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.

Big push for 23andMe at NACDS

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“This is a story about why you became … who you are,” a friendly woman’s voice says in the new TV ads for 23andMe genetic tests, explaining further that results offer “unique insights into your health, traits and ancestry”. It was rather surprising to hear my 16 year-old son say that he might want to try it someday.

In addition to learning where his great great great great grandfather came from, which is interesting to him now, some day my son will be able to learn about his genetic traits in the same way as his caffeine consumption, deep sleep, lactose intolerance, muscle composition and saturated fat and weight. But more importantly, many many many years from now, when he wants to be a father, he will know if he carries genes linked to conditions like cystic fibrosis, sickle cell anaemia and hereditary hearing loss (probably not the same condition as the selective hearing loss that happens when it’s time to take out the trash).

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Currently available through e-commerce, 23andMe is ready for retail and was promoted with a dominant display at last week’s Total Store Expo, held by the National Association of Chain Drug Stores, in Boston.

Personalised medicine is bring developed to give patients the best possible treatment outcomes in a clinical setting – but 23andMe in CVS or Walgreens is bringing DNA testing to the masses, intriguing even a 16 year old…

Nix Ultra Tackles Super Lice Epidemic

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This week, OTCs In Action are targeting the not so nit-picking issue of super lice. For the past few months, the head-scratching solution to the problem of how to defy new bionic strains of lice has plagued traditional OTC pesticide marketers.

New evidence from The Journal of Medical Entomology (JME) found that head lice have developed resistance to two types of common OTC insecticide treatments for lice infestation. Over the past year, 98% of head lice in at least 42 states managed to grow gene mutations that enabled the (super) lice to become resistant to pyrethrins, pyrethriods and permethrin.

However, the invasion of the mutant lice shall no longer reign. Prestige Brands have launched a new product, Nix Ultra, to tackle the super lice epidemic. Nix Ultra safely kills both traditional and super lice, as well as their eggs.

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The combination of mineral oil and dimethicone provides optimal coating and coverage of both lice and hair, creating a slippery surface so lice and eggs, even the pesky super strain, can be easily removed.

This is one of just a few super lice OTC treatment products available on the US market and, with super lice rapidly spreading in the US, there certainly (for now) seems to be a safe and reliable solution for worried parents.

Ice Bucket Challenge Creates Medical Breakthrough

Holly Parmenter, Digital Projects Executive: Back in 2014, the charitable craze of dosing one another in ice-cold water (better known as The ALS Ice Bucket Challenge) went viral. This was all in aid of raising awareness and research funds for amyotrophic lateral sclerosis (ALS).

The incurable progressive neurodegenerative disease predominantly affects the brain and spinal cord, resulting in entire paralysis. Physicist Stephen Hawkins is a well-known sufferer and helped raise awareness during the ALS Challenge as his children gallantly participated on his behalf.

Though seemingly buried deep within the vast world of social media, the ALS Ice Bucket Challenge has resurfaced; not with ice but with results. The Ice Bucket Challenge raised $115m (£87.7m), which funded six research projects.

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One of these was Project MinE, an extensive study involving more than 80 researchers in 11 different countries. This study examined ALS risk genes in families affected by the disease and, thanks to the funding for research raised by the Ice Bucket Challenge, an important scientific discovery was made – the identification a new gene that contributes to the disease, NEK1.

The identification of gene NEK1 means scientists can now develop a gene therapy to treat it. Although only 10% of ALS patients have the inherited form, researchers believe that genetics contribute to a much larger percentage of cases.

Vit D recommended for all

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A report by a committee of independent nutrition experts has recommended that everyone in the UK should take vitamin D supplements. This has been advised despite the initial thought that only certain groups of the population should take the supplement.

The new guidance advice, which applies to England and Wales, suggests that everyone over the age of four should take 10mcg of vitamin D everyday. The guidance advice also suggests that during the chillier seasons this is particularly advised.

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The report strongly suggests that pregnant and breastfeeding women, people from ethnic minority groups with dark skin, elderly people in care homes and those who wear clothing that covers a majority of the skin, should take 10mcg of vitamin D everyday all year round.

The Scientific Advisory Committee on Nutrition (SACN) looked at the issue and decided that, to ensure a majority of the population has enough vitamin D in their blood all year round, daily intake is advisable.

For pregnant women and some children up to and including the age of four, the supplements will be free under the government’s ‘Healthy Start’ scheme. The Department of Health will now have to decide whether to fund free supplements for other groups of the population.

Official estimates suggest one in five adults and one in six children in England may have low levels of the vitamin in their bodies.

Prince Harry gets pricked publicly; Faster OTC HIV test approved

Last Thursday, people all over the world watched the UK’s Prince Harry get his finger pricked when he streamed his HIV test, conducted in a clinic, live on Facebook.

 

People who prefer a less public test will benefit from bioLytical Laboratories’ new INSTI HIV Self Test, which was approved last week by the EU and will be available in retail and e-commerce sites by the fourth quarter of this year. According to bioLytical, INSTI is the world’s fastest HIV Self Test, providing instant results with just one drop of blood. The at-home test reportedly yields greater than 99% accuracy.

Getting tested for HIV is the first step in taking control of one’s health and preventing transmission to others, and it is a step that can be the hardest to take, according to healthcare professionals. “It’s amazing how quick it is,” said Harry about his bioLytical HIV test (negative), performed at the Burrell Street Sexual Health Centre in South London. “Once you get people through the door, that’s the hardest bit out of the way.”

“Accessibility, inconvenience, anxiety, lack of awareness, stigma and discrimination are some of the reasons why a person may hesitate to take an HIV test,” noted Rick Galli, Chief Technical Officer of bioLytical Laboratories, “and this is exactly why we commend Prince Harry’s efforts towards the cause.”

OTCs in Action also commends bioLytical Laboratories for its efforts to improve HIV testing in public and private. 

UK press misreports paracetamol’s autism / ADHD links

Paracetamol is the most widely used analgesic in the world and was once deemed the only painkiller that is safe for mothers-to-be.

However, women who take paracetamol during pregnancy “risk having a child with autism or ADHD”, the Mail Online reported last week. Other UK newspapers, The Times and The Daily Telegraph, are also ‘guilty’ of publishing headlines that could potentially cause unnecessary worry for pregnant women.

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The Spanish study that reported on the matter actually provided no direct link or solid evidence to ADHD or autism. Over 2,000 pregnant women using paracetamol, before and during pregnancy, were assessed between 2004 and 2008. Various developmental and behavioural tests on the children at the ages of one and five were then conducted.

Links were found between paracetamol use and hyperactivity / impulse symptoms at age five, and autism symptoms in boys. There was however no direct link to ADHD or autism symptoms, nor a link to intellect or development in the children being affected.

The study will most likely contribute to the long list of pregnancy “dos” and “don’ts” owing to its media focus. Most importantly, the NHS has confirmed that there was no link with the full diagnostic criteria for attention deficit hyperactivity disorder (ADHD) or autism; highlighting that the study cannot prove that using paracetamol in pregnancy caused these symptoms.