Health Bill

I hope that I will be able to give the noble Baroness some reassurance. Before addressing these amendments, it might be helpful to set out the context of our full package of proposals with regard to medicines and pharmacies. That will also help with some of the later amendments. Within the Medicines Act 1968, there are two separate requirements through which pharmacists ensure the safe sale and supply of medicines. First, each pharmacy must have a pharmacist in personal control of the business, as provided in Sections 70 to 72 of the Medicines Act. Secondly, prescription-only and pharmacy medicines must be sold or supplied from a pharmacy by, or under the supervision of, a pharmacist, as provided in Section 52 of the Act. Personal control concerns the oversight of the pharmacy business, while supervision relates to individual transactions involving the sale or supply of certain medicines. We are seeking to clarify these requirements through the Bill. We are replacing the concept of ““personal control”” with the requirement for each pharmacy to have a responsible pharmacist. The responsible pharmacist will, for the first time, have an explicit statutory duty to secure the safe and effective running of the pharmacy business. They will be in charge of the pharmacy and responsible for ensuring that all activities involving the preparation, assembly, sale and supply of medicines are undertaken safely. The responsible pharmacist will need to set down procedures for these activities, allocating individual duties according to the competence of other members of the pharmacy staff. A record must be kept of the responsible pharmacist at all times. With these safeguards in place, we do not believe it necessary for the responsible pharmacist to be physically present in the pharmacy at all times to maintain patient safety. But I stress that patient safety is a fundamental principle of the Medicines Act, and we would not seek to make changes that are not in keeping with that principle. On supervision, we are retaining the requirement in Sections 10 and 52 of the Medicines Act for the preparation, assembly, sale and supply of certain medicines to be undertaken by, or under the supervision of, the pharmacist. However, pharmacy practice has moved on since the Medicines Act was introduced in 1968, with more medicines supplied already packed for use, more highly trained staff, such as pharmacy technicians, working in pharmacies, and the availability of modern technology. That is why, while retaining pharmacist supervision, we need to clarify which activities in the dispensing process must be undertaken by the pharmacists themselves and which activities can be safely supervised by a registered pharmacy technician, for example, or undertaken by other pharmacy staff. We also need to define the role that modern technology can play in the preparation, sale and supply of medicines. The pharmaceutical societies and pharmacy profession in general welcome and support these changes. For example, 75 per cent of respondents to our consultation wanted clarification of current legislation on pharmacist ““personal control””; 80 per cent wanted the supervision requirements to be clarified and redefined; and only 4 per cent of respondents thought that there was no case for change. I acknowledge that there are some concerns about the fine detail but there is also acceptance that those matters should be addressed in the regulations, on which we will consult widely, rather than on the face of the Bill. I am more than happy to repeat our commitment to continue to work closely with the Royal Pharmaceutical Society of Great Britain, the Pharmaceutical Society of Northern Ireland and others, as we have been doing already on these proposals, in developing the regulations. Amendments Nos. 74 and 75 would, if accepted, effectively prevent remote supervision, whereby the pharmacist supervises the preparation, sale and supply of medicines from another location, through the use of modern technology. As I have said, under Sections 10 and 52 of the Medicines Act, medicines must be prepared, sold or supplied by, or under the supervision of, a pharmacist. Our intention in enabling remote supervision of these activities is to take powers to set conditions to ensure that, when pharmacists supervise from another location, they do so safely through the use of modern technology, such as bar coding, robotics and video links. At present, it is unclear whether the supervision requirement in Sections 52 and 10 could be discharged using remote means. In practice, because the ““personal control”” requirement has been interpreted as requiring a pharmacist to be physically present in a pharmacy at all times, this has not been an issue. The only time the issue was considered by the courts—and then only in passing—was in the case of Roberts v Littlewoods, as long ago as 1943, when the judge commented that a pharmacist might supervise the sale of a medicine ““without being bodily present”” and that this would be possible with the mechanical assistance of a telephone or ““something of that sort””. It is the Government’s view that, in most cases, use of a telephone alone would be inappropriate in meeting the supervision requirements. We consider that remote supervision has the potential to bring benefits to patients but that it should be permitted only in carefully controlled circumstances. It is for this reason that we have taken a power to prescribe the circumstances in which, and the conditions subject to which, remote supervision should be permitted. It would be up to the responsible pharmacist to determine whether to allow remote supervision of the activities in the pharmacy for which he is responsible, provided that the conditions within the regulations are met. The responsible pharmacist would not be obliged to permit supervision from another location but, where he chose to do so, this would need to be covered in the procedures that he sets down under Clause 29. The responsible pharmacist would need to consider the particular circumstances of the pharmacy, its staffing and the available technology to fulfil his statutory duty to ensure the safe and effective running of the pharmacy, including the safe and accurate supply of medicines. Indeed, it is known that where new technology is used, this can reduce medication errors. For example, the electronic transmission of prescriptions can lessen transcription errors, and use of bar coding and robotics can reduce picking errors. Telemedicine is increasingly being used in healthcare. Mail order and internet pharmacies are already permissible under the Medicines Act, provided that the pharmacy is registered and meets the professional standards set by the pharmaceutical societies. As in other pharmacies, pharmacists still advise patients, although different methods may be used. Where a pharmacist remotely supervises the sale or supply of medicines, we would expect, subject to consultation, appropriate technologies to be in place to allow face-to-face contact with pharmacy staff and patients, as necessary. Only a pharmacist will be able to supervise remotely. Through these changes, as well as maintaining patient safety, there is scope to enable better access to medicines. For example, a pharmacist-controlled vending machine, to which the noble Baroness referred, has been developed in Australia. The pharmacist supervises and controls the supply of medicines away from where the vending machine is located and where the supply is actually made to the patient. Using modern technology, the pharmacist can see the prescription, ensure that the right medicine is chosen and labelled correctly before it is supplied, and see and speak to the patient to provide any information and advice in the usual way. The use of such technology might bring particular benefit to remote or rural areas, or in the supply of medicines out of hours. Accepting these amendments would prevent remote supervision. That is why I hope that I have reassured the noble Baroness. In relation to her blue and white pills experience in Norfolk, the standard operating procedures that I have mentioned will set out the safe systems of work. That will make requirements for safe practice more explicit. Staff will need to be appropriately trained to follow the procedures and the pharmacist will still need to be contactable or to arrange for another pharmacist to be contactable in order to provide advice. Procedures will set out when staff should contact the pharmacist, which they should do if an issue is not within their competence, as set out in the procedures. So there will be a lot of safeguards to meet the circumstances referred to by the noble Baroness. I hope that I have been able, admittedly at some length, to provide the reassurances that I think the noble Baroness and those who have been briefing her are looking for.