W8 Political And Legal Frameworks Flashcards
Inc lecs: Medicine regulation Pharmacy Regulation
What are medicinal products used for?
- For preventing or treating disease in human beings
- Restoring, correcting or modifying a physiological function by exerting
a pharmacological, immunological or metabolic action - Making a medical diagnosis.
- Human blood is expressly excluded
What is off-label prescribing?
Treating a patient who has a condition for which the product does not have a marketing authorisation
Examples of Revocation, variation or suspension of marketing authorisation:
(for info)
A. Harmful or ineffective
B. Incorrect information
C. Breach of licence
D. Unfulfilled licence
E. Information not provided
F. No longer EU based
G. Non-compliance with Good Manufacturing Practice (GMP)
H. Unfulfilled licence (non-UK)
I. Public at risk
J. Apply for change
K. Poor manufacturing
What are Orphan drugs?
- Used to treat conditions that occur infrequently.
- Cost of R&D would not be recovered by the expected sales
- Therefore, the pharmaceutical industry would be unwilling to develop the medicinal product under normal market conditions.
How can you qualify for orphan designation?
- For a disease that is life-threatening or chronically debilitating
- not more than 5 in 10,000
- no satisfactory method exists
- Orphan medicinal products will benefit from up to 10 years of market exclusivity from similar products
Modern medicines legislation in the UK was triggered by the…
thalidomide tragedy
Generics
- Have the same composition as a Reference Medicinal Products (RMPs)
- Has the same pharmaceutical form
- Appropriate bioavailability studies (demonstrated bioequivalence)
- Typically, cheaper than branded medicines
Branded generic
- Generics that have a brand name.
- Encourage medical practitioners to prescribe branded generics which have a lower price than non-branded generics
What are Abridged procedures?
- Manufacturers will have incurred the considerable cost of years of R&D
- A competitor can rely on the data for the original product only after the passage of a data exclusivity period.
- The data exclusivity period is eight years for products that have been authorised in the UK.
What is the Early Access to Medicines Scheme (EAMS)?
- Enables patients to have access to medicines which have not yet been authorised
- life-threatening or seriously debilitating conditions,
- no suitable alternative
- Voluntary
Pharmacovigilance
- Detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
- Promote the safe and effective use of drugs by providing reliable information
- Information obtainable before a medicine is placed on the market is ultimately limited
- both the licensing authority and holders of manufacturing authorisations must operate a pharmacovigilance system
- capture and evaluate all information
- take all appropriate measures to minimise and prevent risk,
Yellow Card Scheme
- Can be completed and posted to the MHRA
- Vast majority now submitted online (some in back of BNF)
Yellow Card Scheme
- MHRA scheme for reporting adverse drug reactions
Can be completed and posted to the MHRA
- Vast majority now submitted online (some in back of BNF)
- collecting and monitoring information on suspected safety concerns or incidents involving medicines and medical devices.
- voluntary reporting
- early warning that the safety of a product may require further
investigation. - The Cumberlege Review (2020) concluded that the Yellow Card scheme could not be relied upon to identify promptly significant
adverse outcomes.
What does GpHC stand for?
What was the GpHC created as a result of?
General Pharmaceutical Council.
The Pharmacy Order 2010.
*The creation of the GPhC resulted in the separation of the regulatory and professional leadership roles.
*The Professional Standards Authority for Health and Social Care (PSA), oversees the work of the GPhC
What is the structure of the GpHC
- Chair
- 13 other members of the Council
- Seven members are registrants and seven are lay members.
(Appointed by the Public Appointments Commission)
*Ensure a balance of qualities, skills and experience, and to reflect the diversity of the public and of the pharmacy profession.
GB vs UK
Who does the GPhC have control over? (3)
Regulatory powers in England, Scotland and Wales.
*The Pharmaceutical Society of Northern Ireland is the pharmacy regulator for Northern Ireland,
*The two organisations work collaboratively via a Memorandum of Understanding.
Principal functions of the GPhC (just to read)
To establish and maintain a register of pharmacists, pharmacy technicians and premises at which a retail pharmacy business is, or is to be, carried on
* To set and promote standards for the safe and effective practice of pharmacy at registered pharmacies
* To set requirements by reference to which registrants must demonstrate that their fitness to practise is not impaired
* To promote the safe and effective practice of pharmacy by registrants (including, for example, by reference to any code of conduct for, and ethics relating to, pharmacy)
* To set standards and requirements in respect of the education, training, acquisition of experience and CPD that it is necessary for pharmacists and pharmacy technicians to achieve in order to be entered in the Register or to receive an annotation in the Register and to maintain competence
* To ensure the continued fitness to practise of registrants.
What are the functions of the GpHC? (6)
*Register
*Standards for pharmacies
*Fitness to practise
*Standards for pharmacists
*Education/training
*Ongoing
How do GpHC carry out Education and training of pharmacists?
- Standards for the initial education and training of pharmacists.
- Part 1 comprises learning outcomes
-Describe what a student pharmacist must be able to demonstrate - Part 2 comprises standards for anyone providing initial education and training.
- Pre-registration/Foundation
- GPhC set out conditions for the period of training to be undertaken prior to registration.
- Successful completion of a registration assessment
Registration definition (to read)
*“ A person practises as a pharmacist or a pharmacy technician if, while acting in the capacity of or purporting to be a pharmacist or a pharmacy
technician, that person undertakes any work or gives any advice in relation to the preparation, assembly, dispensing, sale, supply or use of medicines, the science of medicines, the practice of pharmacy or the provision of healthcare”.
What is included in The Register?
*Part 1 relating to pharmacists
*Part 2 relating to pharmacy technicians
*Part 3 relating to premises
*Not impaired by reason of physical or mental health
*Good character
*Knowledge of English for safe and effective practice
* E.g. IELTS 7
Who is and isn’t included on the GPhC register?
IS= Pharmacists and Pharmacy technicians
ISNT= Dispensing assistants, MCAs (medicines-counter assistants)
What is the purpose of CPD and revalidation?
*Keep professional skills and knowledge up to date
*Reflect on how to improve
*Show how you provide safe and effective care
What is revalidation?
Each year a pharmacist must carry out, record and submit:
* Four CPD entries, at least two of which must be planned learning activities
* One peer discussion
* One reflective account
Conducting a Retail Pharmacy Business (to read)
*The Medicines Act 1968
*a registered pharmacist
*a partnership in which all the partners are pharmacists
*a business (usually a limited company)
*the representatives of a deceased pharmacist, a pharmacist who has lost mental capacity or who is adjudged bankrupt or enters into a composition or scheme or deed of arrangement with the pharmacist’s creditors
Superintendent pharmacists
- Historically, the role of superintendent pharmacist was introduced so that if an offence was committed by a business, there was a person who could be held to account in a court of law.
- The Medicines Act 1968
- Must be a pharmacist
- Cannot be the superintendent pharmacist of more than one business at the same time
- Keeping, preparing and dispensing of medicinal product other than those on a General Sale List
Inspection reports
*“excellent practice”
*“good practice”
*“standards met”
*“standards not all met”
*An improvement notice must set out the grounds of the inspector’s
belief that there is a failure, specify the measures that must be taken to
rectify the failure and specify the period within which those measures
must be taken.
Registered pharmacy premises:
What can only be sold here?
*Certain activities by pharmacists can only be conducted from registered pharmacy premises.
* E.g. sale of Pharmacy medicines and the sale or supply of Prescription Only Medicines
*It is the duty of the GPhC to keep a Register of all Pharmacy Premises
*A supermarket might have an area which is a registered pharmacy
and a separate area (which is not a pharmacy) where GSL medicines are sold.
Standards for Pharmacies
- The pharmacy must be managed safely and effectively
- The staff working in the pharmacy must be competent and
empowered to do their roles - The pharmacy premises must be appropriate to provide pharmacy
services - The pharmacy must supply medicines and provide other services
safely and effectively - The pharmacy’s equipment and facilities must be safe and effective
GPhC Inspections (1/2) (for info)
GPhC may conduct routine inspections of registered pharmacies
* Inspectors have the power to enter any registered pharmacy or any other premises at a reasonable hour
* to enforce the GPhC’s standards or to assist the GPhC in investigations
* Any person who intentionally obstructs an inspector in exercising their powers, who fails to give assistance that is reasonably required, who provides false information or who fails to provide a document or record when required by an inspector is guilty of an offence.
*Where an inspector seizes a substance, article, document or other
thing, they must inform the person
*There may be occasions when an inspector operates undercover
What are some of the Restricted titles for a registered pharmacy or registered pharmacist?
Registered pharmacy:
* Chemist
* Chemist and druggist
* Druggist
* Dispensing chemist
* Dispensing druggist
* Pharmacy
Registered pharmacist:
* Pharmaceutical Chemist
* Pharmaceutist
* Pharmacist (or Fferyllydd)
What does the MHRA stand for?
Medicines and Health Products Regulatory Agency
Is human blood an example of a medicinal product under HMR2012?
No
What is the length of the data exclusivity period?
8 years for medicinal products that have been authorised in the UK
How can you qualify for orphan designation? (3)
- For a disease that is life-threatening or chronically debilitating
- Not more than 5 in 10,000
- No satisfactory method exists
Orphan drugs= show promise in the treatment, prevention, or diagnosis of orphan diseases. An orphan disease is a rare disease or condition that affects fewer than 200,000 people in the United States.
