General Flashcards
What are the 7 principles?
- Make patients your first concern
- Use professional judgement in the interest of patients and the public
- Show respect for others
- Take responsibility for yout working premises
- Be honest and trustworthy
- Encourage patients and public to participate in decisions about their care
- Develop your professional knowledge and competence
Explain how you would promote patient centred healthcare.
Medicines optimisation; ensure that patients get best possible outcome from their medicines. Aims to help patients to improve their outcomes, take their medicines correctly, improve adherence, avoid taking unnecessary medicines, reduce wastage, improve medicines and patient safety.
There are 4 principles to it;
- Aim to understand the patients experience (ensure best possible outcomes);
- Evidence based choice of medicines;
- Ensure medicines use is as safe as possible;
- Make medicines optimisation part of routine practice.
What are the 4 principles to patient centred healthcare?
- Aim to understand the patients experience (ensure best possible outcomes);
- Evidence based choice of medicines;
- Ensure medicines use is as safe as possible;
- Make medicines optimisation part of routine practice.
What is professional judgement?
Using accumulated knowledge and experience, as well as critical reasoning, to make an informed professional decision to solve a problem. It takes account the law, ethical considerations, relevant factors and standards around the surrounding circumstances.
Thought process;
- Identify the ethical dilemma or professional issue;
- Gather relevant information;
- Identify possible options;
- Weigh up the benefits and risks of each option;
- Chose and option;
- Record. (P.M.R. = patient medical record)
Can pharmacists choose different outcomes for the same dilemma?
It is possible for two different pharmacist to choose different outcomes if faced with same dilemma.
What do you need to consider during a clinical check?
PATIENT TYPE: A patient can fall into a group where treatment is contraindicated or cautioned. Specific groups of patients to be aware are; CHILDREN, ELDERLY, ETHNICITY, PREGNANT or BREASTFEEDING.
CO-MORBIDITIES: Renal, hepatic of CV impairment or HF can exclude use of a particular treatment or alteration of the dosage.
MEDICATION REGIMENT FACTORS: Indication, Changes in regular treatment, Compatibility, Formulation, Monitoring Requirements, Dose/Frequency.
ADMINISTRATION & MONITORING: Correct route of administration and consider the need for administration aids.
What is a medicine?
A product that someone claims has a medicinal purpose. All medicinal products are “banned” from supply, but exemptions allow them to avoid this ban (P, POM, GSL) and MHRA polices the exemptions.
What is MHRA and what are their aims?
Medicines and healthcare products regulatory agency and MHRA aims to;
- PROTECT THE PUBLIC (regulate and ensure acceptable risk vs benefit ratios of new products);
- PROMOTE PUBLIC HEALTH (by encouraging understanding of use of products);
- IMPROVE PUBLIC HEALTH (by ensuring appropriate products are available).
What is PUMA?
It is the new licensing system for children’s medicines granted by the European commission in September 2011 (Paediatric Use Marketing Authorisation).
What is tort law? What are some examples?
A tort is a civil wrong that unfairly causes someone else to suffer loss or harm resulting in legal liability for the person who commits the tortious act.
It is a part of the civil law.
Other torts are breach of confidentiality or defamation
What is the most common tort in healthcare?
Negligence; three things need to be proved
Battery = treatment without consent
What needs to be proved to show negligence?
- a duty of care between HCP and pt
- a breach of this duty of care
- this breach has caused harm to the pt
These three things are proved on ‘balance of probabilities’ unlike criminal law. Pharmacists need to be able to recognise potential risks and intervene to prevent harm to the pt, while exercising professional judgment and discretion.
No-one can consent to treatment on behalf of an incompetent adult BUT treatment can be given on the basis of ___ _____.
best interest
______ of ______ can be invoked for emergency tx.
doctrine of necessity
Principles of ethical decision making are:
Beneficence - bringing benefit to pt or others
Autonomy; respecting pts decision reg their own healthcare and future
Non-maleficence; not causing harm to pt or others
Justice; fair, everyone has rights
Purpose of consent:
moral consent
clinical consent
legal purpose
Under the consent law, a valid consent is when one has:
- capacity to decide: weigh in the balance to make a choice, understand the info provided, retain info
- sufficient information; material or significant risks must be disclosed, if not it is tort
- acts voluntarily; no pressure or under influence either to accept or refuse treatment or care
Define Gillick competent
A child who is capable of understanding and who has the intelligence to understand fully what is proposed.
Confidentiality is a _________ obligation and ______ ____. Confidentiality can be breached with: _____, for ____ _____, ‘_____ to self, third party or public’ or in the ___ ____ of a person without capacity.
professional moral duty consent public interest danger best interest
The statutory requirements to break confidentiality are:
Certain Infectious Disease Road Traffic Act Abortion Act 1967 Misuse of Drugs Act Prevention of Terrorism Act Health and Safety Act 1974
Health and Safety Act
1974
Abortion Act
1967
Schedule 17 of HMR 2012 states
the persons and organisations that are permitted to sell, supply and administer wholsesale medicines
Schedule 22 of HMR 2012 states
the persons and organisations that can obtain medicines by wholesale
Regulation 237 states
it is unlawful to sell or supply both products (pseduoephedrine and ephedrine) at the same time
Regulations 217 and 28 states
information required for a Rx to be legal
Regulation 225 states
pharmacist should interview patient before emergency supply
Regulation 226 and 247 states
can relax ES if pandemic exemption
When can you supply ES without Rx?
PGD PSD Pandemic exemption Emergency supplies Optometrist or Podiatrist written and signed order
Which Rx are not repeatable
CD 2 and CD 3, NHS Rx
Retain POM for how long?
2 years
Retain CD for how long?
2 years
What is exempt from record keeping?
CD 2 (register) and oral contraceptive
During what circumstances do pharmacies not need a WDA(H)
- transactions take place on occasional basis
- quantity of medicines supply is small
- supply is not for onward wholesale distribution
- medicine supplied is not for a profit basis
What to consider when kid is picking up meds?
Counselling Knowledge of the child Local practices Maturity of the child Nature of medicine(s) supplied Prior arrangement Proof of identity Reason for collection
Misuse of drug act
1971
Misuse of drug regulation
2001
Act in 1971
Misuse of Drugs Act
Act in 2001
Misuse of drugs regulation
Midwife can prescribe
pethidine
diamorphine
morphine
podiatrist can prescribe
temazepam
dihydrocodeine
physiotherapist can prescrible
temazepam
dihydrocodeine
fentanyl
morphine
The role of the RP is:
- secure the safe and effective running of the pharmacy, inc when absent
- display a notice with the name and GPhC number that shows you are the RP
- Complete the RP record
- Establish, maintain and keep under review procesures for safe working (Notices, Absence, Record and SOPs)
RP Notice:
- Show name and GPhC number
- Publicly displayed even when away from pharmacy
- Must be of professional appearance
RP Absence:
- No longer than 2 hours in 24 hrs
- Can only sell GSL within 2 hours, cannot sell beyond this time
- Second pharm is RP if RP is gone for more than 2 hours
- Must be able to return within reasonable promptness
- Must be able to contact to give advice
RP Record:
- Name and reg number
- Date and Time you became RP
- Date and Time you stopped RP
- Date and time of absence
- Reason for absence
RP record kept for
5 years
Failure to keep RP record is a _____ offence
criminal
RP SOPs:
preparation
ordering; who can? what to do if not working?
sale: who can sell what and when? when to refer.
storage: who can put it away? stock rotation. fridge lines/
delivery
disposal
RECORD KEEPING, COMPLAINTS PROCEDURE, WHAT IS TO BE DONE IN CASES OF UNEXPECTED EVENTS
Outline the Caldicott principles”
- Justify the purpose(s) of every proposed use or transfer
- Don’t use unless absolutely necessary
- Use the minimum necessary
- Access should be on strict need to know basis
- Everyone with access should know their responsibilities
- Understand and comply with the law
Vet prescribing cascade:
- Licensed medicine
- Licensed medicine, same condition, different species
- Different condition, same species
- Medicinal product for human use
- Veterinary product licensed in another EU member state, any species
- Supply a veterinary medicine prepared extemporaneously.
What instructions can you NOT write on veterinary medicine?
‘As directed’
Keep vet med Rx for how long?
5 years, my G
Which CDs are valid for 28 days?
2, 3 and 4
Which CD is valid for 6 months?
5
Which CDs are repeatable
4 and 5
How do the MHRA maintain their 3 aims?
System of licensing:
By enforcement with a staged approach to:
1) Try prevent people from breaking the rules
2) Be able to identify if they do
3) Use sanctions if they do
New medicines are put on probation for up to __ years and labelled with a ____ _______ to ensure prescriber are aware of the need to monitor them carefully
2
black triangle
Black triangle is for ___ _______ and ______
new medicines and vaccines in prescribing manuals
Black triangle prompts HCP to…
report any potential side effects to the MHRA.
The black triangle is not removed until
the MHRA are happy that the new medicines/ vaccine works safely in large numbers of people.
The Yellow Card Scheme is…..
You can report by
a reporting system for possible side effects related to medicines.
Call/ phone or fill a report online or by visiting mhra.gov.uk and download a report form for posting INSTEAD of having to wait to speak to a busy HCP.
Puts pt in control
What are the faulty medicines classes?
CLASS 1 - immediate recall because of serious of life threatening risk to health
CLASS 2 - recall within 48 hrs because could cause harm to pt but not life threatening
CLASS 3 - take action within 5 days because unlikely to harm pt and is being carried out for reasons other than pt safety
CLASS 4 - advice caution to be exercised when using product but no threat to pt safety
Traditional Herbal Regisration (THR): You must apply for a THR before you can market a herbal medicine in the UK. THR is only granted if medicine is used for ______ _____ where _______ ________ is not required. If your traditional herbal medicine claims to treat ____ _____ _______ then you must apply for _____ _______ before you can place on the market.
minor health conditions
medical supervision
major health conditions
marketing authorisation
How can you reduce errors with prescriptions. dispensing?
- Always use dispensed by and checked by boxes
- Check label against prescription and medicine against prescription
- Take a mental break when self-checking
Before taking a pt into a consultation room, consider:
- explaining in advance
- avoid physical contact
- offer chaperone
- avoid unneccesary personal comments
Factors to consider if ES at the request of prescriber:
- Appropriate prescriber
- Emergency
- Prescription within 72 hours
- Directions
- NOT for controlled drugs except phenobarbital, CD4 and 5
- Record kept
- Labelling
Factors to consider if ES at the request of patient:
- Interview
- Immediate need
- Previous treatment
- Dose
- NOT for controlled drugs except phenobarbital, CD4 and 5
- Length of treatment
- Record kept
- Labelling
Penalty for supply of Class A (Diamorphine and Methadone)
Life +/or unlimited fine
Penalty for supply of Class B (Barbiturates, Amphetamine, Methylphenidate, + Ketamine)
14 yrs +/or unlimited fine
Penalty for supply of Class C (BDZ, buprenorphine, tramadol)
14 yrs +/or unlimited fine
Penalty for possession of Class A (Diamorphine and Methadone)
7 years +/or unlimited fine
Penalty for possession of Class B (Barbiturates, Amphetamine, Methylphenidate, + Ketamine)
5 years +/or unlimited fine
Penalty for possession of Class C (BDZ, buprenorphine, tramadol)
2 years +/or unlimited fine
Misuse of Drugs Regulation 2001 divided CDs into 5 schedules corresponding to their:
therapeutic use and misuse potential
Health and Safety at Work Act 1974 outline:
Identify the hazards
Decide who might be harmed and how
Evaluate the risk and decide on precaution
Record your findings and implement them
Review your assessment and update if necessary
Part 1 poisons may be sold:
from pharmacies, under the supervision of a pharmacist
Part 2 poisons may be sold
from pharmacies and ‘listed sellers’
What are the most important schedules of poison in pharmacy?
1 and 4
Examples of Schedule 1 poison
Arsenic, used as insecticide
Knowledge of purchaser
Record keeping
Examples of Schedule 4 poison
sulphuric acid, domestic drain cleaner (15% w/w/ or less)
Can be sold from sellers, usually at specific strengths
What are the 3 types of legally useable industrial alcohols?
- Completely denatured alcohol
- Industrial denatured alcohol
- Trade Specific denatured alcohol
Completely denatured alcohol is used for
camping stoves and burners
Industrial denatured alcohol is used for:
Need authorisation to ____ and _____
Generally can only supply ____ litres
general usage in dentistry, hairdressing
supply
receive
Which regulation protects people and environment from dangerous chemicals?
C.H.I.P
C.H.I.P will eventually be replaced by what regulation?
CLP
CIVIL LAW IS:
GIVE EXAMPLES
THE COMMON LAW
BREACH OF CONFIDENCE, DEFAMATION AND NEGLIGENCE
TORT LAW IS:
GIVE EXAMPLES
ALLOWS SOMEONE WHO HAS SUFFERED A WRONGFUL ACT TO SEEK REMEDY E.G. NEGLIGENCE
CRIMINAL LAW IS
REGULATES CRIMES OR WRONGS COMMITTED AGAINSTTHE GOVERNMENT E.G. PRIMARY LEGISLATION - MEDICINES ACT, MISUSE OF DRUGS ACT etc
