For that small percentage of pharmacies that have obtained a wholesale dealers licence, and are selling medicines for export, then some thought needs to be given to written procedures that will demonstrate to an MHRA inspector how products that are listed on the current months shortage list in the PSNC newsletter are being handled.

For wholesalers of medicines the challenge of exporting restricted list medicines is no easier, particularly for those wholesalers who do have community pharmacy customers. Whilst legal action is yet to be taken against an exporting wholesaler or pharmacy, it would be wise for those involved in exporting to consider what written proof they could provide, if challenged, as to how their actions could be proved not have compromised supply to UK patients.

For example, things that could be considered that may go some way towards showing regard for the restrictions upon exporting certain medicines, if challenged, could include:

* which products are exported, what are they used to treat, and how unique are they. The more serious the condition treated and the more unique the product, perhaps the more serious the breach if exported?

* what records are kept on each sale for export occasion to prove that checks have been undertaken upon stock availability from at least main wholesalers and manufacturers?

* are some buffer stocks retained for the UK market, of products in short supply, and appropriate detailed records kept to prove such?

The current situation is clearly unsatisfactory, and it remains to be seen whether 2012 is the year when this issue is taken more seriously by all actors.  In the meanwhile wholesale suppliers should consider carefully their actions and how they would prove that they have not exacerbated the UK supply problems.

Over the last year, I have seen quite a variation in the detail of what matters at an inspection, and from that I have learnt that one really needs to cover as many bases as possible prior to inspection, as almost anything can be brought up, and often is!

Temperature control has certainly received much more emphasis over the last couple of years, and perhaps with global warming this is understandable, as even the UK now can expect a few days, if not a week or two, of 30C plus days, when an un-cooled warehouse could easily exceed 25C. The transportation of cool chain items logically also has received more focus. In the last couple of weeks we have also experienced the opposite problem, and preventing a poorly insulated warehouse or goods in transit  from freezing may have challenged some.

Whilst relatively uncommon, I have also seen interest in ensuring that :

* the authority level and responsibilities of RPs is clearly spelt out in Job Descriptions and/or in technical agreements.

* computer systems in use are properly validated

* controlled secure access to premises works

Later this year it is likely that all Wholesale dealers will have to put in place a Quality System, not necessarily an ISO type system, if an EU consultation conducted at the end of 2011 is enacted without significant modification of proposals. Watch this space for more on this when it becomes known.

The January 2012 PSNC Newsletter carried an excellent 4 page article concerning the many aspects of implementing the service that community pharmacists need to consider. This is well worth reading and keeping for future reference.

The Connecting for Health web site should be visited regularly by pharmacists to check both the dispensing and prescribing systems suppliers status, so that the local situation can be evaluated as it develops.

On the dispensing systems side, most suppliers are ready for a national roll out now. 2 of the 7 system suppliers available to independents are quoted on the CFH site as being ready for clinical release by Q2 this year, so all suppliers should be ready by mid-year.

The PSNC article mentioned above offers good advice on selecting a system supplier, notably the recognition of the importance of the software system to each pharmacy.

In my own view, any pharmacist considering changing PMR systems needs to research the market thoroughly, and then make an early decision to change and get on with it, or to stay put. Changing software systems midway through the EPS implementation would just make the task of implementing EPS harder for staff and pharmacists alike than it really needs to be.

Also, there is no clear statement at the moment about transitional arrangements to cover contract applications that have been made but not determined or determined but not opened to the public  before the new arrangements come into force. Unless transitional arrangements are also put into place alongside the new PNA system, then applicants who have applied under the current (2005) system would be disadvantaged. It is understood that in particular that many more 100 hour applications have been submitted than PCTs are likely to be able to process anytime soon.

As to the new PNA based system, most PCT PNAs will already be out of date, having been put in place as required by the DOH for February 2011. In addition, an analysis conducted by the Cooperative pharmacy chain, showed that many of the published PNAs do not meet all the 29 specific characteristics required by the DOH of such documents. Specifically the average compliance of the published PNAs with the 29 characteristics was only about 70% and in the worst case was as low as 48%.. Only 34% of PNAs made reference to patient disabilities and less than a third of PCTs had considered the future health needs of their populace and under 50% mentioned pharmacy services that could improve the current situation.

This analysis of current PNAs  would suggest that an early implementation of the PNA basis of considering pharmacy contract applications would only result in a myriad of appeals against  such poorly prepared and already out of date PNAs.

A pharmacist obtained an Internet Only Pharmacy contract for a set of premises located in town in the NW of England in a Mews development, located at Number 4.

It also took on the Mews premises situated close by located at  No 1, and joined the two premises together using an air tube to facilitate the transfer of prescriptions between the registered premises where the “Internet only/mail order” prescriptions were dispensed, and the nearby unregistered premises where they were deposited or collected by patients.

The appeal panel took the view that the registered pharmacy premises (at Number 4) effectively extend along the air tube to Number 1, and that thereby members of the public who receive pharmaceutical services via the use of this system, will be receiving pharmaceutical services “at the premises” (Number 4) for the purposes of the regulations.

The appeal panel unsurprisingly found the inventive system in use to be be contrary to NHS regulation 13(4) and decided to remove the company concerned from the pharmaceutical list (effectively closing the internet pharmacy at Number 4 down).

You have been warned.

Moral: Experienced advice should be taken before investing in inventive schemes that may subsequently be found to breach the NHS regulations.

(The full details of this fascinating case are currently available to the public on the NHSLA web site-Reference Decision SHA/16541)

The prime reasons for the Pharma industry to seek the specific mechanism were:

* a fear that EU enlargement would result in a flood of parallel imports from new member countries (generally lower priced countries) to older member states (generally higher priced countries).

* a fear that the extent of patent protection for medicines would vary between old and new members states.

In practice, the specific mechanism means that patent protected medicines in the older member states are protected from imports from the newer member states, if it was impossible for the product owner to obtain a patent or supplementary protection certificate (SPC) for the relevant medicine in the newer member state at the time when the patent or SOC for the same product was filed for in the member state of threatened import.

The specific mechanism only applies if the medicine in question originates in one of the newer EU member states: Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia or Slovakia.  When Malta and Cyprus acceded to the EU, further rules were applied to these 2 countries, but importing to older members states via these 2 countries cannot be used to “get round” the special mechanism, as it is the source country of the product (where it was originally placed on the market) that counts and NOT the latest country from which it is imported

This whole issue is quite complex and totally product and country specific. It is vital therefore that before spending time and money to licence a medicines import in the UK from a newer member state, the specific mechanism legal status of that medicine for that country of potential export is first checked out.

Evidence suggest that the degree of historic involvement of Pharma with pharmacists to develop medicines adherence enhancing activities is patchy at best. There seems so far at least to have been a disbelief and distrust that pharmacists can and will actually give Pharma a return on their investment in adherence enhancing projects. Yet there is good evidence to suggest that well designed adherence enhancing activities, particularly those run run by pharmacists, can and do work. The government’s investment in MURs and in the New Medicines Service both suggest that the DOH at least believe that investing in pharmacy supported adherence enhancing activities is worthwhile, and historically the DOH have not had a reputation for funding pharmacy beyond the minimum required.

It seems to me that Pharma sadly now has quite a long history of having next to no meaningful relationships with pharmacists. The relationship has undoubtedly been made worse in recent times with the introduction by Pharma of DTP activities. Thus it is not perceived to be easy for Pharma to now begin to work closely with pharmacists. Yet there is no absolute bar to doing so and it is never too late to start. The ABPI are broadly supportive of pharmacist involvement in properly structured and professionally developed adherence development activities. When pharmacists have been given an opportunity to get involved in Pharma supported adherence enhancing activities that allows them to make good use their knowledge and skills, they have usually been very open to getting involved.

What has proved a turn-off for pharmacist involvement has been unmanageable bureaucracy that Pharma have required to track pharmacist participation ins such activities. What has also proved to be a negative to the success of adherence developing work has been the lack of clear and long term plans by Pharma to remain involved. Further, regular and ongoing communication channels need to be opened and maintained between Pharma and pharmacists involved in their adherence work for such co-operation to truly succeed.

Finally, I observe that adherence to medicine taking is a complex human psychological issue. Any initiatives developed by Pharma in adherence enhancement need to take full account of the patient’s perspective, as well as also fully considering:

Health-Care system & provider issues, the specific therapy, the specific condition, socio-economic factors and finally costs

My own organisation has been involved in some modest pilot project work in this area, and as a pharmacist myself, I have been able to act as a useful communication bridge between Pharma and community pharmacists.

With Electronic prescribing it is certain that the level of interest and activity in Internet pharmacy will increase. This form of exempt pharmacy contract has not been removed, so the competition will come not only from existing Internet contractors but also from additional new ones. In 2011 it was 100 hour pharmacies that attracted much anger, this year it is likely that Internet pharmacies will become the source of business loss from contractors who are not ready to compete. In order to compete it is necessary, at the very least, to get patients signed up to your pharmacy as their nominated pharmacy for EPS. Also you need to to be ready with R2 accredited pharmacy software and have your staff trained to go with EPSR2  the moment electronic prescriptions start arriving, and of course have a delivery service available too! If you have not refreshed your web site recently that too would be a worthwhile activity, and starting writing blog articles of interest to your patients and customers would help you still further.

My view is that there will be significant additional competition from companies like Pharmacy 2U (P2U) who have last year been funding research into patient’s propensity to collect repeat prescriptions. This new found interest in practice research is unlikely to be purely charitable. I would expect to see some vigorous marketing by such organisations, not only to their existing OTC purchase customers but also to  the wider UK audience whom they could easily service electronically.

In addition to all the above factors, suggesting 2012 will be the year that Internet pharmacy really takes off, the EU commission published on 11th January 2012 a communication on building a “coherent framework for building trust in the Digital single market for e-commerce and on-line services”. The essence of this new communication seems to be NOT to have the EU build another mountain of red tape hindering Internet business, but the EU want to foster a faster growth rate of EU Internet business, which in 2010 was only 3% of total EU trade.

The EU communication sets out an action plan to overcome the perceived obstacles to EU Internet trade with the aim of doubling the contribution of e-commerce to the EU economy, so there is support for internet trade from Brussels too .

It would be wise therefore for community pharmacists to check with their local main surgeries what their intentions and time-scales are for commencing electronic prescribing. Alternatively, or additionally, an idea of expected regional deployment can be obtained as an on-line deployment map from the Connecting for Health web site.

Early adoption of EPS R2 by pharmacists will allow them to:

* position themselves to be ready early

* access the one-off R2 allowance

* enable the pharmacy to begin to set patient nominations on the Personal Demographics Service (PDS) where patients have consented

It is possible for pharmacies not R2 enabled to start collecting patient consents, however if there then proves to be more than a 4-6 week delay between collecting consent and changing the patients preference on the PDS service, the pharmacy contractor will have the additional responsibility of confirming that there has been no subsequent change of patients circumstances including their choice of nominated dispensing site, when the PDS is updated.

As this major development for GPs, patients and pharmacists  now looks certain to proceed to implementation, I would advise pharmacists, particularly those already located in competitive situations, to now move this subject towards the very top of their priorities, as staff training, smart-cards, security passwords all need to be resolved before R2 can be used. Even in apparently low competition areas, it seems reasonable to forecast that there will be a national increase in Internet pharmacy competition, possibly a significant increase, based upon the launch of R2.

What is not yet so clear is what the transitional arrangements will be joining the end of the 2005 regulations with the beginning of the new PNA based control of entry  regulations.

Those who have or applying whilst the current regulations are still fully in force, will probably feel that their application should be processed under the current regulations, regardless of how long the relevant PCT may delay processing the application.  Whilst this seems a reasonable and fair aspiration, it is perhaps just one of the several options open to the regulators.

It could for example be that only those applicants whose applications have been finally decided  before the PNA basis comes into force, will be allowed to proceed with opening.

Whilst I would in no way seek to encourage anyone to open a 100 hours pharmacy lightly, as profit margins in 2012 will undoubtedly be worse than in 2011, there look to be potential risks for those whose applications are submitted late and may therefore not be processed before the new legislation is decided.