Isotretinoin: new safety measures to be introduced in the coming months
The Isotretinoin Expert Working Group of the Commission on Human Medicines has made recommendations to strengthen the safety of isotretinoin treatment. Recommendations include new warnings, the need for consistent monitoring requirements for psychiatric side effects, the introduction of new monitoring requirements for sexual side effects, and additional oversight of the initiation of treatment for patients younger than 18 years.
In September 2019, the Commission formed the Working Group to review the safety of isotretinoin, in particular concerns about suspected psychiatric and sexual side effects and whether, in some cases, these continue after use of isotretinoin has been stopped. While processes to support the implementation of these recommendations across the healthcare system are being developed, prescribers of isotretinoin are reminded of the need to fully inform all patients of the potential benefits and risks associated with isotretinoin treatment and monitor patients closely for any side effects throughout treatment.
No new action from healthcare professionals is needed for now – further communications will be issued once these recommendations are being implemented. Recommendations include the addition of new warnings for the risk of sexual dysfunction, including the possibility of persistence after treatment discontinuation, and advice for healthcare professionals to ask patients about symptoms or signs of sexual dysfunction prior to starting treatment with isotretinoin and to monitor patients for the development of new sexual disorders during treatment.
Recommendations also include the development of consistent monitoring requirements for potential psychiatric and sexual side effects in all patients throughout treatment. The initiation of treatment in patients younger than 18 years will require two prescribers to agree that a patient's acne is severe and that there is no other effective treatment before initiation of isotretinoin therapy. Patients should not take isotretinoin if they are pregnant or think they may become pregnant as it can cause birth defects. If a patient becomes pregnant during treatment with isotretinoin capsules, they should stop taking the capsules and speak to a health professional as soon as possible.
Isotretinoin is effective for severe types of acne, especially if there is a risk of permanent scarring, but like every medicine it is associated with a risk of side effects. Isotretinoin should only be used when other treatments for acne have not worked. Not every patient has side effects, but they should know about the risks and what to do if they occur by reading the leaflet that comes with the medicine to learn about the risks associated with isotretinoin.
Health professionals should advise patients to take time to think about the information from their doctor about the benefits and risks of isotretinoin, and decide if isotretinoin is the right treatment for them.
Nitrofurantoin: reminder of the risks of pulmonary and hepatic adverse drug reactions
Health professionals prescribing nitrofurantoin should be alert to the risks of pulmonary and hepatic adverse drug reactions, and advise patients to be vigilant for the signs and symptoms in need of further investigation, says the MHRA.
Nitrofurantoin is a broad-spectrum antibacterial agent that has been available since the 1950s. It is indicated in adults, children and infants over three months old for treatment and prophylaxis of acute or recurrent uncomplicated urinary tract infections (UTIs), treatment and prophylaxis of acute or recurrent uncomplicated pyelitis.
The NICE guidelines on antimicrobial prescribing for UTIs recommend nitrofurantoin as one of the first choices, particularly if there is a high risk of trimethoprim resistance. Treatment courses for infections are indicated to last between three and seven days. However, some patients may be given a daily dose as prophylaxis for recurrent UTIs. Health professionals should advise patients and caregivers to be vigilant for new or worsening respiratory symptoms while taking nitrofurantoin and promptly investigate any symptoms that may indicate a pulmonary adverse reaction. Pulmonary reactions may occur with short- or long- term use of nitrofurantoin, and increased vigilance for acute pulmonary reactions is required in the first week of treatment. Patients receiving long-term therapy; for example, for recurrent UTIs, should be closely monitored for new or worsening respiratory symptoms, especially if elderly. Immediately discontinue nitrofurantoin if new or worsening symptoms of pulmonary damage occur, and be vigilant for symptoms and signs of liver dysfunction in patients taking nitrofurantoin for any duration, but particularly with long-term use. Monitor patients periodically for signs of hepatitis and for changes in biochemical tests that would indicate hepatitis or liver injury.
Implementing smoking cessation interventions for tobacco users within oncology settings: study recommends trained tobacco specialists to achieve abstinence
A systematic review of 43 articles found that the strategy associated with a change in smoking behaviour and attitudes was to identify a trained tobacco specialist who could assist patients in achieving abstinence, and it was found that standardising screening and advice can be improved by modifying electronic record systems.
Clinicians must be trained and educated; relationships with implementation stakeholders must be developed to make referral systems associated with positive outcomes.
The study aimed to identify and recommend implementation strategies for smoking cessation interventions associated with improved screening, advice-giving, and referral for tobacco users recently diagnosed with cancer, as well as shifting smoking behaviours and attitudes in this patient population.
A systematic analysis was conducted by the authors focusing on studies with low or moderate risk of bias due to high heterogeneity in outcome measurement. MEDLINE, CINAHL, Embase and PsycINFO databases, as well as Google Scholar, were searched for articles published before 7 September 2020 using terms related to cancer, smoking cessation, and implementation science. In total, 6047 records were screened, yielding 43 articles. Outcomes of interest were study characteristics, implementation strategies, and outcome measures. The Cochrane Risk of Bias Tool for randomised and non- randomised studies was used to assess bias. The authors found that supporting clinicians by providing cessation care through a tobacco specialist was important. Combined with a theoretical framework and stakeholder involvement, these strategies provide the basis for successful implementation of cessation support; this systematic review serves as an illustration of the methodological application and synthesis of implementation studies and other conditions more generally.
NHS 111 reliably identified people with COVID-19 who needed urgent care
Assessment by the NHS 111 telephone service provided by Yorkshire Ambulance Service reliably identified people with COVID-19 who needed urgent care. Research found that the telephone service distinguished between people who needed urgent care, and those who could safely look after themselves at home.
The research, carried out during the first wave of the pandemic, analysed NHS 111 telephone triage of people with suspected COVID-19 infection. It found that small numbers of people (one in 100) were missed (considered non-urgent but then became seriously ill or died). A similar proportion of people can be missed when in-person assessments are made in hospital. People who were missed were more likely to be younger, to be living with diabetes, or to have rung 111 multiple times. Ringing multiple times is a potential indicator of increased risk – this finding has been fed back to the ambulance service.
Telephone triage could reduce the numbers of people with a low risk of complications who attend hospitals or other care settings. The authors say this was relevant during COVID-19, and could also apply to future pandemics.
The study included more than 40 000 calls to NHS 111 made by people with suspected COVID-19 infection. The calls were managed by Yorkshire Ambulance Service between March 2020 and June 2020 during the first wave of the pandemic when knowledge about COVID-19 was still emerging. Callers were aged 47 years on average. The findings show that 111 triage has similar accuracy to the triage used in emergency departments and urgent care settings for other conditions.
The risk of being incorrectly told not to seek urgent care is small; the researchers say it may have been the best accuracy that could be achieved (given knowledge of COVID-19 at the time, and that information was via telephone).
The researchers calculate that it replaced 61 ambulance journeys or urgent clinical assessments each day per million people. Telephone triage arguably safely managed demand in this, and possibly future, pandemics. However, small numbers of people were given incorrect advice. Calling multiple times was a strong indicator of the need for emergency care. Younger people and those living with diabetes were more likely than others to be incorrectly told not to seek urgent help. People with long-term lung and kidney disease, or a weakened immune system were more likely than others to be given urgent care they did not need.
This study was part of a larger National Institute for Health and Care Research -funded project on urgent public health priority. The project, called PRIEST, evaluated triage methods for people presenting to emergency departments, ambulance services and NHS 111 during the pandemic. The findings will feed into future triage systems to improve their accuracy. Multiple calls about the same person could be flagged, for example; these people are more likely to need urgent care. The researchers have shared findings from this study with the Royal College of Emergency Medicine and have asked NHS 111 to amend its algorithms. Multiple calls could signal increased risk in other conditions, they say.