STANDARD OPERATING PROCEDURE. Supplying Insulin

Transcription

1 STANDARD OPERATING PROCEDURE Supplying Insulin

2 2 Supplying insulin Contents Page Guidance notes 3 Appendix 1 Frequently asked questions 6 Appendix 2 Model standard operating procedure (SOP) 10 Useful references 13 Further information 13

3 3 GUIDANCE NOTES Supplying insulin On 30 March 2011 the National Patient Safety Agency (NPSA) issued a Patient Safety Alert (PSA) on safer administration of insulin: NPSA Patient Safety Alert 003 The adult patient s passport to safer use of insulin (NPSA/2011/PSA003). The requirements of this NPSA PSA should be implemented by 31 st August Please note that in this PSA the term insulin products means all of the packaging in which the insulin is provided (e.g. vials, cartridges, pens) as well as all of the devices that are used to store, measure and inject insulin. Background This PSA has been issued in response to the high numbers of reports received by the NPSA concerning patients receiving wrong insulin products, missed or delayed insulin doses and wrong doses. Between 1 st November 2003 and 1 st November 2009, 16,600 incidents including six deaths and twelve patients severely harmed were identified involving Type 1 and Type 2 patients with diabetes using insulin. The guidance issued by the NPSA to support the PSA was developed in collaboration with other organisations, clinicians and patients and was designed to help NHS organisations, including community pharmacies, in England and Wales to take steps to minimise the risks associated with insulin therapy and to ensure that potential harm to patients is minimised. The NPSA PSA includes guidance and recommendations that are relevant to community pharmacy. This resource aims to help you review your dispensing procedures and prepare a written standard operating procedure (SOP) to ensure that you are following the guidance when insulin is supplied in your pharmacy. You can use the accompanying model NPA SOP (appendix 2) to write a separate SOP for the supply of insulin or you can incorporate the guidance into your existing dispensing SOPs. Scope of the PSA This NPSA PSA applies to patients aged 18 years or over only. It does NOT apply to children and young persons under 18 years old. All adult patients on insulin: should be offered the use of an Insulin Passport to record information about their insulin and associated injection equipment should be given a patient information booklet which describes known situations where errors may occur and actions to take to minimise harm should be supported by healthcare professionals to understand the risk of error in the correct context and complete details in their Insulin Passport

4 should self-administer their insulin when they are in hospital as in-patients, when it is safe and practical to do so should benefit from greater care and attention by healthcare professionals in ensuring that the correct insulin products are prescribed and dispensed. 4 Children and young people Children and young people under 18 years old are not within the scope of this PSA. Generally, children and young people with diabetes are cared for by specialist teams in secondary care. They and their families are provided with detailed information when diagnosed and during follow up. They are generally reviewed every three months and a diabetes nurse will have regular contact with them and their families. Their needs change with age and there is information available to suit different ages. There is an Insulin Passport available for children similar to the adult Insulin Passport. Healthcare professionals may choose to use the adult Insulin Passport and the patient information booklet. Supporting documents The NPSA has produced two supporting documents as part of their recommendations: 1) Insulin Passport a single double-sided pre-folded sheet which folds up into a creditcard size with a cardboard cover; 2) Patient information booklet explains the use of the Insulin Passport and contains further information to help patients to use their insulin safely. Professional responsibility Insulin Passport Prescribers are responsible for issuing the Insulin Passport and the patient information booklet to the patient. They are also responsible for issuing replacement Insulin Passports as required - when there is no space left, if it is lost or has become unreadable. The Insulin Passport should be updated by the patient as soon as practical to reflect any changes in the patient s insulin products, medicines, and any other information intended to help the patient use their insulin safely. Healthcare professionals must be available to assist the patient in completing the Insulin Passport, e.g. accurately describe their insulin products so there is no ambiguity in what they are using. Patient information booklet The patient information booklet directs patients to show the Insulin Passport to healthcare professionals. Patients with diabetes who use insulin should be offered the patient information booklet and given the opportunity to discuss the information it contains with a healthcare professional. This is necessary to ensure that the patient understands the information within the correct context and does not frighten the patient; in particular, that the patient understands that although errors do occur, they are rare, and there are steps the patient can take to minimise the risk of errors. In most cases, the benefits of using the Insulin Passport should outweigh the risks.

5 5 Please note that this PSA does not override the individual healthcare professional s responsibility to make appropriate decisions based on the circumstances of individual patients, in consultation with the patient and/or carer. Information for community pharmacists to help in advising patients Advise all adult patients using insulin to: be familiar with the details of their Insulin Passport and to keep it up-to-date carry the Insulin Passport with them so that the information is available in an emergency show the Insulin Passport on each occasion they bring in a prescription for insulin to confirm details of their current insulin therapy check their dispensed insulin products on each occasion and question any changes as the names of insulin products can look and sound very similar be aware of the correct dose and frequency of their insulin therapy (please note this information is not recorded in the Insulin Passport) be aware that the abbreviation u for insulin units is sometimes misread as a 0 and can result in an overdose of insulin being administered to the patient be aware that insulin must always be administered using a commercial insulin pen or insulin syringe intravenous syringes must never be used to administer insulin as they have the wrong calibration marks leading to errors avoid missed or delayed doses of their insulin ensure they have their insulin products readily available and ensure have reserve supplies be aware that should they be admitted to hospital as an in-patient, to inform hospital staff that they are willing to self-administer their insulin, if they are able to. Where they are NOT self-administering, they should remind hospital healthcare staff when their insulin dose is due.

6 6 APPENDIX 1 FREQUENTLY ASKED QUESTIONS Supplying insulin How will patients obtain their Insulin Passport and patient information booklet? The prescriber is responsible for supplying both these documents to the patient. Where can patients obtain a replacement Insulin Passport from? The prescriber is responsible for supplying a replacement Insulin Passport. Is it mandatory for patients to use the Insulin Passport? No. The NPSA recommends the use of their Insulin Passport and patient information booklet although the use of these supporting documents is not mandatory under the PSA. Healthcare professionals are required to discuss with patients if they want to use the Insulin Passport or consider a suitable alternative. Diabetes service providers can develop their own versions in conjunction with patients provided they comply with the principles of the NPSA supporting documents for this PSA. Any alternatives to these supporting documents must contain information on situations where errors are prone to occur. Such documents must also ensure that patients receive the correct insulin products and allow for recording of details of current medication. The developer of the alternatives to the Insulin Passport and the patient information booklet is fully responsible for their alternative products. Can community pharmacies supply the Insulin Passport and patient information booklet to patients who use insulin? If you choose to supply the patient information booklet to the patient, you must discuss the issue of the risks involved in using insulin and ensure that the patient understands the risk in the correct context. Where can community pharmacies obtain Insulin Passports and patient information booklets from? You should approach you local primary care organisation (PCO) in the first place to find out if supplies of Insulin Passports and patient information booklets are available for community pharmacists. Alternatively, copies of these are available in Microsoft word format at Supplies in English and Welsh will be available from May 2011 from the current NHS Non- Secure Contract held by 3M. There may be a charge for ordering these. Orders may be placed as follows: 1) Telephone: ) nhsforms@spsl.uk.com 3) Astroweb (if you have access to this electronic ordering system): National Programme Manager contact or kay.ellermeyer@wcheshirepct.nhs.uk

7 Who is responsible for recording information in the Insulin Passport? The patient should record the information in their Insulin Passport and also keep it up-to-date. If there are changes made to their insulin, the previous entry should be crossed out by drawing a single line through it and recording the new information below. Can community pharmacists help patients in recording information in their Insulin Passport? Yes. You should ensure that patients understand their prescribed insulin products. If required, help the patient to keep their Insulin Passport up to date. If you are recording information about a patient s insulin and compatible injection equipment in their Insulin Passport, ensure that you sign it in the far right hand column. If a patient / representative do not have their Insulin Passport with them, can community pharmacists still dispense the insulin? Yes. You should make every effort to cross-check the information on the prescribed insulin before dispensing it by contacting the patient or their GP or the diabetes clinic. Record the circumstances on the patient s PMR. If the patient does not have an Insulin Passport, remind him/her that it is very important that the pharmacist sees it each time a prescription is brought to the pharmacy. Indicate that it is in their interest that the correct insulin and compatible injection equipment are dispensed and that the Insulin Passport is one way of crosschecking this. Ask that it is brought next time. Is the Insulin Passport suitable for all patients who use insulin? The Insulin Passport will not be suitable for all patients who use insulin. Some patients may not be able to develop a balanced view of the innate risk of insulin use, in the judgement of the healthcare professional. In such cases, the circumstances should be fully documented and alternative arrangements made to minimise the risk of errors associated with insulin use in line with the recommendations of this PSA. Will there be information available from the PCOs locally? Local policies and protocols should clearly describe the process for cross-checking information in the Insulin Passport during the prescribing and dispensing stages, as well as the process for situations when cross-checking is not possible. There should also be clear guidance on how to identify and document those patients who decide not to follow the recommendations of this PSA. What should I do when the insulin is being home delivered or collected by the patient s representative? For situations where insulin is delivered to housebound patients or collected by representatives, you are responsible for cross-referencing, reconciling and ensuring as far as possible that the patient s prescribed insulin, the brand and the injection equipment is compatible with the information recorded in the Insulin Passport. You can do this by contacting the patient by telephone and making the necessary checks prior to dispensing. You should also record your actions in the patient s PMR. If an Insulin Passport is not available and you are unable to contact the patient, the patient s carer or surgery / diabetes clinic to make the necessary checks, you should supply the insulin 7

8 based on your own risk assessment. As a principle, therapy should not be withheld unless there is the potential for serious patient harm. How should I deal with prescriptions for insulin for patients who are in care homes? It is a requirement of the PSA that all patients with diabetes who use insulin should be offered the Insulin Passport, and given the opportunity to discuss the contents of the patient information booklet with the healthcare professional issuing it, and informed of the risks of error associated with their therapy. The caveat to this is professional judgement as to whether knowledge of potential errors will adversely affect patient care. It is the responsibility of the prescriber to undertake this task. You may be asked to comment on the matter of safety and errors in care homes. Before engaging, it is essential that you read the accompanying material to this SOP. On visiting the care home, you should make the necessary checks of the patient s using the Insulin Passport, where available. You should contact the care home by telephone before dispensing and confirm if there have been any changes to any patients insulin, and record this on the PMR. What are the symptoms of hypoglycaemia / hypo? Early signs of mild hypoglycaemia include the patient feeling hungry, trembling or shaky, sweating, anxious or irritable, becoming pale, rapid pulse or palpitations or tingling of lips. If the hypoglycaemia becomes severe the patient can have difficulty concentrating, become confused and display disorderly or irrational behaviour which may be mistaken for signs of drunkenness in the patient. How can hypoglycaemia be treated? The urgent treatment is for the patient to have some food or drink containing sugar immediately to end the hypoglycaemia; e.g. a glass of fruit juice, few sugar lumps or three or more glucose tablets. After having a sugary food or drink, the patient should have a carbohydrate-containing food such as fruit, sandwich, cereal bar or some biscuits. When the hypoglycaemia is severe, someone else should help the patient by applying Glucogel (or if unavailable, honey, jam or treacle could be used) to the inside of the patient s cheek and massaging the outside of the cheek. It may take the patient up to fifteen minutes to start feeling better. If the patient is unconscious, call an ambulance. Place the patient in the recovery position and administer a glucagon injection. This should only be done by a trained family member / friend or a healthcare professional. Pharmacists are able to administer glucagon injection in an emergency. An unconscious patient must never have any food or drink put into their mouth because they could choke. What are the symptoms of hyperglycaemia? Hyperglycaemia causes an increase in thirst, frequent urination and tiredness. Symptoms in patients with diabetic ketoacidosis include nausea or vomiting, stomach pain, fruity smell on their breath like nail varnish or pear drops, drowsiness, confusion, hyperventilating, dehydration, unconsciousness. 8

9 How can hyperglycaemia be treated? Treatment of hyperglycaemia depends on the type of diabetes the patient has and how they have been advised on managing their blood glucose levels. Patients may have been advised by the diabetes care team to take certain actions depending on their symptoms; such as increasing their dose of insulin, changing their diet, take more exercise and monitor their blood glucose level. You should advice patients to follow the advice given to them by their diabetes care team. Untreated hyperglycaemia can lead to diabetic ketoacidosis which requires urgent medical attention. You should refer the patient to accident & emergency (A&E) or call an ambulance. How should insulin be stored? Insulin products which are currently in use do not usually have to be stored in the fridge and can be kept for up to four weeks at room temperature, provided that the room temperature is lower than 25ºC (77ºF). In the summer or while on holiday, the temperature can exceed 25ºC: insulin must not be stored near ovens, heaters, fires, radiators or in direct sunlight open vials, cartridges or pre-filled pens of insulin currently in use must be discarded 28 days after opening / start of use. Insulin products in reserve or for future use (i.e. not currently in use) must be stored in the fridge at a temperature of between 2-8ºC (36-46ºF). In addition: insulin must NOT be stored in the freezer compartment insulin must NOT be stored in contact with the internal fridge walls. Which medicines can interact with insulin? Insulin can interact with alcohol, beta-blockers, salicylates, quinine, monoamine oxidase inhibitors (MAOIs), angiotensin converting enzyme (ACE) inhibitors, oral contraceptives, thiazides and thyroid hormones as well as some other medicines. You should check the latest edition of the British National Formulary (BNF) for information on drugs which interact with insulin; or contact the NPA Information Department on /

10 APPENDIX 2 MODEL STANDARD OPERATING PROCEDURE Supplying insulin This model SOP below should be read in conjunction with the accompanying guidance notes and should be tailored to meet your individual circumstances. PURPOSE - To ensure the supply of insulin and associated injection equipment is carried out in a safe, efficient way, which complies with the NPSA recommendations on the supply of insulin products. SCOPE - This SOP covers the supply of insulin and associated injection equipment in pharmacy including receipt of prescription, pharmaceutical assessment, assembly and labelling, accuracy checking, transfer to patient as well as interventions and problem solving. It includes the supply of insulin and associated injection equipment to patients in care homes. 10 Please note that the NPSA Patient Safety Alert does not apply to supplying insulin and associated injection equipment to children and young people under 18 years of age. PROCESS/PROCEDURE - Typical steps may include some of the following. The order and the way in which you do these in your pharmacy may vary from the list below so choose those most suited to your own practice. Prescription receipt checks Ask if the patient has received their copy of the Insulin Passport and the patient information booklet. Attach the Insulin Passport to the prescription and pass to the dispensary team. If the Insulin Passport is not available, alert a member of the dispensary team. Pass any other relevant information obtained to the dispensary team. Pharmaceutical assessment Cross-check the prescribed insulin, its brand and injection equipment with the information in the Insulin Passport. Record the relevant information on the patient s PMR including any changes to the insulin, the brand or injection equipment. Check the dose on the prescription against the PMR record to see if there have been any changes. Check the patient s PMR to see if there have been any changes to the patient s other medication. Many drugs interact with insulin so check to see if there has been a new drug added, a dose change to another medicine or whether an interacting drug has been discontinued (as the insulin dosage may have been stabilised against the interacting drug). NB: Please check the latest edition of the BNF for information on drugs which interact with insulin or contact the NPA Information Department on

11 11 Assembly and labelling Select the correct insulin product(s) and/or injection equipment. Label according to prescriber s instructions. Be aware that the abbreviation u for insulin units is often misread as 0 which can result in a ten times overdose of insulin. Be extra vigilant as many insulin brands sound similar. Check the strength of insulin prescribed, i.e. generally the insulin prescribed in the UK is 100units/1ml strength; however, 500units/1 ml strength also exists. Check injection equipment is compatible with the prescribed insulin. Accuracy checking Check that the correct types of insulin and compatible injection equipment have been selected. Double-check that the labels for different types of insulin have not been transposed. Make sure all prescriptions for insulin are double-checked by another appropriate member of staff. Store the insulin in the fridge (not the freezer) until transfer to patient. Transfer to patient Ask the patient if they have any questions about their insulin therapy or if they have noticed any side effects such as hypoglycaemia and/or hyperglycaemia from their treatment. Check whether the patient has experienced any other changes since their last prescription e.g. changes to diet, weight, lifestyle such as stopped smoking. If the Insulin Passport record of the patient s insulin, brand or injection equipment is confusing, ambiguous or could in any way be misinterpreted, offer to help describe it more accurately. If you do this be sure to sign the Insulin Passport in the dedicated column on the right-hand side of the Insulin Passport to verify the correct products. If the dose is prescribed as directed, check that the patient is aware of what dose they should be injecting and record this on the PMR. Ask the patient if their dose has been changed recently or since their last supply was dispensed. Ensure that they are happy and competent to use the injection equipment. Ensure that the patient understands the storage requirements for insulin currently in use and insulin stock for future use. Additionally, although this is not a part of the PSA, ensure the patient is aware of the potential for insulin to interact with other medicines (prescribed, OTC medicines, supplements, vitamins or herbal products) and that they understand the need to consult with a pharmacist or the prescriber before taking other medicines. Return the Insulin Passport to the patient along with the dispensed items if the patient is going straight home. If the patient is not going straight home, offer to store the dispensed insulin in the pharmacy for collecting later. If you are supplying insulin to care home patients, you should contact the care home by telephone before delivery of medicines and confirm if there have been any changes to any patients insulin, and record this on the PMR.

12 INTERVENTIONS AND PROBLEM SOLVING If the patient, or their representative, does not have the patient s Insulin Passport, contact the patient/carer or prescriber by telephone if possible to obtain the necessary information. If there is no information available, record this on the PMR and ask the patient to verify the dispensed insulin product(s). If there are concerns about the patient s prescribed insulin, dose or administration equipment, contact the prescriber or diabetes clinic to check whether they wish to review the patient. If the patient s prescribed insulin is different from that recorded in the Insulin Passport: o ask/contact the patient to check if they have been advised of change in insulin and confirm the prescribed insulin is correct o contact the prescriber to verify change of insulin and determine whether the correct insulin has been prescribed o advise the patient to update and record the correct insulin information in their Insulin Passport. If you make this record on behalf of the patient, sign the Insulin Passport in the space provided o record these actions on the patient s PMR. If you are unable to reconcile the difference between the prescribed insulin and that recorded in the Insulin Passport, you should still make a supply of the insulin based on your risk assessment of the circumstances. It is essential that you record this assessment in the PMR. If the patient is prescribed other potentially interacting medicines or if an interacting medicine is discontinued, contact the prescriber / diabetes clinic to ensure they are aware of the interaction and that arrangements have been made for additional monitoring. RESPONSIBILITY OF STAFF Your SOP needs to specify who is responsible for dealing with all aspects of the supply of insulin from prescription receipt through to transfer to patient. All staff involved in the supply of insulin should have received adequate training to ensure they have the necessary work competences. KNOWN RISKS These are circumstances that you know can increase the likelihood of things going wrong and where you believe extra care and attention should be paid. Examples of situations where extra attention and care is required include: patients presenting without the Insulin Passport prescriptions with doses expressed in terms of as directed prescriptions for wrong insulin and/or administration equipment, i.e. where there is a discrepancy between the prescribed insulin and what the patient is expecting discrepancy between the prescribed insulin and information in the Insulin Passport. 12

13 13 APPENDIX 3 REFERENCES National Patient Safety Agency NHS Choices NHS Clinical Knowledge Summaries FURTHER INFORMATION National Pharmacy Association (NPA) NPA Pharmacy Services Team on / or information@npa.co.uk National Patient Safety Agency (NPSA) Dr. David Gerrett, Senior Pharmacist by david.gerrett@npsa.nhs.uk. National Pharmacy Association April 2011 Mallinson House, St Peter s Street St Albans Hertfordshire AL1 3NP Tel: