CHPA meeting 2009

Presented at the CHPA Scientific and Regulatory Conference in Washington DC last week.

Rx to OTC switching.

Nice people, well organised. A pleasure!

Naproxen switches for dysmenorrhoea

The Royal Pharmaceutical Society has welcomed the announcement of the POM to P switch of Naproxen 250mg from Bayer Healthcare.

The product, with the brand name Feminax Ultra, is used in the treatment of primary dysmenorrhoea.

The Society’s Lead Pharmacist for self care, Sadia Khan, says: “The Society welcomes the reclassification and believes that this switch will provide women with more choice, convenience and better access to relief from period pains. It also enables pharmacist to use their skills and expertise in medicines.”

Cystobid POM to P consultation - nitrofurantoin

ARM 51

Xenical may switch back to POM in Oz

Roche’s weight-loss medicine Xenical (orlistat) could soon lose OTC status in Australia, just two years after its groundbreaking switch from prescription-only status.

The country’s National Drugs and Poisons Schedule Committee (NDPSC) will review orlistat’s status as a Schedule 3 or pharmacist-only medicine at its next meeting on 20-22 February, following a request from the committee’s chairperson.

Media coverage of an advertisement for Xenical during the television programme Australian Idol had prompted the NDPSC to discuss the weight-loss medicine at its previous meeting in October 2006.

Both orlistat’s inclusion in Appendix H, permitting the medicine to be advertised directly to consumers, and its scheduling as a pharmacist-only medicine were discussed during the October meeting.

The Big Five O

Still feel (and sometimes behave) like a kid!

Curanail - antifungal nail paint moves from POM to P

Amorolfine 5 per cent nail lacquer has this week been launched as a pharmacy medicine. Marketed as Curanail by Galderma, the product becomes the first once-weekly over-the-counter treatment for fungal nail infection (onychomycosis).

Customers who come into the pharmacy with onychomycosis can now be reviewed and treated by a pharmacist. The pharmacy medicine is indicated for use by patients over 18 years with mild cases of distal and lateral subungual onychomycosis affecting up to two nails. Patients with more severe disease and the involvement of more than two nails should be referred to their GP.

Children, women who are pregnant or breastfeeding and patients with certain underlying conditions also need to be referred.The lacquer is applied to the affected nails once a week until the fungal areas have cleared and the healthy nail has regenerated — a process that can take around six months for fingernails and nine to 12 months for toenails.

Kamal Abbasi, marketing manager at Galderma, told The Journal that there was mostly a positive response to the switch during the Medicines and Healthcare products Regulatory Agency consultation.

He said that the main concern raised was about how pharmacists could ensure an accurate diagnosis of infection. “The questions were primarily focused on diagnosis and training … but there is the full support of dermatologists and podiatrists,” he added.

Christie Wicks, Galderma’s training and development manager, said: “In the past, patients have needed to take the time to go to a GP, but won’t, either because of embarrassment or because they didn’t think it was serious enough to warrant the time of a GP appointment.”

According to Galderma, Curanail has the advantage of once-weekly application through its formulation, which, when applied and the lacquer has dried, leaves a 25 per cent-strength, non-water soluble film on the nail surface for one week. “There are no known drug interactions and because it is topically applied … there is minimal systemic absorption and the potential for side effects is decreased,” said Ms Wicks.

The Royal Pharmaceutical Society has published practice guidance (PDF 90K) to assist pharmacists in selling the product.

Sadia Khan, the Society’s lead pharmacist for self care, commented: “Making amorolfine nail lacquer available without a prescription is a safe, effective and convenient route to treatment for customers presenting with mild cases of suspected fungal nail infection.”

A pharmacist training pack has also been produced by the company and accredited by the College of Pharmacy Practice.

Training packs are being sent out to all pharmacies in the coming weeks, ahead of the product hitting pharmacy shelves.

Recommended retail price, 3ml: £18.61

John was delighted to be part of the team that facillitated this switch and wishes Galderma all the best with Curanail.

Imigran Recovery - the first UK OTC triptan

A migraine drug is to be made available over-the-counter in the UK for the first time, the medicines watchdog has announced.

The Medicines and Healthcare products Regulatory Agency said Imigran Recovery (sumatriptan) can be safely sold for the relief of acute migraine attacks.

It is a type of drug called triptans, the first to treat the causes of migraine rather than the symptoms.

The drug will be available in chemists throughout the UK from mid-June.

"It gives patients more flexibility in how they want to manage their migraines" says Ann Turner of The Migraine Association.

Migraine affects up to 15% of the UK population, and around two thirds of sufferers are women. An attack can last from 4 hours to 72 hours.

There are a range of triggers, including emotional or physical stress, foods - such as coffee or cheese and hormones.

Up to 60% of people affected rely on over-the-counter medicines to cope with their symptoms.
However, the drugs currently available can only relieve symptoms, rather than treating the cause of migraine.

The MHRA said that being able to buy the drug in a pharmacy would allow patients to manage their own symptoms without having to spend time visiting their doctor.

Pharmacists will have to abide by a strict protocol when selling the medication to ensure it is safe and effective.

The drugs will be sold in packs of two, costing £7.99.

Professor Kent Woods, chief executive of the MHRA, said: "The ability to buy these medicines in a pharmacy under carefully controlled conditions will enable patients to get treatment straight away and will reduce the burden of migraine.

"As triptans should be taken as early as possible in a migraine attack, the pharmacy availability of these important medicines will be beneficial to patients who suffer from migraines, especially those who have infrequent attacks and may not always have prescription medicines to hand."

Professor Gordon Duff, chairman of the Commission on Human Medicines (CHM), said, "The first consideration with any switch to over-the-counter availability must always be patient safety.

He added: "Before a medicine can be made more widely available, it is assessed against strict criteria relating to its safety in the circumstances in which it will be used.

"Sumatriptan has been available in the UK since 1991 on prescription and the safety profile is well established."

Ann Turner, director of the Migraine Association, welcomed the MHRA's decision.

"It gives patients more flexibility in how they want to manage their migraines.

"This class of drugs really did change people's lives when it was introduced.

"It was the first class to really address the cause of migraine and not just treat the symptoms."

Hemant Patel, President of the Royal Pharmaceutical Society of Great Britain, said: "Acute migraines are a serious health issue for those who suffer from them and treatment at the first sign of an attack can help speed up recovery time."

He said the move would allow pharmacists to play a greater role in helping people with an established pattern of migraine manage their condition.

John has worked on the OTC switching of another triptan and was involved in the early discussions with GSK on Imigran moving from POM to P status.

He wishes GSK all the best with Imigran Recovery.

DUPHAT 2006 - Dubai

Alison and I are back from this conference.

It was fantastic! The energy level was amazing.....especially from the pharmacy students attending the meeting.

A big thank you to the organisers for inviting us both to speak and visit Dubai for the first (but hopefully not the last) time.