Chapter 15: Medicines optimization: ensuring quality and safety
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Source: Adapted from Bonsell ([27]), Elliot and Lui (2010), Federico ([92]), MacDonald ([179]), Perry ([282]).
Supply of medicines
Medicines reconciliation
NICE ([247]) highlights medicines reconciliation as an important component of medicines optimization. NICE uses the Institute for Healthcare Improvement's definition:
Medicines reconciliation … is the process of identifying an accurate list of a person's current medicines and comparing them with the current list in use, recognising any discrepancies, and documenting any changes, thereby resulting in a complete list of medicines, accurately communicated. The term ‘medicines’ also includes over‐the‐counter or complementary medicines, and any discrepancies should be resolved. The medicines reconciliation process will vary depending on the care setting that the person has just moved into – for example, from primary care into hospital, or from hospital to a care home.(NICE [247], p.18)
Medicines reconciliation is the process of determining an accurate list of medicines currently being taken by a patient. The process of medicines reconciliation has five steps (Aronson [14]):
- list the patient's current medications
- list the medications currently needed
- compare the lists
- make a new list based on the comparison
- communicate the new list to the patient and caregivers.
NICE ([247]) recommends that in acute settings, an accurate list of all of the person's medicines (including prescribed, over‐the‐counter and complementary medicines) should be assembled and a medicines reconciliation carried out within 24 hours or sooner if clinically necessary, when the person moves from one care setting to another, typically if they are admitted to hospital. It is also important to recognize that a medicines reconciliation may need to be carried out on more than one occasion during a hospital stay (e.g. when the person is admitted, transferred between wards and discharged).
In primary care, NICE ([247]) recommends that medicines reconciliation is carried out for all people who have been discharged from hospital or another care setting. This should happen as soon as is practically possible, before a prescription or new supply of medicines is issued and within 1 week of the GP practice receiving the information.
Irrespective of the care setting, organizations should ensure that a designated healthcare professional has overall organizational responsibility for the medicines reconciliation process, including:
- organizational responsibilities
- responsibilities of health and social care practitioners involved in the process (including who they are accountable to)
- individual training and competency needs.
Medicines reconciliation should be carried out by a trained and competent healthcare professional, ideally a pharmacist, pharmacy technician, nurse or doctor, who has the necessary knowledge, skills and expertise. In most UK hospitals, medicines reconciliation is performed by a member of the pharmacy team who has completed the necessary local accreditation processes deemed essential to perform this role safely and accurately. NICE ([247]) also recommends that patients and their family members or carers, where appropriate, should be involved in the medicines reconciliation process.
The NICE pathway on medicines optimization highlights the place and role of medicines reconciliation in the overall medicines optimization process (NICE [246]).
Use of patients’ own drugs
Currently, the use of patients’ own drugs falls under guidance from the Royal Pharmaceutical Society (RPS [316]). Patients are encouraged to bring their medications into hospital with them to facilitate a comprehensive medicines reconciliation process. Patients’ own medicines that are brought into hospital to be used to continue their treatment should be checked for quality and accuracy of labelling. This is frequently done during the medicines reconciliation procedures. Patients’ own drugs should be stored at the same security standards as other medicine stock on the ward. They should be used solely for that patient and returned to them on discharge as they remain the patient's property (RPS [316]). They should not be destroyed without prior consent from the patient or, if appropriate, their representative. If the patient agrees to the destruction of the medicines, they must be sent to the pharmacy for destruction. If the patient does not want the medicines to be stored in the hospital or sent to the pharmacy for destruction, they must be sent home with the patient's representative.
Safe storage of medicines
Professional guidance on the safe and secure handling of medicines (RPS [316]) recommends that the overall responsibility for establishing and maintaining a system for the security of medicines should be that of the chief pharmacist in the hospital. They should do this in consultation with senior nursing staff and appropriate medical staff. The appointed nurse in charge of the area will have the responsibility of ensuring that this system is followed and that the security of medicines is maintained. The nurse in charge may delegate some of these duties but always remains responsible for this task. The safe and secure handling of medicines on the ward is governed by a number of principles, as follows.
Security
All medicines (including intravenous fluids) should be stored in a locked cupboard that complies with British Standard (BS) 2881 and/or a locked room with separate storage for internal medicines, external medicines, and medicines needing refrigeration or storage in a freezer. Locks for cupboards (except for patients’ own lockers) must comply with BS 3621 as a minimum. All medicines, including intravenous infusion fluids and small‐volume injection ampoules, must be securely stored in their original packaging and not loose or decanted (RPS [316]).
A separate cupboard should be provided for CDs; this cupboard must comply with the specifications set out by the Misuse of Drugs (Safe Custody) Regulations ([219]) as a minimum. The cupboard must be locked with a key and locking mechanism that complies with BS 3621. Intravenous infusion fluids should also be securely stored in a locked facility.
Diagnostic reagents, including for urine testing, should have a separate cupboard, and there should be separate areas for flammable fluids and gases. Bulk flammable solutions must be stored in a metal cabinet, and a risk assessment must be carried out to determine whether a fire‐resistant cabinet is required (RPS [316]).
Where computer‐controlled cabinets are used for medicines, they should provide at least the same level of security as traditional lockable cupboards (RPS [316]).
Finally, medicine trolleys should be lockable and immobilized when not in use.
Stability
No medicinal preparation should be stored where it may be subject to substantial variations in temperature (e.g. it should not be stored in direct sunlight). The normal temperature ranges for storage are as follows:
- Cold storage: for products that need to be stored between 2°C and 8°C. Refrigerators should be placed in an area where the ambient temperature does not affect the temperature control within them. Refrigerators should have minimum and maximum thermometers fitted; these should be read and reset daily, including at weekends.
- Cool storage: for products that need to be stored in a cool place or between 8°C and 15°C. If these temperatures cannot be achieved, these products should be stored in a fridge provided that temperatures below 8°C do not affect the stability of the product.
- Room temperature: for products that need to be stored at room temperature or not above 25°C. Temperatures must be monitored on a daily basis and action taken in accordance with local procedures if maximum temperature limits are exceeded (RPS [316]).
Containers
The type of container used may have been chosen for specific reasons. Therefore, all medicines should be stored in the containers in which they were supplied by the pharmacy. Medicinal preparations should never be decanted or transferred from one container to another except in the pharmacy.
Stock control
A system of stock rotation must be operated (e.g. first in, first out) to ensure that there is no accumulation of old stock. Only one pack or container of a named medicine should be in use at any one time. A list of stock medicines to be kept on the ward should be regularly reviewed according to usage figures. The medicines to be held on the ward should be discussed between the nurse in charge and a pharmacist with relevant medical staff (RPS [316]).
Storage requirements for specific preparations
Certain preparations have specific storage requirements:
- Flammables must be stored in a separate metal cupboard. If large quantities are required to be stored, then a specific flammables cupboard should be used.
- Aerosol containers should not be stored in direct sunlight or over radiators: there is a risk of explosion if they are heated. They must also not be punctured.
- External creams may deteriorate rapidly if subjected to extremes of temperature, while ointments can become liquid if stored at excessively high temperatures.
- Eye drops and eye ointments may become contaminated with micro‐organisms during use and thus pose a danger to the recipient. Therefore, in hospitals, eye preparations should be discarded 7 days after they are first opened, unless local policies extend this limit. Eye preparations prescribed for use at home should be discarded after 28 days unless otherwise advised by the manufacturer (BNF [25]).
- Reconstituted liquid preparations have a limited shelf life and therefore will have a short expiry date once reconstituted. If they have been prepared by a pharmacy, the expiry date will be clearly written on the label. In the unusual situation of the product having to be reconstituted by ward staff or the patient/carer, the packaging should be consulted and the expiry date clearly written on the label of the bottle.
- Liquids must be used within 6 months of opening unless stated otherwise by the manufacturer.
- Tablets and capsules are relatively stable but are susceptible to moisture unless correctly packed. They should be stored only in the containers in which they were supplied by the pharmacy. It is important to ensure that if a bottle contains a desiccant this remains in the pack until it is empty, and it is essential that the desiccant is never inadvertently administered to a patient.
- Vaccines and similar preparations usually require refrigerated storage and may deteriorate rapidly if exposed to heat.
- Medical gases should be securely stored in a separate area. The health and safety issues associated with medical gas cylinders must also be adhered to (see Chapter c12: Respiratory care, CPR and blood transfusion).
Safe and secure handling of medicines
Handling of medicines is a frequent, everyday nursing activity that carries great responsibility. Nursing associates were added to the NMC register as a separate role in January 2019, and this task has been extended to them, as they are able supply, dispense and administer medicines (but not prescribe them) (NMC [257]).
The effective and safe prescribing, dispensing and administration of medicines to patients demands a partnership between the various healthcare professionals concerned – that is, doctors, pharmacists, nurses and nursing associates. Professional Guidance on the Administration of Medicines in Healthcare Settings (RPS [317]) details how the key principles of compliance with legislation, adherence to guidance, and safety of patients and staff should be applied to the management and handling of medicines. In order to achieve this, organizations should have in place standard operating procedures for each activity in the medicines trail; these should indicate clear responsibilities, training, competencies and performance standards for each member of staff. Processes for validation, audit and risk assessment of the activities also need to be included.
Safe administration of medicines
All nurses and other staff who administer medicines must be familiar with the professional guidance on administration of medicines included in Professional Guidance on the Administration of Medicines in Healthcare Settings (RPS [317]). Nurses are accountable for the safe administration of medicines, which is arguably one of the most common clinical procedures that they will undertake. This can be regarded as the greatest area of risk in nursing practice. To achieve safe administration, nurses must have a sound knowledge of the therapeutic use, usual dose, side‐effects, precautions and contraindications of the drug being administered. If nurses lack knowledge of a particular medicine, they must not administer it and must seek advice from a senior colleague.
Institutional policies and procedures will assist nurses to administer drugs safely, and a sound working knowledge of these is essential. Medicines administration requires thought and the exercise of professional judgement. There are a number of ‘rights’ associated with medicines administration; publications refer respectively to five rights (Federico [92], MacDonald [179]), six rights (Perry [281]), eight rights (Bonsell [27]) and nine rights (Elliot and Lui 2010) (Table 15.3).
Table 15.3 The rights associated with medicines administration
Five rights | Six rights | Eight rights | Nine rights | |
---|---|---|---|---|
Patient
| ✓ | ✓ | ✓ | ✓ |
Medicine
| ✓ | ✓ | ✓ | ✓ |
Route
| ✓ | ✓ | ✓ | ✓ |
Time
| ✓ | ✓ | ✓ | ✓ |
Dose
| ✓ | ✓ | ✓ | ✓ |
Documentation
| ✓ | ✓ | ✓ | |
Reason/Action
| ✓ | ✓ | ||
Response/Form
| ✓ | ✓ | ||
Education/Consent
| ✓ |