Jurisprudence 1 Flashcards
What are the 6 ways the OCP serves and protects the public?
- Oversee and license Ontario Pharmacies and technicians
- Develop standards and programs aimed to promote the quality of safety practice
- Assess community and hospital pharmacies regularly
- Conduct practice assessments to ensure they maintained their skills during careers
- manage the complaints received by the public
- communicate with the public
What are the 4 classes of registration?
Pharmacist (protected title)
Registered pharmacy student (temporary)
Intern (temporary)
Pharmacy technician (protected title)
What is the vision of the OCP?
a trusted, collaborative leader that protects the public and drives quality and safe pharmacy care and improved patients’ outcome
What is the OCP’s mission?
the OCP regulates pharmacy practice to serve the interests, health, and well-being of the public
What are the values of the OCP?
accountability, integrity, transparency
Main points of the OCP and its mandate
Incorporated in 1871
Registering and regulating body for pharmacy in Ontario
Mandate is to serve and protect the public and hold Ontario’s pharmacists and pharmacy technicians accountable to the established legislation, standards of practice, code of ethics, and policies relevant to pharmacy practice
Roles of the pharmacy act
Sets out the official name of the college
The scope of practice
The controlled acts
Composition of governing council
Permits regulations of the prescribing and administration of drugs
2 Branches of the RHPA (Regulated Health professions Act)
Topics External to the Regulatory Colleges
- Role and powers of minister of health and long-term c are
- Advisory council to the minister on health issues
- Health professions appeal and review board
- Controlled acts (dispensing drugs that authorized persons can do)
Health Professions Procedural code
- Public interest mandate of governing council
- Registration of new applicants
- Complains, and investigations
- Patient relations program
- Quality assurance program
DPRA (Drug and Pharmacy Regulation Act) roles
- Works closely with RHPA and Pharmacy Act
- Deals with slightly different topics
- Was enacted with the RHPA and PA
Roles of the DPRA:
- Accreditation, Inspection, Ownership of Pharmacies
- Rules for dispensing drugs including prescription requirements for the re-authorization of drugs
What must all 4 registration classes exhibit?
Language proficiency
Good character
What does a Part A Pharmacist do?
can provide patient care
What does a part B pharmacist do?
TCLs
Cannot provide patient care
cannot dispense, sell, compound drugs
cannot supervise a pharmacy
cannot be a manager
cannot supervise any practice of pharmacy student or intern
must self-identify as a non-practising pharmacist
What are the TCLs of pharmacy students?
Only engage in practice if completing an education program or training
Engage in practice while under the direct supervision of a pharmacist or health care professional in a rotation
Cannot dispense or compound drugs unless under supervision of pharmacist
Cannot delegate or accept delegation
Cannot supervise a pharmacy
What are the TCLs of interns?
Engage of practice of pharmacy when:
- Drug and pharmacies regulation act applies
- Pharmacist present and under direct supervision
- Cannot supervise a pharmacy
- Cannot delegate a controlled act
- Can provide the full practice if fully competent
- Can accept delegation of controlled act
What are the TCLs of pharmacy technicians?
Pharmacy technician must only engage in pharmacy practice when under direct supervision of a pharmacist in an accredited pharmacy
Cannot supervise pharmacy
Cannot delegate a controlled act
Cannot provide information/education relating to drug use to a patient, where therapeutic information must be known
Pharmacy techs can ensure the technical accuracy of a prescription and can independently check the technical component while the pharmacist remains responsible for the therapeutic component (check prescriptions)
The Role of the Board of Directors
The board’s primary role is to ensure that the interests of the public are protected and maintained
Oversight and policy making group
Responsible for carrying out these policies and administering the Regulated Health Professions Act, the Pharmacy Act, and the Drug and Pharmacies Regulation Act and associated regulations
Board meetings are open to the public – scheduled in March, June, September, December
Controlled Acts
-Regulation stipulates which class of members the pharmacy profession can perform which controlled acts, such as dispensing or prescribing
-Also identifies the requirements that must be met before the controlled acts can be performed
-Ex. The influenza vaccine may only be administered by pharmacist in Part A of the register (injection training)
oPatient must be over 5 and give consent
-Members of pharmacy profession who give injections, must have continuous education of CPR
Quality Assurancec
- How members of the profession will be selected for practice review
- Ensure competency of pharmacists and pharmacy technicians
- Self-assessment and peer-review
Professional Misconduct
- Failing to maintain the standard of practice of the profession
- Conflicts of interest
- False billing
- Misrepresentation of qualifications
- Failing to cooperate with the college
- Disgraceful, dishonourable, unprofessional behaviour
By Laws
- Internal or administrative maters
- Council elections
- Banking and audit arrangements
- Professional liability insurance
- Colleges public register
- Not subject to government approval
Standards of Practice Definition
-Minimum expectations and behaviour
oEx. All reasonable steps to ensure the appropriate medication is dispensed
-Apply standards of practice when dealing with members of the pharmacy profession
-Code of ethics
Practice policies and guidelines
- Certain expectations of the college and providing direction to the members of the profession on how they can meet their responsibilities
- Outline how members of the pharmacy profession are expected to practice within legislative framework
- Clarify the intent of the legislation
- Set out how the college would apply the legislation to practice
- College expectations when considering delegation and responsibilities
- Interpretation of the legislation that surrounds practices
- Provide support and guidance for the practice of the pharmacy profession
Regulatory models
regulate registered individuals or places that choose to become regulated but do not require the individuals or places to become registered
-A massage can be given by anyone, but only someone registered with the regulatory college are allowed to use the title registered massage therapist
oAssure customers of their recognized expertise
-License models prohibit people or places from doing certain activities unless they hold a license
What is the pharmacy scope of practice?
scope of practice - describes with the profession does
Custody, compounding, dispensing, and prescribing of drugs
Provision of health care aids and devices
Provision of information and education
The promotion of health, prevention and treatment of disease, disorders, and dysfunctions through monitoring and management of medication history
- this statement helps the public and profession understand what the members do
Controlled Acts Model
Government can prohibit anyone who is not registered with the college from using a protected title such as
- Apothecary
- Druggist
- Pharmacist
- Pharmaceutical chemist
- Pharmacy technician
The government can prohibit anyone who is not registered with the college from practising
-Government created a list of acts that are harmful if not performed by competent, authorized individuals
- Allows for greater precision
- Only members of professions who are authorized to complete these acts may do so
-Controlled acts are tasks with the potential to cause harm if not done correctly by a competent person
- Dispensing, selling, or compounding a drug, where drugs are kept is the most relevant controlled act for pharmacists
- Only members of pharmacy profession (and nurses and doctors) are authorized to dispense drugs
Members of pharmacy are authorized to perform other controlled acts including prescribing and administering, by injection or inhalation
EXCEPTIONS:
- People can perform controlled acts in an emergency
- Family members can perform some controlled acts
- Controlled acts may be delegated by a member in accordance with profession-specific regulations
Controlled Acts for Pharmacy Profession
- Dispensing, selling, or compounding a drug, or supervising the part of a pharmacy where drugs are
- Pharmacists of part A
- Administering, by injection or inhalation, a substance
- Prescribing a drug specified in regulations
Some members of pharmacy profession can prescribe varenicline and bupropion for smoking cessation purposes
Prescribing a drug in accordance with regulations
Pharmacists in part A, techs, and pharmacy students can renew a patient’s prescription for the purpose of continuity of care
Can also adapt prescriptions (dose, dosage form, directions, route)
Not allowed for narcotics, controlled, or monitored substances
Performing a procedure below the dermis
Professional Responsibilities
Reporting child abuse (Child and Family Services Act)
- Keeping patient information confidential and secure (Personal Health Information Protection Act)
- Discrimination
- Sexually assaulting a patient can result in civil suit for damages and criminal charges by the college
- Members are said to have a “fiduciary duty” to their patients
- Fiduciary duty is an obligation of undivided loyalty and utmost good faith to the person being served
- Put the interest of the patient before their own
- The information on health record belongs to the patient – and can be shared with the patient
- Pharmacists must never engage in sexual relationship
- A pharmacist must not have a conflict of interest with patient (having a deal with a company to dispense high levels of an expensive drug)
- Come from RHPA, Pharmacy Act, and DPRA
Responsibilities to patients
- Professional misconduct regulation, standards of practice and code of ethics
- Abusing a patient
- Engaging in sexual activity in a patient
- Cannot provide care to one’s spouse
- Discontinue services abruptly without good reason
- Maintain standards of practice like filling a prescription properly
- Keep complete and honest records
- Be honest and transparent in their use of titles and in their billing practices
Responsibilities to the college
- Members must be truthful with the college
- Information on annual renewal form must be accurate and complete
- When personal information changes, it must be reported to college
- Members must cooperate with any college inspections
- Mandatory reports are required
Responsibilities to third party
- False or misleading invoices to the government or private health insurance
- False advertising
- Any report to a lawyer or employer must be complete and accurate
- Must be respectful to the public and their colleagues, staff
Mandatory Reporting
Outweighs the considerations of privacy
- Must be made even if one would prefer not to, and one can report another’s actions
- Sexual abuse
- When there are reasonable grounds to believe that a member of pharmacy has engaged in sexual abuse (does not have to be directly observed)
- If a patient comes to the pharmacy to tell us that they just had sex with their doctor, we must report it
Facility operators and employers
- Member of pharmacy terminates the employment of another member for professional misconduct, incompetence, or incapacity
- If someone quits or resigns
- Practitioners can also be reported if deemed incompetent or incapacitated
Self-reports
-If a member is found guilty of an offence
-Can be an offence to not report a need of a child to the Children and Family Act
-Findings of professional negligence (malpractice)
oWhen someone has not fulfilled their duty to a patient
oMust be made in writing to the registrar
College Council
- College is led by its council
- Board of directions
- Under PA
- 9-17 members of the profession (2 hospital pharmacists, 2-4 technicians)
- Deans of the Ontario pharmacy programs
- 9-16 public members appointed by government
- The council is supported by its committees and its registrar
Statutory committees: Executive committee
oReceives and studies the reports from other college committees before forwarding them for action
oHelps prepare agenda for council meetings
Statutory committees: registration committee
Determines whether an applicant meets the requirements for registration
Statutory committees: quality assurance
Develops and maintains the quality assurance program, continuing education, minimum practice requirements and practice review process
Statutory committees: Inquiries, complaints, reports committee
Investigates complaints and other concerns about pharmacists
Professional misconduct, incompetence, or incapacity
Statutory committees: Discipline committee
Holds hearings to determine whether a member of pharmacy has engaged in professional misconduct or is incompetent
Has the authority to revoke, suspend or limit a registration
Full hearing is held, and open to the public
Formal allegations
College gives full disclosure to the member
Both sides can hire lawyers, call witnesses, and make arguments
Discipline committee makes an independent determination
The consequences include fine, restrictions or revocation of registration or accreditation
Statutory committees: fitness to practise committee
Holds hearings to determine whether a member of the pharmacy profession is capable or impaired
Similar to discipline hearings
Allegations are about the capacity of the member of the pharmacy profession to practise safely and effectively
Hearings are closed to the public
If incapacity is made, the most common consequence is monitored treatment program
statutory committees: patient relations committee
Develops programs to encourage health interactions between patients and members of pharmacy profession
Sexual abuse prevention plan
Accreditation committee: PA
8 statutory committee that reviews concerns about the operation of pharmacies
If it appears that a pharmacy is not meeting standards, the committee can direct further inspections
Standing committees: communications committee
Provides direction and guidance on all matters supporting public education and outreach
Standing committees: drug preparation premises committee
Considers matters relating to the operation of drug preparation
Standing committees: elections committee
Overseeing the elections process for the elected members of council
Standing committees: finance and audit committee
Oversees financial and physical assets of the college
Operating and capital budget
Standing committees: professional practice committee
Provides direction and guidance on matters pertaining to professional practice
Responsible for development and ongoing review of standards of practice
Regulatory activities: restrictive regulation
Limiting those who can perform pharmacy activities and use titles
Regulatory activities: reactive regulation
Responding to complaints and concerns about conduct, competence, and capacity of members
The pharmacist can respond to the complaint in writing first and provide documentation
Other witnesses may be approached, and the person who made the complaint can provide evidence
Other professionals will be involved to determine if any pre-existing issues
Sometimes no action is required, or the ICRC can decide if the professional needs more courses, continued education, or stand in front of the ICRC to get a formal warning
Regulatory activities: proactive regulation
Designed to enhance the knowledge, skill, and judgement of members
Regulatory activities: transparent regulation
Providing information to the public about members so public can make informed decisions
Restrictive regulation
College sets out requirements for registration in its regulations
The college has requirements for good character
If it is unclear that an applicant meets these requirements, the registrar refers the application to the registration committee to make the decision
Good character and education
A panel of the registration committee can exempt an applicant from an exemptible requirement where the public can be protected
An applicant not satisfied with the decision of the registration committee can appeal it to the Health Professions Appeal and Review Board (HPARB)
Independent of the college
If an unregistered person uses the protected titles and holds themselves out of a member of the college, the college can prosecute them in court
It is professional misconduct for a member of the pharmacy profession to help an unregistered person use a protective title, or perform a controlled act
Incapacity vs incompetence
Incapacity:
Has physical or mental condition
Requires restrictions in their ability to practise in order to protect the public
Member must be required to be examined by health practitioner (mental health or addiction)
Fitness to practice committee
Hearings are avoided by most cases, by telling the member to enroll in a program
No cost to the member for the confidential assistance program/service
It is available to all pharmacists, pharmacy technicians, and students
Incompetence:
Occurs when a member lacks knowledge, skill, and judgement to the extent that restrictions should be imposed to protect the public
Preventing complaints or concerns
Regularly review new or revised standards and guidelines Code of ethics review Active participation in College Quality assurance program Protocols followed to prevent mistakes Being professional and sensitive Keep all conversations professional Avoid disclosing personal information Avoid asking inappropriate questions Non-clinical touching
Registrars’ investigation
No complaint in writing, but college can still investigate
Report is made in writing to ICRC
Member of profession is given the results of the investigation and opportunity to respond in writing
Pharmacy operations concerns:
- Accreditation committee makes the decision
- No action
- Educational action
- Refer serious concerns to the discipline committee
Quality assurance program
- All members must engage in continuing professional development and maintain learning portfolio
- Participate in formal self-assessment program every 5 years
- 5% of practising pharmacist are randomly selected for peer review process
- Also uses the peer review process for a pharmacist in Part B to re-enter Part A
Inspection/Practice assessments
- Drug preparation premises (any place other than pharmacy or hospital) where a pharmacist or pharmacy tech engages in drug preparation activities or supervises
- By preparing for inspections and receiving feedback, members of the pharmacy can enhance their practice
Patient relations program
- Detailed plan to prevent sexual abuse of patients from occurring
- Includes education in pharmacy schools, providing resources for members, through public education
- Training college staff on recognizing and understanding patient concerns about sexual abuse by a member
- Can take years for a survivor of sexual abuse to come forward of the allegations
- College staff are trained in the importance of using appropriate and sensitive language when communicating with a victim
Preventing sexual abuse and harassment
- Consent is never an excuse
- Sexual abuse causes significant psychological harm for the breach of trust and the lack of confidence in the pharmacy profession and health system in general
- Practical suggestions:
- Show sensitivity and respect
- Avoid any physical contact
- Avoid any behaviour or remarks that may be interpreted as sexual
- Be aware of culture and religious background
- Do not make sexualized comments about body or clothing
- Do not criticize or comment on sexual preference
- Do not ask details of sexual history
- Be aware of social interacts
- Do not talk with patients about own sexual preferences
- Learn to control the consultation setting and detect possible erosions in boundaries
Transparent regulations
Public expects to know about the background and any significant concerns
- Allowing the public to see the regulation can prevent misconceptions about the College’s commitment to protecting public interest
- Under RHPA, the college maintains a public register on its website of all members and accredited pharmacies
- Name, location, registration status, regulation history of members, TCL
- Provides status and outcome of inspections of accredited pharmacies
Open public hearings
- Members of pharmacy profession can observe key aspects of regulatory process
- Allows for feedback and better-quality decision making
- Not public if it involves personal health information
