Law & regulation of medicines

Question 1

Define Medicine management

Answer 1

MM considers the systems of processes & behaviours in determining how medicines are used by the patients and the NHS. Mostly led by pharmacy teams.

It is distinct from medicine optimization which focuses on actions taken by all health & social care practitioners and requires greater patient engagement, professional collaboration across health & social care settings.

Question 2

Where do patients get there healthcare information?

Answer 2

Social media

Magazines

Relatives

GP’s & other healthcare professionals

Question 3

Describe the EU & UK principles of laws in medicine

Answer 3

Principles of laws in medicine:

EU law: divided into directives, regulations, decisions & recommendations

UK law: divided into common law (criminal & civil) & statute law

Question 4

Describe the components of the primary legislation in the UK

Answer 4

The medicines act (1968)

Misuse of drugs (1971)

The health & social act (2001) (section 63)

Question 5

Describe the components of the secondary legislation in the UK

Answer 5

• power is given to ministers
• usual form is statutory instruments
• approx 3000 issued annually
• ‘speed, flexibility, adaptability’

Question 6

Describe criminal legislation (statutory)

Answer 6

Enforcement agencies: police officers, inspectors

Action for breach: prosecution in criminal courts

Sanctions available to society at large: fines, community service or imprisonment

Redress available to unsuccessful party: Appeal to a higher court

Question 7

Describe administrative legislation (statutory)

Answer 7

Enforcement agencies: Administrative representative

Action for breach: Appearance before relevant tribunal

Sanctions available to society at large: withdrawal of position or contractual rights

Redress available to unsuccessful party: Judicial review

Question 8

Describe professional legislation (statutory)

Answer 8

Enforcement agencies: GphC regulator

Action for breach: Appearance before fitness to practice committee

Sanctions available to society at large: applying conditions to registration or removal of professional registration

Redress available to unsuccessful party: Appeal to higher tribunal

Question 9

Describe common law, right and duties, (civil)

Answer 9

Enforcement agencies: Direct action my claimant

Action for breach: sued in the civil courts

Sanctions available to society at large: having to pay compensation or entering the register of county court judgements

Redress available to unsuccessful party: Appeal to higher tribunal

Question 10

Describe the purpose of the DA

Answer 10

The devolved administrations in the United Kingdom refer to the systems of government that have been established in Scotland, Wales, and Northern Ireland to allow these regions to have control over certain domestic affairs, while remaining part of the UK. Each devolved administration has its own set of powers and responsibilities.

England minister signs on behalf of Scotland & Wales, the northern ireland minister countersigns the amendments.

Question 11

Define human medicine regulations & CD’s

Answer 11

Started in august 2012 to reinforce law of UK concerning medical products for human use. Should be referred in conjunction with the Medicines act from 1968.

Misuse of drugs (1971): graded broadly according to the harmfulness attributed to each drug when it is misused

Question 12

Describe the classification of drugs system

Answer 12

Classification of drugs: different countries categorize substances based on their potential for harm, medical use, and addiction risk. The most commonly used system in the UK is the Misuse of Drugs Act 1971, which classifies drugs into three main categories: Class A, Class B, and Class C

Question 13

Describe the classification of class A drugs

Answer 13

Class A drugs: cocaine, LSD, MDMA, morphine, opium & pethidine. These classes of drugs are classified to be the most harmful & dangerous. They hold the most significant risk for users & potential for abuse.

Penalties: Possession: Up to 7 years in prison, an unlimited fine, or both. Trafficking/Distribution: Up to life imprisonment, an unlimited fine, or both.

Question 14

Describe the classification of class B drugs

Answer 14

Class B drugs: oral amphetamines, barbiturates, cannabis resin & codeine. These drugs cause less harm than class A drugs, however, still possess a potential for moderate abuse & harm to users.

Penalties: Possession: Up to 5 years in prison, an unlimited fine, or both. Trafficking/Distribution: Up to 14 years in prison, an unlimited fine, or both

Question 15

Describe the classification of class C drugs

Answer 15

Class C drugs: some amphetamines, benzodiazepines, anabolic steroids & growth hormone. These drugs have a low risk of harm & addiction but can carry health risk if misused.

Penalties: Possession: Up to 2 years in prison, an unlimited fine, or both. Trafficking/Distribution: Up to 14 years in prison, an unlimited fine, or both.

Question 16

Describe the schedule of CD’s

Answer 16

SCH1: drugs such as LSD are not used medically, so possession and supply is prohibited except with HO authority
SCH2: diamorphine, morphine, pethidine, amphetamine, cocaine & cannabis
SCH3: Temazepam, barbiturates & midazolam
SCH4: benzodiazepines
SCH5: low strength CD’s e.g., codeine

Question 17

What is required for a medicine to be deemed as safe

Answer 17

Must pass an evaluation that includes safety, quality & efficacy, this is regulated by the commission of human medicine (CHM) & medicines & healthcare products regulatory agency (MHRA)

CHM & MRHA require pre-clinical studies, phase 1-3 clinical trials & phase 4 pharmacovigilance.

Question 18

When is a drug a medicine?

Answer 18

A medicine is any substance or combination of many substances that present as having properties that treat & prevent diseases in human beings. They should aim to restore physiological functions via exerting a pharmacological, immunological or metabolic action. They can be used to help make a medical diagnosis.

A medicine must have scientific evidence supporting its medical benefits. Clinical trials are conducted to establish whether a drug can effectively treat a condition with an acceptable risk-to-benefit ratio. For a drug to be marketed as a medicine, the manufacturer must make specific medical claims that are supported by clinical data.

Unlike drugs, a medicine is typically subject to specific regulations, such as labelling, manufacturing practices, and sale restrictions.

Question 19

Define GSL, P, POM & CD’s

Answer 19

GSL: general sales list, this refers to medicine that is freely available to purchase with limits on quantity

P: pharmacy only, this refers to medicine that can be accessed from a pharmacy under the supervision of a registered pharmacist

POM: prescription only medicine, this refers to medicine that can only be given with an authentic prescription from an authorised prescriber

CD: controlled drugs: this refers to medicine that is separately designated and is dictated by controls and records. Not all POMS are CDS, but to have a CD one must have a prescription from an authorised prescriber

Question 20

What does a prescription mean?

Answer 20

To order a supply of a specific medication for a named patient

To authorise the supply of any medication at the expense of the public, by means of an NHS prescription

Advice of medicine should not be strictly prescribing but should be covered with competence

Question 21

Define unlicensed medicine

Answer 21

Unlicensed medicine: a medicine that has no EU authority, prescriber takes full responsibility for the use of the medicine, the main concern is over the safety & quality of the product

Question 22

Define off-label medicine

Answer 22

Off label medicine refers to a medicine that has a market authority, but it is outside that of the EU market authority of that medicine, the prescriber takes full responsibility for the medicine, there is a need to justify off label medicine

Question 23

Define mixing of medicines

Answer 23

Mixing of medicine: where medicines are combined for the purpose of administering them to a patient to meet their specific needs

Question 24

Define patient group direction

Answer 24

Patient group direction: these are written instructions for the supply & administration of a licensed medicine in an identifiable clinical setting by designated professional groups

Question 25

In what scenarios can a HP provide medicine without a prescription

Answer 25

Emergencies: if a person’s life is at stake, e.g., anaphylactic shock Statutory exemptions Patient specific directions Patient group directions Supplementary prescribing Independant prescribing

Question 26

Describe emergency exemption

Answer 26

Emergency exemptions: this ensure that members of the public cannot be prosecuted for administration of emergency medicinal products to save a life. In this scenario no prescription is required or PGD (patient guided direction). this includes: diabetic emergencies, anaphylaxis, heroin overdose

Question 27

Describe the legal mechanism, who can do it, how it help and limitation of emergency exemptions

Answer 27

Where there are specific exemptions for particular professional groups from the provision of medicinal legislation. some medicines may be given in order to save a life Who can do it: nurses, midwives, podiatrists etc How it helps: enables professionals to provide medicine which are known to their professional practice without need to refer to a prescriber Limitations: specific to each professional group & medicine must be licensed

Question 28

Describe the podiatry exemptions

Answer 28

They can sell, supply & administer certain medicines in their professional practice, to do so they must have completed approved training & education & have relevant annotations. POM's: allows registered podiatrists to prescribe & administer, POM's, cannot mix meds & must used pre-combined meds, they can also sell certain POM's pharmacy only meds & GSL

Question 29

Give examples of medications podiatrists can sell and supply

Answer 29

Antiobiotics e.g., amoxicillin, erthymocyin Co-codamol topical hydrocortisone 1%

Question 30

Give examples of medications podiatrists can administer

Answer 30

1. Methylprednisolone 2. Lidocaine 3. Prilocaine 4. adrenaline injection

Question 31

Define the exemption list

Answer 31

These provide that a person that lawfully conducts a pharmacy business can sell or supply a specific range of medications on a repeat basis based on a signed prescription from an authorized prescriber e.g., podiatrist The medications can be sold to a podiatrist or directly to the patient The signed order must include: An original signature from the authorised prescriber The name, quantity, pharmaceutical form & strength of a drug

Question 32

Describe patient specific direction, who can do it, why it helps and the limitations of it

Answer 32

PSD: The traditional written instruction from a doctor. dentist or other HP, for a medicine to be supplied and administered to a named patient Who can do it: doctors, dentists & other non-medical prescribers How it helps: It enables delegation of administration of medicine to suitably trained professionals e.g., nurses. It can cover a course of medication e.g., pain relief for chronic pain patients Limitations: requires a prescriber with associated training/expertise

Question 33

Describe patient group direction, who can do it, why it helps and the limitations of it

Answer 33

PGD: Written instructions for the supply/ administration of a licensed medicine in a clinical scenario, can be used by HP's Who can do it: nurses, paramedics, pharmacists etc How it helps: allows trained staff to deliver one-off care without need to call a prescriber, e.g., asthma attack, giving an inhaler Limitations: no professional judgement is allowed, does not allow dose modifications, no off-label or unlicensed meds are acceptable

Question 34

Define PGD

Answer 34

PGD: patient guided directions Healthcare providers give the medicines to be listed, it does not include the use of unlicensed medicines & most CD’s, they are subject to NICE guidelines on PGD standards for organisation & individual competence.

Question 35

Define independent prescribing, who can do it, why it helps and the limitations of it

Answer 35

Type of P: allows trained HP's to prescribe licensed meds to a medical condition they are competent to treat Doctors, dentists and non-medical prescribers e.g., radiographers, nurses etc It allows competent qualified professionals to deliver complete care involving medicines Limitations: relies in training, individual accountability & clinical experience

Question 36

Define supplementary prescribing, who can do it, why it helps and the limitations of it

Answer 36

A voluntary partnership between two HP's e.g., doctor or dentist & a supplementary prescriber, e.g., dietician, nurse, paramedic They can prescribe CD's for treating addiction, must have a UK address, Can prescribe off-label and unlicensed meds, subject to acceptable clinical practice Limitations: prescribed items are subject to clinical competence & must fit with agreed treatment plan, not ideal for emergency/unscheduled care

Question 37

Define medical prescribing, who can do it, why it helps and the limitations of it

Answer 37

types of prescribers: Doctors registered in the UK, foundation Yr1 doctors have provisional CD's can be prescribed e.g., to treat addiction, can schedule 4/5 CD's, prescriber must live in UK to prescribe drugs in the UK, They can prescribe off-label & off-licensed medicine Limitations: Prescription of drug is based of clinical expertise

Question 38

Define podiatry prescribing, off-label & unlicensed meds, why it helps and the limitations of it

Answer 38

Type of prescriber: chiropodistss & podiatrists Some CD's can be prescribed, much more limited list of CD's, they can not supply or possess these drugs They can prescribe off- label & not unlicensed meds, they can mix medicinces Limitations: prescribing of medicines for any medical condition must be within their competence

Question 39

Define physiotherapy prescribing, off-label and licensed medicine, why it helps and the limitations of it

Answer 39

Type of prescriber: physiotherapist prescriber These prescribers can prescribe CD's e.g., diazepam, oral morphine and fentanyl injections Off-licensed medicine can be prescribed, but Physios are unable to mix medicines together Limitations: prescribing of medicines for any medical condition must be within their competence

Question 40

Describe the single competency framework

Answer 40

It is a generic framework for any prescriber regardless of their professional background, it must reflect the expertise levels & different areas of practice. It reflects key competencies needed by all prescribers. It applies equally to independent & supplementary prescribers