Legislation 1 - Human medicines regulations Flashcards
What are the healthcare provisions in the UK? (2)
- NHS healthcare
- Private healthcare
Who is the NHS healthcare provided for, available to, funded by?
- the government
- available to all
- funded by taxation (NI contributions), £114bn 2018-2019)
Who is the private healthcare provided for, available to, funded by?
- businesses and individual practitioners
- available to all who pay
- funded by patient - insurance
What are the cares in both the NHS and private healthcare? (3)
- primary care
- secondary care
- tertiary care
what are examples of primary care? (4)
- GPs
- dentists
- community pharmacists
- optometrists
what are examples of secondary care?
hospitals
what are examples of tertiary care? (2)
specialities
- neurosurgery
- transplant
What are the healthcares before the NHS? (3)
- doctors
- hospitals
- national health insurance act 1911
what is access to a doctor like? (2)
- free to workers on low pay
- charge to spouses, children and workers on higher pay
what is access to hospitals like? (2,2)
Dispensaries
- free (need letter of recommendation)
- small charges (poorer people may be reimbursed)
Voluntary hospitals
- free medical care for the poor
- small charges (what the patient can pay)
what is the national health insurance act 1911 like?
gave statutory recognition to dispensing by, or under the supervision of a pharmacist
What is the national health service (NHS)? + date
comprehensive health service to secure the improvement in the physical and mental health of the people . . . and the prevention, diagnosis and treatment of illness
- 5th july 1948…Aneurin Bevan (minister of health)
what does the NHS aim to provide?
healthcare based on need, not the ability to pay
what is the NHS like in terms of charges (before+after)?
- originally free at the point of delivery
- now charges for some services (prescriptions)
why did we need the medicines act?
before the medicines act 1968
- most medicines were regulated as poisons with no control over the marketing of new medicines
What is the act in 1851?
arsenic act
What is the act in 1868?
pharmacy act - poisons list
What is the act in 1908?
poisons and pharmacy act
What is the act in 1925?
therapeutic substances act (manufacture)
What is the act in 1933?
pharmacy and poisons act
What is the act in 1941?
pharmacy and medicines act (composition)
What is the act in 1947?
penicillin act
What is the act in 1953?
therapeutic substances (prevention of misuses) (manufacture and supply)
what is the therapeutic substances act?
1925
- Medicinal products were increasingly coming from a chemical origin rather than a plant source
what does the therapeutic substance act provide a form of licensing for? (4)
- inspection of manufacturing sites
- personnel suitability
- record keeping
- labelling requirements introduced
What was thalidomide like? (4)
- 1961
- marketed as safe sleeping tablet and antiemetic
- prescribed for morning sickness in pregnancy
- increased babies with phocomelia (hands feet attached to body or reduced limbs)
what is the committee on safety of drugs? (3)
- voluntary agreement by ministers of health to look at the safety of new drugs
- products already on the market were granted a provisional licence of right
who does the committee on safety of drugs consist of? and what do they do? (5)
- scientists
- physicians
- toxicologist
- statisticians
- pharmacists
checking for reasonable safety drugs intended purpose
what is the medicines act? (4)
- 1968
- regulated manufacture, distribution, importation, (limited control on medicines for exports)
- by licence and enforced MHRA
- advised by medicines comission
what is the MHRA?
medicines and healthcare products regulatory agency
what are statutory instruments? (2)
- orders and regulations
- secondary legislation
What does the Human medicines regulation do? (4) what is it based one?
- 14th august 2012
- regulates everything to do with human medicines
- SI due to European legislation
- replaces much of the medicines act and around 200 SI’s
- based on EU legislation (amended due to brexit 2020 & 2021)
what do regulations do?
consolidate nearly all existing UK medicines legislation and simplify the way it is drafted
what does the HMR regulate? (6)
- manufacture
- distribution
- importation
- sale and supply
- labelling and advertising
- pharmacovigilance
(does so by licence)
what does the enforcement of the HMR lie with? (3)
- secretary of state
- general pharmaceutical council (GPhC)
- drugs authority - local council
what are the main aims of the HMR? (3)
maintain
- quality
- safety
- efficacy
What are the different parts of the HMR? (2)
- general
- administration
what is GSL?
medicinal product - should be available on general sale
what is POM?
medicinal product - should be available only on prescription
what is P?
medicinal product that is not a prescription only or on general sale - available only from a pharmacy
what is a medicinal product? (2)
any substance/ combination
- presented as having properties of preventing or treating disease in human beings
- may be used/administered to human beings to restore, correct physiological function by exerting a pharmacological, immunological or metabolic action or medical diagnosis
what is the medicinal purpose? (5)
- treating or preventing disease
- diagnosing disease, ascertaining the existence, degree or extent of a physiological condition
- contraception
- inducing anaesthesia
- prevent normal physiological function perm/temp by terminating, reducing, postponing, increasing or accelerating the function in any other way
who is an appropriate practitioner? (5)
- doctor
- dentist
- supplementary prescriber
- nurse independent prescriber
- pharmacist independent prescriber
what are exceptions to appropriate practitioners? (6)
- community practitioner nurse prescriber (laxatives, mebendazole, nystatin)
- optometrist (POM for ocular conds but not CDs)
- EEA health professional (UK MA POM not CDs Sch1,2 and 3)
- paramedic (cannot prescribe CDs)
- physiotherapist (some CDs, fentanyl)
- podiatrist (some CDs, diazepam)
what does administration in HMR allow continuation for? (3)
- commission on human medicines (CHM)
- british pharmacopoeia commission (BPC)
- expert advisory groups (EAG)
what is the MHRA?
Medicines and Healthcare products Regulatory Agency
what is the mission of the MHRA?
enhance and safeguard the health of the public by ensuring that medicines and medical devices work, are acceptably safe
what is the MHRA responsible for? (4)
- regulation of medicines
- medical devices and equipment used in healthcare
- the investigation of harmful incidents
- looking after blood and blood products
what are activities of MHRA? (9)
- assess safety, quality and efficacy of medicines, authorise sale or supply for human use
- oversee UK notified bodies that audit med dev
- operating yellow card scheme, proactive compliance programme for med dev
- sampling and testing
- regulating clinical trials
- ensure compliance with statutory obligations
- promote good practice in use of meds and med devs
- manage GPRD and BP
- info provision to public and professions
what is the GPRD?
general practice research database
what are medical devices?
all products except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability
what are examples of med devs? (7)
- admin sets
- dressings
- orthotics
- catheters
- condoms
- urine test strips
- contact lenses
what is the commission on human medicines (CHM)? (5)
- advised by expert advisory groups (EAG’s)
- minimum of 8 members (appointed by ministers)
- proactively give info to ministers
- advise ministers when asked
- meet once each month
what are the functions of the CHM? (4)
- advise ministers -execution of duty imposed by HMR 2020 regs/clinical trial regulations (CTR), the exercise of power from them, MPs
- advise safety, quality and efficacy of MPs
- promote collection and investigation of ADR’s
- provide independent expert advice to the regulatory agency of the MHRA
what are the functions of the british pharmacopoeia commission (BPC)? (4)
- preparations of the BP (may be used in practice of med/surgery, dentistry or midwifery, separate compendia for vet med/surgery)
- preparation of other appropriate compendia
- preparation of cumulative list of rINN
- european pharmacopoeia
what is the british pharmacopoeia (the book) comprise descriptions for and specify the standards for?
- substances which may be used in the practice of med & manufacture of MPs
- for MPs
what are the EAG? (5)
- appointed by BPC/CHM
- ministers may instruct BPC/CHM to appoint EAG
- members don’t have to be part of CHM/BPC
- chair appoint by CHM/BPC
- independent and transparent
what does the EAG undertake detailed examination of issues prior to referral to? (2)
- new medicines licensing
- risk management plans
what are the current established EAG’s? (12)
- anti-infectives/ HIV/ hepatology
- biologicals/vaccines
- cardiovascular/ diabetes/ renal/ respiratory/ allergy
- chemistry, pharmacy and standards
- clinical trials
- dermatology/ rheumatology/ gastroenterology/ immunology
- medicines for women’s health
- neurology/ pain/ management/ psychiatry
- oncology and haematology
- paediatric medicines
- patient and public engagement
- pharmacovigilance
what are ministers solely responsible for? (3)
- licensing (MHRA)
- hospitals
- practitioners premises
what is the GPhC responsible for? (4)
- register of pharmacists, pharmacy technicians and pharmacy premises (pharmacy order 2010, revalidation)
- disciplinary control of pharmaceutical profeesion
- sale and supply of MPs (POM’s and P medicines)
- restriction of titles
what does the registrar & chief executive of the GPhC keep a register of? (3)
- premises
- pharmacists
- pharmacy technicians
what is a registered pharmacy?
premises entered for the time being on the register
what is a registered pharmacist?
person registered in the register of pharmacists
what is a registered pharmacy technician?
person registered in the register of pharmacy technicians
(mandatory since June 2011)
