Law & regulation of medicines Flashcards
Define Medicine management
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.
Where do patients get there healthcare information?
Social media
Magazines
Relatives
GP’s & other healthcare professionals
Describe the EU & UK principles of laws in medicine
Principles of laws in medicine:
EU law: divided into directives, regulations, decisions & recommendations
UK law: divided into common law (criminal & civil) & statute law
Describe the components of the primary legislation in the UK
The medicines act (1968)
Misuse of drugs (1971)
The health & social act (2001) (section 63)
Describe the components of the secondary legislation in the UK
- power is given to ministers
- usual form is statutory instruments
- approx 3000 issued annually
- ‘speed, flexibility, adaptability’
Describe criminal legislation (statutory)
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
Describe administrative legislation (statutory)
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
Describe professional legislation (statutory)
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
Describe common law, right and duties, (civil)
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
Describe the purpose of the DA
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.
Define human medicine regulations & CD’s
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
Describe the classification of drugs system
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
Describe the classification of class A drugs
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.
Describe the classification of class B drugs
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
Describe the classification of class C drugs
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.
Describe the schedule of CD’s
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
What is required for a medicine to be deemed as safe
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.
When is a drug a medicine?
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.
Define GSL, P, POM & CD’s
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
What does a prescription mean?
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
Define unlicensed medicine
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
Define off-label medicine
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
Define mixing of medicines
Mixing of medicine: where medicines are combined for the purpose of administering them to a patient to meet their specific needs
Define patient group direction
Patient group direction: these are written instructions for the supply & administration of a licensed medicine in an identifiable clinical setting by designated professional groups
In what scenarios can a HP provide medicine without a prescription
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
Describe emergency exemption
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
Describe the legal mechanism, who can do it, how it help and limitation of emergency exemptions
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
Describe the podiatry exemptions
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
Give examples of medications podiatrists can sell and supply
Antiobiotics e.g., amoxicillin, erthymocyin
Co-codamol
topical hydrocortisone 1%
Give examples of medications podiatrists can administer
- Methylprednisolone
- Lidocaine
- Prilocaine
- adrenaline injection
Define the exemption list
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
Describe patient specific direction, who can do it, why it helps and the limitations of it
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
Describe patient group direction, who can do it, why it helps and the limitations of it
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
Define PGD
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.
Define independent prescribing, who can do it, why it helps and the limitations of it
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
Define supplementary prescribing, who can do it, why it helps and the limitations of it
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
Define medical prescribing, who can do it, why it helps and the limitations of it
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
Define podiatry prescribing, off-label & unlicensed meds, why it helps and the limitations of it
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
Define physiotherapy prescribing, off-label and licensed medicine, why it helps and the limitations of it
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
Describe the single competency framework
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
