Nelsons Homeopathic Pharmacy #3
Challenging misleading healthcare claims
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Nelsons Homeopathic Pharmacy #3
The previous instalments of this saga covered the MHRA's role in dealing with our complaints against Nelsons Homeopathic Pharmacy. Now the GPhC…
Our complaints arose from a visit we paid to Nelsons Homeopathic Pharmacy in Mayfair, London on 12 May 2015. We were appalled by what we saw there and, in summary, we submitted the following complaints about the pharmacy, their pharmacy website and their Nelsons Natural World website, each complaint following the previous because we felt they were not dealt with properly:
Complaint 1: 28 May 2015 Joint complaint to the MHRA and GPhC about Nelsons' pharmacy and website.
Complaint 2: 28 July 2016 Second joint complaint to the MHRA and GPhC about Nelsons' pharmacy.
Complaint 3: 28 November 2016 Third joint complaint to the MHRA and GPhC about Nelsons' pharmacy.
For the background to all this, see:
Our complaint was submitted to both the GPhC and the medicines regulator, the MHRA, in May 2015. We weren't sure what specific aspects each would deal with and neither, it seems, did they. The GPhC had to discuss the case with the MHRA and decide what their remit was and took legal advice.
What were we complaining about?
Our complaint covered a number of issues that concerned us (including the kits of homeopathic products that were on sale, tissue/cell salts, point of sale (POS) advertising, various herbal products and their price list) but we will focus on the main one here: on our first visit to Nelsons premises, Maria self-selected a tube of a homeopathic product labelled 'Diarrhoea'.
Why was this a problem?
This product is not registered and not authorised by the MHRA. As such, it is essentially an unlicensed medicine (technically, the MHRA had not determined its status but it clearly was not a registered and not an authorised homeopathic product), it should not have had indications (in this case diarrhoea), should not have been advertised, should not have been available for self-selection by a customer and should not have been sold other than in very limited circumstances — more on that later.
This tube was just one of many:
The labels on the front of the boxes tells us they contained homeopathic products for:
That's quite a list of medical conditions, but the one we selected was labelled:
That is a very bold therapeutic claim: as well as breaching the medicines regulations, we believed this was highly irresponsible. Note that it doesn't say to consult your GP if symptoms, just your (homeopathic) practitioner.
The most interesting ingredient here is the Podophyllum: also known as May Apple, Devil’s Apple, Wild Lemon and Indian podophyllum, it is a herbaceous perennial plant in the family Berberidaceae, and is poisonous. As such, it is designated as a banned and restricted herbal ingredient by the MHRA and medicines containing it are classed as Prescription Only Medicines (POM).
The label on the diarrhoea product claims it is diluted to 30C, that is, one part in 1,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000, but, of course, that depends on it having been properly manufactured. The MHRA decided it wasn't a POM because it was diluted so much.
That out of the way, the GPhC turned to dealing with our complaint.
Eventually, in February 2016, we were told the case was going to be sent to their Investigating Committee. It took a while to get our witness statements sorted out but they eventually took our statements, our full complaint, the video we had taken and the MHRA's decision to their committee. We didn't get their decision on the complaint until May 2016, one full year after we had submitted our complaint. They said:
Considering the seriousness of the issues we complained about, we found this dismissal astonishing. However, the four reasons they gave for this decision were, we believed, entirely spurious and erroneous:
The incompetence here is quite astounding. Addressing each of these points briefly (and this really didn't cover all of our complaint):
We complained again, taking apart this wholly inadequate decision, and this was passed to the investigator's line manager to deal with. We got his response a few months later in July 2016. It was confusing and totally unhelpful in understanding the original decision and simply raised more questions than it answered.
It really did beggar belief that a statutory regulator could have produced such a sloppy and ill-reasoned response.
Needless to say, it essentially upheld the original decision. However, on the point of the unauthorised medicines being on sale, the manager decided there was now enough evidence and has issued 'formal advice' to the Superintendent Pharmacist at Nelsons, Suzanne Haar — this was to be kept on record and referred to whenever the site is next due for a routine inspection. We were not given a copy of this advice despite attempts to find out so we could better understand the legal position regarding these unlicensed products.
Because we were completely unsatisfied with this response, we paid Nelsons another on 28 July 2016. Guess what Maria was able to purchase? Exactly the same diarrhoea product she did the first time. We also noticed the same unauthorised products on sale as well as unauthorised tissue salts products. Perhaps the most galling thing was that the booklet Which remedy do I need? that was banned by the MHRA from Holland and Barrett was still there despite that being part of our complaint. It's not believable that Nelsons were not aware of our three MHRA complaints on this and the MHRA's decision.
It appears that despite our complaints to the MHRA and the GPhC and despite their investigations and the formal advice given to them, absolutely nothing had changed.
So, we responded to both the MHRA and the GPhC again with all we found and we were told that they were both considering this as new complaints against Nelsons and the pharmacist/pharmacists.
As we said in the last instalment, we kept it as a joint MHRA/GPhC complaint because we didn't want anything to fall through the cracks. We have copied correspondence to both regulators throughout: that seems to have been a wise move. We said:
Some of these points relate to the complaint to the MHRA so read the previous newsletter to find out what they are all about. The GPhC seemed a tad confused:
It's difficult to understand what was unclear.
While we were waiting for the GPhC to deal with this, we received a reply from the MHRA telling us they had received confirmation from Nelsons that they had taken action to address points 1, 2, 3, 4, 5 and 7. We wanted to check to see what had changed, so we paid them another visit.
We told both the MHRA and the GPhC:
This was our third complaint to both statutory regulators about the exact same issues. It has taken eighteen months thus far. We said:
We also said to the GPhC:
It beggars belief that Nelsons thought that putting up a notice on the shelf saying 'Not for self selection' would be considered anywhere near adequate: the products were still available for self-selection.
The GPhC eventually referred the case to their Investigating Committee (IC) and a further eight months later in July 2017, we received their outcome. The allegations they considered were:
Haar is the Superintendent Pharmacist at Nelsons Homeopathic Pharmacy and, as such, takes responsibility for the way in which a company carries out its professional pharmaceutical activities. The decision they came to included:
The warning placed on Haar's record is:
So despite all the issues we found, the multiple failings by Nelsons to abide by the regulations and to heed advice given to them by the regulators, it was not deemed to be a fitness to practice issue.
Although we received this last July, we were waiting for the MHRA to publish their final decision notice, which they did last week.
Three years, a 22-page initial complaint, two further complaints, two statutory regulators, multiple occasions where we had to chase both regulators and multiple occasions where we had to correct their misunderstandings and errors, but we finally got there.
We did not do this to have anyone punished: we started this as an attempt to discover and understand precisely what pharmacies and pharmacists were and were not permitted to do in terms of selling homeopathic products and to test the statutory regulators' resolve to enforce those rules and regulations. The failures of Nelsons Homeopathic Pharmacy to implement the guidance provided by the regulators are what have caused this to have dragged on so long. But a complaint should never have been necessary in the first place: understanding the Human Medicines Regulations, the Medicines Act and all the other legislation surrounding the operation of pharmacies are part of the responsibilities of pharmacists. There can be no excuses. It should not have taken one complaint, never mind three, and it should not have taken nearly three years to resolve these very simple and straightforward issues.
What can we learn from this? What can homeopaths and homeopathic pharmacies learn from this? What, precisely, can pharmacies do in terms of selling homeopathic products, whether authorised, registered or neither?
This exercise has revealed a lot about all that, but that's for the next instalment.
26 February 2018
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Alan & Maria
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