The MHRA (The Medicines and Healthcare Products Regulatory Agency) has announced it is seeking to regulate inter-pharmacy trade more closely, i.e. transactions pharmacies make with other pharmacies involving stock. The MHRA wishes to "ensure that pharmacists engaging in inter-pharmacy trade that is not explicitly to meet local emergencies are licensed as wholesale dealers."
Rxchange believe this action would limit your ability to reduce waste write-off and recovery of capital from stock, adversely affecting your business performance and profitability.
To trade with other pharmacies you would, therefore, need a Wholesale Dealers' License (WDL) and be expected to meet any costs in obtaining one. They are also proposing to both tighten the criteria for issuing these licenses and reduce the number issued. In effect pharmacies may not be able to get a license at all, thus disadvantaging their current position and activities.
The MHRA say this action is required to reduce the threat of counterfeit stock reaching the patient, despite the fact that stock detected to date cannot necessarily be claimed to have come from other pharmacies.
Rxchange would like to represent the interests of independent community pharmacy in this matter and would value your responses to the questions below. We intend to collate comments and formally respond to the consultation.
Please email your response to: consultation@rxchange.co.uk or add a comment below.
We require your response by 3rd March 2009 in order for us to respond to the MHRA deadline
The full MHRA consultation document can be found here
Please complete our quick poll regarding ethical stock wastage here
Q1. Do you see this as a proportionate and effective measure to reduce the threat of counterfeit stock entering the supply chain?
NO
Q2. Do you believe this action will disadvantage your existing business?
Yes
Q3. Do you believe this action may adversely affect you financially?
Yes
Q1. Do you see this as a proportionate and effective measure to reduce the threat of counterfeit stock entering the supply chain?
No, all fakes have entered the supply chain by the mainline wholesalers and PIs.
Q2. Do you believe this action will disadvantage your existing business?
Yes it will be. This will increase waste and costs. Rxchange is also widely used for items that are temporarily unavailable and allow access to all pharmacies across the UK.
Q3. Do you believe this action may adversely affect you financially?
Yes, as we will be left with unsaleable and unuseable stock, that we cannot move. This will effectively increase costs to the NHS. The majority of drugs originate from when you have kept a particular product in stock for a patient for years and they die or move away. This stock ends up, as becoming redundant stock
on our shelves, gathering dust and waiting to go out of date.
Q1 No it won't make any difference to counterfeit stock as far a we're concerned.... we tend to buy/sell "unusual" expensive drugs which i cant see anyone bothering to counterfeit e.g recently purchased Fosrenol 1000mg
Q2 Yes slightly
Q3Yes slightly
Q1. I do not believe that this measure will aid in insuring that counterfeit medication does not reach the individual. I believe this because the pharmacies who use RXchange are registered UK pharmacies who will have already obtained their (excess) stock through the correct and legitimate supply chain and so counterfeit medicines are unlikely to be involved with any inter-pharmacy transaction.
Q2. I believe RXchange to provide a useful service by which I can dispose of stock that is no longer required and is likely therefore to expire. The restriction of this service would disadvantage my business – but not to a significant degree.
Q3. I believe that the restriction of RXchange would adversely effect my business financially to a small degree.
I do not believe that the service offered differs from a multiple pharmacy chain that sends excess stock from one branch to another to prevent wastage and save costs. If you are to restrict RXchange, then you must consider preventing for example one Boots branch sending stock it no longer requires to another Boots branch, as in essence the effect is the same.
Q1. Do you see this as a proportionate and effective measure to reduce the threat of counterfeit stock entering the supply chain?
I think the idea to force all UK pharmacies wishing to trade pharmaceuticals with one another to obtain a WDL is unrealistic, overly burdonsome and unnecessary and unlikely to reduce entry of counterfeit medicines into the supplychain. Pharmacies are already suitable places to store pharmaceuticals and supply them to patients. They are regulated by the Medicines Act and are inspected by the RPSGB to ensure compliance to the regulations. The public should have as much trust in obtaining noncounterfeit medicines from a pharmacy as a propritor of another pharmacy would in obtaining the same product from that pharmacy. The level of trade between pharmacies is insignificant compared to the amount occuring between WDL holders and pharmacies. Effects of reducing counterfeit medicines by regulation at the pharmacy end would be proportionately ineffectual.
Far better to police and control entry of pharmaceuticals into the EU from known sources of counterfeiting countries. Greater expenditure on finding and fineing counterfeitors would be a better use of resources than policing an already well regulated pharmacy sector. A pan Europen mechanism of encoding product data into barcodes to enable tracing and reconcilliation would be more effective. This should be made part of Good Distribution Practice. In this way, the souce and movement through the supply chain could be traced as in the food indusrty. Using fakable holograms on packaging is unlikely to deter counterfeiters of expensive medicines.
Q2. Do you believe this action will disadvantage your existing business?
In the UK patients are not required to register with a pharmacy. Pharmacies are unable to plan accurately what and when to carry stock and how much. Patients conditions change, they move around and pass away. Consequently a pharmacy always carrys a proportoion of redundant stock. An average branch of our writes off £20000 pa. If the NHS would compensate contractors with an extra £400million + costs of disposing of this waste then interpharmacy trade would reduce massively. In the mean time, pharmacys try to offset this loss by selling or exchanging stock between (licensed) branches. Furthur I would estimate that 5% of turnover would fall and gross profit would fall by 3% since trade between pharmacies is at a steep discount to trade prices. A reduction in suppliers would reduce competition and also drive up prices.
Q3. Do you believe this action may adversely affect you financially?
If contractors are not able to distribute medicines to other pharmacies and only to patients (unless in possesion of a WDL), then either more stock will be thrown away which the government must conpensdate contractors for or the viability of community pharmacies providing a valuable service will be put under threat. In summary pharmacies must be given WDL exemption if trade constittes less than 10% of their business.
This proposal is dispropotionate will adversly affect my business and
will result in financial loss
q1. no
q2. yes
q3. yes
Q1. Do you see this as a proportionate and effective measure to reduce the threat of counterfeit stock entering the supply chain?
Not at all; this is totally over-the-top. There is no proven threat and this will simply disadvantage community pharmacies in terms of their ability to manage their stock. The paperwork requirements will no doubt be onerous also.
Q2. Do you believe this action will disadvantage your existing business?
Yes
Q3. Do you believe this action may adversely affect you financially?
Yes
I believe this is a money making exercise by the MHRA and all it does is add extra costs when we are going through recession. In addition if pharmacies can wholesale up to 5 % (under exemption from Wholesale deal
licence) then why is there a need.
Q1. Do you see this as a proportionate and effective measure to reduce the threat of counterfeit stock entering the supply chain? NO as direct distribution has only become an anti competative scheme. THe European court is reviewing this issue. Small wholesalers go out of business and also have to obtain licenses when there is no need. That same product goes to the market so counterfeit issues would not arise. Pharmacy products if not sold to other pharmacies would be dispensed on prescriptions so where is the threat of counterfeit.
Q2. Do you believe this action will disadvantage your existing business? Yes because extra costs will be incurred. Q3. Do you believe this action may adversely affect you financially? yes as costs for inspections, annual fees, fees for variation etc will add up.
As an independent pharmacist can i just say i find your service very useful and have used it on many occasions.I have never had any causes for concern with any dealings with other pharmacists also using your service.The issue of counterfeits that the manufacturers seem to be pushing hard i quite frankly have never seen any evidence of or have heard of any incidences with other colleagues.
Pfizer as well change their uk packaging through unichem and dont keep us pharmacists informed which i would have thought was an important counterfeit measure!I will agree to these new measures if there is ANY evidence this scheme is a source of counterfeit medicine entering the uk market. This scheme from the mhra would impact on the financial viability of my buisness!
It appears to be a bit overkill!
Q1. not proportionate and unlikely to have any impact on the supplies of counterfeit drugs. will however increase and potentially boost big-pharma's profits at the expense of small businesses. presumably, and rather conveniently, multiples will still be able to transfer between branches therefore giving them an advantage.
Q2. Little impact in my business as we do little of this activity. add all the little bits up though and nationwide it becomes significant.
Q3. will lead to more stock being written off at my expense.
Firstly we actually hold a wholesale license as we supply a number of surgeries with pharmaceuticals and the total annual amount is such as to require such a license. If there was a risk of this license being withdrawn then it would seriously affect our business and would also affect those surgeries who rely on us for their day to day requirements.
I do not agree with this widespread concern about counterfeit products. Yes there are products with counterfeit drugs but not to the extent claimed by the manufacturers. It is more a case of manufacturers talking up this problem, in order to restrict export of their products to other countries, thereby undermining the large profits they make in such countries. Apparently it is the large volume of exporting being carried out by the large wholesale companies such as Unichem and AAH that has brought about much of this problem. The knock-on affect of this is that we now have shortages of many products in the UK retail pharmacy market which is denying patients their much needed medicines. It would be better if MHRA concentrated their efforts on introducing some form of regulation on this export trade with a view to looking after our own patients’ needs.
I object to these silly proposals, I will lose money there will be more waste and the truth is that Big Pharam is try to protect the parallel trade Counterfeit is as excuse
Q1. Do you see this as a proportionate and effective measure to reduce the threat of counterfeit stock entering the supply chain?
No. This will have a very negligible effect in our humble opinion!
Q2. Do you believe this action will disadvantage your existing business?
Yes. We rely on transfer of stock between Pharmacies to minimise wastage and expiry of stock.
Q3. Do you believe this action may adversely affect you financially?
Yes. Obtaining and maintaining a WDL is an expensive proposition
My initial thoughts are this is yet another disproportionate and over regulatory action. The threat of counterfeit medicines entering the supply chain seems to me to be an imagined one, artificially created by large Pharmaceutical companies ,e.g. Pfizer trying to protect their sales of Viagra from unregulated internet sites http://www.realdanger.co.uk/. I would like to see the evidence of unlicensed medicines entering the legitimate supply chain and the number of cases where this has involved community pharmacies passing on counterfeit medicines to other pharmacies. I suspect the number of these in the last 5 years you could count on one hand.
If the MHRA would like to counteract the threat of counterfeit medicines they should clamp down on bogus pharmacy internet sites. The easy option of course is to target law abiding and regulated pharmacies.
How do they propose to stop transfers between different branches in the same pharmacy chain?
What quantity of a medicine would be regarded as sufficient to deal with a local emergency ?
How could this be regulated without increasing an already burdensome amount of bureaucracy that pharmacists working at the coal face already have to deal with?
The recent current direct supply arrangements, quotas, restricted choice of wholesalers imposed by manufacturers to stop ‘Parallel Exporting’ of their products mean that pharmacies have increasingly to turn to neighbouring pharmacies to maintain supplies to patients. I have had cause to contact my local MP recently over difficulty in obtaining supplies for patients prescriptions because of these new manufacturer imposed arrangements.
The proposed action would not overly effect my existing business, it may even benefit it. If I am forced to obtain a wholesale Dealers license, I would have to consider increasing my sales to other pharmacies and even ‘Parallel Export’ to justify the cost. With the low value of the £ at the moment the latter action could hopefully benefit my business and that of other community pharmacies substantially.
Of course the poor patient would suffer with increasing delays in obtaining medicines in the UK since they were all being exported.
That is, all except those patients buying Viagra online from dodgy internet pharmacies, who will be able to continue trading unfettered by any restrictions!!
Sorry if this has been a bit of a rant, but I believe Big Pharma and their current advertising campaign is the main reason behind this ‘knee jerk reaction’ by the MHRA. A more simple measure to end all the supply issue & counterfeit medicine problems at a stroke would be for the Government to:-
a) ban all parallel imported and exported medicines and
b)crack down on unregulated internet sites.
I think us exchanging stock will not have any effect on counterfeit stock within the supply chain. And the measures now are not preventing this happening. The suppliers now have all the power to release stock to us and we are experiencing large out of stocks. I have to ring manufacturers direct and then I have to pay a handling charge to get these products via Unichem. I do not believe as a registered pharmacy we require a wholesalers licence nor should we pay for it! This would seriously undermine my profits and costs!
Q1. Do you see this as a proportionate and effective measure to reduce the threat of counterfeit stock entering the supply chain?
This will not reduce the threat of counterfeit stock
Q2. Do you believe this action will disadvantage your existing business?
My business and other small business will be disadvantaged.Borrowings from other and neighbouring pharmacies goes on all the time for the benefit of the patient .
Q3. Do you believe this action may adversely affect you financially?
This will reduce the profitability of my business as I will not be able to purchase in bulk to get the best discounts.
Q1. Do you see this as a proportionate and effective measure to reduce the threat of counterfeit stock entering the supply chain?
No. It as bureaucratic, anti-competitive over-reaction. I'm quite sure it contravenes the government's own "Better Regulation" principles (available online) and could be challenged on that basis
Q2. Do you believe this action will disadvantage your existing business?
Absolutely. It will make RxChange non-viable for 99% of pharmacies
Q3. Do you believe this action may adversely affect you financially?
Yes. We will lose the benefits of RxChanmge savings at a time when the government claims it wants to support small businesses.
Have you asked NPA for lobbying support?
I have never actually used Rxchange [but] The proposals by MHRA seem ludicrous and the idea that it will help to stop counterfeit medicines reaching the public is as ridiculous as this being given as the reason why so many of the manufacturers have altered their supply route to Pharmacies, when it is obviously a thinly veiled excuse to with hold more of the profit for themselves at OUR expense. In answer to your 3 questions:-
Q1. answer NO.
Q”. answer YES.
Q3. answer YES most definitely, by more stock going out of date-but the manufacturers won’t mind this at all coz they can then sell more!!!
Q1. Do you see this as a proportionate and effective measure to reduce the threat of counterfeit stock entering the supply chain?
No.
Q2. Do you believe this action will disadvantage your existing business?
Yes.
Q3. Do you believe this action may adversely affect you financially?
Yes.
Pharmacies are expected by the NHS to have medicines on the shelf ready to supply to patients. If doctor’s surgeries suddenly decide to change their prescribing habits then medicines get left on the shelf which the NHS will not reimburse us for. This can cost pharmacies a lot of money. Bigger chains can overcome this by means of ‘inter branch transfers’ (IBT’s) moving stock around. Moss Pharmacy used to run an email service listing stock that was needed/ difficult to get in other pharmacies. Independent pharmacies do not have this luxury. Newer medicines are getting more expensive and to expect pharmacies to bear this loss in money is unbelievable.
Regarding counterfeit stock, this problem only affects more expensive medicines. Some of the manufacturers of these products used holograms as an easy and quick way of identifying real product. These may not be cheap but as a % of the total price of the product then it won’t be too much at least not for expensive items. If manufacturers are really concerned with dealing with the issue of counterfeit stock then they could have identified their stock in to smaller groups. Presently they are divided in to batch/lot number. There could be thousands of boxes within each batch. If they were to make batches of say 10,000 then have these subdivided in to lots of 100’s with each lot going to a specified wholesaler, then there would be greater traceability of the item. All pharmacists could then check to see which wholesaler their item originated from. This tied in with the hologram would increase security/ safety.
Good luck with the campaign
Q1. Do you see this as a proportionate and effective measure to reduce the threat of counterfeit stock entering the supply chain?
No there is no evidence that transfer of stock between pharmacies would reduce the threat of counterfeit stock entering the supply chain. The efforts must to be to put actions in place that will prevent them entering pharmacies via the main chain of supply in the first instance.
Q2. Do you believe this action will disadvantage your existing business?
I believe this action would limit your ability to reduce waste write-off and recovery of capital from stock, adversely affecting your business performance and profitability. Most definitely yes.
Q3. Do you believe this action may adversely affect you financially?
Yes and therefore risk access to Pharmaceutical services that the community current have come to rely on. Any action the MHRA must have a "NIL detriment" effect on current services available. This proposal will put the viability of current small independent Pharmacies at risk.
While we agree that 'appropriate' measures should be taken to prevent counterfeit medicines entering the supply chain, it does seem that the economic reality for UK pharmacies risks being totally ignored. If a product is not dispensed and cannot be redistributed it will go to waste - at the expense of the pharmacy.
Based on the current average ethical stock wastage figure calculated from the Rxchange survey, the following figures show the cost implications of ethical waste to UK pharmacies.
Using publicly available figures for the cost of medicines to the NHS for 2006/2007, we see:
£8.1B Primary care prescriptions dispensed in the community England
£0.2B Hospital prescribed, dispensed in community England
£0.6B Prescriptions dispensed in the community in Wales
£0.9B Prescriptions dispensed in the community in Scotland
£0.4B Prescriptions dispensed in the community in Northern Ireland
Total prescriptions dispensed in the community £10.2B
Therefore assuming total value of £10B
Ethical waste @ 4% = £400,000,000 (£0.4B);
There are 11,000 Pharmacies in England and Wales
There are 1,150 pharmacies in Scotland
There are 514 pharmacies in Northern Ireland
Total UK pharmacies = 12,600 (approx)
Therefore £400,000,000/12,600 pharmacies = £31.7K average cost of ethical waste per UK pharmacy. Therefore a chain of 8 pharmacies would write-off £0.25M.
These figures to not consider waste from OTC, private scripts, dentists, vets, wholesalers or from the additional £2.8B dispensed by hospital pharmacies. Neither do they consider the financial and environmental costs of transporting and destroying the waste.
Incidentally, £400M was also the figure for the Oct 07 Cat M clawback.
Q1. Do you see this as a proportionate and effective measure to reduce the threat of counterfeit stock entering the supply chain?
The MHRA proposal is definitely a disproportionate measure to reduce the threat of counterfeit stock entering the supply chain. We are all individually responsible professionals who at the heart want the best for our patients. We have traditionally discarded items unsuitable for supply at our own loss. No pharmacist would entertain counterfeit products.
All pharmacies only buy from reputable wholesalers and so a pharmacy buying surplus stock from another pharmacy does not increase the risk to public any more than buying the medicine from the main wholesaler direct. It is just a way of helping each other out.
Rxchange must reconsider how and which “small wholesaler” are allowed to trade on the Rxchange to ensure that these wholesalers do not increase the risk to public of counterfeit products any more than the “mainline wholesalers”. In order to maintain a secure supply system, Rxchange must continually monitor and reassess the “wholesalers” who trade on the RxChange in order to maintain the credibility of this system of stock swap.
Q2. Do you believe this action will disadvantage your existing business?
Yes. Definitely
Q3. Do you believe this action may adversely affect you financially?
Yes, I believe it will make a difference of about 5% p.a. which is significant amount for a small business.
1) This measure is not proportionate and would not be effective in reducing the threat of counterfeit stock entering the supply chain. The occurence of counterfeit stock in the UK supply has never been linked to inter pharmacy trade which only ever occurs in relatively limited amounts anyway to shift items ordered for patients that are no longer required. If the proposals were implemented it would result in financial losses for pharmacies or just result in the practice occurring in a more secretive fashion which would increase the risks of counterfeits!! The MHRA would do better to focus their attention on internet sales which are a proven source of substantial quantities of counterfeits.
2) As highlighted above the proposed action would disadvantage my business by affecting my customer service - I would be less likely to order items for customers in advance of prescriptions for fear of being stuck with an expensive product I could do nothing with! NOt only would I suffer but more importantly, so would patients.
3) Yes - as above.
We have had a letter published in PJ online regarding their recent article on counterfeits. You can read it here (copy and paste the link into your browser)
http://www.pjonline.com/forum/counterfeit_medicines
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