Quality statement 4: Monitoring drug treatment

Quality statement

People receiving drug treatment for inflammatory bowel disease are monitored for adverse effects.

Rationale

People with inflammatory bowel disease may experience different responses to drug treatment, including adverse effects. How a person responds to drug treatment therefore needs to be monitored using local safety policies and procedures, and treatment adjusted to ensure the best quality‑of‑life outcomes and patient safety.

Quality measures

Structure

Evidence of documented local safety policies and procedures to monitor for adverse effects in people receiving drug treatment for inflammatory bowel disease.

Data source: Local data collection. Data on local protocols and monitoring arrangements for immunosuppressives are available in the National audit of inflammatory bowel disease (IBD) service provision, section 3, and the National audit of paediatric inflammatory bowel disease (IBD) service provision, section 3.

Process

Proportion of people receiving drug treatment for inflammatory bowel disease who are monitored for adverse effects.

Numerator – the number in the denominator for whom there is documented evidence that there is monitoring for adverse effects of drug treatment according to local safety policies and procedures.

Denominator – the number of people receiving drug treatment for inflammatory bowel disease.

Data source: Local data collection. Data on local protocols and monitoring arrangements for immunosuppressives are available in the National audit of inflammatory bowel disease (IBD) service provision, section 3, and the National audit of paediatric inflammatory bowel disease (IBD) service provision, section 3. Data on treatment follow‑up, acute reactions and adverse events are available in the results tables of the National clinical audit of biological therapies, Adult report and Paediatric report.

Outcome

The number of adverse events reported because of drug treatment for inflammatory bowel disease.

Data source: Local data collection. Data on adverse events are available in the results tables of the National clinical audit of biological therapies, Adult report and Paediatric report.

What the quality statement means for different audiences

Service providers (general practices and district general hospitals) ensure that they have documented local safety policies and procedures that are used for monitoring for adverse effects in people receiving drug treatment for inflammatory bowel disease and for acting on abnormal results.

Healthcare professionals ensure that they monitor for adverse effects in people receiving drug treatment for inflammatory bowel disease, using documented local safety policies and procedures, and they act on abnormal results.

Commissioners (clinical commissioning groups and NHS England) ensure that they commission services in which there is monitoring for adverse effects in people receiving drug treatment for inflammatory bowel disease, using documented local safety policies and procedures, and abnormal results are acted on.

People taking medication for inflammatory bowel disease have regular check‑ups for any side effects, and healthcare professionals take action if there are any concerns. This will lower the chances of the person having problems caused by the medication. People should be helped by their care team to understand treatment options and monitoring, including benefits, risks and possible consequences.

Source guidance

Definitions of terms used in this quality statement

Drug treatment for inflammatory bowel disease

A number of drugs are used to treat inflammatory bowel disease, depending on the type and severity of the disease, observed side effects, contraindications and patient preference. Drugs used include aminosalicylates, corticosteroids, biological treatments and immunosuppressives. Full details of treatment options for people with inflammatory bowel disease, including drug treatment, can be found in NICE's guidelines on Crohn's disease and ulcerative colitis.

[Adapted from NICE's guidelines on Crohn's disease and ulcerative colitis]

Monitoring for adverse effects

Treatment of inflammatory bowel disease aims to induce remission and control symptoms. Monitoring for adverse effects should identify side effects and potential adverse outcomes from long‑term use. Treatments that can cause adverse outcomes include thiopurines, methotrexate, aminosalicylates, immunosuppressives and corticosteroids.

[Adapted from NICE's guidelines on Crohn's disease and ulcerative colitis]

Full details of side effects, contraindications and monitoring (including blood tests, procedures and clinical review) that should be carried out for specific drugs are detailed in the current online version of the BNF or BNF for children.

Local safety policies and procedures

There should be monitoring for adverse effects in people having drug treatment for inflammatory bowel disease using local safety policies and procedures. These should include:

  • shared care arrangements between primary and secondary care and clearly defined responsibilities for healthcare professionals in primary and secondary care

  • clear referral pathways

  • locally agreed monitoring guidelines

  • clear access routes to urgent care

  • a nominated member or members of the multidisciplinary team to act on abnormal results and reports of side effects and communicate with relevant healthcare professionals and people with inflammatory bowel disease (and/or their family members or carers, as appropriate).

[Adapted from NICE's guidelines on Crohn's disease and ulcerative colitis, and expert opinion]