Good practice for the preparation of injectable medicines in clinical areas

A step-by-step guide for nurses, doctors and all

other healthcare professionals who prepare and

administer injections

Baxter Healthcare Ltd, Wallingford Road, Compton, Berkshire, RG20 7QW.

Baxter is a trademark of Baxter International Inc. © Copyright (July 2006), Baxter Healthcare Corporation. All rights managed.

Further readingDougherty L and Lister S (Eds). The Royal Marsden Hospital Manual of Clinical Nursing Procedures (6th edition), Blackwell Publishing, Oxford, 2004.

NMC standards for medicines management (2008).

RCN Standards for Infusion Therapy (2005), RCN, London

If you would like to know more about how Baxter can help you, contact: pharmacy_services@baxter.com

Baxter Healthcare Ltd:Pharmacy Services, Hospital Products,Wallingford Road, Compton, Newbury,Berkshire RG20 7QW.

Tel: 01635 206 060Fax: 0870 850 7075email: pharmacy_services@baxter.comwww.baxterhealthcare.co.uk

Surecall – Baxter Medical Information:Clinical and technical information at the speed you need – supporting the optimum use of Baxter products for patients.

Tel: 01635 206 345Fax: 01635 206 071email: surecall@baxter.com

Pharmacyservices

UK

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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Any adverse events relating to Baxter products can also be reported direct to Baxter Pharmacovigilance on 01635 206360, or by email to vigilanceuk@baxter.com

32

IntroductionIncreasing numbers of medicines are being prepared and given by healthcare professionals in clinical areas. There are risks associated with these procedures, partly due to lack of essential information about injectable medicines.

The aim of this guide is to inform healthcare professionals involved in the preparation of medicines, how to safely prepare injectables. It is based on the template standard operating procedures for prescribing, preparing and administering injectable medicines in clinical areas. These are outlined in the National Patient Safety Agency (NPSA) patient safety alert 20: promoting safer use of injectable medicines, 28 March 2007.*

We should do everything possible to make sure “that the right drug is given – in the right dose, by the right route, by the right person, to the right patient and at the right time.”1

The objective of this guide is to provide clear step-by-step guidelines that healthcare professionals can use, in conjunction with their own policies and procedures, to minimise these risks. It can be used as part of a training process and subsequently as a practical reminder of good IV practice.

All injections should be prepared by following the NPSA patient safety alert 20, manufacturer’s product information, local guidelines and the relevant guidance in this booklet.

We hope that you find this guide useful and we will be evaluating its usefulness through our clinical nurse teams in the near future. However, if you have any comments, we would like to hear from you at pharmacy_services@baxter.com

“Ensure there are up-to-date protocols and procedures for prescribing, preparing and administering injectable medicines in all clinical areas.”NPSA patient safety alert 20.

Reference: 1 Bates DW et al. Consensus development conference statement on the safety of intravenous drug delivery systems: balancing safety and cost. Hospital Pharmacy. 2000; 35:150–155

Contents Page

Page

General preparation 4

Withdrawing solution from 6 an ampoule (glass or plastic) into a syringe

Withdrawing solution or 7 suspension from a vial into a syringe

Reconstituting powder 8 in a vial, drawing the resulting solution/suspension into a syringe

Adding a medicine 9 to an infusion bag

Diluting a medicine in 10 a syringe for use in a pump or syringe driver

Reconstituting powder or 11 solution in a vial using a reconstitution device to be administered by infusion

Adding a drug to a bag with 12 integral reconstitution device

Adding a drug to a bag 13 using a vial with integrated transfer device

Using ready-to- 14 administer bags

Labelling injection 14 and infusion containers

Checks to be made before 15 administering any injection

Further reading 16

or

* Note that the NPSA is now part of NHS England.

54

Confirm the prescription relates to the patient being treated. Check the patient is ready to have the medication. There may be a written instruction, such as a Patient Group Direction.

Wash hands thoroughly according to local policy. Put on a pair of disposable gloves.

Avoid touching areas where bacterial contamination may be introduced e.g. additive port, syringe-tips, needles, vial tops. Never put down a syringe attached to an unsheathed needle.

Disinfect a plastic tray with a 70% alcohol wipe or spray. Peel open wrappers on syringes and needles carefully. Arrange all ampoules/vials, syringes and needles neatly in the tray.

Assemble sharps bin, medicine ampoule(s)/vial(s), diluent, syringe(s), 21g, 23g, 25g needle(s), alcohol wipes, disposable protective gloves, clean re-usable plastic tray. Check product expiry dates and packaging, and read their labels carefully. Also check that products were stored correctly (e.g. in a refrigerator). Prepare a label for the prepared medicine (see page 14).

• The formulation, dose, diluent, infusion fluid and rate of administration correspond to the prescription and product information

• The patient has no known allergy to the medicine

• You understand the method of preparation

Calculate the volume of medicine solution required, write it down and get it checked by another qualified person.

Area should be clean, uncluttered and as free from interruptions and distractions as possible.

Also follow manufacturer’s product information or local guidelines.

General preparationThe basic steps that should be followed before any injection or infusion procedure is started:

1 5

7

6

3 4

2

8

Read the prescription carefully Wash your hands

Use a non-touch technique

Prepare plastic tray and products

Assemble everything you need Check that:

Clean preparation area

Prepare the injectable medicine using one of the following step-by-step procedures

76

Note: The vial(s) and any unused medicine should be kept until administration to the patient is complete.

Withdrawing solution or suspension from a vial into a syringeWithdrawing solution from an ampoule (glass or plastic) into a syringe

Remove tamper-evident seal from vial. Wipe rubber septum with an alcohol wipe. Allow to dry for at least 30 seconds.

1

Tap the ampoule gently to dislodge any medicine in the neck. Snap open neck of the glass ampoules, using an ampoule snapper if required.

1

Attach the prepared label to the syringe.

5

Keep the ampoule and any unused medicine until administration is complete.

6

Attach a needle to a syringe.* Draw required volume of solution into the syringe. Tilt the ampoule if necessary.

2

If the ampoule contains a suspension rather than a solution, it should be gently swirled to mix the contents immediately before they are drawn into the syringe.

3

Invert the syringe and tap lightly to aggregate the air bubbles at the needle end. Expel the air carefully. Fit a new needle or sterile blind hub.

4

If a large volume of solution is to be withdrawn use a push-pull technique: repeatedly inject small volumes of air and draw up an equal volume of solution until the required total is reached. This ‘equilibrium method’ helps to minimise the build-up of pressure in the vial.

6

With the needle sheathed, draw into the syringe a volume of air equivalent to the volume of solution to be drawn up.

2

Alternatively, pierce rubber septum with a second needle to let air into the vial as solution is withdrawn. The tip of the vent needle must be kept above the solution to prevent leakage.

7

Remove the needle cover and insert the needle into the vial through the rubber septum.

3

With the vial still attached, invert the syringe. With the needle and vial uppermost, tap the syringe lightly to aggregate the air bubbles at the needle end.

8

Invert the vial. Keep the needle in the solution. Slowly depress plunger to push air into the vial. Release the plunger so that solution flows back into the syringe.

4

Push the air back into the vial. Fill the syringe with the required volume of solution then draw in a small volume of air. Withdraw the needle from the vial.

9

If the vial contains a suspension rather than a solution, it should be gently swirled to mix the contents, immediately before they are drawn into the syringe.

5

Expel excess air from the syringe. Remove the needle and exchange it for a new needle or a sterile blind hub. Attach the prepared label to the syringe.

10

Note: The neck of some plastic ampoules is designed to connect directly to a syringe without the use of a needle, after the top of the ampoule has been twisted off. This is easier with a luer slip syringe and there is less chance of contamination.

* Your local policy should be referred to as some organisations may advocate the use of filter straws or filter needles when drawing from glass ampoules.

98

Remove tamper-evident seal from the vial and wipe the rubber septum with an alcohol wipe. Allow to dry for at least 30 seconds.

1

Prepare the medicine in a syringe using one of the previously described methods.

1

Use the procedure on page 6 to withdraw the required volume of diluent (e.g. water for injections or sodium chloride 0.9%) from ampoule(s) into the syringe.

2

Check wrapper of the bag is undamaged. Remove wrapper and check the bag itself in good light. It should be intact and free of cracks, punctures/leaks. Check infusion solution is free of haziness, particles and discolouration.

2

Inject the diluent into the vial. Keeping the tip of the needle above the level of the solution in the vial, release the plunger. The syringe will fill with the air that has been displaced by the solution, (if the contents of the vial were packed under a vacuum, solution will be drawn into the vial and no air will be displaced).

3

Remove the tamper-evident seal on additive port or wipe rubber septum on the bag with an alcohol wipe. Allow to dry for at least 30 seconds. Lay the bag flat on a clean surface.

3

If a large volume of diluent is to be added, use a push-pull technique (see procedure on page 7).

4

If volume of medicine to be added is more than 10% of the initial contents of the bag, e.g. more than 50ml to a 500ml or 100ml to a 1 litre infusion, an equivalent volume must first be removed with a syringe and needle.

4

Note: If a purpose-designed reconstitution device is used, the manufacturer’s instructions should be read carefully and followed closely.

Note: Do not add anything to any infusion container other than a burette when it is hanging on the infusion stand since this makes adequate mixing impossible.

Before adding a medicine to a hanging burette, administration must be stopped. After the addition has been made and before administration is re-started, the contents of the burette must be carefully swirled to ensure complete mixing.

With the syringe and needle still in place, gently swirl the vial to dissolve all the powder, unless otherwise indicated by the product information. This may take several minutes.

5

Inject the medicine into the bag through the centre of the injection port. Keep the tip of the needle away from the side of the bag!

5

Follow the relevant steps in the procedure on page 7 to withdraw the required volume of solution from the vial into the syringe.

6

Withdraw the needle. Invert the container at least five times to ensure thorough mixing before starting the infusion.

6

Alternatively, the rubber septum may be pierced with a second needle to let air into the vial as solution is withdrawn. The tip of the vent needle must always be kept above the solution to prevent leakage (see the procedure on page 7).

5

Check the appearance for absence of particles, cloudiness or discolouration. Attach the prepared label to the bag.

5

Attach the prepared label to the syringe.

6

Reconstituting powder in a vial, drawing the resulting solution/suspension into a syringe Adding a medicine to an infusion bag

1110

Prepare the medicine in a syringe using one of the previously described methods.

1

Draw the diluent into the syringe to be used for administration by the pump or syringe driver. Draw in some air (slightly more than the volume of medicine needed) and remove the needle.

2

Stand the diluent syringe upright. Insert the needle of the syringe containing the medicine into the tip of the diluent (administration) syringe and add the medicine to it.

3

Alternatively, a disposable sterile connector may be used to connect two syringes together directly.

4

Note: Check that the rate of administration is set correctly on the device before fitting the syringe, priming the administration set and starting the infusion device.

Check that:• The total volume of injection solution

in the syringe is as specified in the prescription and that the infusion can be delivered at the prescribed rate by the administration device chosen

• The rate of administration is set correctly on the administration device and according to the manufacturer’s instructions

5

Fit a blind hub to the administration syringe. Invert several times to mix the contents.

6

Remove the blind hub. Tap syringe lightly to aggregate the air bubbles at the needle end. Expel the air and refit the blind hub.

5

Carefully check the syringe for cracks and leaks and then label it, noting the requirements specific to syringe drivers.

6

Diluting a medicine in a syringe for use in a pump or syringe driver

Squeeze bag to fill half of the drug vial with diluent.

6

Remove tamper-evident seal from vial. Wipe the rubber septum with an alcohol wipe. Allow to dry for at least 30 seconds.

2

Swirl vial gently to mix and check the appearance.

7

Open the outer wrapper of the reconstitution device, leave the device in its opened outer wrapper.

3

Invert vial/bag assembly. Squeeze the bag to allow the dissolved medicine to go back into the diluent bag. Remove the reconstitution device with vial.

8

Connect the reconstitution device to the drug vial, without removing the outer wrapper from the part of the device to be connected to the bag.

4

Shake bag gently to mix. Check the appearance for absence of particles, cloudiness or discolouration.

9

Remove the outer wrapper from the device and connect the device into the bag port.

5

Cover the additive port of the bag with a cap. Attach the prepared label to the bag.

10

Reconstituting powder or solution in a vial using a reconstitution device for administration by infusion

Remove wrapper from bag. Remove the tamper-evident seal on the additive port or wipe the rubber septum on the infusion container with an alcohol wipe. Allow to dry for at least 30 seconds.

1

1312

Remove tamper-evident seal from the vial. Wipe the rubber septum with an alcohol wipe. Allow to dry for at least 30 seconds.

1

Peel back the foil cover from the end of the reconstitution device.

2

Push the adaptor firmly down onto the vial until a clear “snap” is heard. The vial is now safely pierced.

3

Bend the frangible connector up and down to break the seal.

4

Note: Do not detach vial from reconstitution device at any time.

Squeeze the fluid into the vial until half full. Shake to dissolve the drug.

5

Invert and squeeze air into the vial to displace fluid back into the bag.

6

Shake bag gently to mix products. Check the appearance for absence of particles, cloudiness or discolouration.

5

Attach the prepared label to the bag.

6

Adding a drug to a bag with integral reconstitution device

Note: Do not detach vial from reconstitution device at any time.

Adding a drug to a bag using a vial with integrated transfer device

Remove cap from vial.

1

Swirl vial gently to mix and check the appearance.

6

Invert vial/bag assembly, squeezing bag to transfer medicine back into the bag.

The vial remains permanently attached, showing clearly the drug being administered.

7

Connect device to bag.

3

Shake bag gently to mix products. Check the appearance for absence of particles, cloudiness or discolouration.

8

Push down the transparent mobile part of the device to activate the system.

4

Attach the prepared label to the bag.

9

Squeeze the diluent bag to fill half of the vial with diluent.

5

Remove the wrapper from the infusion bag. Remove the tamper-evident seal on the additive port or wipe the rubber septum on the infusion container with an alcohol wipe. Allow to dry for at least 30 seconds.

2

1514

• Check the medicine is due for administration and has not already been given

• Assemble everything you need including flushing solution(s)

• Explain and discuss the procedure with the patient

• Check appearance of infusion already in progress

• Check that an appropriate access device is in place. Flush it immediately before and after administration of a medicine and between doses of different medicines administered consecutively, according to local policy

• Check the administration site for signs of leakage, infection or inflammation

If any question arises; do not hesitate to contact the pharmacist or healthcare practitioner who ordered the medication for more information.

Check wrapper of the bag is undamaged. Remove wrapper and check the bag itself in good light. It should be intact and free of cracks and punctures/leaks.

1

All injections, including medicines and flushes, should be labelled immediately after preparation. The only exceptions are syringes intended for immediate push (bolus) administration when they have not left the hands of the person who prepared them between preparation and administration.

There should never be more than one unlabelled syringe in a tray at any one time, nor must an unlabelled syringe be fitted to a syringe driver or similar device.

‘Flag labelling’ should be used to make sure that the volume gradients on syringes are not obscured.

Labels used on injectable medicines prepared in clinical areas should contain the following information:

• The patient’s name

• Name of the medicine

• Strength

• Route of administration

• Diluent

• Final volume

• Expiry date and time

• Name of the practitioner preparing the medicine

Place the final syringe or infusion and the empty ampoule(s)/vial(s) in a clean plastic tray for transport with the prescription to the bedside for administration.

Check infusion solution is free of haziness, particles and discolouration.

2

Using ready-to-administer bags

Labelling injection and infusion containers

Confirm that the prescription relates to the patient being treated by checking all of the following:

3 Full name

3 Address

3 Date of birth

3 Hospital number

3 NHS number

Then re-check all the following:

3 Prescriber’s signature

3 The approved medicine name

3 The dose and frequency of administration

3 The date and route of administration

3 The allergy status of the patient

Also check, where relevant:

3 Brand name and formulation of the medicine

3 Concentration or total quantity of medicine in the final infusion container or syringe

3 Name and volume of diluent and/or infusion fluid

3 Rate and duration of administration

3 Type of rate-control pump or device(s) to be used

3 The age and weight of any patient under 16 years of age

3 Date on which treatment should be reviewed

Checks to be made before administering any injection