The Royal Pharmaceutical Society has received a number of queries asking whether dispensed prescriptions can be supplied and pharmacy medicines sold while the pharmacist is undertaking a private consultation with a patient on the pharmacy premises (for example, when a pharmacist is conducting a medicine use review in a private consultation area).
The Medicines Act 1968 requires that pharmacy and prescription only medicines be sold or supplied by a pharmacist or by someone acting under the supervision of a pharmacist. Supervision is not defined in the Act, but is currently interpreted to mean that the pharmacist must be aware of the transaction and in a position to intervene. Since the introduction of the sale of medicines protocols, in the mid1990s, a pharmacist has not needed to be personally involved in every pharmacy medicine sale, provided sales are carried out by suitably trained and competent members of staff acting in accordance with agreed protocols.
Pharmacists who are involved in a consultation with a patient in a private area or room in the registered pharmacy premises are unlikely to be aware of the content of the medicine sales taking place or know which dispensed prescriptions are being supplied. However, in taking into consideration current legal and professional requirements for the sale and supply of pharmacy and prescription only medicines and being mindful of the potential changes to the existing supervision requirements of the Medicines Act, the Society has issued the following interim guidance.
Interim guidance
If a pharmacist is involved in a consultation with a patient in a private area or room of a registered pharmacy premises, pharmacy medicines may be sold and dispensed prescriptions that have been checked for clinical appropriateness and accuracy may be supplied, provided that robust standard operating procedures (SOPs) are in place. The pharmacist will still have professional responsibility for any sales or supplies of medicines that take place while they are involved in the consultation and it is essential that the SOPs clearly identify when a pharmacist’s intervention in such medicine sales or supplies is required and that systems provide for this intervention. All members of staff need to be aware of the circumstances where pharmacy medicine sales or dispensed medicine supplies cannot proceed without further intervention from the pharmacist, and patients should be advised accordingly. Pharmacy staff who are given delegated authority to sell pharmacy medicines and supply dispensed prescriptions must have undertaken an accredited training course relevant to their duties and the pharmacist must be satisfied that the staff are competent to perform the tasks delegated to them. Clinical governance arrangements must ensure appropriate audit and risk assessments are conducted and that adherence to SOPs is regularly monitored and reviewed.
Pharmacists are required to make a professional assessment of every prescription to determine its suitability for the patient. If this assessment has not been performed, prescribed medicines cannot be supplied. Pharmacists must also ensure that patients receive sufficient information and advice (from either a pharmacist or an appropriately trained member of staff) to enable the safe and effective use of the medicines that are sold or supplied.
Pharmacy owners and superintendent pharmacists will wish to reassure themselves that the pharmacist in personal control of the pharmacy only allows delegation of tasks when it is safe to do so. This may be covered in company procedures. However, a pharmacist in personal control should decide whether he or she is personally satisfied that the systems in place, and the level of trained pharmacy staff present on any particular day, are sufficient to ensure that patient safety will not be compromised. If the pharmacist cannot be satisfied that appropriate systems are in place, sales of pharmacy medicines and supplies of dispensed prescriptions should not proceed when the pharmacist is involved in a private consultation with a patient. It should also be noted that if a pharmacist has to leave the registered pharmacy premises to conduct a patient consultation (or for any other reason) the current personal control requirements of the Medicines Act will not be met and no sale or supply of medicines, including general sale list medicines, should take place.
Next steps
This interim guidance will be reviewed in light of any changes to the current requirements of Medicines Act legislation.
