Pharmacy Legislation II Flashcards

1
Q
  1. Which bodies govern pharmacy practice and ownership?
A

Pharmacy Board Australia (PBA) - governs the registration of pharmacists, the professional standards to which we adhere and practice. Complaints and notifications regarding the profession, and training/qualifying/ assessing overseas practitioners.

VPA- govern pharmacy ownership (business, pharmacy, and pharmacy depots). They also govern premises approvals and inspections

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2
Q
  1. Which legislations govern pharmacy practice and ownership?
A

Victorian Legislation

Health Practitioner Regulation National Law (Victoria) Act 2009
Pharmacy Regulation Act 2010
Victorian Pharmacy Authority Guidelines
Drugs Poisons and Controlled Substances Act 1981 and Regulations 2017
Drugs Poisons and Controlled Substances Act (Precursor Supply) Regulations
Health Services Act and Regulations
Health Records Act etc.

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3
Q
  1. What are the requirements of registration?
A
  1. Criminal History
  2. Professional Indemnity Cover-required to have PII arrangements that include a level of cover not less than $20 million for any single claim (that is, for each claim), or for all claims in the aggregate, that may be made against you.
  3. Continous Professional Development-complete CPD activities that have an aggregate value of 40 or more CPD credits during each 12-month CPD period ending 30 September, which: a. consist of at least 20 CPD credits from Group 2 and/or Group 3 activities
  4. Recency of Practice-must have practised a minimum 450 hours in 3 year period prior to applying for general registration or renewal of general registration, or • 150 hours in the 12 month period prior.
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4
Q
  1. What is unprofessional conduct?
A

UNPROFESSIONAL CONDUCT, of a registered health practitioner, means professional conduct that is of a lesser standard than that which might reasonably be expected of the health practitioner by the
public or the practitioner’s professional peers, and includes—
(a) Breaking the law whether or not the practitioner has been prosecuted for, or convicted of,
an offence in relation to the contravention; and
(b) contravention by the practitioner of—
(i) a condition to which the practitioner’s registration was subject; or
(ii) an undertaking given by the practitioner to the
National Board that registers the practitioner; and
(c) Conviction in an offence
(d)Excessive/unnecessary services being provided (going to customers houses uninvited)
(e) taking a bribe
(f) referring a customer to a place for monetary reasons
(g) negatively influencing the behaviour of others

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5
Q
  1. What is professional misconduct ?
A

PROFESSIONAL MISCONDUCT, of a registered health practitioner,
includes—
(a) unprofessional conduct by the practitioner that amounts to
conduct that is substantially below the standard reasonably
expected of a registered health practitioner of an equivalent
level of training or experience; and
(b) more than one instance of unprofessional conduct that, when
considered together, amounts to conduct that is substantially
below the standard reasonably expected of a registered
health practitioner of an equivalent level of training or
experience; and
(c) conduct of the practitioner, whether occurring in connection
with the practice of the health practitioner’s profession or
not, that is inconsistent with the practitioner being a fit and
proper person to hold registration in the profession.

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6
Q
  1. What are the pharmacy board codes and guidelines for dispensing medicines?
A

Refer to notes

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7
Q
  1. What are the pharmacy board codes and guidelines regarding social media?
A

refer to notes

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8
Q
  1. What are the regulations for pharmacy ownership?
A

The VPA is responsible for administration of the Pharmacy Regulation Act 2010 which provides for the regulation of pharmacy businesses, pharmacy departments and pharmacy depots in Victoria.

The Pharmacy Regulation Act 2010 requires the owners of pharmacy businesses, pharmacy departments and pharmacy depots to hold a licence and the premises of pharmacy businesses, pharmacy departments and pharmacy depots to be registered

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9
Q
  1. What are the regulations for pharmacy access and operation?
A
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10
Q

The TGA

A

The Therapeutic Goods Administration (TGA) is a Commonwealth Government agency that regulates medical devices and drugs and what can be sold at the pharmacy

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11
Q

What is the National Scheme?

A

The National Scheme is the UMBRELLA body that oversees the registration of health professionals from 16 different professions.

For example the PBA is a sub under the National Scheme. Under the Scheme, there are different boards for different professions.

The National Scheme has enabled common standards across professions when this is appropriate. These are mandatory registration standards (English language skills, professional indemnity insurance, criminal history, recency of practice and continuing professional development).

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12
Q

TYPES OF REGISTRATION

A
  1. General Registration
  2. Provisional Registration- for students required to complete supervised practice but have completed an accredited degree in the profession
  3. Non Practice registration
  4. Student registration
  5. Limited registration; may be renewed for a maximum of three times, after which a new application can be made. The four types of limited registration are:
    - Postgraduate registration/ supervised practice
    - Area of need registration
    - Public interest registration
    - Research / Teaching registration
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13
Q

Who can own a pharmacy/pharmacy business?

A

Ownership and operation
The following persons can have a proprietary interest in a pharmacy business:
• A registered pharmacist as a sole proprietor or partner;
• A company whose directors and shareholders are all registered pharmacists;
• A mutual not-for-profit company that was registered as a friendly society at 1 July 1999 and has retained a mutual structure. In the 19th century, not-for-profit associations called friendly societies were common in Great Britain and Australia. These existed before government-sponsored health schemes. Eligible friendly societies have been allowed to continue to own pharmacies. In Victoria, there are about 50 pharmacies owned by friendly societies. Hospital pharmacy departments can be owned either by the State or private hospitals, some of which have religious associations.

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