The Medicines Act 1998 and HMR 2012
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- Created by: Millie Smith08
- Created on: 23-04-23 13:58
NHS healthcare
provided by gov
available to all
funded by taxation- NI contributions
(3144bn 2018-19)
available to all
funded by taxation- NI contributions
(3144bn 2018-19)
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private healthcare
provided by businesses and individual practitioners
available to all who pay
funded by patient- insurance
available to all who pay
funded by patient- insurance
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primary care (community care)
GPs
dentists
community pharmacists
optometrists
dentists
community pharmacists
optometrists
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secondary care
hospitals
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tertiary care
specialities eg neurosurgery, transplant
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healthcare before the NHS
access to a doctor
- free to workers on low pay
- charge passed on to spouses, children and workers on higher pay
access to hospitals
- dispensaries
- free but a letter of recommendation needed
- small charger; poorer people might be reimbursed
voluntary
- free to workers on low pay
- charge passed on to spouses, children and workers on higher pay
access to hospitals
- dispensaries
- free but a letter of recommendation needed
- small charger; poorer people might be reimbursed
voluntary
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the National Health Insurance Act 1911
Act gave statutory recognition to dispensing by, or under the supervision of, a pharmacist
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the National Health Service
5th July 1948
Aneurin Bevan (Minister for Health)
5th July 1948
Aneurin Bevan (Minister for Health)
the NHS Act established a 'comprehensive health service to secure the improvement in the physical and mental health or people... and the prevention, diagnosis and treatment of illness'
aim was to provide healthcare based on need, not the ability to pay
or
aim was to provide healthcare based on need, not the ability to pay
or
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the NHS Act 1977
repealed the whole of the 1946 Act
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why did we need the Medicines Act?
until the introduction of the Medicines Act 1968 most medicines were regulated as poisons with no control over the marketing of new medicines
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Medicines related Acts
Arsenic Act 1851
Pharmacy Act 1868- poisons list
Poisons and Pharmacy Act 1908
Therapeutic Substances Act 1925 (manufacture)
Pharmacy and Poisons Act 1941 (composition)
Penicillin Act 1947
Therapeutic Substances (prevention of misuses) Act 1953 (manufactu
Pharmacy Act 1868- poisons list
Poisons and Pharmacy Act 1908
Therapeutic Substances Act 1925 (manufacture)
Pharmacy and Poisons Act 1941 (composition)
Penicillin Act 1947
Therapeutic Substances (prevention of misuses) Act 1953 (manufactu
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1925 Therapeutic Substances Act
MPs were increasingly coming from a chemical origin rather than a plant source
eg anti-syphylis drug Salversan contained 606 toxic impurities
eg anti-syphylis drug Salversan contained 606 toxic impurities
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Therapeutic Substances Act (TSA) provided
a form of licensing which included:
- inspection of manufacturing sites
- personnel suitability
- record keeping
- labelling requirements introduced
- inspection of manufacturing sites
- personnel suitability
- record keeping
- labelling requirements introduced
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1961
Thalidomide
Thalidomide
marketed as a safe sleeping tablet and antiemetic (anti-sickenss)
prescribed for morning sickness in pregnancy
pregnant women taking thalidomide led to an increased incidence of babies born with phocomelia (hands and feet attached directly to the body, or
prescribed for morning sickness in pregnancy
pregnant women taking thalidomide led to an increased incidence of babies born with phocomelia (hands and feet attached directly to the body, or
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Committee on safety of drug
1963
1963
voluntary agreement by the Ministers of Health to look at the safety of new drugs
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the Committee on Safety of Drugs consisted of:
- scientists, physicians, toxicologist, statistician and pharmacists
- who were checking for 'reasonable safety of a drug's intended purpose'
- still nowhere near the level of safety required today
- products already on the market were granted a provision
- who were checking for 'reasonable safety of a drug's intended purpose'
- still nowhere near the level of safety required today
- products already on the market were granted a provision
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Thalidomide tragedy
May 8th 1964
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the Medicines Act 1968
it regulated:
- manufacture
- distribution
- importation
- and it also limited control on medicines for exports
- manufacture
- distribution
- importation
- and it also limited control on medicines for exports
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how did the Act achieve this?
by licence
medicines must have a licence
medicines must have a licence
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who was it enforced by?
MHRA
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who was the Act advised by?
the Medicines Commission
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since 1968, many more rules and legislation made
- achieved by Statutory Instruments (SI)
- Orders and Regulations
- Referred to as secondary legislation
- Much of Medicines Act 1968 now revoked
- Orders and Regulations
- Referred to as secondary legislation
- Much of Medicines Act 1968 now revoked
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the Human Medicines Regulations 2012
from the 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
- Medicines Act still exists
- regulates everything to do with Human Medicines
- SI due to European legislation
- replaces much of the Medicines Act and around 200 SI's
- Medicines Act still exists
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the Human Medicines Regulations
consolidate nearly all existing UK Medicines legislation and simplify the way it is drafted
HUMANS
HUMANS
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what does this Act regulate?
- manufacture
- distribution
- importation
- sale and supply
- labelling and advertising
- pharmacovigilance
(medicines for human use)
- distribution
- importation
- sale and supply
- labelling and advertising
- pharmacovigilance
(medicines for human use)
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how does the Act achieve this?
by licence
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the licencing authority is
either or both of the ministers (Secretary of State and the Minister of Health, Social Services and Public Safety) -> MHRA
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the HMR 2012 also deals with
- Supply of Medicines to the public
- Labelling and Containers
- Sales promotion (advertising)
- Preparation of BP and other books of standards
- Labelling and Containers
- Sales promotion (advertising)
- Preparation of BP and other books of standards
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enforcement lies with
Secretary of State
GPhC
'Drugs authority' - local council (only for GSLs)
(registration of Retail Pharmacies still lies with the Medicines Act 1968)
GPhC
'Drugs authority' - local council (only for GSLs)
(registration of Retail Pharmacies still lies with the Medicines Act 1968)
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main aims of HMR
maintain:
- quality
- safety
- efficacy
(of a medicinal product)
- quality
- safety
- efficacy
(of a medicinal product)
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from HMR 2012 application for Marketing Authorisation:
'the positive therapeutic effects of the product outweigh the risks to the health of patients or of the public associated with the product'
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HMR part 1
general- terminology and definitions
the licensing authority and the Ministers
general- terminology and definitions
the licensing authority and the Ministers
licensing authority is either or both of the ministers (Secretary of State and the Minister of Health, Social Services and Public Safety)
MHRA- licensing in the UK- gov agency (London)
Brexit- EU law written into UK law (EU retained law)
MHRA- licensing in the UK- gov agency (London)
Brexit- EU law written into UK law (EU retained law)
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HMR part 1
general- terminology and definitions
advertisements
general- terminology and definitions
advertisements
in relation to a medicinal product, includes anything designed to promote the prescribing, supply, sale or use of that product
general interpretation (may have lots of definitions)
MA
Pharmacist
Registered pharmacy
retail pharmacy business
general interpretation (may have lots of definitions)
MA
Pharmacist
Registered pharmacy
retail pharmacy business
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special provisions for pharmacies
exempts the need for manufacturing licence when extremporaneous dispensing
(the pharmacist making the product themselves- still able to do this under law)
(the pharmacist making the product themselves- still able to do this under law)
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GSL
medicinal product covered by authorisation that states it should be available on general sale
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POM
medicinal product covered by authorisation that states it should be available only on prescription
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P
medicinal product that is not a prescription only medicinal product or a medicinal product on general sale- covered by authorisation that states it is to be available only from a pharmacy
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medicinal product means
any substance or combination of substances presented as having properties of preventing or treating disease in human beings, or
any substance or combination of substances that may be used by or administered to human being with a view to:
1- restoring, co
any substance or combination of substances that may be used by or administered to human being with a view to:
1- restoring, co
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Medicinal purpose (from MA 1968)
means any one or more of the following:
a) treating or preventing disease
b) diagnosing disease or ascertaining the existence, degree or extent of a physiological condition
c) contraception
d) inducing anaesthesia
e) otherwise preventing or interfering w
a) treating or preventing disease
b) diagnosing disease or ascertaining the existence, degree or extent of a physiological condition
c) contraception
d) inducing anaesthesia
e) otherwise preventing or interfering w
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HMR
who is an appropriate practitioner?
who is an appropriate practitioner?
in relation to a POM:
a) a doctor
b) a dentist
c) a supplementary prescriber
d) a nurse independent prescriber
e) a pharmacist independent prescriber
a) a doctor
b) a dentist
c) a supplementary prescriber
d) a nurse independent prescriber
e) a pharmacist independent prescriber
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exceptions
a)Community Practitioner Nurse Prescriber- certain laxatives, Mebendazole, Nystatin, etc
b) Optometrist Independent Prescriber- any POM for ocular conditions but not CDs
c) EEA health professional (approved countries list)- any UK MA POM except Cds Sch 1,
b) Optometrist Independent Prescriber- any POM for ocular conditions but not CDs
c) EEA health professional (approved countries list)- any UK MA POM except Cds Sch 1,
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HMR
part 2
administration
part 2
administration
allows for continuation of:
- commission on Human Medicines (CHM)- advisory body
- British Pharmacopoeia Commission (BPC)- advisory body
- Expert Advisory Groups (EAG)
- commission on Human Medicines (CHM)- advisory body
- British Pharmacopoeia Commission (BPC)- advisory body
- Expert Advisory Groups (EAG)
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Medicines and Healthcare products Regulatory Agency (MHRA)
executive agency of Departmnet of Health and Social Care (DHSC)
the MHRA's mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe
the MHRA's mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe
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MHRA are responsible for:
- regulation of medicines
- medical devices and equipment used in healthcare
- the investigation of harmful incidents
- looking after blood and blood products (which is a medicinal product)
- medical devices and equipment used in healthcare
- the investigation of harmful incidents
- looking after blood and blood products (which is a medicinal product)
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activities of the MHRA
- assessing the safety, quality and efficacy of medicines, and authorising their sale or supply in the UK for human use
- overseeing the UK Notified Bodies that audit medical device manufacturers
- operating the yellow card scheme (medicines and devices)
- overseeing the UK Notified Bodies that audit medical device manufacturers
- operating the yellow card scheme (medicines and devices)
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the yellow card scheme
allows regulators to see patterns of side effects that cause issues
tend to report side effects for new drugs/ new side effects for older drugs
tend to report side effects for new drugs/ new side effects for older drugs
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'medical device'
this term covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability
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examples of medical devices
- IV admin sets
- dressings
- orthotics
- catheters
- condoms, urine test strips, contact lenses
- dressings
- orthotics
- catheters
- condoms, urine test strips, contact lenses
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Status Quo (CE mark) on medical devices remains until
2023 when UK introduces its own mark
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Commission on Human Medicines (CHM)
advised by Expert Advisory Groups (EAG's)- individuals who are experts in their fields
minimum of 8 members
appointed by Ministers
Chair appointed by Ministers
proactively give info to Ministers about drugs
Advise Ministers when asked
meet once a month
minimum of 8 members
appointed by Ministers
Chair appointed by Ministers
proactively give info to Ministers about drugs
Advise Ministers when asked
meet once a month
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CHM functions
1/ advise the appropriate Ministers about:
- the execution of duty imposed by the HMR 2020 regs or Clinical Trials Regulations (CTR)
- the exercise of any power from HMR 2020 and CTR
- MPs
2/ generally advise about safety, quality and efficacy of MPs
3/ p
- the execution of duty imposed by the HMR 2020 regs or Clinical Trials Regulations (CTR)
- the exercise of any power from HMR 2020 and CTR
- MPs
2/ generally advise about safety, quality and efficacy of MPs
3/ p
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the MHRA is independent of
the gov and MHRA
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the CHM advises ministers on safety, advising on applications for National marketing authorisations:
- considering further representation against our provisional advice in respect of national applications
- advising on the need for, ad content of, risk management plans for new medicines
- advising on the impact of new safety issues on the balance of ris
- advising on the need for, ad content of, risk management plans for new medicines
- advising on the impact of new safety issues on the balance of ris
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BPC functions
- preparation of the BP (contains substances which are or may be used in the practice of medicine or surgery (not vet), dentistry or midwifery)
- separate compendia for Veterinary medicine/ surgery
- preparation of other appropriate compendia
- preparatio
- separate compendia for Veterinary medicine/ surgery
- preparation of other appropriate compendia
- preparatio
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British Pharmacopoeia (the book)
comprises descriptions for substances which may be used in the practice of medicine and the manufacture of MPs
specifies the standards for MPs
specifies the standards for MPs
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EAG's
appointed by either BPC or CHM
ministers may instruct BPC and CHM to appoint an EAG
range of EAG's undertake detailed examination of issues prior to referral to CHM or BPC, eg
- New medicines licensing
- risk management plans
independent and transparent
ministers may instruct BPC and CHM to appoint an EAG
range of EAG's undertake detailed examination of issues prior to referral to CHM or BPC, eg
- New medicines licensing
- risk management plans
independent and transparent
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do members of EAG's have to be members of CHM or BPC?
no
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who is the chair appointed by?
CHM/ BPC
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current established EAG's
anti-infectives/ HIV/ hepatology
biologicals/ vaccines
cardiovascular/ diabetes/ renal/ respiratory/ allergy
chemistry, pharmacy and standards
clinical trials
dermatology/ rheumatology, gastroenterology/ immunology
medicine's for women's health
neurolog
biologicals/ vaccines
cardiovascular/ diabetes/ renal/ respiratory/ allergy
chemistry, pharmacy and standards
clinical trials
dermatology/ rheumatology, gastroenterology/ immunology
medicine's for women's health
neurolog
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policing of regulations
enforcement
enforcement
primary responsibility with Appropriate Minister who may delegate some functions
Ministers solely responsible for:
- licensing
- MHRA- licensing MPs in UK- MHRA can put pharmacists in prison under law
- hospitals
- practitioners premises
Ministers solely responsible for:
- licensing
- MHRA- licensing MPs in UK- MHRA can put pharmacists in prison under law
- hospitals
- practitioners premises
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the GPhC is responsible for
1/ registration of pharmacists, pharmacy technicians and pharmacy premises
- Pharmacy Order 2010 (Medicines Act 1968)
- revalidation
2/ disciplinary control of pharmaceutical profession
3/ sale and supply of MPs
(POMs and Ps not GSL)
4/ restriction of
- Pharmacy Order 2010 (Medicines Act 1968)
- revalidation
2/ disciplinary control of pharmaceutical profession
3/ sale and supply of MPs
(POMs and Ps not GSL)
4/ restriction of
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the registrar and chief executive of the GPhC
keep a register of premises, pharmacists and pharmacy technicians
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a registered pharmacy
means premises are open and can be entered for the time specified with being on the register
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a registered pharmacist
a person registered in the register of pharmacists
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a registered pharmacy technician
a person registered in the register of pharmacy technicians
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technician registration is mandatory since
June 2011
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GPhC responsible for
quality and purity of medicines for sale
labelling, packaging and advertising of MPs for sale
labelling, packaging and advertising of MPs for sale
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local council responsible for
sale of GSL medicines (can be found anywhere)
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Other cards in this set
Card 2
Front
private healthcare
Back
provided by businesses and individual practitioners
available to all who pay
funded by patient- insurance
available to all who pay
funded by patient- insurance
Card 3
Front
primary care (community care)
Back
Card 4
Front
secondary care
Back
Card 5
Front
tertiary care
Back
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