Medicine And Law Part One Flashcards
What are the three pieces of legislation that govern pharmacy and the sale and supply of medicines?
- The Medicines Act 1968
- The Human Medicines Regulations 2012
- The Pharmacy Order 2010
Who regulates the pharmacy profession?
The General Pharmaceutical Council (GPhC)
When was the GPhC established?
2010
What is the purpose of the GPhC?
- The GPhC took over all of the regulatory functions carried out previously by the royal pharmaceutical society of great britain (RPSGB) from september 2010
- Responsible for regulating and ensuring good practise in relation to the profession by setting and maintaining standards
Describe the steps to become a pharmacist
- Obtain an MPharm degree from a British accredited school of pharmacy
- Complete a 52 week foundation period supervised by an experienced pharmacist at an authorised presmises
- Meet a list of professional competences
- Pass the registration assessment
- Complete a fitness to pracitce declaration
- Pay the required fee
What is a pharmacy?
- A pharmacy is described in law as a retail pharmacy business (RPB)
- Must be registered with the GPhC
- Pay the annual retention fee
- Is inspected periodically by the GPhC inspector to ensure standards are maintained
- Must have a responsible pharmacist appointed by law and meet the conditions to be able to lawfully sell or supply any medicines
What premises can call themselves a pharmacy?
Any pharmacy business inclcuded in part 3 of the GPhC register
What premesis can call themselves a chemist?
Pharmacies owned by a pharmacist or where the superintendent of a body corporate is a member of the company board of directors
The Human Medicines Regulations 2012 allow for the prescribed supply to be:
- Againdst a prescription from an authorised prescriber either privately or on the NHS
- A counter prescription determined by a pharmacist and sold to the patient
What are the reasons for legislation?
- Legislation is designed to protect patient safety
- In general, medicines are sold or supplied only though pharmacies but there are some exemptions to this
What is law?
- A basis in morality and ethics
- Sets the rules for a harmonious society
- Gives guidance about the right way to behave towards each other
- Enables penaltites or punishment to be issued to those who do not adhere to acceptable norms
What are the two main types of law?
- Statute law which has its origins in Parliament and includes criminal law, professonal law and administrative law
- Civil law about duties towards each other and includes common law and case law
Who makes the laws?
- Politicians
- Civil servants
- Courts and lawyers
Desribe the four stages of clinical trials used to investigate a new medicine:
Phase 1: Medicine is tested in a small number of healthy volunteers to find out how it owrks in the body and whether side effects increase at higher doses
Phase 2: The medicine is tested in moderate numbers of people with a particular condition or disease to see how effective it is and identify common short-term side effects
Phase 3: information about the medicine is gathered from a larger number of people to see how well it works and how safe it is
Phase 4: This happens after the license has been granted and involves stufies to monitor the mediccine on an ongoing basis to see if there are any unexpected side effects, or if it causes problems in certain categories or people
What information does the licence for a medicine include?
- What health condition is the medicine used to treat?
- What dose should be used?
- What formulation it takes
- Who can use the medicicne
- How long the treatment of medicine should last
- Warnings about known safety issues
- How the medicine should be stored
- When the medicine expires
