Asked by: Pauline Latham (Conservative - Mid Derbyshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what evidence has been provided to Ministers on the comparative effectiveness of (a) mandatory self-isolation and (b) a mandatory testing regime for arrivals into the UK from amber destinations for managing the risk to public health from covid-19.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
We are unable to provide the evidence provided to Ministers as it relates to the formulation of ongoing border policy and its release could prejudice decision making.
Asked by: Pauline Latham (Conservative - Mid Derbyshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether (a) he and (b) officials in his Department have had discussions with counterparts in the Department for Transport on permitting the use of NHS lateral flow tests for mandatory covid-19 testing for arrivals into the UK from (i) amber and (ii) green list destinations.
Answered by Jo Churchill - Minister of State (Department for Work and Pensions)
Officials in the Department of Health and Social Care and the Department for Transport have discussed options for reducing the cost of travel testing, including whether National Health Service lateral flow tests could be used by arrivals from ‘amber’ and ‘green list’ countries. However, lateral flow tests are not permitted for most international arrivals as they are not suitable for identifying variants. Polymerase chain reaction testing of inbound travellers and genome sequencing of positive samples are crucial for disease surveillance and identification of potentially harmful variants.
Asked by: Pauline Latham (Conservative - Mid Derbyshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the potential merits of establishing fluoroquinolone toxicity as a diagnosis in response to (a) tendon injury, (b) mitochondrial dysfunction and (c) oxidative stress attributed by some patients to the use of that drug.
Answered by Nadine Dorries
The Yellow Card Scheme is the system used in the United Kingdom for reporting adverse drug reactions (ADRs). This acts as an early warning system for the identification of previously unrecognised adverse reactions and also provides valuable information on recognised ADRs, allowing the Commission on Human Medicines and Medicines and Healthcare products Regulatory Agency (MHRA) to identify and refine the understanding of risk factors that may affect the clinical management of patients.
The following table shows spontaneous suspected ADR reports for fluoroquinolones in association with tendon injury, mitochondrial dysfunction and oxidative stress to 25 May 2021 in the UK.
Reaction | Number of reports |
Tendon disorders* | 1,381 |
mitochondrial cytopathy, mitochondrial toxicity, mitochondrial myopathy acquired | 1 |
Oxidative stress | 2** |
Source: MHRA Sentinel database for Adverse Drug Reactions.
Notes:
*Tendon disorders includes 21 different relevant reaction terms.
**These reports are duplicates and have been subsequently merged on the database.
The frequency of tendonitis range from 1 in 100 to less than 1 in 10,000, depending on the specific fluoroquinolone medicine. For the products that provide an estimate of the frequency of tendon rupture, this is listed as less than 1 in 10,000. Mitochondrial dysfunction and oxidative stress are among the possible mechanisms that might lead to tendon injury or other ADRs caused by fluoroquinolones, but this association is not fully understood and mitochondrial dysfunction and oxidative stress are not listed as ADRs in the product information for fluoroquinolones.
The MHRA continues to review information about the safety of all medicines, including fluoroquinolones, and will take appropriate regulatory action as appropriate on the basis of new safety information. Serious side effects of fluoroquinolone antibiotics can be varied, potentially affecting several different parts of the body. An assessment of the potential merits of fluoroquinolone toxicity as a clinical diagnosis in response to tendon injury, mitochondrial dysfunction or oxidative stress has not been made.
Asked by: Pauline Latham (Conservative - Mid Derbyshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many and what proportion of patients who are prescribed fluoroquinolone antibiotics suffer adverse reactions in the form of (a) tendon injury, (b) mitochondrial dysfunction and (c) oxidative stress.
Answered by Nadine Dorries
The Yellow Card Scheme is the system used in the United Kingdom for reporting adverse drug reactions (ADRs). This acts as an early warning system for the identification of previously unrecognised adverse reactions and also provides valuable information on recognised ADRs, allowing the Commission on Human Medicines and Medicines and Healthcare products Regulatory Agency (MHRA) to identify and refine the understanding of risk factors that may affect the clinical management of patients.
The following table shows spontaneous suspected ADR reports for fluoroquinolones in association with tendon injury, mitochondrial dysfunction and oxidative stress to 25 May 2021 in the UK.
Reaction | Number of reports |
Tendon disorders* | 1,381 |
mitochondrial cytopathy, mitochondrial toxicity, mitochondrial myopathy acquired | 1 |
Oxidative stress | 2** |
Source: MHRA Sentinel database for Adverse Drug Reactions.
Notes:
*Tendon disorders includes 21 different relevant reaction terms.
**These reports are duplicates and have been subsequently merged on the database.
The frequency of tendonitis range from 1 in 100 to less than 1 in 10,000, depending on the specific fluoroquinolone medicine. For the products that provide an estimate of the frequency of tendon rupture, this is listed as less than 1 in 10,000. Mitochondrial dysfunction and oxidative stress are among the possible mechanisms that might lead to tendon injury or other ADRs caused by fluoroquinolones, but this association is not fully understood and mitochondrial dysfunction and oxidative stress are not listed as ADRs in the product information for fluoroquinolones.
The MHRA continues to review information about the safety of all medicines, including fluoroquinolones, and will take appropriate regulatory action as appropriate on the basis of new safety information. Serious side effects of fluoroquinolone antibiotics can be varied, potentially affecting several different parts of the body. An assessment of the potential merits of fluoroquinolone toxicity as a clinical diagnosis in response to tendon injury, mitochondrial dysfunction or oxidative stress has not been made.
Asked by: Pauline Latham (Conservative - Mid Derbyshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the extent of under-reporting of adverse drug reactions to the Yellow Card scheme.
Answered by Nadine Dorries
The reporting rate for spontaneous adverse drug reactions (ADR) is variable and can depend on a multitude of factors. Although some historical studies have estimated only 10% of ADRs are reported, the actual rate is unknown and variable because it is influenced by public awareness and seriousness of the event.
Asked by: Pauline Latham (Conservative - Mid Derbyshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to increase awareness of fluoroquinolone toxicity among healthcare professionals.
Answered by Nadine Dorries
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued reminders for healthcare professionals that fluoroquinolones should not be used in conditions that are not serious or improve on their own and that they should only be used for acute episodes of chronic bronchitis and uncomplicated cystitis if other antibiotics cannot be used.
This also includes stronger warnings about the potential side effects of fluoroquinolones in the product information for healthcare professionals and for patients and mandating pharmaceutical companies to issue letters to healthcare professionals on the new restrictions and stronger warnings about these serious risks, including signs and symptoms which can appear.
The MHRA is working with the National Institute for Health and Care Excellence and the British National Formulary to promote appropriate use of fluoroquinolones and ensure that the restrictions are aligned with United Kingdom national guidance on the antibiotic treatment of infections.