Professionalism, Skills and Attributes for Pharmacy Flashcards

1
Q

Miller’s triangle

A

Required level of competence.

bottom (widest part) - knows, knows how, shows how, does - Top (smallest part)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Medicines reconciliation

A

The process of accurately listing a persons current medicines, this could be when they are admitted into a service or when their treatment changes.

Typically the role of a hospital pharmacist.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Medicines formulary

A

This is a list of medicines that are available for use within an organisation such as a hospital, the main purpose is to specify which medicines are approved for use under particular circumstances.

The formulary takes into account the efficacy, safety and cost-effectiveness of medicines.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Aseptic Services

A

NHS Pharmacy aseptic services in England provide sterile controlled environment for the preparation of injectable medicines into ready-to-administer formats for patients.

Products include: chemotherapy, injectable nutrition and clinical trials for new medicines.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Radiopharmaceutical product

A

These are radioisotopes bound to biological molecules able to target specific organs, tissues or cells within the human body. These radioactive drugs can be used for the diagnosis and, increasingly, for therapy of diseases.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Royal Pharmaceutical society

A

It is a professional body that represents the interests of its members. It is NOT compulsory to join to practice as a pharmacist.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

General Pharmaceutical Council (GPhC)

A

This is an independent regulator for pharmacists, pharmacy technicians and pharmacy premises in GB. Their aims are to protect, promote and maintain health, safety and wellbeing of members of the public by upholding standards and public trust in pharmacy. This is COMPULSORY.

Requires an annual declaration of FTP, 4 CPD records and a written reflective piece alongside a discussion about their practice with a professional colleague.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

GPhC standards

A

Effective leadership
Person-centred care
Partnership working
Effective communication
Professional knowledge and skills
Professional judgement
Professional behaviour
Confidentiality and privacy
Speaking up about concerns

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Duty of Candour

A

Pharmacists have a professional duty to be open and honest with patients when things go wrong, this is irrespective of a pharmacists work domain, whether it is in public, private or the voluntary sector.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Primary Care Networks (PCNs)

A

This is made up of a group pf a group of GP practices who work together and in partnership with services in the local area. PCNs build upon existing care services and enable greater provision of proactive, personalised, coordinated and more integrated health and social care for people close to home.

serve from 30,000 to 50,000 people.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Integrated Care Systems (ICSs)

A

ICSs bring together local organisations to redesign care and improve population health, creating shared leadership and action.

Made up of two parts:

Integrated care board (ICB) which allocates the NHS budget and commissions services; produces a 5 year plan for health services.

Integrated care partnership (ICP) which brings together a wider range of partners, not just the NHS, to develop a plan to address the broader health, public health, and social care needs of the population; it does not commission services

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Thalidomide

A

Sold and prescribed during the late 1950s to pregnant woman to combat morning sickness. The drug was considered to be very safe as it was impossible to establish a lethal dose during animal testing.

Pre-release testing was poor by modern standards and post-marketing surveillance was non-existent. There was also no requirement to demonstrate that the drug is safe or effective.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Commission on Human Medicines (CHM)

A

The Medicines Act 1968 introduced a number of different committees.

Committee on Human Medicines (CHM), this is an advisory, non-departmental public body which is sponsored by the department of Health and Social Care.

The CHM provides advice to ministers on safety, efficacy and quality of medicines.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Committee for Medicinal Products for Human use (CHMP)

A

After the UK joined the European Economic Community (EEC) in 1973, the UK had a prominent role in the development of EU legislation.

These developments resulted in a Europe-wide licensing procedure which was overseen by the Committee for Medicinal Products for Human use (CHMP)

It is the EMA’s committee responsible for human medicines; is plays a vital role in the authorisation of medicines

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

European Medicine Agency (EMA)

A

Their role is to protect and promote human and animal health by evaluating and monitoring medicines within the EU, this now only applies to northern Ireland.

Summary of Product Characteristics (SmPCs) are a key component of the marketing authorisations in the EU

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Medicines & Healthcare products Regulatory Agency (MHRA)

A

Established after the Medicines Control Agency, which is responsible for regulating medicines in the UK, the Medical Devices Agency, which had similar responsibilities for regulating medical devices.

The MHRA is responsible for regulating medicines, medical devices and blood components from transfusion in the UK.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Medicines Act 1968

A

It governs the control of medicines for human use, which including the manufacture and supple of medicines, and the manufacture and supple of medicated feeding stuffs.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Human Medicines Regulations 2012

A

The new regulations set out a comprehensive regime for the authorisation of medical products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Pharmacy Order 2012

A

Established the GPhC as an independent statutory regulator, the council has powers and responsibilities for the registration of pharmacy premises and for enforcing certain provisions under the Medicine Act 1968.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Sources of Law

A

Made of a mix of statue law and common law.

Statue Law consists of both primary and secondary legislation. Primary legislation is a term used to describe the main laws passed by the legislative bodies of the UK Parliament. Parliament is sovereign (supreme legal authority in the UK which can create or end any law)

Secondary legislation is created by ministers or other bodies under powers given to them by an Act of Parliament, usually in the form of regulations or Orders in Council, these are all known as statutory instruments that once in effect are the same strength as primary legislation.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

Statue Law/Parliamentary Process

A

Green paper - a consultation document put together by a government department. It is not a statement of policy but supposed to stimulate discussion by putting forward ideas for future government policy. Anyone can comment.

White paper - this explains the Governments preferred future policy on the subject before it introduces legislation. White paper allows the government to test public opinion and gather feedback before presenting a Bill to Parliament.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Common Law

A

Common law is a body of law that has been built up over many years, it is based on the principle of judicial precedent. Judicial precedent means that, when a decision has been made by a judge sitting in a court, that decision is binding in later cases where the facts are the same or similar.

Common law covers civil and criminal law.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

Criminal Law

A

A crime happens when a person intentionally commits one of these activities or intentionally fails to do something required by criminal law, for most offences the intentions are important.

Most crimes are broken town into the criminal act and intent.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

Strict Liability

A

This is when intent is not important, known as strict or absolute liability offenses eg. speeding. The prosecution would not have to prove that there was intent to speed.

25
Q

Burden and standard of proof (criminal)

A

The standard of proof is the degree to which a party must prove its case to succeed, the burden of proof is a requirement to satisfy that standard.

In a criminal case the burden rests with the prosecution to prove their case beyond reasonable doubt in court. In more serious cases this decision is made by a 12 jury person, in less serious the magistrates decide the outcome.

Beyond reasonable doubt is the standard of proof required in a criminal court, this means there is no other logical explanation that can be deducted from the facts and evidence presented except that the defendant committed the crime.

26
Q

The burden and standard of proof (civil)

A

In a civil case the burden of proof is on the claimant. The claimant must prove on the balance of probabilities that the defendant is responsible for the problem. This is a lower standard of proof than used in criminal law. Typically if the claimant is successful, a court awards compensation or take action to the problem.

Civil law is not designed to punish or deter only to correct problems.

Rarely there is an award designed to punish the defendant this is called punitive damages or an exemplary award.

27
Q

Negligence and Duty of Care

A

A tort is a civil wrong and negligence is the most common tort. (Donoghue v Stevenson 1932).

For claims of negligence to be successful the following elements must exist:
Must be a duty of care owned by the defendant to the claimant.
The defendant must have breached that duty.
The claimant must have suffered loss or injury as a result of that breach.
The next stage, if breach of duty and causation is established, is to quantify the claim for compensation or damages.

28
Q

The Bolam test.

A

Clinical negligence (Bolam v Friern Barnet Hospital Management Committee)

Eg if no specific counselling information was given about a medicine was considered “standard practice” among peers, then the pharmacist in question would usually be not found negligent. Safeguard was introduced in 1998 to allow courts to override this.

29
Q

Administrative law

A

This is a part of civil law which created and regulates public bodies such as NHS authorities and hospitals trusts and regulates their activities. It sets out responsibilities and gives them the authority they need to take in those responsibilities.

30
Q

Professional law

A

It gives regulatory bodies such as the GPhC or the GMC powers to register and discipline the relevant health professionals. This is the class of law that allows the GPhC to remove pharmacists from the register of pharmacists.

The idea of an expected standard is used to gauge weather a pharmacist is guilty of professional misconduct.

31
Q

The English Court systems

A

Criminal cases are initially heard in a Magistrates court. Less serious cases (summary offenses) are dealt with in these courts.

More serious cases are dealt within a Crown Court where they are heard in front of a jury.

Civil cases are initially heard in a County court or a Family court, more serious cases are passed to High Court.

Both types can be appealed in a Court of Appeal, important cases which may set a precedent for the future may pass upwards to the supreme court.

Can be passed to the European Court of Human Rights as its not an EU institution.

32
Q

The Medicines and Medical Devices Act 2021

A

Enacted to allow amendments to be made to the Human Medicines Regulation 2012 as well as other legislation now that we have left the EU.

It also established a new Patient Safety Commissioner in England.

33
Q

European Convention on Human Rights (ECHR)

A

The ECHR is an international human rights treaty between 47 states that are members of the Council of Europe, it represents a legal commitment to guarantee certain fundamental freedoms, to protect the rule of law and promote democracy.

Some articles in the ECHR are relevant to pharmacy practice and the standard of behaviour expected by pharmacy professionals.

34
Q

4 moral principles in healthcare

A

Beneficence - This considers the balancing of benefits of treatment against the risks and costs; the healthcare professional should act in a way that benefits the patient.

Non-maleficence- Avoiding the cause of harm; the healthcare professional should not harm the patient. All treatment involves some harm, even if minimal, but the harm should not be disproportionate to the benefits of the treatment

Respect for autonomy- Respecting the decision-making capabilities of autonomous persons; enabling individuals to make reasoned informed choices.

Justice- Distributing benefits, risks and costs fairly; the notion that patients in similar positions should be treated in a similar manner

35
Q

Professional Judgement

A

‘the use of accumulated knowledge and experience, in order to make an informed decision. It takes into account the law, ethical considerations and all other relevant factors related to the surrounding circumstances.

  1. Gather relevant facts
    • criminal/civil law?
    • GPhC professional standards?
    • NHS law?
  2. Prioritise and ascribe values
    • patient/public/carers/other HCP?
  3. Generate options
    • professional consequences of each option?
    • how likely are these consequences?
  4. Choose an option
    • what are you going to do?
    • can you justify your decision?
36
Q

Phocomelia

A

Rare congenital deformity in which the hands or feet are attached close to the trunk, the limbs being very underdeveloped or absent.

This condition is a side effect of the drug Thalidomide taken during pregnancy in the late 1950s

37
Q

Antiemetic

A

Drug effective against motion sickness/vomiting.

They are antagonists of serotonin, dopamine, histamine and others

38
Q

Marketing Authorisation (MA)

A
  • Before a medicinal product can be marketed, sold, supplied or imported. Regulation 46 of the HMR states that us must have a marketing authorisation (MA).
  • This is one of the key parts of the regulations and means that all conventional medicines and appliances marketed, sold, supplied or imported to the UK have to have been approved by a regulatory body which has seen evidence of their safety, quality and efficacy when used as specified in the MA.
  • The medicines and healthcare products Regulator Agency (MHRA) is responsible for issuing MAs in the UK.
  • Normally granted for a period of 5 years or less and is specified in the MA
39
Q

Centrally Authorised Products (CAPs)

A

If a centrally Authorised Product (has a community Marketing Authorisation) was approved by a European medicines agency (EMA) it would be valid throughout the EU, this changed after Brexit.

All CAPs automatically became UK MAs unless the holders opted out. This automatic conversion process is sometimes known as grandfathering.

40
Q

Unlicensed Medicines

A

A medicine which does not have a valid MA in the UK. The examples where this is permitted:

  • A medicine with authorisation elsewhere but being imported for a specific patient who has been prescribed them
  • A medicine that has been medicine which has been manufactured against a specific prescription. eg difficulty swallowing and needs to take a medicine with an MA only for solid oral dose) ‘specials’
  • A mixture of two or more medicines before administration.
  • A medicine from a UK licensed manufacturer that is awaiting an MA or had its MA suspended
  • A new medicine undergoing clinical trails which does not yet have an MA

Patient must be aware that the medicine is unlicensed.

41
Q

‘Off label’

A

Means that a medicine is being used in a different way from described in the MA. Examples include:

  • Using a medication for a different indication from that stated in the MA. There may be plenty of evidence but the manufacturer may not have extended its MA to cover this.
  • Using the medicine in an age group not specified in the MA
  • Using a medicine in a higher dose than stated on the MA
42
Q

Generic v proprietary products

A

A generic medicinal product means a medical product that:
- has the same qualitative and quantitative composition in active substance as the reference medicinal product (RMP)
- has the same pharmaceutical form as the RMP
- whose bioequivalence with the RMP has been demonstrated in appropriate studies

A proprietary product (branded) tends to be more expensive than the generic so prescribers and encouraged to prescribe these instead of the proprietary alternative.
- there is also a category of drugs known as branded generics which are generic drugs with a brand name, they are sometimes cheaper than the non-branded generics.

e.g proprietary is Heinz, generic is asda baked beans

43
Q

Borderline products

A

These are products where the status is queried. medicinal product? a medicinal device? food supplement? cosmetic product?

For nutritional and dermatological products there is a committee called the Advisory Committee on Borderline Substances (ACBS) which advises on their use in NHS primary care.

Once a decision about the status has been made the MHRA can serve a notice in writing

44
Q

Orphan drug

A

A synthetic pharmaceutical which remains commercially underdeveloped

45
Q

Parallel import

A

Non-counterfeit product imported from another country without the permission of the intellectual property owner. (grey imports)

46
Q

Manufacturer’s licence (ML)

A

MLs are required if you c=want to manufacture, assemble or import human medicines other than from an approved country for import.

Without an ML you can’t apply for an MA.

When applying for a ML you must do so in line with Good Manufacturing Practice (GMP), which is the minimum standard that must be met with respect to production processes.

47
Q

Wholesale Dealer’s Licence

A

Wholesale dealing refers to the sale or supply of a medicinal product to a person who is not the person who will actually use that medicinal product (eg sale to a pharmacy)

Must have an MA

48
Q

Pharmacovigilance

A
  • monitoring the use of medicines in everyday practice to identify previously unrecognised adverse effects or changes in patterns
  • assessing the risks and benefits of medicines in order to determine what action, if any, is necessary to improve their safe to use
  • monitoring the impact of any action taken
49
Q

Yellow card scheme

A

Used to report adverse drug reactions. Can be done by both patient or pharmacist or other staff.

50
Q

Traditional herbal medicines

A

Herbal remedies have to have either a full MA based upon safety, quality and efficacy or a Traditional Herbal Registration (THR)
Conditions for licensing:

  • product has been in medicinal use for a continuous period of at least 30 years or 15 years in another country listed by the MHRA.
  • has been established that the traditional use of the product is not harmful and that the pharmacological side effects or efficacy of the product are plausible based on long standing use and experience.
51
Q

Homeopathic products

A

No evidence that homeopathy is effective as a treatment for any condition, but evidence of a strong placebo effect.
Two main principles:
- ‘like cures like’
- diluting a substance makes it more potent.

They are sometimes diluted so heavily that the tablet/capsule has no molecules of the original substance but the ‘memory’ of the molecule.

They must prove product quality and safety.

52
Q

Legal classes of medicines

A

Perspiration only (POM)
- DIRECT supervision of a pharmacist

Pharmacy only (P)
- MUST be under the supervision of a pharmacist

General sale (GSL)
- self-selection items
- premises must be lockable to exclude the public

53
Q

Supervision

A

A non-pharmacist can sell/supply a P medicine but it must be supervised by a pharmacist.

The sale/supply must be not any less safe that it was being sold/suppled by a pharmacist

The pharmacist must be in a position to intervene to prevent any inappropriate sale.

54
Q

Appropriate practicioner

A

Under the HMR: doctors, dentists, supplementary prescribers, nurse independent prescribers, pharmacist/paramedic independent prescribers and EEA health professionals can all write prescriptions for any POM.

There are more but they are subject to some restrictions.

55
Q

Faxes

A

A fax can’t be a legally valid prescription but could be used as evidence that a legally valid prescription exists, this is relevant when making an emergency supply.

56
Q

Repeatable prescriptions

A

A private prescription can be made repeatable by the prescriber. They will normally add repeat x6 this would mean 6 repeats but 7 total supplies including the initial.

If repeat is alone then assume x1 so one repeat but 2 total supplies unless an oral contraceptive then it can be repeated x5. The first dispensing must be made within 6 months of the appropriate date, then after that no legal limit on the remaining repeats.

A standard NHS prescription is NOT repeatable.

57
Q

Electronic Prescription Service (EPS)

A

EPS allows prescriptions to be sent electronically from a prescriber and then to the NHSBSA for payment. (currently on EPS phase 4).

Under phase 4 prescriptions are sent via EPS by default, weather a patient has nominated an EPS or not. (patient can explicitly request a paper prescription from their GP or when the medicine is not on the NHS list of medicines)

  • saves money
  • secure and transmitted to the NHS spine
    Accessed and controlled by smartcard pin so only people with a reason can view it.
58
Q

Record Keeping for supplies of POMs

A

Exceptions: health prescriptions, oral contraceptives, supplies of controlled drugs, wholesale supplies

Must be that day or the following day if not practical. NHS prescriptions don’t require records, only private and emergency prescriptions. Records are kept for 2 years.

The record must include:
- date of supply AND prescription
- Name and address of patient AND prescriber
- details of the medicine supplied (name, quantity, pharmaceutical form and strength