Proveca letter on unlicensed/off-label glycopyrronium ruled threatening and misleading (Sialanar) – breaches of Clauses 2, 8.2, 9.1 and 9.5 | PMCPA Case

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Key facts

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Case numbers	AUTH/3058/8/18 and AUTH/3060/8/18
Complainants	Two prescribing team pharmacists from a CCG (AUTH/3058/8/18) and a community pharmacist (AUTH/3060/8/18)
Respondent	Proveca Ltd
Material	Letter (ref Sia/Legal/01) sent August 2018 about supply/dispensing of unlicensed and off-label glycopyrronium bromide; copied to MHRA
Medicine	Sialanar (glycopyrronium bromide)
Indication mentioned	Symptomatic treatment of severe sialorrhoea (severe drooling) in children aged 3–17 years
Distribution	16,154 pharmacies across the UK (per Proveca); primarily community pharmacists and hospital outpatients pharmacists
Key issues	Threatening tone; misleading implication that dispensing specials/off-label was always illegal; disparagement of health professionals; MHRA reference implying endorsement; failure to maintain high standards
Breach clauses	Clause 8.2; Clause 9.1; Clause 9.5; Clause 2
Appeal	Proveca appealed; Appeal Board upheld all breaches
Sanctions	Undertaking received; Advertisement
Applicable Code year	2016
Complaint received	21 August 2018 (as stated in the case report); HTML page for AUTH/3058/8/18 also states complaint received 21 September 2018
Case completed	11 December 2018

Download the full case report (PDF)

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

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Two prescribing team pharmacists from a CCG (AUTH/3058/8/18) and a community pharmacist (AUTH/3060/8/18) complained about a Proveca letter (ref Sia/Legal/01) sent in August 2018 about supply/dispensing 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 was sent widely (Proveca said 16,154 pharmacies; the Panel also referred to around 16,000) and urged pharmacies to refrain from dispensing glycopyrronium bromide ‘specials’/off-licence preparations for children with chronic drooling and to ensure Sialanar was dispensed.
The letter bore prescribing information and was treated as promotional material by the Panel and Appeal Board.
Complainants said the letter’s tone was aggressive/threatening (eg references to “breach of the law”, “officially putting you on notice for illegitimate dispensing practices”, and implying “commercial and financial damage” to Proveca), and that it disparaged pharmacists/surgeries for dispensing what was prescribed.
Complainants highlighted clinical nuance: Sialanar concentration was 2mg/5ml whereas historical ‘specials’ were often 5mg/5ml, so switching could increase volume administered 2.5-fold and might not be straightforward; there could be valid reasons to use a special.
The letter stated it was copied to the MHRA; recipients were asked to confirm by email that they had ceased the activities.
PMCPA noted negative responses from at least six recipients; five of the six negative responses (plus the complainant) described the letter as threatening (per the Appeal Board).
Proveca said it had consulted the MHRA generally (telephone discussion in September 2017 about cease and desist letters referencing MHRA Guidance Note 14) and took legal advice; it said supply of unlicensed medicines was permissible only under narrow ‘special need’ circumstances and that it was not saying bona fide special-need prescriptions should not be dispensed.

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Outcome

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The Panel ruled breaches of Clauses 8.2, 9.5, 9.1 and 2.
Proveca appealed all rulings; the Appeal Board upheld all breaches.
The Appeal Board found the letter’s content and tone implied dispensing was illegal in all cases (which was not so), questioned professional judgement, implied possible damages, and implied MHRA endorsement.

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Proveca letter on unlicensed/off-label glycopyrronium ruled threatening and misleading (Sialanar) – breaches of Clauses 2, 8.2, 9.1 and 9.5

Key facts

What happened

Outcome

Clauses

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