The scheme enables the MHRA to take appropriate action if there is evidence of causal association between a particular medicine and an ADR. If confirmed, the MHRA may require changes to product licences, information leaflets, Summary of Product Characteristics, or even withdraw products from the market. The YCS is therefore important for safeguarding public health, but a lot of Yellow Cards are needed to allow the MHRA to take these important safety-related actions.
The YCS is not a complaints system, nor a way to obtain compensation for injury caused by suspected ADRs. There is also no opportunity for individual advice to be provided on suitable courses of action. While most healthcare professionals understand this, not all patients do, so an appreciation of what the YCS is for and what it is not for is important.
Pharmacist roles in ADR reporting
There are three levels at which pharmacists can contribute:
- Reporting themselves;
- Supporting and encouraging patients to report;
- Supporting and encouraging GPs and nurses to report.
Pharmacists should report serious suspected ADRs to any drug or vaccine and all suspected ADRs to ‘black triangle’ drugs. The MHRA particularly wants to receive reports about ADRs in children and the elderly, delayed effects, ADRs from OTC products and herbal remedies. As a community pharmacist, you are well placed to make a substantial contribution to all Yellow Card reporting, but especially so for OTC and herbal remedies.
So if you suspect an ADR, you should first find out more about it, then check if the suspect drug is black triangle. If not, decide whether or not it is serious, then complete a Yellow Card.
Obviously the patient is the most important information source regarding the reaction, so you need to question them or their carer closely. You do not have to be certain that the medicine and the adverse reaction are associated, only suspicious. But it important to be sure at least that the medicine was started before the symptoms developed. It is also sensible to determine when the problem started in relation to medicine-taking.
Many ADRs are apparent within hours of starting a new medicine but others are delayed for days, weeks, months or even years. Has the patient stopped taking the medicine? If so, did the effect disappear? Perhaps they reduced the dose and again, if so, did the effect reduce in severity? What other medicines is the patient taking? Also remember to ask about OTC or herbal products.
What else happened? Did the patient receive or take any remedy to alleviate the symptoms? Did this work? How is the patient now? All this is important information which should be included on the Yellow Card.
A black triangle is assigned to products new to the UK market, because the clinical trials required prior to marketing involve few patients and are not designed to identify all possible ADRs. There are many instances of fairly new drugs being removed from the market following discovery of a side effect not identified during pre-marking trials. The scheme therefore provides essential information about new medicines.
All suspected ADRs to black triangle drugs should be reported, whether serious or not. The MHRA defines serious as: fatal, life-threatening, disabling, incapacitating, resulting in or prolonging hospitalisation, medically significant, plus congenital abnormalities. This provides a guide, but some reactions may be described by individual patients as severe, regardless of whether they fit these criteria. A list of severe reactions is available on the MHRA website.
Yellow Cards are available in the BNF, MIMS Companion, and from the MHRA, or you can report on line at yellowcard.mhra.gov.uk. You can also download and print a hard copy to send by post. When completing the card, do include your details so the MHRA can contact you for extra information if needed, plus some sort of patient identifier, for your own record. Do not include the patient’s name or other details that enable the MHRA to identify them. This maintains confidentially between you and the patient.
Obviously you must include medicine name, preferably also brand/manufacturer, strength and dose, plus patient age, sex and if possible weight/height. Include other medicines being taken concomitantly and any details of timing obtained from the patient.
If you do not report, you should encourage patients to report themselves. Patient Yellow Cards require similar information and again patients do not have to be certain that the medicine caused the problem. The form requests reporter contact details, so MHRA can obtain any extra information.
Make sure your patients are aware they can report. Do you have a poster in your pharmacy? Have you got some patient Yellow Cards and do you know where they are kept? Are they on display? You can request patient Yellow Cards from the MHRA on 020 7084 2000, by e-mailing [email protected] or by post: MHRA, CHM Freepost, London SW8 5B. Patients can also report on line at www.mhra.gov.uk or by telephone, Monday to Friday 10am-2pm, on 0808 100 3352.
Patients may need your help to complete the Yellow Card, particularly with drug names, indication, doses, and start and stop dates. You may have a good record of their medicines use you can provide. These details should be included on the form, plus information about medical conditions which you may also be able to help with.
You may feel it is the GP’s responsibility to report, not yours. Everybody tends not to report suspected ADRs and it’s quite possible the GP will not report it. In fact, it doesn’t matter how many people report, because MHRA staff try to identify duplicate reports involving the same reaction in the same patient. But the GP may have additional important details, or know the patient’s circumstances better than you, so support them to report. Provide additional information, such as OTC products purchased or details of prescription dispensing, to support the timing of medicine taking (dispensing dates may differ from prescription issue dates).
How pharmacists can make a difference
Pharmacists have a real opportunity to identify suspected ADRs and to dramatically increase reporting by themselves or patients. Why? Because patients often tell pharmacists about their experiences with medicines and pharmacists often tell patients about potential side effects.
How often do you tell patients to let you know if they have a problem with a medicine? Why not add that they can also report the problem to the MHRA? Remember that excipients can cause ADRs, which may differ between brands. This may be related to your purchasing, hence it is your responsibility to ensure the problem is reported. ADRs from OTC products are also very much in your domain, so it’s your responsibility to ensure the problem is reported.
Lastly, you have many opportunities to enquire about ADRs, which you probably already take, without thinking about reporting:
- How often do you dispense a prescription for the first time and say: “This may cause so-and-so and if it does then....”, recommending some suitable course of action. Adding an extra sentence: “If it is really troublesome then you may want come back and tell me or to report it yourself, using a Yellow Card,” takes no time at all.
- When patients present with a symptom seeking treatment, how often do you ask: “Are you taking any medicines at the moment?” Every time. But how often do you think the symptom could be an ADR? Probably less often. It’s always worth considering.
- When you’re doing an MUR aren’t you asking patients if they are happy with their medicines and more specifically about side effects? But how often, if there is a problem, do you actually tell patients they can report it?
Pharmacists, like other health professionals, are more concerned about solving the patient’s problem than reporting it and quite rightly so. But get into the habit of thinking of both and, if at all possible, report yourself. Encourage the patient to report or inform their GP and encourage them to report.
Janet Krska is Professor of Pharmacy Practice at Liverpool John Moores University