***not applicable anymore, pharmacists may proceed with local destruction without notifying and receiving acknowledgement from Health Canada

A

Fill out the destruction authorization form OR

provide this information to the OCS:

  • name, address, phone and fax numbers of the pharmacy
  • name and license number of submitting pharmacist
  • date
  • substance name, quantity and strength
  • expiry date of substance
  • lot #
66
Q

How are pharmacists to destroy narcotic medications?

A

Not specified by the CDSA however for public safety, the drugs are to be altered or denatured to render them more unlikely to be consumed

67
Q

What is OCS?

A

Office of Controlled Substances

68
Q

What is the process of destroying Benzodiazepines and targeted substances?

A

Do not need OCS approval for destruction

Record of destruction is required including;

  • name, strength, and quantity of targeted substance
  • date of destruction
69
Q

What do the precursor control regulations do?

A

Regulate the sale, purchase, possession and use of precursor materials for illoct drugs such as crystal meth

70
Q

What is the difference between the schedules that pseudoephedrine and ephedrine are placed in by the FDA versus NAPRA?

A

FDA states that this is not a drug, listed in natural health products

NAPRA lists products containing these substances as either Schedule II or III, restricting their sale to pharmacies

71
Q

What do the Marihuana for Medical Purposes Regulations do and how does this apply to pharmacies?

A

Allows patients to be able to access marihuana BUT pharmacies and pharmacists do not play a role in the purchase or distribution of medical marihuana

72
Q

What are the factors leading to increased risk of health and safety in Ontario in terms of narcotics?

A
  • narcotic-related deaths
  • drug abuse and addiction
  • pharmacy theft of prescription narcotics
73
Q

Define monitored drug

A
  • any controlled substance listed in a schedule in the CDSA
  • other drugs not listed that the Ministry of Health wishes to track
  • any other drug as listed by the Ministry of Health
74
Q

What is NMS?

A

NMS = Narcotics Monitoring System

Provincial database with information on prescribing and dispensing activities to allow for drug utilization reviews of monitored drugs

75
Q

What is a prescriber responsible for recording on a prescription for a monitored drug?

A
  • patient ID number and type of ID shown
  • prescriber registration #
  • other information required on a prescription

***verbal orders; pharmacist can document this on the verbal script record

76
Q

What information is the pharmacy required to submit to the NMS when dispensing a monitored drug?

A
  • prescriber registration # and registered regulatory body
  • patient ID # and type of ID
  • name of patient
  • DOB and gender of patient
  • date dispensed
  • DIN
  • quantity of monitored drugs dispensed
  • prescription #
  • pharmacist registration #
  • pharmacy ID
77
Q

What does the NMS do when receiving a dispensing record from a pharmacy?

A

Data Integrity Check –> ensures information submitted is complete

Drug Utilization Review (DUR) –> analysis of current dispensing record and previous dispensing record to identify potential drug therapy concerns

78
Q

What types of concerns will be alerted to a pharmacy when identified by a DUR?

A
  • duplicate prescriptions from different prescribers
  • duplicate prescriptions from multiple pharmacies

**should be discussed with the patient; patients should be included and informed in any discussions where there may be concerns with the use of monitored drugs

79
Q

Is patient consent required when submitting their information to the NMS?

A

NO –> they also cannot choose to withdraw from the requirements of the act

80
Q

What are the exemptions under which the NSAA does not apply and submission to the NMS is not required?

A
  • hospital in-patients where monitored drugs are provided as part of a patient’s treatment in a hospital
  • prisoners or inmates in correctional institutions, prisons, or in youth custody

***these prescriptions are not monitored

Jurisprudence Part 2 (2 decks)

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