Blenkinsopp Pharma Consultancy

CHPA meeting 2009

2009-05-11T11:19:00.002+01:00

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

2008-04-16T12:33:00.003+01:00

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

2008-03-11T15:34:00.003Z

ARM 51

Xenical may switch back to POM in Oz

2007-01-20T16:15:00.000Z

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

2006-07-04T11:21:00.000+01:00

Still feel (and sometimes behave) like a kid!

Curanail - antifungal nail paint moves from POM to P

2006-05-20T11:59:00.000+01:00

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

2006-05-20T11:49:00.000+01:00

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

2006-03-20T16:41:00.000Z

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.

LUTO Research Ltd - User testing experts

2006-02-16T15:13:00.000Z

Formed in August 2004, LUTO Research Limited is a pharmaceutical consultancy specialising in the enhancing, editing and user testing of patient information for pharmaceutical, generic and OTC companies.

Crucially, user testing is the gold standard for performance-based testing of medicine information leaflets, an area where Prof Raynor and fellow co-founders Dr Peter Knapp and Mark Gibson have in excess of 20 years of experience.

Luto's fundamental business proposition is to provide a user testing service by which the company designs and tests Patient Information Leaflets (PILs) on behalf of pharmaceutical clients with the aim of ensuring that they are appropriate for use by end user patient groups.

Importantly, improving patients' understanding of their medicines is now being addressed by Council Directive 2004/27/EC, which originated from the Review of Medicines Legislation (Review 2001).

The directive makes it mandatory that the results of user testing be documented and submitted with other mandatory regulatory information necessary for the licensing of a drug (effective from July 1st 2005). The market value for user testing projects specifically for the pharmaceutical industry (branded and generic manufacturers) has a baseline total market value in the UK of 10's of £million with good levels of associated recurring annual revenues.

Luto's management team is highly committed to developing the business and is led by co-founder Professor Theo Raynor (Executive Chairman). Theo is a highly experienced health services researcher with a background in pharmacy. He is Professor of Pharmacy Practice at the University of Leeds, having previously been employed in hospital pharmacy practice. His strong track record of research into consumer medicines information is complemented by a focus on linking research with practice.

The two other co-founders are Dr Peter Knapp (Scientific Director) who has worked for the past 6 years in research on pharmacy and consumer medicines information at Leeds and Mr Mark Gibson (Operations Director) who specialises in qualitative research in social and health sciences.

The team is further strengthened by Dr John Blenkinsopp who joins Luto as a non-exec director and brings specialised pharmaceutical consultancy experience and contacts.

For more information visit www.luto.co.uk

Naproxen remains OTC in Germany

2006-01-19T14:05:00.000Z

Oral medicines containing naproxen should remain available without a prescription in Germany, the country’s Expert Committee for Prescription recommended at a meeting on 17 January.
The committee rejected a move by Germany’s federal institute for drugs and medical devices, BfArM, to reverse switch the non-steroidal anti-inflammatory drug (NSAID) from non-prescription to prescription-only status.

Germany’s medicines manufacturers’ association, the BAH, said it “welcomed greatly” the expert committee’s recommendation, which will now be passed on to the country’s health ministers.

Speaking to OTCbulletin shortly before the expert committee met, a BfArM spokesperson said the agency’s reverse-switch proposal had not been triggered by individual adverse-reaction reports, but by international studies comparing NSAIDs – and naproxen in particular – with cox-2 inhibitors. These studies had used naproxen as the control drug because it had the poorest safety profile of all NSAIDs in relation to gastrointestinal complaints, commented the spokesperson.

According to the umbrella organisation, the US National Institutes of Health, data from the US National Institute on Aging’s Alzheimer’s Disease Anti-Inflammatory Prevention Trial (ADAPT) “indicated an apparent increase in cardiovascular and cerebrovascular events among the participants taking naproxen when compared with those on placebo”.

The US Food and Drug Administration (FDA) advised people taking OTC naproxen to stick to the recommended dose and duration of use, and asked manufacturers to include more specific information about cardiovascular and gastrointestinal risks in their product labels.

Nevertheless, the BfArM spokesperson insisted that the evidence that had emerged since Germany’s expert committee recommended naproxen for OTC use in 2001 justified returning the NSAID to prescription-only status. However, the expert committee disagreed and maintained the status quo.

Fenistil Cold Sore Cream up for POM to P switch

2006-01-19T12:59:00.000Z

The MHRA consultation docs are here:

Fenistil

FDA reform labelling

2006-01-19T12:28:00.000Z

NEW YORK - Responding to years of criticism that the labels of prescription drugs do not do enough to impact the way doctors and patients use medicines, the U.S. Food and Drug Administration is announcing a plan to put much clearer and more concise prescribing information on the package inserts for new drugs.

According to the FDA, 300,000 people are injured in some way because of drug side effects each year--a flaw the agency blames partly on confusing medical information.

In a prepared statement, FDA Acting Commissioner Andrew C. von Eschenbach, M.D., said, "The new label design makes it easier for doctor to get access to important information and benefits, and this in turn will help them have more meaningful discussions with their patients."

http://www.forbes.com/sciencesandmedicine/2006/01/18/fda-drug-labeling-cx_mh_0118fda.html?partner=rss

Blogging - why?

2006-01-19T12:05:00.000Z

This might help to explain:

https://extranet.edelman.com/bloggerstudy/Default.aspx

'Nuf said

2006-01-02T11:39:00.000Z

Information Design for Patient Safety

2005-11-28T10:52:00.000Z

http://www.hhrc.rca.ac.uk/resources/publications/IDPS.pdf

Linguistics

2005-11-11T12:22:00.000Z

Noticed a new document on the EMEA website, dated 20 October 2005: "The new linguistic process of product information in the centralised procedure" http://www.emea.eu.int/pdfs/human/regaffair/554202en.pdf

The document also helpfully includes a full page of URLs for "Useful reference documents".

EU/EFPIA guidelines on User Testing

2005-10-21T09:13:00.000+01:00

http://www.efpia.org/6_publ/RecommendationPLtest.pdf

Pharmafocus on POM to P switching

2005-10-12T15:03:00.000+01:00

John was interviewed for this article in Pharmafocus. Its quite long, but worth reading!

http://www.pharmafocus.com/cda/focusH/1,2109,22-0-0-0-focus_feature_detail-0-385550,00.html

At last! FDA labeling update.

2005-10-06T14:32:00.000+01:00

New rules detailing an improved format for prescription drug labels will be issued later this year, US Food and Drug Administration deputy commissioner for medical and scientific affairs Scott Gottlieb has said.

“Right now, too much important medical information is poorly accessible today or not accessible at all because we have failed to adapt for healthcare simple IT innovations that have long permeated the workplace,” he said in a presentation at the National Press Club in Washington DC.

Beginning in November 2005, healthcare professionals, patients, and other consumers will be able to access high-quality, up-to-date information on medications via the Internet free of charge through the Daily Med system, which will receive, distribute and display medication information that has been developed by Federal agencies.

http://www.in-pharmatechnologist.com/news/ng.asp?id=63044

The two of us

2005-10-05T15:20:00.000+01:00

Here we are at a recent function at Harewood Hall, near Leeds. A memorable evening!

OTC Triptans

2005-09-29T20:24:00.000+01:00

This brief editorial on the proposed POM 2 P switch of triptans is from The Lancet Neurology

Interview in Pharmacy Magazine

2005-09-28T19:34:00.000+01:00

John was recently interviewed by Pharmacy Magazine for an article on switching medicines from POM 2 P.

Click on the picture enlarge it.

Canada considering medicines deregulation

2005-09-27T18:08:00.000+01:00

In a thoughtful essay Lynd et al, from Vancouver, present some interesting points.

Governments in several countries, including the UK, and in a few provinces in Canada are considering reclassifying some drugs from prescription to over-the-counter status. In a CMAJ essay, Lynd and colleagues comment on the economic effects of such changes.

The drugs being considered are used in a wide variety of chronic diseases. They include proton pump inhibitors, beta-blockers, diuretics, calcium channel blockers, angiotensin-converting enzyme inhibitors, HMG CoA reductase inhibitors, inhaled corticosteroids, short and long-acting B2 agonists, bisphosphonates and oral contraceptives.

In the UK, 100 drugs are on the RPSGBs' list for conversion to over-the-counter status. In Ontario, 8 of these drugs account for $540 million (27%) of the Ontario Drug Benefit Plan budget. In BC, 49 of these drugs account for $266 million (44%) of total Pharmacare drug expenditures.

If the medicines were deregulated to behind-the-counter status (No Public Access), pharmacists would not just dispense medications, they would have a clinical and consultative role. Visits to physicians for routine control of chronic diseases might also decline.

http://www.cmaj.ca/misc/press/pg775.pdf

For those interested in the UK situation see this article, from last year (when I was at Bradford University). Since then a number of POM to P switches have "gone public", including: simvastatin tablets and chloramphenicol eye drops.

In the MHRAs' approval pipline are: trimethoprim tablets, triptans, topical steroids and topical treatment for fungal nail infections.

http://www.pjonline.com/pdf/agenda/pj_20040424_pomtop.pdf

See also this important BMA report on OTC medications (co-written by Alison).

http://www.bma.org.uk/ap.nsf/content/OTCmedication/$file/OTC.pdf

Welcome to Our Weblog

2005-09-27T10:37:00.000+01:00

Alison and I plan to update our blog with information that we hope you will find interesting and helpful. We welcome your feedback.

For more information on Blenkinsopp Pharma Consultancy please visit the website: http://www.blenkinsopp.co.uk

The BPC website also has a regular news feed for both medical and pharma personnel.