Renal and ureteric stones NICE guideline published

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National Institute for Health and Care Excellence

  • Renal and ureteric stones: assessment and management – new guideline published.
  • Recommended treatments:
    • Regorafenib for previously treated advanced hepatocellular carcinoma
    • Pembrolizumab with pemetrexed and platinum chemotherapy, within CDF, for lung cancer.
  • Erenumab not recommended for migraine prevention in draft guidance.
  • Technologies not recommended:
    • Mepilex Border Heel and Sacrum dressings for the prevention of pressure ulcers
    • Darvadstrocel for treating complex perianal fistula in Crohn’s disease.

Medicines and Healthcare products Regulatory Agency

  • Drug safety updates published:
    • Ipilimumab: reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation
    • Tapentadol: risk of seizures and reports of serotonin syndrome when co-administered with other medicines.

Pharmaceutical Services Negotiating Committee

  • Pregabalin and gabapentin to be controlled drugs.

Royal Pharmaceutical Society

  • Falsified Medicines Directive: pharmacy guide published.

Public Health England

  • New measles and rubella elimination strategy maps published.
  • Two cases of resistant gonorrhoea diagnosed in the UK.

World Health Organisation

  • Global guidelines on the prevention of surgical site infection published.

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

RENAL AND URETERIC STONES: ASSESSMENT AND MANAGEMENT – NEW GUIDELINE PUBLISHED  

NICE has published a new guideline on the assessment and management of renal and ureteric stones. It aims to improve the detection, clearance and prevention of stones, so reducing pain and anxiety, and improving quality of life. The guideline includes recommendations on:

It does not cover the infected obstructed kidney, which needs urgent drainage.

REGORAFENIB RECOMMENDED FOR PREVIOUSLY TREATED ADVANCED HEPATOCELLULAR CARCINOMA

NICE has published evidence-based recommendations which recommend regorafenib (Stivarga) as an option for treating advanced unresectable hepatocellular carcinoma in adults who have had sorafenib, only if:

  • they have Child–Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and
  • the company provides it according to the commercial arrangement.

Clinical trial evidence comes from people who have advanced hepatocellular carcinoma that has been treated with sorafenib, and who have an ECOG performance status of 0 or 1 and Child–Pugh grade A liver impairment. This shows that people having regorafenib live longer than people having best supportive care. However, the trial does not include people who cannot tolerate sorafenib, or who have more severe liver disease or a poorer performance status. So it can't be assumed that these people would get the same benefits from regorafenib as the people in the trial. Regorafenib meets NICE's criteria to be considered a life-extending treatment at the end of life. The most plausible cost-effectiveness estimates are within the range that NICE normally considers an acceptable use of NHS resources for end-of-life treatments.

PEMBROLIZUMAB WITH PEMETREXED AND PLATINUM CHEMOTHERAPY RECOMMENDED, WITHIN CDF, FOR LUNG CANCER

NICE has published evidenced-based recommendations which recommend pembrolizumab (Keytruda), with pemetrexed and platinum chemotherapy, for use within the Cancer Drugs Fund, as an option for untreated, metastatic, non-squamous non-small-cell lung cancer (NSCLC) in adults whose tumours have no epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)-positive mutations. It is only recommended if:

  • pembrolizumab is stopped at two years of uninterrupted treatment or earlier if disease progresses and
  • the company provides pembrolizumab according to the managed access agreement.

Clinical-effectiveness evidence comes from an ongoing trial (KEYNOTE-189). Pembrolizumab with pemetrexed and carboplatin or cisplatin (pembrolizumab combination) is likely to improve how long people live but it is difficult to establish the size of the benefit in the long term, because the trial is ongoing. Therefore, the cost-effectiveness estimates are also very uncertain. Pembrolizumab combination meets NICE's criteria to be considered a life-extending end-of-life treatment compared with standard care and chemotherapy but does not meet the criteria when compared with pembrolizumab monotherapy. Pembrolizumab combination has the potential to be cost effective, but more evidence from the trial is needed to address the clinical uncertainties. Therefore, pembrolizumab combination is recommended for use in the Cancer Drugs Fund.

ERENUMAB NOT RECOMMENDED FOR MIGRAINE PREVENTION IN DRAFT GUIDANCE

NICE has published draft guidance for public consultation which does not recommend erenumab (Aimovig) for preventing migraine. The draft guidance looks at erenumab for preventing chronic and episodic migraine in adults who have four episodes or more of migraine every month where at least three previous preventive treatments have failed. The evidence shows that erenumab is a clinically effective treatment. However, the committee considered that the trial evidence doesn’t fully reflect patients seen in clinical practice in the NHS and nor does it include all the relevant comparators and outcomes. Because of this the cost-effectiveness estimates for erenumab are higher than what NICE usually considers to be acceptable when there is substantial uncertainty. Erenumab costs around £5000 per year at its list price, although a confidential commercial arrangement has been agreed with the company which would have made it available at a discounted price. The closing date for comments on the draft recommendations is 31 January 2019.

MEPILEX BORDER HEEL AND SACRUM DRESSINGS FOR THE PREVENTION OF PRESSURE ULCERS NOT RECOMMENDED FOR ROUTINE ADOPTION IN THE NHS

NICE has published evidence-based recommendations for Mepilex Border Heel and Sacrum dressings for the prevention of pressure ulcers in people who are considered to be at risk in acute care settings. Despite showing promise, NICE says there is currently insufficient evidence to support the case for routine adoption in the NHS. Research is recommended to address uncertainties about the claimed benefits of using Mepilex Border Heel and Sacrum dressings. This research should also explore issues such as:

  • the incidence of heel and sacrum pressure ulcers in NHS acute care settings
  • criteria for patient selection to reduce pressure ulcer incidence with Mepilex Border Heel and Sacrum dressings in addition to standard care.

NICE will consider reviewing this guidance when substantive new evidence becomes available.

DARVADSTROCEL NOT RECOMMENDED FOR TREATING PERIANAL FISTULA IN CROHN’S DISEASE

NICE has published guidance which does not recommend darvadstrocel (Alofisel), within its marketing authorisation, for previously treated complex perianal fistulas in adults with non-active or mildly active luminal Crohn's disease. Nice says that in a single clinical trial comparing remission rates for darvadstrocel and placebo, only an additional 14% of people showed a beneficial effect from darvadstrocel over and above placebo. Reliable follow‑up results are only available for up to one year during which time more than 50% of patients who had remission subsequently relapsed in both the darvadstrocel and placebo arms, so it is unclear how long the treatment benefit will last. The additional evidence submitted after consultation did not clarify the uncertainties around long-term benefits of darvadstrocel. The committee considered that further research in this area would be beneficial. The cost-effectiveness estimates are therefore highly uncertain and the committee was unable to decide on the most plausible cost-effectiveness estimate.

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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

CASES OF CMV GASTROINTESTINAL INFECTION OR REACTIVATION IN PATIENTS ON IPILIMUMAB REPORTED

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a drug safety update due to reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation for patients on ipilimumab (Yervoy ▼). Patients on ipilimumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infections such as CMV. There have been post-marketing cases of gastrointestinal CMV infection or reactivation in ipilimumab-treated patients reported to have corticosteroid-refractory immune-related colitis, including fatal cases. Healthcare professionals area advised to:

  • Advise patients to contact their healthcare professional immediately at the onset of symptoms of colitis (including diarrhoea, blood in stools, or abdominal pain). Colitis occurs commonly in patients treated with ipilimumab for advanced melanoma.
  • If patients on ipilimumab present with diarrhoea or colitis, investigate possible causes, including infections; perform a stool infection work-up and screen for CMV
  • For patients with immune-related colitis that is corticosteroid refractory, use of an additional immunosuppressive agent should only be considered if other causes are excluded (including with screening for CMV, culture, Clostridium difficile, ova, and parasite) using viral PCR on biopsy, and other viral, bacterial, and parasitic causes
  • Report suspected adverse drug reactions associated with ipilimumab to the Yellow Card Scheme.

RISK OF SEIZURES AND REPORTS OF SEROTONIN SYNDROME IN PATIENTS TAKING TAPENTADOL WITH OTHER MEDICINES

The MHRA has published a drug safety update due to the risk of seizures and reports of serotonin syndrome in patients taking tapentadol (Palexia) with other medicines that lower seizure threshold, for example, antidepressants and antipsychotics. Serotonin syndrome has also been reported when tapentadol is used in combination with serotoninergic antidepressants. The MHRA’s advice to healthcare professionals is as follows::

  • As for all opioid medicines, tapentadol can induce seizures
  • Tapentadol should be prescribed with care in patients with a history of seizure disorders or epilepsy
  • Tapentadol may increase seizure risk in patients taking other medicines that lower seizure threshold, for example, antidepressants such as serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), tricyclic antidepressants, and antipsychotics
  • Serotonin syndrome has been reported when tapentadol is used in combination with serotoninergic antidepressants (see the
    MHRA’s drug safety update for typical presenting symptoms)
  • Withdrawal of the serotoninergic medicine, together with supportive symptomatic care, usually brings about a rapid improvement in serotonin syndrome
  • Report suspected adverse drug reactions, including those resulting from interactions between drugs, on a Yellow Card.

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PHARMACEUTICAL SERVICES NEGOTIATING COMMITTEE

PREGABALIN AND GABAPENTIN TO BE CONTROLLED DRUGS

The Pharmaceutical Services Negotiating Committee (PSNC) has reported that following a government consultation and recommendations made from the Advisory Council on the Misuse of Drugs, that from 1st April 2019, amendments to the Misuse of Drugs Regulations 2001 and the Safe Custody Regulations 1973 will mean that pregabalin and gabapentin will be classified as Schedule 3 Controlled Drugs (CDs). Additional safeguards have been put in place because of concerns around the misuse of these drugs. Community pharmacy teams should note that pregabalin and gabapentin will be included in the list of “exempted drugs” in the safe custody regulations which means that they will not be required to keep these drugs in the CDs cabinet. Pregabalin and gabapentin will also be subject to the prescription writing requirements for Schedule 3 CDs.

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ROYAL PHARMACEUTICAL SOCIETY

FALSIFIED MEDICINES DIRECTIVE: PHARMACY GUIDE PUBLISHED

The Royal Pharmaceutical Society has produced an online guide aimed at pharmacists in the NHS and private sector who dispense, handle or supply prescription only medicines, and the entire supply chain, in order to clarify the requirements of the Falsified Medicines Directive (FMD) legislation, which comes into force on 9th February. The guide provides advice for members working in community, hospital, homecare, GP practices and pharmacists with a wholesaler dealers licence. The guidance outlines:

  • FMD requirements in practice
  • Practical FMD guidance for pharmacists
  • Professional dilemmas that could be faced in practice
  • FMD requirements by sector - signposting to further guidance, resources and FAQs.

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PUBLIC HEALTH ENGLAND

NEW MEASLES AND RUBELLA ELIMINATION STRATEGY MAPS PUBLISHED

Public Health England (PHE) has published new measles and rubella elimination strategy maps which make recommendations on how the UK can eradicate measles, rubella and congenital rubella syndrome. The strategy, developed by PHE and supported by partners across the NHS and the devolved administrations, builds on the experience of 50 years of measles vaccination and 30 years of the measles, mumps and rubella (MMR) immunisation programme. The new strategy makes clear that partners in the local health economy need to work together to continue to increase uptake of the MMR vaccine in all children, and address immunity gaps across the population by catching up teenagers and young adults who missed out on the vaccine when they were younger. It includes a number of recommendations, which cover four main areas:

  1. Achieving and sustaining over 95% coverage with two doses of MMR vaccine in the routine childhood immunisation programme.
  2. Achieving over 95% coverage with two doses of MMR vaccine in older age groups.
  3. Strengthening measles and rubella monitoring.
  4. Ensuring easy access to high-quality, evidence-based information for health professionals and the public.

TWO CASES OF RESISTANT GONORRHOEA DIAGNOSED IN THE UK

PHE is investigating two cases of Neisseria gonorrhoeae in heterosexual females with similar resistance patterns to the antibiotics (ceftriaxone and azithromycin) that are used as the first-line treatment for gonorrhoea. While this type of resistance is unusual, there have been cases in other countries. Both cases were successfully treated and PHE are following up sexual contacts to minimise the risk of any onward transmission. One of these cases appears to have been acquired in Europe and the other has links to Europe but was acquired in the UK.

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WORLD HEALTH ORGANISATION

GLOBAL GUIDELINES ON THE PREVENTION OF SURGICAL SITE INFECTION PUBLISHED

The World Health Organisation has published global guidelines on the prevention of surgical site infection. The guidelines, which were updated in 2018, are valid for any country and suitable to local adaptations, and take account of the strength of available scientific evidence, the cost and resource implications, and patient values and preferences.

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