Medicinal Product Authorisation Information and Frequently Asked Questions for Registered Nurse Prescribers

Transcription

1 Medicinal Product Authorisation Information and Frequently Asked Questions for Registered Nurse Prescribers March 2011 Changing practice to support service delivery

2 ISBN Health Service Executive March 2011 Office of the Nursing & Midwifery Services Director Health Service Executive Dr Steevens Hospital Dublin 8 Ireland telephone: nursing.services@hse.ie

3 Information and Frequently Asked Questions - Medicinal Products Authorisation 1 Purpose of this information leaflet The purpose of this information booklet is to provide information for registered nurse prescribers (RNP s) on medicinal product authorisation. This is to support RNPs when considering their prescribing authority and the identification of medicinal products for inclusion on Attachment B (listing of products) of their Collaborative Practice Agreement (CPA). This leaflet should be read in conjunction with: An Bord Altranais (2010) Practice Standards and Guidelines for Nurses and Midwives with Prescriptive Authority. Dublin: An Bord Altranais An Bord Altranais (2007) Collaborative Practice Agreement for Nurses and Midwives with Prescriptive Authority. Dublin: An Bord Altranais An Bord Altranais (2007) Guidance to Nurse and Midwives on Medication Management. Dublin: An Bord Altranais Drennan J., Naughton, C., Allen, D., Hyde, A., Feele, P., O Boyle, K., Treacy, P., and Butler, M. (2009) National Independent Evaluation of the Nurse and Midwife Prescribing Initiative. Dublin: University College Dublin Medicinal Products (Control of Placing on the Market) Regulations Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007 Medicinal Products (Prescription and Control of Supply) Regulations 2003 as amended) State Claims Agency (2010) Unlicensed and Off License Use of Licensed Medicinal Products. Dublin: Clinical Indemnity Scheme State Claims Agency (2008) Nurse and Midwife Prescribing. Dublin: Clinical Indemnity Scheme 2 Background Primary legislation was introduced in May 2006 to provide for prescriptive authority for nurses and midwives. Following a public consultation undertaken by the Department of Health and Children the following were signed into law on 1 May 2007: Irish Medicines Board (Miscellaneous Provisions Act) 2006 (Commencement) Order 2007 Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007, Statutory Instruments No. 201 of 2007 Misuse of Drugs (Amendment) Regulations 2007, Statutory Instruments No. 200 of These regulations specify the legislative requirements and conditions for prescribing of medicinal products by nurses and midwives. The introduction of nurse and midwife prescribing is underpinned by a twin-track approach - encompassing amending Irish legislation and the introduction of new professional nursing and midwifery regulation through the Nurses Rules (An Bord Altranais, 2007). Table 1 outlines the regulations associated with the Act. 3

4 Medicinal Product Authorisation - Information and Frequently Asked Questions for Registered Nurse Prescribers Table 1: Regulations Associated with the Irish Medicines Board (Miscellaneous Provisions) Act 2006 The Regulations attach the following conditions which must be met where nurse or midwife prescribing takes place: the nurse or midwife must be employed by a health service provider in a hospital, nursing home, clinic or other health service setting (including any case where the health service is provided in a private home) the medicinal product is a medicinal product which would be given in the usual course of the provision of the service provided in the health service setting in which the nurse or midwife is employed the prescription is in fact issued in the usual course of the provision of that health service. the An Bord Altranais registration number (also known as the Personal Identification Number (PIN)) must be stated on the prescription The Regulations do not inhibit the right of an employer to impose further restrictions including prohibiting a nurse or midwife from prescribing. Note: For full details reference must be made to the individual regulations identified in section 2 An Bord Altranais is invested with the power to provide professional regulation for nurse and midwife prescribing. The professional regulatory framework was effected through the changes to the Nurses Rules in 2007, which created a new division of the Register for Registered Nurse Prescribers. An Bord Altranais has provided regulation for: education; registration; clinical competence and clinical governance. Table 2: An Bord Altranais Regulatory Framework for Nurse and Midwife Prescribing Education An Bord Altranais published the Requirements and Standards for Education Programmes for Nurses and Midwives with Prescriptive Authority (2007) to guide the regulation of these new roles. This comprises: extracts from the Nurses Rules 2007 requirements for nurse and midwife education for prescriptive authority the approval process for educational providers for the provision of education for prescriptive authority the standards for the approval of educational providers and health care providers involved in the delivery of such programmes the competencies that must be attained through successful completion of the programme. Registration An Bord Altranais sets out the practice standards, collaborative practice agreement and decision-making framework in their publications of 2007 and These outline the requirements for registration. Clinical Governance An Bord Altranais advises that organisations should refer to the Practice Standards and Guidelines for Nurses and Midwives with Prescriptive Authority (2010) and the Decision Making Framework (2007) in the development of clinical governance structures to support the introduction of nurse and midwife prescribing. 4

5 In fulfilling the Ministers commitment to evaluate the initiative within two-years an independent external evaluation was undertaken in The purpose of the evaluation was to examine the effectiveness of the introduction of nurse and midwife prescribing and to establish if the model adopted in Ireland achieved the stated objectives in terms of quality, patient safety, communication and patient/client benefits and satisfaction. The report (Drennan et al, 2009) demonstrated that the model for nurse and midwife prescribing for Ireland was safe and effective. Ten recommendations which provide a clear direction for the further roll out of independent nurse and midwife medicinal product prescribing across Ireland were made. Some of the key recommendations were: Nurses and midwives should be enabled to prescribe unlicensed medications once they come within their scope of practice and nurse/midwife prescribers are cognisant of best practice in the prescribing of unlicensed medications. Following a series of meetings with officials of the Department of Health and Children during summer 2010 it was identified that this recommendation would require changes to regulations. As the use of unauthorised medications in Ireland was highlighted as a concern by the Commission on Patient Safety (2008) and is currently being addressed by the Departments Forum on Medication Safety it was agreed to await the findings of the Forum on the matter before considering the recommendation further. Nurses and midwives should be enabled to prescribe off-label medications once they come within their scope of practice and nurse/midwife prescribers are cognisant of best practice in the prescribing medications outside their terms of licence 1. Department of Health and Children officials reviewed the relevant medicines legislation and advised An Bord Altranais that there is no impediment in the relevant legislation and regulations to prevent a registered nurse from issuing a prescription (in accordance with Reg 5A of the Medicinal Products (Prescription and control of Supply) Regulations 2003 as amended) for an authorised (licensed) medicinal product in respect of an unauthorised indication (i.e. off-label). It was clarified that it is permissible for an authorised medication to be supplied from a prescription issued by any prescriber, including where the medication is to be used for an unauthorised indication. Arising from this advice the practice standards were amended and further guidance was given to the professions by An Bord Altranais (Practice Standards and Guidelines for Nurses and Midwives was with Prescriptive Authority, 2010). The new practice standards and guidelines are effective from the 1st December An Bord Altranais, in conjunction with health service providers, should review practices standards with a view to outlining the criteria that should be recorded on patient /service-user case notes and medication administration records following a prescribing consultation by an RNP. Support was provided to An Bord Altranais, by the HSE, in the review and expansion of the practice standards for nurse and midwife with prescriptive authority. The Practice Standards and Guidelines for Nurses and Midwives with Prescriptive Authority 2010 were issued by An Bord Altranais on the 11th November The document sets out three additional practice standards: Practice Standard 1 Clinical decision-making process Practice Standard 2 Communication and history taking Practice Standard 3 Documentation The text also provides more detailed guidance for practice and additional appendices. 1 When reviewing this recommendation the independent evaluation suggested that the following should be taken into consideration: 1) the off-label medication is regularly used to treat patients in the prescriber s area of practice, 2) the off-label medication to be prescribed must be agreed in advance with the prescriber s Drugs and Therapeutics Committee, 3) it is acknowledged by the prescriber that an alternative medication would not be more suitable, 4) the patient should be made aware that the drug being prescribed is off-label. 5

6 Medicinal Product Authorisation - Information and Frequently Asked Questions for Registered Nurse Prescribers 3 Definitions 3.1 Irish Medicines Board The Irish Medicines Board (IMB) is the licensing authority for medicinal products for human use in Ireland. The powers and functions of the IMB are set out in the Irish Medicines Board Act 1995 as amended. The IMB is the competent authority for the licensing and supervision of human and veterinary medicines in Ireland. The mission of the IMB is to protect and enhance public health and animal health through the regulation of human and veterinary medicinal products. The regulation of these products is founded on science and law to ensure their purity, potency, safety, efficacy and appropriate storage, transport and distribution. The IMB also participates in systems designed to ensure quality, safety and efficacy of medicines throughout the European Union. For further information see Medicinal Product The definition of a medicinal product in Article 1 of Directive 2001/83/EC was amended by Directive 2004/27/EC. This definition states that a medicinal product is: Any substance or combination of substances presented as having properties for treating or preventing disease in human beings. Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action or by making a medical diagnosis. (Irish Medicines Board, 2008). 3.3 Authorised Medicinal Product Under European and Irish legislation, all medicinal products must be authorised before being placed on the market. Medicinal products placed on the market in Ireland must be authorised by the Irish Medicines Board (IMB). Such products have a product authorisation issued by the IMB (PA Number) or, in the case of centrally authorised products an authorisation issued by the European Medicines Agency (EU Number).. This was previously referred to as a licensed medicinal product. 3.4 Unauthorised Medicinal Product Unauthorised Medicinal Products do not have a product authorisation for use in Ireland, and have not been assessed by the IMB against the criteria of safety, quality and efficacy. Schedule 1 of the Medicinal Products (Control of Placing on the Market) regulations 2007 includes an exemption for medical practitioners to prescribe unauthorised medicinal products for individual patients under their direct responsibility, in order to fulfil the special needs of those patients. Such products are defined as exempt medicinal products this was previously referred to as an unlicensed medicinal product. An RNP may not prescribe an unauthorised medicinal product Authorised Medicinal Product prescribed for an Unauthorised Indication The prescription of an authorised medicinal products for an unauthorised clinical indication is often described as off-label. Off label use of a medicine refers to the use of an authorised ( licensed ) medicinal product outside the terms of its product authorisation. The terms of the license are described in the summary of product characteristics (SPC) for each product. This is available online ( or directly from the PA holder. 2 Exempt medicinal product means a medicinal product to which paragraph 2 of Schedule 1 to the Medicinal Products (Control of Placing on the Market) Regulations 2007, or an equivalent legislation in any EEA State other than the Sate, applies ref SI 538/2007 and SI 539/2007). 6

7 Off label prescribing as defined above is not prohibited by the medicines regulations. The Medicinal Products (Control of Placing on the Market) Regulations 2007 as amended, does not prohibit the sale, supply, manufacture, possession or procuring the sale, supply manufacture of an authorised medicinal product for an unauthorised indication. It is permissible for an authorised medication to be supplied from a prescription issued by any prescriber (both Registered Medical Practitioner and RNP), including where the medication is to be used for an unauthorised indication (An Bord Altranais, 2010). 3.6 Clinical Indemnity Scheme The Clinical Indemnity Scheme (CIS) was established in July 2002 and is managed by the State Claims Agency. Under the scheme the state assumes full responsibility for the indemnification and management of all clinical negligence claims against enterprises and practitioners covered by the scheme. CIS cover applies equally to the prescription/use of licensed and unlicensed medicinal products (including the off licensed use of licensed medicinal products) providing the latter is used with the expressed knowledge and consent of the enterprises management. For further information see Appendix 2 and 3 and European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. The Agency is responsible for the scientific evaluation of applications for European marketing authorisations for both human and veterinary medicines (centralised procedure). Under the centralised procedure, companies submit a single marketing-authorisation application to the Agency. Once granted by the European Commission, a centralised (or Community ) marketing authorisation is valid in all European Union (EU) and EEA-EFTA states (Iceland, Liechtenstein and Norway). The capital Agency is involved in the scientific evaluation of the hundreds of medicines that fall within the scope of the centralised procedure. However, thousands of other medicines that do not fall within this scope are marketed in the European Union either in individual Member States, in accordance with their national authorisation procedures, or in multiple Member States through the decentralised or mutual-recognition procedures. The Agency only becomes involved in the assesment of such medicines when they have been referred to the Agency due to a disagreement between two or more Member States about the authorisation or use of the medicine, or due to some other issue that requires resolution in the interest of protecting public health. For further information see 7

8 Medicinal Product Authorisation - Information and Frequently Asked Questions for Registered Nurse Prescribers 4 Prescribing Medicinal Products Each RNP must have a thorough knowledge of the authorisation status of each medicinal product they are considering including within their prescribing authority. All medicinal products in Ireland can be divided into two categories Authorised Medicinal Product (formally know as licensed). Unauthorised Medicinal Product (formally know as unlicensed) now termed exempt medicinal product. RNPs may not prescribe an unauthorised medicinal product. An authorised medicinal product can be prescribed in two situations, for: Authorised indications - the terms of the authorisation from the IMB are described in the summary of product characteristics (SPC) for each product. The SPC for each product can be located on the IMB website. Unauthorised indication. Certain criteria must be fulfilled if an RNP is to prescribe an authorised medicinal product for an unauthorised indication. 4.1 Prescribing unauthorised medicinal products The prescribing of unauthorised medications by an RNP is not provided for in the current medicines regulation. The RNP is legally and professionally accountable and responsible for prescribing practices as mandated by the medicines legislation and the professional standards established by An Bord Altranais (2010) The Medicinal Products (Control of Placing on the Market) Regulations, provide statutory authority for a medical practitioner to treat a patient under his/her care, using unauthorised (known as exempted) medicinal products. It does not extend this authority to an RNP to issue a prescription for unauthorised medications. This action is outside the nurse/midwife scope of practice for prescriptive authority. A patient/service-user need for a prescription for an unauthorised medication should be referred to the appropriate medical practitioner. 4.2 RNPs prescribing authorised medicinal products for unauthorised indications The Department of Health and Children reviewed the relevant legislation in relation to off label medication prescribing and advised An Bord Altranais that there is no impediment in the relevant legislation and regulation to prevent an RNP prescribing an authorised medicinal product for an unauthorised indication, (i.e. off label). The issuing of a prescription for an unauthorised indication for an authorised medication must be in accordance with Regulation 5A of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 as amended. An Bord Altranais published further Practice Standards and Guidelines for Nurses and Midwives with Prescriptive Authority in Standard 7 addresses prescribing of unauthorised and off-label medications and provides guidance for practice to RNPs (p17). 8

9 In tandem with the legislative requirements the RNP should be aware of best practice guidance and organisational policy in considering whether to prescribe an off label medication. As with all decisions in prescribing of medications for patients and service users the use of off-label medications must be within the RNP s scope of prescribing practice. The RNP should be knowledgeable of best practice for prescribing an authorised medication for an unauthorised indication. This includes determining: if there is an alternative licensed medication that could be prescribed if the medication is regularly used to treat patient/service users in the RNP s area of clinical practice the listing of the specific medication within the health service provider s prescribing formulary and/or guidelines Newly authorised medications and medications being used in clinical trials should not be considered for unauthorised indication use by the RNP. The RNP should review the inclusion of any authorised medication to be used for an unauthorised indication for Attachment B (medication listing) of the CPA with the Collaborating Medical Practitioner(s) and the Drug and Therapeutic Committee. The health service provider s organisational policy for nurse/midwife prescribing should detail the process for reviewing and approving the use of authorised medications for unauthorised indications by a RNP (pp 17-18). The HSE developed a template for the statutory and voluntary services of the Health Service Executive (HSE) to assist in the decision making in authorising an RNP to prescribe an authorised (licensed) medicinal product in respect of an unauthorised indication (off-label). The form (see Appendix 1) provides a guide for health service providers in reviewing Attachment B of an RNPs Collaborative Practice Agreement (CPA) where the listing contains an authorised (licensed) medicinal product in respect of an unauthorised indication (i.e. off-label). An Bord Altranais supports the use of this template (or a similar tool) for all nurses and midwives with prescriptive authority to ensure the safety and quality of care for patients and service users requiring an off label medication for a clinical indication. 9

10 Medicinal Product Authorisation - Information and Frequently Asked Questions for Registered Nurse Prescribers 5 Frequently Asked Questions Q1: What are the legislation/regulations pertaining to Nurses and Midwife prescribing? Answer The primary legislation the Irish Medicines Board (Miscellaneous Provisions) Act 2006 provides for amendments to medicines regulations by Ministerial order for nurses and midwives to prescribe medications. The Medicinal Products (Prescription Control and Supply) (Amendment) Regulations, 2007 (Statutory Instrument, No. 201 of 2007) and the Misuse of Drugs (Amendment) Regulations, 2007 (S.I. No. 200 of 2007) signed into law on May specify the legislative requirements/conditions for prescribing of medicinal products by nurses and midwives. Q2: Who authorises medicinal products in Ireland? Answer The Irish Medicines Board (IMB) is the competent authority for authorisation of medicinal products in Ireland. Before a medicinal product can be authorised for use, an application must be made to the Irish Medicines Board and this must contain all of the necessary data supporting its quality, safety and efficacy. The role of the IMB is to protect and enhance public health by regulating medicines. Medicinal products can also be authorised by the European Medicines Agency (EMA) for use in Ireland. Q3: What is the difference between an authorised and unauthorised medicinal product? Answer: An authorised medicinal product is one which has been authorised by the Irish Medicines Board (IMB) or the European Medicines Agency (EMA) to be placed on the market in Ireland. An authorised medicinal product will always have a PA number or EU number clearly labelled on the outer and inner packaging. An unauthorised medicinal product has not been assessed by the IMB or EMA against the criteria of safety, quality and efficacy. Such a product will not have a PA number or EU number on the packaging. The legislation specifies that the responsibility for the clinical use of such products rests with the prescriber (Medicinal Products (Control of Placing on the Market) regulations 2007, SI 540 Schedule 1, Par 2). Q4: What is an unauthorised medicinal product? Answer: An unauthorised (exempt) medication has not been the subject of a marketing authorisation, certificate of registration or approved for licensing as per the Irish Medicines Board or the European Medicines Evaluation Agency. Schedule 1 of the Medicinal Products (Control of Placing on the Market) regulations 2007 includes an exemption for medical and dental practitioners to prescribe unauthorised medicinal products for individual patients under their direct responsibility, in order to fulfil the special needs of those patients. An RNP may not prescribe an exempt medicinal product. Q5: Can RNPs prescribe unauthorised medicinal products? Answer No. The Medicinal Products (Control of Placing on the Market) Regulations, provide statutory authority for a medical practitioner to treat a patient under his/her care, using unauthorised (known as exempted) medicinal products. It does not extend this authority to a registered nurse prescriber to issue a prescription for unauthorised medication. This action is outside the nurse/midwife scope of practice for prescriptive authority. A patient/service-user need for a prescription for an unauthorised medication should be referred to the appropriate medical practitioner. 10

11 Q6: Can a registered medical doctor/dentist prescribe or use an unauthorised medicinal product? Answer: Yes, according to Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations 2007, a registered medical practitioner/dentist may prescribe an unauthorised medicinal product for the treatment of individual patients under his direct personal responsibility, in order to fulfil the special needs of those patients. There are several conditions restricting the supply in the above-mentioned Schedule 1. It should be noted that the use of unauthorised medicinal products falls within the professional responsibility of the prescriber. Q7: What are unauthorised (off label) indications? Answer: Off label use of an authorised medicinal product typically occurs when a product is prescribed for: An unapproved indication/disease At a dose outside of approved range or frequency Via an unapproved route For an unapproved duration In a patient group (e.g. children) for whom it is not approved Q8: Can RNPs prescribe off label medicinal products? Answer Yes subject to certain criteria. The Department of Health and Children in 2010 reviewed the relevant medicines legislation and has advised that there is no impediment in the relevant legislation and regulations to prevent a registered nurse from issuing a prescription (in accordance with Reg 5A of the Medicinal Products (Prescription and control of Supply) Regulations 2003 as amended) for an authorised (licensed) medicinal product in respect of an unauthorised indication (i.e. off-label). Therefore RNPs may be authorised by their employer to prescribe authorised medicinal products for an unauthorised clinical indication (i.e. off-label) once they come within their scope of practice, and the nurse/midwife prescriber is cognisant of best practice in the prescribing of off label medications. Q9: Where can I find out if a medicinal product is authorised or unauthorised? Answer: You can search the Human Medicines Products Listing on the IMB website at this provides a listing of all medicinal products authorised for use in Ireland. If the product is not authorised it will not appear on the listing. The summary of product characteristics (SPC) for each authorised medicinal product is available through the search function. If you are unclear of the authorisation status of a particular medicinal product you should check this with your supplying pharmacist. Q10: Can a registered medical doctor/dentist use a medicine off-label? Answer: Yes. However, such use cannot be considered to be within the terms of the product authorisation as issued by the IMB and as such is outside the remit of the IMB. It should be noted that such use falls within the professional responsibility of the prescriber. 11

12 Medicinal Product Authorisation - Information and Frequently Asked Questions for Registered Nurse Prescribers References An Bord Altranais (2010). Practice Standards and Guidelines for Nurse and Midwives with Prescriptive Authority. Dublin: An Bord Altranais. An Bord Altranais (2007). Collaborative Practice Agreement (CPA) for Nurses and Midwives with Prescriptive Authority. Dublin: An Bord Altranais. An Bord Altranais (2007). Guidance to Nurse and Midwives on Medication Management. Dublin: An Bord Altranais. An Bord Altranais (2007). Decision Making Framework for Nurse and Midwife Prescribing. Dublin: An Bord Altranais. An Bord Altranais (2007). Requirements and Standards for Education Programmes for Nurses and Midwives with Prescriptive Authority. Dublin: An Bord Altranais. Department of Health and Children (2008) Building a Culture of Patient Safety: Report of the Commission on Patient Safety and Quality Assurance. Dublin: The Stationery Office. Drennan J., Naughton, C., Allen, D., Hyde, A., Feele, P., O Boyle, K., Treacy, P., and Butler, M. (2009). National Independent Evaluation of the Nurse and Midwife Prescribing Initiative. Dublin: University College Dublin. Irish Medicines (Miscellaneous Provision) Act 2006 (Commencement) Order Dublin: Stationery Office. Irish Medicines Board (Miscellaneous Provision) Act 2006 (No. 3 of 2006). Dublin: Stationery Office. Irish Medicines Board (2008). IMB Guide to the Definition of a Human Medicine. Dublin: Irish Medicines Board. Medicinal Products (Control of Placing on the Market) Regulations Dublin: Stationery Office. Medicinal Products (Control of Wholesale Distribution) Regulations 2007, Statutory Instrument No. 538 of Dublin: Stationery Office. Medicinal Products (Control of Manufacture) Regulations 2007, Statutory Instrument No. 539 of Dublin: Stationery Office. Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007, Statutory Instrument No. 201 of Dublin: Stationery Office. Medicinal Products (Prescription and Control of Supply) Regulations Statutory Instrument No. 540 of 2003 (as amended 2005, 2007 and 2008). Dublin: Stationery Office. Misuse of Drugs (Amendment) Regulations 2007, Statutory Instrument No. 200 of Dublin: Stationery Office. Office of the Nursing Services Director (2008). Guiding Framework for the Implementation of Nurse and Midwife Prescribing in Ireland. Dublin: Office of the Nursing Services Director, Health Service Executive. State Claims Agency (2008). Nurse and Midwife Prescribing. Dublin: Clinical Indemnity Scheme. State Claims Agency (2010). Unlicensed and off Licence Use of Licensed Medicinal Products. Dublin: Clinical Indemnity Scheme. 12

13 Appendix 1 Nurse and Midwife Medicinal Product Prescribing Template HSE RNP Guidance Process Regarding the Prescribing of Medications for Off Label use Process for the Statutory and Voluntary Services of the Health Service Executive (HSE) to authorise Registered Nurse Prescribers (RNPs) to prescribe an authorised (licensed) medicinal product in respect of an unauthorised indication (off-label) Introduction This document provides a guide for health service providers in reviewing Attachment B of an RNPs Collaborative Practice Agreement (CPA) where the listing contains an authorised (licensed) medicinal product in respect of an unauthorised indication (i.e. off-label). Background Arising from the recommendations of the National Independent Evaluation of the Nurse and Midwife Prescribing Initiative (Drennan et al 2009) the Department of Health and Children reviewed the relevant medicines legislation and has advised that there is no impediment in the relevant legislation and regulations to prevent a registered nurse from issuing a prescription (in accordance with Reg 5A of the Medicinal Products (Prescription and control of Supply) Regulations 2003 as amended) for an authorised (licensed) medicinal product in respect of an unauthorised indication (i.e. off-label). RNPs employed in the statutory and voluntary services of the HSE may be authorised by their employer to prescribe authorised medicinal products for an unauthorised clinical indication (i.e. off-label) once they come within their scope of practice, and the nurse/midwife prescriber is cognisant of best practice in the prescribing of off label medications. The State Claims Agency has confirmed that the Clinical Indemnity Scheme (CIS) cover applies equally to the prescription/use of licensed or unlicensed medicinal products providing that the latter are used with the express knowledge and consent of the enterprises management (see Appendix 2). 13

14 Medicinal Product Authorisation - Information and Frequently Asked Questions for Registered Nurse Prescribers Section 1: To be completed by Candidate/RNP Please complete all sections and answer the questions below 1 Name of Candidate/RNP Personal Identification Number (PIN) 2 Clinical area(s) of practice 3 Name of medicinal product 4 Dose, route, form 5 Clinical indication for off-label prescription of the authorised medicinal product 6 Rationale for inclusion of off label medicinal product on my Collaborative Practice Agreement (CPA) (evidence base must be included/attached) 7 Is this medicinal product regularly used to treat patients/service users in my area of clinical practice? 8 Is this medicinal product included in the organisations prescribing guidelines? 9 Is there an alternative authorised medicinal product that could be prescribed? If the answer is YES the Candidate/RNP must not submit this form for authorisation 10 Is this a new medicinal product? If the answer is YES the Candidate/RNP must not submit this form for authorisation 11 Is this medicinal product on clinical trial? If the answer is YES the Candidate/RNP must not submit this form for authorisation Signature of Candidate/RNP: Include Date 14

15 Collaborating Medical Practitioners Support This form should be discussed with the relevant Collaborating Medical Practitioner(s) I support the inclusion of the above off label medicinal product (ordinarily used in the clinical setting) on the Collaborative Practice Agreement setting out the RNPs scope of practice and prescriptive authority Signature of Collaborating Medical Practitioner: Include Date I support the inclusion of the above off label medicinal product (ordinarily used in the clinical setting) on the Collaborative Practice Agreement setting out the RNPs scope of practice and prescriptive authority Signature of Collaborating Medical Practitioner: Include Date I support the inclusion of the above off label medicinal product (ordinarily used in the clinical setting) on the Collaborative Practice Agreement setting out the RNPs scope of practice and prescriptive authority Signature of Collaborating Medical Practitioner: Include Date Section 2: To be reviewed by the Drugs and Therapeutics Committee Please complete all sections and answer the questions below 1 Name of medicinal product 2 The medicinal product is regularly used to treat patients/service users in the Candidate/RNPs clinical area of practice? 3 The medicinal product is included in the organisations prescribing guidelines? 4 Is this medicinal product licensed for use in any European Country or other international country? (please specify the country and authorising authority) 5 There is no alternative authorised medicinal product that could be prescribed? 15

16 Medicinal Product Authorisation - Information and Frequently Asked Questions for Registered Nurse Prescribers 6 This is not a new medicinal product? 7 The medicinal product is not on clinical trial? 8 Is the committee satisfied with the prescribing information, safety profile and appropriateness of the proposed clinical indications for prescribing the off label medicinal product? 9 Is there a clear rationale and evidence base for this medicinal product to be prescribed by this RNP? The committee has reviewed and considered the information supplied and support the inclusion of the authorised medicinal product in respect of an unauthorised indication (off label) on the RNPs Collaborative Practice Agreement Signature of Chair of Drugs and Therapeutics Committee: Include Date Section 3: Authorisation This Candidate/RNP is authorised to include this authorised medicinal product in respect of an unauthorised indication (off label) on their Collaborative Practice Agreement and when registered as an RNP is authorised to prescribe the medicinal product within their scope of practice and the organisations prescribing policy. Name of Medicinal Product Name of RNP Clinical Area of Practice Signature of authorised representative of Health Service Employer: (Chief Executive Officer/Medical Director/Director of Nursing/Midwifery/Public Health Nursing) Include Date This form is available to download from the web site at 16

17 Appendix 2 Clinical Indemnity Scheme State Claims Agency Unlicensed and Off License Use of Licensed Medicinal Products The Clinical Indemnity Scheme (CIS) was established in July 2002 and is managed by the State Claims Agency. Under the scheme, the State assumes full responsibility for the indemnification and management of all clinical negligence claims against enterprises and practitioners covered by the scheme. For more information on which enterprises are covered by the scheme, please go to The Clinical Indemnity Scheme (CIS) provides indemnity to hospitals/enterprises and, vicariously, practitioners in respect of a suit for personal injuries brought by a person alleging negligence, statutory or at common law, in respect of the provisions of, or failure to provide, professional medical services. CIS cover applies equally to the prescription/use of licensed and unlicensed medicinal products (including the off-license use of licensed medicinal products) providing the latter is used with the express knowledge and consent of the enterprise s management. It is a policy issue for the hospital/enterprise, and any regulatory body, to decide whether or not to sanction the use of unlicensed medicines (including the off-license use of licensed medicinal products) The CIS does not lay down any guidelines in relation to this. The CIS does not provide representation for clinical staff in relation to fitness to practice issues. In that regard, the State Claims Agency advises clinical staff to purchase additional benefits cover, specifying cover in respect of criminal and fitness to practise matters, from a relevant defence organisation. For any queries regarding this please contact info@stateclaims.ie March 2010 Treasury Building, Grand Canal Street, Dublin 2, Ireland Telephone Facsimile info@stateclaims.ie Website 17

18 Medicinal Product Authorisation - Information and Frequently Asked Questions for Registered Nurse Prescribers Appendix 3 18

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20 ISBN Health Service Executive March 2011 Office of the Nursing & Midwifery Services Director Health Service Executive Dr Steevens Hospital Dublin 8 Ireland telephone: nursing.services@hse.ie