Three reprimands for poor practices in the manufacture of “specials”
The Statutory Committee has reprimanded two pharmacist brothers and
their pharmacy company after it found proved a catalogue of complaints
about
the company’s practices as a manufacturer of pharmaceutical “specials”.
On 23 and 24 November and 13 December 2004, the committee inquired into
a complaint by the Council of the Royal Pharmaceutical Society against
Hitesh Govind Vaghjiani (registration number 83253) and Kamlesh Govind
Vaghjiani (registration number 85388), both of London NW9, and Orbis
Consumer Products Ltd, a company registered as a retail pharmacy and
engaged in pharmaceutical manufacturing and wholesale dealing on an industrial
estate in Wembley, Middlesex.
The Council alleged that the brothers might be unfit to remain on the
register and the company might be liable to disqualification because
of a wide range of unsatisfactory practices, among which were:
· Failing to complete batch manufacturing records adequately
· Retrospective dating of the quality control section of a batch manufacturing
record
· Receipt of telephoned orders by staff with no pharmacy training
· Leaving the raw material store unlocked
· Incorrectly storing raw materials on which assessments under the Control
of Substances Hazardous to Health (COSHH) Regulations 2002 had not been
carried out
· Failing to separate out products that had passed their retest dates
· Using chemicals not intended for medicinal use in the preparation of
medicines
· Failing to list in the log books any products purported to have been
made under the Section 10 exemption of the Medicines Act 1968
· Falsely claiming that a product was made in accordance with a specials
licence
· Falsely representing that unlicensed products purportedly made under
the Section 10 exemption were manufactured in accordance with the specials
licence
· Preparing an unlicensed penicillin product in the same room as licensed
specials
· Failing to use separate spatulas or ointment slabs in the preparation
of coal tar products
· Failing to write COSHH assessments in relation to coal tar
· An inadequate knowledge of what constituted a sensitising product or
a product with a narrow therapeutic index
· Inadequate product preparation facilities
· An inadequate labelling procedure
· Inadequate procedures for supervising product preparation
· Leaving methadone mixture on an open bench in the quality control laboratory
· Failing to maintain adequate safe custody storage facilities for methadone
· Inadequate recording and custody of Controlled Drugs
· Storing about 900 litres of methadone mixture 1mg/ml in unlabelled
plastic drums in an accessible storage area
· Falsely representing in the methadone register that the methadone had
been returned to its supplier
The Vaghjiani brothers, who had admitted the allegations, were not present
or represented at the inquiry.
The committee heard that the allegations related to the period between
January and June 2003, during which Orbis held a manufacturer’s
licence and a wholesale dealer’s licence and its premises were
licensed for the manufacture of medicinal products (specials) and also
registered as a retail pharmacy. The Section 10 exemption provided by
registration as a pharmacy allowed the company to make small batches
of extemporaneous products under less stringent conditions than under
the specials licence.
The committee was told that the supplier of the methadone, which was
recorded as having been returned to the supplier on the day of supply,
had confirmed that it should have been removed on that day. But neither
brother could give any good reason for its continued presence, with their
knowledge, over a period of years. Furthermore, Hitesh Vaghjiani, at
least initially, had sought to mislead the investigating team by asserting
that the drums were empty.
Giving the committee’s determination, the chairman, Lord Fraser
of Carmyllie, QC, said: “With the exception of the receiving of
orders by telephone by untrained staff, which we question as being required
in any part of the standards set by the Society, we find the case
… established, in so far as is not already admitted. We also conclude
that individually and cumulatively their acts amount to such misconduct
as to render them unfit to be on the Register, and in the case of company
liable to disqualification. We then have to consider whether we will
direct the removal of their names from the Register.”
As the committee saw it, there was no intent to mislead, and the brothers
had ceased any involvement Controlled Drugs. A Society inspector had
visited the premises on several occasions and had reported many improvements,
although she still had some concerns. There were plans to relocate the
business to larger premises in June 2005, with separate rooms for Section
10 production and for the production of coal tar preparations.
The chairman concluded that, in the circumstances, the committee, with
some hesitation, would restrict itself to reprimanding both brothers
and the company. However, if any Society inspector were to report adversely
on the new premises the committee might then be compelled to take a different
view.
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