Legislation: HMR Flashcards
WHO PROVIDES NHS HEALTHCARE AND HOW IS IT FUNDED?
Funded by the government
Funded by taxation (and is therefore available to all)
WHO PROVIDES PRIVATE HEALTHCARE AND HOW IS IT FUNDED? WHO IS IT AVAILABLE TO?
Provided by private businesses and individual practitioners
Funded by the patient-insurance
Available to all that will pay
EXAMPLES OF PRIMARY CARE.
EXAMPLES OF SECONDARY CARE.
EXAMPLES OF TERTIARY CARE.
GP
Dentist
Community Pharmacists
Optometrists
Hospitals
Specialities; e.g neurosurgery, transplant
THE NATIONAL HEALTH SERVICE (5TH JULY 1948)
- The NHS Act established a ‘comprehensive health service to secure the improvement in the physical and mental health of the people . . . and the prevention, diagnosis and treatment of illness’.
- Aim to provide healthcare based on need, not the ability to _.
- Originally free at the point of delivery.
- Now charges for some services including _.
- The NHS Act 1977 repealed the whole of the 1946 Act.
Pay
Prescriptions
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 1933
- Pharmacy and Medicines Act 1941 (composition)
- Penicillin Act 1947
- Therapeutic Substances (prevention of misuses) Act 1953. (manufacture and supply)
1925 THERAPEUTIC SUBSTANCES ACT
- Medicinal products (MP) were increasingly coming from a chemical origin rather than a plant source
- Anti-syphyllis drug Salversan contained 606 toxic _.
- Therapeutic Substances Act (TSA) provided a form of licensing which included:
- Inspection of manufacturing sites
- Personnel suitability
- Record keeping
- Labelling requirements introduced
Impurities
1961- THALIDOMIDE
- Marketed as a safe _ tablet and antiemetic.
- Prescribed for morning sickness in _.
- Increased incidence of babies born with phocomelia (hands & feet attached directly to the body, or reduced limbs)
- Drug withdrawn from the market
Sleeping
Pregnancy
COMMITTEE ON SAFETY OF DRUGS
- _ agreement by the Ministers of Health to look at the safety of new drugs.
- The Committee on Safety of Drugs consisted of: scientists, physicians, toxicologist, statistician and pharmacists checking for “reasonable safety of a drug’s intended purpose”.
Products already on the market were granted a provisional Licence of Right.
Voluntary
MEDICINES ACT 1968
Regulated:
- Manufacture
- Distribution
- Importation (limited control on medicines for _)
- Did so by licence and enforced by MHRA (Medicines and Healthcare products Regulatory Agency).
- Advised by Medicines Commission
HOWEVER, much of this 1968 act has now been revoked.
Exports
THE HUMAN MEDICINES REGULATIONS 2012
- Regulates
- Manufacture
- Distribution
- Importation
- Sale and supply
- Labelling and advertising
- Pharmacovigilance
Does so by licence
Licensing authority is either or both of the ministers [Secretary of State and the Minister of Health, Social Services and Public Safety].
———–> MHRA
ALSO DEALS WITH:
- Supply of Medicines to the public
- Labelling and Containers
- Sales promotion (advertising)
- Preparation of BP & other books of standards
Enforcement lies with:
Secretary of State
General Pharmaceutical Council (GPhC)
“Drugs authority” – Local Council
[Registration of Retail Pharmacies still lies with the Medicines Act 1968]
WHAT ARE THE THREE MAIN AIMS OF HMR?
Quality
Safety
Efficacy
(of medicinal products)
WHAT IS A LICENSING AUTHORITY?
Either or both of the ministers [Secretary of State and the Minister of Health, Social Services and Public Safety].
WHAT IS ADVERTISEMENT IN RELATION TO A MEDICINAL PRODUCT?
Includes anything designed to promote the prescribing supply, sale or use of that product.
WHAT DO SPECIAL PROVISIONS FOR PHARMACIES DO?
Exempts the need for manufacturing licence when extemporaneous dispensing.
CLASSIFICATION OF MEDICINAL PRODUCTS
- GSL (medicinal product covered by authorisation that states it should be available on general sale).
- POM (medicinal product covered by authorisation that states it should be available only on _).
- 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 _).
Prescription
Pharmacy
WHAT IS THE DEFINITION OF A MEDICINAL PRODUCT (MP)?
- 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 beings with a view to:-
- Restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or
- Making a medical diagnosis.
MEDICINAL PURPOSE; WHAT DOES IT MEAN?
Medicinal Purpose means any one or more of the following
(a) treating or _ 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 with the normal operation of a physiological function whether permanently or temporarily and whether by way of terminating, reducing or postponing or increasing or accelerating the operation of that function in any other way.
Preventing
ACCORDING TO THE HMR ACT 2012, WHO WOULD BE CONSIDERED AN APPROPRIATE MEDICINES PRESCRIBER (FOR POM’S)?
(a) doctor;
(b) a dentist;
(c) a supplementary prescriber;
(d) a nurse independent prescriber; and
(e) a pharmacist independent prescriber.
EXCEPTIONS:
- Community Practitioner Nurse Prescriber (Certain laxatives, Mebendazole, Nystatin, etc)
- Optometrist Independent Prescriber (Any POM for ocular conditions but not CDs)
- EEA health professional (Any UK MA POM except CD’s Sch 1, 2 and 3)
- Physiotherapist Independent Prescriber (Some CDs e.g. Fentanyl (Transdermal) )
- Podiatrist Independent Prescriber (Some CDs e.g. Diazepam (Oral) )
HMR 2012; AMINISTRATIONS
Allows for continuation of:
- Commission on Human Medicines (CHM)
- British Pharmacopoeia Commission (BPC)
- Expert Advisory Groups (EAG)
MEDICINES AND HEALHCARE PRODUCTS REGULATORY AGENCY
Executive agency of Department of Health and Social Care (DHSC)
- Mission - 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 _.
Responsible for:
- regulation of medicines
- medical devices and equipment used in healthcare
- the investigation of harmful incidents.
- Looking after _ and blood products.
Safe
Blood
ACTIVITIES OF 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 _ card scheme (medicines + devices)
- Operating a proactive compliance programme for medical devices
- Sampling and testing of medicines, including imported.
- Regulating clinical trials of medicines and medical devices
- Ensuring compliance with statutory obligations (inspection and enforcement)
- Promoting good practice in the safe use of medicines and medical devices,
- Managing the General Practice Research Database (GPRD) and the British Pharmacopoeia (BP).
- Information provision to public and professions – informed choice
Yellow
WHAT IS MEANT BY THE TERM ‘DEVICES’?
The term ‘medical device’ covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability (e.g. dressings, orthotics, cathters etc)
COMMISSIONS ON HUMAN MEDICINES (CHM)
- Advised by Expert Advisory Groups (EAG’s)
- Minimum of 8 members
- Appointed by Ministers
- Chair appointed by Ministers
- Proactively give info to Ministers
- Advise Ministers when asked
- Meet once each month.
CHM FUNCTIONS
Advise the appropriate Ministers about:
- The execution of duty imposed by the HMR 2012 regs or Clinical Trials Regulations (CTR).
- The exercise of any power from HMR 2012 and CTR.
- Medicinal Products.
- Generally advise about safety, quality and efficacy of medicinal products.
- Promote collection and investigation of ADR’s (Yellow Card scheme).
- The CHM provides independent expert advice to the regulatory agency the MHRA
WHAT DOES THE CHM ADVISE MINISTERS ON?
The safety, advising on applications for both National and European marketing authorisations:
- Considering further representation against our provisional advice in respect of national applications
- Advising on the need for, and content of, risk management plans for new medicines
- Advising on the impact of new safety issues on the balance of risks and benefits of licensed medicines - eg adding warnings, restricting or suspending use of a medicine
- Advising the licensing authority on changes to legal status of marketing authorisation, efficacy and quality of medicinal products.
BRITISH PHARMACOPOEIA COMMISSION (BPC)
Functions:
- Preparation of British Pharmacopoeia
- 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
- Preparation of cumulative list of rINN
- European Pharmacopoeia
- At intervals as it thinks appropriate.
WHAT DOES THE BPC BOOK CONSIST OF?
Comprises descriptions for substances which may be used in the practice of medicine & the manufacture of medicinal products
Specifies the standards for medicinal products
EXPERT ADVISORY GROUPS (EAG)
- Appointed by either BPC or CHM.
- Ministers may instruct BPC or CHM to appoint an EAG.
- Range of Expert Advisory Groups (EAG) undertake detailed examination of issues prior to referral to CHM or BPC, e.g.
- New medicines licensing
- Risk management plans.
- Members of EAG’s do not have to be members of CHM or BPC.
- Chair appointed by CHM/BPC.
- Independent and transparent.
WHAT ARE SOME EXAMPLES OF SOME CURRENT EXPERT ADVISORY GROUPS?
HIV/Anti-infectives
Biologicals/vaccines
Oncology
Diabetes
Paediatric medicines
Clinical trials
ENFORCEMENT
- Primary responsibility with Appropriate Minister who may delegate some functions
- Ministers solely responsible for:
Licensing
- MHRA – licensing MPs in UK
- EMA – licensing under EC Council Directives
- Hospitals
- Practitioners premises
ENFORCEMENT; THE GPhC IS RESPONSIBLE FOR:
- Register of Pharmacists, Pharmacy Technicians and Pharmacy premises
- Pharmacy Order 2010 (Medicines Act 1968)
- Revalidation
- Disciplinary control of Pharmaceutical profession
- Sale & Supply of MPs
- POM’s and P medicines (not GSL)
- Restriction of Titles (Medicines Act 1968)
ENFORCEMENT 2
- The registrar & chief executive of the GPhC keeps a Register of premises, pharmacists & pharmacy technicians
- A registered pharmacy means premises entered for the time being on the Register
- A registered pharmacist means a person registered in the Register of pharmacists
- A registered pharmacy technician means a person registered in the Register of pharmacy technicians
-Technician registration is mandatory since June 2011
GPhC :
- Quality & purity of medicines for sale
- Labelling, Packaging & Advertising of MPs for sale.
Local Council responsible for:
- of GSL medicines
MARKETING AUTHORISATION
Needed for every Medicinal Product before being prescribed or sold.
Licensing body – Either or both of the Ministers
Functions carried out by MHRA
European Medicines Agency
Usually submitted by Pharmaceutical Industry
But, anyone can submit a request.
Can take up to 210 days to go through process
Can take 30 days to inform approval granted
MANUFACTURING AND WHOLESALE DEALING PART III
Sets out the rules for manufacturing, importing and wholesale dealing
It requires these activities to be subject to a licence
Establishes what the licencing authority must consider when assessing an application
Sets out requirements for Responsible Persons and Qualified Persons
Manufacturer’s or wholesale dealer’s license:
- Granted by licensing authority (Within 90 days)
- Remains in force until surrendered/revoked
- Licensing authority may suspend/revoke/vary (28 day notice)
= Immediate suspension possible for safety reasons (Max 3 months + further 3 months…..)
LICENSING
Manufacturer’s licence:
-Medicinal products manufactured in the UK must be produced on a site that holds an appropriate manufacturer’s licence (ML).
Wholesale dealer’s licence:
-Any company or individual wishing to wholesale deal (defined as selling, supplying or procuring to anyone other than the end-user) medicinal products within the EU must hold a wholesale dealer’s licence (WDL).
Clinical trial authorisation
- Needed by new products under development.
- Needed before being tested on humans.
WHEN WOULD A COMPANY NEED A WHOLESALE DEALER’S LICENCE?
Any company or individual wishing to wholesale deal (defined as selling, supplying or procuring to anyone other than the end-user) medicinal products within the EU must hold a wholesale dealer’s licence (WDL).
WHEN WOULD A COMPANY NEED A MANUFACTURER’S LICENCE?
Medicinal products manufactured in the UK must be produced on a site that holds an appropriate manufacturer’s licence (ML).
MANUFACTURER’S LICENCE 1
A person may not, except in accordance with a licence (a “manufacturer’s licence”)
o(i)Manufacture, assemble or import from a state other than EEA state any medicinal product; or
oPossess a medicinal product for the purpose of any activity in (i) above.
Marketing Authorisation issued by a competent authority
- MHRA
- EMA
Manufacturing license not needed by a person who imports a medicinal product for _ use.
Manufacturing license does not apply to the mixing of medicines.
Personal
MANUFACTURER’S LICENCE 2
Considerations:
- Manufacture includes any process carried out in the course of making a MP including packaging and labelling (assembly) of the final product
- The MP being manufactured must have a MA
- The MA of that product must be held by that manufacturer who is making or ordering the making of the product.
QP needed to oversee process.
MANUFACTURER’S LICENCE 3
The site is inspected by the MHRA Inspectorate to ensure that the following criteria and standards are met:
- Appropriate facilities, equipment and suitably trained staff are available and maintained
- All products are manufactured to the standards detailed by the EC Guide to Good Manufacturing Practice
- Quality Assurance measures are built into each step of the manufacturing process to ensure the safety, quality & efficacy of the product.
The site is inspected by the MHRA Inspectorate at least every two years
WHOLESALE DEALER’S LICENCE 1
Distributing by way of wholesale dealing is a reference to –
- Selling or supplying it; or
- Procuring or holding it or exporting to another EEA state for the purpose of sale or supply.
To a person who receives it for a purpose of –
- Selling or supplying the product
- Administering it or causing it to be administered to one or more human beings, in the course of a business carried on by that person.
WHOLESALE DEALING: WHAT DOES IT REFER TO?
Covers the sale of a MP to a person who buys the product for the purpose of sale or supply to someone else
Includes the sale of a MP to a Medical Practitioner for use in their practice.
Excludes :
- Pharmacy supplying to a patient
- Supply by one hospital to another in the same trust
- Supply by a hospital pharmacy to a ward for administration to a patient
WHOLESALE DEALER’S LICENCE 2
The licensing is primarily concerned with:
- Identification of the Distributor
- Suitability of the premises used for storage, distribution and stock control
- Wholesalers are inspected before a WDL is granted, and at least once during the 5-year period of the licence
- Wholesale dealer (GSL) available
(Only deal in GSL medicines)
RP needed to oversee process.
WHAT IS A WHOLESALE DEALER’S LICENCE PRIMARILY CONCERNED WITH?
Identification of the Distributor
Suitability of the premises used for storage, distribution and stock control
Wholesalers are inspected before a WDL is granted, and at least once during the 5-year period of the licence
Wholesale dealer (GSL) available
WHOLESALE DEALER’S LICENCE 3
Registered pharmacies traditionally allowed to trade small volumes of medicines without a WDL.
“….. Such dealing constitute no more than an inconsiderable part of the business carried on by the pharmacist at that pharmacy”
HOWEVER on repeal of this part of MA1968 brought uncertainty
WHEN A WDL WOULDN’T BE NEEDED:
- It takes place on an occasional basis
- The quantity of medicines supplied is small
- The supply is made on a not for profit basis
- The supply is not for onward wholesale distribution
WHAT FOUR SITUATIONS WOULD A WDL NOT BE NEEDED?
- It takes place on an occasional basis
- The quantity of medicines supplied is small
- The supply is made on a not for profit basis
- The supply is not for onward wholesale distribution
DRUG DEVELOPMENT PROCESS
DRUG DEVELOPMENT: CLINICAL TRIALS
Phase 1 trials usually involve healthy people to find out how the medicine works in the body
-Usually less than 100 people
Phase 2 trials look at how the drug works in a particular condition
-Several hundred people
Phase 3 looks at how well the medicine works and how safe it is in the general population
-Several hundred to several thousand people
WHAT ARE THE THREE PHASES OF CLINICAL TRIALS AND WHAT HAPPENS IN EACH ONE?
Phase 1 trials usually involve healthy people to find out how the medicine works in the body
-Usually less than 100 people
Phase 2 trials look at how the drug works in a particular condition
-Several hundred people
Phase 3 looks at how well the medicine works and how safe it is in the general population
-Several hundred to several thousand people
CLINICAL TRIALS APPLICATION
- New legislation introduced in May 2004.
- Emphasis shifted from controlling the product to _ of the trial.
- Trial approved by MHRA within 60 days.
- Regulation of _ volunteer trials.
- _ trials licence required.
- Inspections for standards of ‘Good Clinical Practice’ (GCP) and Good _ Practice (GMP).
- Labelling requirements
- Ethics committee system
Authorisation
Healthy
Manufacturer’s
Manufacturing
EVALUATION: SAFETY AND EFFICACY
- Nature of the _ ingredients
- Dosage form
- Nature of disease or condition treated
- Type of patient
- _ of treatment
- More effective than _
- Risk to Benefit ratio
Active
Duration
Placebo
EVALUATION: QUALITY
- Product’s physical, pharmaceutical and biological characteristics to ensure that each batch of the medicine is capable of performing reliably and consistently.
GRANTING OF MARKETING AUTHORISATION
- Submission of necessary documentation (requires fees).
- Validation (ensure forms are completed accurately).
- Assessment; assessor determines whether there is sufficient information to evaluate the safety, quality and efficacy of the product. They may seek further advice from the CHM.
- Applicant has the right to appeal.
CONSIDERATIONS WHEN GRANTING A MA
- Benefits vs risks
- _ form?
- Nature of disease
- Dose
- Patients (age, sex etc).
- Side-effects
REQUIREMENT FOR AUTHORSATION PART IV
- Medicinal product must be subject of appropriate _.
- MA
- Homeopathic certificate of registration
- Traditional herbal registration
- Article 126a authorisation
- Illegal to sell/supply/offer to an unauthorised MP.
- Offences lead to fines/imprisonment.
MARKETING AUTHORISATION PART V
Authorises the holder to:
- Sell, supply or export the medicinal product.
- Procure the sale, supply or export of the MP.
- Procure the manufacture or assembly of the MP for sale, supply or export.
- Import the MP.
The holder of the MA is either the manufactuer or the person to whose order the product is made.
WHAT FOUR THINGS DOES A MA AUTHORISE THE HOLDER TO DO?
Sell, supply or export the medicinal product.
Procure the sale, supply or export of the MP.
Procure the manufacture or assembly of the MP for sale, supply or export.
Import the MP.
MARKETING AUTHORISATION CONTINUED
- Valid for _ years initially.
- On renewal, unlimited period unless _ concerns.
- On renewal, up to date data must be supplied.
- New medicines are usually POMs.
- Product must be on market within 3 years of granting _ _.
- Subject to pharmacovigilance
- Black triangle drugs
- ‘Yellow card’ reporting
5
Safety
Marketing Authorisation
WHAT FOUR SYSTEMS ARE USED TO REGISTER MEDICINES IN EUROPE?
Centralised
Decentralised
Mutual recognition
National
SYSTEMS USED TO REGISTER MEDICINES IN EUROPE: CENTRALISED
One single application is made to the EMA
One single European Authorisation is granted by the EMA
Certain medicines can only be licenced in this way to ensure that they are automatically available to every EU member (gene therapies, medicines for HIV/diabetes/cancer, Orphan drugs aka medicines for rare diseases).
WHAT TYPES OF MEDICINES CAN ONLY BE LICENCED BY A CENTRALISED SYSTEM IN EUROPE?
Gene therapies
Medicines for HIV/AIDs, cancer, diabetes, Alzheimer’s
Orphan drugs (medicines for rare diseases, occurs in less than 5 in 10,000 people)
SYSTEMS USED TO REGISTER MEDICINES IN EUROPE: DECENTRALISED
The same application is submitted simultaneously in a number of member states (UK plus other named EU).
One state takes the lead in the application
Identical national licences issued in each state involved in the application.
SYSTEMS USED TO REGISTER MEDICINES IN EUROPE: MUTUAL RECOGNITION
First application is made to one or more EC member state Authority.
National/decentralised authorisation granted.
Mutual recognition of this authorisation by other Concerned Member State Authorities.
Each member state issues an Authorisation.
TYPES OF MA APPLICATION
- Dependent on the nature of the _ ingredient.
- New active substances= full applications
- Biological and biotechnology products= fixed combination application.
- Abridged products
- Generics
- Informed consent application
- ‘Well established’ use application
WHAT THREE THINGS MUST EVERY MEDICINAL PRODUCT HAVE?
Summary of product characteristics (SPC)
Label
Patient Information Leaflet (PIL)
SUMMARY OF PRODUCT CHARACTERISITICS (SPC)
- Legal document containing factual information about an MP based on data generated during the development of the product.
- Name, strength and pharmaceutical form
- Qualitative and quantitative composition
- Clinical particulars
- Pharmacological properties
- Pharmaceutical particulars
- Name of UK MA holder
- Number of UK MA etc
WHAT IS A SUMMARY OF PRODUCT CHARACTERISTICS? (SPC)
A legal document containing factual information about an MP based on data generated during the development of the product.
PARALLEL IMPORT LICENCE (PLPI) 1
Allows MP’s with an MA to be bought in one European Member State and _ in another.
However, the importer must hold:
- A Wholesale Dealer’s licence (import)
- A Manufacturer’s licence (re-package and re-label)
WHAT DOES A PARALLEL IMPORT LICENCE ALLOW TO HAPPEN?
Allows Medicinal Products with a MA to be bought in one European Member State and sold in another .
PARALLEL IMPORT LICENCE 2
Conditions must be met that:
- Is not a vaccine, toxin, blood product, radioactive isotope or homeopathic product.
- Is covered by European MA and is a version of a product which already holds UK MA.
- Has the same _ effect as the UK product.
- Must be made by, or under licence to the UK manufacturer or by a member of the same group of companies.
- Must be _ and have PIL in English.
Therapeutic
Labelled
MANUFACTURER’S SPECIALS LICENCE 1
Specials’ are products which have been specially manufactured or imported for the treatment of an individual patient after being ordered by a:
- Doctor
- Dentist
- Nurse independent prescriber
- Pharmacist independent prescriber
- Supplementary prescriber
Not all ‘prescribers’ can order a special
WHAT ARE ‘SPECIALS’?
Products which have been specially manufactured or imported for the treatment of an individual patient after being ordered by a doctor, dentist etc
MANUFACTURER’S SPECIALS LICENCE 2
For a manufacturer to make an unlicenced MP (a ‘special’) they must hold Manufacturer’s ‘Specials’ Licence.
- No advertising of the products only for service
- Doctor takes responsibility for the efficacy of the product
- Licence holder takes responsibility for the _ of the product.
Inspected by MHRA.
Quality
HOMEOPATHIC MEDICINES
- Homeopathic Certificate of Registration
Simplied scheme:
- Safety and quality demonstrated
- No medical claims or indications allowed
- Restricted to products for oral or external use
- Products must be sufficiently diluted to ensure safety
National Rules Scheme:
- Product can be registered with indications for relief or treatment of minor symptoms.
- Applications supported by data on quality and safety.
HERBAL MEDICINES
- All herbal products required to have a THR or an MA.
1. Traditional Herbal Registration- Simplified registration scheme (required to reach specific standards of safety and quality).
2. Licensed Herbal Medicine (needs MA)- Quality, safety and efficacy has been demonstrated.
