Law And Principles Flashcards
What is a consultation?
Any conversation you have with a patient or customer, about their health, wellbeing or medication
What are Picker’s eight principles of patient-centred care?
How did the Human Medicines Regulations 2012 come about?
The MHRA conducted a consultation and the outcome was ‘the consolidation, delivered through the Human Medicines Regulations 2012, modernises medicine legislation. It replaces most of the Medicines Act 1968 and over 200 statutory instruments, which had been cluttering up the statue book and complicating the law.’
Legal definition of medicinal product
1a) any substance or combination of substances presents as having properties of preventing or treating disease in human beings 1b) and substance or combination of substances that may be used by or administered to human beings with a view restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action or making a medical diagnosis The regulations do not apply to: A) whole human blood B) any human blood component, other than plasma prepared by a method involving an industrial process
What is GSL
General sales list Can be sold in pharmacies and other retail outlets that can ‘close so as to exclude the public’ -Classed as GSL by an EU or UK marketing authorisation - if they hold a traditional herbal registration - if they have a certificate of registration as a GSL homeopathic product
Sales of GSL
When within a pharmacy can only be sold when assumed responsible pharmacist role (but may still be sold during absent periods whilst still RP) If sold from non-pharmacy outlet then there is no requirement for RP
What is GSL-PO
Not an official legal category but may be referred to by manufacturers where the legal category is GSL but they want the product only to be sold in pharmacies
What is a P medicine
A pharmacy medicine is a product that can only be sold from a registered pharmacy by a pharmacist or person acting under the supervision of a pharmacist.
What is a POM
A prescription only medicine. Generally subject to the restriction of requiring a prescription
Appropriate practitioner prescribers in the UK
Doctor Dentist Supplementary prescriber Nurse independent prescriber Pharmacist independent prescriber Community practitioner nurses Optometrist independent prescribers Physiotherapist independent prescribers Paramedic independent prescribers Podiatrist independent prescribers Therapeutic radiographer independent prescribers
Appropriate practitioners non-UK
Must be by the following to be legal in the UK: Doctors Dentists Pharmacists Nurses Chiropodist/podiatrist Paramedic Optometrist Physiotherapist Therapeutic radiographers
Approved countries for a prescription to be legal in the UK
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lichtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and Switzerland
What is AVM-GSL
Authorised veterinary medicine that is available on general sale
What is a NFA-VPS
A category of medicine for non-food animals that can be supplied by a veterinary surgeon, pharmacist or suitable qualified person. A prescription is not required
What is a POM-VPS
Prescription only medicine that can be prescribed and supplied by a veterinary surgeon, pharmacist or suitable qualified person with an oral or written prescription. A written prescription is only required if the prescriber is not going to be the supplier
What is a POM-V
A prescription only medicine that can only be prescribed by a veterinary surgeon and supplied by a veterinary surgeon or pharmacist with a written prescription
Who licenses medicines in Europe?
The European Medicines Agency (EMA) Began operating in 1995 Agency is responsible for the scientific evaluation of applications for European Union (EU) marketing authorisations for human and veterinary medicines in the centralised procedure Under the centralised procedure, pharmaceutical companies submit a single marketing-authorisation to the EMA. Once granted by the European Commission, a centralised marketing authorisation is valid in all EU member states, as well as in EEA.
Who licenses medicines in the UK
Medicines and healthcare products regulatory agency (MHRA) Principal aim of the agency is to safeguard the public’s health. By making sure medicines and medical devices work properly and are acceptably safe; and by responding promptly when new concerns come to light. No product is completely free of risk but sound evidence underpins all the MHRA’s decisions to ensure that the risks are minimised
What kinds of licenses are needed before a medicine can be sold in the UK
Marketing Authorisation- for the product itself Manufacturers and wholesale dealers licenses- required by all companies involved in any stage of the manufacture and distribution of the product Clinical trials authorisation- for new products still in development need a license before they can be tested on human subjects
What is taken into account for a marketing authorisation l
Nature of active ingredient Dosage form Nature of disease/condition treated Effective dose that is needed Type of patient Duration of treatment
What does the licensing process not take into account?
Cost or patient factors NICE tries to resolve this by reviewing licensed medicines in the context of rational prescribing models
Types of herbal product licensing
Unlicensed (no longer used) Traditional herbal medicines registration scheme Marketing authorisation as a herbal medicine
Type of registration for homeopathic remedies
Simplified scheme National rules scheme (since September 2006)
Basic prescription requirements
Age if under 12 (does not apply if written in EEA) Patients name Patients address (does not apply if written in EEA) Prescriber signature Appropriate date Address of prescriber Details to indicate type of appropriate prescriber All in ink and indelible
Basics on repeatable prescriptions
Prescriber to state number of repeats (if no number stated the rx can be repeated once apart from contraceptive pills which can be 6 time in 6 months) First dispensing must be in usual time period No limit on when repeats are collected Repeats do not have to be with same pharmacy so rx remains with patient until finished
NHS repeat prescriptions
Can be RA/RD or EPS Issued by prescriber Allows repeat issue without a signature but there is a token for each supply This is an essential service within community pharmacy contractual framework from March 2015
Legal requirements on a dispensing label
Name of patient Name and address of supplying pharmacy Date of dispensing Name of medicine Directions for use Precautions relating to use of medicine
Recommendations for dispensing labels
Quantity in the container “Keep out of the sight and reach of children” (legal for labelling of manufactured products, but not dispensing labels)
Private prescription legality
Rx must be retained for 2 years from last issue if repeatable (not CDs) Record must be made in POM register (unless oral contraceptive or schedule 2 CDs) Record must include date of supply, date on prescription, name, quantity, formulation and strength of medicine supplied, name and address of prescriber, name and address of patient Entry should be made on the day but if not practical the day after is acceptable May be written or electronic Register should be retained for 2 years from date of last entry
Examples of supplying POMs without prescription
Wholesale supply Emergency supply Patient Group Directions
Wholesale supply
where a supply is made to someone who is going to supple it to someone else, legally a wholesale dealers license is required (although pharmacies may be exempt in the following circumstances: only takes place on an occasional basis, supply is not for a profit basis, supply is not for onward wholesale distribution) Supply must be recorded in POM register. Date, name/quantity/formulation/strength of POM, name and address/trade/business/profession of whom was supplied, purpose of supply With a license it may be individual practitioners e.g. midwives or organisations such as masters of ships, universities
Legal requirements of manufactured medicines outer packaging
1) name of product 2) strength and form 3) if appropriate whether intended for babies, children or adults 4) common name of each active ingredient (if up to 3 ingredients) 5) statement of active ingredients in the product expressed qualitatively and quantitatively per dosage unit using their common name a 6) form and contents by weight, by volume or number of doses of product 7) list of excipients (ALL if injectable, topical or ophthalmic. Those known to have action or effect and included in Article 65 of 2001 directive for all others) 8) method/route of administration 9) Space for prescribed dose to be indicated if appropriate 10) warning regarding reach/sight of children 11) special warning applicable to product 12) expiration date 13) special storage requirements 14) special requirements relating to disposal 15) name and address of holder of marketing authorisation 16) number of marketing authorisation 17) batch number 18) instructions for use, if not POM
Securing the safe and effective running of a registered pharmacy in relation to RP
Establish scope of roles and responsibilities as RP Only take role of RP if within competence Only be RP of one pharmacy at one time Secure the safe and effective running of pharmacy business at the registered pharmacy before any operational activities take place
Information needed on RP notice
Pharmacists name Pharmacist registration number ‘The named person is the responsible pharmacist in charge of the registered pharmacy premises’
Maintaining the pharmacy record in relation to RP
Shows who was RP on any given date/time May be electronic, written or both May be made remotely as long as the record complies with all relevant requirements Must contain: pharmacist name, GPhC number, date and time which RP started and ended, any absence times
Pharmacy procedures in relation to RP
Must have SOPs
Absence in relation to RP
Up to 2 hours is permitted RP must maintain contactable and able to return if needed or arrange for another pharmacist to be available and contactable
A1 supervision activities
Require RP to be in charge of premises and need to take place under supervision where the RP is physically present. Clinical and legal check of prescription Sale of P meds Supply of POMs Supply under PGD Wholesale supply Emergency supply
A2 supervision activities
Require RP to be in charge of premises but may not need to be physically present. Assembly process of prescriptions
A3 supervision activities
Requires RP to be in charge of premises but no supervision. Sale of GSLs
Types of consultation?
Pendleton Neighbour BARD Calgary-Cambridge
Pendleton model?
By David Pendleton in 1987 Aims to be more patient centred Four key questions: 1) who is the patient 2) what has changed for the patient 3) why has the patient come in now 4) how do we tackle to problem
Neighbour (inner) model?
Interviewers ability to identify and act on ‘information-rich’ moments Five key points: 1) develop connection/rapport 2) summarising- reason for attending; ideas, feelings and concerns 3) handing over- share agenda and management plan 4) safety-netting- covering (un)foreseen eventualities 5) house keeping- minimise distractions
BARD model?
Uses interviewers own personality and behaviour positively in the consultation 4 key points: Behaviour- how the patient presents, humour, professionalism Aims- of the consultation Room- the environment Dialogue- tone, words, language
Calgary-Cambridge 5 points?
1) initiate the session 2) gather information 3) physical information 4) explanation and planning 5) close consultation
Initiating the session in Calgary-Cambridge model?
Prepare if possible- check PMR but consultations not always planned Introduce yourself Welcome the patient- ask name and how they would like to be addressed Establish initial report Identify reason for consultation
Gathering information in Calgary-Cambridge model?
Effective questioning- open, closed, probing, clarifying Effective listening
Physical information in Calgary-Cambridge model?
Not always appropriate for consultation Can be used for: rash, eye problems, insect bites, BP monitoring Do they need a chaperone? Always ask for consent
Explanation and planning in Calgary-Cambridge model?
Provide information in an appropriate manner Aid accurate recall and understanding Shared understanding including the patients perspective Shared action plan development
Close of consultation in Calgary-Cambridge?
Summarise key messages Final contract Safety netting Final check if patient is comfortable with plan
What should feedback be like?
Constructive What went well What can improve Be realistic Ways to improve Be honest and kind
Adherence definition?
The extent to which the patients behaviour matches agreed recommendations from prescriber
Concordance meaning?
this is a recent term whose meaning has changed. It was initially applied to the consultation process in which doctor and patient agree therapeutic decisions that incorporate their respective views, but now includes patient support in medicine taking as well as prescribing communication.
WWHAM acronym?
Who? What symptoms? How long for? Action taken? Medication?
ASMETHOD acronym?
Age/appearance Self or someone else Medication Extra medicines Time persisting History Other symptoms Danger symptoms
ENCORE acronym?
Explore No medication Care Observe Refer Explain
SITDOWNSIR acronym?
Site or location of the symptom Intensity or severity Type or nature Duration Onset With (other symptoms) N aNNoyed or aggravated by Spread or radiation Incidence or frequency Relieved by
Marginal decision-making theory?
Focuses on profit maximisation
Psychological decision-making theory?
Focuses on the satisfaction of the person, patient or client
Mathematical (game) decision-making theory?
Considers everybody’s decisions using probability or programming
What is the 1st NHS constitution principle?
- The NHS provides a comprehensive service, available to all It is available to all irrespective of gender, race, disability, age, sexual orientation, religion, belief, gender reassignment, pregnancy and maternity or marital or civil partnership status. The service is designed to improve, prevent, diagnose and treat both physical and mental health problems with equal regard. It has a duty to each and every individual that it serves and must respect their human rights. At the same time, it has a wider social duty to promote equality through the services it provides and to pay particular attention to groups or sections of society where improvements in health and life expectancy are not keeping pace with the rest of the population.
What is the 2nd NHS constitution principle?
- Access to NHS services is based on clinical need, not an individual’s ability to pay NHS services are free of charge, except in limited circumstances sanctioned by Parliament.
What is the 3rd NHS constitution principle?
- The NHS aspires to the highest standards of excellence and professionalism It provides high quality care that is safe, effective and focused on patient experience; in the people it employs, and in the support, education, training and development they receive; in the leadership and management of its organisations; and through its commitment to innovation and to the promotion, conduct and use of research to improve the current and future health and care of the population. Respect, dignity, compassion and care should be at the core of how patients and staff are treated not only because that is the right thing to do but because patient safety, experience and outcomes are all improved when staff are valued, empowered and supported.
What is the 4th NHS constitution principle?
- The patient will be at the heart of everything the NHS does It should support individuals to promote and manage their own health. NHS services must reflect, and should be coordinated around and tailored to, the needs and preferences of patients, their families and their carers. As part of this, the NHS will ensure that in line with the Armed Forces Covenant, those in the armed forces, reservists, their families and veterans are not disadvantaged in accessing health services in the area they reside. Patients, with their families and carers, where appropriate, will be involved in and consulted on all decisions about their care and treatment. The NHS will actively encourage feedback from the public, patients and staff, welcome it and use it to improve its services.
What is the 5th NHS constitution principle?
- The NHS works across organisational boundaries It works in partnership with other organisations in the interest of patients, local communities and the wider population. The NHS is an integrated system of organisations and services bound together by the principles and values reflected in the Constitution. The NHS is committed to working jointly with other local authority services, other public sector organisations and a wide range of private and voluntary sector organisations to provide and deliver improvements in health and wellbeing.
What is the 6th NHS constitution principle?
- The NHS is committed to providing best value for taxpayers’ money It is committed to providing the most effective, fair and sustainable use of finite resources. Public funds for healthcare will be devoted solely to the benefit of the people that the NHS serves.
What is the 7th NHS constitution principle?
- The NHS is accountable to the public, communities and patients that it serves The NHS is a national service funded through national taxation, and it is the government which sets the framework for the NHS and which is accountable to Parliament for its operation. However, most decisions in the NHS, especially those about the treatment of individuals and the detailed organisation of services, are rightly taken by the local NHS and by patients with their clinicians. The system of responsibility and accountability for taking decisions in the NHS should be transparent and clear to the public, patients and staff. The government will ensure that there is always a clear and up-to-date statement of NHS accountability for this purpose.
What is the NHS constitution?
Establishes the principles and values of the NHS in England Sets out rights and pledges
How often is the NHS constitution renewed?
Every 10 years
What are the NHS values?
Working together for patients Respect and dignity Commitment to quality of care Compassion Improving lives Everyone counts
What are pledges?
Go above and beyond legal rights Not legally binding but represent a commitment by the NHS
Who can contacted regarding an NHS complaint?
The healthcare provider The commissioner
Timeframe for making an NHS complaint?
Usually within 12 months of the incident or within 12 months of the matter coming to your attention
Who to raise an NHS complaint to if you are not happy with the outcome?
Parliamentary and health service ombudsman
What to expect after making a complaint about the NHS?
Complaint acknowledged and looked into Kept informed of progress and the outcome Treated fairly, politely, and with respect Care and treatment will not be affected Offered the opportunity to discuss with a complaints manager Appropriate action to be taken
Purpose of a chaperone?
Safeguard for the person receiving care and the healthcare professional Also, witness the person continuing consent
What should a pharmacist do if they need advice in a specific situation regarding profession judgement?
Ask advice from: Employer Professional indemnity insurance Union Professional body Independent legal advice
Legislation relating to confidentiality?
GDPR 2016 Human rights act 1998
When can confidentially be broken?
Have consent from the patient Have to disclose by law Should do so in the public interest Vital interests of the patient e.g. if a patient needs urgent medical attention
When getting a patients consent to share information the patient should be made aware of?
What information Why Who it will be disclosed to Consequences of disclosing and non disclosing
Types of data disclosures required by law?
Police Healthcare regulator NHS counter fraud protection Coroner
Types of data disclosures that should be made in the public interest?
Serious crime Serious harm to patient or third party Serious risk to public health
Examples of situations some pharmacists may feel unable to provide due to personal belief?
Contraception Fertility medication Hormonal therapies Mental health and well-being Substance misuse Sexual health
What does duty of candour mean?
Being honest when things go wrong
What act protects employees who raise a genuine concern?
Public Interest Disclosure Act 1998
Consent definition?
Express willingness, give permission, agree
What are the two types of consent?
Explicit Implied
What is explicit consent?
When a patient gives specific permission, either verbally or in writing
What is implied consent?
Giving consent indirectly, such as, bringing a prescription to be dispensed
For consent to be valid, the person must?
Have capacity Acting voluntarily Have sufficient information and be capable of using this Understand the consequences of not giving consent
What is capacity?
A person lacks capacity if, at the time a decision needs to be made, they are unable to make or communicate the decision because of an impairment or disturbance that affects the way their mind or brain works
What is a supplementary prescribed?
Works with a medical or dental practitioner within a specific clinical management plan (CMP) but does not prescribe independently
Who regulates veterinary medicines?
Veterinary medicines directorate (VMD)
Key act for veterinary medicine?
Veterinary medicines regulation 2013
For a veterinary medicine to be authorised it must not cause harm to…
The animal being treated The person administering the medicine The food consumer if being administered to a food-producing animal The environment
In regards to veterinary medicine who is a suitably qualified person(SQP)?
Included on the SQP register of the Animal Medicines Training Regulatory Authority (AMTRA) Such as veterinary nurses, agricultural merchants, pet shop workers, internet retailers
When can a veterinary medicine not be licensed?
Under schedule 6 of the veterinary medicines regulations- exemption for small pet animals
How to find out if a veterinary medicine is licensed?
Check Noah Compendium
How long should veterinary prescriptions be retained?
5 years
Veterinary cascade?
1) supply a licensed veterinary medicine 2) a licensed veterinary medicine for another species or condition 3) a licensed human medicine or an EU-licensed veterinary medicine 4) extemporaneous or specially manufactured
When is it lawful to supply a human medicine on a veterinary prescription?
Must be prescribed by a vet Must state ‘for administration under the cascade’ or similar
Legal requirements of pharmacists who supply NFA-VPS or prescription POM-VPS?
Ensure advise is given on using product safely Offer advise on applicable warnings and contraindications Take steps to ensure the product is intended to be used correctly Prescribe/supply minimum quantity required
Veterinary prescription requirements?
Name, address, number, qualification and signature of prescriber Name and address of owner Identification and species of animal and its address if different from owner Date Name, quantity, dose and admin instructions Any warnings and withdrawal period if applicable Under the cascade if applicable
Can veterinary prescriptions be repeated?
Yes if directed by prescriber but all must be collect within six months
VMD advice on directions?
Use as directed is not acceptable
Veterinary prescriptions for CDs?
Usual 28 day expiry for 2,3,4 If 2,3 must state the item has been prescribed for an animal or herd under the care of the veterinarian
Labelling of dispensed vet medication NOT under the cascade?
No specific requirements but RPS recommend a dispensing label is added
Labelling of dispensed medication under the cascade?
Name of vet Name and address of owner Name and address of pharmacy Identification and species of animal Date of supply Expiry date of product Name of drug Dosage and admin instructions Special storage if required Warning for the user Withdraw period if applicable For animal treatment only Keep out of reach of children (RPS advise to add sight)
Records to keep for supplies/receipt of POM-V and POM-VPS?
Name of medicine Date of receipt or supply Batch number Quantity Name and address of supplier or recipient
What is the veterinary adverse reaction scheme?
Animal equivalent of yellow card
