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Adverse drug reactions - Management
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How should I assess someone with a suspected adverse drug reaction?

  • When a person presents with a suspected adverse drug reaction:
    • Assess the nature and severity of the reaction.
    • Review the history of the presenting symptoms, the drug history, any history of allergy or previous adverse drug reactions and the known adverse effect profile of the suspected drug.
    • Consider further examination and investigations if required.
Additional information
  • Assess the nature and severity of the reaction:
    • This will determine whether urgent action is required or whether the individual can be managed in primary care. See Managing a suspected reaction for further information:
      • For example, a cough due to an angiotensin-converting enzyme inhibitor can be troublesome but not life threatening, but an anaphylactic reaction is a medical emergency.
    • The nature of the presenting condition may strongly suggest that it is an adverse drug reaction (ADR). For example, the following conditions are often ADRs:
      • Acute dystonias
      • Blood dyscrasias
      • Skin reactions, such as Stevens–Johnson syndrome and toxic epidermal necrolysis
      • Neuroleptic malignant syndrome
  • Take a history of the presenting symptoms:
    • Timing:
      • The time from when use of the medicine was started to when the reaction develops may be characteristic of the reaction (e.g. anaphylaxis usually develops within a few minutes of parenteral drug administration).
      • If the drug was stopped, the time it took for the reaction to abate will often be related to the known duration of action of the drug.
    • Relationship to dose:
      • Adverse drug reactions are often dose related and may be minimized by reducing the dose.
      • If the symptoms resolve when the medicine is withdrawn, the symptoms may have been associated with the medicine although it could still have been coincidental.
      • If a medicine is reintroduced and symptoms recur, the medicine is most probably responsible. However, deliberate re-challenge is only very rarely justified (clinically and ethically) after serious adverse reactions because of the risks involved.
    • Other possible causes:
      • The symptoms may be a manifestation of the person's underlying illness or another disease.
      • Other medications (including self-medication and herbal remedies) could be responsible.
      • Consider the possibility of drug interactions (including with food and drinks).
  • Consider the drug history and review any history of allergy or previous adverse drug reactions:
    • Take a complete drug history including when the drug was started, what dose is being taken, what other drugs are being taken and whether the patient is also on over-the-counter or herbal medicines.
    • Check whether the person ever had similar symptoms or presentation in the past when taking other drugs (from the same or a different drug class) or has a history of atopy or of adverse drug reactions with different presentation(s).
    • Even if a drug has been withdrawn some time before, it may have been responsible for the adverse effect if it has a very long duration of action (e.g. amiodarone).
  • Review the adverse effect profile of the drug:
    • Are the signs and symptoms in keeping with the documented adverse effect profile of the drug?
    • Has the ADR been reported before?
      • This can be checked with the readily available sources of information listed below.
    • How common is the suspected adverse reaction?
    • Readily available sources of information regarding the ADR profile of individual drugs include:
      • The British National Formulary (BNF), available online.
      • The electronic Medicines Compendium (www.medicines.org.uk). A complete listing of suspected ADRs reported to this agency through the Yellow Card scheme by health care professionals and patients is available for individual drugs. These reports (termed Drug Analysis Prints) can be accessed online.
      • Regional and district medicine information services. Details of regional centres and other useful contacts can be found in the front of the BNF and BNFC (or online). Local services can found by contacting the medicines information department or the hospital pharmacy in major hospitals.
  • Consider further examinations and investigations:
    • Are specific investigations and laboratory tests required (e.g. liver or renal function tests)?
    • Will the adverse drug reaction lead to further complications (e.g. gastrointestinal bleeding)?
    • Is drug monitoring necessary (e.g. checking the serum digoxin concentration in a person with suspected toxicity)?
Basis for recommendation

These recommendations are based on advice from the Medicines and Healthcare products Regulatory Agency for establishing causality between the drug and the suspected adverse reaction [MHRA, 2006a].

How should I manage someone with a suspected adverse drug reaction?

  • When managing an individual with a suspected adverse drug reaction (ADR):
    • Assess the reaction:
      • Arrange emergency hospital admission if the ADR is serious or life threatening.
      • Assess whether the ADR can be managed in primary care.
      • Consider seeking specialist advice.
    • Review and discuss treatment with the individual:
      • Stop use of the suspected drug if the ADR is serious or at the request of the individual, and avoid its use in future.
      • Consider alternative drug therapy if treatment of the original condition is still required.
      • Consider altering the dose or temporarily stopping drug treatment if the benefit to harm balance of drug treatment is favourable.
      • Consider the effects of concomitant therapy (drug interactions).
      • Consider the possibility of withdrawal effects if drug treatment is stopped suddenly.
    • Manage symptoms of the ADR as appropriate:
      • Explain the benefits and harms if another drug is prescribed to treat the ADR.
    • Record the ADR in the individual's health record.
    • Consider submission of an ADR report (Yellow Card) if appropriate.
  • See the CKS topics on Angio-oedema and anaphylaxis and Urticaria.
Basis for recommendation

These recommendations constitute pragmatic advice for managing people who experience an adverse drug reaction.

Which kind of suspected adverse drug reactions should I report?

  • Consider reporting all serious and previously unreported suspected adverse drug reactions using the Yellow Card scheme:
    • Report suspected adverse reactions of these kinds to any therapeutic agent, including prescribed medicines, over-the-counter and self-administered medicines, blood products, vaccines, radiographic contrast media and herbal products.
    • Report any suspected adverse reactions involving Black Triangle drugs.
    • If in doubt, it is best to submit a report.
  • When reporting an adverse drug reaction, it is not necessary to be certain that an adverse drug reaction (ADR) has occurred in order to submit a Yellow Card report.
  • For more information, see Additional information.
Additional information
  • For information on how to decide whether a person could be experiencing a suspected adverse drug reaction (ADR), see Assessment.
  • The Medicines and Healthcare product Regulatory Agency (MHRA, www.mhra.gov.uk) collects Yellow Card reports from both health professionals and members of the public on:
    • Prescription medicines
    • Herbal remedies
    • Over the counter (OTC) medicines (available on sale from pharmacies only)
    • Unlicensed medicines in cosmetic treatments
  • The MHRA is particularly interested in receiving ADR reports (via the Yellow Card scheme — www.yellowcard.gov.uk) from health care professionals on the following:
    • Adverse reactions in children:
      • Very little is known about the safe use of medicines in children because they are generally not exposed to medicines in clinical trials.
      • In addition, many drugs that are routinely used to treat children are not licensed for use in this age group.
    • Adverse reactions in elderly people:
      • Elderly people may be more susceptible to developing reactions because they may metabolize or excrete medicines less effectively and may be more sensitive to their effects.
    • Black Triangle products:
      • These are new drugs and vaccines that are being intensively monitored to confirm their risk/benefit profile. In addition, they also cover new combinations of drugs, new routes of administration for established drugs and established drugs with significant new indications.
      • These drugs are marked with an inverted Black Triangle in the British National Formulary (BNF) and also in the Summaries of Product Characteristics (SPCs).
      • The MHRA and the Commission on Human Medicines are interested in all reports of suspected adverse reaction associated with these products. This is to confirm the risk/benefit profile established during the pre-marketing phase as well to increase understanding of the safety profile of these new medicines. In addition, previously unrecognized adverse effects will be identified as quickly as possible.
      • There is no standard time for a product to retain Black Triangle status. However, an assessment is usually made following two years of post-marketing experience and the Black Triangle symbol is not removed until the safety of the drug is well established.
      • The list of Black Triangle drugs are updated monthly and can found on the MHRA website.
    • Serious reactions with established medicines:
      • These include reactions that are fatal, life threatening, disabling, or incapacitating; those that result in hospitalization, increased duration of hospitalization, or congenital abnormalities; and those that are medically significant.
      • Serious reactions differ from severe reactions.
      • A severe reaction might not be life threatening or disabling, but in the individual patient, it is extreme. An example would be a headache, which would not normally be considered serious but may be very severe.
      • A comprehensive list of serious reactions can be found on the MHRA website.
      • Established drugs and vaccines no longer require intensive monitoring because the safety of the products has been well established. However, previously unrecognized adverse effects, in particular rare or delayed effects, may still be identified when a medicine has been available for many years.
    • Delayed drug effects:
      • These reactions may appear months or years after exposure (e.g. cancers or retroperitoneal fibrosis).
      • These adverse reactions are not likely to be identified in short-term clinical studies and may become apparent only after extensive and long-term use of the drug.
      • Report any suspicion of such an association.
    • Congenital anomalies:
      • Information on these adverse reactions is very limited, given that clinical trials do not generally involve pregnant women.
      • Report to the MHRA instances of babies born with a congenital abnormality and pregnancies that result in a malformed aborted fetus if a drug is thought to be implicated. Include information about any medicine taken during the pregnancy, including self medication.
    • Herbal remedies:
      • Although some herbal medicines are licensed for use, many unlicensed herbal remedies available from outlets other than pharmacies or are supplied by herbal practitioners.
      • It is important for the MHRA to monitor all herbal products to ensure their safety. For example, Yellow Card reporting identified hepatotoxicity associated with Kava-Kava which resulted in its supply being prohibited in the UK in 2003 [Independent Steering Committee, 2004].
      • Include as much information as possible about the herbal remedy, including its ingredients, source or supplier (if known), and what the product was being used for. If the remedy was supplied by a herbal practitioner, try to obtain their name and address.
      • Consider retaining a sample of the product if the reaction is severe, in case the MHRA needs to investigate further.
  • Reports from the general public:
    • The MHRA is especially interested in any suspected adverse reactions that are:
      • Not mentioned in the patient information leaflet.
      • Have caused problems serious enough to interfere with everyday activities.
  • Further information on reporting suspected adverse drug reactions can be found online for health care professionals and members of the public or via www.yellowcard.gov.uk.
Basis for recommendation

These recommendations are based on those issued by the Medicines and Healthcare products Regulatory Agency (MHRA) [MHRA, 2006a; MHRA, 2006b].

How do I report a suspected adverse drug reaction?

Additional information
  • Health care professionals and members of the public can report suspected adverse drug reactions (ADRs) by using the Yellow Card scheme:
    • This is a voluntary scheme for spontaneous ADR reporting.
    • A Yellow Card is a standard form, used to report a suspected ADR, that can be submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) electronically or by post.
  • To ensure patient confidentiality when reporting:
    • Healthcare professionals:
      • A local patient identification number (e.g. the patient's local practice or hospital number or any reference number created by the reporter) should be included in order to help the reporter identify the patient in any future correspondence. This does not breach patient confidentiality.
    • Members of the public:
      • Ask a representative to complete the Yellow Card if the individual wants to remain anonymous or is unable to complete the form.
      • Correspondence from the MHRA can be directed to the representative.
  • For healthcare professionals:
    • Electronic submission:
    • Alternatively, paper copies of the Yellow Card can submitted by post and these are available:
      • By downloading a electronic copy from the MHRA website.
      • By writing to MHRA, CSM Freepost, London, SW8 5BR.
      • From the British National Formulary and British National Formulary for Children.
      • From the Nurse Prescribers' Formulary.
      • From the Association of the British Pharmaceutical Industry Compendium of Data Sheets and Summaries of Product Characteristics.
      • From the MIMS Companion.
      • By writing to one of the Commission on Human Medicines Yellow Card Centres (addresses can be found on the MHRA website).
  • For members of the public, suspected ADRs can be submitted to the MHRA via:
    • The patient reporting of suspected adverse drug reactions section of the MHRA website.
    • By post, using Patient Yellow Card report forms:
      • These are different from those used by healthcare professionals and are designed for use by the members of the public.
      • They are available in GP surgeries and pharmacies or can be obtained by contacting the MHRA by telephone on 020 7084 2000, or by downloading from the MHRA website.
Basis for recommendation
  • The Yellow Card scheme is operated by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines.
  • The MHRA has issued the recommendations [MHRA, 2006a; MHRA, 2006b]:
    • For protecting patient confidentiality.
    • For increasing the rate of reporting of suspected ADRs by [Independent Steering Committee, 2004]:
      • Expanding reporting to healthcare professionals and the members of the public.
      • Improving access to reporting by offering both electronic and non-electronic routes for submitting reports.

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