Self-care in Canada: Meandering Path to New Regulations

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Mathematically, the shortest distance between two points is a straight line. However, in public policy it is rare to chart such a clear direction. Reading through the “What was Heard” report from Health Canada’s public consultation on self-care regulation, which was conducted online in late 2016, there does not appear to be any real consensus over new proposals for an overhaul of all the regulations for non-prescription medicines, Natural Health Products (NHPs) and cosmetics.

Although the report was completed months ago, it was only released in late March this year, as a backgrounder to a series of town hall style discussions on a more detailed set of changes starting 4th April. While the government has developed a more detailed set of proposals that address some of the concerns set out in the report from last year’s consultation, it would appear that those attending the provincial feedback forums will not have the opportunity to digest these details prior to giving their advice. In fact, one of the key findings of the report was that all stakeholders felt that the original outline lacks enough specificity to make cogent comment.

Reading the report, it is interesting how what was heard may not actually be fully representative of what was said. For example, the report concludes that “many participants in the consultation see considerable value in the clarity that would be provided by a single regulatory approach to all three affected areas” (i.e. cosmetics, NHPs and OTCs). What the data show is that in virtually all stakeholder categories, the support across several key measures was only around 30%. Taken another way, roughly 70% or more of the stakeholders would not be more confident in these proposals.

The report notes that most of the concerns came from the NHP segment. This should not be a surprise since all previous consultations were only about moving OTCs out of the prescription drug regulations. For non-prescription medicines, this was round two of the discussions but for the NHP and cosmetics sectors this was novel territory. The visceral reaction was clear given that the NHP community spent years developing a set of regulations independent from drug classification and achieved it through a parliamentary process. They perceived that rolling all OTCs and NHPs into one single regulation was a step back in time, especially given the tone of the documents about claims-based barriers to market access.

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There weren’t many points where all stakeholders agreed. However, it seems there was a strong consensus that self-care products (OTCs, NHPs and cosmetics) “should not be regulated in the same manner as prescription drugs”. Far from an epiphany, this was the basis for the idea that OTCs should be granted their own regulations outside the prescription regulations, just as NHPs were granted such regulatory status. Cosmetics have never been in the prescription drug framework.

There was no consensus on the specific elements of the new framework. The risk-based approach was supported to the degree that most agreed that “products which pose a greater risk of harm should receive greater scrutiny and be subject to significant requirements”. Where the consensus fell into disarray was around the confusion between evaluating products for their individual risk and categorising products broadly into risk levels. The proposal seemed to set out a lower-risk category where claims would be limited and as such the government would not review and license them for sale. This type of product would be supported by pre-cleared information such as monographs.

The logic suffered in some stakeholders’ view since the model would seem to require lower-risk products to move into higher risk categorisation when clinical data would be provided to create greater confidence in the claims. The report notes that “there is no consensus that the proposed risk-based approach would create more confidence when purchasing self-care products”. In fact, 82% of consumers and healthcare professionals and 93% of cosmetics manufacturers said it would not give them more confidence.

The thought of requiring only “scientific” proof to justify health claims met with resistance from most stakeholders (except the five OTC drug companies). Only 30% of all respondents agreed with this notion and that was not highly differentiated across several segments. The support for stricter reliance on “science” (not defined but often assumed to be clinical trial data) was low with consumers (30%), healthcare professionals (33%), NHP companies (21%) and cosmetics manufacturers (30%). On the other side of the argument, academics and researchers were more supportive (60%).

A concept floated by government was that they would not evaluate and license certain types of products based on the types of claims being made. This was suggested to be accompanied by a disclaimer that Health Canada did not assess the claim. While cosmetics already enjoy a similar notification system, most stakeholders didn’t appear to support adopting a cosmetic-like system for OTCs and NHPs. The report notes that “participants are somewhat divided on the use of a disclaimer on products whose efficacy would not be reviewed”.

Despite the lack of consensus on a disclaimer, there would appear to be acceptance that changes could be made that would “facilitate informed consumer choice”. Some stakeholders have proposed adding labelling statements that would make it clearer when traditional evidence was used to support the claim. This, they feel, would add information that enhances consumer choice.

This consultation elicited a very strong response relative to most government consultations. Perhaps this was influenced by the fact that during the consultation period, Health Canada put out a very strong social media campaign and used traditional media stories to “clarify” some aspects of their proposals. With the communications efforts to ensure that the consultation garnered significant and reasoned responses, it should give some confidence in the results.

Perhaps one of the most telling observations related to the confidence stakeholders would have in the newly designed system. Consumers (78%), healthcare professionals (75%), NHP companies (80%) and cosmetics firms (63%) did not feel more confident with the new proposals. In a similar vein, 82% of consumers didn’t feel that the proposals adequately addressed their needs. The numbers were similar for healthcare professionals (78%), NHP companies (81%) and cosmetics businesses (74%). Only two OTC companies felt that their concerns were addressed.

The report concludes that “there is clearly a need for further detail on the proposed approach so that stakeholders may provide more specific feedback to Health Canada as the framework continues to be developed”. No doubt this is true and, as the government heads into the next phase of face-to face discussions, it would have been helpful to have that kind of detail available before asking stakeholders to respond.

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Google Launches “Health Cards” in Australia

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Self-diagnosis can often lead to much panic and anxiety. UK newspaper The Telegraph reported in a 2015 survey that one in four of us choose to self-diagnose on the internet instead of visiting doctors. With OTC products so readily available in numerous regions, self-diagnosis could lead to self-medicating incorrectly.

Last week, Google launched verified medical information in Australian search results, detailing common health complaints such as coughs, infections, rashes and snakebites. However, Australian doctors have warned that while the information might be a conversation starter, it could lead to misdiagnoses and should never replace seeing a specialist.

Google revealed plans to launch Health Cards as part of Google search results in Australia after working on the project with doctors and medical agencies, one of which was the Mayo Clinic. The cards cover the details and symptoms of over 900 health conditions and diseases recommending next steps for concerned sufferers.

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llnesses and concerns featured in Google’s Health Cards will include tonsillitis, coeliac disease and eye infections, with some cards also featuring animated GIFs to demonstrate illnesses. Google Health Cards programme manager Isobel Solaqua said the project was created to address the growing number of medical questions fired at its search engine, stating that: “In fact, one in 20 Google searches are for health-related information … We developed this feature to help people find the health information they need more quickly and easily.”

Australian Medical Association federal vice-president Dr Tony Bartone said users should be “careful not to substitute health information for a qualified medical opinion”. Dr Bartone added that Google’s Health Cards could help patients refine questions for their doctor but medical professionals did not “want to end up with 50 reams of Google pages” brought into consultations.

Online health advice offers us a potential quick fix solution for ongoing health issues, enabling us to ease discomfort and anxiety. Considering this, Google Health Cards will no doubt be a feature that is used and appreciated by many. Though consultants have expressed concerns about confusion and misdiagnosis, is there the potential that this could boost OTC sales and allow people to avoid visiting consultants for minor issues?

OTC Vending Machines in USA IN 2017?

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Vending machines are commonly used for distributing fizzy pop or a sugary / savoury snack to perhaps curb a period of waiting, quench thirst or eat on the go. Now that self-service is so available to us, why not use vending machines to offer other products?

In the US, a bill seeking to revise the current Pharmaceutical Affairs Law to allow OTC vending machines is currently under final review by the Ministry of Government Legislation, before being submitted to the National Congress for approval.

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Of course machines selling OTCs such as condoms, feminine hygiene products and tights are already a common feature in pubs, restaurants, clubs and cinemas but there are many possibilities to extend the product range beyond these common items.

The amendments are expected to be passed without difficulty and will come into effect on 1st January 2017. They will allow pharmacists to sell OTCs through vending machines located outside their premises after conducting a consultation with consumers via video call through the machine.

Jacksonville are already one step ahead as Jacksonville Memorial Hospital recently started offering prescription medicines through an “Rx-to-go” kiosk in its emergency room. At the start of this month, three Jacksonville pharmacists also launched medical vending machines of their own which provide OTC medicines and personal hygiene products.

J&J Focuses On Consumer Innovation In Africa

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As part of its ongoing commitment to Africa, J&J has announced the launch of the Africa Innovation Challenge. The project will support Africa’s growing ecosystem and help develop consumer health solutions for local towns.

Earlier this year, J&J announced its global public health strategy in Cape Town, South Africa. The operations expand upon the company’s presence in Africa, which began in 1936.

“Our goal is to improve the health and wellbeing of families and communities around the world,” said Josh Ghaim, J&J’s Chief Technology Officer, Consumer R&D. “With its focus on consumer healthcare, the Africa Innovation Challenge will help to surface important issues impacting local communities. We look forward to engaging with the continent’s top entrepreneurs and scientists, and through collaboration, helping advance their ideas and bringing meaningful solutions across three very important healthcare areas.”

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The Africa Innovation Challenge seeks ideas focused on three critical health areas, promoting early child development and maternal health; empowering young women; and improving family wellbeing.

Challenge participants with successful solutions will receive up to US$100,000 in funding and mentorship from scientists, engineers and researchers in the J&J Consumer Research & Development organisation.

The news of J&J’s latest innovative challenge comes alongside the recent decision to drop ‘McNeil’ from their OTC business name, opting for J&J Consumer instead.

To apply to the challenge and review the applicable terms and conditions, please visit the Africa Innovation Challenge website. The deadline to submit applications is 17th January 2017.

OTC DASHBOARD is your sole Nicholas Hall & Company source of regular updates on the OTC market in Africa and the Middle East. Explore our Rest of World section for the latest content.

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”.