The Human Medicines Regulations 2012 introduce changes to labelling and medicines-use which advance the clinical role of pharmacists in supporting people to get the most from prescribed medicines across the UK, providing greater clinical flexibility for prescription intervention.
From 14 August 2012, subject to professional skill and judgment, a pharmacist who is of the opinion that the directions for use, name or common name of the medicine, or precautions relating to the use of the medicine are not appropriate on the prescription, can substitute these with appropriate particulars of a similar kind when producing the dispensing label.14
The General Pharmaceutical Council (GPhC) and Pharmaceutical Society NI are the regulatory bodies for pharmacists and registered premises in Great Britain and Northern Ireland.
The Medicines Healthcare Regulatory Agency is an executive agency of the Department of Health responsible for ensuring that medicines and medical devices are safe. This includes the regulation of product information, packaging and labelling. This professional guidance is distinct from regulation, but supports pharmacist to meet applicable regulatory standards of conduct, ethics and performance or codes of ethics when undertaking dispensing label optimisation.
The decision pathway for the optimisation of dispensing labelling and medicines-use involves:
Step one: Identifying a problem
Step two: Deciding on the right solution for the patient
Step three: Successfully implementing the decision
The first two steps, identifying a problem which may be solved by optimisation of the dispensing label and deciding on the right solution for the patient requires the exercise of professional skill and judgment underpinned by clinical skills.
The following elements should be considered:
- Relevant clinical specialism and competency, knowledge and experience of pharmacist
- Availability of information, such as:
- Patient characteristics
- Nature of clinical condition
- Lifestyle e.g. shift-work
- Co-morbidities e.g. renal failure
- Patient type e.g. children, pregnant, breast-feeding, elderly, ethnic group
- Access to and information about the patient (e.g. patient medication records and medication history.)
- Diagnosis (indication for medicines use)
- Medication regimen factors
- Nature of the medicine e.g. narrow therapeutic index or specialist use
- Availability of standard dosing information from national or local formularies
- Access to clinical reference sources and guidelines
- Evaluation of benefit and risk of the various options for the patient
- To optimise medicines label and supply
- To optimise medicines label and an interim supply pending clarification of information
- To clarify with the prescriber prior to supply
- To refer the patient back to the prescriber
- To supply without the need to optimise the label
The elements above inform upon the choice of solution.
It is important to understand that the change is enabling and not mandatory. The options to contact the prescriber or refer the patient to the prescriber remain available and should be used where this is appropriate in the opinion of the pharmacist having exercised professional skill and judgment.
Table 1 - Examples where optimisation of medicines-use and labelling could be considered.
This list is indicative and not exhaustive
Directions for use
Precautions for use
Correcting erroneous prescription directions or precautions
e.g. wrong direction or dosing frequency for the indication, or wrong route of administration (without clinical explanation)
Supplementing prescription directions where details are missing
e.g. 'as directed'directions or where information about food or after food, timing of doses, routes of administration are missing
Clarification of existing prescription directions
e.g. a reducing dose which may be confusing to the patient (10mg, reduce by 2mg every three weeks)
Name or common name
|Choosing to label with a more appropriate synonym where the generic name is meaningless to the patient or it is important to use an alternative which is understandable or provides reassurance
e.g. sometimes encountered with contraception, HRT, vitamin preparations, topical formulations or where it is important that the patient stays on a particular brand of medicine but when it is prescribed generically.
Where the name used could be misleading
e.g. unlicensed use of eye drops intended for use in the ear
Table 2 - Examples of limitations of the legislation changes for optimising medicines labels.
This list is indicative and not exhaustive
||The dispensing of a medicine that is not specified on the prescription is not enabled. Generic substitution is not enabled by this change.
|Schedule 2 and 3 controlled drugs
||Controlled drugs legislation is not amended by this change and continues to apply. There would be limitations on the application of optimisation to labels for schedule 2 and 3 controlled drugs.
|Restriction of optimisation to 'directions for use, precautions for use, and name or common name'
||This change does not enable the amendment of other prescription details either specified by the prescriber or required by packaging legislation.For example, where a total quantity has been stated, this cannot be exceeded or where the strength of preparation has been specified, this cannot be changed.
|Existing conventions for dealing with incomplete prescriptions
||This change does not replace existing recognised conventions for dealing with incomplete prescriptions. e.g. British National Formulary general guidance strengths and quantities for systemically administered preparations (BNF 64, pg 2) or 'not dispensed' conventions which can continue to be used.
||The HMR 2012 change enabling labelling optimisation is supported by this professional guidance to achieve better patient clinical outcomes.Reimbursement arrangements are unchanged.
Making an intervention
If there is a decision to intervene it is important that the pharmacist exercises professional judgment in deciding:
- The appropriate patient counselling required to support the intervention
- Whether the intervention requires notifying to the prescriber to maintain patient care.
Record keeping can be useful for maintaining a clinical audit trail underpinning patient care. It is recommended that details of the intervention are:
- Annotated onto the prescription or drug chart making the annotation attributable to the pharmacist making the optimisation
- Annotation of details into the patient medication records
- Where appropriate into an interventions log.