Controlled drugs Flashcards
Which federal Acts and Regulations govern controlled drugs and targeted substances in Canada:
Controlled Drugs and Substances Act (CDSA)*
-Narcotic Control Act
-Benzodiazepines and Other Targeted Substances Regulations
Food and Drug (FDA) Regulations – Part G AND J
Controlled substances means
A substance included in Schedule I, II, III, IV or V
Practitioner means
A person who is registered and entitled under the laws of a province to practice in that province the profession of medicine, dentistry or veterinary medicine, and includes any other person or class of persons prescribed as a practitioner;
Provide regarding drugs means
To give, transfer or otherwise make available in any manner, whether directly or indirectly and whether or not for consideration
Sell regarding drugs means
To legally offer for sale, expose for sale, have in possession for sale and distribution
Traffic regarding drugs means
To “sell” based on “other than under the authority of the regulations” i.e. illicit sale
Controlled drugs and substances act is used for and regulates what
To fulfill Canada’s obligations under the international Conventions
To establish domestic controls over the distribution and possession of some psychotropic substances that are not listed in the schedules to one of the international Conventions
To rectify deficiencies in previous drug legislation
To consolidate the Narcotic Control Act and Parts III and IV of the Food and Drugs Act into one piece of legislation
To control the availability and possession of psychotropic substances in Canada.
Pyschotropic Substance are
Has the capacity to produce a state of dependence and CNS stimulation or depression
Dependence includes both psychological and physical dependence
What has the CDSA deemed illegal
Possession-other than named practitioners or person with a prescription for a person or animal.
Double doctoring
Trafficking, possession for the purpose of Trafficking
Importation, exportation and possession for the purpose of exporting
Production
Controlled drugs are identified under
Identified in the Controlled Drugs and Substances Act, Schedules I – VIII
Schedule I substances are the most tightly controlled with most severe punishments for offences
Most of the commonly used veterinary drugs are listed under Schedules I and IV
Exemption for certain anabolic steroid derivatives when contained in an agricultural implant (hormone implant for weight gain)
CDSA Schedule I regulates
Metamphetamines - ephedrine, phenylpropranolamine, pseudoephedrine
Opioids - morphine, dihydrocodeine, hydrocodone, hydormorphone, apomorphine, naloxone (prescription), oxycodone
Coca (cocaine)
Phenylpiperidines
Methadols
Morphinines
Fentanyls
CDSA Schedule IV regualtes
Barbiturates (phenobarbital, pentobarbital), thiobarbiturates, butorphanol, benzodiazepines (alprazolam, clonazepam, diazepam, midazolam), anabolic steroids
Examples of narcotics
Heroin (diacetylmorphine)
Cocaine
Methadone
PCP (phencyclidine) - ketamine
Morphine (and derivatives e.g. hydromorphone, fentanyl)
Codeine
How do you treat narcotics in vet med
For purposes of veterinary medicine, treat like controlled drugs, but NO REPEATS allowed on prescriptions
Benzodiazepines and Other Targeted Substances is controlled how
Possession, sale and distribution covered as Schedule IV of CDSA
Least controlled of drugs listed in CDSA schedules
Identified on label with symbol T/C in square
Controls sale and distribution of benzodiazepines and other targeted psychotropic substances
Examples of Benzodiazepines and Other Targeted Substances
diazepam (Valium®)<– sedative, anticonvulsant
alprazolam (Xanax®) ← anti-anxiety, behavioral modifier
clonazepam (Klonopin®) ← anti-anxiety, behavioral modifier
Controlled drugs regulates what part of drug dispensing
Possession
Prescription Requirements
Repeats
Ordering
Record of Receipt
Record of Dispensing
Storage
Disposal
Part G of the food and drug act regulates
Govern the activities of producers, distributors, importers, exporters and health care professionals relating to N/C/T
Regulates possession, sale and distribution
Restrict the distribution activities of pharmacists, practitioners and hospitals and outline the records that must be kept for these drugs
Part J of the food and drug act regulates
Provides appropriate control measures for “Restricted Drugs”, most of which demonstrate hallucinogenic properties, have no recognized therapeutic use and are dangerous. They are only available for scientific research use.
Double doctoring is
A person in whose favor a prescription or a narcotic has been issued shall not seek or receive another prescription or a narcotic from a different practitioner without disclosing to that practitioner particulars of every prescription or narcotic that he has obtained within the previous 30 days.
To follow the intent of this law, clinics should be diligent in ensuring medical histories transferred from a different clinic are reviewed.
How do you fill a script without a VCPR
This translates into…. Need to communicate with the prescribing clinic to verify script and that no double-doctoring/double-filling
Must have hand-written script with original signature. Recommended to have script sent direct from clinic.
If sending an existing script, must be current for number of repeats (e.g. phenobarb) still available.
Written prescription requirments
Can be faxed or e-written
Saskatchewan pharmacists can request written only as written prescriptions is a provincial requirement
Verbal prescription requirements are
Federal law allows verbal prescriptions (must be recorded by a “pharmacist”)
Technically, veterinarians follow federal law, but licensed pharmacy can require in writing
Verbal orders are allowed for in-hospital use, must be recorded into permanent record
Why do we follow the prescription requirements
Duty to ensure prescription is legitimate
Controlled prescriptions are generally similar to prescriptions for Pr drugs
Exceptions of prescription requirements
Prescribing methadone requires a special exemption
Provincial pharmacy standards do require that in the case of repeats, the interval between repeats is also stately clearly
Ex. 3 repeats (every 30 days)
No repeats allowed for narcotics
How do you limit access to unnecessary drugs
Should be a reasonable attempt to limit access to unnecessary drug – Intent of the law
Limiting quantity of Schedule I drugs dispensed at a time to 1 month
Limiting quantity of Schedule IV drugs used for maintenance of chronic conditions to 3 months (ex. phenobarbital for epilepsy control)
Federal requirements for record keeping
A practitioner shall
(a) Furnish to the minister on request such information respecting
(i) the receipt and use by the practitioner of (including the administering and furnishing thereof to a person), and
(ii) the prescriptions for narcotics issued by the practitioner, as the minister may requirement
Why is recording keeping important for drugs
At any time the Minister (of Health) can request documentation of a practitioner’s receipt of narcotics AND their use by the practitioner.
Usually inspection of records is delegated to the provincial regulatory and licensing bodies
I.e., SVMA
It is felt these organizations are better suited to monitoring compliance of their members.
Why should we keep the record in one place
(2) a practitioner who is required by this section to keep a record shall keep the record in a place, form and manner that will permit an inspector to readily examine and obtain information from it.
Federally, only amounts more than 3 days needed to be recorded in a separate registry. It is allowed to review medical and surgical records in order to generate the needed information for less than 3-day quantities.
As per SVMA Practice Standards, every dispensing act should be logged into a dispensing registry.
Triplicate Prescription Program (TPP) - Alberta
SVMA Record Requirements
Practice Standards 7g Medical Records (Major)
Requires a controlled log with 2 major components
Registers can be physically separate (in 2 different binders) or they can be combined
Cannot be combined with other logs (i.e. part of an anesthesia log or general prescription log)
Must be filed in chronological sequence
Master register should ahve what
AKA Acquisition Log
Tracks purchase
Records total inventory
Dispensing register has what
Tracks use of the inventory
List of individual transactions (administered, dispensed, wastage, discard)
Examples of Controlled Drug Logs
Controlled drug log for a large multi-use bottle
-Euthanasia solutions
-Ketamine
-Hydromorphone
Controlled drug log for individual-use vials or small vials
-Fentanyl
-Hydromorphone (10 ml)
-Valium vials (2 ml)
Who should do record keeping
Weekly reconciliation is recommended
Daily, weekly, monthly depending on size of practice
Where should drug logs be kept
The logs must be kept separate from the actual drugs
Minimizes ability to alter logs or remove logs completely
Ambulatory (ANY) practice CANNOT keep logs with the drug bottle – can have temporary then transfer to clinic log.
General practice in Saskatchewan with $0 - 500 market value (Security Level 1): can keep controlled drugs where
Cupboard, refrigerator, a drawer in a steel cabinet, or an equivalent may be used for this level of security provided it is located in a locked room and fastened to the room’s floor or wall. The device used to store the inventory is to be secured with an approved padlock or its equivalent.
Located in an area to which the public does not have access.
List of people with access is maintained and available to inspectors
How to fix a mistake with the drug log and what is the hub loss
When reconciling, the hub of a needle holds 0.05 mls of solution
Errors are crossed out with a single stroke correction made initialed
Must be in blue or black pen
In the a general practice in Saskatchewan with $501 - 2500 market value (Security Level 2) controlled drugs need to be kept where
Steel cabinet, refrigerator or equivalent provided it is located in a locked room and fastened to a wall or floor in such a manner that it is not moveable. The cabinet or refrigerator must be locked with an approved padlock
Located in an area to which the public does not have access.
Alarm system is required. Minimum of local horn if unauthorized access.
List of people with access is maintained and available to inspectors
SVMA Practice Standards
7e Procedure ©
Narcotic and controlled drugs are stored in a locked secure location. An immovable safe is used as per federal legislation.
Rationale: The Narcotic Control Regulations and the Controlled Drugs and Substances Act state that a practitioner must take adequate steps to protect such drugs in his possession from loss or theft.
Guidelines: All narcotic and controlled drugs should be kept in a safe.
For ambulatory work, small amounts of these drugs can be kept in a locked vehicle. The drugs should be in a container (e.g., medical kit, drug box) and not loose on the seat or dash. If drugs are kept in kits, and the kits are brought into the clinic when not in use, they should be stored in a secure location (e.g., locked storage room) and not left in areas where they could be accessed by members of the public. Similarly, small amounts of these drugs that are used in clinic should be stored either in the safe or in a locked area (e.g., locked drawer in the treatment room) when not in use.
Storage in Patient Care Areas with the controlled drugs
Typically smaller amounts of drugs consistent with Security Level 1
Drugs can be locked in an automated dispensing cabinets (security-based patient dispensing centre, e.g., Pyxis)
Ideally locked cabinet inside locked room (2 separate keys)
Locked containers and carts are also acceptable, but must be attended at all times, or secured and locked to a wall or placed in a locked room when not in use.
Access must be controlled - pass cards, keys, pass codes should never be shared
Who has access to the room (practitioner, nurse, student, other staff is determined by the facility)
3 reasons to discard controlled drugs
Discarding unused, assigned amounts that were originally prescribed for a patient. Must be recorded and witnessed (see section on records). Referred to as “wastage” e.g. giving drug to effect and the entire dose is not used.
Spills and breakage. Must be recorded as “spill or breakage” in the dispensing log, dated, signed by DVM and witness
Expired drug. Must be disposed of in the presence of a witness (legally another practitioner; but RVT or other staff person is acceptable when there is no other practitioner available) and recorded in the dispensing log. Referred to as “discard”
Waste and discard of controlled drugs can be done because
Can either destroy in-hospital or return to licensed dealer
No regulations related to method of destruction or discarding of controlled substances
Drug must be altered or denatured to such an extent that its composition has been rendered impossible or improbable
SVMA recommends squirting volumes into cat litter before discarding into biohazard waste container
All waste and discard must be recorded and witnessed by a health care professional (DVM; if not available, then an RVT)
Loss and theft with controlled drugs
Theft is easier to detect
Loss is difficult to detect
Must be reported within 10 days of discovery of the theft
Report to the Office of Controlled Substances, Health Canada
List of missing drugs, amounts, the date of (discovery of) loss
Also requires a post-loss review and risk mitigation plan to prevent future loss/theft
Examples of diversion= using for purpose other than intended
Entering a quantity of drugs into inventory that is different from quantity received
Pilfering and reporting a missing dose
Replacing package contents with look-alike drug
Replacing prepared syringe contents with saline
Removing controlled drugs without an order
Falsifying a verbal or electronic order
Documenting administration of drugs without doing so
Removing and documenting administration of a full dose, but administering a partial dose
Removing a higher dose than ordered and not wasting the excess
Pilfering from drug waste, sharps containers, or patches removed from patients
Pilfering patient-supplied drugs or not returning them at discharge
Removing drugs for a discharged or nonexistent/ deceased patient
Signs of Diversion of controlled drugs
missing purchase order or packing slip
compromised packaging (watch for excessive “accidents” and check rubber stoppers for punctures)
verbal orders created but not verified by prescriber
numerous unresolved discrepancies
numerous corrected transactions
removing drugs for more patients than are generally assigned to a single practitioner
failing to document waste
failing to discard wastage or render it unusable
frequent breakage or waste of entire doses
controlled drugs disposed of in regular trash; staff member frequently volunteering to take out the trash
patient or family complaints of inadequate pain management
