Capita Stripped of NHS Cervical Screening Contract

Peter Russell

March 22, 2019

NHS England announced this week that it would bring administration of its cervical cancer screening programme back in-house following a series of well-publicised mistakes by the private health service provider.

We also round-up this week's guidance by the National Institute for Health and Care Excellence (NICE), and announcements on drug recalls and restrictions made by the Medicines and Healthcare products Regulatory Agency (MHRA).

Capita and Cervical Cancer Screening

NHS England announced that it would take back administration of its cervical screening programme following blunders made by current contract holders, Capita.

The private NHS service provider apologised last year after it emerged that around 43,200 women who should have received an invitation, and a reminder letter about cervical cancer screening only received one piece of correspondence.

Referring to the cervical cancer screening programme before the House of Commons Public Accounts Committee on Thursday, Simon Stevens, chief executive of NHS England, said: "As you know, we have not been satisfied with the way in which that has been performing. As you also know, there was an issue last year that came to light when we were notified late by Capita about delays in letters going out.

"Therefore, today I am announcing that we are bringing the cervical screening service back in-house to the NHS from Capita, beginning in June and with a phased transition through the rest of the year."

Responding to the announcement, Dr Krishna Kasaraneni, an executive member of the British Medical Association's GP committee, said: "We have long been raising concerns about Capita's frankly shambolic running of GP support services – and most notably called for their contract to be stripped when it was revealed at the end of last year that thousands of patients had not received vital information about cervical screening, potentially putting them at risk.

"It is only right that NHS England has followed through and removed this service from Capita, and now any transition process must be robust and not be done as a cost-cutting exercise at the expense of patient safety.

"Furthermore, we know there are still fundamental ongoing issues with Capita's delivery of other backroom functions – including the transfer of patient records, pensions administration and payments to practices – and we demand that NHS England ultimately takes responsibility for all of these shortcomings, and brings these back in-house as well."

Heart Medication Recall

The MHRA recalled three further batches of losartan tablets due to contamination with the nitrosamine, N-nitroso-N-methylamino butyric acid.

It said the recall, described as precautionary, was part of a continued investigation into potential nitrosamine contamination of sartan-containing medicines.

The investigation into possible contamination of sartan medicines began in 2018, after the nitrosamine N-nitrosodimethylamine (NDMA), was identified in valsartan manufactured at a facility based in China.

The MHRA recalled batches of valsartan-containing tablets from pharmacies in July and November last year due to possible NDMA and N-nitrosodiethylamine (NDEA) contamination.

In January and February 2019 the MHRA recalled batches of irbesartan-containing tablets after testing revealed possible contamination with NDEA.

Bernadette Sinclair-Jenkins from the MHRA's Regulatory Assessment Unit of the Inspection, Enforcement and Standards Division, said: "This recall shows we are continuing to investigate potential contamination of sartan-containing medicines."

The MHRA said there was currently no evidence that nitrosamine impurities could cause harm and that patients should be advised to continue taking their medication.

The affected tablets, manufactured by Accord Healthcare, were identified as:

  • Losartan Potassium 50mg Film-coated Tablets, PL 20075/0022: Batch Number PT04882

  • Losartan Potassium 100mg Film-coated Tablets, PL 20075/0023: Batch numbers PT02738 and GX0135

Advice on Fluoroquinolone Antibiotics

New restrictions and precautions were implemented on the use of fluoroquinolone antibiotics by the MHRA due to very rare reports of disabling side effects.

It said long-lasting or potentially irreversible adverse reactions affecting musculoskeletal and nervous systems lasting for 30 days or more had been reported in 286 cases in the EU over a 21-year period.

The MHRA said that health professionals should advise patients to stop treatment at the first signs of a serious adverse reaction such as tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, or central nervous system effects.

It said that fluoroquinolones should not be prescribed for non-severe or self-limiting infections, or non-bacterial conditions.

Positive Decision on Breast Cancer Drug

NICE recommended pertuzumab (Perjeta, Roche), with intravenous trastuzumab (Herceptin, Roche) and chemotherapy for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer in adults.

It said pertuzumab could be routinely prescribed on the NHS in England and Wales in cases where patients had lymph node-positive disease.

In final guidance, NICE said that despite some uncertainties about the size of the clinical benefit, trial evidence measuring invasive disease-free survival suggested that 1.7% fewer people with this type of cancer had invasive disease at 4 years with adjuvant pertuzumab.

Approval was subject to the manufacturer supplying the drug at a commercially confidential price discount.

Lung Cancer Drug Approval

ALK-inhibitor brigatinib (Alunbrig, Takeda) was recommended by NICE for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults who have already had crizotinib (Xalkori, Pfizer).

An assessment of clinical evidence suggested that people having brigatinib lived longer than those having usual treatment ceritinib (Zykadia, Novartis), and that they lived longer before their condition worsened.

Final guidance said that approval was conditional on the manufacturer supplying brigatinib at an agreed price discount.

Paula Chadwick, chief executive of the Roy Castle Lung Cancer Foundation, commented: "The approval of brigatinib by NICE adds another option for patients with this particular type of lung cancer.

"We know it will benefit only a fairly small number of people; however, since it will prolong lives and help patients live more comfortably, it's a very welcome development."

Lymphoma Treatment

NICE issued draft guidance which recommended brentuximab vedotin (Adcetris, Takeda) as an option for treating CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one systemic therapy in adults.

Treatment was conditional on patients having mycosis fungoides stage IIB or over, primary cutaneous anaplastic large cell lymphoma or Sézary syndrome.

Appraisers said that clinical trial evidence showed that brentuximab vedotin was better than current second line options methotrexate or bexarotene (Targretin, Esai Ltd) in terms of response rates and extending how long people lived without their disease getting worse.

Approval was dependent on the manufacturer supplying the drug at a discounted price.

Consultation on the draft guidance closes on 4th April 2019.

Transurethral Laser Ablation for Bladder Cancer

NICE issued draft interventional procedures guidance which found that evidence on the safety of transurethral laser ablation for recurrent non-muscle-invasive bladder cancer showed no major safety concerns.

However, it said that owing to limited evidence on its efficacy, the procedure should only be used with special arrangements for clinical governance, consent, and audit or research.

The guidance is out for public consultation until 19th April 2019.

Uterine Fibroid Treatment Consultation

In draft interventional procedures guidance, NICE said that current evidence on the safety of ultrasound-guided high-intensity transcutaneous focused ultrasound for symptomatic uterine fibroids showed there were well-recognised complications, including skin burns.

It said that because of limited evidence on efficacy, the procedure should only be used with special arrangements for clinical governance, consent, and audit or research.

A public consultation on the draft guidance will end on 18th April 2019.

Twin and Triplet Pregnancies

An update to NICE's clinical guidance on twin and triplet pregnancies has been put out for public consultation.

It covered the care that should be offered to women with a twin or triplet pregnancy that is additional to the routine care offered to all women during pregnancy, with the aim of reducing the risk of complications and improving the outcome for women and their babies.

The update followed a review of foetal complications, including adverse events of monochorionicity, such as twin anaemia polycythaemia sequence, as well as preterm birth, timing of birth, and intrapartum care in twin and triplet pregnancies.

The consultation period will close on 9th May 2019, with final guidance expected in September 2019.

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