STANDARD OPERATING PROCEDURE FOR

Standardisation of Insulin Pen Needles to Ensure Best Value Usage

(Drug Tariff Part IXA – Appliances/BNF subsection 6.1.1.3)

NHS Stockport Clinical Commissioning Group will allow people to access health services that empower them to

live healthier, longer and more independent lives.

NHS Stockport Clinical Commissioning Group7th FloorRegent HouseHeaton LaneStockportSK4 1BS

Tel: 0161 426 9900Fax: 0161 249 4251 (Safehaven)Text Relay: 18001 + 0161 426 9900Website: www.stockportccg.nhs.uk

STANDARD OPERATING PROCEDURE FORStandardisation of Insulin Pen Needles to Ensure Best

Value UsageSUMMARY

Key objectiveTo change appropriate patients using insulin pen needles to better value pen needles listed in the guidance section.

We also aim To make this change successfully, where possible in consultation with the patient, with as little

disruption as possible for both the patient and the practice. To ensure changes are appropriately documented and monitored To ensure that the patient is consulted and involved in the process and that their confidentiality

is respected throughout the process. To ensure that the patient, practice staff and local pharmacies are informed of the change.

SCOPE The work will cover all patients identified as currently using pen needles (all sizes, see guidance

below) in the last 12 months. The practice and the local pharmacies must be informed of the work before it is carried out. This

is essential to allow pharmacies to alter stock levels.

RESPONSIBILITIES The overall responsibility for the work that is undertaken lies with the Lead GP and they should

sign the practice authorisation form, indicating the required protocol to be followed and responsibilities if different from the standard protocol.

The Lead GP should identify a designated clinician as reviewer to make the clinical assessment and recommendations for a change, after reviewing the patient record.

The Lead GP is responsible for authorising all changes if the reviewer is not themselves a prescriber

The Lead GP is responsible for ensuring patients who have their needles changed are informed and are followed up if necessary.

The practice-based medicines co-ordinator (PBMC) where available, or a Medicines Co-ordinator, is responsible for identifying patients using the listed pen needles and will prepare the authorisation sheets. Once the changes have been authorised, they will be responsible for carrying out changes to the medication on the GP clinical system, communicating changes to patients and informing the rest of the practice team and local pharmacies of the change, depending on the protocol followed.

Note where there are large numbers of patients require changes to be made to a new medication/ product, the practice may prefer not to issue paper letters informing patients and/or their carers of the details. Discuss other options with your Medicines Optimisation Pharmacist and annotate the practice agreement as necessary. A documented protocol for the process should be agreed with Medicines Optimisation and be provided to the person making the changes. Alternative methods such as attaching letters to prescriptions before issue, using pop-up messages, preparing sticky labels for the prescriptions can be considered, alone or in combination.

RISK ASSESSMENTInsulin Pen Needle Standardisation v2 Nov 2018 Page 2 of 13

This SOP has been assessed as very low risk. The fit of the needles is universal for all pen devices so should have no impact on needle use. There is a choice of brands which can be prescribed to offer all sizes and common gauges of needle. Safety needles may be needed where the patient is not self-administering their insulin-please refer to your practice Pharmacist for advice.

GUIDANCEAny pen needle range over £6 per 100 is blacklisted within Greater Manchester. This includes the brands named below.Their continued use will require that there is something exceptional about an individual patient that means they cannot be changed to better value brand. An approval requestmust be submitted to continue prescribing.

BD Autoshield Duo®

BD Micro-Fine+®

BD Micro-Fine Ultra®

Dropsafe® Safety Pen needles IME-FINE®

Insupen®

Microdot Verifine Safety Pen Needle®

Mylife Clickfine®

Mylife Clickfine AutoProtect®

Nanopass®

NeedleBay Fine®

NovoFine®

NovoFine® Autocover Novotwist®

Unifine Pentips Unifine Pentips plus

Pen needles for all insulin pen devices are universal, and therefore interchangeable. Currently permissible brands for switching are:

4Sure ( has all 6 sizes or gauge of needle available) BD Viva®

CarePoint® (formerly Comfort point®) Glucoject®

GlucoRx Fine Point Ultra®

GlucoRx Fine Point®

Haemofine®

Microdot Droplet®

Mylife Penfine Classic®

Neon Verifine®

Neon Verifine Safety® (for use where a safety needle is required) Neon Verifine Ultra®

Omnican Fine®

PROFine®

Insulin Pen Needle Standardisation v2 Nov 2018 Page 3 of 13

TriCare®

The price of needles will vary over time but the brands listed are consistently of better value for the full range of sizes marketed. Prices will be kept under review and practices informed if any of the listed brands change substantially. Please refer to Medicines Optimisation staff for current prices at the time of your decision on which brand/s to use. Practices may wish to choose a preferred brand to allow local pharmacies to keep adequate stock.

NB. some brands (such as Insupen®) are good value in certain sizes only and so should not be prescribed due to the risk that a change of size leads to an unacceptable cost increase. They have therefore been excluded from this list. Not all brands have all sizes and gauges of pen needle available ( see Appendix 1 for details of which brands provide which sizes and gauges,)

The use of low cost pen needles is fully supported by the local diabetes specialist team to ensure the best value for the NHS.

The preferred brands cover a wide range of sizes, though clinicians may wish to take the opportunity to switch appropriate patients to shorter needle, as 4mm pen needles are recommended for all adults regardless of age, gender or Body Mass Index (BMI). If patients need to use needle lengths longer 4mm they must use a correctly-lifted skinfold to avoid intramuscular injections.Very young children (6-years old and under) and extremely thin adults (BMI<19) should use the 4mm needle by lifting a skin fold and inserting the needle perpendicularly into it.

Pen needles over 6mm are blacklisted in GM . For more information about appropriate needle length and best injection practice generally, please refer to the latest Forum for Injection Technique (FIT) UK recommendations http://www.fit4diabetes.com/files/4514/7946/3482/FIT_UK_Recommendations_4th_Edition.pdfPatients who are found to still be on longer needles should be managed by Protocol 2

Safety needles should not be prescribed where a patient self-administers. Currently the best value safety needle is Neon Verifine Safety and this is the only brand that should be prescribed where a safety needle is required.

OTHER RELEVANT INFORMATION TO BE CHECKED WHEN REVIEWING

Check the patient’s medical history and note Reason for discontinuation if new needle has been tried previously, exclude if a clinically

significant adverse effect is specified. Requirements for a safety needle where already prescribed, please ensure this is

documented in the notes.

Insulin Pen Needle Standardisation v2 Nov 2018 Page 4 of 13

THE PROCESS STAGESThe scope for the SOP should be determined including The lead GP for the work. The clinical indications to be considered for changes should be identified and added to the

Practice Agreement. Any additional exclusion criteria should be agreed with Medicines Optimisation and added to the

Practice Agreement. Who will review the patients and make the recommendations for change. How the patients will be informed and how they will be given the opportunity for discussion. Patients with the blacklisted brand of pen needles in past drugs should have a message added not

to re-start and to use an alternative.

Protocols for switchingPatient changes can be managed by a standard letter process (i.e. Protocol 1). Face to face consultation and managed change by the Practice Nurse/Practice Medicines Optimisation Pharmacist should rarely be necessary and is therefore not included in this SOP. If this is deemed necessary for any individual patient they should be invited for review as per the Practices routine processes.

If the Practice would prefer not to send letters regarding this change then, you may at your discretion choose an alternative method of communication. Please discuss your preferred process with your Medicines Optimisation Pharmacist to ensure suitability and document the chosen process on the Practice Agreement form. A protocol for the change process should be provided for the PBMC/ Medicines Optimisation Co-ordinator when making the changes. A template process will be made available soon based on current practice systemsProcesses such as prescription messages, slips, e-mailed letters and text messages have all been used in the past but are not as successful as the standard letter process.

The Practice Agreement must be completed The practice details and the people responsible for each step of the audit must be completed on

the form and any planned deviation from the standard protocol must be noted on the agreement before signing.

The Designated Lead GP must be given the form to agree and sign on behalf of the Practice. (Authorisation will remain effective until the planned review date or a change of version of the SOP)

The PBMC (where one is available) and/or Medicines Optimisation Team members (if involved) must sign the form.

Document Preparation Templates should be prepared for any letters that may be required and agreed by the Lead GP

Informing staff involved After the practice agreement has been signed, the practice staff and local pharmacies must be

informed of the proposed work that is to be carried out and the time frame for the first changes to allow time for the Pharmacy to reduce its stock levels of pen needles likely to be discontinued and obtain supplies of the practice’s preferred brand.

Every prescriber should be made aware of the guidance provided in the SOP and given a printed copy if requested.

Insulin Pen Needle Standardisation v2 Nov 2018 Page 5 of 13

Searches for patients taking the target products must be run This must take into account patients who been prescribed these products on repeat or acute

prescription, in current and past medications in the last 12 months.The searches run must contain the following list of needles:

o BD Autoshield Duo®

o BD Micro-Fine+®

o BD Micro-Fine Ultra®

o IME-FINE®

o Insupen®

o Microdot Verifine Safety Pen Needle®

o Mylife Clickfine®

o Mylife Clickfine AutoProtect®

o Nanopass®

o NeedleBay Fine®

o NovoFine®

o NovoFine® Autocover®

o Novotwist®

o Unifine Pentips®

All gauges and lengths of the above needles should be included. BD Micro-Fine can be found in EMIS by ensuring the hyphen is included and the brand is

entered as Bd. Using BD or missing the hyphen may not get correct returns. The search results should be printed off/ saved electronically and retained for 2 years for future

reference.

The following brands should be run for sizes larger than 6mm 4Sure ( has all 6 sizes or gauge of needle available) BD Viva®

CareFine® (formerly Comfort point®) Glucoject®

GlucoRx CarePoint Ultra®

GlucoRx CarePoint®

GlucoRx FinePoint Ultra®

GlucoRx FinePoint®

Haemofine®

Microdot Droplet®

Mylife Penfine Classic®

Neon Verifine®

Neon Verifine Safety® (for use where a safety needle is required) Neon Verifine Ultra®

Omnican Fine®

PROFine®

TriCare®

Insulin Pen Needle Standardisation v2 Nov 2018 Page 6 of 13

Authorisation sheetsThese sheets may be filled in by the Practice Based or CCG Medicines Coordinator, but the “Suggestions for change” column must be left blank for the reviewer to complete. A prescriber should authorise or decline, with a reason, each change and indicate the protocol by which the change should be managed.

EXCLUSION CRITERIAExclusion criteria

Past use of all value brands of needle, with a relevant clinically significant adverse event recorded that would make a switch inappropriate. This will require a request to continue to prescribe on the grounds of exceptionality to be submitted to the CCG.

Insulin Pen Needle Standardisation v2 Nov 2018 Page 7 of 13

PROTOCOLS FOR CHANGESBefore making changes ensure you are familiar with the warning that will appear when adding the new medication. This is caused by having the same medication on a drug list twice. This warning and ONLY this exact warning can be ignored. If any other warnings appear, it is not safe to continue making the change and the reviewer must be informed. If in any doubt, consult a prescriber.

A.

Protocol 1 – changing a patient’s medication by letter

Adding the new pen needle The new pen needle must be added to the patient medication screen making sure that

the correct size and gauge specified on the signed authorisation sheets has been selected

The directions should read “Use as necessary” unless there is an obvious reason for a different direction.

If any warnings appear from the clinical system, stop at this point and delay continuing with this patient’s change until a prescriber can review the warning.

The number of repeats must be altered to match the number of repeats that remain of the old medication, or to cover the period until the next medication review.

B. Removing the old medication When the new pen needle has been checked as correct and there is no alteration

needed then the old pen needle can be deleted. The reason for the pen needle being deleted should be added where possible; this must

be “NHS Stockport pen needle SOP – Do not re- prescribe”. A read code of 66R5 (repeat medication changed) must be added to the patient’s notes.

A free text message of “NHS Stockport pen needle SOP” must be added.

C. Communicating the change A letter must be prepared using the appropriate template letter and including the

practice’s usual heading unless a different method of communication is agreed. The patient’s name and address must be taken from the patient’s computer record when

preparing the letter. Add the date to letter. The names of the old pen needle and the new pen needle must be stated on the letter. An updated repeat medication slip should be included with the letter if possible when

posting. The letter must be completed and placed in the addressed envelope if using non-

electronic communication, before moving on to the next patient.

Repeat the process A-C for each patient where necessary. Any letters must be produced on the same day as the computer record is changed.

Once all the relevant patients have been changed then a final check search is to be completed that will flag up any patients where the original needle was not removed. Create a new search including patients taking both “original needle” and “new needle” This will bring up any patients who have been left on both the original and the new needles.

NOTEIf an alternative method of informing the patients of the change is to be used by the practice the full details of this method which has been discussed with the prescribing adviser should be agreed with the lead GP. The details should then be added to the practice agreement before it is signed.

Insulin Pen Needle Standardisation v2 Nov 2018 Page 8 of 13

FOR ALL PATIENTSPatient Dissent Any patient who contacts either the practice or NHS Stockport CCG with a valid reason as to

why their medication should not be changed should be referred to the Prescriber/ Medicines Optimisation Pharmacist and if the outcome is a decision not to change, the patient should have a Read code of 8B30 (drug declined) added to the notes along with the message “patient does not wish to change” and the reason why.

Keeping a record The printed list of patients identified from the report must be marked to show those patients that

have changed and the patients who could not be changed. Documentation containing patient information must not be removed from the practice. Any documentation that you have produced must be placed in a designated file held within the

practice and retained for 2 years Details of any consultations either face to face or by telephone should be recorded in the

patient’s record

SafetyShould there be any doubt with patients’ records, refer to the Medicines Optimisation Pharmacist or GP

After 3 months the final check search should be run again to see if any patients have had the original needle brought back from past to repeat prescription. Any patients brought up in this search should be flagged up to the Prescribing Advisor/Technician.

Patients changed who are unable to use the new pen needles For any patient changed to the new pen needles who is subsequently unable to use them the

reason for discontinuation should be recorded. They should not automatically be changed back to their original pen needles, but a review

conducted to select the most cost effective alternative. (See Guidance)

Version 1 Prepared by: Mike WalkerDesignation: Prescribing Adviser

Version 2 Updated by: Liz Bailey , Head of Medicines Optimisation following change to the Greater Manchester DNP list

Approved by: Dr Simon WoodworthDesignation: Medical Director

Date approved: November 18This SOP will be reviewed within 3 years of approval but may be reviewed sooner if there is a significant change in pricing, practice, guidance or a safety concern

Planned Review Date – November 2021

Insulin Pen Needle Standardisation v2 Nov 2018 Page 9 of 13

Practice agreement for changes to best value pen needlesPractice

I / we agree to adhere to this protocol to undertake the change to the best value pen needles in suitable patients.

II / we agree that the guidance on product selection given in the guidance is appropriate for our patients and that all changes will be authorised by a GP or Non-Medical Prescriber

I / we agree that patients will normally be informed of a change by letter which provides details of how they can gain more information and from whom

I / we agree that the reviewer will indicate which patients will be informed of a change by letter (Protocol 1) which provides details of how they can gain more information Changes for any patients needing face to face appointments will be made by invitation for review with a clinician and change during a consultation

OR Add details of any practice agreed process I / we agree for the PBMC to undertake authorised changes and send out the appropriate letters

I / we agree that where a patient has a complaint the normal practice complaints procedure will be followed

Date program will commence

Lead GP on behalf of the practice

Name__________________ Signature______________________ Date_________

Designated Reviewer (GP/ NMP/ Pharmacist/ Technician) delete as appropriate

Name__________________ Signature________________________ Date______

PBMC or Medicines Optimisation Technician

Name__________________ Signature________________________ Date______

Insulin Pen Needle Standardisation v2 Nov 2018 Page 10 of 13

Authorisation Form for changes from various pen needles to better value pen needles PracticeDate Data Collected Date Authorised

Patient’s Name

Patient Number

Current Needle Length and

Gauge

Past issue with pen needles

that may affect change

Switch to (please specify brand)

Length and

Gauge

PrescriberAuthorised

Change made

Savings (£/28 days)

e.g. Fred Hobbs

12345 e.g. BD Micro-Fine+

5mm 31g

No e.g. Neon Verifine

5mm31g

Shaded columns to be completed by reviewer.. If reviewer is not a prescriber a prescriber must authorise changes

Signature of reviewer _____________________________ Print Name _______________________ Date ____________________

Signature of authorising prescriber ___________________ Print Name _______________________ Date ____________________

Insulin Pen Needle Standardisation v2 Nov 2018 Page 11 of 13

Protocol 1- Sample letter to Patients Prescribers Name

Practice NameStreet Name

StockportPostcode

DatePrivate and confidential

Patient NameHouse Number and street nameTownPostcode

Dear _____________________________ (add usual form of address for patients)

CHANGES TO YOUR INSULIN PEN NEEDLES

We have been reviewing the use of pen needles following advice from local Diabetes Specialist Teams and NHS Stockport which recommends the use of ……………(Insert name of chosen pen needle here) pen needles. All insulin pen needles are made to fit all makes of pens.

You are currently using (insert name of current needles and size) pen needles

We would instead like you to start using …………… (Insert name and size of chosen pen needle here) needles.

Please be assured that all pen needles can be used with all injectable pen devices.

If the size or gauge of needle have been changed add this sentence.

We have made one slight alteration in your size/ gauge of needle. This is following national guidance on pen needles and we feel this is the best size/ gauge for you to use.

Please use up all of your previous needles before starting with the new needles. If you have any queries regarding this change, please contact the practice and arrange to speak to …………………………………. (a named person should be given)

Yours sincerely

Lead GPOn behalf of (Dr X and Partners)

Insulin Pen Needle Standardisation v2 Nov 2018 Page 12 of 13

Appendix 1

Size 4Sure BD Viva

CarePoint

Glucoject

GlucoRx Fine Point

GlucoRx Fine Point

ULTRA

Haemofine

Microdot Droplet

Mylife Penfine Classic

Neon Verifine

Neon Verifine SAFETY

Only

Neon Verifine ULTRA

Omnican Fine

PROFine TriCare

Unifine Pentips PLUS

4mm

31G

32G

5

mm

31G

32G

6

mm

31G

32G

Total No. of sizes 6 2 3 3 3 1 5 2 2 3 1 1 3 3 3 3

Current range of sizes for best value pen needles (June 17)

Insulin Pen Needle Standardisation v2 Nov 2018 Page 13 of 13