Analysis: Where have all the drugs gone?
As supply problems at pharmacies cause major headaches for GPs, Caroline Price examines the root causes of the problem
It may seem hard to believe that drug shortages are possible in Britain in the 21st century. But not only are they happening, they are understood to be getting worse.
Some GPs say they are now spending up to an hour a day dealing with prescription problems related to shortages of drugs or particular preparations at pharmacies.
In many cases, the first warning GPs get that a drug is not in stock is when a patient reports they have been to multiple pharmacies, but have been unable to have their prescription dispensed.
GP leaders say the situation is unacceptable and has deteriorated over the past year, with supply problems increasingly affecting more commonly prescribed drugs and for longer periods.
Dr Andrew Green, chair of the GPC’s clinical and prescribing subcommittee and a GP in Hedon, East Yorkshire, says the problem is having a ‘significant’ impact and is occurring more frequently.
‘This has been going on for several years, but seems to have been getting worse,’ he says.
‘We receive regular [complaints] from GPs who are finding that they are having to deal with these problems on a daily basis. One GP emailed only yesterday to say that in a single day she had dealt with non-availability of four drugs – naproxen, minoxidil, madopar and valsartan.’
Dr Jim Kennedy, medical director of Berkshire, Buckinghamshire and Oxfordshire LMCs and a GP in Wargrave, Berkshire, says the shortages are the worst he has experienced in 20 years. He estimates GPs at his practice are now spending between 30 minutes and an hour every day sorting out prescriptions that have been sent back because of supply issues.
‘In the past year in particular it’s increased very significantly. There are more drugs affected and they’re affected for longer, and there’s less understanding of how long they’re going to be affected for,’ he says.
‘The opportunity costs of this are enormous. With the number of appointments used to sort out these drugs, I suspect the costs to the NHS overall are well into the tens of millions.’
Supply chain problems
A 2012 report into drugs shortages by MPs on the All-Party Pharmacy Group (APPG) found drug shortages were only affecting around 30 to 40 products at any given time, out of a total of around 16,000 licensed preparations of medicines in the UK.
At the time of writing, the Pharmaceutical Services Negotiating Committee lists 22 drugs as being in ‘short supply’, including a number of commonly used generics such as naproxen, co-amoxiclav and propranolol.
Pulse has also learned that NHS England has recently taken the unusual step of issuing a warning over ‘intermittent shortages’ of the angiotensin-receptor blocker valsartan, saying it is monitoring the situation ‘closely’ and is working with suppliers to ensure the situation is resolved.
Dr Green says: ‘Even superficially simple changes like prescribing two 250mg tablets instead of one 500mg tablet, or altering the formulation, can lead to patients not taking their medications properly, with a risk of under- or overdosing.
‘Sometimes, as with valsartan, the only option is to change to a different drug within the same group, but this exposes the patient to possible side-effects or loss of disease control.’
The APPG report identified a number of problems in the NHS medicines supply chain that it said had contributed to the shortages.
The MPs said successive cuts in the NHS price of branded medicines and the favourable exchange rate between the pound and the euro since 2008 meant drugs were now much cheaper in the UK, compared with other EU countries. This has led to the ‘parallel exporting’ of drugs – whereby drug suppliers and pharmacists with a licence are allowed by EU rules to sell drugs abroad that were originally intended for UK patients. Although the main wholesalers are not involved in this practice, which is entirely legal, some ‘speculators’ have been using it to make money, the report claimed.
Why does the UK have drug shortages?
• Free movement of goods across borders allows ‘parallel exporting’, and some drugs are being sold abroad by ‘speculators’ to boost profits, resulting in shortages at home.
• Some manufacturers have cut out wholesalers and are dealing with pharmacies directly, giving them more leeway to control the distribution of their medicines.
• Quotas on drugs have been introduced, but these often run out leaving pharmacies to resort to emergency supplies, resulting in more paperwork and delays.
Source: All-Party Pharmacy Group report on medicines shortages, May 2012
It also said quotas for medicines were failing to solve the problem, with pharmacists regularly having to rely on emergency supplies from manufacturers, leading to delays and difficulties for patients.
The APPG recommended that the Government curb parallel exporting, tighten up monitoring of the supply chain and enforce supply guidance more rigorously.
However, Oliver Colvile, MP for Plymouth Sutton and Devonport and vice-chair of the APPG, says nearly two years on there is little evidence that the Government has taken those recommendations seriously.
Read which medicines are currently in short supply – according to Pharmaceutical Negotiating Services Committee
‘The Government needs to revisit this area, and I’ll be raising medicines shortages personally with Jeremy Hunt when we next speak.’
A DH spokesperson told Pulse: ‘The vast majority of the two million prescription items dispensed in England every day are provided without problem.
‘We work closely with NHS England, the supply chain and the Medicines and Healthcare products Regulatory Agency to make sure patients get the medicines they need.’
But critics say the DH also needs to start looking at the wider impact of its drug pricing policies, such as the constant squeeze on the reimbursement price paid to pharmacies for commonly used generic drugs placed on the ‘category M’ list.
This year, the DH plans to cut the reimbursement price paid to pharmacies for 471 out of 534 category M drugs, but it can take time for pharmacies to put pressure on wholesalers to respond to a price reduction. Fin Mc Caul, chair of the Independent Pharmacy Federation, says continual reductions in the price of these drugs are causing problems for pharmacies trying to source adequate supplies at a price they can afford.
He says: ‘It isn’t about getting cheap products anymore but getting a sustainable market for patients to be confident they can access the medicines they need.’
‘If you can do that for bread rolls you can surely do it for drugs.’
Dr Mark Robinson, pharmacy lead at the NHS Alliance, places the blame firmly on Whitehall.
He says: ‘We urgently need robust monitoring arrangements for shortages and quotas to measure the additional costs and workload and the impact on patients.
‘The ridiculous thing is the Government is ignoring this, causing community pharmacy a lot of extra work and putting patients at risk.’
Meanwhile on the frontline of the drugs shortage in Berkshire, Dr Kennedy is adamant the Government must use its power much more effectively.
He says: ‘If this was Waitrose or Sainsbury’s with a contract for, say, bread rolls, you would want to be sure that the organisation can continue putting bread rolls on the shelves on Christmas Eve, New Year’s Eve or when there’s a bright spell and people want to have barbecues. You want to make sure you’ve got adequate supplies.
‘If you can do that for bread rolls you can surely do it for drugs.’
Dealing with medicine supply problems
1 The onus is on the pharmacy to supply an alternative. Only as a last resort should you be asked to recommend the nearest alternative.
2 If this does happen, ‘acute’ prescriptions are rarely problematic but for a long-term prescription, such as valsartan, an alternative in the same class should usually be prescribed.
3 If the medication changed is for hypertension, blood pressure should be checked after a few weeks. For ARBs and ACE inhibitors urea and electrolytes will also need checking.
4 If large numbers of patients are affected the practice may need to arrange a substitution process and either see patients and/or provide patient information, for example a letter alongside prescriptions.
5 The CCG or health board should take the initiative on issuing guidance. The GP should not have to ‘go it alone’ and a collective decision should be made for the practice and the area.
Dr Martin Duerden is the RCGP’s clinical adviser on prescribing