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
