Summative meds

Flashcards for revising for CYP medicine management summative exam

Paracetamol pharmacokinetics

A Majority is absorbed from the GI tract, mainly the small intestines

D Rapidly and evenly throughout most tissues and fluids

M Predominantly by the liver

E In urine (by kidneys)

Half life ~2 hours

Paracetamol pharmacodynamics

Paracetamol’s exact mechanism of action has not been fully established. It’s usually categorised alongside NSAIDs due to its ability to inhibit the cyclooxygenase (COX) pathways. It’s thought to exert central actions which ultimately lead to the alleviation of pain symptoms. One theory is that it increases the pain threshold by inhibiting COX-1 and COX-2, which are involved in prostaglandin (PG) synthesis. Prostaglandins are responsible for eliciting pain sensations. 

It has no anti-inflammatory affects. Paracetamol does not inhibit cyclooxygenase in peripheral tissues and, therefore, has no peripheral anti-inflammatory effects. The antipyretic actions of paracetamol are likely attributed to direct action on heat-regulating centres in the brain, resulting in peripheral vasodilation, sweating, and loss of body heat.

Ibuprofen pharmacokinetics

A In the upper GI tract

D Around the body in the blood and serum

M By the liver into inactive metabolites

E Excreted as metabolites and a small amount unmetabolised, by the liver. Almost completely in urine (>95%)

Half life ~ 2 hours

Ibuprofen pharmacodynamics

Ibuprofen has multiple actions in different inflammatory pathways involved in acute and chronic inflammation. The main effects reported in ibuprofen are related to the control of pain, fever and acute inflammation by the inhibition of the synthesis of prostanoids by COX-1 and COX-2.

It’s a non-selective COX inhibitor and hence, it inhibits the activity of both COX-1 and COX-2. The inhibition of COX-2 activity decreases the synthesis of prostaglandins involved in mediating inflammation, pain, fever, and swelling while the inhibition of COX-1 is thought to cause some of the side effects of ibuprofen including GI ulceration.

The exact mechanism of action of ibuprofen is unknown. However, ibuprofen is considered as an NSAID and thus it is a non-selective inhibitor of cyclooxygenase, which is an enzyme involved in prostaglandin (mediators of pain and fever) and thromboxane (stimulators of blood clotting) synthesis.

Sodium Valproate pharmacokinetics

A rapidly from the GI tract

D primarily distributed within the extracellular plasma

M extensively (90%) in the liver, producing over 220 metabolites

E urine

Half life in children 6-9 hours, in adults ~15 hours

Sodium Valproate pharmacodynamics

Thought to increase cortical inhibition contributing to control of neural synchrony and may have a neuroprotective effect preventing damage and neural degeneration. Exact mechanisms unknown.

Known to inhibit the inhibitor of GABA (increases succinic semialdehyde), which increases GABAergic neurotransmission (an inhibitory neurotransmitter). GABA is an inhibitory neurotransmitter (primary neutrotransmitter for the CNS) which reduces neuronal excitability and slows down neuronal activity

Midazolam pharmacokinetics

A rapidly absorbed dependent on route. buccal and nasal mucosa rapid. IM rapid. poorly orally/GI tract

D high volume of distribution, almost 97% protein bound

M primarily in the liver and gut into hydroxylated metabolites

E in urine

Half life ~2 hours (1-2 in children)

Midazolam pharmacodynamics

Short-acting benzodiazepine CNS depressant. Enhances the inhibitory action of GABA neurotransmitters (gamma-aminobutyric acid).

When binding to the GABA receptors, it increases the frequency of chloride channels opening – produces a sedating effect, relaxes skeletal muscles and reduces the (overactive) electrical signals in the brain (causing the epileptic seizures). The receptors are found in the heart and skeletal muscles, but mainly in the CNS

Benzylpenicillin pharmacokinetics

A - benpen is poorly absorbed orally, easily destroyed by stomach acid (best absorbed by small intestine). Therefore given as IV or IM. Slow absorption. Penicillins generally are absorbed in the GI tract at varying rates and extents.

D - widely distributed, into body tissues and fluids. Poor penetration into BBB/CSF except when meninges inflamed.

M - mostly by liver into metabolites such as peniclloic acid

E - rapidly in urine (and a small amount in bile). Most of it excreted unchanged in therapeutic concentrations.

Half life ~1- 2 hours (older = faster)

Benzylpenicillin pharmacodynamics (penicillin)

Causes the inhibition of cell wall synthesis (bactericidal).

Are beta lactam antibiotics

Penicillins are mainly effective against gram positive (benpen is) but some are gram negative

• bacterial cell walls are made up of peptidoglycan made using the enzyme transpeptidase.

• Transpeptidase is targeted by beta lactam antibiotics which trick it into binding to peniciliin instead of the cell wall, this stops the enzyme from working

• without a cell wall the bacteria lyses

Ondansetron pharmacokinetics

A from GI tract

D widely distributed, around 80% binds to plasma proteins

M some limited first pass metabolism in liver. Later extensively metabolised into major urinary metabolites

E in urine (and faeces)

Half life ~3 hours

Ondansetron pharmacodynamics

Selective antagonist of the serotonin receptor subtype 5-HT3 – it’s an antiemetic. Suppresses vomiting reflex (particularly seen after chemotherapy and radiotherapy as they are associated with the release of 5-HT). the serotonin stimulates the vagal and splanchnic receptors that project to the medullary vomiting centre. Ondansetron stops this.

What are controlled drugs?

Substances regulated by law due to potential for misuse or harm. They include opioids, benzodiazepines and stimulants. CDs are essential for pain management, anesthesia and some MH conditions

What was in the misuse of drugs act 1971?

• The act is a statutory framework for the manufacture supply and possession of controlled drugs in order to prevent misuse

• Act sets out categories of drugs A, B, C based on harm

• Enforced a penalty for use was dependent on the class of drug 

What was in the misuse of drug regulations in 2001?

• Governs the control and use of CDs, working alongside the Misuse of Drugs Act 1971, providing a more detailed framework for the practical management of CDs within healthcare and research

• The regulations control the production, possession, supply, storage, and prescribing of controlled drugs

• The regulations classify controlled drugs into five schedules, based on their potential for harm, medical use, and the need for regulatory oversight

What was in the controlled drugs regulations (2006, revised 2013)

• In 2007, The Controlled Drugs (Supervision of Management and Use) Regulations (2006) were introduced as part of the Government’s response to the Shipman Inquiry.

• The aim of these regulations was to strengthen the governance arrangements for the use and management of CDs.

• As a consequence of passing the Health and Social Care Act 2012, the 2006 regulations were revised - The Controlled Drugs (Supervision of Management and Use) Regulations 2013 came into force

What are the schedules of controlled drugs - what does each mean and gives examples (there’s 5 - 2, 3, 3, 2, 1)

What are CD accountability officers (CDAOs)?

The Controlled Drugs (Supervision of Management and Use) Regulations (2013) require NHS Trusts to appoint CDAOs - Senior professionals responsible for overseeing the safe management and use of CDs within their organisation.

Their role involves:

• Developing and implementing systems for monitoring the prescribing, storage, administration, and disposal of CDs.

• Overseeing the reporting and management of any incidents, discrepancies, or concerns related to CDs.

• Investigating breaches or concerns, including loss, theft, or inappropriate prescribing

How to safely store CDs?

• Controlled drugs, particularly those in Schedules 1, 2, and certain Schedule 3 drugs must be stored securely in a manner that limits access to authorised staff only.

• CDs must be kept in locked cabinets or safes that meet British Standard security levels

• Cabinets should be located in a secure area, out of public view, and inaccessible to unauthorised people.

• Only authorised staff should have access to the storage area.

• Keys must be kept under secure control or in a digital access system

How to record keep CDs?

• A Controlled Drugs Register is a legal requirement for all Schedule 2 drugs and some other CDs as per local policies.

• It ensures accountability and traceability of every transaction involving CDs.

• Must be a bound book or electronic system that prevents retrospective alteration.

• Entries must be made chronologically and at the time of administration. Each entry should be signed by the person responsible for administering and a second checker. CDRs are retained for 2 years after their last entry.

• Contents of the CDR:

- Date and time of use

- Name of the drug and its form

- Strength and quantity administered

- Name of the person the drug was administered too

- Amount remaining following administration

How to manage discrepancies in CDs stock?

• Regular checks of stock against the CDR should be conducted

• Discrepancies may occur due to errors in recording, loss, theft or diversion

• Any discrepancies must be investigated and the findings documented

• CDAOs should be informed

• In cases or theft or diversion, the police and regulatory bodies should be informed

How should you dispose of CDs?

Expired CDs or those that are no longer required must be destroyed in a manner that prevents misuse. Schedule 2 drugs require destruction in the presence of an authorised witness.

Records of destruction must include:

• drug name, form and quantity

• date and method of destruction

• signatures of those involved in the process

What do you need to remember when administering a CD?

Monitor for side effects e.g. resp rate after morphine

Take CD book, drug, and drug chart with you to the patient

Follow the Rs still

Still need a 2nd checker

Fill in CD book - document

Compliance vs adherance?

compliance - ‘‘the extent to which the patient’s behaviour matches the prescriber’s recommendations”

adherence - “the degree to which a person’s behaviour corresponds with the agreed recommendations from the HCP” (assumes an agreement between the patient and prescriber)

Direct methods of monitoring adherence?

• assessment of blood levels

• measurement of the control of the condition

• rates of repeat prescriptions

• measuring physiological parameters

Indirect methods of monitoring adherence?

• taking an adherence history

• reviewing the clinical response to treatment

• self-report questionnaires

Issues with non adherence?

• increase in morbidity

• increase in medical complications

• poor QOL

• overuse of the healthcare system

• leads to ethical debate

Factors that can lead to non adherance

• development stage

• family dysfunction/positive family functioning

• transition

• MH issues for the CYP

• MH issues for the care giver

• complex therapy

• side effects

• denial of illness

• close friends

• internal locus of control

• treatment with immediate benefits

• parents beliefs in seriousness of illness and efficacy of treatment

• HCP empathy

What does NICE say about involving people in relation to adherence?

• adapt communication style to meet an individuals needs

• offer all patients the opportunity to be involved in DM of their medications

• offer patients info that is relevant to their conditions and treatments in a way that is easy to understand

• be aware of patients concerns over their medications

• routinely assess non-adherence in a non-judgmental way

What is polypharmacy?

• The use of multiple medications by a patient

• Changed over time from 4-5 medications to upward of 10 by some authors

• McCraken et al (2017) cites 9 or more medications

• NG5 (2015)- the use of multiple medications by a person

• More frequently associated with older adults or CYP with complex, long-term conditions that require complex treatment

Appropriate vs problematic pharmacy (Kings Fund, 2013)

Appropriate - Prescribing for an individual for complex conditions or for multiple conditions in circumstances where medicines use has been optimised and where the medicines are prescribed according to the best evidence

Problematic - The prescribing of multiple medicines inappropriately or where the intended benefit of the medicines are not realised

What are the benefits of polypharmacy?

• helps to treat co-existing conditions

• can reduce symptoms and improve daily functioning

• can prevent the progression of certain diseases e.g. cardiovascular disease

What are the challenges of polypharmacy?

• risk of adverse drug reactions (ADRs)

• increased side effects

• medication non-adherence

• confusion over multiple prescriptions

• higher healthcare costs

What method do we use in CYP for medications reviews and why?

Need and indication

Open questions

Tests and monitoring

Evidence and guidelines

Adverse events

Risk reduction or prevention

Simplification or switches

• promotes shared DM and empowerment

What are the 7/8Rs of safe medication administration

Drug

Dose

Patient

Route

Time

Documentation

Refusal

(Reason/form)

What should happen if there is a drug error?

If still being administered and wrong dose/drug etc. stop it

Inform NIC and medical team

Document

Datix

Duty of Candour to explain to patient and family what has happened.

What is self-administration and why is it important?

When patients take responsibility for managing and administering their prescribed medication.

Promotes independence, encourages patient autonomy, and prepares patient for LT conditions

Benefits of SAM for the patient

• gives increased understanding of their medication

• improves adherence

• enhances independence

• allows patients to become familiar with new medication in a safe environment

Benefits of SAM for the healthcare system?

• reduces nurse workload eventually

• identifies potential for education

• can support smoother transitions from hospital to home

• reduces medication errors

• improves long term health outcomes

• ? cost effective

Disadvantages of SAM for patients?

• risk of non-adherence or misuse

• patient may not want to self administer

• might not be suitable for all medications

Disadvantages of SAM for healthcare systems?

• clear policies and guidance need to be in place and adhered to

• education, training as assessment of patients is time consuming

Legal and ethical considerations of SAM?

consent and capacity

• ensure the patient has capacity

• document discussions around consent/assent

accountability

• nurses remain accountable for patient safety during the SAM process

• clear communication and documentation are essential

professional standards

• adhere to NMC code principles of promoting patient safety

What is level 1 of SAM?

Nurse led administration

• nurse administers all meds to the patient

• the patient is encouraged to observe and learn, fostering understanding of their medication regimen

• this level is used when the patient lacks the capacity, confidence or knowledge to self administer safely

What is level 2 of SAM?

Supervised self-administration

• the patient administers their own medication under direct supervision from a nurse

• this level helps assess the patient’s ability to self-administer correctly and safely, while providing real-time support and education

• suitable for patients transitioning to independence but requiring oversight

What is level 3 of SAM?

Independent self-administration

• the patient takes full responsibility for managing and administering their own medication without supervision

• the nursing team provides ongoing support as needed but does not actively intervene

• this level is for patients who demonstrate full understanding, competence, and adherence to their medication regimen

Things to consider when initiating self-administration

• CYPs developmental stage

• age-appropriate communication

• parental involvement when appropriate (family education)

• health literacy and understanding

• liase with school staff

• consider safe storage

• how it may affect them socially

• regularly review adherence

• remember positive reinforcement and empowerment

• cultural and individual needs

• legal and ethical considerations

Steps for successful SAM implementation?

• conduct a thorough risk assessment

• develop individualised plans with patient and family

• provide training and resources e.g. leaflet and apps

• monitor outcomes and address issues promptly

• encouragement e.g. sticker charts

What is an advanced drug reaction, and what are the 2 types?

An adverse drug reaction (ADR) is a noxious and unintended response to a medicine, where a causal relationship between the medicine and the adverse event is either known or strongly suspected.

could be mild-severe or life-threatening

A = dose related, B = allergic reactions

ADRs vs side effects

• ADRs: Harmful, unintended responses to a drug that occur at normal doses. They are typically classified based on their mechanism (e.g., Type A - dose-dependent, Type B - unpredictable).

• ADRs can range from mild to life-threatening and may require medical intervention.

• ADRs can be unpredictable, particularly Type B reactions (e.g., allergic reactions).

• ADRs are more significant in regulatory reporting and patient safety as they can lead to drug withdrawals or warning

• Side Effects: Unintended effects of a drug that occur at normal doses but are not necessarily harmful. They may be predictable.

• Side effects are usually mild and do not always require stopping the drug

• Side effects are often predictable and based on the drug’s pharmacology

• Side effects are typically expected and listed in drug information leaflets

Why are children more vulnerable to ADRs?

• Immature liver and kidney function affecting drug metabolism and excretion.

• Differences in enzyme activity leading to variations in drug efficacy and toxicity.

• Weight-based dosing challenges.

• Limited clinical trials in paediatrics leading to gaps in drug safety knowledge

Common ADRs in children

• allergic reactions e.g. anaphylaxis, rashes

• GI effects e.g. nausea, vomiting and diarrhoea

• CNS effects e.g. drowsiness, agitation, seizures

• haematological effects e.g. thrombocytopenia, neutropenia

High risk medications for ADRs

• antibiotics e.g. penicillin, cephalosporins - risk of hypersensitivity reactions

• opioids and analgesics e.g. respiratory depression with morphine

• anticonvulsants e.g. sodium valproate - risk of hepatotoxicity, Stevens-Johnson syndrome

• chemotherapeutic agents e.g. risk of bone marrow suppression and organ toxicity

How to recognise and assess for ADRs?

• regularly assess vital signs and symptoms for potential ADRs - early recognition is important

• gain a through medication history to identify potential ADR risks including: current and past meds, allergies and previous ADRs, polypharmacy, any recent changes to meds

• inform patients of any side effects and when to seek help

How to classify ADRs as mild moderate severe or delayed?

Mild = nausea, dizziness, headaches, mild rashes

Moderate = diarrhoea, significant drowsiness, hypotension, minor bleeding

Severe = anaphylaxis, severe rashes (e.g. Stevens-Johnson syndrome), organ toxicity (hepatoxicity, nephrotoxicity)

Delayed = conditions affecting the blood (e.g. anaemia, thrombocytopenia), long term organ damage, carcinogenic effects

Management of mild/moderate ADRs

• immediate actions: stop the medication if necessary and put in place any interventions required e.g. antiemetics, antihistamines

• remember A-E

• communicate - inform prescriber, doctors and pharmacist

• provide support, reassurance and education to the CYP and their family

• close observation to look out for worsening symptoms

• consider lowering the dose of medication or switching to an alternative

Pathophysiology of anaphylaxis

On first exposure the allergen stimulates B cells to produce IgE antibodies which bind to the surface of mast cells and basophils “priming” them

On subsequent exposure, the allergen binds to IgE antibodies on these, triggering a huge histamine release from these cells.

Leads to vasodilation, increased vascular permeability and bronchoconstriction

Systemic effects of anaphylaxis (CVD, resp, GI, skin+mucous)

Cardiovascular - vasodilation (hypotension and shock due to fluid leakage into tissues), tachycardia and arrhythmias (due to compensatory adrenaline release)

Resp - bronchoconstriction (airway narrowing, wheezing and distress), mucosal oedema (swelling of airway leading to laryngeal obstruction)

GI - smooth muscle contraction (abdo pain, vomiting and diarrhoea)

Skin and mucous membranes - urticaria (hives) and angioedema (due to increase cap permeability)

Management of anaphylaxis

• Immediate IM adrenaline

• Oxygen and IV fluids to maintain O2 and BP

• continuous monitoring for biphasic reactions

• Meds such as antihistamines, corticosteroids, beta-2 agonists

• crash bell, crash trolley, A-E, inform PA, Dr, pharmacist

• document in notes, datex, and yellow card reporting

• reassure CYP and family

What is the yellow card scheme?

• national reporting system for ADRs run by MHRA

• encourages HCPs, patients and caregivers to report ADRs to improve drug safety monitoring

What is covert administration?

The practice of administering medication to a patient without their knowledge, typically disguised in food or drink.

For children and young people under 16, this practice may be considered when the child refuses essential medication and lacks capacity to make informed decisions

Legal frameworks to consider for covert administration

For those over 16 years:

• Mental Capacity Act (2005)- Ensures decisions are made in the patient's best interests if they lack capacity.

For those under 16 years:

• Gillick competence- a child/young person can consent to their treatment if they have sufficient understanding and intelligence to appreciate what it involves. If not Gillick competent, decisions are made by parents/guardians in the child’s best interests.

• The Children Act (1989)- requires actions to prioritise the child’s welfare as the paramount concern.

• NMC Code (2018)- Uphold professional accountability and ethical standards

Ethical considerations for covert administration

• Balancing beneficence and non-maleficence.

• Respect for developing autonomy- children/young people should have the opportunity to engage the child in discussions about their treatment.

• Parental responsibility- parents (or legal guardians) can provide consent for a child who lacks capacity

• Best interests- consider the short- and long-term benefits for the child’s health and wellbeing

DM for covert administration in over and under 16s

Over 16s

• assess capacity

• convene a best interests meeting

• document decisions

Under 16s

• assess competence

• consult parents/guardians if the child is not competent or refuses medication

• engage the MDT

• document decisions and discussions and strategies attempted

Challenges of covert administration in practice

• Navigating ethical dilemmas and ensuring the best interest's principle is upheld.

• Conflicts between parents wishes and healthcare professionals recommendations

• The emotional impact of refusal and covert administration on the child/young person, family and healthcare professionals

• Cultural/religious beliefs may influence decisions

• Medication efficacy needs to be considered

• Staff may need training to administer medication correctly

• Hospitals, schools and home settings needs to align their approaches to avoid errors

Strategies to overcome challenges of covert administration

• promote shared DM - use appropriate communication and work with parents

• ensure legal compliance - follow MCA or Gillick to assess capacity, seek support from safeguarding if parental disagreements or concerns, keep reviewing and document

• clinical and safety concerns - consult pharmacist, implement clear protocols, minimise deception, support wellbeing

• practical challenges - standardised training, use behavioural strategies e.g. rewards

• MDT oversight - involve everyone in DM, review to assess if needed

What to remember when doing covert administration?

• Should only be considered when all other methods have been explored and have failed.

• Ensure the decision aligns with the child/young person’s best interests

• Follow pharmacist recommendations to avoid altering medication efficacy

• Ensure all are aware of the agreed upon method to prevent errors

• Monitor for ADRs

• Regularly assess the need for covert administration of med

Step down plan from covert administration

• Schedule periodic reviews to assess whether covert administration is still necessary

• Work towards open administration- involve the CYP in medication discussions if appropriate

• Develop a tailored step-down plan (small realistic goals)

• Gradual exposure and reduced concealment

• Encourage independence with medication

• Gradually shift towards open exposure

• Transition to full awareness

• At all times, monitor for emotional and behavioural responses