Medication Management

Author:	Jono Erodotou
Responsibility:	All Staff
Effective Date:	01 June 2024
Review Date:	30th May 2025
Approved By:
Version Number:	01

Amendment / Review History #

Date	Author	Comments
12/09/2024	J Erodotou	Spelling and Grammar issues IR1 link added to stock loss or damage Changes to CD drugs

Introduction #

K4 Medical Services has statutory duties under the Human Medicines Regulations 2012 (HMR) in relation to the procurement, storage and administration of medications.

Purpose #

The purpose of this policy is to:

• To minimise the risk to patients through issues to medication and administration.
• To describe the mitigations in place within the company to reduce the risk of medication errors.
• To describe the process in place in case of medication errors.
• To describe the process and risk categorisation around the introduction or removal of medication from use within the company.
• To details the medications used within the company, with their prescribed presentations, storage, usage, and associated scope of practice.
• To describe the systems for the management, availability, storage, stocking and disposal of medicinal products used within the company.
• To describe the system in place for the safe custody of controlled medications.

Definitions #

Abbreviation	Meaning
PGD	Patient Group Direction
EDD	Emergency Drug Directive
S17	https://www.legislation.gov.uk/uksi/2012/1916/schedule/17/made
S19	https://www.legislation.gov.uk/uksi/2012/1916/schedule/19/made
ALS	Persons who holds the Advanced Life Support
GLS	General Sales List
P	Pharmacy Medicine
POM	Prescription-only Medicine
CD	Control Drugs
MSL	Minimum Available Stock for Dispensing

Responsibilities #

Operational Manager

Within the scope of this policy, the Operation Manager is responsible for the following:

• Making sure the policy is updated.
• Making sure all clinical staff are following the policy.
• Supporting the Medical Director, Clinical Manager within the roles of this policy. 

 

Medical Director (Doctor)

Within the scope of this policy, the Medical Director is responsible for the following:

• Overseeing the safe use of medicines used within the company.
• Reviewing the clinical audit.
• Writing letters of authorisation to the approved pharmacy suppliers.
• Providing input into Clinical Directives, PDG and EDD

 

Clinical Manager

Within the scope of this policy, the Clinical Manager is responsible for the following:

• Audit and oversee that medications are administered safely and effectively.
• Ensure that medicines are administered for the benefit of the patient.
• Ensure the suite of medicines available within the company is appropriate and suitable for the work the company carries out.
• Defining and listing the minimum stock level each grade of meds bags should include.
• Ensuring that the stock list is current with national guidelines and industry best practices.
• Overseeing the process to validate the skills, knowledge and competence of each individual who is expected to administer medication

 

Pharmacy Advisor

Within the scope of this policy, the Pharmacy Advisor is responsible for the following:

• To support the Medical Director and Clinical Manager with this policy giving advice and support.

 

Clinical Personnel

Within the scope of this policy, the Clinical Personnel is responsible for the following:

•  Ensuring they are adequately trained, skilled, competent and authorised to administer medications.
• Only administer medications when clinically indicated.
• Seek consent of the patient or parent or guardian (as appropriate before administering medications.
• Administer medications with regard to the rights of medicine administration.
• Report any Adverse Events / Near Misses with medications.

Pre-Administration #

Authorisation
The company has a signed agreement with a GMC Registered Doctor to write a letter of authorisation for using specified listed medications. This agreement has a 12 month life span.

Suppliers
The company has agreement with Wells Medical and Lynam Pharma to procure authorised medicines as approved by the Medical Director.

Ordering
Only nominated individuals are approved to order medications from our approved supplier. The nominated individuals are Ops Manager and Office Manager.
Before ordering any medication, we will we sure the following:

• The Specified MSL for that medication is met.
• Ensure there is sufficient medication to meet any expected surge in service demand.
• Ensure they are sufficient medications to replenish any stock that will soon go out of date.
• Ensure that the medications ordered match the concentration and presentation of that authorised by the Medical Director.

In some instances where ideal storage cannot be met and within manufacturers specifications, a modified Expiry Sticker should be attached. E.g. Glucagon

Image needed

Medicine Shortages #

It is recognised that at times, the company may be unable to procure specific medicines due to manufacturer issues, supply chain issues, or an increase in demand meaning supplies are prioritized to higher priority organisations, users or patients. In such instances, the company will employ the following steps to firstly try to remedy the shortage or mitigate the effect on the clinical services the company provides. The company will operate a risk-based approach to managing shortages.

Remedy

• The company will maintain more than on pharmacy/medicine supplier.
• The company will carry out periodic demand forecasting, using historical data to help identify possible future trends and usage.
• The company will carry a small amount of stock to allow for an approx. 5 days buffer with normal usage for each individual medicine.
• Where a manufacturer shortage has been notified to the national medicine regulator, the company may, under the direction of the medical director, maintain expired medicine until in-date medicine can be provided. This will be by exception only and is dependent on the possible effect on patient care, where a medicine is unavailable.

Mitigate

Where it is not suitable to continue to carry an out-of-date medicine, or the resupply date that has been notified to the national regulator is for far in the future that it is expected it may impact patient care the company may;

•  Reduce the stock level of medicines normally held in bags to spread the available quantity over all medicine bags.
• Remove medicines from medicine bags, that are to be deployed to events that are historically unlikely to be necessary. For example, naloxone for a school sports day.
• Prioritising specific medicines to clinical levels/grade that may be more dependent on it. For example, naloxone to paramedics who may be administering morphine.
• Prioritising specific events that are expected to have a higher clinical need for a specific medicine. For example, naloxone to a multiday festival with high level of recreational drug use.

Where a mitigation measure has been enacted, the company will circulate a memo detailing the
measures that have been enacted, and how that may manifest for each individual clinical grade.

The risk assessment for the medicine will be included in the memo to demonstrate the rationale for the measures taken.

Temperature Monitoring

Due to the nature of the work carried out by the company, both events and ambulance work, it is foreseeable that there will be temperature excursions in warm or cool weather, steps can be taken pro-actively to minimise their impact.

Ambient Temperature

Most medicines may be stored at temperature up to 25°C, some allow up to 30°C and some medicines have no storage conditions specified by the manufacturer. A single, isolated excursion of less than 5°C above the specified maximum storage temperature for less than 7days is unlikely to have an adverse effect on the medicines.

High Temperatures and Heatwaves

Monitor stock turnover closely; keep stock levels to the minimum and ensure stock is strictly rotated:

For high stock turnover areas, this means that the medicines will only be exposed to high temperatures for a brief time before being used for low stock turnover areas, this means that the minimum quantity of medicines will be affected by the excursion.

A system of manually reducing the expiry date on medicines that are frequently exposed to temperatures a few degrees above their required storage temperature may also be used. Some medicines also have additional information in their SmPCs permitting storage at higher temperatures.

Dispensing / Allocating #

When allocating medication to a bag or container, we will ensure the following:

• That, as far as it is practical, all outer packaging will remain intact.
• Only medications that are applicable to that grade of the bag are added.
• The bag template is adhered to in respect of dose, concentration, presentation and quantity.
• The bag is sealed once the requirements of the template have been met.
• A printout of the bag live stock list is printed and stored with the bag for review by clinical personnel before their shift.
• A security tag is properly affixed to the bag, securing the zips to restrict access.
• The earliest expiry tag is updated with the closest expiry date and the names of the person who sealed the bag.

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Auditing / Checking #

Audits of medicines available for allocation will be carried out monthly. This will ensure that the system stock is always correct. It will also allow for the removal of soon-to-be or out-of-date stock.

Risk Register #

The company maintains a live risk register. Changes to policies, processes, templates, or addition/removal of medicines will require a review of associated risks.

Service Delivery Audit / Needs Analysis #

The company will primarily utilise the latest edition of JRCALC to guide the medicines utilised within the organisation.

Every quarter as part of our clinical audit process, we will examine clinical records to look for opportunities for improvement in terms of service delivery and patient needs.

There is also an opportunity for individual clinicians to feedback about their own experiences within the company and identify opportunities for improvement regarding medicines availability and service delivery.

For specific clinical services, we will proactively examine authorised medicines, available quantities and other associated policies where there is a visible clinical need or specific patient demographic above that which we would normally expect to find in the course of our service delivery.

Administration #

Right of Medication Administration

In order to safely administer medication, the following must all be considered and evaluated.

• Right to Administer – That you are authorised to give the medication.
• Right to Refuse – That the patient has the right to refuse.
• Right Medication – That it is the correct medication.
• Right Patient – That it is the correct patient.
• Right Dose – That the dose is correct.
• Right Time – That the time is correct.
• Right Route – That the route is correct.
• Right Reason – That the reason for administration is correct.
• Right Assessment – That the assessment prior to administration is correct.
• Right Documentation – That full and accurate contemporaneous notes are recorded.
• Right Effect – That the medicine has the desired effect.
• Right Disposal of Medicine Waste – That the clinical and medical waste is properly disposed of.

 

Refusal / Consent

A person has the right to refuse all, some or none of a recommended medication administration, even if this refusal may be deleterious to their health or the health of their unborn baby.

Consent must always be:

• Valid – the patient must consent voluntarily and continually throughout the interaction.
• Informed – the patient must be given the benefits and disbenefits of any action in order to fully understand their decision.
• With capacity – the patient must be capable of understanding the impact of their consent or refusal.
• Of specific duration – consent only lasts for as long as the patient specifies and can be withdrawn at any time.
• Obtained by the person administering – consent is only valid if gained by the person undertaking the action for which consent is required.

 

Refusal / Withholding / Revoking of consent should be clearly documented no the patients report form.

Risk Assessments / Reduction

When considering risk and risk reduction initiatives, we will be mindful of the 12 documented rights of administration. To this end, the company has adopted the following risk-reduction initiatives:

• Well-defined stock templates
• Well-defined scope of practice
• Automatic alerts for soon expiring and expired medications
• Security tags to limit authorised access to medications.
• Colour Coded identity labels to reduce the risk of wrong medication administration

Infusion stickers for when medications are added to fluids

Images of fluid labels

Medication Errors

A medication error is any preventable event that may cause or lead to inappropriate medication use or patientharm while the medication is in the control of the healthcare professional, patient or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labelling, packaging, nomenclature, compounding, dispensing, distribution, administration; education, monitoring; and use.

An error is deemed to have been made if one or more of the following circumstances apply:

• Omissions – any dose not given other than in circumstances where professional judgement has been used.
• Incorrect dose administered
• Unauthorised medicine is given – the administration to a patient of any medicine not indicated for the condition
• Incorrect administration from that specified – administration of a medicine by a different route or in a different form from the specified by the medication formulary.

Any medication error must immediately be reported as per the company Adverse Incident Report Policy. Any near-miss medication error must also be reported.

Post – Administration #

Returns

Any damaged, broken, soiled or medication that is otherwise unsafe for administration must be returned to the office to have its batch number and quantity updated on the system. Such medication should be stored outside of the meds bag to minimise the risk of accidental administration.

Disposal

Medications may only be disposed of, once the stock has arrived back in the office. Once the system has been updated to show the stock has been removed from the bag, it must be either disposed of in the clinical waste or a Medication Return Form filled in and brought to the designated pharmacy for a signed return. The Medication Return Form will be kept for audit and quality control purposes.

Adverse Reactions

All adverse reactions to a medication administration must be reported via the Yellow Card Portal.

Further assessment, intervention and medication administration may be administered in situations where an adverse reaction is present. Good clinical governance would suggest that individuals who suffer from an adverse reaction rather than a known side effect should be seen by a doctor.

Medical Gases #

The responsibility for the administration is no less than that of other medications. Clinical personnel must satisfy themselves that they have properly considered the Rights of the Medication Administration before administering any medical gas.

Storage

Cylinders should only be stored in designated storage areas. Portable cylinders should never be loose in vehicles. Patients requiring oxygen during transport should be connected to the main oxygen system.

Where possible, cylinders of the same gas should be stored together without mixing with other gasses; empty cylinders should always be stored separately from full cylinders.

Intravenous Fluids #

Fluids will be stored in accordance with the manufacturers’ requirements. All bags of fluids will remain in their sterile outer packaging to ensure that the port on the bag is not prematurely exposed. Fluids will be labelled with both expiry labels and Medication Name labels to reduce the risk of administering the wrong medications.

In some instances, it may be necessary to infuse medication into a fluid before it is administered to a patient.

In this instance, the clinician drawing up the infusion should affix an Infusion label to the bag to denote what medication is present in the fluids.

In the event that infusion has not to be administered within 8 hours, it will be discarded.

High-Risk Medications #

Black Triangle

Black Triangle Information

New medicines are intensively monitored to ensure that any new safety hazards are identified promptly. The Commission on Human Medicines (CHM) and the MHRA encourages the reporting of all suspected reactions to newer drugs and vaccines, which are denoted by an inverted Black Triangle symbol (▼).

While it is unlikely that any medications are used within the company during normal day-to-day activities, there may be instances where presenting patients are on prescribed black triangle medicines. Practitioners should not rule out that the patient’s presentation may be a result of a known side effect or adverse reaction to their black triangle medication.

High-Alert Medications

These medications are defined as medications which can cause serious harm if used in error. K4 Medical Services supplies a number of High-Alert medications; these medications are:

• Lidocaine
• Amiodarone
• Midazolam
• Morphine
• Reference: ISMP’s List of High-Alert Medications

 

Look Alike, Sound Alike

• Amiodarone confused with Amantadine
• Epinephrine confused with Ephedrine
• Morphine confused with Hydromorphone
• Naloxone confused with Lanoxin and Nalbuphine
• Diazepam confused with Diltiazem

While these medications are defined as look Alike, Sound Alike Medications, K4 Medical Services does not supply medications that look and sound alike, eliminating the risk of confusion.

This will be assessed every time a new medication is introduced into the service.
Reference: ISMP Confused Drug Names.

Stock Loss / Damage #

Any discrepancy in stock should be recorded on the shift sheet and reported to the office. In the event of any quantity of Controlled Medication is found to be damaged, missing or unaccounted for, the following must be adhered to:

• As soon as a medication is confirmed damaged, lost or missing, the office should be advised by telephone.
• The individual must complete an IR1 as soon as possible (but preferably no later than the end of the shift) https://k4group.jotform.com/info/incident-form
• Identify what happened to cause the loss or damage to the medication and where it happened.
• Secure the name and contact details of any other persons involved or witnessing the event.
• If a medication is damaged, then a picture should be taken of the damage to the ampoule.
• Any suspension, ampule or vial may be denatured in the Doms kits, and the contaminated kit returned to the office at the end of shift for documentation and disposal.

Medication for Personal Use #

Individuals must not take medicines from stock or bags for personal use. Individuals must never self-administer medications. If an individual is sick/unwell, or injured, they should request different clinical personnel to assess and administer medication as appropriate. In all instances, a full patient report form is required.

In an emergency or working alone, staff should call 111 or 999/112 as appropriate.

Patients Own Medicine #

Any medication previously prescribed to the patient that is taken in the presence of K4 Medical Services staff must be documented on the PRF.
Any member of staff that has been appropriately trained may assist a patient in taking their own medication if appropriate to their presenting complaint.

Medication for Resupply of Personal Kit #

Under no circumstances may any individual take medication to replenish their own kit. The company considers this theft and will act accordingly when discovered.

Scheduled & Controlled Medications #

No controlled drugs will be issued to any staff by K4 Medical Services.
Some Paramedics may choose to supply their own controlled drugs, in this case, the Paramedic must provide K4 Medical Services with information on the batch number, expiry date and type of drugs being carried this must be recorded when signing out your drugs bag.
Paramedics that choose to carry their own controlled drugs must keep the drugs in their possession at all times whilst on duty, must be in a portable lockable case.
Any unused controlled drugs must be destroyed in the presence of a witness, and the destruction recorded on the PCR and double signed in the Paramedic drug register.
Paramedics using their own controlled drugs are responsible for their own record keeping, supply, disposal and replenishment of controlled drugs.

Appendix 1 – Approved Medicines List #

Name	Dose	Presentation	Ref
Adrenaline	1:1000	Ampoule	JRCALC
Adrenaline	1:10000	Prefilled	JRCALC
Amiodarone	300mg/10ml	Prefilled	JRCALC
Amiodarone	150mg/3ml	Ampoule	JRCALC
Aspirin	300mg	Tablet	JRCALC
Atrophine Sulfate	1mg/10ml	Prefilled	JRCALC
Benzylpenicillin	600mg	Injection Vial	JRCALC
Chlorphenamine	10mg/1ml	Ampoule	JRCALC
Chlorphenamine	4mg	Tablets	JRCALC
Cetirizine	10mg	Tablets	JRCALC
Diazepam	10mg/2ml	Ampoule	JRCALC
Diazepam	5mg and 10mg	Rectal Tube	JRCALC
Furosemide	50mg/5ml	Ampoule	JRCALC
Glucagon	1mg	Vial	JRCALC
Glucose 10%	500ml	Solution	JRCALC
Glucose 40%	25ml	Plastic Gel	JRCALC
Glyceryl Trinitrate	400 micrograms	Sublingual Spray	JRCALC
Heparin	5000units per ml	Ampoule	JRCALC
Hydrocortosine	100mg/1ml	Injection Vial	JRCALC
Ibuprofen	100mg/5ml	Solution	JRCALC
Ibuprofen	200mg and 400mg	Tablets	JRCALC
Ipratropium Bromide	250mcg/1ml and 500mcg/2ml	Nebuliser Liquid	JRCALC
Magnesium Sulfate	2g/10mls	Ampoule	JRCALC
Metoclopramide	10mg/2ml	Ampoule	JRCALC
Morphine	10mg/1ml	Ampoule	JRCALC
Naloxone	400mcg/1ml	Ampoule	JRCALC
Entonox	1ml per 1ml	Gas	JRCALC
Ondansetron	2mg/2ml	Ampoule	JRCALC
Oxygen		Gas	JRCALC
Paracetamol	1000mg/100ml	Solution	JRCALC
Paracetamol	500mg	Tablets	JRCALC
Paracetamol	120ml/5ml and 250ml/5ml	Solution	JRCALC
Methoxyflurance	3ml	Vial	JRCALC
Salbutamol	2.5mg/2.5ml	Nebuliser Liquid	JRCALC
Sodium Chloride 0.9%	10ml	Pre Filled	JRCALC
Sodium Chloride 0.9%	250ml and 500ml	Solution	JRCALC
Sodium Lactate Compound	250ml	Solution	JRCALC
Syntometrine	5units/1ml	Ampoule	JRCALC
Tenecteplase	10000units	Vials	JRCALC
Tranexamic Acid	500mg/5ml	Ampoule	JRCALC
Water For Injection	10ml	Ampoule	JRCALC

Appendix 2 – Approved Medicines List #