Pharmacy Law

Question 1

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

Answer 1

Medication

Question 2

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)

Question 3

WHAT ARE THE THREE LEGAL JURISDICTIONS OF THE UK?

Answer 3

English Law in England and Wales

Northern Ireland Law in Northern Ireland

Scots law in Scotland

Question 4

WHAT IS THE LAW?

Answer 4

The regulation of human affairs and human relationships

Question 5

WHAT ARE THE FIVE CATEGORIES OF ENGLISH LAW?

Answer 5

Criminal Law (statute law)

Civil Law

Administrative Law

Judicial precedent (common law)

Europian Union Law (for now)

Question 6

WHAT IS TORT?

Answer 6

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).

Question 7

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.

Question 8

WHAT ARE THE RESPONSIBILITIES OF THE COURT?

Answer 8

To determine whether the law has been breached and to settle disputes

Question 9

CRIMINAL VS CIVIL LAW

Question 10

WHAT ARE GREEN GOVERNMENT PAPERS?

Answer 10

Consultative documents- what the government might do

Question 11

WHAT ARE WHITE GOVERNMENT PAPERS?

Answer 11

Firm proposals- what the government will do, given the acceptance of the parliamentary majority

Question 12

PARLIAMENTARY PROCEDURE IN ENACTING LEGISLATION

Question 13

PRIMARY AND SECONDARY LEGISLATION

Question 14

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

Question 15

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

Question 16

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

Answer 16

Rome

Five

Question 17

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

Question 18

WHAT DOES THE ‘COUNCIL OF MINISTERS’ DO?

Answer 18

–Decision making body of the EU. Ministers appointed by member states. Presidency rotates every six months

Question 19

WHAT DOES ‘THE COMMISSION’ INSTITUTION DO?

Answer 19

–Concerned with implementation of treaties

–Commissioners (27) appointed for five-year period. Each has an area of responsibility

Question 20

WHAT DOES ‘THE EUROPEAN PARLIAMENT’ INSTITUTION DO?

Answer 20

–Gives opinion on Commission proposals

–Control of EU budget

Question 21

WHAT DOES ‘THE ECONOMIC AND SOCIAL COMMITTEE’ INSTITUTION DO?

Answer 21

–Representatives of economic & social groups in member states

Question 22

WHAT DOES ‘THE COURT OF JUSTICE OF THE EUROPEAN UNION’ INSTITUTION DO?

Answer 22

–The European Ensures that EU legislation is properly implemented in member states

Question 23

WHAT ARE THE FOUR CATEGORIES OF EU LAW?

Answer 23

•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

Question 24

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

Question 25

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

Answer 25

Misuse

Health

GPhC

Question 26

WHAT DOES THE HUMAN MEDICINES REGULATIONS 2012 ACT DO, AND WHY MIGHT BREXIT CAUSE AN ISSUE FOR THIS?

Answer 26

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.

Question 27

CURRENT UK PHARMACEUTICAL LEGISLATION

Miscellaneous legislation concerning:

• Customs & Excise
• Health and Safety
• Control of hazardous substances
• Consumer protection
• Employment
• Retailing
• Confidentiality / data protection