Legislation: HMR Flashcards by Deleted Deleted

WHO PROVIDES NHS HEALTHCARE AND HOW IS IT FUNDED?

Funded by the government

Funded by taxation (and is therefore available to all)

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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

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EXAMPLES OF PRIMARY CARE.

EXAMPLES OF SECONDARY CARE.

EXAMPLES OF TERTIARY CARE.

Dentist

Community Pharmacists

Optometrists

Hospitals

Specialities; e.g neurosurgery, transplant

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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The NHS Act 1977 repealed the whole of the 1946 Act.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

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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 1933
Pharmacy and Medicines Act 1941 (composition)
Penicillin Act 1947
Therapeutic Substances (prevention of misuses) Act 1953. (manufacture and supply)

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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

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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Drug withdrawn from the market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

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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

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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

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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]

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WHAT ARE THE THREE MAIN AIMS OF HMR?

Quality

Safety

Efficacy

(of medicinal products)

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WHAT IS A LICENSING AUTHORITY?

Either or both of the ministers [Secretary of State and the Minister of Health, Social Services and Public Safety].

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WHAT IS ADVERTISEMENT IN RELATION TO A MEDICINAL PRODUCT?

Includes anything designed to promote the prescribing supply, sale or use of that product.

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WHAT DO SPECIAL PROVISIONS FOR PHARMACIES DO?

Exempts the need for manufacturing licence when extemporaneous dispensing.

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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

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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.

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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

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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) )

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HMR 2012; AMINISTRATIONS

Allows for continuation of:

Commission on Human Medicines (CHM)
British Pharmacopoeia Commission (BPC)
Expert Advisory Groups (EAG)

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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

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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

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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)

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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.

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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

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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_** ## Footnote 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_** ## Footnote 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_** ## Footnote 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_** ## Footnote 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?_** ## Footnote 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_** ## Footnote 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: ## Footnote 1. It takes place on an occasional basis 2. The quantity of medicines supplied is small 3. The supply is made on a not for profit basis 4. The supply is not for onward wholesale distribution

WHAT FOUR SITUATIONS WOULD A WDL NOT BE NEEDED?

1. It takes place on an occasional basis 2. The quantity of medicines supplied is small 3. The supply is made on a not for profit basis 4. 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.