Pharmacy Law Flashcards
PHARMACISTS AND DISPENSING
- Producing and working to Standard Operating Procedures (SOPs)
- Dispensing of prescription / supervision of dispensing technicians and assistants
- Maintain patient _ records (PMRs)
- Release of medicine to patient / representative with advice on use
Medication
LEGISLATIVE FRAMEWORK
All of these activities regulated in various ways:
- UK Parliamentary legislation
- European Union law (at present)
- NHS Administrative law
- Civil law
–Duty of care – liability for injury (tort)
WHAT ARE THE THREE LEGAL JURISDICTIONS OF THE UK?
English Law in England and Wales
Northern Ireland Law in Northern Ireland
Scots law in Scotland
WHAT IS THE LAW?
The regulation of human affairs and human relationships
WHAT ARE THE FIVE CATEGORIES OF ENGLISH LAW?
Criminal Law (statute law)
Civil Law
Administrative Law
Judicial precedent (common law)
Europian Union Law (for now)
WHAT IS TORT?
Wrongful act for which someone can be sued for damages in a civil law court;
Includes act such as trespass and injury done to someone (can be either intentionally or through negligence, e.g. mis-diagnosing, dispensing error etc).
JUDICIAL PRECEDENT
- The principles of judicial precedent are such that when a case is decided in higher courts, lower courts have to follow the decision
- Judges can manipulate the common law provided without waiting for parliament to enact legislation.
- Judges can be subsequently overruled.
WHAT ARE THE RESPONSIBILITIES OF THE COURT?
To determine whether the law has been breached and to settle disputes
CRIMINAL VS CIVIL LAW
WHAT ARE GREEN GOVERNMENT PAPERS?
Consultative documents- what the government might do
WHAT ARE WHITE GOVERNMENT PAPERS?
Firm proposals- what the government will do, given the acceptance of the parliamentary majority
PARLIAMENTARY PROCEDURE IN ENACTING LEGISLATION
PRIMARY AND SECONDARY LEGISLATION
ADVANTAGES OF DELEGATED LEGISLATION
•Saving of Parliamentary time
–Delegated legislation is enacted by appropriate minister
- Greater flexibility
- Greater speed of action and implementation in an emergency
- Allows greater use of consultation with qualified and technical experts
CHECKS ON DELEGATED LEGISLATION
- Parliament usually imposes limitations within Enabling Act on the extent to which a Minister may legislate
- The Delegated Powers and Regulatory Reform Committee has responsibility of reviewing all Statutory Instruments presented to Parliament
- Courts may be used to challenge validity of delegated legislation on the grounds that it is either outside power conferred by Enabling Act or has been made without observing some important procedure
EUROPEAN UNION LAW
Under the Treaty of _, and amended by the Treaty of Maastricht, _ institutions have been established to deal with the law-making process
Rome
Five
EU INSTITUTIONS RESPONSIBLE FOR DEALING WITH THE LAW-MAKING PROCESS
•The Council of Ministers
–Decision making body of the EU. Ministers appointed by member states. Presidency rotates every six months
•The Commission
–Concerned with implementation of treaties
–Commissioners (27) appointed for five-year period. Each has an area of responsibility
•The European Parliament
–Gives opinion on Commission proposals
–Control of EU budget
•The Economic & Social Committee
–Representatives of economic & social groups in member states
•Court of Justice of the European Union
–The European Ensures that EU legislation is properly implemented in member states
WHAT DOES THE ‘COUNCIL OF MINISTERS’ DO?
–Decision making body of the EU. Ministers appointed by member states. Presidency rotates every six months
WHAT DOES ‘THE COMMISSION’ INSTITUTION DO?
–Concerned with implementation of treaties
–Commissioners (27) appointed for five-year period. Each has an area of responsibility
WHAT DOES ‘THE EUROPEAN PARLIAMENT’ INSTITUTION DO?
–Gives opinion on Commission proposals
–Control of EU budget
WHAT DOES ‘THE ECONOMIC AND SOCIAL COMMITTEE’ INSTITUTION DO?
–Representatives of economic & social groups in member states
WHAT DOES ‘THE COURT OF JUSTICE OF THE EUROPEAN UNION’ INSTITUTION DO?
–The European Ensures that EU legislation is properly implemented in member states
WHAT ARE THE FOUR CATEGORIES OF EU LAW?
•Regulations
–Become law in member states as they stand. No need for further implementation
•Directives
–Binding on member states. Must be enacted by national legislation
•Decisions
–Binding on individuals or institutions to which they are addressed
•Recommendations
–Advisory statements
THE FOUR CATEGORIES OF EU LAW
•Regulations
–Become law in member states as they stand. No need for further implementation.
•Directives
–Binding on member states. Must be enacted by national legislation
•Decisions
–Binding on individuals or institutions to which they are addressed
•Recommendations
–Advisory statements
CURRENT UK PHARMACEUTICAL LEGISLATION
- Medicines Act 1968
- _ of Drugs Act 1971
- Poisons Act 1972 and Rules
- _ Act 2006
–Pharmacy Order 2010 established the _
•Human Medicines Regulations 2012
Misuse
Health
GPhC
WHAT DOES THE HUMAN MEDICINES REGULATIONS 2012 ACT DO, AND WHY MIGHT BREXIT CAUSE AN ISSUE FOR THIS?
It governs most day-to-day aspects of medicine control.
This act is delegated legislation under the European Communities Act 1972; one consequence of Brexit will be that this legislation will need to be amended.
The European Union (Withdrawal) Act 2018 intends to convert existing EU law that applies in the UK into domestic law.
CURRENT UK PHARMACEUTICAL LEGISLATION
Miscellaneous legislation concerning:
- Customs & Excise
- Health and Safety
- Control of hazardous substances
- Consumer protection
- Employment
- Retailing
- Confidentiality / data protection
