09 May 2017
By charlotte.cash
Tags: 
MHRA
Medical Device Alert

Medicines and Healthcare Products Regulatory Service Agency are responsible for the safeguarding of public health by ensuring that medicines and medical devices in the UK are fit for purpose and not a danger. They investigate harmful incidents and they act as a law enforcement agency in the UK under Human Medications Regulations 2012 and 1968 Medicines Act.

Dental practices should sign up to receive MHRA alerts. Subscribe using the following link:

https://www.gov.uk/drug-device-alerts/email-signup

If an alert is received about a dental product or device then the alert should be:

  • Printed out
  • The product or device should be removed from use
  • The product or device should be disposed of according to the MHRA alert or manufacturer’s guidelines
  • Alert should be recorded and discussed in practice meetings

Adverse Drug Reaction

The definition of the term ‘adverse reaction’ covers noxious and unintended effects resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product.

The range of pharmaceuticals used in dental practice is relatively small, consisting primarily of sedatives, local anaesthetics, analgesics, and antibiotics.

Adverse drug reactions are categorized as type A or type B.

  • Type A: reactions are more common and are generally attributable to known pharmacological or toxic effects of the drug.
  • Type B: Idiosyncratic, unpredictable, acute / sub-acute, not related to known mechanism

Managing a suspected reaction

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 harm if another drug is prescribed to treat the ADR.
  • Record the ADR in the individual's health record.

Report suspected adverse reactions of these kinds to any therapeutic agent, including:

  • Prescription medicines
  • Herbal remedies
  • Over the counter (OTC) medicines (available on sale from pharmacies only)
  • Unlicensed medicines in cosmetic treatments
  • Blood products, vaccines, and radiographic contrast media.

MHRA & Adverse Drug Reactions Reporting

The Medicines and Healthcare products Regulatory Agency (MHRA) is particularly interested in receiving Adverse Drug Reaction reports from health care professionals on the following:

  • Adverse reactions in children.
  • Adverse effects in elderly people.
  • Black Triangle products. Black triangle products 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. Black triangle drugs are marked with an inverted Black Triangle in the British National Formulary and also in the Summaries of Product Characteristics.
  • The list of Black Triangle products are updated monthly and can found on the MHRA website.
  • Serious reactions with established medicines.
  • Delayed drug effects.
  • Congenital anomalies.
  • Herbal remedies.
  • Reports from the general public.
  • If in doubt, it is best to submit a report.
  • It is not necessary to be certain that an adverse drug reaction (ADR) has occurred before submitting a Yellow Card report.

Online via the MHRA Yellow Card website (at www.mhra.gov.uk/yellowcard) or by post. Paper copies of the Yellow Card are available:

  • By downloading an electronic copy from the MHRA Yellow Card website (pdf).
  • By calling the National Yellow Card Information Service on 0808 100 3352 (10am to 2pm Monday–Friday).
  • From the British National Formulary and British National Formulary for Children.
  • From the Nurse Prescribers' Formulary.

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.

Recent Alerts

These are some recent MHRA alerts which are relevant to dentistry.

Glucagen Alert, Click here >

Medical Device Alert August 2016, Click here >

Medical Device Alert October 2016, Click here >

Medical Device Alert January 2014, Click here >

Medical Device Alert February 2014, Click here >

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