#NPPG2016. ENFit syringes. Andrew Wignell, Paediatric Pharmacist, Nottingham University Hospitals

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1 #NPPG2016 ENFit syringes Andrew Wignell, Paediatric Pharmacist, Nottingham University Hospitals

2 ENFit Syringes Andrew Wignell

3 Objectives Describe the background to the changes in productswhat are the drivers, and what equipment is available. Allow discussion of the potential risks and challenges when implementing the new equipment. Understanding the risks, start to formulate solutions for implementation in individual Trusts. NUH Pharmacy

4 Overview Background Risks Possible Solutions Checklist for Implementation Advice from elsewhere. NUH Pharmacy

5 What I can t do.. Pretend that there is a perfect solution.or that the situation is ideal.! However, centres have managed to implement with few issues, so this should be reassuring. NUH Pharmacy

6 Background What national publications have there been around wrong route (enteral vs. IV) errors?

7 Background Key requirement that enteral feeding tubes and enteral syringes are of such a design, that they cannot not physically be connected to IV syringes and catheters respectively UK changed to using reverse luer lock devices to prevent misconnection, and enteral syringes (and associated equipment) became purple in colour to make them visibly different to IV syringes.

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9 International Standardisation New standard design of syringe-to-feeding-tube connector, known as ENFit has been adopted by all manufacturers of enteral feeding tubes and syringes internationally. Products have been available on the UK market since July A wide range of ENFit compatible equipment is now available, including: Feeding Tubes Syringes Feed giving sets Bottle adaptors, or bungs. Quills, or filter straws. Adaptors, allowing the connection of ENFit syringes and giving sets to existing gastrostomy tubes.

10 Safety of ENFit Syringes for Administering Medicines Due to the relatively large hub on the end of the ENFit syringes, there is a risk of inaccurate dosing. Current syringes have been modified from earlier designs to reduce the volume of the hub. Risk of inaccurate dosing has therefore been reduced, but has not been removed completely. Significance of risk is dependant upon several factors, including: 1. Volume of medicine dose being administered. 2. Size/type of syringe. 3. Other equipment used, e.g. bottle adaptors, quills etc. 4. Route of administration: oral vs. enteral tube.

11 Risk of Medicine Overdose Looking at the syringe tips in each of the scenarios given below, will the dose administered to the patient be accurate?

12 Risk of Medicine Overdose Looking at the syringe tips in each of the scenarios given below, will the dose administered to the patient be accurate?

13 Risk of Medicine Overdose If the hub is left full before oral administration and is still full after administration, the correct dose will have been given. If the hub is left full before oral administration but is empty after administration (due to sucking) overdose of about 0.2mL will have been given. If the hub is empty before administration (drawn up from a bottle adaptor or using a medicine straw) and full after administration then an under dose of 0.2ml will have been given. If the hub is empty before administration but is empty after administration (due to sucking) then the correct dose will have been given.

14 Standard Syringes Syringes 5ml and above have a large hub at the end which holds a volume of about 0.2mL. An under or overdose of 0.2mL for any dose above 2.5mL is unlikely to be of any clinical significance, but consistency of use should nonetheless be advised.

15 Low Dose Syringes Due to the large hub at the end, standard syringes are not appropriate for the delivery of small doses (particularly under 1mL). Low-dose syringes are available, primarily 1mL and 2.5mL and 3mL syringes. Each company has a slightly different design, but they are all similar this: Risk of significant drug overdose if used incorrectly, due to the presence of an outer moat, or deadspace on the tip of the syringe. The volume of the outer moat varies according to manufacturer and syringe size, but may be as much as 0.025mL (25% error on a dose of 0.1mL).

16 Low Dose Syringes Low dose syringes can be used orally, though the syringe necks and wings are larger than those on other syringes. May be an issue in particular patient groups e.g. cleft lip and palate patients, neonates etc. Low dose syringes will deliver accurate low doses orally, providing the outside hub has been cleared of fluid before administration.

17 Low Dose Syringes Some of the syringes available are manufactured in two parts, and there are reports of the tips snapping off. The affected syringes are being redesigned to be manufactured as one unit. However, the two-part syringes could be in circulation for some time. There is a theoretical choking risk if the two-part syringes are used orally, but snapping is much more likely to happen when connecting/disconnecting from a tube. Risk can be mitigated by holding hub of syringe when connecting/disconnecting rather than twisting the whole syringe.

18 Administering Medicines- Options Appraisal Discussion: What are the advantages and disadvantages of the following approaches? 1. Using a Bottle Adaptor. 2. Using a medicine Straw or blunt filter needle 3. Decanting medicine into medicine pot, then flicking. 4. Drawing up directly from the bottle, then flicking.

19 Using a Bottle Adaptor. Advantages Moat will be empty after medicine has been drawn up, removing the risk of overdose. Syringe does not come into contact with the liquid in the bottle, reducing the risk of cross contamination if an individual syringe is used for multiple doses. If used routinely, bottle adaptors may further prevent the risk of a wrongroute never event by preventing the drawing up of a medicine into an IV syringe. Although it depends on the manufacturer, many bottle adaptors can be left in situ until the bottle is empty, or at least for multiple doses. Disadvantages It may not be possible to obtain a bottle adaptor to fit all medicine bottles. If using crushed tablets the liquid will be in an open container not a bottle Some adaptors do not allow the original Child Proof bottle cap to be replaced over the top. This can lead to leaking of medicine, particularly during transit and risks a child gaining access to a medicine. ENFit Bottle adaptors are NOT compatible with oral syringes, meaning that drawing up doses from the same bottle using an oral syringe is not possible. Cost of adaptors, in addition to syringe costs.

20 Using a medicine Straw or Blunt filter needle Advantages Moat will be empty after medicine has been drawn up, removing the risk of overdose. Syringe does not come into contact with the liquid in the bottle, reducing the risk of cross contamination if an individual syringe is used for multiple doses. Filter straws could also be used for oral administration, once attached to the syringe, and may be preferable to the LD tip in some situations. Due to the high negative pressure in a filter straw attached to an empty syringe, it is unlikely that a patient will be able to suck out the contents of the tube, so the risk of inadvertent overdose by this method is low. Disadvantages Routine use of filter straws or quills is likely to increase medicines wastage due to drug adherence to the tubing. This may be most problematic with controlled drugs. Cost of medicines straws, in addition to syringe costs, particularly given they are only appropriate for single use. Potentially a less robust physical barrier to the use of an IV syringe to draw up an oral dose than a bottle adaptor: IV filter straws are also available plus individual drawing needs to remember to use the medicine straw

21 Decanting medicine into medicine pot, then flicking Advantages Syringe does not come into contact with the liquid in the bottle, reducing the risk of cross contamination if an individual syringe is used for multiple doses. Reduced costs for equipment needed. Removes the need for duplicate supply of each stock medicine (one with an ORAL medicines bottle adapter and one with an ENFit medicines bottle adapter) Disadvantages Person administering medicine may forget to flick the syringe and administer a wrong dose. Potential for occupational exposure to medicines through flicking of syringe. This may be especially significant with more toxic drugs. Potential for increased wastage of medicine. Does not prevent the use of an IV syringe to draw up an oral dose.

22 Drawing up directly from the bottle, then flicking. Advantages May not be possible if not much liquid in the bottle. Reduced costs for equipment needed. Removes the need for duplicate supply of each stock medicine (one with an ORAL medicines bottle adapter and one with an ENFit medicines bottle adapter) Disadvantages Person administering medicine may forget to flick the syringe and administer a wrong dose. Potential for occupational exposure to medicines through flicking of syringe. This may be especially significant with more toxic drugs. Potential for increased wastage of medicine. Does not prevent the use of an IV syringe to draw up an oral dose. Syringe comes into contact with the liquid in the bottle, so potential cross contamination if an individual syringe is used for multiple doses.

23 What are other Centres Doing? Straw poll of 8 centres suggests that all 8 hospitals will be using the bottle adaptor. Mixture of DGHs and Teaching Hospitals.

24 Using ENFit Syringes Orally? Discussion- 2 options: 1)To use ENFit syringes for enteral (tube) administration, and use oral syringes for oral administration? 2)To use ENFit syringes for both routes? What are the advantages/ disadvantages of each?

25 Using ENFit Syringes Orally? Option Advantages Disadvantages Using ENFit syringes Reduced risk of confusion for enteral (tube) administration, and at ward level as fewer syringe types stocked. using oral syringes for oral administration If using bottle adaptors, no need for separate bottles for oral and enteral administration. Size and shape ( wings ) of ENFit syringes may increase risk of damage to the oral mucosa. May be more of an issue in some patient groups: could use oral syringes just in this group, or ENFit plus medicine straw. ENFit syringes not CE marked for oral administration. Using ENFit syringes for both routes Avoids CE marking issue. Oral syringes less likely to cause trauma to the oral mucosa. If using bottle adaptors, need separate bottles for oral and enteral administration. Risk of confusion at ward level due to increase in syringe types stocked. Staff may not use the correct syringe for the correct route. If using bottle adaptors, need separate bottles for oral and enteral administration.

26 What are other Centres Doing? Straw poll of 8 centres suggests that 7 hospitals will be using ENFit for both Oral and Enteral Tube administration. Mixture of DGHs and Teaching Hospitals. The 8 th centre said not planning to, but expect it to happen! Concern over fitting the syringe tip into the corner of a baby s mouth and potential injury with the syringe tip thread (but to date the baby ward has not had an issue).

27 Implementation- things to consider Enteral only, or Oral plus Enteral. Bottle adaptors: To use, or not to use. Single wrapped, vs. bulk wrapped. When/who to insert? Ward level, or on dispensing? TTOs: Re-usuable syringes. Bottle adaptors (or not). Special patient groups, e.g. cleft patients? Which manufacturer(s)- possibly more complicated in mixed adult/paed Trusts?

28 Implementation- things to consider Education /training. Communication, communication, communication. Use of non-enteral formulations orally e.g. IV solutions: Filter straws? Blunt needles? Need to involve a wide range of people in the Trust in the plans dieticians, procurement, pharmacy, nursing staff, community nursing staff, risk management, communications Liaise with community teams- pharmacy and nursing.

29 Advice from Centres who have Implemented Try and keep it as simple as you can, Need strict control on procurement, nursing educators key to role out, there is no one right answer, all choices carry with them risks. Understand the risks, but take the plunge as it does work Just get on and do it - in six months you won't have a choice.

30 Thanks for your attention..any questions???