Completed cases

Complaints considered by the Code of Practice Panel are judged on the evidence provided by both parties. Once concluded a case report is published on this website. Good compliance decisions rely on both the interpretation of the Code and an understanding of its application, published case reports help in this regard and set precedent in a particular set of circumstances. When making decisions on compliance with the Code, knowledge gained from previous case reports can be beneficial.                        

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This is an interim case report because the final report will be delayed due to the Code of Practice Appeal Board’s requirement for audits of Otsuka Pharmaceuticals Europe Ltd and Otsuka Pharmaceuticals Ltd’s procedures in relation to the Code (Paragraph 11.3 of the Constitution and Procedure refers). An Otsuka employee complained about the company’s procedures for updating the summary of product characteristics (SPC) and prescribing information for Jinarc (tolvaptan, used in chronic kidney disease), Samsca (tolvaptan,...

Applicable Code: 2016

Received: 01 June 2018

Completed: 25 June 2020

A complainant who described himself/herself as a concerned UK health professional, complained about the promotion of Eliquis (apixaban) by Pfizer Limited and Bristol-Myers Squibb Pharmaceuticals Limited. The material at issue appeared on the Pulse website (Pulsetoday.co.uk). Eliquis was indicated, inter alia, for the prevention of stroke and other vascular emergencies in adults such as deep vein thrombosis (DVT) and pulmonary embolism (PE). The complainant explained that he/she had received a promotional email with the subject heading...

Breach Clause(s): 2, 4.1, 9.1, 7.2, 7.4

Applicable Code: 2019

Received: 27 September 2019

Completed: 13 May 2020

A general practitioner complained about a page of an Eliquis (apixaban) six-page, landscape, gatefold leavepiece (ref PP-ELI-GBR-4453) issued by Pfizer Limited and Bristol-Myers Squibb Pharmaceuticals Limited. Eliquis was a non-vitamin K antagonist oral anticoagulant (NOAC) indicated, inter alia, for the prevention of stroke and systemic embolism in certain adults with non-valvular atrial fibrillation (NVAF). The complainant provided a page of the leavepiece headed ‘Eliquis is the only factor Xa inhibitor that does not require a dose...

Breach Clause(s): 2, 3.2, 7.2, 7.3, 9.1

Applicable Code: 2019

Received: 21 June 2019

Completed: 13 May 2020

Norgine voluntarily admitted a breach of the Code in that claims for Feraccru (oral ferric maltol) were based on inaccurate statistical reporting from a clinical trial. Feraccru was indicated in adults for the treatment of iron deficiency. As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Norgine. Norgine explained that the claims at issue, ‘In the new head-to-head trial, Feraccru was...

Breach Clause(s): 7.2

Applicable Code: 2019

Received: 19 March 2020

Completed: 28 April 2020

An anonymous individual, who described him/herself as a concerned health professional employed by Otsuka, complained in his/her private capacity that GlaxoSmithKline UK Limited’s website promoted prescription only medicines to the public. The complainant alleged that the GlaxoSmithKline website for members of the public had links to the various company products and included the brand name of the medicine, non-propriety name and the indication promoted to members of the public and encouraged them to ask for these...

No breach Clause(s): 2, 9.1, 26.1, 26.2

Applicable Code: 2019

Received: 07 June 2019

Completed: 27 April 2020

A complainant, who described him/herself as a concerned UK health professional, complained about the online Gedeon Richter Resource Centre which provided training for health professionals and resources to use with patients. The complainant, not sure whether the website was promotional, noticed a link to prescribing information for Esmya (ulipristal acetate), Levosert (levonorgestrel) and Bemfola (follitropin alfa) in the lower left-hand corner of the webpage provided. The generic name was not stated for any of these three...

Breach Clause(s): 4.3, 9.1

No breach Clause(s): 2, 12.1, 26.1, 28.1

Applicable Code: 2019

Received: 28 October 2019

Completed: 24 April 2020

An anonymous employee who described him/herself as a concerned health professional, complained that Otsuka UK webpages promoted prescription only medicines to the public. The webpages were part of the Otsuka Europe website and the matter was taken up with Otsuka Europe. The complainant stated that as the Otsuka UK website products page listed the brand names, non-proprietary names and indications of the medicines sold by Otsuka UK, it promoted them to the public and encouraged patients...

Breach Clause(s): 9.1, 26.1, 26.2, 28.1

No breach Clause(s): 2, 9.1, 26.2

Applicable Code: 2019

Received: 07 June 2019

Completed: 23 April 2020

A complainant who described him/herself as a concerned UK health professional, complained that on a webpage (downloaded 6 February 2020), Napp Pharmaceuticals Limited described Nyxoid (intranasal naloxone spray) as ‘a new option’ for treating overdose. The complainant noted that Nyxoid had been on the market for more than 12 months. The detailed response from Napp is given below. The Panel noted that the word ‘new’ must not be used to describe any product or presentation which had...

Breach Clause(s): 7.11

Applicable Code: 2019

Received: 06 February 2020

Completed: 09 April 2020

A complainant who described him/herself as a concerned UK health professional, complained about an advertisement for DuoResp Spiromax (budesonide/formoterol fumarate) placed on the BMJ website by Teva UK. DuoResp Spiromax, available in two strengths, 160/4.5mcg and 320/9mcg, was indicated for use in certain patients with asthma or chronic obstructive pulmonary disease (COPD). The complainant stated that his/her initial impression was that DuoResp Spiromax was licensed for use in all asthma and COPD patients – then he/she...

Breach Clause(s): 2, 3.2, 7.2, 9.1

Applicable Code: 2019

Received: 16 July 2019

Completed: 07 April 2020

A BBC radio 4 programme broadcast in May 2019 and a subsequent article published on the BBC website entitled ‘Doctors used as “guinea pigs” in opioid painkiller promotion’ were critical of the activities of Napp Pharmaceuticals Limited. The PMCPA Constitution and Procedure is such that public criticism of the industry is taken up by the Director and dealt with as a complaint under the Code. The article included criticism of a meeting sponsored by Napp and...

Breach Clause(s): 2, 9.1, 18.1 and 19.1

No breach Clause(s): 19.1

Applicable Code: 2001

Received: 21 May 2019

Completed: 03 April 2020

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