Statutory committee - determination

THE ROYAL PHARMACEUTICAL SOCIETY OF GREAT BRITAIN

STATUTORY COMMITTEE


Wednesday, 28 June 2006 1 Lambeth High Street London, SE1 7JN
Chairman – Lord Fraser of Carmyllie QC
Case of:
SHAH, Manherlal Keshavlal
MAM International Limited

__________________________________________ Transcript of the shorthand notes of T A Reed & Co __________________________________________ T A REED & CO
THE ROYAL PHARMACEUTICAL SOCIETY OF GREAT BRITAIN

STATUTORY COMMITTEE


Wednesday, 28 June 2006
Chairman – Lord Fraser of Carmyllie QC
Panel Members:
Dr D N John FRPharmS
Professor K A Khan MRPharmS
Lady R Moore BA (Hons) JP
Mr W Rucker FRPharmS
CASE OF:
SHAH, Manherlal Keshavlal
MAM International Limited

---------------------------------------------------- THE SECRETARY TO THE COMMITTEE: The Statutory Committee will delivery its determination in the case Mr Manherlal Keshavlal Shah and MAM International Limited. THE CHAIRMAN: This is a complaint at the instance of the Council of the Royal Pharmaceutical Society. Mr Shah was first registered as far back as February 1969. At the material times he was not only the superintendent pharmacist for MAM International Limited but also a director of the company. At the material time on or about 20 February 2004 it is alleged he supplied to a patient 28 Enalapril tablets at the strength of 2.5 mg. The trouble was that while the response to the prescription was correct the expiry date of these tablets was October 2003 and, as I have indicated, the date of the prescription was on or about 20 February 2004. In other words, what was supplied was months beyond the manufacturer's expiry date. The patient in question consumed some of the pills but did draw to the attention of Mr Shah that the tablets in question were out of date. His response on this was to say tablets could be taken up to six months after their use-by date. In that he may be right but the manufacturer's advice was unequivocal and it should have been observed. There is also something of an acknowledgement of this by Mr Shah in that he exchanged one tablet in March 2004 but in error supplied a 5 mg tablet to a patient when the prescription called for a strength of only 2.5 mg. The patient personally had to correct this error. Shortly after this in March 2004, in response to another prescription, Mr Shah supplied a patient with 28 Enalapril tablets in four blister strips at the correct strength but in a plain box with no expiry date, no patient information leaflet and no batch number on it. Subsequent to this, in late May 2004, Inspectors from the Royal Pharmaceutical Society visited his pharmacy premises and found on the premises significant quantities of inadequately segregated out-of-date medicines, all as are set out in the first schedule to the Notice of Inquiry. They also found medicines in the dispensary where the date of expiry and batch numbers were not present or had been removed, and I would refer there to schedule 2. Paragraph 8 sets out what are also described as mixed batches and are set out and described in the shorter schedule 3. The Inspectors also discovered in sliding dispensary drawers medicines from other pharmacies for various patients, all as are set out in schedule 4. What concerned them was that these were stored amongst current stock in alphabetical order in such a way as to lead to the conclusion that they were so stored for reuse. They also found medicines removed from the manufacturer's packaging and left unlabelled or only partially labelled, and I would refer in that context to schedule 5. T.A. REED
& CO.
01992-465900

Finally, on the first floor of the pharmacy they found European products which had no product licence number on them, and I refer to schedule 6. The summary of the allegations in the Notice of Inquiry is extensive, running to over one page. The hearing lasted three days and at the conclusion I indicated we were going to conclude that Mr Shah was guilty of such misconduct as to render him unfit to be on the Register. Mr Shah's explanation for how all these medicinal products were on the premises strained our credulity and even today we have difficulty in understanding exactly what it was he was trying to convey to us. Having come to that conclusion, we then paused, as we are required to, to ask whether anything was known. Mr Ryder, for the Royal Pharmaceutical Society, pointed us to an earlier appeal by Mr Shah in 1988 and quoted extensively from the judgment. On that occasion, his appeal was successful. There was no substitution though of a reprimand in place of a direction for removal and I was curious to know what was on Mr Shah's record with the Royal Pharmaceutical Society. It appears that there was no stain on him at all in such circumstances, and I was advised that his record at that stage was, and I refer to page 48 of the transcript, "clean". However, there was then a second complaint and conviction against Mr Shah in 1992 relating to his keeping of the controlled drugs register. He was reprimanded on that occasion and the matter did not go before the courts. We were provided with references and there was a character reference from a Dr Mazunder. Notwithstanding Ms Glynn's submission that the present case could be dealt with by way of a reprimand, we have had to conclude we should give a direction for Mr Shah's removal from the Register. Even if Mr Shah had had no previous history of appearances before the Committee, we would have had to consider his removal from the Register in the circumstances of the facts which we found established. Taking those facts together with his past history we consider we are bound to direct his removal. There will, however, be no further action against the company. As Ms Glynn correctly submitted, my view on a complaint where effectively the company is being blamed for the conduct of its owner and superintendent pharmacist is that it is inappropriate to take any action against the company unless there are particular circumstances relating to the state of the premises or the state of the dispensary, and neither of those matters significantly occurred in this case. Approved without amendment by Lord Fraser of Carmyllie QC on 11th July
T.A. REED
& CO.
01992-465900

Source: http://files.pharmacyregulation.org/ConceptLinkedFiles/2015891/Determination%20-%20Shah%20%26%20MAM%20International.pdf