Pharmacy Law Flashcards
What are primary and secondary legislation
Primary legislation is the act of parliaments
Secondary legislations are laws created by the minister or other bodies under power given to then by the acts of parliament
List the types of laws
Statute law, public law, administrative law, professional law (at work) , common law, civil law
What is statute law?
Statute law is an act of parliament, can be public or private. They are statutory instruments
What is public law?
Involves the state or government includes criminal law which is an offence against society
What is the MHRA ?
A government agency responsible for enforcing medicines legislations in the uk able to bring criminal prosecutions in case such as unlawful manufature
What is administrative law ?
Controls how public bodies and individuals including NHS and community pharmacies contractors and how they operate
What is Professional law?
professional law allows disciplining of health professionals
pharmacist and pharmacy technicians order 2007: gives GPhC power to discipline pharmacist and technicians
What is common law?
Duties and obligations between citizens and is built up of court judgment to create a body of decisions and precedents
What is civil law?
disputes between individuals or organisations regarding duties, rights and obligations e.g property, defamation etc
Accountability and responsibility
as a professional you are personally accountable for actions and omissions in your practice and must always justify your decisions
obliged to take care, liable to be blamed for failure
What is vicarious liability?
Used to explain the legal responsibility that one party may hold for the harmful actions of another, even if they’re not the party that directly caused the harm
A employer can be held vicariously liable for the consequences of the actions/omissions of an employee.
Human rights acts 1998
Requires all public bodies (like courts, police, local authorities, hospitals and publicly funded schools) and other bodies carrying out public functions to respect and protect human rights
Equality act 2010
Protects people from discrimination, harassment and victimisation because of a “Protected Characteristic”
sexual orientation, disability, gender reassignment, religion and belief, race, pregnancy and maternity, sex etc
Mental capacity act 2005
Designed to protect an empower people h who may lack the mental capacity to make their own decisions about their care and treatment. It applies to people aged 16 and over
The human medicines regulations 2012
The Human Medicines Regulations 2012 sets out a comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance
The pharmacy order 2018
legal defences to prevent the automatic criminalisation of inadvertent preparation of dispensing errors by registered pharmacy professionals
the legislation reduces the fear of prosecution which leads to an increase in reporting of dispensing errors, which may help prevent the error happening again
When can the pharmacy order 2018 defense be used?
When the dispensing error :
occurred in a registration pharmacy
was by or under the supervision of a registered pharmacist or technician
supplied against a prescription, PGD, emergency supply or direction from a prescriber
has been promptly notified to the patient once the pharmacy team are aware of the effort
General data protection regulations
Anyone processing personal data must have a lawful basis for doing so, if its data concerning health processing only for the provision of healthcare or treatment
The Medical Devices Regulations 2002
A medical device is any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, ….to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application
