W5, Pharmacy Business Regulation 1

Question 1

Why examine regulatory framework?

Answer 1

• use your knowledge of the law to your advantage
• know your legal obligations & limitations
  
  • to minimise exposure to risk or liability
• know your legal rights
  
  • need to know your rights in order to exercise them
• evaluate your choices
  
  • e.g. choose a business structure that enables you to minimise your tax liability; evaluate the feasability of a new business model

Question 2

What entities are regulated in pharmacy businesses?

Answer 2

• people: owners, pharmacists, interns, other staff, customers
• products: medicines, equipment, other items
• premises: pharmacy, manufacturing sites, surrounding areas

Question 3

• What are some examples of legislative framework?

Answer 3

• pharmacy act 2010 WA
• medicines and poisons regulation
• taxation acts
• business legislation
• privacy act 1988
• therapeutic goods act 1989
• occupational health & safety act 1984 WA
• health practioner regulation national law act 2009
• compliance is a must, mandatory
• ignorance of the law is no excuse

Question 4

What about guidelines and standards?

Answer 4

• codes and standards
  
  • must be followed
• guidelines
  
  • should be carefully considered and applied where appropriate
• QCPP requirements
  
  • must conform if seeking accreditation

Question 5

What are the responsibilities of pharmacy business owners?

Answer 5

• pharmacy board of australia- no direct role in owndership control
• board has developed guidance addressing proprietor responsibilities
  
  • proprietary (ownership) or pecuniary (relating to or consisting of money) interest means a legal or beneficial interest and includes a proprietary interest as a sole proprietor, as a partner, as a director, member or shareholder of a company and as the trustee or beneficary of a trust
• owner must intervene if business not conducted appropriately
• owners must ensure there are policies, procedures and protocols in place
• a proprietor/ owner or partner-in-owndership of a pharmacy cannot delegate his or her professional obligations, even if that partner is not regularly present at the pharmacy
  
  • this applies to pharmacists who own a pharmacy or pharmacies, in all forms of business structures

Question 6

What are the professional responsibilities of pharmacists?

Answer 6

• PSA code of ethics
  
  • to practice as a pharmacist means undertaking any role, whethere remunerated or not, in which the individuals uses their skills and knowledge as a pharmacist in their profession. Practice is not restricted to the provision of direct clinical care. It also includes working in a direct nonclinical relationship with clients; working in management, administration, education, research, advisory, regulatory or policy development roles; and any other roles that impact on safe, effective delivery of services in the profession

Question 7

What is the integrity principle 1 for professional responsibilities?

Answer 7

A pharmacist:

• provides accurate, truthful, relevant, and independent information in a form that is appropriate for and not misleading to patients
• will only purchase, supply or promote any medicine, complementary medicine, herbal remedy or other healthcare product where there is credible evidence of efficacy and the benefit of use outweights the risk
• does not engage in inappropriate advertising or promotion that could undermine public trust in the profession
• ensures that business practices are conducted primarily in the interests of patient health
• inappropriate advertising- any promotional, marketing or advertising activity that does not comply with, or align with the intent of, relevant requirements, such as:
  
  • therapeutic goods advertising code 2014
  • AHPRA guidelines for advertising regulated health services 2015
  • TGA price information code of practice
  • australian consumer law

Question 8

What are examples of inappropriate advertising?

Answer 8

Any promotional, marketing or advertising acitivity that does not comply with or align with intent of relevant requirements such as:

• Therapeutic Goods Advertising Code 2015
• AHPRA guidelines for advertising regulated health services 2014
• TGA price information code of practice
• Australian consumer law

Question 9

A proprietor/owner or partner-in-ownership of a pharmacy cannot delegate his or her professional obligations, even if that partner is not regularly present at pharmacies

true or false

Answer 9

true