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Winterton of Doncaster, Baroness (5)
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Pharmacy (5)
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To ask the Secretary of State for Health, whether it is his policy to support rights for patients (a) to refuse to accept medicines from pharmacies if they are packaged in a way that the patient believes is substandard and (b) to accept medicine only in the packaging intended by...
To ask the Secretary of State for Health, whether it is his policy to support rights for patients (a) to refuse to accept medicines from pharmacies if they are packaged in a way that the patient believes is substandard and (b) to accept medicine only in the packaging intended by...
Asked by
Adrian Flook
(Conservative)
Answered by
Baroness Winterton of Doncaster
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
29 November 2004
For answer on
9 December 2004
Answered on
9 December 2004
Mr. Flook: To ask the Secretary of State for Health whether it is his policy to support rights for patients (a) to refuse to
accept medicines from pharmacies if they are packaged in a way that the patient believes is substandard and (b) to accept
medicine only in the packaging intended by the manufacturer for the UK. [201681]
Ms Rosie Winterton: The Department's policy is for medicines to be dispensed with sufficient information and advice to enable the
patient to use them safely and effectively. Pharmacists should use their professional judgment and conform to the generally accepted
standards of the profession to convey this information in a way, which the patient readily understands. Patients encountering any
problems with National Health Service medicines supplied should discuss this further with their pharmacist or general practitioner.
If a patient remains dissatisfied, he or she can lodge a formal complaint with the pharmacy or GP.
All medicines licensed for sale in the United Kingdom, including parallel imports, must comply with the UK medicines labelling
regulations, which set out the information that must be provided, in English, on the product packaging. Following importation, the
importer will re-label or repack the product and produce a patient information leaflet in English so that these regulations are
complied with. Packaging and labelling are evaluated during the licensing process for parallel imports.
Subjects
Drugs; Labelling; Imports; NHS; Patients; Pharmacy; Packaging; Patients' rights; Regulation
Date
9 December 2004
Reference
201681; 428 c757W;428 c757-8W
House
House of Commons
To ask the Secretary of State for Health, what discussions he has had with parallel trade associations about possible risks to patient safety from re-packaged medicines; what discussions he has had with patient organisations regarding (a) parallel traded medicines and (b) substandard and poorly repackaged medicines.
To ask the Secretary of State for Health, what discussions he has had with parallel trade associations about possible risks to patient safety from re-packaged medicines; what discussions he has had with patient organisations regarding (a) parallel traded medicines and (b) substandard and poorly repackaged medicines.
Asked by
Adrian Flook
(Conservative)
Answered by
Baroness Winterton of Doncaster
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
29 November 2004
For answer on
9 December 2004
Answered on
9 December 2004
Mr. Flook: To ask the Secretary of State for Health (1) what discussions he has had with parallel trade associations about possible
risks to patient safety from re-packaged medicines; [201684]
(2) what discussions he has had with patient organisations regarding (a) parallel traded medicines and (b) substandard
and poorly repackaged medicines. [201685]
Ms Rosie Winterton: The Medicines and Healthcare products Regulatory Agency (MHRA) is in regular discussions with the parallel
importer's trade association (British Association of European Pharmaceutical Distributors), United Kingdom marketing authorisation
holders and individual parallel importers to discuss aspects of the packaging of imported medicines. This has generally been done on
a case-by-case basis if issues are identified or when new requirements or guidance are introduced. The agency has not had any formal
discussions with parallel trade associations regarding the possible risks to patient safety from re-packaged medicines from the
parallel trade in pharmaceuticals.
To date, the Medicines and Healthcare products Regulatory Agency (MHRA) has not received any representation from, nor had any
discussions with patient organisations regarding any substandard and poorly repackaged medicines from the parallel trade in
pharmaceuticals, nor has had any discussions specifically dealing with parallel trade in medicines.
The MHRA has received some letters from individual patients, patient carers and health professionals on the packaging of parallel
imports. In these cases, the product labelling and repackaging has been reviewed and, where appropriate, the parallel importer asked
to address the concern raised.
The agency has also met with the National Patient Safety Agency (NPSA) to advise them of its requirements relating to parallel
imports so that patients and their carers can have access to accurate information about these medicines.
In licensing parallel imports, the MHRA ensures the products comply with the appropriate regulations.
The repackaging of licensed medicinal products, such as parallel imports, is controlled by the specification registered in the
parallel import licence and may only be carried out by assembly sites licensed and inspected by the MHRA.
During the repackaging operation parallel importers are not permitted to change or interfere with the primary packaging of the
product--that is the immediate packaging in contact with the product itself (for instance the blister packaging). However to comply
with the ED labelling regulations as laid down in Title V of the Directive 2001/83/EC the importer is required to over label the
immediate packaging with certain details in English and to over label or replace the outer packaging to provide additional
information in English. Each product must also contain a patient information leaflet in English. These operations may be carried out
by the importer if the company holds an assembly licence, issued by MHRA after the inspecting the site. Any repackaging and
re-labelling proposed by a parallel importer is considered by MHRA before a parallel import licence is issued.
MHRA operates a Defective Medicines Report Centre (DMRC) which deals with reports of defects to all medicines, including parallel
imports. All reports made to the DMRC are investigated and where necessary, appropriate action taken.
MHRA would be happy to meet with any patient organisation to discuss parallel imports.
Subjects
Licensing; EU law; Drugs; Labelling; Imports; Patients; Pharmacy; Packaging; Regulation; Safety; Trade associations; Medicines and Healthcare products Regulatory Agency
Date
9 December 2004
Reference
428 c757-9W;428 c758-9W; 201684;201685
House
House of Commons
To ask the Secretary of State for Health, what role he plans for pharmacists in (a) promoting healthcare and (b) providing information to patients. (Failed OPQ)
To ask the Secretary of State for Health, what role he plans for pharmacists in (a) promoting healthcare and (b) providing information to patients. (Failed OPQ)
Asked by
Kerry Pollard
(Labour)
Answered by
Baroness Winterton of Doncaster
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
27 October 2004
For answer on
2 November 2004
Answered on
2 November 2004
Mr. Pollard: What role he plans for pharmacists in (a) promoting health care and (b) providing information to patients. [195023]
Ms Rosie Winterton: The new contractual framework for community pharmacists, subject to a ballot of contractors, should go live from
April 2005. Nationally, it comprises a range of services which all pharmacists will provide, including helping patients make better
use of medicines through repeat dispensing, promoting public health, providing information and support to patients, as well as
signposting them to other healthcare providers. Primary care trusts will be able to commission a range of additional services from
community pharmacists to meet specific patient needs locally.
Subjects
Consumer information; Patients; Pharmacy
Date
2 November 2004
Reference
195023; 426 c169-70W
House
House of Commons
To ask the Secretary of State for Health, what systems are in place to monitor the amount of drugs prescribed to NHS patients which have been donated by pharmaceutical companies as promotional material.
To ask the Secretary of State for Health, what systems are in place to monitor the amount of drugs prescribed to NHS patients which have been donated by pharmaceutical companies as promotional material.
Asked by
Mike Hancock
(Liberal Democrat)
Answered by
Baroness Winterton of Doncaster
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
31 August 2004
For answer on
14 September 2004
Answered on
14 September 2004
Mr. Mike Hancock: To ask the Secretary of State for Health what systems are in place to monitor the amount of drugs prescribed to
NHS patients which have been donated by pharmaceutical companies as promotional material. [187520]
Ms Rosie Winterton: The supply of samples by pharmaceutical companies is regulated under the Medicines (Advertising) Regulations
1994. These stipulate that a free sample must be of the smallest pack of a medicine available for sale, that it may only be provided
to a prescriber in response to a written request and that it should be clearly labelled as a promotional sample not for resale. We
expect primary care trusts to act on any local evidence that promotional material is being misused.
Subjects
Drugs; NHS; Patients; Pharmacy; Monitoring; Prescriptions; Corporate hospitality
Date
14 September 2004
Reference
424 c1504W;424 c1502W; 187520
House
House of Commons
To ask the Secretary of State for Health, if patient registration will become an aspect of Local Pharmacy Services pilots.
To ask the Secretary of State for Health, if patient registration will become an aspect of Local Pharmacy Services pilots.
Asked by
Lord Cryer
(Labour)
Answered by
Baroness Winterton of Doncaster
(Labour)
Answering body
Department of Health
Type
Written questions
Status
Answered
Tabled on
15 October 2003
For answer on
4 November 2003
Answered on
4 November 2003
John Cryer: To ask the Secretary of State for Health if patient registration will become an aspect of local pharmacy services
pilots. [133268]
Ms Rosie Winterton: Local pharmaceutical services pilots can offer patient registration although there is no requirement for
patients to use the scheme if they do not wish to do so.
Subjects
Patients; Pharmacy; Registration
Date
4 November 2003
Reference
133268; 412 c595W;412 c602W
House
House of Commons