Esomeprazole, Ibuprofen OTC Changes Take Effect In Canada

In February this year, Health Canada announced its intention to make two changes to the Prescription Drug List (PDL). Specifically, it was proposed that the PDL be amended to allow an OTC version of esomeprazole for heartburn and to make technical changes that would permit modified-release ibuprofen products available for self-care.

While this announcement was not a surprise as the six-month period for comment elapsed on 5th August, the delay in making the change effective (18th August) was more likely owing to administrative matters than anything therapeutic in nature. The two changes to the federal list are as follows:

  • Esomeprazole or its salts except when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg
  • Ibuprofen or its salts except:
    1. An oral dosage form that provides 400mg or less per dosage unit; or
    2. A modified-release oral dosage form that provides 600mg or less per dosage unit

While the Federal decision had no further restrictions attached, the provincial scheduling of these products do take on some further limitations as decided by the National Association of Pharmacy Regulatory Authorities (NAPRA).

Now that the federal switches are finalised, the interim decision made by NAPRA becomes effective. Specifically, the provincial decision on these two items were:

  • Ibuprofen or its salts, when sold in a modified-release oral dosage form that provides 600mg or less per dosage unit would be placed into Schedule III (sold only where a pharmacist is present)
  • Esomeprazole or its salts, when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg, in package sizes of no more than esomeprazole 280mg would be assigned to Schedule II (available only from a pharmacist directly)
  • Esomeprazole or its salts, EXCEPT when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg in package sizes of no more than esomeprazole 280mg will not be switched provincially (it will remain in Schedule I – Rx only)

The ibuprofen decision was notable since the regular dosage form is available as an unscheduled item (available through any outlet when sold in package sizes of up to 18,000mg) while the modified release product is restricted. The esomeprazole decision matched the decision made for omeprazole in 2014.

Changing pharmacy for changing Germany

Germany is ageing, and fast – the UN puts the current average age at 46, second only to Japan, with the number of people over 60 set to reach 39% of the population by 2050. As younger Germans increasingly leave for the big cities, many small countryside towns are becoming depopulated, making it both hard for independent pharmacies to stay open and then to find replacements for them.

The small German town of Hüffenhardt – population 2,000 – is one such case, but luckily DocMorris has come up with an innovative solution to the problem – the telepharmacy, set to be opened as a pilot project in summer 2016. In the space of the old pharmacy, Hüffenhardt residents will be able to access a video screen linking them with a live pharmacist, with whom they can hold individual private discussions on health complaints, receive advice and product recommendations. At the end of the consultation, consumers can then choose to buy an OTC, or to hand in a GP prescription for checking, with the medicines then dispensed via a terminal controlled by the pharmacist. OTCs and Rx products which are not immediately needed can be delivered via DocMorris’ standard mail order service, or picked up at the neighbouring town at the next visit.

Hüffenhardt mayor Walter Neff commented: “The closure of our pharmacy affected our elderly and less mobile residents, who had to walk several kilometres to the next town to pick up medicines. Thanks to digital advances, Hüffenhardt residents can get personal face-to-face advice and pick up the most important medicines directly in the town”.

A longer version of this article will appear in the March 2016 issue of Nicholas Hall’s OTC INSIGHT Europe, a monthly publication reporting on OTC trends & developments throughout the region. For details on how to subscribe, contact melissa.lee@NicholasHall.com.

 

OTCs in Action Episode 54: Japan’s First Food for Cognitive Function

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This week OTCs are in Action in Japan, where Otsuka has introduced Nature Made Ginkgo Biloba, Japan’s first Food with Function Claim for cognitive function. Research has shown that flavonoid glycosides and terpene lactones extracted from ginkgo biloba can improve perception and recall of perceived objects.

According to Otsuka: “Traditionally prized in Europe for its health benefits, ginkgo biloba has also been recognized as a health food in Japan for many years. A systematic review of research results for flavonoid glycosides and terpene lactones extracted from ginkgo biloba leaves led to notification and acceptance of this supplement as Japan’s first Food with Function Claim for cognitive function.” Nature Made Gingko Biloba is delivered in tablet form.

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The Food with Function regulatory classification was introduced in April 2015 and allows food supplements to be supported by nutrient claims, as long as scientific evidence has been provided to the Consumer Affairs Agency, reports the December issue of Nicholas Hall’s OTC INSIGHT Asia-Pacific. Unlike Foods for Specified Health Use, these products are not subject to case-by-case review by the agency.

Another recent innovation from Otsuka offers heart health benefits to Japanese consumers. In November, the company expanded claims for Nature Made Super Fish Oil in Japan with the specific health benefit of “inhibition of triglyceride levels in the blood”.

Editor’s Introduction to Cough, Cold & Allergy

Sneak peek at some highlights from Global OTC Cough, Cold & Allergy

With so much going on in the US allergy remedies category ­– from Allegra’s swift dash up the rankings to the switch of intranasal corticosteroid Nasacort, from new A+P campaigns to allergy extensions of blockbuster cough & cold brands Mucinex and Vicks – it is small wonder that it was the source of double-digit growth (+11%) in 2014. Not to mention 2015 developments like the February debut of Flonase and the planned launch of Rhinocort. Yet this was just one of a handful of strong performances around the globe in the past year, with the global CCA market responding positively to a spike in flu infections across several regions, switch activity, format innovation and other new launches.

A handful of highlights from around the globe include:

  • In Brazil the move to Rx status of vasoconstrictor-based nasal decongestants led to a significant downturn, but innovative launches subsequently revived topical decongestants sales
  • China’s cough and sore throat remedies benefited from A+P targeting smokers, both for treatment of respiratory conditions caused by smoking and for freshening breath
  • In France dereimbursement is gradually transforming CCA into a pure OTC market, with increasing numbers of semi-ethicals losing reimbursement and becoming pure OTCs – and so able to be advertised
  • CCA is Russia’s largest OTC category by a considerable margin, with over $400mn separating it from VMS (second largest category); CCA options are prominent on a proposed mass market list
  • In Turkey marketers are increasingly launching products classified as food supplements (particularly throat lozenges) and medical devices (notably saline topical decongestants) as these are less tightly controlled than registered medicines

For a comprehensive view of the Global OTC Cough, Cold & Allergy market, including in-depth coverage of the 15 leading CCA markets, check out our just-published report. For more information, download the brochure or contact Nino Hunter.

OTCs in Action Episode 31: Therapeutic Devices as Band-Aids and Beyond

OTCinActionheaderAlthough they prevent infection, Band-Aids with fun characters do not really make the pain go away – but little children think that is what happens. Tears, Band-Aid, then tremulous Smile is a gratifying cycle for parents. As we get older, we learn that it’s the capsule or cream that actually minimises the pain.

However, that paradigm is shifting — clinically proven therapeutic devices are OTCs in Action. A medical student at Aarhus University in Denmark has developed the tiny nasal filter, Rhinix, which prevents allergy symptoms when inserted in the nose. Earlier this month, study results for Rhinix were presented at the 2015 Annual Congress of the European Academy of Allergy and Clinical Immunology. Although the trial was small, held over two days with 65 allergy sufferers, the filters made a significant reduction in blocked nose, runny nose, nasal itching, sneezing and itchy, swollen and watery eyes when compared to placebo, Nicholas Hall & Company’s OTC.NewDirections reported this week. 

Consumer demand for OTC allergy treatments is supported by sales data. The global market for OTC systemic and topical allergy treatments was valued at $7.7bn in 2014*, a 26% increase since 2010. This growth has been driven by the switch of successful Rx allergy brands to OTC status.

But Rx-to-OTC switch need not be the only way to deliver safe and cost-effective treatment to consumers. Perhaps it’s time to view the market with younger eyes as technology enables products that made us feel better as children, actually prevent and treat symptoms.

*Source: Nicholas Hall & Company’s DB6 Global OTC Database.

Homeopathy: The debate rumbles on…

The publication of Prince Charles’ “Black Spider” letters last month again brings up the much-debated question of homeopathy, with the Prince’s Trust having lobbied Tony Blair both to retain NHS funding in the UK, as well as minimize criticism of alternative medicines. While critical evidence accumulates against the efficacy of homeopathy, from the UK’s House of Commons study in 2010 to an independent report from the Australian National Health and Medical Research Council in 2015, consumer support for the practice, even in countries with high levels of education and fast access to healthcare info, is as strong as ever.

Patient requests for homeopathic medicines on the NHS prevented Tony Blair’s government from cutting funding. In Germany, a 2014 study found 60% of Germans use homeopathics, a rise of 7% since 2009, with the vast majority of the 60 health funds offering OTC reimbursement doing so only for homeopathic and anthroposophic medicines. A recent study by the Dutch Office of Statistics revealed that homeopathy came second only to acupuncture as the favoured alternative medicine in the Netherlands, with women aged 30-65 with higher education the most frequent users. And this is before we touch on use in India, with its 100,000+ trained homeopaths…

Despite the recent efforts of regulatory authorities to make life hard for homeopathic manufacturers, in Germany (huge price rises for homeopathic registration), the Netherlands (no more indications on homeopathic packs) and the USA (see the FDA’s public hearing in April), the practice is unlikely to disappear any time soon. Nor should it. So long as marketers make no claims beyond soft indications, and HCPs ensure consumers return to them if symptoms have not cleared up, homeopathy can be a gentle and natural alternative to the often confusing world of medicated options. With the correct guidance, there’s enough space in OTC for everyone.

OTCs in Action Episode 28: DNA-based diets a beacon of future OTCs

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EXTRAORDINARY PEOPLE OFFERED DNA-BASED DIETS

UK: Overweight patients in Essex are being offered the opportunity to receive DNA-based tailored diets and exercise regimes under a pilot scheme offered by the National Health Service. The “Extraordinary People” project, run by the NHS’ Enable East, is a free programme funded by the Big Lottery Fund. To date, 56 participants have completed DNA tests provided by DNAFit, which will give personalised reports on their key genes related to diet, nutrition, physical health and fitness. Based on the findings, participants will be allocated to one of 5 diet plans and tailored exercise regimes. If successful, the programme could be rolled out across the UK.

(from Nicholas Hall’s OTC.NEWSFLASH, May 23, 2015)

OTCs are in Action in the UK, where the NHS is attempting to validate DNA-based, individualised weight loss programmes. The connections between DNA make-up and body weight are becoming increasingly apparent as the human genome is unravelled. Earlier this year, US National Institutes of Health Director, Dr Francis Collins, blogged about a study of the genomes of more than half a million people to look for genes and regions of chromosomes that play a role in body fat distribution and obesity. They turned up over 140 genetic locations that contribute to these traits, and further analyses suggest the possibility that the programming behind how fat cells form may influence their distribution.

In fact, OTC tests for DNA weight loss programmes are available online as OTCs and were a hot topic in the media several years ago, but have not become mainstream. While a positive result of the NHS study will offer credibility for this OTC category, it’s still early stages. In an interesting twist, DNAFit subscribers can become members of 23andMe, the pioneer in OTC genetic testing, which made its first appearance in OTCs in Action Episode 22: Genetic disorders vs Alcoholic Blushes.

In theory, the personalised weight loss programmes of today could be successful, but OTC marketers know that the human / actual use factor in compliance can offset the best science. The significance is the future prospects – perhaps some day, prospective dieters will review a 23andMe report before choosing between weight loss OTCs such as orlistat-based Alli (GSK) or raspberry ketone dietary supplements.

New transparency rules in Canada will affect OTC marketers

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According to our industry contacts, there are some important issues to consider for marketers planning to launch OTC products in Canada. Over the past several months, the Minister of Health has been rolling out a number of initiatives designed to improve the department’s image concerning transparency. The most recent decision will require all drug approvals to be put into a publicly available database, whether these products are marketed or not. While this may or may not help improve the government’s reputation on transparency in some sectors, it is most likely that competitive interests will have the most to gain through this policy.

Until now, only those products that were on the Canadian market were entered into the Drug Product Database. The purpose of which is to allow stakeholders to know whether a product that is being sold in Canada has been approved or not. This database is an excellent tool for compliance officers at both the federal and provincial levels. The change this time is that the government will now place all approved drugs into the database even if the manufacturer has not yet commenced sale.

This new policy will likely change the way companies plan for and market their new products. In some cases a manufacturer will file applications for new products with the intent of rolling them out over a period of time. This allows the marketer some flexibility in planning for administrative delays in approval, seasonality or retail sell-through of older products. Since the products were not on the market, there was nothing for compliance officers to worry about. However, by making such registrations public, competitors will now know what products are coming to the market well in advance of new launches.

This policy has its genesis in the realm of prescription drugs but has been extended to all drug products. Yet there are significant differences between how companies approach the marketing of prescription and OTC products. New prescription drugs have regulatory provisions for protecting new products from competition through data protection or patent laws. Therefore, it could be argued that making competitors aware that a new prescription drug has been approved would not change the ability of those competitors to respond since they must wait for a statutory period anyway.

However, for OTC products, the only market advantage available to companies is usually through the opportunity to hit the market before store brands and other competitors can react with their own offerings. Now the lead time for brand innovators will be largely eliminated through this administrative tool. This is even more important for products being switched from Rx to OTC since there can often be a lag between product approval and final legal status of the new ingredient. Unless there is an offsetting regulation to encourage innovation, this new policy could give the advantage to subsequent entry products after the innovator takes on the burden of satisfying the requirements for a switch.

For monthly updates on the latest markets developments and trends in the US and Canada, make sure you subscribe to OTC INSIGHT North America.

OTCs in Action Episode 21: Medicine men and OTC marketers

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“Medicine men key to halting Ebola spread in Guinea”

A fascinating Reuters article published last week says: “In a land where witchcraft is sought after more than science for curing illness, medicine men in Guinea say the Ebola epidemic would be over by now if they had been properly included in the outbreak response.”

It seems that an educational campaign using mass media did not reach villages with limited electricity and broadcast signals. Jean Marie Dangou, head of the World Health Organisation in Guinea, observed “For about one year the main communication strategy was built around media, mainly radio and TV, but it wasn’t successful. The country is still dealing with tough and repetitive resistance.”

Karamoko Ibrahima Fofana, president of an association of traditional healers, guérisseurs, told Reuters: “Guérisseurs are often the first port of call for the sick. We could have spread information on how to protect against Ebola or told people with symptoms to seek help in the treatment centers.” Fofana explained that the guérisseurs in his association are now keen to do so, having been trained by UN staff.

One can only wonder if OTC marketers had led the campaign, whether the approach to reach patients may have been different – suppose health education campaigns were put through the rigours of an Rx-to-OTC switch, for example, where consumers of every reading level must be able to comprehend and appropriately act on instructions on product labels, especially when to seek medical assistance. If these villagers were our potential customers, would we not have been in those villages to assess their needs and communication resources? Would we have respected the influence of the guérisseurs, as we do the pharmacist?

Source: Reuters

Germany finally rolling over EHC bump

Following the European Commission’s decision in January to switch HRA Pharma’s emergency contraceptive EllaOne (ulipristal acetate) to OTC status, the reaction of both government policymakers and healthcare professionals in pushing through the switch at national level has made for exciting viewing, particularly given the historically stubborn opposition to the free sale of EHCs, both among ruling politicians and GPs.

Regulatory authority BfArM, which makes regular switch proposals to the Health Ministry (BMG), had suggested the Rx-to-OTC switch of EHC levonorgestrel way back in 2003, with the recommendation last reviewed and updated in January 2014, only for Health Minister Hermann Gröhe and Jens Spahn – both CDU centre-right politicians – to resolutely reiterate the party’s age-old stance that the morning after pill would remain Rx. But the European Medicines Agency’s recommendation in November last year that ulipristal be made OTC prompted a sudden announcement by Gröhe that its classification would be reviewed, to the delight of centre-left coalition party the SPD, and the Greens.

Nevertheless, given the CDU’s resistance in the past, the speed with which the BMG initially planned to adopt the Commission’s centralised switch was surprising. Within a day of the announcement, a popular pharmacist publication quoted a BMG spokesperson as saying, “As far as we’re concerned, (the new classification)… is valid from today”, leading to a flurry of confused questions from pharmacist associations…Today? How… but… what?… Really? Manufacturer HRA Pharma even put in a request for pharmacists to be able to sell Rx packs without prescription as it had no packs ready for OTC sale, although this was refused by a local authority.

Things have slowed down a bit. As it stands, the Health Ministry has set out a decree, proposing both ulipristal and levonorgestrel be switched to OTC status, to be passed by the parliamentary Federal Council, with 15th March set as the date when consumers will actually be able to roll into a pharmacy and buy an EHC without a prescription.

Still to be decided on is whether consumer advertising should be restricted, what advice pharmacists will have to be provided alongside an EHC sale, and if a strict in-store protocol should be laid out, with GP associations extremely vocal about what they see as pharmacists’ lack of qualifications in advising on such a sensitive product, together with the frequent lack of an appropriate space for discussion between pharmacist and consumer. However, bespoke training programs and seminars led by female GPs are already underway in preparation, which should help to allay many of the safety concerns held by Health Minister Gröhe.

So despite initial confusion, the switch looks to be going ahead and it is undoubtedly a positive move, with around 60% of German consumers in favour according to a 2014 survey by research body Mingle. It is likely that the situation will be monitored for some time, to avoid the pills being dispensed “like smarties” as Mr Spahn feared they might be. German politicians need only look to responsible retailing in UK and France, where the birth rate is also markedly higher than in Germany, to see that pharmacists are unlikely to forget the “emergency” part of emergency contraception in a hurry.