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Section 29:
Procedure to be adopted following a suspected incident or defect involving a medicinal product

The Scottish Office Health Department in National Health Service Circular No 1982 (GEN) 32 provided guidance. The objectives of the system are to provide a mechanism for -
(a)		Reporting of incidents involving the safety of patients or staff or of defects which could potentially affect their safety;
(b)		the rapid dissemination of relevant information to Health Boards by the Scottish Executive or the CSA Supplies Division to prevent a recurrence of the incident.
If the reporting system is to be fully effective, the method of operation must be clearly appreciated by staff at all levels. It is essential that every effort is made to collect as much information as possible concerning any incident which occurs. Thereafter there shall be local consultation at senior level to enable an adequate assessment of the seriousness of the incident and the need for action at local or national level.
29.1	Procedure to be adopted following a suspected incident or defect involving a medicinal product: Defects In Medicinal Products
29.1.1	Before reporting an incident which may be due to a defective medicinal product every effort must be made to ensure, as far as is reasonably practicable, that the incident is in fact due to a defect in the product and not to an accident or error in its administration or to an adverse patient reaction. However, all suspicions must be reported and discussed in order to arrive at a decision regarding the most likely cause. Once information about a defective medicinal product is disseminated widely a great deal of activity ensues throughout the country in arranging for the withdrawal of the defective batch.
29.1.2	Where the defect is detected by a hospital pharmacy technician or pharmacist prior to issue to patients it is their responsibility to report the matter through the Senior Pharmacist in the dispensary, to the Director of Pharmacy or Consultant in Pharmaceutical Public Health.
29.1.3	In the event of a clinical incident thought to be due to a defective medicinal product the nurse or clinician suspecting the incident, after local consultation with medical colleagues preferably of consultant status, must report the matter at once to the clinical pharmacist for that ward/department. The latter in consultation with the Principal Pharmacist Dispensing Services shall inform the Director of Pharmacy. Advice may be sought from Medicines Information and Quality Assurance services as appropriate. The Scottish Executive Health Department is informed if a national alert is required.
29.1.4	In all instances the defective or possibly defective medicinal product along with any associated equipment used in the administration must be preserved for analysis or examination. They must be placed in a suitably labelled plastic bag and returned to pharmacy for appropriate storage. A record of these actions shall be kept.
29.1.5	Ward or department nursing staff shall remove all material bearing the same batch number from their ward stock. This must be placed in quarantine (preferably a locked receptacle or room) and be clearly labelled to prevent further use pending investigation by the Pharmacist.
29.1.6	The Clinical Pharmacist/Senior Pharmacist Patient Services must initiate whatever further action is considered necessary to ensure the safe use of the medicine throughout NHS Tayside. This may involve withdrawal of the drug/device in accordance with the Drug Alert and Related Medical Devices Alert procedure.
29.2	Procedure to be adopted following a suspected incident or defect involving a medicinal product: Other Reporting Procedures
29.2.1	It must be noted that the system described does not affect in any way existing obligations placed on staff to report adverse reaction to medicine and adverse incidents. Adverse reaction to medicine must be reported to the Committee on Safety of Medicines. This must be done using the Yellow Card provided for this purpose, copies of which are included in the current edition of the British National Formulary. Click here for guidance.
29.2.2	Adverse incidents involving medicines must be managed and reported in accordance with the Adverse Incident Management Policy. Data is also being collected on incidents involving extravasation of drugs into tissues and the subsequent treatment.
29.3	Procedure to be adopted following a suspected incident or defect involving a medicinal product: Medicine Administration Accidents / Errors
	It is very important that an open culture exists in order to encourage immediate reporting of errors or incidents in the administration of medicines. A culture, which discourages the reporting of incidents, can increase significantly the risk to patients as well as be detrimental to the maintenance of standards. Any errors or incidents must be reported immediately to the person in charge (line manager). All staff involved in or identifying a medicines administration incident must ensure the safety and well-being of the patient / client concerned. Medical staff must be informed and advised of any immediate actions/interventions to ensure the well being of the patient. An IR1 must be completed and the incident graded, further actions / reporting undertaken in accordance with the NHS Tayside Adverse Incident Management Policy (AIM). Details relating to the incident must also be recorded in the patients medical / nursing records. Registered Midwives must also report the error or incident to their supervisor of midwives as soon as possible after the event. Immediate / Line managers have specific responsibilities to ensure all incidents are investigated fully, and that the required actions, i.e. that risk review reports, trend analysis, risk control plans and where appropriate referral / communication with other agencies are carried out.