Class notes
Pharmacy Law
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All Pharmacy laws within the UK. From how to check if a prescription is legally valid to the rules and regulations for wholesalers of pharmaceutical drugs
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The PharmacistUK Legislative System
2 types of law:
o Criminal: Relationship between an individual and the state and relates to the
regulation of human behaviour
o Civil: relationship between individuals and relates to the conduct of human
relationships
Criminal Law
Penal law
Bodies of law with the potential for severe impositions as punishment for failure to
comply
Criminal cases involve an action that is considered to be harmful to society as a
whole
Civil Law
Dealing with disputes between individuals and/or organisations, in which
compensation may be awarded to the victim
Civil cases usually involve privates disputes between persons or organisations
Protect and enforce right of individuals
Criminal Law Vs. Civil Law
Dispensing error: Criminal
Pharmacists now need professional indemnity insurance. Requirement by pharmacy
regulator (GPhC)
Primary legislation
Act of Parliament- Acts lay down general principle
E.g. Medicines Act 1968
Formal procedure of enactment involves
“White paper”- Government signals its intentions (before bill)
Sometimes preceded by a “Green paper”- discussion document
Cetin out proposals and inviting comments from invited parties
Bill:
o Proposal to introduce new legislation
o Government bills (most)
o Private members bill= Individual MP bringing a bill to parliament
Bill is debated in both houses of Parliament
Passed
Formal enactment takes place when he bill receives “Royal Assent” (Queen signs).
At this stage, the Bill is known as an Act
Once passed, an Act cannot be altered or mended except by a further Act
,The Pharmacist
Secondary Legislation
Most Acts delegate power to other bodies to make detailed rules= They are
“enabling”
Subsidiary to an Act
Normally in the form of Statutory Instruments
o Including regulations and orders
Statutory Instruments (SI)
SI are concerned with wording detail
SI is not complete in itself but refers back to the Act
SI can amend a previous SI
Initiated by a government minister under powers conferred by an Act
Becomes law after “laying on the table” for 3 days
Both Act and SI may have Schedules (like an appendix) which lists details better
separated from the main requirements
Both Act and SI form Statutory Law
Judicial Precedent
Known as case law, common-law or Judge-made law
JP is a statement of the legal position in a particular case or situation based on the
decisions of previous courts in similar cases
Judges make laws:
o If there is no law on a particular issue
o Where there is legislation, but its meaning is unclear
EU Law
European Commission- Initiates most European Law
Council of the EU- Makes ultimate decisions on European Law
European Parliament- Directly elected chamber
European Court of Justice- Decisions by them must be accepted by courts in member
states and there is no right of appeal
Primary legislation is in the Treaties, which established the original communities
Secondary legislation is:
o Regulations
Direct effect and binding on all member states and individuals
o Directives
Binding by their objectives but leave to member states method of
implementation (legislative or administrative)
Are usually incorporated into UK law by use of SI
o Decisions
,The Pharmacist
Binding to those to whom they are addressed to and often of an
administrative nature
Harmonisation of laws by member states is usually by directives
Key Definitions
Medicinal product:
o Having properties of preventing or treating disease
o Used or administered with a view to:
Restoring, correcting or modifying a physiological function by exerting
a pharmacological, immunological or metabolic action
Making a medical diagnosis
Authorised medicinal product
o Authorised if there is in force for the product:
Marketing authorisation
Certificate of Registration
Traditional herbal registration
Article 126a authorisation
Relevant medicinal product
o A medicinal product that is not:
A registrable homeopathic medicinal product
A traditional herbal medicinal product
Medicinal purpose
o Treating or preventing disease
o Diagnosing disease or measuring the existence, degree or extent of physical
condition
o Contraception
o Inducing anaesthesia
o Otherwise preventing or interfering with the normal operation of a
physiological function, whether permanently or temporarily, and whether by
way of terminating, reducing, postponing, increasing or accelerating the
operation of that function
Administer
o Orally, injection, or by introducing to the body in any other way
o By external application (whether or not by direct application to the body)
, The Pharmacist
Misuse of Drugs Act 1971
Controls export, import, production, supply and possession of dangerous or other
harmful drugs
Termed Controlled Drugs (CDs)
Controls treatment of addicts
General effect is to make unlawful all activities with drugs controlled by the Act
Schedule 2
Morphine, diamorphine, methadone, fentanyl, alfentanil, oxycodone,
methylphenidate, dexamphetamine, ketamine
3 classes based on degree of harmfulness, class are solely for the purpose of
determining penalties for offences:
o Class A
o Class B
o Class C
Legal Highs (NPs)
Ban on novel psychoactive substances
o Psychoactive Substances Act, May 2016
Made an offence to manufacture, import, supply, or distribute- but not possess:
o Any substance deemed to be psychoactive
o Exception of alcohol, tobacco, certain foods or medicines
Directions following convictions of practitioners for offences concerning CDs
Pharmacists
o Prohibited from any possession, supply, dispensing, compounding etc of any
CD
Retail pharmacy owner (or corporate body)
o Removal of premises from the register of pharmacies
Similar effects for doctors
Misuse of Drugs Regulations 2001
Permits use of CDs used as medicines
Other regulations deal with:
o Misuse of Drugs (safe custody) Regulations 1973 Storage and safe custody
of CDs
o Health Act 2006”Accountable officer” Standard Operating Procedures
(SOPs)
5 Schedules of CDs:
o Schedule 1 – CD Lic POM
o Schedule 2 – CD POM
o Schedule 3 – CD No Register POM
o Schedule 4
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