Time for an evidence review of OTC analgesics?
This SelfCare week, 18-22 November, a new survey published in SelfCare reveals that pharmacist perceptions do not always reflect the clinical evidence around over the counter (OTC) analgesics including ibuprofen.
Key findings from Pharmacist Survey
- 76% (n=221) of pharmacists believe OTC / branded ibuprofen should always be taken during or after food[1]
- 65% (n=242) of pharmacists believe paracetamol is safer than ibuprofen with 58% (n=236) believing that the risks of prescription-strength ibuprofen can be transferred to OTC doses 1
- Only 13% of pharmacists believe paracetamol is more effective than OTC / branded ibuprofen yet most pharmacists (89%) still recommend paracetamol as their first-line choice (n=251)1
Key conclusions from SelfCare
- Pharmacist advice on taking OTC ibuprofen with food and not recommending for patients with minor GI issues and asthma contradicts the evidence1
- Pharmacist beliefs around ibuprofen extrapolated from prescription use rather than OTC evidence base1
- Improved education on safety and efficacy of analgesics in the OTC environment is required to ensure patients receive advice that optimises outcomes1
The role of the community pharmacist in promoting self-care has become increasingly important in recent times, with the number of services expanding, due to the increased pressure experienced by GPs and the spiralling costs to the NHS.[2] With 79% of the population of Great Britain having a pharmacy within one kilometre of their home[3], they are now recognised as being the most accessible healthcare professional.
Painful conditions are currently among the most commonly presenting minor ailments in general practice2, and the scope for pharmacy input in supporting self-care for these is evident; so, it is vital that pharmacists and pharmacy support staff have relevant and evidence-based knowledge to inform their practice.1 A recent survey by the Royal Pharmaceutical Society (RPS) revealed nearly a third believe they have insufficient knowledge around different mechanisms of action, doses and contraindications for OTC analgesics.[4]
Against this backdrop, a new online survey, run by IQVIA (formerly IMS Health) and funded by Reckitt Benckiser (RB) was conducted with 242 UK community pharmacists to explore OTC analgesic recommendations for specific pain states, and to understand their perceptions of analgesic efficacy and safety, in general, and in specific patient populations such as people with asthma.1
Results of the survey highlight the disconnect between pharmacist perceptions on OTC analgesic safety and efficacy:
Efficacy
· Just 13% of pharmacists believe paracetamol was more effective than OTC / branded ibuprofen, even though paracetamol was still most pharmacists’ first-line recommendation (89%) (n=251)1
· More recommendations were made for paracetamol (branded 41%, generic 24%) for the treatment of headache/migraine in comparison to ibuprofen (branded 17%, generic 18%) (n=251)1
Safety
· Most pharmacists (76%) believe that OTC / branded ibuprofen should always be taken with or after food (n=221)1
· Nearly two thirds of pharmacists (65%) believe paracetamol is safer than ibuprofen (n=242), with half of pharmacists believing OTC / branded ibuprofen is not as well tolerated as paracetamol (n=235)1
Patient populations
· Over 80% of pharmacists (86%) would never or infrequently recommend branded ibuprofen to patients suffering with minor GI problems (e.g. indigestion, heartburn or dyspepsia) (n=242)1
o 43% of pharmacists believe OTC / branded ibuprofen causes gastrointestinal (GI) bleeding (n=242)1
· More than three quarters of pharmacists (77%) would never or infrequently recommend branded ibuprofen to patients suffering with asthma (n=242)1
Commenting on the results, Fin McCaul, Owner of Prestwich Pharmacy and co-author of the publication said:
“Results show that pharmacists’ perceptions of analgesic safety and efficacy do not reflect the existing evidence base for OTC use, which may negatively impact on patient outcomes and satisfaction with pharmacy advice.
Pharmacists’ beliefs around ibuprofen are extrapolated from prescription use, rather than the OTC evidence base, which demonstrates comparable safety for ibuprofen and paracetamol at OTC doses. Pharmacists’ advice on taking OTC ibuprofen with food and not recommending for patients with minor GI issues or asthma also contradicts the evidence and Summary of Product Characteristics.” *
Terry Maguire, Senior Lecturer at School of Pharmacy, Queen’s University Belfast, Community Pharmacist and Investigator of the research added:
“The results demonstrate that improved pharmacy education on the safety and efficacy of analgesics in the OTC environment is required to ensure patients receive advice that optimises clinical outcomes and reduces the risk of dissatisfaction with pharmacists’ recommendations.
It is vital that pharmacists have access and training on the latest clinical evidence in over the counter (OTC) medication to ensure that patients are receiving the best advice from their pharmacists and effectively managing their pain.”
To support the continual education of pharmacists and the management of pain, Nurofen have created a series of educational resources which are available on the RB for Health platform and accredited by the Royal Pharmaceutical Society. The RB ‘Pharmacy Training Partner’ supports pharmacists by providing quick and easy training modules based on clinical evidence and designed to fit in with busy working life. Topics covered in the modules include how to manage and treat headaches, muscle pain, joint pain and back pain.
Commenting on the RB for Health platform, Cornelia Hersch, Global Professional Marketing, RB, said:
“At RB, we have an ongoing commitment to improve everyday pain management by supporting education into the science of pain and increasing expert knowledge and general public awareness of the latest developments. We hope that our Health platform, will support and empower pharmacists to make confident recommendations and give practical self-help advice that will help consumers to manage minor ailments and everyday pain”.
*Consumers who have experienced previous reactions to NSAIDs, or who have a history of, or active GI ulcer or haemorrhage, should not be given ibuprofen. It can be taken in patients with minor GI problems (e.g. indigestion, heartburn or dyspepsia) or asthma that have not previously shown prior sensitivity to NSAIDs, when taken under pharmacist or physician supervision. Please refer to specific individual product SPCs for further information.
Pharmacists perceptions vs the evidence
Efficacy
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Survey result |
The evidence |
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· Some UK and EU guidelines suggest paracetamol is less effective than non-steroidal anti-inflammatory drug (NSAIDs) in tension-type headache[6],[7] · The European Federation of Neurological Societies (EFNS) recommends ibuprofen 400 mg (amongst the NSAIDs) for tension-type headaches[8]
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Safety
|
Survey result |
The evidence |
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· Most pharmacists (76%) believe that OTC / branded ibuprofen should always be taken with or after food (n=221)1 |
· While it is widely thought that food has a gastroprotective effect, for OTC ibuprofen, there is no evidence that food offers gastroprotective benefits[9],[10]
· In 38 clinical studies completed between 1972-2012 and involving around 900 participants (874), it was shown that taking ibuprofen with food significantly delays absorption. This may reduce analgesic efficacy and increase the chance of needing of additional doses or different analgesics to manage a patients pain.[11]
*OTC ibuprofen does not need to be taken with food unless a patient is specifically advised to by a healthcare professional. Check individual SPCs for specific administration instructions |
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· Nearly two thirds of pharmacists (65%) believe paracetamol is safer than ibuprofen (n=242) with half of pharmacists believing OTC / branded ibuprofen is not as well tolerated as paracetamol (n=235)1
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· Data shows that, at OTC dose and in OTC use, when used in accordance with the Summary of Product Characteristics (SmPC), the adverse event rate of OTC ibuprofen is comparable to paracetamol in adults1 · One study found, when used at OTC dose for up to seven days, ibuprofen was statistically equivalent to paracetamol in total adverse event rates (13.7% and 14.5%, respectively)[12]
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Patient populations
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Survey result |
The evidence |
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· Ibuprofen can be an effective option for patients with minor GI problems that have not previously shown prior sensitivity to NSAIDs*, when taken under pharmacist or physician supervision
*Consumers who have experienced previous reactions to NSAIDs or have a history or active GI ulcer or haemorrhage should not be given ibuprofen. Check individual SPCs for specific administration instructions |
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· 43% of pharmacists believe OTC / branded ibuprofen causes gastrointestinal (GI) bleeding (n=242)1 |
· One study found that OTC dose ibuprofen (≤ 1,200 mg) had a similar odds ratio (1.1) to paracetamol (2,000-3,999 mg; OR 1.2) for upper GI bleeds, with a dose-response relationship resulting in increased risk at higher, non-OTC doses[13] |
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· Ibuprofen can be an effective option for patients with asthma that have not previously shown prior sensitivity to NSAIDs*, when taken under pharmacist or physician supervision · According to the Global Initiative on Asthma, only a small population of asthma sufferers (7% in general adult asthma populations or 15% in cases of severe asthma) experience asthma-exacerbated responses when taking NSAIDs such as ibuprofen[14]
*Consumers who have experienced previous reactions to NSAIDs should not be given ibuprofen. Check individual SPCs for specific administration instructions |
About Nurofen
Nurofen is the original OTC ibuprofen, bringing the pioneering benefits of ibuprofen to consumers for the first time, and has been providing effective pain relief to millions of families ever since.
Since its launch in 1983, Nurofen has continuously invested in research and development to find innovative ways to target everyday pain better. Over the years, Nurofen has brought many pioneering pain relief moments to consumers, for example, with the first clinically proven ibuprofen patch to continuously target pain and inflammation at the source for 24 hours.[15]
Beyond product innovation is Nurofen’s ongoing commitment to improve everyday pain management by supporting education into the science of pain and increasing expert and general public awareness of the latest developments in self-care. The RB for Health Platform which is accredited by the Royal Pharmaceutical Society, supports pharmacists to improve everyday pain management and advance their customers self-care.
NUROFEN PAIN RELIEF 200mg SOFT CAPSULES: Ibuprofen 200mg/capsule. Indications: Relief of rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza. Legal category: GSL. MA Holder: Reckitt Benckiser Healthcare (UK) Ltd, SL1 3UH. Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at: https://www.medicines.org.uk/emc/product/5089
NUROFEN JOINT & MUSCULAR PAIN RELIEF 200mg MEDICATED PLASTER: Ibuprofen 200mg. Indications: Short-term symptomatic treatment of local pain in acute muscular strains, or sprains in benign traumas close to the joint of the upper or lower limb in adults or adolescents aged 16 years and older. Legal category: P. MA Holder: Reckitt Benckiser Healthcare (UK) Ltd, SL1 3UH. Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at: https://www.medicines.org.uk/emc/product/9321
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.mhra.gov.uk Adverse events should also be reported to Reckitt Benckiser Healthcare (UK) ltd on: 0333 200 5345.
About Ibuprofen
Ibuprofen has been benefiting millions of people around the world, for the last 50 years.
With its distinct triple-action, it targets pain, inflammation and fever and has been proven to be an effective treatment.
Initially developed to overcome the challenges associated with aspirin for rheumatoid arthritis, it was later perceived to be the ideal analgesic for mild to moderate pain.
About the Survey and SelfCare Paper
The survey and paper investigated recommendations and perceptions of OTC analgesics among pharmacists in the UK. It includes an analysis of an exploratory online survey of 242 UK community pharmacists to better understand their perceptions of analgesic efficacy and safety.1 The paper was co-authored by a variety of specialists working in organisations, universities and pharmacies across the UK. Specialists included Fin McCaul, Managing Director of Prestwich Pharmacy, Manchester, and Founder of the Independent Pharmacy Federation; Cornelia Hersch, RB; Sunil Kochhar, Pharmacist at Regent Pharmacies, Gravesend; Terence Maguire, Owner, Maguire Pharmacy, Honorary Senior Lecturer at Queen’s University Belfast, and Past President of the Pharmaceutical Society of Northern Ireland; Andy Tisman, Global Senior Principal Consumer Health, IQVIA, London; and Alyson Brown, Lecturer at the School of Pharmacy and Life Sciences, Robert Gordon University, Aberdeen.1
About the RPS Survey
The Pharmaceutical Journal surveyed members of the RPS to better understand how pharmacists and related staff consult with patients with acute pain. 1,000 members responded but not all answered every question.4 Their findings provide insight into how pharmacists feel about discussing the management of acute pain with patients and how pharmacists support patients to self-manage their condition.4
[15] Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster SmPC. EMC. Available from: https://www.medicines.org.uk/emc/product/9321/smpc (Last accessed: May 2019).
[13] Lewis SC, Langman MJS, Laporte J, Matthews JNS, Rawlins MD, Wiholm BE. Dose – response relationships between individual non-aspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) and serious upper gastrointestinal bleeding: a meta-analysis based on individual patient data. Br J Clin Pharmacol. 2002;54(3):320-6.
[14] Global Initiative for Asthma. Global strategy for asthma management and prevention. Updates 2019. Available from: https://ginasthma.org/wp-content/uploads/2019/06/GINA-2019-main-report-June-2019-wms.pdf (Last accessed: July 2019)
[9] Rainsford KD, Bjarnason I. NSAIDs: Take with food or after fasting? J Pharm Pharmacol. 2012;64(4):465–9.
[10] Bjarnason I. Gastrointestinal safety of NSAIDs and over-the-counter analgesics. Int J Clin Pract Suppl. 2013;67(178):37–42.
[11] Moore RA, Derry S, Wiffen PJ, Straube S. Effects of food on pharmacokinetics of immediate release oral formulations of aspirin, dipyrone, paracetamol and NSAIDs - A systematic review. Br J Clin Pharmacol. 2015;80(3):381–8.
[12] Moore N, Van Ganse E, Le Parc J-M, et al. The PAIN Study: Paracetamol, Aspirin and Ibuprofen New tolerability study. A large-scale, randomised clinical trial comparing the tolerability of aspirin, ibuprofen and paracetamol for short-term analgesia. Clin Drug Invest. 1999; 18:89–98.
[5] Moore, RA, Derry, S. Aldington, D. Wiffen P. Single dose oral analgesics for acute postoperative pain in adults – an overview of Cochrane reviews. Cochrane Database Syst Rev. 2015; Issue 9.Art. No.:CD008659.DOI:10. 1002/14651858.CD008659.pub3.
[6] British Association for the Study of Headache. Guidelines for all healthcare professionals in the diagnosis and management of: migraine, tension-type headache, cluster headache and medication-overuse headache. 3rd edition (1st revision). 2010.
[7] Steiner TJ, Martelletti P. Aids for management of common headache disorders in primary care. J Headache Pain. 2007;8(S1):1–47.
[8] Bendtsen L, Evers S, Linde M, Mitsikostas DD, Sandrini G, Schoenen J. EFNS guideline on the treatment of tension-type headache - Report of an EFNS task force. Eur J Neurol. 2010;17(11):1318–25.
[1] McCaul F, Hersch C, et al. Do pharmacists’ perceptions of OTC analgesia reflect existing evidence? An exploratory survey of UK community pharmacists’ views and opinions of the use of over-the-counter (OTC) analgesics, SelfCare 2019;10(3):79-92
[2] Pillay N, Tisman A, Kent T, et al. The economic burden of minor ailments on the National Health Service (NHS) In the UK. SelfCare. 2010;1(3):105–16.
[3] Office of fair trading, The Control of Entry Regulations and Retail Pharmacy Services in the UK. A report of an OFT market investigation. January 2003.
[4] Robinson J. Pharmacists should do more to help patients with OTC analgesics, experts say. Pharm J 2019;302(7922):81–83. doi: 10.1211/PJ.2019.20205474.
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