Canadian Controlled Substances Legislation

Controlled Drugs and Substances Act (CDSA)

• A federal law applicable to handling controlled substances in Canada
• Developed to control the import, export, and distribution of all controlled substances in Canada

Narcotics Safety and Awareness Act (NSAA)

• A provincial act
• Affects the dispensing in Ontario of monitored drugs

Overview of Legislation

• Legislation are rules to follow when handling controlled drugs, ensuring safe drug supply and distribution to the public
• An act outlines what may or may not be done
• Regulation provides more detailed rules about how something is to be achieved
• A schedule is used when a list of information is required, typically contained in a section that includes drugs, lab tests, disease conditions, and international standards

Main Acts Governing Controlled Substances in Canada

• Controlled Drugs and Substances Act (CDSA)
• Food and Drugs Act (FDA)
• FDA defines how pharmacy professionals deal with different classes of controlled substances and how to achieve the derivatives outlined in the act

Classifications of Controlled Substances in Canada

• Narcotics
• Controlled Drugs
• Benzodiazepines or other targeted substances

Regulation Sets Governing Classifications

• Narcotic Control Regulation (under the CDSA)
• Food and Drug Regulations Part G (under the FDA)
• Benzodiazepines and other Targeted Substances Regulations (under the CDSA)

Controlled Substances

• Substances which have the ability to alter mental processes, and produce harm to health/society if distributed/used without supervision
• Controlled Drugs refers only to items listed in Schedule G to the FDA Regulations

Schedules of Controlled Substances

• Controlled substances are divided into Schedules I to VIII
  • Schedules not used by pharmacists/pharmacy technicians when dispensing prescriptions
  • Schedules used by law enforcement for manufacturing, possession, and trafficking penalties for controlled substances
  • They are not the same as the National Drug Schedules by NAPRA

Prescribing Authority

• Physicians, dentists, veterinarians, and any other person prescribed as a practitioner such as midwives, podiatrists, and nurse practitioners are allowed to prescribe
• Prescriptions not authorized for controlled substances by a health care professional are illegal

Narcotics Defined

• Includes any substance included in the Schedule to the Narcotic Control Regulation (NCR), and is strictly regulated
• Must be labeled with an "N" symbol adjacent to the trade name

Classification of Narcotics

• Narcotics Drugs (Schedule N): Commonly referred to as 'written prescription narcotics' or 'straight narcotics' or 'reportable narcotics'
• Narcotic Preparations (Verbal Rx Narcotics and Exempted Codeine Preparations): Any narcotic drugs that do not fit these definitions are classified as Narcotic Drugs
• Purchase and sale records, Rx requirements, and dispensing or sale to the patient differ between classes

Narcotic Drugs

• Products with only a single narcotic ingredient, such as codeine tablets
• Narcotics in injectable form for parenteral use, like meperedine injection
• All narcotic compounds with more than one narcotic drug
• All narcotic compounds containing less than two other non-narcotic ingredients
• Contains methadone, hydrocodone, oxycodone, pentazocine, or diacetylmorphine
• Heroin, even in combination with 2 or more non-narcotic medicinal ingredients
• Includes Teva-Lenoltec No.4 tab and Fentanyl patch

Narcotics Precription Rules

• Must be written or faxed, cannot be ordered verbally
• Cannot be refilled
• Must be prescribed and dispensed as part-fills in divided portions with the total and part fill quantities indicated
• Transfers are not permitted, including part-fills

Dispensing Requirements for Rx

• The dispensing record for all Rx must show the patient's name and address, drug name, strength, quantity, manufacturer, directions, prescriber's name and address, DIN number, price charged, and dispensing date
• Prescribers must record their registration/license number, patient identification number, and type of patient identification

Narcotic Preperations

• Contain only one narcotic drug plus two or more non-narcotic medicinal ingredients in therapeutic doses
• Not intended for injection
• Includes Teva-Lenoltec No.2,3 tablets and Fiorinal C1/2

Precriptions

• Verbal, written, or faxed
• Pharmacists in training can accept if under supervision of a pharamcist
• RPhT cannot accept verbally
• Must contain same dispensing information as narcotic drugs
• Cannot be refilled, only part fills and divided portions
• Transfers are not permitted

Exempted Codeine Preperations

• Are narcotic preparations with containing codeine up to 8 mg per solid oral dosage form, or 20 mg/30 mL of liquid
• Contains 2 or more active non-narcotic ingredients
• e.g acetaminophen/caffeine/codeine 8mg and Mersyndol

Refusal to Sell

• A pharmacist will not supply the product if they believe it will be used for non-medical/dental purposes
• Patients should be consulted and refused if misuse is expected

Conditions for Sale

• Non-Rx codeine products are NAPRA Drug Schedule II products
• Must be sold from an area where self-selection is not possible, and must not be visible to the public

Advertisement

• Any means of promoting directly or indirectly the sale or disposal of a narcotic
• Pharmacies cannot advertise exempted codeine preparations, or their sale through promotional print/web-based materials
• Products must not be visible to the public

Prescription for Narcotics

• "An authorization given by a practitioner that a stated amount of the narcotic be dispensed for the person named in the prescription"
• Mitte is the exact quantity the practitioner must specify or authorize

Quantity Authorized

• An actual numerical value (e.g., 50 tabs or 75 mL) which is stated by the prescriber
• Must be written or faxed for a narc drug, must be written, fax or verbal for (narc. preparations)
• Verbal Rx's are accepted by a RPh and intern pharmacist
• The validity of the Rx must be ensured
• Pharmacists are expected to verify the Rx if the prescriber is not known to the pharmacist, to reduce narcotic loss

Practitioners "in a notice"

• Notice indicating restriction on their practice with respect to controlled substances
• A practitioner/pharmacist in a notice of restriction is included online, and may not be allowed to prescribe some or all controlled substances, be a Designated Manager, or order some or all controlled substances for their pharmacy

Double-Doctoring

• When anyone obtains a controlled substance from a practitioner must disclose if they have received and Rx, or obtained, any controlled substances within the last 30 days from any other practitioner
• Signs of misuse/abuse should lead the pharmacist to intervene and educate the patient

Part-Fills

• Instead of refills, they are allowed for narcotics
• The prescriber must authorize a larger total qty that is stated on the initial Rx to be dispensed in smaller portions or "part-fills"
• If there is not interval indicated in the Rx, the pharmacist can use their professional judgment to monitor the patient's adherence to drug therapy

Refills

• A smaller authorized quantity that is multiplied and dispensed repeatedly

Methadone

• A narcotic that treats opioid dependence and pain

Selling or Providing Medicine

• A pharmacist may sell or provide methadone to a:
  • licensed dealer
  • another pharmacist
  • a hospital employee being practicing, or if there is a written order from a practitioner

Dispensing Requirements for Methadone

• The owner/designated manager (DM) of a pharmacy dispensing methadone must provide OCP with information such as:
  • notice of intention to dispense methadone
  • if accepting news patients
  • names of pharmacists trained to dispense methadone and any changes in this status

Methadone Education and Training

• The DM of a pharmacy dispensing methadone must be trained by completing the Centre for Addiction and Mental Health (CAMH) Opioid Use Disorder Treatment (OUDT) Course
• Must an an approved course within 6 months of beginning the practise
• Staff pharmacist must complete trainings within one year, and updated every 5 years
• Pharmacists should be trained and familiar with dispensing methadone documents

Narcotics - Maintaining Records Introduction

• Narc. Rx must be kept separate from regular Rx records
• Narc. dispensing records are often filed with controlled drug dispensing records
• Records for benzodiazepines/targeted substances may be filed with the narcotic and controlled drugs dispensing records but not a requirement

Records Retention

• Federal legislation requires records be kept for a minimum of 2 years
• The DPRA in Ontario requires electronic dispensing records be kept:
  • for 10 years from the last recorded professional pharmacy service provided to the patient
  • until 10 years after the day on which the patient reached 18 years of age

Purchase Records

• Regulations require pharmacies to keep a record of all narcotics received including:
  • name of narcotic, quantity received, date received, and name/address of the licensed dealer
• This info must be in a register, easily retrievable, in chronological order, lasting at least 2 years

Inventory Records

• System/procedures when medications are ordered/received: Once received, these medications must be under the control of the pharmacist
• Reconcile shipments as soon as they are received to ensure the safety of the narcotics, controlled drugs and targeted substances inventory in pharmacies

Sales Records

• When a narcotic is dispensed, the sale must be documented when dispensing
• All Rx software systems have ability to produce this sales record
• Ensures all narcotics are captured on the report, and is a consolidated listing of all higher risk Rx and to identify patterns prescribing or dispensing

Emergency Supply

• Pharmacies can purchase an "emergency supply" from another pharmacist if their supply is insufficient for their patient's needs
• This includes the name/address of ordering pharmacy, name of medication, quantity requested, and signature of ordering pharmacist

Emergency Order Rules

• A written order can be delivered in person or faxed
• Pharmacies can only purchase enough to fill the Rx they have at the time of the request, and they must record the purchase
• The pharmacy selling the narcotic must document the sale in their sales report, even if the product is not reportable

Loss, Theft, Forgery

• Loss refers to anything that would lead to a loss of narcotics, including: theft, forgery, expired drugs, miscounts, damaged or mishandled drugs
• Loss should be reported to the police immediately for theft/forgery, and to the Office of Controlled Substances (OCS), Health Canada within 10 days of discovery

Prescription Forgery

• A dispensing (either partially/fully) forged Rx is considered a loss
• The RPh and RPhT are responsible for using their professional judgement when determining the authenticity of an Rx

Controlled Drugs

• Found in Part G, Food and Drug Regulations
• Symbol "C" in a diamond shape
• Subdivided in 3 parts
  • Part I: All straight controlled drugs and al combinations with more than 1 controlled drug
  • Part II: Most barbiturates and others as listed
  • Part III: Anabolic steroids and derivatives

Controlled Drug Preperations

• All combos containing:
  • 1 controlled drug in either Part I, II, or III
  • 1 or more non-controlled ingredient(s) in therapeutic doses

Controlled Drugs - Prescriptions Introduction

• Prescriptions need valid authorization by a practitioner, and transfers are not permitted

Refills

• Written and faxed prescriptions, Part 1 are permitted if the prescriber has directed the number of refills and dates for, or intervals between refills
• If Rx is given verbally, no refills are permitted but part-fills are allowed
• For Part II or III, the practitioner directs refills on either written or verbal prescription at the time it is issued with dates and intervals

Prescription Record Rules

• Fill all dispensing records in order by date and number sequence
• Must be kept for at least 2 years according to regulations

Purchase Records

• Include name and quantity of the controlled drug, name and address of licensed dealer/pharmacist that provided it, date it was received, kept in chronological order and a minimum of 2 years

Emergency Supply Rules

• Regulations allow pharmacies/pharmacists to purchase emergency supplies of a controlled drug from another for a shortage of a particular product or delay in delivery
• The purchasing pharmacy must record the pharmacy in their controlled substance purchase records and the selling pharmacy must keep track of the sale

Sales Record Rules

• Required for Controlled Drugs, Part 1 and similar to narc drugs
• Not required for Controlled Drugs, Part II and III

Loss, Theft and Forgery Rules

• Pharmacists must be responsible for the safety and security of controlled drug inventory as for narcotics

Benzodiazepines and Other Targeted Substances Regulations

• Symbol is a T \ C in cubed shape, e.g. Alprazolam, Diazepam, Lorazepam.
• written, faxed, or verbal
• Valid for one year from prescribed date

Refills Rules

• Are permitted without interval
• If practitioner specifies intervals, they are honored, but refills are only valid one year from when practitioner issued prescription

Prescription Rules

• Can be with filed with narc. and controlled drugs, or with all other regular Rx

Transfer Rules

• May be transferred one time from one pharmacy to another
• Require the date of authorized Rx from transferring pharmacy

Purchase Record for Benzodiazepines and Other Targeted Substances

• Is required, although there is no requirement for the recording of sales of any targeted substances
• Only for Rx dispensing records or sales to other pharmacies

Emergency Supply

• Allowed if there is shortage or delay in delivery, no specific qty restriction, but professional judgment should be used
• Pharmacies should not use other pharmacies as wholesalers
• Purchasing pharmacy must record the purchase, and selling pharmacy must keep track

Ordering, Receipt, and Reconciliation of Controlled Substances

• Only persons authorized may order controlled substances

Designated Manager Responsibilities

• Purchasing, receiving, storing, distributing and disposing of medications in the pharmacy, including controlled substances
• Also considered a "controlled substance signer"

Controlled Substance Signer

• Term in Ontario for a pharmacist authorized to order controlled substances from licensed dealers on behalf of the pharmacy
• Only a pharmacist designated as a "Controlled Substance Signer" by the pharmacy owner/Designated Manager has the authority

Ordering and Purchasing Controlled Substances

• May be ordered: in writing (by fax), through a computer, verbally over the phone for drugs prescribed verbally

Signed Receipt of Order

• Must be returned to the licensed dealer within 5 business days
• If a drug is ordered verbally, the dealer must obtain a signed and dated receipt specifying the drug name and the quantity, within 5 working days
• The pharmacist who signed and returned the receipt is responsible for the order
• If unsigned receipt is not returned within 5 business days, dealer cannot further supply further qty until receipt is returned

Controlled Substance Reconciliation

• Responsible for the pharmacist to protect controlled substances against loss/theft
• Includes verifying Rx, ensuring safe storage, monitoring usage/inventory levels, security systems, and reconciliation

What is reconciliation?

• Audit of current inventory i.e. of drugs purchased / dispensed compared
• Used to assess losses, overages, and inventory problems

Completing a Controlled Substance Reconciliation

• Take baseline/starting inventory
• Add all purchases from wholesalers, manufacturers, and pharmacies used for emergency use
• Deduct all sales and prescription dispensed, including the amounts to other pharmacies for emergency use
• Expected inventory on hand equals starting inventory plus purchase amount, minus sales
• The actual inventory is the actual physical inventory count on hand
• Reconciliation requires reviewing expected and actual inventory and then reconciling any discrepancies between each other
• Must be reported to office of health Canada, office within 10 days of it being lost / stolen

How Frequently Should I Reconcile Controlled Substances?

• Volume of Rx for controlled substances dispensed
• Number of staff accessing inventory
• Number of temporary or relief pharmacies utilized
• If ther have been problems int he past

Pharmacy Closure

• The pharmacist must disclose the remaining inventory of controlled substances to the OCS
  • Where the controlled substances were transferred (to what pharmacy)
  • Name of drug and quality
  • Pharmacy Closure Date

Destruction of Controlled Substances

• The Regulations to the CDSA require pharmacists to take all steps necessary to protect the security of these drugs in their possession, ensuring they’re accounted for through inventory accounts/reconciliation

Destruction Procedure

• The pharmacist must destroy products in the presence of at least one other RPh, RPhT, and another practitioner
• The regulations to the CDSA do not specify how a RPh should destroy these medications, it is best to ensure drugs do not leave the pharmacy intact when sent off for medical waste disposal
• Drugs must be altered or denatured to become very unlikely of being consumed

Destruction Record Keeping

• Record Keeping requirements are different for local destruction versus licensed dealer destruction, and should be separated
• Local destruction records should contain: date of destruction, DIN number of container, number of containers destroyed, and witnessed by another practitioner who prints and signs

Other Regulations Under The CDSA - Intro

• Precursor Control Regulations regulates the sale/use of pseudoephedrine, commonly used in crystal meth
• According to the Federal Legislation, Pseudoephedrine and ephedrine are not considered drugs but listed in the Natural Health Products Regulation to the Food and Drug Act
• Falls from schedule II to schedule III under NAPRA that needs pharmacist intervention

Cannabis Act

• Pharmacists do not play a role in the purchase/distribution of medical cannabis

Narcotic Safety and Awareness

• Health and long term care are undertaken the initiatives to improve overall health/safety of all ontarians
• Partnering with health care sectors
• Identifying and reducing abuse, supporting narcotics, addiction

Narcotic Safety and Awareness Act (NSAA)

• Legislation regarding prescribing, dispensing of measured drugs in Ontario
• Created to help control inappropriate prescribing/dispensing, misuse, or diversion of measured drugs

Definition of Measured Drug

• Any controlled substance listed in Canadian Drug Substance Act
• Ministry of Health drugs that they wish to track
• Any other drug listed by the Ministry of Health

Narcotic Monitoring System

• Collects information on prescribing and submitting
• Acts as central data base

Prescriptions Requirement

• Patient identification like health card, type of ID, prescriber registration, patient name, date, address of prescriber, name, strength, quality and directions

Missing Patient Info

• If received verbally, document
• If missing, ask/document

Pharmacy Submission to NMS

• Measure drug to MNS included drug registration(body)
• Patient ID,name, date, number, length, registration, Pharmacy ID

Patient Identification

• must have government isued

Data Intergrity Check/DUR

• NMS checks everything when receiving recording with Date Intergrity and Drug Utilization Review

DUR

• Ensures correct information is sent by pharmacies that also identifies by drug concerns

Narcotic Monitoring system alerts

• Send allerts out to pharmacy with concerning issues

DUR includes

• Duplicate registration
• Duplicate pharmacies

Patient Consent

• Not requested with submitting information

NMS

• Provides complete prescription account
• Supports way to prescribed, dispense and use

Exemptions to NSAA

The NSAA does not apply:

• Hospitals, prisoner or inmates of correctional institutions, prisons

Safeguarding out communities act

• Introduced patch-for- patch program in
• Prescription, dispenser and patients in terms of dispensing and using Fentanyl patches

Drug Interchangeability and Dispensing Fee

• Provincial law that regulates drug interchangeability in Ontario
• Applied in addition to the other laws governing prescriptions in Ontario

(DIDFA) Overview

• Provides requirements/guidance
• Does not apply to public hospitals
• Clarifies interchangeability, fees
• May be confused with Ontario Drug BenefitsAct(ODBA) due to overlapping principles
• Principles are important, to apply community practices
• Safe to use quality generic drugs

Interchangeable Products

• Specified name designation with one or more designation as interchangeable as products
• Active ingredients are similar
• Executive officer- Responsible for ensuring interchange products/ensuring high quality

Defining "Drugs"

• Allows dispensers to replace or dispense a lower cost interchangeable
• Allows conditions/restrictions on "sale"

Understanding DIDFA

• Every RX in Ontario pharmacies ,providing requirements and guidance with dispensing
• Meets regulated practice in standards- pharmacists, techniques are protected with the dispensation
• Executive office - ensuring dispensing/designing as interchange

Formulary

• listing for dispense medications
• Identifying interchanges
• helps inventory purchases ,hospitals,drug plans

Overview of the formulary

• Divided into 12 points and contains links to products/benefit

Off Formualry Interchangabilty (ODI)

• Refers to original names products no benefited on formulary
• Executive officer determines non beneficial products

Not a benefit

• ODP dose not reimburse for product
• Cost option to pay
• Pharmacists intervene by talking to the writer

Is a benefit

• Reimbursed by ODP

Interchangeability VS.

• Applies to every dispensed Rx
• Is used in ODBA

Rules for interchangeable

• Consists of six subsections and contains rules for interchangeability and guidelines for all
• Serves foundation
• first 3- Preserves the patient

DIDFA

• Authority for dispense substitute. If a writer request with a specific product, the dispenser provides
• Therefore unless required dispensers trade name, branded and specifics

Interchangablitity

• dispenser that Dispense brand product and a substitute
• Patents must request product so the dispenser has no choice in products
• Put up on yellow boards "patients"

DIDFA Inform the PAtients

• If dispensing of product without knowing

Interchangeable, patient has right, has the right to ask to has specific of their choice

Amount of charge for the product/exceptions

Interchanges products for every practice

Interchangeable product.

• Selection for dispense products/active ingredients
• Products on formualt can change/noted non-formulary but on formylart may substituted

DIDFA substitution

• "Subsections do not apply to Rx."

• Written with "no subsitittion" direction for products

• Choose for patient , sub requested and cancel

• Prescriber no substitution requests,

• Must ask Patients to authorize

• Must maintain complete documentation on their chart

DIDFA Summary

• Dispenses a specific of manufacturer product

DIDFA Dispense the generic

• Doesn't specifically identity it.
• Chemical names are substituted
• The Dispenser is able to dispense something with the formulary
• Product with active ingredients.

Notice, Receipts and Records

• Yellow signs
• Yellow signs must be available to see the information while presenting prescription

Notice of Patients

• Patients have the right, products are substituted
• May request to be changed and known
• Usual customs/fee for dispensing services

Quantities Dispended

• Requirements for quantities of drugs in order/patients requested
• patients need document so acts for there right
• Quantifies can be reduced due to dispensing and documentary
• Didfa Requires community pharmacies to follow