Medicines Q&As Q&A 353.2 Should my patient buy that “miraculous cure” advertised on the internet or in a magazine? Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals Before using this Q&A, read the disclaimer at www.ukmi.nhs.uk/activities/medicinesQAs/default.asp Date prepared: 31st May 2012 Answer The internet, magazines and other media allow people to make claims for medicines that can seem dubious. It is not possible to individually evaluate every medicine marketed, but the aim of this Q&A is to provide a set of general points to help you when patients come to you for advice. It is a structured way of thinking about some of the important issues. 1. MANUFACTURER If no manufacturer is identified, or the product is made by a company you have never heard of, or the company has no website identifying how to contact them, you might be suspicious that whoever produces this product has something to hide. If there are contact details on a manufacturer’s website why not contact them for more information? This will at least show that the contact details are correct. If you can’t identify the manufacturer you may have no fall-back if the product doesn’t work, is of poor quality, or is harmful. Is a manufacturer identified? Have you heard of them? Do they make products you’ve heard of? Does the manufacturer have their own website and does it give their contact details? 2. INGREDIENTS If there are no ingredients, or you’ve never heard of the ingredients, how can you be sure the product is safe? If the ingredients are just combinations of vitamins and minerals, what evidence is there that this combination actually does anything useful? If you have concerns about the identity of the manufacturer, you may be concerned that the ingredients list may not be correct. For example, in the past some manufacturers of “all natural” medicines have secretly included prescription medicines in their products. So stick with a recognised manufacturer so that you have some assurance about the identity, quality and quantity of ingredients. What are the ingredients and have you heard of them? 3. EVIDENCE If medicinal claims are made, what effort if any is made to support the claims? Testimonials from “real patients” can easily be fabricated and should not be trusted. Often websites contain vague claims or hype without any attempt to prove value (e.g. “The quickest way to a lean physique” or “As recommended by leading specialists”). In an attempt to establish their credentials some companies cite research which is irrelevant (e.g. it involves a totally different product), or research that has only been carried out in animals or on very small numbers of healthy volunteers (rather than patients). If research is cited, has it actually been published? You can look up research on Medline or Embase. Medline can be accessed for free at PubMed: www.ncbi.nlm.nih.gov/sites/entrez What research evidence is provided to substantiate medicinal claims? Is the research relevant and has it actually been published? From the NHS Evidence website www.evidence.nhs.uk 1 Medicines Q&As 4. SPONSORSHIP It is quite common to find a product endorsed by a supposedly famous scientist, or by something that sounds like a well-respected medical body or research institute. Check these sponsors out. Look in Medline to see if the scientist has ever published anything relevant. See if the medical body or research institute actually exists and whether they really have an interest in the product concerned. Do they have a website? Who is the sponsoring doctor, scientist or institute? Do they exist? Are they authoritative? 5. SAFETY Websites can claim that products are “totally safe”, often because they are “natural”. The most potent poisons in the world are natural. So just because a product comes from a plant does not guarantee it is safe. The Medicines and Healthcare products Regulatory Agency (MHRA) has a guide to specific and general safety concerns that have been raised with herbal medicines at: www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Herbalmedicines/Usingher balmedicinessafely/index.htm . What evidence is provided to demonstrate the product’s safety? Is it made clear which patients the product is not suitable for? Are the dose and the duration of treatment given? Do the doses of recognisable ingredients agree with those found in authoritative sources such as the British National Formulary (BNF)? In addition, the new medicine may interact with existing conventional treatments to stop them working or to cause toxicity. This would be of particular concern with medicines that have a narrow therapeutic range (e.g. warfarin, chemotherapy, digoxin, anticonvulsants etc). ‘Natural’ does not mean safe. What evidence is provided that this product is safe? Are the benefits to the patient worth the risk of taking something that might not be safe? Might there be any interactions with existing medication? 6. COST Does the website make clear how much of the product the patient will have to take before they see any benefit? Weigh up the possible benefits against the cost. Work out the total cost and don’t forget to include the inevitable VAT, postage and packaging, handling charges, minimum order charges, credit card charges etc. Make sure that there is a secure method of payment. If you know the ingredients, is there a cheaper alternative product from a more reputable supplier? What will be the real total cost? If there might be benefits from taking the product, is it worth this cost? 7. DELAYING CONVENTIONAL TREATMENT Taking an unproven medicine advertised on the internet may delay a patient seeking more appropriate conventional medical treatment that has evidence proving its worth. Are there more appropriate (evidence based) conventional medicines the patient should be offered to treat their condition? FINALLY... If more advice is needed, then healthcare professionals can contact their nearest Medicines Information Centre. Contact numbers are on the inside front cover of the BNF or from the Preface section of eBNF. The pharmacists employed there may not be able to provide a definitive assessment of individual products but may be able to advise about the safety and efficacy of key ingredients. From the NHS Evidence website www.evidence.nhs.uk 2 Medicines Q&As Summary This Medicines Q&A provides some questions and thoughts to help structure your discussions with a patient if he or she asks about buying a medicine that may be of dubious worth. Before buying, encourage them to investigate the manufacturer, ingredients, evidence for efficacy, product sponsorship, safety, cost, and the use of evidence-based conventional medicines. Some online resources which patients can be signposted to: NHS Choices Avoid medicine scams Supplements: Who needs them? Limitations This Q&A assumes that the product is not a UK licensed medicine because manufacturers must by law provide data on efficacy and safety. If you are not sure, then check out these three websites which list licensed medicines: The BNF for most prescribable medicines http://bnf.org/bnf/index.htm . The eMC for branded and some generic prescription medicines www.medicines.org.uk/emc/ Medicines Chest for many over the counter “pharmacy” medicines www.medicinechestonline.com/ This Q&A is not concerned with obtaining prescription only medicines online, counterfeit medicines, or using online pharmacies. Quality Assurance Prepared by Sue Gough (based on the opinions and experience of the original author, Dr Simon Wills), Wessex Drug and Medicines Information Centre, University Hospital Southampton NHS Foundation Trust. Date Prepared 31st May 2012 Checked by This Q&A was not subject to a formal quality assurance check because the content represents the opinion and experience of the original author. However, the text was read and commented upon by Kate Pickett, Wessex Drug and Medicines Information Centre, University Hospital Southampton NHS Foundation Trust. Date of check 18th July 2012 From the NHS Evidence website www.evidence.nhs.uk 3