Pharmacy Consulting Ltd (PCL) have been involved in various projects in which pharmacies have been considering a move into a nearby Health Centre. Amongst the many learning lessons so gained, the importance of establishing and maintaining goodwill between the pharmacist/pharmacy owner  and the GPs cannot be understated. Whilst it is possible to develop goodwill without a shared commercial interest, without doubt a shared commercial interest does tend to foster both parties working well together for mutual benefit

Looking forwards, the new 2012 control of entry regulations will affect relocations into health centres as the concept of a neighbourhood and the concept of a minor relocation are both set to disappear. It would be wise to take professional advice from organisations like PCL, who are keeping close to the new regulations, before submitting a relocation application, once the new regulations come into force, which a PSNC source believes could be as early as July 2102.

The location of the pharmacy within the health centre can have a massive influence upon the commercial success of the pharmacy, and the size shape and orientation of the pharmacy space are all also important. If the relocated pharmacy is expected to be very busy with prescriptions, then automating the pharmacy from day one is a good idea, and will probably be cost justified. PCL has been involved with several such projects with ARX in particular

The design of the pharmacy should also be focussed upon optimising customer service, as well as upon optimising operational efficiency-with or without automation.

Pharmacy Consulting Ltd have worked with independent pharmacists to successfully develop a wide-ranging profit improvement action plan, based upon their individual business after a pharmacy visit, to improve the margins that will be achieved.

For those who may also be beginning to think about selling their pharmacy or retiring, this subject is particularly important as in the current market conditions pharmacy buyers will be much more likely to value a pharmacy based upon a multiple of net profit rather than upon a multiple of turnover. So getting the net margin as high as possible will maximise the pharmacy sale price.

The eSubmision gateway is an electronic submission channel  that allows applicants to securely submit electronic documents supporting all types of applications for human medicines using the Electronic Common Technical document (eCTD) format.

Those wishing to use the gateway, need to have access to the Electronic Standards for the Transfer of Regulatory Information (ESTRI) gateway by registering  to use it, unless they were already involved in the pilot use

Later this year, there should also be a web-based submission client developed especially for low transmission volume customers, which would suit small and medium companies

The EMA will continue to accept submissions made on physical media such as CDs or DVDs, for those who prefer to use physical media but the EMA does not want to see duplicated transactions using both media

The EMA is presently testing out via a pilot study until July 2012, electronic application forms that use an interactive PDF form which applicants can fill out on-line

These developments should in due course speed up the marketing application process  whilst keeping the process and data secure

Those wholesale exporters in particular who are currently buying small quantities of stock from pharmacies who do not hold a wholesale dealers license, will from 12th July be open to enforcement action by the MHRA, as from that date wholesale commercial transactions with pharmacies can only be with WDL licensed pharmacies.

Unless pharmacies have already applied for a WDL, they are almost certain NOT to get one before 12th July, as the MHRA typically have a 3 month waiting list of license applications to be processed and approved. So, wholesale dealers need to be particularly careful to demand copies of pharmacies WDLs after 12th July, otherwise they could be putting their own WDL at risk.

Finally, all wholesale dealers should have regard to the monthly list of branded medicines in UK short supply published in the PSNC month contractor newsletter  (which is freely available to all from www.psnc.org) . These listed branded medicines should not be exported without the exporter taking various steps both to verify the current stock situation and other steps to protect themselves legally from prosecution.

Pharmacy Consulting Ltd offer independent advice and support in all the above situations.

After that date, the MHRA have made it clear that they will NOT pursue pharmacies who are borrowing or lending stock, for the benefit of an NHS patient, but pharmacies who continue to trade commercially in pharmaceuticals after July 12th, without a WDL,  WILL lay themselves open to prosecution by the MHRA. Further, the publication in the PSNC newsletter each month of UK branded medicines in short supply lays a further trap for those who continue to sell those listed branded products for export, unless they take a number of precautions to protect their situation.

There is usually a waiting list of WDL applications to be processed at the MHRA of approximately 3 months from receipt of a completed WDL application. The WDL application form has to be accompanied by a relevant set of wholesaling SOPs, and “technical agreements” with any 3rd party couriers or contract Responsible Persons (RPs) and the license application fee of some £3600 has to be pre-paid [This RP is NOT the same as a Pharmacy Responsible Pharmacist].

There are commercial exporting organisations offering to complete the whole WDL application process for pharmacists  without charge, but there is usually a quid pro quo condition that such pharmacies must sell products for export to the company who conducted the application work and sell them at prices fixed by the purchaser.

Those pharmacists who wish to retain their independence in this matter will wish to retain the services of a reputable pharmacist run consultancy company to help obtain their WDL, after which they will be free to operate  as they see fit.

Many types of initiative have been tried over the years, to try to improve patients adherence to prescribed therapy, with mixed results. Pharmacists have been shown to often be more successful than Nurses or Doctors in this arena, hence the launch in 2011 of the New Medicines Service (NMS) and targeted Medicine Use Reviews (MURs) through all community pharmacies in England. Yet these programmes by their very nature have to be quite “broad-brush” and cannot offer a very different service to different types of patient.

There is little doubt that adherence is a complex issue involving both psychology as well as pharmacology. Patients are consumers who have an illness, and their attitude to their well-being and what they are willing to do to maintain or improve their health varies considerably between individuals and also varies with the perceived threat of the condition suffered.   Maladherence can usually always be justified in the patients minds, so to make progress on adherence  patients emotions concerning their condition and their treatment need to be well understood, ideally at an individual level.

Whilst it is all too easy for healthcare professionals to solely blame the patient for non-adherence, patients can often be so overwhelmed by a negative diagnosis that they forget about the instructions given to them for improvement action.

As with all initiatives, you can’t change everyone’s approach and the received wisdom is that the groups to focus investment upon those whose attitudes and behaviours are easiest to influence, as some patients will always be mal-adherent. If you understand the different stages of mal-adherence in a therapy area, and understand the underlying feelings that the patients experience, then you can better target with adherence initiatives those groups with the highest potential to respond.

Finally, in order to be successful and remain successful it helps enormously if adherence programmes can be engaging and stimulating from a patient perspective. Patients need to understand “what is in it for them” and want to become involved because the programme pulls them in.

This is a subject area where Pharmacy Consulting Ltd, have some experience both on their own, and in partnership with Zaicom MMC.

* Temperature Conditions

* Quality Management Systems (QMS)

* Documentation

With temperature conditions, the most common inspection failures were concerned with the control and monitoring of ambient storage conditions, the control and monitoring of cool chain storage and finally cold chain transportation. With global warming, it is not at all uncommon for the UK to experience ambient temperatures in excess of 25C and within buildings and transport containers such temperatures can easily be exceeded for sustained periods. Only very well insulated warehouse buildings are likely to be able to live within 25C without a cooling system

With QMS, the main failure areas were: Unauthorised activity, Quality system and the RP duties, and self-Inspection audits. As the current consultation on changing GDP guidelines has much to say about QMS including making a QMS obligatory for all WDL holders, this area is one that RPs and managers need to focus on in 2012, before the new guidelines come in in 2013.

With documentation, Lack of or inadequate procedures, or the availability of adequate documentation were the main failures. From 2013, documentation will become subject to version control and records will have to include batch numbers where required

As the MHRA now run a “risk-based system” to calculate wholesale dealers premises inspection frequency, good results at an inspection now, could result in future less frequent inspections, saving wholesalers money in the long run.

As mentioned in another blog, traditional 40 hour pharmacies have to give the PCT  at least 3 months written notice of intended closure. There are however no clear  regulations as to whether having given notice to close, whether the notice can then be rescinded or not. To apply to replace such a pharmacy before it has actually closed therefore runs the risk that the outgoing contractor could possibly change their mind, and stay open.

As to making the case for replacing a closed pharmacy, there is definitely no supposition that such a proposal will be welcomed or approved by a PCT. Factors the PCT will consider include the adequacy of local service provision relative to current and planned population, additional services that may be offered that the PCT commission, the PNA, and “choice” although few contracts if any have been won on the concept of “choice” alone.

Successfully gaining a NHS dispensing contract clearly has a significant value, yet few independent pharmacists seem willing to make even a modest investment in specialist advice to make their dream of pharmacy ownership much more likely to be achieved.

Although ARX provide a design and installation service, working together with shop fitters, and provide staff training, a Robot is quite a complex engineered machine, in some ways like a high quality car. It therefore often take quite a long time for pharmacist owners and their staff to gain the full benefits of their automation investment. (Equivalent to competently driving the car!)

As a pharmacist and because I have been involved in so many automation installations, both in community and hospital, and also in Europe an pharmacies. I can help pharmacists new to automation, to ask themselves the right questions at the beginning of the automation project, and support and encourage them all the way through until they and their staff become fully competent machine users.

The very latest development from ARX is to offer customers a one-size version of the established V-Max robot machine called SMART. If this standard sized machine can be fitted conveniently into your pharmacy, SMART will provide a less expensive solution than ordering a “made to measure” machine. As a guide SMART can handle up to around 9000 items per month.

Customers considering investing in a standard machine like this should particularly consider availing themselves of my support service, directly, or via ARX, as the standard installation will in most cases require considerably more thought and planning than with a full-custom installation. Pharmacists buying SMART through Pharmacy Consulting Ltd will receive the PCL support service free of charge, which includes at least two site visits plus telephone/e-mail support by our consultant from the design stage through to customers becoming competent SMART users.

Bearing in mind that the profitability from a 100 hour pharmacy may be questionable anyway below a certain level of turnover, those considering this route of market entry should also be aware that one cannot simply close down quickly, if the business develops less well than expected.