Jurisprudence 2 Flashcards
What the DPRA regulates:
- Licensing and ownership of pharmacies
- Standards for accreditation
- Dispensing drugs
- Record keeping
- Accountability and responsibility
Overview of the DPRA
- Regulates the practice site or accredited pharmacy, including both hospitals and its members
- Regulate both the member and under the PA and RHPA
Defining the term “drug”
- DPRA definition is based on the Food and Drugs Act:
- Mean any substance of preparation containing any substance
- Manufactured sold or represented for use in
- Diagnosis, treatment, mitigation or prevention of disease, disorder, abnormal physical mental state, or the symptoms thereof in humans, animals, or fowl
- Restoring, connecting, or modifying functions in humans, animals, fowl
- Referred to in schedule 1,2,3
- Listed in publication named by the regulations
What is not a drug?
-Anything that is approved for sale as food, drink or cosmetic
Regulated by health Canada
-Natural health products (NHP)
A NHP could be deemed a drug in Ontario if it is listed in the regulations
Ex. Pseudoephedrine and ephedrine
In Ontario, these are defined in the DPRA regulations as drugs due to the potential for abuse
Schedule U
-Any substance that is found in the Unscheduled category (Schedule U) of the National Drug schedules by NAPRA is not considered a drug in Ontario
Compounding, dispensing and selling of drugs is restricted to…
Pharmacist
Intern, or registered pharmacy student acting under the supervision of a pharmacist who is physically present
Pharmacy technician acting under the supervision of a pharmacist who is physically present
For remote dispensing locations, a pharmacy technician needs to be supervised by a pharmacist through audio/visual link
A pharmacist must be physically present in the accredited pharmacy that operates the remote location
Schedule 1 drugs
- Require prescription
- All drugs in prescription drug list (PDL)
Schedule 2
- Do not require prescription
- Only available through professional intervention by pharmacist
- Kept in restricted area of a pharmacy, not accessible to public
Schedule 3
- Available without a prescription
- Sold in a pharmacy from the dispensary or area of a pharmacy that allows for patient self-selection
- Member of college must be available if needed
Schedule 4-5: Unscheduled
- Sold without professional intervention
- Not included in schedules 1,2,3
- Sold at any retail outlet
- Information on product label is sufficient
conditions for schedule 1 sale
Pharmacist must be physically present
For remote locations, the pharmacist must be physically present at RDL
Drugs must only be sold from the automated pharmacy system
There must be a prescription
Pharmacist approves the sale
Drugs can only be sold from the dispensary
Conditions for schedule 2 sale
Sold without a prescription
No public access (within the dispensary)
Pharmacist should assess appropriateness
Pharmacist must be present
Pharmacist must approve and intervene in the sale
Drugs can only be sold from the dispensary
For remote locations, the pharmacist must be physically present
Must be sold only from the automated pharmacy system
Conditions for schedule 3 sale
Pharmacy only sales
Self-selection by patients
Pose minor risks for patients
Pharmacist must be physically present in the pharmacy or remote location
Drugs only available from automated system or dispensary
Only available for sale from the area of the pharmacy
Member must be available for consultation as needed
conditions for unscheduled drugs
Any retail outlet
Sold without professional intervention
rules for selling and purchasing drugs
Drugs cannot be misrepresented
- Improper labelling
- Ex. Prozac should not be used on a label when fluoxetine has been dispensed
Pharmacies should only sell drugs that are approved by Health Canada
Pharmacies should only purchase drugs from dealers or wholesalers approved or licensed by Health Canada
Wholesalers
- DPRA requiring wholesalers of drugs to register with the College
- Wholesalers are regulated by Health Canada
Defining a prescription
Definition of a prescription in DPRA refers to the prescribing and dispensing of a drug or mixture
Prescription can be used by other health professionals for prescribing and supplying items such as glasses and hearing aids
Prescriber – broad term as it deals with several health disciplines
Order for a specific individual ordered by a prescriber after diagnosis
Can be for a medical device (hearing aids) or medication
Rules regarding dispensing
Drugs will not be dispensed in pharmacy unless authorized by prescriber
Authorization may be given verbally or signature
Out of province prescriptions
DPRA permits pharmacists to accept prescriptions from out of the province but within Canada
Provided they are from a prescriber licensed in Canada
A prescriber is anyone who has the authority to prescribe a drug from that Canadian Jurisdiction
Verbal prescriptions
Acceptable if:
- Drug is not a narcotic
- Must be received by a member:
- Pharmacist
- Intern or pharmacy student
- Pharmacy technician may not accept verbal prescriptions for controlled substances
Documentation of verbal prescriptions
Member receiving the verbal prescription must record the date, number of authorized refills, and the name of member receiving the prescription
Information required on verbal prescriptions
DPRA requires that every person who requests a prescription include:
Name and address of the person for whom the drug is prescribed
The name, strength, and quantity of prescribed drug
Directions for use as prescribed
Name and address of the prescriber
Must reflect where the patient record resides
Identity of the manufacturer
Identification number (prescription number)
Signature of the person dispensing the drug
- Or the one receiving the verbal
Date of the drug dispensed
How much it costs
What is required on the label of a prescription?
No matter what type of label used it must comply with the act Identification number (Rx number) The name, address, and telephone number of the pharmacy Drug name, strength, manufacturer Quantity of drug dispensed Name of the owner of the pharmacy Date being dispensed Name of prescriber Name of the patient Directions for use as prescribed
Child-resistant
Due to safety concerns over accidental poisoning and overdoses
Some situations where child-resistant packing may not be appropriate
Elderly patients may have trouble opening them, so need easy open
Member can use professional judgement to change containers
Not all dosage forms are suitable for child-resistant packaging
Labeling of prescriptions
Single entity drugs: where the product only contains one drug
Lipitor which only contains atorvastatin
These drugs are labeled with the chemical name of the drug, including the name of manufacturer
Lipitor would be labeled as atorvastatin, Pfizer
multi-medication compliance aids
Compliance labels are used for multi-medication packages
When the packaging contains more than one drug in the package
Description of each tablet must also be added to the label
Registered mail of prescriptions
Delivering prescriptions can only be registered by mail
The person addressed on the package signs and received the prescription
Other delivery methods (courier) must meet the same principles
Delivery must be traceable and auditable including the signature of the patient or agent of the patient upon receipt of the order
Any drug can be mailed or delivered within Canada
Shipping prescriptions outside of canada
Check with the country’s rules
Call the courier for their rules
Narcotic, controlled drugs, benzodiazepines/targeted substances cannot be shipped to the U.S. by international agreements
A patient can bring their own prescription drugs in but cannot be shipped by pharmacy
Transferring prescriptions
- Prescription from one pharmacy to another based upon the request of the patient
- In compliance with federal and provincial legislation
- Food and Drug relations outline the requirements for transferring prescriptions:
Transferring prescriptions: accountability
A patient’s choice of pharmacy must be respected, and the pharmacy must transfer in a professional and timely manner
Transfers of prescriptions occur between pharmacies
Accountability and responsibility for transferring prescriptions falls on the member of the pharmacy
Prescriptions can be transferred between pharmacies in Canada
Narcotic or controlled drug transfers are not allowed
Requirements of information when transferring:
•Name and address of patient •Name and strength of drug prescribed •Directions for use •Name and address of prescribed •Name of manufacturer of the drug •Total quantity of drug related •Prescription number •Quantity most recently dispensed if different than quantity prescribed (drug plan rules) •Name of member transferring prescription (either verbally or under signature) •Date the drug was first dispensed •Date of last refill oFor benzodiazepines – need the original date that the prescription was issued
Transferring prescriptions: other information
Prescription cannot be transferred if there are no refills
Once a prescription has been transferred to another pharmacy, all authorizations are transferred with it
Benzodiazepines/targeted substances can only be transferred once
They are also only valid for 1 year after being prescribed
Transfers of benzodiazepines
Date the practitioner issued the prescription is required for benzo and targeted substances
Prescriptions are only valid for one year from the date it was written or authorized
Benzo and targeted substances can only be transferred once
When completing a transfer, keep record of:
- Date of transfer
- Identity of the transfer pharmacy
- Name of the member responsible for the transfer by the pharmacy
- Name of the member accepting the transfer
Pharmacy accepting the transfer must record:
- Name of pharmacy where it originated (Validated)
- Information regarding the prescription from that pharmacy is complete
- The name and signature of the member receiving and recording the information
copies of prescriptions
Every patient is entitled to a copy of their prescription
Must be marked as a copy to prevent misuse
Copies can be provided to agent or a pharmacist acting on behalf of the patient
Patient record keeping:
Patient profile
Electronic record of original prescription
Prescription information
Dispensing record of all prescriptions with pharmacist/technician signature
Documentation or information about the patient
Meds check documentation
Prescription initiation/adaptation/refill documentation
Medication management
Drug therapy problems
Consent forms
Dialogue with patient
retention of records
Must be kept for 10 years from the last recorded professional pharmacy service provided to the patient
If a patient received services from 2001 to 2013, you would keep records until 2023
Or until 10 years after the patient would have reached until 18 years
Ex. If the patient got a prescription at 3 years old, the pharmacy service must be kept for the longer period (patient is 28 years old)
Always go off what is the longer period
Must include scanned copy of the prescription, and the copy of signatures
Destruction of records
Destruction of any record during an audit or inspection is not allowed
Permission to destroy any records must be granted by the registrar
Any record relating to the pharmacy must be available for an inspector of the college
Safeguard and storage of records
The records, stored electronically or manually, are secure and protected
Proper backups are done daily
Adequate recovery systems are in place
All copies of backup are kept secure to avoid unauthorized use or disclosure
A copy of the backup must be kept offsite
Or in a fireproof area
disposal of information of records
Disposal of prescriptions needed when a pharmacy closes or is sold
A pharmacy that is sold remains responsible for the retention, transfer, and disposal of records until custody of records is transferred to the purchaser
Patients must continue to be able to access all their information
- Take reasonable efforts to give notice before transferring their records
While an inspection is being performed, no record or document shall be destroyed until the inspection is completed
Certificates of accreditation
The college regulates both the member and the pharmacy site
Regulation of the pharmacy and safe dispensing of drugs happens through the DPRA
Only pharmacies with a certificate of accreditation issued by the registrar of the college may operate a pharmacy in Ontario
College expects pharmacy to be operated according to the standards of operation
application process/issuance
Application form, background information, and payment of fees are standard requirements
Additional information may be requested by the registrar
Pharmacy inspection happens before it opens to make sure the physical requirements comply, and the pharmacy is safe to operate
Relocation and acquisition of a pharmacy
Every acquisition and/or relocation of a pharmacy will need an application for a new certificate of accreditation
The certificate is specific to both the physical address and the name of the owner of the pharmacy
The owner files the application 30 days before relocating or prior to owning an operating the existing pharmacy
accreditation committee
Accreditation committee is one of the statutory committees of the college
Deals with matters related to pharmacies, such as certificates of accreditation, pharmacy inspections and pharmacy operations
If the registrar has reason to believe that the applicant will not operate the pharmacy in accordance with the legislation, will refer the application to the accreditation committee
Accreditation committee can direct the registrar to:
- Refuse the certificate
- Place terms, conditions, and limitations
- Issue the certificate of accreditation
Inspections
- Certificates of Accreditation expire yearly on May 10th and must be renewed
- Registrar has the authority to refuse to renew a certificate under certain conditions, including non-payment of fees
College inspections
Inspections ensure the pharmacy is maintaining or meeting all the standards set out in the regulations
College notifies pharmacies of the inspection, but not necessary
Intent is to encourage pharmacies to comply with the legislation, but to also promote an understanding and awareness of any relevant and current pharmacy practice issues
Most inspections will conclude without any action, upon an acceptable action plan that addresses any deficiencies that were identified during the inspection
In some cases, a re-inspection at a future date is required
- If the results of the re-inspection still indicate deficiencies, the matter is referred to the Accreditation Committee
- The outcome and/or status of a pharmacy inspection is posted on the college’s public registrer
Access to documents during inspections
Any documents that are relevant to the practice may be requested and available for examination
When document or object is hard to copy, it may be taken from the pharmacy and copied elsewhere
Inspectors can certify copies of documents, and these are admissible as evidence during hearing or proceeding at the college
A pharmacy cannot refuse entry to an inspector
if they do, it is considered proprietary misconduct
it is also an offence to conceal or destroy anything relevant to an inspection
Certificate renewal of college inspections
Renewals are authorized by the registrar
Qualification for renewal is like issuance of a new certificate
If requirements are not met, or the registrar proposes that terms, conditions, or limitations be attached to the certificate, the mater may be referred to the accreditation committee
Referral to accreditation committee
Referral to accreditation committee: process to ensure transparency and fairness
Certificate of accreditation remains valid only if the denial of renewal is confirmed
Upon the regulations, when the Registrar refers an application to the accreditation committee, it has 3 choices:
- Direct the registrar to renew the certificate
- Direct the registrar to renew the certificate with terms, conditions, or limitations
- Direct the registrar not to renew the certificate
Revoke or suspend certificate of accreditation
Regulations deal with the issuance and renewal of certificates of accreditation
Provide the authority to refuse an application to issue or renew a certificate of accreditation if the applicant:
- Shows deficiencies or fails to comply with the standards of accreditation
- Provides false information at issuance or renewal
If accreditation believes the information is false, the certificate can be revoked
Matters referred to the accreditation committee are decided case-by-case
A member’s responsibility to ensure they provide as much information as possible for the committee
Responsibility of owner and designated manager
Every owner or manager is responsible and liable for any offence against the DPRA made by a person under their supervision or employment
Every director of a corporation operating a pharmacy is liable for any offense against the DPRA made by anyone under the corporation (hospital pharmacies)
For hospital pharmacies: a contact person must be designated
Referral to discipline committee happens if the accreditation committee believe that:
A pharmacy is not operating according the DPRA and its regulations
A pharmacy is not complying with any term, condition, or limitation that its certificate of accreditation requires
An act of proprietary misconduct has been committed
the discipline committee will direct the registrar to one of the following decisions:
Revoke the certificate
Suspend the certificate for a period
Impose a fine of not more than $100,000
Impose terms, conditions, limitations of the certificate
Conflict of interest regulations
Situation where a person’s private interests might benefit from their professional actions or influence
Conflicts of interest are a matter of proprietary misconduct
Persons held accountable for proprietary misconduct includes owners, directors, and designated managers
To ensure transparency and full disclosure even if you only think there may be a conflict of interest
closing of a pharmacy
Owner must remove all signate related to the pharmacy
Most notify the registrar within 7 days of closing
Must notify the Office of Control Substances about the disposal of its narcotics, controlled drugs, and benzo/targeted substances
Pharmacy to inform patients before they close so they can make arrangements
ownership of pharmacies
Ontario requires a pharmacy to be owned and operated by a pharmacist Majority of directors must be pharmacists and most of each class of shares must be owned/registered in the name of a pharmacist
exemptions to ownership requirements
Pharmacies that were operating on May 14, 1954: a pre-54 charter
- Allows a non-pharmacist to own a pharmacy
- Majority of directors of the corporation must be pharmacists
- Must have a designated manager to operate the pharmacy
Non-profit, multidisciplinary health care facilities
- Hospitals
designations
Certain designations used to name a pharmacy are protected
Can only be used by a pharmacy for the name of the retail business
Only an accredited pharmacy in Ontario can use the following designations:
Drug store
Drug department
Drug or drugs
Medicines
Pharmacy
Drug sundries
Drug mart
impact of revocation on ownership
No longer a member of the college
Cannot be employed as a pharmacist in a pharmacy
Cannot act as a director or shareholder of a corporation owning a pharmacy
The corporation can:
- Use the name of the revoked pharmacist as a director for up to 6 months
- During this time, the revoked pharmacist cannot act in the capacity of director or shareholder
- Cannot vote or make decisions
impact of suspension on ownership
If a member is suspended, they are not considered a member of the college
To maintain the required composition of directors and shareholders, a suspension of a pharmacist’s licence does not affect the corporation’s ability to continue naming that person as a director or shareholder during the suspension
This allows the pharmacy to remain open
bankruptcy of a pharmacy
The person owning the pharmacy must notify the college
The trustee in bankruptcy may operate the pharmacy during this time
death of a pharmacy owner
Death of a sole owner of a pharmacy, a personal representative may own and operate the pharmacy for 4 years
This gives time to either sell the pharmacy or form a corporation with a pharmacist who would own most shares and be the director of the company
They can also operate the pharmacy for 4 years, or period approved by the council
supervision of a community pharmacy
Pharmacist must be physically present when the pharmacy is open
Exception: remote dispensing locations
A pharmacist named by the owner to manage the pharmacy: designated manager or DM
Every DM must ensure that his or her name certificate of registration, or both are clearly displaced in the pharmacy
lock and leave pharmacies
There are times when a pharmacist may close and leave the professional area, but the rest of the store remains open for business: Lock and Leave
The legislation allows an area of the store to operate without a pharmacist present
If a pharmacist wants to operate a lock and leave, they must:
- Apply to the registrar
- Submit floor plans with their application and have an inspection by the college
- Ensure that all scheduled drugs are completely inaccessible to the public
standards for accreditation
Safe, clean, and properly maintained environment
Secure and safeguarded pharmacy
Patient confidential information protected
Equipment and technology as needed
Appropriate staffing and resources
information management system
audit trail for drugs
equipment requirements
Practice is continually changing as members move into different practice areas and specializations
Ex. Non-sterile, non-hazardous, or hazardous sterile preparations, long-term care, opioid dependence treatment
No specific list of equipment required for a pharmacy
Designated manager is responsible ensuring the pharmacy has equipment and resources needed for meeting standards of practice and patient safety
computer system requirements
Storing and reporting patient records and dispensing transactions
Sufficient security
Ability to uniquely identify each staff member who accesses the system
Control functions allowed by each staff member
Ability to create an audit trail
Capable of collating and generating reports
Sufficient speed and capacity
pharmacy structure requirements
Community pharmacists must be a minimum of 18.6 sq. metres or 200 sq. feet in size
The dispensary must be at least 9.3 square meters
Safe and orderly fashion
All pharmacies must provide an area that offers acoustical privacy to ensure patients can discuss their health conditions and medications privately
A separate and distinct patient consultation area
Sufficient shelving, drawers, and fixtures for all drugs, NHP and unscheduled products
sterile compounding requirements
Pharmacies offering sterile compounding must have the appropriate facilities, equipment, and properly trained staff
OCP has adopted the Model Standards for Pharmacy Compounding of Non-Hazardous sterile preparations and the model standards for pharmacy compounding of hazardous sterile preparations by NAPRA
physical lay-out requirements
Operational requirements regarding the physical layout of every pharmacy to maintain a clean, hygienic, professional environment
Pharmacy rooms, passageways, equipment, furniture, and fixtures must be kept:
- Clean and orderly
- In a good state of repair
- Well-lit and ventilated
- Pharmacy designed to ensure the integrity, safety, storage of all drugs
- Must have a program to ensure cleaning, maintenance, safe disposal of waste, hygienic behaviours of staff and hand washing
resource and reference requirements
Library requirements or availability of resources for pharmacies are minimum
The internet provides access such as OCP, CPSO, NAPRA, Health Canada and MOHLTC
Pharmacists are expected to purchase additional resources for their practice
The library requirements are outlined in the required reference guide-library guide on our website
- Compendium of pharmaceutical specialities (CPS)
- Drug interaction publication
- Pharmaco-therapeutics publication
- Subscription to drug information service
- Patient counselling publication
- Internet access
OCP symbol requirements
College’s trademarked symbol
Can only be used in Ontario by an accredited community pharmacy
Helps public identify that the pharmacy is registered and licensed with OCP
This symbol must be displayed and visible to the public
definition of a remote dispensing location
The DPRA permits the operation of a remote dispensing location (RDL) provided a certificate of accreditation has been granted and the operation meets the requirements of the regulations
A premise where drugs are dispensed or sold by retail to the public and operated at a different location from the accredited pharmacy
Remote does not refer to a geographical location
A remote dispensing location is an alternate business model for pharmacy services
remote dispensing location with an automated pharmacy system
A self-contained dispensing system that uses technology to perform the technical functions of dispensing
Operated remotely from the accredited pharmacy
Like a service kiosk or vending machine
Dispensing style is like a regular pharmacy
rules to operate a remote dispensing location
First meet the qualifications and requirements to operate a pharmacy in Ontario and be granted a certificate of accreditation
Apply for an amended certificate of accreditation that will allow the operation of one or more RDLs
An RDL cannot operate independently and can only exist if there is an accredited pharmacy operating it
The DM is accountable and responsible for the proper operation of the remote location
The operation of a RDL is restricted to the opening hours of the pharmacy operating it where a pharmacist is physically present
The accredited pharmacy is responsible for record keeping
RDL security requirements
Alarm systems
The system must prevent any an authorized access, theft or tempering of equipment
APS must be securely always locked
Dispensing should be done with technology like barcodes and microchips
RDL restrictions
Cannot carry any narcotics, controlled drugs, or target substances unless safeguards are in place
All RDLS must display the 2 yellow notification signs:
•Notice to patients
•Usual and customary fees
The DM should complete onsite inspections
RDLs cannot operate without:
- live, real time, 2 way audio-visual links to have contact with the pharmacist
- meet the same standards as a regular pharmacy
- situated indoors and in well-lit and ventilated areas
- areas should provide ample space and privacy
RDLs are exempt from:
Does not have to meet the requirements for sinks, equipment, fixtures, minimum floor area, or designated areas for schedule 3 drugs
technology of RDLs
Be able to easily verify the authenticity of the prescription to determine if any alterations have been made
Maintain a temperature between 2-8 degrees C if they contain refrigerated items
advertising of pharmacies
All health professionals have advertising regulations
Advertising should be clear and easily understood
Ethical and professional, dignified and in good taste, and not making claims that are not true
2 ways of advertising:
commercial over-the-counter products
professional services offered by a pharmacy
testimonials and endorsements
When advertising, pharmacies are not allowed to use testimonials, endorsements, or comparative statements
When a member makes a claim about a specific area of practice, the advertisement must mention the members area of expertise
The pharmacy cannot advertise or promote the safety of any drug
prescription pricing
Any advertising of prescription prices, which includes the usual and customary fees, must include at least 15 different drugs from 10 therapeutic categories
Also include ethe quantity, total cost, brand name, strength, and dosage form of the drug
The only price that can be advertised without all these requirements is ODB co-payment or dispensing fees
