When assessing medicines management, we look at Regulation 12: Safe care and treatment.
Arrangements must be in place for the secure storage and management of any medicines held at the practice. Policies and procedures around the management of medicines should be in line with current legislation and guidance. They should address:
- ordering
- storage
- prescribing and supply
- dispensing and preparation
- administration and recording
- safe disposal.
Staff must follow provider policies and procedures to ensure the safe management of medicines including controlled drugs. GP mythbuster 28 provides practical guidance on controlled drugs.
Prescription stationery must be stored and recorded in line with national guidance. Read GP mythbuster 23: Security of blank prescription forms.
Medicines storage
When we inspect, we should see medicines stored securely with access limited to authorised staff only. All medicines must be stored in an appropriate environment following manufacturers’ recommendations. Temperatures should be monitored regularly. Appropriate actions must be taken if medicines are not stored correctly. Processes should also be in place to regularly check expiry dates of medicines and medical equipment. For example, medicines can be accessed by dentists who know the key code to the medicine cabinet. Staff monitor the temperature regularly to make sure medicines are stored appropriately and within the manufacturers’ temperature limits.
Prescribing and supply of medicines
Private patients
Dentists can prescribe and sell or supply any medicine to patients receiving private treatment, although dentists should restrict prescribing to areas in which they are competent. Private patients should not be prescribed medicines on NHS prescriptions.
NHS patients
Only medicines in the Dental Practitioners’ Formulary can be prescribed on a dental NHS prescription form, FP10D. Dentists cannot supply any medicines, other than those for immediate use or as an emergency supply, to a patient receiving NHS treatment.
Medicines can be supplied or administered to patients in line with a prescription or patient group direction (PGD). PGDs can be used by certain registered professionals including dental hygienists and dental therapists. GP mythbuster 19 provides more information about PGDs.
Medicines must be sourced from a suitable supplier.
Dispensing and preparation of medicines
Staff handling medicines must be appropriately trained to do so. Practices must have processes to assess the competency of staff managing medicines.
Appropriate quantities of medicine must be supplied. For example, the correct course lengths of antibiotics.
All medicines that are issued (dispensed) to patients must be suitably labelled, packaged appropriately and include a patient information leaflet. There is a legal requirement under The Human Medicines Regulations 2012 for the following information to appear on the label of any prescribed medicine:
- name of the patient
- name and address of the supplying dental service
- date on which it was sold or supplied
- name of the medicine
- directions for use of the medicine
- precautions relating to the use of the medicine
- Warning label: ‘keep out of reach and sight of children’.
Disposal of medicines
Arrangements should be in place for the safe disposal of medicines in the practice. Practices should have processes in place to manage any patient returns as well as expired medicines. There should be a secure designated area where medicines waiting to be disposed are stored. These should be segregated from all other medicines still in use.
Practices should have a contract with a licenced clinical waste management company. They will collect unwanted medicines and medical appliances and dispose of them appropriately.
Emergency medicines and equipment
Emergency medicines and equipment should be in an accessible and central location, known to everyone.
The General Dental Council (GDC) standards for the dental team state that dental professionals must follow the guidance on medical emergencies and training updates issued by Resuscitation Council (UK).
Dentists must consider what resuscitation equipment they need when they carry out domiciliary dental treatment. Read Dental mythbuster 24: Medical resuscitation equipment for domiciliary dental care.
Quality improvement activity: clinical audits
Dental practices should routinely review the effectiveness and appropriateness of the care provided to ensure effective, safe care. This includes the appropriate and safe prescribing of medicines. Read Dental mythbuster 17: Audits in primary care dental services.
Clinical audit is a process or cycle of events that help ensure patients receive the right care and treatment. Care and services are measured against evidence base standards and changes are implemented to narrow the gap between existing and best practice. Ideally, a clinical audit is a continuous cycle that is continuously measured with improvements made after each cycle. For example, a clinical audit that can improve practice is an antimicrobial prescribing audit. Public Health England has produced a dental antimicrobial stewardship toolkit to help primary care practitioners promote the appropriate use of antibiotics in dental care.
Acting on alerts
Practices need systems and processes to share and act on information from external sources which could affect patient safety.
Sources of information include:
- Medicines and Healthcare products Regulatory Agency (MHRA) - produces drug alerts, medical device alerts, drug safety updates and field safety notices.
- Central Alerting System (CAS) - web-based cascading system for patient safety alerts, public health messages and other safety information and guidance.
- Local or national clinical guidance.
- National and local formularies.
Consider who receives the alerts and information within the service. This includes cover for staff absences.
Dental practices should:
- have systems in place to identify, recall and follow-up affected patients where required.
- have a process to recall a medicine or device.
- incorporate prescribing advice into routine clinical practice.
A practice should keep a log of relevant alerts received. They should document action taken in response to these. There should be clinical oversight of the process.
Healthcare providers have a duty to report any adverse incidents relating to medicines and devices to the MHRA using the Yellow Card Scheme.