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She has been involved in discussions about the Responsible Pharmacist regulations with the Department of Health from the outset and, as a practising pharmacist, is able to relate national policy to the reality of working in a pharmacy.
Over the next few months, Michelle will be on hand to answer any questions you have regarding the implementation of the Responsible Pharmacist regulations.
To ask Michelle a question click here >>
Why are these changes happening?
Why are these changes happening? The Government says that the four The new changes support delivery of these plans whilst maintaining public safety in relation to the dispensing and sale of medicines. The existing concept of “personal control” is generally agreed to be a barrier to the provision of new clinical services by community pharmacy as it requires the physical presence of the pharmacist in the pharmacy at all times The responsible pharmacist concept allows the responsible pharmacist to be absent from the pharmacy premises under certain circumstances and this will allow a little flexibility for the development of new roles away from the premises. In addition the changes will address the anomaly which allows GSL medicines to be sold in garages and other retail outlets without a pharmacist, and will allow GSL medicines to be sold from pharmacy premises while the responsible pharmacist is absent. Does everyone agree with the changes? When the Department of Health consulted on the changes, it reported that 9% of respondants did not support any of the proposals. Some respondants commented that this was because they wanted to maintain the status quo, or had concerns about safety. There are still concerns that allowing responsible pharmacists to be absent from the pharmacy could lead to safety problems, or accountability confusions if errors are made in their absence. As the changes are legislative changes, they cannot be ignored. From 1st October 2009 it will be a legal requirement under the Medicines Act 1968 as amended for a pharmacy to have a responsible pharmacist who has a legal duty to secure the safe and effective running of the pharmacy. Thus if a responsible pharmacist is not in the charge of a pharmacy it will be operating unlawfully. Do I need any extra qualifications to be a responsible pharmacist? The responsible pharmacist must be a registered pharmacist and may be a locum or relief pharmacist. No additional qualifications or experience levels are required to be a responsible pharmacist, however some of the changes are quite complex so it would be advisable to read guidance documents and practice standards to ensure that you understand the legal obligations. It is important to note that where the premises has not been registered for at least 3 years then a pharmacist who is registered in the UK by virtue of an equivalent European qualification may not be the responsible pharmacist. (This is not a new requirement.) However, you do need to understand the new law and ensure that you can comply with the requirements placed on a responsible pharmacist. The government originally proposed that a responsible pharmacist would need some additional level of qualification or experience to take on the role. However, in responding to the consultation many pharmacists and organisations were opposed to this idea. The government said: “In the light of views expressed by pharmacists and pharmacy organisations, the government does not propose to bring forward regulations in relation to the eligibility (ie qualifications and experience needed) to be a responsible pharmacist.” But it was stressed that there was a need to review pharmacy training and to consider both the development of CPD programmes in relation to the role of the responsible pharmacist and professional training and standards. So what exactly is a responsible pharmacist responsible for? The Department of Health says that a responsible pharmacists is essentially “in charge of the business at the premises” where this relates to the retail sale and supply of medicinal products. The responsible pharmacist has a legal duty to secure the safe and effective running of the pharmacy as it applies to the sale and supply of medicinal products. In order to do this, and to comply with the law, responsible pharmacists must: Establish (if not already in place), maintain and review pharmacy procedures designed to secure the safe and effective running of the pharmacy Make a record of the pharmacist responsible for the pharmacy on any date and at any time There can only be one responsible pharmacists at a time in a pharmacy, and the responsible pharmacist must also comply with regulations on absences. They must also display a notice in the pharmacy, stating that his/her name, that s/he is the pharmacist in charge of the pharmacy on that date and at that time, together with details of his/her registration number. Isn’t every pharmacist ‘responsible’? All pharmacists will remain professionally accountable for their actions, and must work to professional standards and guidelines, adhering to the code of ethics and to the standard operating procedures in place. The ‘responsible’ pharmacist is simply the pharmacist-in-charge of a registered pharmacy on any day and at any time and has the legal obligation to secure the safe and effective running of the pharmacy business. In some cases they will be the only pharmacist working in the store, but in others there may be a second pharmacist. If there is more than one pharmacist, all pharmacists can supervise the dispensing, sale and supply of medicines but only one can be the responsible pharmacist. However the responsible pharmacist has an additional legal obligation to ensure the safe and effective working of the pharmacy. This means they must set out procedures for safe and effective working in the pharmacies and are professionally accountable for those procedures. The Department of Health says if another pharmacist diverges from those procedures they will be held professionally accountable for that decision and for working in that way.
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