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Which OTC painkiller in a post-codeine world?

 

From February 1st next year, all codeine-based pain relief medications will become prescription-only. GPs may get a surge of patients asking for codeine prescriptions, but they will probably also get people asking them for good over-the-counter alternatives to the opioid. So what should they be telling their patients?

According to NPS MedicineWise, the best alternative for the short-term management of acute pain may be an paracetamol/ibuprofen combination pill, of which there are several OTC formulations on the Australian market.

NPS MedicineWise says the best treatment for mild pain is still paracetamol only or non-pharmacological measures, such as ice packs. But when that doesn’t do the trick, paracetamol/ibuprofen may prove more effective, as long as the patient is able to take an NSAID.

Evidence from a number of studies show that for acute pain, the combination is better for analgesia than either drug on its own, although it is not indicated for chronic pain. Paracetamol/ibuprofen has been found to be effective for a variety of pain states, including postoperative pain, dysmenorrhoea and musculoskeletal pain.

A Cochrane review has looked at the combination’s efficacy after wisdom tooth removal and found it better than either paracetamol or ibuprofen on its own for relieving pain six hours after the intervention.

Short-term studies have not identified any safety concerns for the combination other than those already known for the individual components, although one study found an increase in bleeding over 13 weeks, suggesting caution with long-term use.

Paracetamol is relatively safe, although inadvertent overdose is possible, but more precautions are needed with the use of ibuprofen. Lower doses are recommended for older people, and those with kidney disease, a history of peptic ulcers, asthma, high blood pressure or in pregnancy.

Another possible OTC alternative to codeine is diclofenac potassium, which has been shown to be effective in a variety of pain states, including acute lower back pain, tension-type headache, musculoskeletal pain, dysmenorrhoea and dental pain.

For chronic pain, analgesic medicines are only mildly effective and their use is recommended only as an adjunct (paracetamol) to non-pharmacological strategies, or in small doses for a short time (NSAIDs).

Source: NPS MedicineWise

Tensions reach boiling point over codeine changes

 

The row between the Pharmacy Guild and the medical community over the coming upscheduling of codeine products has well and truly boiled over this week, with the Guild accusing doctor groups of “hurling abuse and playing political games”.

Over-the-counter codeine products will become prescription-only as of February next year, in a move by the Therapeutic Goods Administration that has received the support of all main medical associations, including the AMA, RACGP, RACP and Pain Australia.

In its decision, the TGA cited the issue of opioid misuse and addiction as well as the poor additional pain relief offered by codeine compared with other common over-the-counter painkillers.

Over 6 million codeine-containing products, such as Panadeine and Nurofen Plus, are sold every year by pharmacists, who stand to lose up to $120 million in sales once these painkillers are upscheduled.

But the Guild has lobbied hard for a softening of the upscheduling decision. It wants pharmacists to continue to be able to continue supplying over-the-counter codeine products for the temporary treatment of acute pain, with a mandatory requirement for real-time monitoring to identify non-legitimate misuse.

Their argument is that upscheduling of codeine will merely overburden GP surgeries and ER departments, and that in rural and regional areas people will find it hard to see a doctor to get their medication.

The Guild’s intense lobbying efforts appear to be paying off. This month, health ministers from all state and territories, with the exception of South Australia, wrote to federal Health Minister Greg Hunt to express their concern about the new rules.

“Some people managing chronic conditions with codeine medications will deteriorate as they abandon medication due to the out-of-pocket expenses associated with accessing GPs for their prescription,” they wrote.

AMA President Michael Gannon hit back at the “irresponsible and unprincipled lobbying of state and territory governments”, while RACGP President Dr Bastian Seidel pointed to the $340,000 the Guild has donated to the major political parties in the past two years alone.

“They are trying to introduce policy by chequebook by donating large amounts to state and federal parties to gain open access to decision makers,” he said.

But on Wednesday the Guild said it rejected “the outrageous and baseless claim that it is putting the commercial interests of pharmacies ahead of patients in relations to the upscheduling of codeine”.

It said its arguments had been motivated solely by “the need to maintain convenient access for patients who use these products legitimately, and the safeguard of real-time monitoring for at-risk patients with addiction issues”.

It said that “rather than throwing mud”, doctor groups should be taking responsibility for the “very real patient issues that doctors will need to manage” once codeine is upscheduled.

It questioned how overstretched doctors will manage the increase in demand in areas where patients already have to wait long periods before seeing their GP.

At the same time the presidents of five high-profile medical and health consumer associations, including the RACGP and Pain Australia, have written an open letter to all state and territory health ministers, warning that any changes to the TGA’s plan to upschedule codeine will put health and lives at risk.

“The Guild’s proposed alternative model carries a serious risk of increased harms and potentially preventable deaths and cannot be supported by the medical community and consumer advocates,” the letter says.

It also notes the “serious and far-reaching implications” of any state or territory creating exemptions, as it would be “tantamount to walking away from nationally consistent regulation of medicines in this country”.

The European Union, Japan and Canada all require a prescription for codeine-containing products.

Neuropathic pain drug no good for sciatica

The increasingly popular painkiller pregabalin (Lyrica) is no better than placebo for sciatica, say Australian researchers.

Their study of 209 patients randomised to pregabalin or placebo over eight weeks showed that not only was the drug ineffective for pain, it also caused almost twice as many adverse events.

Senior author Associate Professor Christine Lin from Sydney’s George Institute says there’s been an exponential rise in the amount of pregabalin scripts written for sciatica since its PBS listing in 2013, but that until now there’s been no solid evidence that the drug actually works.

“Our results have shown pregabalin treatment did not relieve pain, but did cause side effects such as dizziness.”

She says that ironically, most people in both groups reported satisfaction with their treatment. Indeed, over the course of the trial levels of pain did lessen, but the decreases were the same in both arms.

“It seems people associate a drop in pain being due to taking a capsule, rather than something that would happen entirely naturally over time.”

Dr Lin says there are currently no drugs proven to work for sciatica, and even epidural injections only provide a small benefit in the short term.

“What we do know is that most people with sciatica recover over time. It’s also important to avoid bed rest and to stay as active as possible.”

Related: Misusing opioids for chronic pain

However, pregabalin’s maker Pfizer has pushed back against the study’s findings.

A Pfizer spokesperson told trade publication Pharma In Focus that less than a third of study participants had the characteristics of neuropathic pain.

The spokesperson added that the vast majority of patients were being treated for acute rather than chronic sciatica, even though the acute form generally clears without the need for treatment.

The study findings comes amidst alarm at the high rate of pregabalin prescribing in Australia, a large proportion of which is likely to be off-label.

Last year, a Pharmaceutical Advisory Board report found that around half a million people were given the drug between March 2014 and February 2015, considerably more than had been predicted.

Nearly half of patients discontinued pregabalin after just one prescription, suggesting that the drug was being prescribed for acute rather than chronic neuropathic pain as indicated.

Around 45% of patients started pregabalin without being on a prior drug regimen, although the drug is not indicated as a first line treatment.

You can read the study abstract here.