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First “digital” pill approved by the FDA in circulation

The Food and Drug Administration announced on Tuesday they have approved the first digital pill in the United States to help health professionals ensure patients are taking their medication. This revolutionary, and uneasy, advancement in technology and medicine came as an interesting surprise. Abilify MyCite is a pill used to treat patients with mental disorders such as  schizophrenia, depression, and bi-polar disorders. The pill looks like any other normal pill, but it is engrained with a tiny ingestible sensor no bigger than a grain of sand.

Once ingested and mixed with acid in the stomach, Abilify MyCite activates an electrical signal. This signal is then transmitted to a patch that is worn by the patient on their left rib cage.  The information is then sent via bluetooth to a smartphone app, which can list the time the pill was taken, the dosage, and gives the patient the option to upload these results to a database where doctors can access the file.

Image courtesy of Proteus Digital Health

The sensor then passes through your body naturally, as the little chip is made of silicon, copper, and magnesium. The patch that will be worn on the body can last up to seven days and will continually record the data every time you take the pill. The patch is also able to track physical activity, steps taken, heart-rate, sleeping patterns and other data similar to a smart fitness tracker. This pill/patch combo does raise many concerns about patient privacy and the vulnerability of having our personal information available to others..

The patient has the power to upload the data, but can allow access to four other members, including family members or significant others. While this is a big step in digital health, there is also cause for concerns in terms of information sharing, especially considering the increase in data breaches and internet hacking.

Doctors must determine if the patient is capable and willing to use the pill/patch combo. Being an antidepressant, Abilify MyCite, does come with risks, including worsening suicidal thoughts and a list of side-effects determined during the clinical trial, including a possible skin irritation from the patch.

The pills are manufactured by Japanese pharmaceutical company, Otsuka, in collaboration with the producers of the sensors, Proteus Digital Health. Concerns have been raised that the FDA may have opened the door for other potential digital pills, but advocates says the technology will ensure medication is not wasted and that patents are actually taking their pills and getting the treatment they need.

Abilify was first approved by the FDA in 2012 and since then, the pill with an included sensor was in the works and Abilify MyCite was first approved for marketing in 2012 as well.

What are your thoughts on the first approved digital pill and does this reinforce the fact that Big Brother is always watching ? Comment below.

 

Medical abortion drug available at no cost in Alberta

Earlier this year, a potentially life changing prescription drug arrived in Canada called Mifegymiso. What is Mifegymiso? With a name as complicated as it sounds, the drug follows a lot of controversy. It is the medical abortion pill that can terminate a pregnancy for up to 49 days following conception.

Women are slowly gaining access to more reproductive choices and on Monday, it was announced in Alberta that this pill will receive universal coverage, which means it will be free.  Alberta is the second Canadian province to approve universal coverage, following in the steps of New Brunswick. The new policy in New Brunswick also led to a change in abortion access.

Mifegymiso has been the choice drug for medical abortions for over 30 years and it was approved for use by Health Canada in July 2015, following an application time of three years. It became available in January 2017 for a cost of $300 and physicians are required to complete a training program before prescribing. In April 2017, New Brunswick approved coverage and now Alberta has joined them in July 2017.

The idea behind universal coverage is to remove financial barriers and allow women complete freedom over their reproduction choices. It also allows access to rural parts of Canada, where it is more difficult to access reproductive health care services due to the lack of physicians and skilled workers operating clinics.

Sandeep Prasad, the executive director for Action Canada for Sexual health and Rights, remarked that Alberta has shown great leadership in implementing universal coverage of the drug, and hopes it will  motivate other territories. “They have demonstrated that cost coverage is both necessary and possible, she said in a news release after the Government of Alberta announced their decision. “That is why we expect all provincial and territorial governments to commit to cost coverage programs of at least the same caliber as Alberta’s before the health ministers’ meeting in the Fall of 2017.”

Abortion is legal in Canada and in the province of Ontario, but there has been no amendment to covering the cost of Mifegymiso, but many expect the cost to be covered in this province by the end of the year as mentioned in the last budget.

Free Mifegymiso does not mean that the process is simple, as women are still required to do ultrasounds first before taking the pill so that doctors will assess if the candidate can undergo use of the drug. The pill is only available through prescription by your doctor.