Disregard what you may have read about possible delays to of the introduction of the responsible pharmacist regulations: nothing will stop them from coming into force on 1 October 2009.

In very basic terms, the Responsible Pharmacist legislation is about records, procedures and absence. Record keeping should be very straightforward and a way of almost ‘clocking in and out’ of the pharmacy and for this, a simple notation in a desk diary would be sufficient, though pharmacists are reminded that legislation requires the Pharmacy Record be maintained by the Pharmacy Owner for a period no less than five years.

But administrative tasks could be overlooked on occasion, so will the DHSSPS prosecute if records are not kept accordingly? “That is a matter for the Department,” Brendan explained. “However, keeping a record of who the Responsible Pharmacist should not be seen as ‘just another task’, it is a valuable and important tool to ensure professional accountability in the workplace. Pharmacists should also be mindful that failure to maintain the Pharmacy Record appropriately can potentially be pursued as a criminal matter.”  

Community pharmacies ought to have many of these procedures in place already so concerns of additional workplace burdens may not be as weighty as originally feared.

But the big question still remains; what happens during a pandemic? “In pandemic circumstances procedures may change on a daily basis,” Brendan continued. “However the regulations are there to ensure accountability, the maintenance of quality and to enhance the protection of the patient and the public. There is therefore a strong argument to have them introduced before a full pandemic arises.”

The Responsible Pharmacist regulations are currently seen as an uneasy fit for registered hospital pharmacy premises, so additional guidance for hospitals is currently being developed. This will be published by the regulators close to the 1 October deadline and may be the single potential reason why the deadline to introduce the regulations might be extended.

So it appears that the last-gasp efforts from the Pharmacists’ Defence Association, when their representatives met with the Department of Health (England) were unsuccessful in their primary aim. The PDA appealed to the Department to allow a trial run of the regulations, so that any teething problems could be ironed out before full introduction. PDA chairman Mark Koziol said that officials “took a constructive interest in our concerns” and that a number of possible options were discussed.

The chairman added: “Because a trial run could be detached from any new statutory consequences, pharmacists would be able to try out some of the new processes that are required under the regulations such as recording the signing on or off, maintaining or amending SOPs and complying with the ‘pharmacist in charge’ signage arrangements without fear that, if they get it wrong, there could be serious consequences.” In a statement the Department of Health in England confirmed that it was listening to views on the introduction of the regulations but a spokesperson refused to say whether they would honour the PDA’s request.

This will be concerning for the 93 per cent of pharmacists which in a recent PDA survey admitted to feeling ‘ill-prepared’ for the bureaucratic onslaught of the new regulations. However, does the profession really understand what it could be in for? The survey also revealed that 22 per cent of respondents intended to retire from practice when the Regulations come in, or not to work until they are clear about the impact the regulations will have on their professional practice.

There will be no sympathy from the multiples however, who are confident in their preparation. “We’re not joining any campaign for a delay,” CCA chief executive Rob Darracott said recently. “Our members are ready to do what they need to do in terms of providing information to employees and locums.” CCA members all agreed that their pharmacies would be ready by 1 October. Speaking to NIPinF, Paul Bennett, professional standards director and superintendent pharmacist from Boots UK said; “Boots has been planning in readiness for the forthcoming regulations. All of our stores will be ready to comply with the statutory implementation date.”

So what is the future for the way community pharmacy operates? If these regulations are successfully implemented and universally observed, will the two hour period be extended over the next few years? Will there come a time when pharmacists are no longer found in dispensaries at all? Robotics and pharmacy automation are already speeding up activity and some are being developed to work around the clock, with frightening pace and accuracy. Lloyds Pharmacy has just launched a new online service for remote patient consultation which is designed to provide everything from symptom identification and diagnosis through to medicine delivery, without the customer once setting foot in a pharmacy.

Also, it certainly appears that pharmacists on the ground are anxious about what these new regulations could spell the beginnings of. “How odd that the companies with the most to gain from the new Responsible Pharmacist regulations don't want them held up,” one pharmacist commented. “With just one change in regulations, any problems at branch level become the responsibility of the employee pharmacist or manager to sort out. I saw this coming the moment the Responsible Pharmacist paperwork came out. Pharmacists could find themselves held responsible for company policy that they cannot change at branch level.

“I have spent many a busy year dealing face-to-face with customers, discussing problems with doctors, district nurses, practice nurses, local hospices, care homes, supervising methadone, etc. That is, of course, between updating my continuing professional development and standard operating procedures, performing medicines reviews and dealing with the ever increasing paper workload that seems to have mushroomed out of all proportion.

“The Responsible Pharmacist legislation will allow pharmacy owners to delegate the running of their business to a nominated pharmacist absent from the premises. The Department of Health in England has said that currently pharmacy technicians will be excluded from taking charge although this is likely to be reviewed in the future. This statement should be enough to make all community pharmacists sit bolt upright and spend a moment thinking where this legislation is taking the profession.”

Coming Up Short

Nothing could be better described as being at the heart of pharmacy than the supply of medicines, although pharmacists in Northern Ireland are now discovering that even this fundamental exercise is not so straightforward. Stock shortages have marred the dependable face of pharmacy and while those contractors surveyed anonymously by NIPinF have appreciated the support received from wholesalers, every single pharmacy we contacted had experienced delays. Some had discovered supply difficulties with several manufacturers, and while pharmaceutical companies had provided emergency fax numbers for urgent orders, even procuring directly spelled delays.

“We are used to ordering and getting items in the same day but dealing with the manufacturer actually takes longer,” said one respondent. “By the time they process everything, have asked for details such as account numbers through your local wholesaler and then sent the drugs through the normal postal system, several days could have elapsed.”
At the time of going to press, Leo Pharma made announcement of their single supply chain arrangements with AAH Pharmaceuticals, Alliance Healthcare and Phoenix Distribution. While it is too early to say whether or not this arrangement will be problematic for contractors, it will be largely unwelcome news.

Furthermore, certain products have become frighteningly scarce. “We have found stocks of Actonel 35mg to be really short. There have also been problems with Co-Aprovel 300mg and 150mg. I have been contacting the wholesalers themselves and they are telling me that there is nothing they can do since they’ve hit their quotas. I have received some deliveries directly from the manufacturer, although it can take anything from five to ten days to get them in. I have ended up placing a lot on wholesale back orders and then when you use that up prematurely, you have the same problem next month.

“A lot of our patients have tried to go back to their GPs to be prescribed something else but this is not always possible. Alternatives are not available for all drugs, especially the branded ones which are under DTP – so therein lies the vicious cycle. We currently owe between fifteen and twenty patients Actonel, for instance.”

Speaking to NIPinF, a spokesperson for drug giant Proctor and Gamble commented; “P&G are aware that in some areas of the country, there are some local ‘out of stock’ situations affecting a number of pharmaceutical brands at the wholesaler and pharmacy level. Regrettably, our Actonel brand is one of the brands affected. We would like to reassure customers that this is unrelated to our manufacturing process or supply chain.”
However, P&G were quick to insist that they are not wholly to blame. “It is our understanding that these local ‘out of stock’ situations are linked to third parties choosing to export of certain pharmaceutical brands, including Actonel, to the continent,” the spokesperson added.

“The effect of this may be to reduce the amount of product available in the domestic market. P&G has no control over this practice. P&G are working with wholesalers directly to resolve this situation, and have a contingency facility to arrange emergency ‘direct to pharmacy’ transfers of Actonel as needed.”

42 per cent of those surveyed had admitted to referring patients back to their GP, to be prescribed a different treatment. However, what effect will this have upon the profession? Concerns about the reaction from primary care have been raised, particularly about who GPs will blame. “I think that doctors think it’s our error and that we’re not keeping sufficient stock levels,” one pharmacist mused. “They’re just saying go to another pharmacy. However, of course we cannot discourage them from prescribing what they want. If generic prescribing rates were as high here as they are elsewhere in the UK, would it make a difference? Probably not, since some of the short supply items are still under patent.”

Another said; “Some of these companies need a short, sharp lesson in zero prescribing. Perhaps we should be speaking to all of our local doctors and encouraging them to switch as many patients as possible on to generic lansoprazole capsules.”

Following the OFT’s ruling from almost two years ago that DTP arrangements do not present a threat to the public’s health or that they contravened any existing competition laws, what can be done to stop them? There are now fewer instances of one manufacturer selecting just one wholesaler and instead, many changes to the supply chain are involving two or three distributors. Despite this, fears that patient safety will be compromised before any action is taken are evident.

“I think it is one of these situations that will become worse the longer it goes on,” one pharmacist said. “Pharma need to get their act together and if there are certain medicines which you cannot obtain, there will be consequences at some point. Patients are not receiving the best treatment. Some have been referred from secondary care with very specific needs and there simply are not the alternatives available. The cost involved in referring them back to hospital must be significant.”

Who’s to blame?
85 % Manufacturers
15 % Wholesalers

“Our wholesalers have been sympathetic but they have their hands tied. I’ve asked to back order some drugs but I have been told that is impossible as their supply is very limited.”

Have you opened a new account?
67% Yes
33% No

“I’ve had to open numerous new accounts which has adversely affected my discounts. I’ve had no option because I don’t have time to shop around to find out who is providing at the cheapest rate and it takes days to procure directly.”