Responding to reports of possible malicious tampering

Malicious tampering can be defined as sabotage of or tampering with medicines or medical devices by staff, with intent to injure patients or carers. In the event of an unexplained patient safety incident, pharmacy teams may be asked to facilitate toxicology-like screening of one or more medicines to exclude or confirm the presence of foreign substances and the possibility that one or more doses or packs of medicine have been tampered with.

Consider criminal behaviour

It is extremely important to consider at the outset the possibility of criminal behaviour. Any circumstances involving potential criminal behaviour will need to be reported to the Police who have strict requirements for managing the security and continuity of evidence if it is to be admissible in a court of law.

If Trusts wish to undertake an initial investigation (e.g. where a leaking bag is found and the possibility of tampering is to be excluded, or when investigating a suspected error) security and continuity of evidence must still be considered in case Police involvement is necessary later on. The following is based on recent anecdotal experience of others and is intended as a prompt for some things which should be taken into consideration. It should not be relied upon as a comprehensive source of advice about everything senior pharmacy staff need to consider and to do in these circumstances.

Securing the evidence

It is essential that a secure chain of custody for all samples including reference samples (and other potential evidence) is maintained. This may include:

• appointing a Continuity Officer (CO) responsible for managing this
• ensuring samples are stored securely e.g. in a CD cupboard or room
• the use of tamper-evident packing if samples need to be transported. An Envopak-type bag closed with a numbered seal would meet this requirement.
• written statements from everyone involved with handling samples at any stage detailing what they did and when, including a description of the sample(s) as handed to them and handed over by them.
• a written audit trail at every stage including timed signatures for all handovers, held by the CO.

Specialist advice and analytical support

The decision about where to seek advice and analytical support should reflect local circumstances and resources. Possible external sources of advice and testing services include, but are not limited to:

Pharmacy QA/QC teams

Relatively few NHS hospital pharmacy QC labs now have capacity for comprehensive chemical analysis of medicines. Those that do are likely to be able to test  for only a few specific single active chemical substances and are unlikely to be able offer a clinical toxicology-type screening service. “Blind testing” a medicinal product to determine the contaminant is unlikely to be possible.

NHS clinical toxicology services

Sandwell and West Birmingham Hospitals NHS Trust offers a forensic toxicology service (contact: swbh.toxicology@nhs.net) and can do a qualitative screen for drugs of abuse, novel psychoactive substances, OTC & POM medicines but cannot, for example, quantify potassium chloride content.

The Welsh Emerging Drug and Novel Substance Identification Service (WEDINOS) is run by Public Health Wales and can test suspect materials. The service is free of charge, but results are qualitative only, anonymised and publicly reported.

Public Analyst Laboratories

For a list see http://www.publicanalyst.com/about_us
The Kent Laboratory is believed to offer toxicology services that would be able to screen samples. .

National Poisons Information Service

The National Poisons Information Service (NPIS) offers comprehensive advice.

Forensic Science Laboratories

There is no longer a government-funded UK-wide service. The Metropolitan Police hosts a physical forensics laboratory, and there are many private sector providers of forensics science services. Local police services may be able to advise on access.

NHS SPS Medicines Advice Service

Please see https://www.sps.nhs.uk/home/about-sps/get-in-touch/medicines-information-services-contact-details/

Testing Samples

It is essential that if testing is required it is carried out by a laboratory accredited for medico-legal/forensic testing. Transport of samples to the laboratory should be under a chain of secure custody as described above. The agreement between the testing laboratory and the Trust should state exactly what tests are required. Examples include:

• Identification of suspected contamination
• Physical examination of the container such as checking for needle-pricks
• Physical examination of the medicine such as checking for particles or colour change
• Testing for presence of insulin or potassium (as the most likely potential contaminants)
• Testing for other specific contaminants, if suspected
• Testing for suspected dilution

Further action

Test results may show presence or absence of contaminants, or may be inconclusive. Depending on the results and other findings, consequent actions may include:

Reporting to the Police

If criminal intent is suspected it is essential to contact police at the earliest possible opportunity. The police will take the lead on any further evidence/sample collection and/or testing and their instructions on every aspect of next steps should be followed.

Reporting patient safety incidents

Additional advice about reporting patient safety incidents can be found in our article Reporting and management of medication incidents and harms.

Reporting a defective medicine

Sometimes medicines may initially be suspected to have been tampered with, but subsequently it is suspected of being defective. Our article Managing defective medicines provides further advice.