AUTH/3060/8/18 - Pharmacist v Proveca

Letter regarding the supply of unlicensed and off-label glycopyrronium see also AUTH/3058/8/18  

  • Received
    21 August 2018
  • Case number
    AUTH/3060/8/18
  • Applicable Code year
    2016
  • Completed
    11 December 2018
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    Appeal by the respondent
  • Review
    Published in the May 2019 Review

Case Summary

Two prescribing team pharmacists from a clinical commissioning group (CCG) (Case AUTH/3058/8/18) and a community pharmacist (Case AUTH/3060/8/18) complained about a letter sent in August 2018 by Proveca about the supply of unlicensed and off-label glycopyrronium bromide.  Proveca marketed Sialanar (glycopyrronium bromide) for the symptomatic treatment of severe sialorrhoea in children aged 3-17 years.  The letter at issue was copied to the Medicines and Healthcare products Regulatory Agency (MHRA). Case AUTH/3058/8/18

The complainants noted that the letter was sent to at least two GP surgeries within the CCG and alleged that Proveca had taken a very aggressive marketing approach since it launched Sialanar and appeared to be communicating with surgeries and provider trusts in a similar intimidating vein.  One of the complainants stated that he/she had previously received a similar letter in his/her capacity as a hospital pharmacist approximately three months ago. 

The complainants explained that one key distinction between glycopyrronium ‘specials’ and Sialanar was the concentration of glycopyrronium bromide; the branded product was 2mg/5ml whereas the concentration historically used as a ‘special’ was 5mg/5ml.  Hence, the two products were not of an equivalent strength.  A switch from a ‘special’ to Sialanar might be appropriate in some instances but it meant that the liquid volume to be given to a child with severe drooling would be increased 2.5 – fold.  There might be valid reasons why a specials product had to be used.  The last sentence of the letter (‘It is only failing all of the above, and lack of importation of an approved medicinal product, that a ‘special’ may be supplied’) recognised that there might be exceptions to the general guidance of using a special, although the first sentence of the same paragraph (‘Therefore, not only is it not allowed to dispense an unlicensed drug where there is a licensed alternative, but a licensed product should be the preferred option for other indications outside of its authorization, given that it has already been assessed for safety and efficacy’) seemed to claim that it was not permissible to dispense an unlicensed medicine.

The complainants alleged that although the letter described the relevant national guidance on the prescribing of ‘specials’ – from the MHRA and General Medical Council (GMC) – the way the letter was written and some of the wording was in breach of the Code.

The style of the letter was explicitly aggressive and threatening.  The second paragraph referred to a ‘breach of the law’.  The sentence ‘…. officially putting you on notice for illegitimate dispensing practices …’ was clearly designed to scare staff.  Likewise, the request that surgeries confirmed that they had ceased these activities back to the company was totally unnecessary and a scare tactic.

Although addressed to the surgery, the letter referred to ‘your pharmacy’ and implied that there might have been commercial and financial damage to Proveca.  Pharmacies, or even dispensaries in surgeries, dispensed what was prescribed on the GP prescription and their actions should not be disparaged for doing so.  Further, the letter seemed to suggest that specials were used on cost grounds (‘Dispensing off-label on cost grounds where a licensed product is available and will meet the same therapeutic need is not acceptable…’).  The complainants stated that the ‘special’ had been used for many years and any move away from the special to Sialanar needed careful consideration because of the different concentration.  If the switch did not happen quickly enough for Proveca then it was likely to be because this was not a simple switch.

The letter referred to the Medicines and Healthcare products Regulatory Agency (MHRA) and a copy had supposedly been sent to the MHRA.  The complainants queried whether this was a copy of every single letter or just a copy of the master letter and whether the MHRA had given the permission required to include reference to it in the letter.

The detailed response from Proveca is set out below.

The Panel noted that according to Proveca the letter at issue was sent to around 16,000 pharmacies, primarily consisting of community pharmacists and hospital outpatients.  The letter urged pharmacies to refrain from dispensing glycopyrronium bromide ‘specials’, and off-license preparations for children with chronic drooling and ensure that Sialanar was dispensed. 

The Panel noted that the letter in question was promotional and bore prescribing information.  It was not necessarily unacceptable to draw the attention of prescribers to the prescribing legal framework, however such material had to comply with the Code.  In the Panel’s view there was a difference between writing to all pharmacists as opposed to those whose dispensing was the subject of Proveca’s concern.  The Panel noted the company’s submission that it was not possible for the company to know which pharmacists were dispensing glycopyrronium bromide. 

The Panel noted that another letter which the complainant referred to briefly as a similar letter had been sent by Proveca’s Medical Director in March 2018. That letter, which was not the subject of complaint, gave the licensed indication of Sialanar and stated that it had come to Proveca’s attention that many pharmacists were continuing to supply unlicensed and off-label glycopyrronium bromide products even when the prescription was for a child with chronic drooling.  The letter further stated that unless specifically requested by the prescribing physician, the licensed product should be dispensed as per the National Pharmacy Association (NPA) guidance on the supply of unlicensed medicines, and an extract of the guidance was included at the bottom of the letter.  The Panel noted that the letter sent in March 2018 was very different to that sent in August 2018.

Turning to the letter at issue, sent in August 2018, the Panel noted the complainant’s concern that pharmacies and dispensaries in surgeries were being disparaged for dispensing what was prescribed by GPs.  Paragraph 2.2 of the MHRA guidance on ‘The supply of unlicensed medicinal products (“specials”)’ allowed a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or other prescriber to decide whether an unlicensed medicine should be supplied in preference to a licensed medicine where the licensed product could not meet an individual patient’s special needs.  The Panel noted that the letter at issue highlighted that any pharmacy continuing to dispense unlicensed and off-label preparations for children was in breach of the pharmaceutical legal framework.  The Panel noted the complainant’s allegation that the letter implied that supplying a special in preference to the use of Sialanar was illegal.  The Panel noted the company’s response that if there was a bona fide reason for the prescription of an unlicensed product then it was the prerogative of the prescriber and Proveca was not suggesting that it was not dispensed.  The Panel noted Proveca’s submission that it might be suitable to prescribe an unlicensed product instead of Sialanar when the concentration of Sialanar (2mg/5ml) was too low and a much lower volume of product would be required.  However, the Panel considered that the letter misleadingly implied that the activity was illegal by stating that if a pharmacy was supplying unlicensed or off-label preparations of glycopyrronium bromide for the indication of chronic drooling in paediatric patients then it should consider the letter as officially putting it on notice for illegitimate dispensing practices which might be a contravention of legally established rights and have caused Proveca significant commercial and financial damage.  The Panel noted, as acknowledged by Proveca, that the supply of an unlicensed medicine was legally permissible in certain circumstances where there was a patient with a ‘special need’.   The Panel considered that the letter in question queried a health professional’s decision to prescribe a special and the pharmacist’s action of dispensing against a prescription, without any knowledge of the clinical circumstances, which in the Panel’s view might potentially put patient safety at risk.  The letter stated that such a decision was inconsistent with MHRA Guidance and law and implied that serious consequences could ensue.  The Panel further noted the negative responses received from at least six recipients of the letter.  It appeared that the recipients considered that the content of the letter was such that it questioned the reader’s professional judgement.  In the Panel’s view, the content and tone of the letter was such that it disparaged the professional opinion of health professionals and a breach was ruled. 

The letter stated that Proveca had brought the disparaging practice at issue to the attention of the MHRA which was copied into the letter.

In the Panel’s view, the implication was that the MHRA approved or otherwise endorsed the content of the letter.  The Panel noted that it appeared that the MHRA had not asked to be copied into the letter. The Panel did not consider that Proveca’s account of a conversation with the MHRA meant that the wording in the promotional letter in question was specifically required by the MHRA and thus a breach was ruled. 

The Panel noted its comments and rulings above and ruled that Proveca had failed to maintain high standards.

The Panel considered that the letter in question queried a health professional’s decision to prescribe a special and the pharmacist’s action of dispensing against a prescription, without any knowledge of the clinical circumstances which in the Panel’s view might potentially put patient safety at risk.  The letter stated that such a decision was inconsistent with MHRA Guidance and law and implied that serious consequences could ensue if the letter was not adhered to.  The Panel was very concerned about the content and tone of the letter and noted its comments and rulings above.  In the Panel’s view, pharmacists who had received the letter would be very concerned by the misleading implication that his/her dispensing practices were potentially illegal and that legal consequences including an implication that a claim for financial damages might ensue.  The Panel noted that not all recipients of the letter would have dispensed glycopyrronium bromide.  The tone of the promotional letter could be seen as threatening and, in the Panel’s view, brought discredit upon, and reduced confidence in, the pharmaceutical industry.  A breach of Clause 2 was ruled.

Proveca appealed all the Panel’s rulings of breaches of the Code.  The Appeal Board upheld all the rulings of breaches of the Code.

Case AUTH/3060/8/18

The complainant stated that the crux of his/her complaint was that the tone of the letter was quite threatening; it had been copied to the MHRA and alleged that illegitimate dispensing practices were being followed.

The complainant had had a discussion with colleagues at a local surgery about the issues surrounding the letter to remedy any issues following clinical review from a local GP.  The complainant alleged that the letter was unnecessarily threatening towards the pharmacy and making the switch would pose an additional cost burden on the NHS.  An additional concern was that the original prescriptions were initiated in secondary care so there might be clinical reasons for prescribing the original unlicensed special.  The complainant had sought clarification from a local primary care clinician who would hopefully feedback at the appropriate time.

The detailed response from Proveca is given below.

The Panel noted that the letter urged pharmacies to refrain from dispensing glycopyrronium bromide ‘specials’, and off-license preparations for children with chronic drooling and ensure that Sialanar was dispensed. 

The Panel noted that the letter in question was promotional and bore prescribing information.  The Panel noted that it was not necessarily unacceptable to draw the attention of prescribers to the prescribing legal framework, however such material had to comply with the Code.  In the Panel’s view there was a difference between writing to all pharmacists as opposed to those whose dispensing was the subject of Proveca’s concern.  The Panel noted the company’s submission that it was not possible for the company to know which pharmacists were dispensing glycopyrronium bromide. 

The Panel noted the complainant’s submission that the original prescriptions were initiated in secondary care so there might be clinical reasons for prescribing the original unlicensed special.

The Panel noted Proveca’s submission that it might be suitable to prescribe an unlicensed product instead of Sialanar when the concentration of Sialanar (2mg/5ml) was too low and a much lower volume of product would be required (provided by a higher concentration of special eg 5mg/5ml).  However, the Panel considered that the letter in question misleadingly implied that the activity was illegal by stating that if a pharmacy was supplying unlicensed or off-label preparations of glycopyrronium bromide for the indication of chronic drooling in paediatric patients then it should consider the letter as officially putting it on notice for illegitimate dispensing practices which might be a contravention of legally established rights and have caused Proveca significant commercial and financial damage.  The Panel noted, as acknowledged by Proveca, that the supply of an unlicensed medicine was legally permissible in certain circumstances where there was a patient with a ‘special need’.  The Panel considered that the letter in question queried the health professional’s decision to prescribe a special and the pharmacist’s action of dispensing against a prescription, without any knowledge of the clinical circumstances, stating that such a decision was inconsistent with MHRA Guidance and law and implying that serious consequences could ensue. 

The Panel noted that the letter in question stated that Proveca had brought the dispensing practice at issue to the attention of the MHRA which was copied into the letter.  In the Panel’s view the implication was that the MHRA approved of or otherwise endorsed the content of the letter which was not so.  The Panel further noted the negative responses received from at least six recipients of the letter at issue.  It appeared that the recipients considered that the content of the letter was such that it was threatening and questioned the reader’s professional judgement.  In the Panel’s view Proveca had failed to maintain high standards and a breach was ruled. 

The Panel considered that the letter in question queried a health professional’s decision to prescribe a special and the pharmacist’s action of dispensing against a prescription, without any knowledge of the clinical circumstances which in the Panel’s view might potentially put patient safety at risk.  The letter stated that such a decision was inconsistent with MHRA Guidance and law and implied that serious consequences could ensue if the letter was not adhered to.  The Panel was very concerned about the content and tone of the letter and noted its comments and rulings above.  In the Panel’s view, pharmacists who had received the letter would be very concerned by the misleading implication that his/her dispensing practices were potentially illegal and that legal consequences including an implication that a claim for financial damages might ensue.  The Panel noted that not all recipients of the letter would have dispensed glycopyrronium bromide.  The tone of the promotional letter could be seen as threatening and, in the Panel’s view, brought discredit upon, and reduced confidence in, the pharmaceutical industry.  A breach of Clause 2 was ruled.

Proveca appealed all the Panel’s rulings of breaches of the Code.  The Appeal Board upheld all the rulings of breaches of the Code.