Technology Horizon Scanning Centre ALERT December 2014

Macy catheter for rectal drug administration

TECHNOLOGY

The Macy catheter, developed by Hospi Corporation, is a single use disposable device that allows rectal administration of medication and liquids to adults in whom the oral route is compromised. Its main indication is in the palliative care setting.

The Macy catheter has a small flexible silicone shaft and an inflatable retention balloon. The catheter is inserted into the rectum just past the rectal sphincter. The soft retention balloon is then inflated with water via the inflation valve. A separate medication valve delivers medication and liquids through the catheter and into the distal third of the rectum. Once in place, the device can be used for repeated administration until it is removed for, or by, a bowel movement. © Hospi Corporation

The company plans to receive a CE mark for the Macy catheter next year with plans to enter the European market in the second half of 2015. This will include the UK, and entering the NHS market will be investigated.

POTENTIAL FOR IMPACT

For some patients, the rectal route is an alternate method of drug administration when intravenous access is not possible or the oral route is compromised. This could include patients who have difficulty swallowing, nausea and vomiting, and also those with serious or terminal ill health. Currently, routes of rectal administration can include suppositories or an enema. Although suppositories and enemas are effective, they are not often preferred by patients due to the inconvenience of repeated administration and issues surrounding expulsion and leakage after insertion.

The Macy catheter is the first device to permit repeated delivery of medication to the rectum, and with its small and flexible design, should exert very little pressure on the rectal

This alert presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health.

NIHR Horizon Scanning Centre, University of Birmingham Email: [email protected] Web: www.hsc.nihr.ac.uk

NIHR Horizon Scanning Centre

membrane making it safe, comfortable, and discreet for the patient. However, catheters require active management to prevent local irritation and infection.

Rectally administered drugs can improve the speed at which medication is absorbed and the Macy catheter may enhance palliative care by relieving pain and other symptoms near the end of life faster than other treatment methods.

The company claim that the Macy catheter could provide a less costly and less complex alternative to subcutaneous and intravenous delivery with lower iatrogenic complication risks. Furthermore, the simplicity of use of the Macy catheter may allow for more patients to remain at home in their last days and avoid the discomfort and expense of hospitalisation and other higher levels of clinical care.

The company states that certain features of the Macy catheter may optimise its use as a medication delivery system such as a non-clogging one way medication port, adapted to mate only with an enteral syringe. The latter is to avoid misconnection errors associated with luer connectors.

This technology is predicted to have an impact on the following domains of the NHS Outcomes Framework:

Domain 2 Enhancing quality of life for people with long-term conditions; Domain 3 Helping people to recover from episodes of ill health or following injury; and Domain 4 Ensuring that people have a positive experience of care

For more information on the NHS Outcomes Framework, please go to www.england.nhs.uk/resources/resources-for-ccgs/out-frwrk

EVIDENCE

COMPLETED UNPUBLISHED STUDIES

A quality improvement study: use of a rectal medication administrative device, an intervention to manage end-stage symptoms in hospice patients when the oral route fails. http://www.hpna.org/DisplayPage.aspx?Title=2012%20CPF%20Poster%20Presentations

ONGOING STUDIES

The company report an ongoing phase II study for the development of a paediatric catheter, pharmacokinetics of rectal mucosal administration and broadened use of the catheter in a home setting.

INFORMATION FROM

This Alert is based on information from the company and a time-limited internet search.

2