Vol 52 | No 6 | June 2014
CME/CPD section inside ▶
Downloaded from http://dtb.bmj.com/ on August 11, 2015 - Published by group.bmj.com
62 DTB Select: 6 - June 2014 66 Relvar Ellipta for COPD
69 Prescribing drugs for Alzheimer’s disease in primary care: managing cognitive symptoms
Implementing drug safety updates In August 2007, the Medicines and Healthcare products Regulatory Agency (MHRA) launched its monthly Drug Safety Update.1 As would be expected from a publication produced by the MHRA, it is based on robust analysis of pharmacovigilance data and evidence, and has received NHS Evidence accreditation. Drug Safety Update has established itself as one of the most influential sources of new information about the safety of medicines for UK-based healthcare professionals. Articles describe the nature of the safety problem and in the majority of cases outline what actions should be taken to mitigate the identified risk. However, on occasion safety notices have not included any practical implementation advice. Although rare, such omissions can create significant challenges for healthcare professionals who are left uncertain as to the appropriate action and the degree of urgency. As a result, it may lead to an inconsistent, fragmented or delayed response. In June 2013, Drug Safety Update reported that codeine should no longer be used in patients aged under 12 years. 2 This advice was based on an evaluation of the benefit and safety profile following deaths of several children in North America. However, no guidance was given on suitable alternatives to codeine, the comparative safety of other drugs or the timescale for implementation. In November 2013, the Royal College of Paediatric Child Health in association with the Royal College of Anaesthetists and the Association of Paediatric Anaesthetists issued guidance on alternative opioid analgesics in children. 3 They noted that different approaches to implementing the MHRA’s advice were being employed across the UK, with some centres continuing to use codeine, albeit with increased caution, while others had switched to oral
morphine, dihydrocodeine, oxycodone or tramadol. The authors questioned whether such drugs are safer than codeine. Recommendations issued in November 2013, relating to brand prescribing of antiepileptic medicines4 advised that patients taking phenytoin, carbamazepine, phenobarbital or primidone for epilepsy should be maintained on a specific manufacturer’s product. To implement the guidance would require clinicians and pharmacists to identify which manufacturer’s products their patients are currently receiving and then make arrangements for all pharmacies to routinely stock such products. Alternatively, specialists, GPs and pharmacists would need to reach agreement that all local dispensaries will stock a particular manufacturer’s products before switching all patients to those products. Given the current fluidity of NHS networks and the fragility of the pharmaceutical supply chain, neither option appears to be particularly achievable. When the MHRA issues guidance that practice needs to change in light of new safety information, there is an expectation that it will be implemented immediately in order to reduce risk to patients (and avoid potential litigation). This is in contrast to other types of national guidance for which there is usually consultation beforehand and a defined period to deliver an implementation plan. Although in most circumstances safety alerts do provide sufficient information to support immediate action, there are occasions when they fail to do so. Leaving healthcare professionals without a clear indication of the severity, urgency and appropriate course of action increases the risk of a fragmented and incomplete response. We would therefore urge regulatory authorities to ensure that each safety alert is accompanied by a prioritised implementation plan that is robust, practical and achievable within a clearly defined timeframe.
1. Medicines and Healthcare products Regulatory Agency, 2014. Drug Safety Update index [online]. Available: http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/ index.htm [Accessed 21 May 2014]. 2. Medicines and Healthcare products Regulatory Agency. Codeine for analgesia: restricted use in children because of reports of morphine toxicity. Drug Safety Update 2013; 6 (12): A1 [online]. Available: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON296400 [Accessed 21 May 2014]. 3. Royal College of Anaesthetists, Association of Paediatric Anaesthetists and Royal College of Paediatric Child Health, 2013. Guidance for the administration of codeine and alternative opioid analgesics in children [online]. Available: http://www.apagbi.org.uk/sites/default/files/images/Codeine_Nov2013.pdf [Accessed 21 May 2014]. 4. Medicines and Healthcare products Regulatory Agency. Antiepileptic drugs: new advice on switching between different manufacturers’ products for a particular drug. Drug Safety Update 2013; 7 (4): A1 [online]. Available: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON336716 [Accessed 21 May 2014].
DOI: 10.1136/dtb.2014.6.0256
To comment on material published in DTB, please email [email protected]
[email protected]
Downloaded from http://dtb.bmj.com/ on August 11, 2015 - Published by group.bmj.com
Implementing drug safety updates
DTB 2014 52: 61
doi: 10.1136/dtb.2014.6.0256 Updated information and services can be found at: http://dtb.bmj.com/content/52/6/61
These include:
Email alerting service
Topic Collections
Receive free email alerts when new articles cite this article. Sign up in the box at the top right corner of the online article.
Articles on similar topics can be found in the following collections Contraindications and precautions (17) Medicines regulation (11) Safety (18) Warnings, precautions and contraindications (18) Public health (199) Paediatrics (59) Drug interactions (7) Drug interactions (7) Toxicology (14) Unwanted effects / adverse reactions (20) Psychiatry (86) Health Policy (10) Health service research (10) Infections (174) Malignant disease and immunosuppression (205) Musculoskeletal and joint disorders (103) Neurology (154) Neurology (drugs and medicines) (18) Anaesthesia (17)
Notes
To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/
CME/CPD section inside ▶
Downloaded from http://dtb.bmj.com/ on August 11, 2015 - Published by group.bmj.com
62 DTB Select: 6 - June 2014 66 Relvar Ellipta for COPD
69 Prescribing drugs for Alzheimer’s disease in primary care: managing cognitive symptoms
Implementing drug safety updates In August 2007, the Medicines and Healthcare products Regulatory Agency (MHRA) launched its monthly Drug Safety Update.1 As would be expected from a publication produced by the MHRA, it is based on robust analysis of pharmacovigilance data and evidence, and has received NHS Evidence accreditation. Drug Safety Update has established itself as one of the most influential sources of new information about the safety of medicines for UK-based healthcare professionals. Articles describe the nature of the safety problem and in the majority of cases outline what actions should be taken to mitigate the identified risk. However, on occasion safety notices have not included any practical implementation advice. Although rare, such omissions can create significant challenges for healthcare professionals who are left uncertain as to the appropriate action and the degree of urgency. As a result, it may lead to an inconsistent, fragmented or delayed response. In June 2013, Drug Safety Update reported that codeine should no longer be used in patients aged under 12 years. 2 This advice was based on an evaluation of the benefit and safety profile following deaths of several children in North America. However, no guidance was given on suitable alternatives to codeine, the comparative safety of other drugs or the timescale for implementation. In November 2013, the Royal College of Paediatric Child Health in association with the Royal College of Anaesthetists and the Association of Paediatric Anaesthetists issued guidance on alternative opioid analgesics in children. 3 They noted that different approaches to implementing the MHRA’s advice were being employed across the UK, with some centres continuing to use codeine, albeit with increased caution, while others had switched to oral
morphine, dihydrocodeine, oxycodone or tramadol. The authors questioned whether such drugs are safer than codeine. Recommendations issued in November 2013, relating to brand prescribing of antiepileptic medicines4 advised that patients taking phenytoin, carbamazepine, phenobarbital or primidone for epilepsy should be maintained on a specific manufacturer’s product. To implement the guidance would require clinicians and pharmacists to identify which manufacturer’s products their patients are currently receiving and then make arrangements for all pharmacies to routinely stock such products. Alternatively, specialists, GPs and pharmacists would need to reach agreement that all local dispensaries will stock a particular manufacturer’s products before switching all patients to those products. Given the current fluidity of NHS networks and the fragility of the pharmaceutical supply chain, neither option appears to be particularly achievable. When the MHRA issues guidance that practice needs to change in light of new safety information, there is an expectation that it will be implemented immediately in order to reduce risk to patients (and avoid potential litigation). This is in contrast to other types of national guidance for which there is usually consultation beforehand and a defined period to deliver an implementation plan. Although in most circumstances safety alerts do provide sufficient information to support immediate action, there are occasions when they fail to do so. Leaving healthcare professionals without a clear indication of the severity, urgency and appropriate course of action increases the risk of a fragmented and incomplete response. We would therefore urge regulatory authorities to ensure that each safety alert is accompanied by a prioritised implementation plan that is robust, practical and achievable within a clearly defined timeframe.
1. Medicines and Healthcare products Regulatory Agency, 2014. Drug Safety Update index [online]. Available: http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/ index.htm [Accessed 21 May 2014]. 2. Medicines and Healthcare products Regulatory Agency. Codeine for analgesia: restricted use in children because of reports of morphine toxicity. Drug Safety Update 2013; 6 (12): A1 [online]. Available: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON296400 [Accessed 21 May 2014]. 3. Royal College of Anaesthetists, Association of Paediatric Anaesthetists and Royal College of Paediatric Child Health, 2013. Guidance for the administration of codeine and alternative opioid analgesics in children [online]. Available: http://www.apagbi.org.uk/sites/default/files/images/Codeine_Nov2013.pdf [Accessed 21 May 2014]. 4. Medicines and Healthcare products Regulatory Agency. Antiepileptic drugs: new advice on switching between different manufacturers’ products for a particular drug. Drug Safety Update 2013; 7 (4): A1 [online]. Available: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON336716 [Accessed 21 May 2014].
DOI: 10.1136/dtb.2014.6.0256
To comment on material published in DTB, please email [email protected]
[email protected]
Downloaded from http://dtb.bmj.com/ on August 11, 2015 - Published by group.bmj.com
Implementing drug safety updates
DTB 2014 52: 61
doi: 10.1136/dtb.2014.6.0256 Updated information and services can be found at: http://dtb.bmj.com/content/52/6/61
These include:
Email alerting service
Topic Collections
Receive free email alerts when new articles cite this article. Sign up in the box at the top right corner of the online article.
Articles on similar topics can be found in the following collections Contraindications and precautions (17) Medicines regulation (11) Safety (18) Warnings, precautions and contraindications (18) Public health (199) Paediatrics (59) Drug interactions (7) Drug interactions (7) Toxicology (14) Unwanted effects / adverse reactions (20) Psychiatry (86) Health Policy (10) Health service research (10) Infections (174) Malignant disease and immunosuppression (205) Musculoskeletal and joint disorders (103) Neurology (154) Neurology (drugs and medicines) (18) Anaesthesia (17)
Notes
To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/
