1. Do you think the RPSGB should place professional restrictions on the way in which Pharmacy medicines are displayed and made accessible to the public?

Yes X  No�� Not sure ��

Please explain your answer

The NPA believes that the public’s interests are best served if Pharmacy medicines are not available for self-selection however this does not preclude open display. We recognise that the current professional restrictions on the display of Pharmacy medicines may cause problems in some small pharmacies where lack of space behind the medicines counter means that the full range of medicines cannot be adequately displayed.  We also recognise that there is a need to adopt a more modern approach to the display of goods and to understand the technologies that exist to permit more open display without necessarily allowing self-selection.

The NPA understands the difficulties imposed by the current legislative and ethical framework, and the challenges of interpreting this within the context of modern competition law.  The NPA is also aware of commercial pressures to review the display of Pharmacy medicines. These external pressures must be balanced with measures which continue to uphold the principles of patient safety.

However, we are also mindful of the fact that this is a time of great change for the practise of community pharmacy. The current interpretation of the term ‘supervision’ will change radically when Regulations are made under the Health Act later this year and remote supervision is likely to become a reality. Legislation will also define the role and responsibilities of the ‘Responsible Pharmacist’ and will permit activities, including the sale of medicines, to be carried on in the pharmacy in the absence of a pharmacist.

The Royal Pharmaceutical Society will be required to divest itself of its current regulatory functions in line with the recommendations made in the Government’s white paper on healthcare professional regulation, Trust, Assurance and Safety - The Regulation of Health Professionals in the 21st Century. It is not clear whether responsibility for compilation of and compliance with a Code of Ethics will be a regulatory or professional matter.

We believe that the time is not right to impose a further change on the profession and that it would be better to wait until it is clear what impact these changes will have on professional practise.

To this end, we believe that RPSGB should continue to place some professional restrictions on the display of P medicines and that the Code of Ethics should encourage and promote safe, responsible and professional display. The NPA welcomes the opportunity to work closely with RPSGB to develop a pragmatic solution for the future.

2. If you believe that there should be restrictions on the way in which Pharmacy medicines are displayed, do you consider a complete prohibition on the self-selection of all Pharmacy medicines to be appropriate?

Yes �� No�� Not sure X

Please explain your answer

There is a small but distinct difference between the terms ‘self-selection’ and ‘open display’. The former implies that there is no need for any intervention or input from a healthcare professional and that the consumer is the final arbiter of product choice; the latter allows a degree of flexibility.

The NPA believes that there should continue to be a complete prohibition on self-selection of P medicines. Medicines are not consumer goods and should not be treated like any other commodity. The real problem at the heart of this issue is the potential for increased consumerism. All healthcare professionals are struggling to find the appropriate middle ground between professional control on the one hand and informed consumerism on the other. It will be much more difficult for pharmacists to maintain professional control over the sale of P medicines if power is shifted to the consumer. The consumer will become the determinant in the selection of the product and the ability of pharmacists to advise on or intervene in the sale will be undermined considerably. Consumers holding a pack of medicines will expect to be able to purchase that medicine, regardless of whether it is safe or appropriate for them.

If Pharmacy medicines are to be on more open display, the public needs to be able to distinguish them from General Sales List medicines and to recognise that professional input is required before purchases can be completed.

Unrestricted display of P medicines is likely to lead to a weakening of professional input into the sale of medicines in this category and the long-term viability of the P category may be called into question. This could lead to a US-type situation with only two categories of medicine, POM and GSL. The Committee on Human Medicines which reviews medicines classifications is unlikely to recommend future switches if the route is directly from POM to GSL. It may even be reluctant to agree POM to P switches if the medicines were likely to be made available on self selection.  At a time when pharmacy is embracing the self-care concept and preparing to help patients self-manage long-term conditions, it is vital that there continues to be a category of effective medicines available to purchase without prescription.

There is also the concern that unrestricted display of P medicines may actually reduce access to NHS services. For example, customers may lose the opportunity to receive advice or a medicine free of charge from a Minor Ailments Scheme if they are unaware that such a scheme exists or if they have selected a medicine and intimate that they do not require professional advice.

3. As an alternative to a complete prohibition on the self-selection of all Pharmacy medicines, are there certain types or classes of Pharmacy medicines that should not be available for self-selection?

Yes �� No�� Not sure X

Please explain your answer. If you answered yes please give details of the classes of Pharmacy medicines that you do not think should be available for self-selection.

As mentioned previously the NPA does not support self-selection of P medicines. Moreover there are many types or classes of Pharmacy medicines that are inappropriate not only for self-selection  but also for open display, for example, those liable to misuse, recently reclassified medicines and those where questionnaires need to be completed before a sale can take place.  Rather than supply an exhaustive list of medicines that are unsuitable, we suggest that pharmacists should be able to use their professional discretion to decide which medicines are appropriate for their particular practice depending on misuse potential, customer profile and demographics, local misuse patterns and so on.

The pharmacist should undertake a detailed risk assessment to determine where each particular P medicine should be displayed and should be able to defend this professionally if the need arises. The risk assessment should be included as part of a SOP detailing how medicines are chosen for open display and should take into account the risk of significant adverse events, allergies and interactions, the risk of patients misdiagnosing symptoms and local misuse patterns.  In addition, RPSGB should be able to provide professional guidance on the display of specific medicines if it becomes clear that there is the potential for patient safety to be compromised on a large scale (for example, pseudoephedrine).

And, as previously mentioned, one should not rule out the possibility in the future that, if the profession moves to open display practices, the decision about whether a medicine is suitable for open display or not may be taken out of the pharmacist’s hands – the CHM could specify, as a condition of a POM to P switch, that it is kept behind the counter.

4. If Pharmacy medicines are made available for self-selection what, if any, professional restrictions should be put in place? (For example, should Pharmacy medicines be displayed in a designated area of the pharmacy or should Pharmacy medicines be stored at a certain height above the floor?)

Yes X No�� Not sure ��

Please explain your answer

In addition to the need for a detailed  risk assessment as outlined above, we recommend the following professional restrictions be put in place to ensure that sales are carried out at all times under the supervision of a pharmacist.:

• Sales, as well as displays of P medicines must take place on registered pharmacy premises by trained and competent staff. This is particularly relevant to large in-store pharmacies where customers often pay for goods at a remote checkout.

• In stores with unregistered parts, signs should alert customers to the fact that medicines must be purchased at pharmacy tills. We would not wish to see a return to the situation where buzzers are pressed when a P medicine is sold at a remote location or packs are held up at the check out as is the case when alcohol is passed by a till operated by a person under 18 years of age.

• The pharmacist or a trained member of staff on the pharmacy premises should be able to intervene in the sale once a consumer has selected a medicine (or dummy pack).

• Staff should receive training on the open display of P medicines, particularly on aspects of communication such as refusing sales, dealing with inappropriate choices, managing conflict and so on.

• Pharmacy medicines on open display must be clearly distinguished from GSL medicines.

• There should be prominent signage indicating the need for professional advice before purchasing the medicine and reminding customers that questions will be asked at the till. Signs should also warn customers that the pharmacist may refuse to make a sale under some circumstances.

• In line with retailing industry standards, we agree with the suggestion that either P medicines should be displayed out of the reach of children at a minimum height of 1.2m above floor level or there should be some other means of restricting access to P medicines by young children.

• There should be a range of robust SOPs in place covering the sale of different products, dealing with inappropriate customer choices, induction of staff who have not worked with open display etc.

• Records should be kept of errors or near misses and complaints relating to open display. Records should be reviewed regularly to identify how improvements could be made and issues addressed.

• Protocols should enable the pharmacy staff to continue to meet their obligations under the New Pharmacy Contract in England and Wales – that interventions relating to self care are recorded.

5. Instead of making full packs of Pharmacy medicines accessible to the public by self-selection, are there other alternative options that you consider may be appropriate? (For example, would the display of empty packs of Pharmacy medicines containing a patient information leaflet be an alternative option?)

Yes  X No�� Not sure ��

Please explain your answer

We are aware some companies have undertaken trials  regarding the effect of display of dummy packs on sales of P medicines.

Since then, a variety of merchandising devices have been deployed to display (and increase visibility of) P medicines without making them accessible for self-selection, for example, display of dummy packs, use of Perspex screens, cupboards with glass doors, transparent lockable security packs etc. It is worth exploring the potential contribution that more innovative merchandising solutions and physical barriers can make to prevent self-selection.

Further Comments

Please let us have any other comments on this matter.

We appreciate the Society is faced with a difficult issue where trade and industry pressures impinge on what is in the public’s best interests.  However, we believe that the Society should show professional leadership in this issue and protect public safety.  In addition, as we have stated earlier, we believe that this may not be the most appropriate time to implement changes to the restrictions on the display of pharmacy medicines due to the great changes facing community pharmacy at this time, but we would support further discussion of this issue.