Greek hospitals and pharmacies are running short of around 300 medicines because drug companies are refusing to supply them.

Hospitals failing to pay drug bills and parallel trading by wholesalers and pharmacists are the main reasons for supplies being withheld.

Major pharmaceutical companies that have admitted halting shipments of some products include Pfizer, Roche and Sanofi.

Medicines for arthritis, hepatitis C and hypertension, statins, antibiotics, anaesthetics, antipsychotics and antidepressants are all affected.

Dimitris Karageorgiou, Secretary General of the Panhellenic Pharmaceutical Association, said: “I would say supplies are down by 90%. The companies are ensuring that they come in dribs and drabs to avoid prosecution. Everyone is really frightened.

“The government is panic-stricken and the multinationals only think about themselves and the issue of parallel trade because wholesalers can legally sell them to other European nations at a higher price.”

According to the Greek government, more than 50 companies are holding back products or planning to do so. The Ministry of Health is intending to fine eight major drug companies, which have not been named.

There are reports of widespread panic and anger among patients who are going from one pharmacy to another with prescriptions. “We have reached a tragic point,” commented Karageorgiou.

With austerity tightening in Greece, the debts owed to pharma companies by hospitals and social insurance funds has reached €1.9bn (£1.6bn).

Pfizer has admitted withdrawing four medicines “because alternatives were available and because of the parallel trade situation”: leukaemia drugs Zavedos and Aracytin, the analgesic Neurontin and the epilepsy treatment Epanutin.

Roche said it was withholding supplies to Greek public hospitals, apart from “critical medicines” such as HIV drugs, but was still supplying pharmacies.

Sanofi claimed it was still supplying public hospitals with life-saving and unique products (for which no generic version or recommended alternative exists).

GSK, AstraZeneca, Novartis and Boehringer Ingelheim denied they had stopped supply of any products to Greece.

The pharmaceutical industry has urged the Greek government to set its drug prices in accordance with a eurozone standard. Greek drug prices are 20% lower than the next lowest in the EU, giving rise to widespread parallel trading.

Greek regulator the National Organisation for Medicines has banned the export of 60 medicines and is considering another 300. It will fine wholesalers and pharmacists who have broken the export ban.

The lack of new antibiotics is exposing the UK population to serious risk from untreatable gonorrhoea, the Health Protection Agency (HPA) has warned.

The Agency’s Gonorrhoea Resistance Action Plan aims to maximise the effectiveness of existing treatments after a year in which new diagnoses rose by 25%.

The increasing prevalence of antibiotic-resistant strains draws attention to the lack of new therapies, a problem highlighted by GSK’s Andrew Witty in 2012.

The action plan, developed by the HPA’s Gonococcal Resistance to Antimicrobials Surveillance Programme (GRASP), places emphasis on data collection, rapid detection of treatment failures, and actions to reduce infection rates.

The GRASP data show that new gonorrhoea diagnoses rose by 25% in 2011 to nearly 21,000. Men who have sex with men made up a third of new infections, compared to a quarter in 2010.

With treatment failures occurring worldwide and no new antibiotics in the pipeline, England’s Chief Medical Officer recently argued that antibiotic resistance should be considered a civil emergency on a par with terrorism.

Professor Cathy Ison, lead author of the action plan, said: “Ensuring treatment-resistant gonorrhoea strains do not persist and spread remains a major public health concern. The GRASP Action Plan sets out practical, measurable actions to extend the useful life of the current recommended therapies in England and Wales.”

Current fears that the transfer of sexual health services to the council-funded public health system will see cuts in these services has intensified concern about the likely spread of untreatable gonorrhoea.

Andrew Witty, CEO of GSK, commented in 2012 that by the time a viable commercial model for new antibiotics existed, it would be too late to avert a serious pandemic. “The market has failed,” he concluded.

Antibiotic Action, a new UK-led initiative to encourage global investment in the development of new antibiotics, is working to establish an all-party Parliamentary Group that can address the issue.

Professor Laura Piddock, Director of Antibiotic Action, commented: “The GRASP Action Plan is a good example of why we need new drugs, and begs the question why they are not being developed for this infection. Government must act now to avert this and similar crises that threaten the health of our nation.”

The ‘empty’ antibiotic pipeline threatens a future of mass death from antibiotic-resistant infections, the UK Chief Medical Officer has said.

Professor Dame Sally Davies told a Parliamentary committee that the pharmaceutical industry has no solutions to the growing problem of antibiotic resistance.

Overuse of antibiotics, especially in the developing world, and the combined impact of sex tourism and medical tourism were globalising the most serious health threats, the committee heard.

Antibiotic resistance has been recognised as a problem in Europe for decades, with the power of the standard antibiotics to fight disease steadily waning.

However, the massive current use of antibiotics in countries such as India, where private drug supply is deregulated, has caused a proliferation of drug-resistant infections that are spreading through the developed world.

Professor Davies warned: “The apocalyptic scenario is that when I need a new hip in 20 years I’ll die from a routine infection because we’ve run out of antibiotics.”

Antibiotic-resistant strains of tuberculosis and gonorrhoea are spreading globally, she said. Meanwhile, the pharmaceutical industry is failing to develop new antibiotics because there is no urgent need for them – but when there is, it may be too late to prevent a lethal pandemic.

GSK’s CEO, Andrew Witty, made the same point last year and warned that “the market has failed” to address the danger. He called for global collaboration between health systems and industry.

“There is a broken market model for making new antibiotics, so it's an empty pipeline, so as they become resistant, these bugs... there will not be new antibiotics to come,” said Professor Davies.

Overuse of antibiotics for minor infections is leading to the prevalence of deadly ‘superbugs’, experts have warned.

According to the European Centre for Disease Prevention and Control (ECDPC), antibiotic-resistant bacterial infections kill 25,000 people in the EU each year.

Bacterial diseases that are becoming harder to treat include E. coli (pictured), K. pneumoniae and gonorrhoea.

Noting the lack of new antibiotics and the waning effect of existing ones, the ECDPC called for major investment in antibiotic R&D.

Speaking on the fifth European Antibiotic Awareness Day, NHS Chief Medical Officer Prof. Dame Sally Davies said: “Antibiotics are losing their effectiveness at a rate that is both alarming and irreversible – similar to global warming.

“I urge patients and prescribers to think about the drugs they are requesting and dispensing. The more you use an antibiotic, the more bacteria become resistant to it.”

The inappropriate prescribing of antibiotics for viral infections has been identified as a major cause of antibiotic resistance.

Overuse of antibiotics is a historic medical problem, and at present is a major issue in India’s health system.

New ECDC data shows a significant rise over the last four years of resistance to multiple antibiotics in K. pneumoniae and E. coli in the EU. These are normally harmless gut bacteria, but certain strands can cause lethal infections.

The last-line antibiotics, carbapenems, that are the only way to treat ‘superbug’ infections are used much more widely than five years ago, the ECDC noted – while carbapenem-resistant K. pneumoniae strains are common and increasing.

Robert-Jan Smits, Director General for Research & Innovation at the European Commission, said the rise in antibiotic resistance makes a “dedicated research effort” necessary.

Maxine Vaccine raises an eyebrow at the ABPI’s declaration that the ‘social contract’ between the pharma industry and the NHS has broken down. What do they think has been going on for the last few years?

Hi folks. Sorry I’ve been quiet on the blog front for a while. Bit of a busy time. Also, I’ve been struggling with a seasonal respiratory infection. Being mindful that overuse of antibiotics dilutes their long-term effectiveness, I left it a fortnight before dragging my shivering self to the local medical centre and asking for some.

My GP offered me a week’s worth of generic amoxicillin – the Special Brew of antibiotics, cheap but potent – but I held out for the more refined (and branded) huletthemycin from Munchkin Pharmaceuticals. Anticipating my argument that GPs should not be refusing NICE-approved medicines to patients on grounds of cost, my GP did a quick search and tilted the screen towards me so I could read the relevant NICE appraisal. To focus my reading, he had highlighted the phrase “worthless crap”. I told him they had meant to say it was “reassuringly expensive”. He made a kind of “harrumph” sound and dutifully applied his healing hands to the keyboard.

A week later, I was back at my desk in the comfy offices of Munchkin Pharmaceuticals, sipping coffee and reading the latest ABPI press release. Stephen Whitehead told the Association’s annual conference that the “social contract” between the pharma industry and the NHS, which has lasted for decades, has now “broken down”. Companies can no longer trust the NHS to buy gold standard medicines that they have spent blood, sweat and tears in developing. Austerity was not only damaging patients but damaging the industry, which had lost 16,000 jobs in the UK in four years.

If I weren’t at risk of another coughing fit, I would laugh out loud. I’m sorry, Stephen, but where have you been the last four years? We’re in the depths of the worst economic collapse since the 1930s. Companies everywhere are going down like ash forests hit by fungal blight. So many people are out of work that the Government is trying to find new ways of not paying them any benefit – as if that would make millions of new jobs appear. Does the ABPI expect a telegram from George Osborne saying “There, there”?

But when he talks about the “social contract” between the NHS and the pharma industry being broken, Whitehead is genuinely rocking the boat. Where was the ABPI when the social contract between the NHS and the people was being torn up? Standing in the gallery, applauding. Now it’s realised that breaking up the NHS and reshaping it as a competitive market takes away the structures that, for decades, gave pharma companies some stability and traction at a national level. Now, local prescribers and commissioners are free to seek the lowest bidder – and not free to do anything else.

The ABPI is learning that when you wave goodbye to the planned, Keynesian version of capitalism, you get what Ted Heath called its “unacceptable face”. In a deregulated, competitive healthcare market, there is no role for the ABPI, because there is no court of appeal for it to turn to and no shared ethos for it to refer to. The message for pharma companies, NHS organisations and patients is: You’re on your own.

But maybe the tide is turning. Whitehead’s speech reveals a nostalgia for the Darzi version of NHS reform: service redesign for long-term sustainability and effectiveness, as opposed to brutal cost-cutting with no element of service redesign. Jim Easton may have quit, but Mike Farrar is still making the case for a coherent and planned NHS that does things better. Perhaps the pharma industry is realising that you can’t have a social contract if, as Margaret Thatcher put it, there is no such thing as society. And it’s beginning to ask whether there could be a different approach.

Or maybe the antibiotics are making me dream.

Maxine’s views are not necessarily those of Pharmaceutical Field.

NICE has recommended the use of Novartis’ Tobi Podhaler tablets but failed to back Forest Laboratories UK’s Colobreathe tablets for treating cystic fibrosis patients with a pseudomonas lung infection.

The draft guidance recommends a nebulised version of Tobi Podhaler if it is considered appropriate when nebulised Colobreathe is contraindicated, not tolerated or has not produced adequate clinical response.

Tobi Podhaler tablets should also only be prescribed under the terms of an agreed patient access scheme between Novartis and the Department of Health.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said the Institute was “pleased to recommend” another treatment option for patients.

Cystic fibrosis is one of the UK’s most common life-threatening inherited diseases. It currently affects around 8,000 people – although more than two million people carry the faulty gene.

Sufferers are prone to lung infections by a range of pathogens. The aim of treatment is to clear the respiratory sections to maintain lung function whilst reducing inflammation and bacterial growth. Although there is no cure, treatment includes regular physiotherapy, antibiotics, and inhaled mucolytics through a nebuliser.

Tobi Podhaler is inhaled using a breath activated hand-held device which works by reducing the amount of bacteria in the lungs. NICE’s independent Appraisal Committee concluded the Podhaler was a cheaper and more effective option than a nebulised option.

However, the Committee said the economic analysis for Colobreathe was less effective and less costly than nebulised Tobi Podhaler. Additionally, analysis could not convey that Colobreathe is a cost-effective use of NHS resources.

The draft guidance is now open for consultation. NICE expects to publish final guidance in March 2013.

The NHS needs to prioritise the treatment of sick babies and administer antibiotics appropriately to reduce the risk of youngsters developing bacterial resistance, new NICE guidelines state.

The guidelines are part of a series of recommendations issued to the NHS to tackle early-onset neonatal bacterial infection in newborn babies.

Neonatal bacterial infection is a major cause of mortality and morbidity in newborns and causes the death of 1 in every 4 babies who develop it – despite antibiotics.

Professor Mark Baker, Director of the Centre for Clinical Practice at NICE, believes the new guideline “will be welcomed as a useful tool” for healthcare professionals.

Other recommendations included in the guidelines include:

• Using a framework based on risk factors and clinical indicators to identify and treat babies at risk
• Intrapartum antibiotic prophylaxis offered to women whose babies are at a higher risk of infection
• Babies suspected to be at risk should receive antibiotics within an hour of the decision to treat
• Benzylpenicillin and gentamicin should be used in combination as the first-choice antibiotic regimen
• A blood culture should be performed on babies before they are administered their first dose.

Mark Turner, Senior Lecturer and Consultant in Neonatology, University of Liverpool and Liverpool Women’s NHS Foundation Trust – who also chaired the guideline development group – said the NHS should prioritise treatment for sick babies and ensure the correct antibiotics are used “sensibly”.

Advanced physiotherapists and podiatrists are set to become prescribers by 2014.

New legislation will enable these clinic-based practitioners to prescribe drugs such as painkillers, asthma inhalers, steroid creams and antibiotics.

The relevant professional associations have welcomed the changes, which will significantly bridge the gap between primary and outpatient care.

Physiotherapists and podiatrists in the UK will be the first worldwide to prescribe medicines for their patients.

People with neuromuscular and foot disorders are often shuttled back and forth between specialist practitioners and GPs.

The new arrangements promise to simplify patient pathways and accelerate treatment of conditions such as chronic pain, asthma, arthritis and diabetic ulcers.

“Physiotherapists and podiatrists play a vital role in ensuring patients receive integrated care that helps them recover after treatment or manage a long-term condition,” said Health Minister Lord Howe.

“By introducing these changes, we aim to make the best use of their skills and allow patients to benefit from a faster and more effective service.”

Dr Helena Johnson, chair of the Chartered Society of Physiotherapy, commented that being able to prescribe would “hugely improve” the care therapists could provide, giving patients “a more streamlined and efficient service”.

The College of Podiatry said the changes would particularly benefit patients with foot wounds, infections and diabetic ulcers, for whom rapid access to medication can prevent hospital admissions.

The changes are expected to become law in April 2013, and physiotherapists and podiatrists will be able to become prescribers by 2014.

The spread of drug-resistant strains of gonorrhoea led to a 25% rise in newly diagnosed cases of the disease in England in 2011.

With some European patients showing full resistance to first-line treatments, the Health Protection Agency has warned that gonorrhea may become “a very difficult infection to treat”.

The growing medical crisis highlights the need for new and more specific antibiotics that was noted by GSK’s Andrew Witty in March.

Gonorrhoea is a bacterial infection that can lead to infertility if not effectively treated with antibiotics.

Professor Cathy Ison, a gonorrhoea expert at the HPA, said that drug resistance had been dealt with in the past by the use of a new drug – but now there isn’t one.

Dr Gwenda Hughes, Head of Sexually Transmitted Infection Surveillance at the HPA, warned: “We are worried that in the next five years, or some point in the future, that this is going to be a very difficult infection to treat.”

Sexual health will shortly become the responsibility of local authorities rather than the NHS, though medication will remain essential to the treatment of sexually transmitted infections.

Treatment with antibiotics is a safe and effective alternative to surgery for acute appendicitis, according to a new study published in the BMJ.

A meta-analysis of four clinical trials showed that antibiotic therapy achieved a 63% success rate while reducing complications by 31% relative to surgery.

The study concluded that antibiotics should be considered as a first-line therapy for uncomplicated appendicitis.

In cases where appendicitis has led to peritonitis or perforation, surgery remains essential, the researchers said.

Removal of the inflamed appendix has been the standard treatment for acute appendicitis since 1889 – but the study argued that this is based “mainly on tradition rather than evidence”.

The study, by researchers at the Nottingham Digestive Diseases Centre NIHR Biomedical Research Unit, compared the safety and efficacy of antibiotic therapy with surgery as a first-line treatment for uncomplicated acute appendicitis.

It analysed the results of four randomised controlled trials covering 900 adult patients diagnosed with uncomplicated acute appendicitis, of whom 470 received antibiotics and 430 underwent surgery.

Treatment with antibiotics was associated with a 63% success rate at one year, and offered a 31% reduction in risk of complications compared to surgery.

There were no significant differences in length of hospital stay or risk of developing complicated appendicitis between the two patient groups.

The researchers suggested that a ‘wait, watch and treat’ policy could be adopted in patients who appear to have uncomplicated appendicitis, since the benefits of using only antibiotic therapy outweigh the risks.

Antibiotic therapy is “a safe initial therapy for patients with uncomplicated acute appendicitis” and “merits consideration as a primary treatment option for early uncomplicated appendicitis,” they concluded.

However, early surgery would remain the standard treatment for patients with clear signs of perforation or peritonitis.