Showing posts with label Mifegymiso. Show all posts
Showing posts with label Mifegymiso. Show all posts

Wednesday, March 29, 2023

Part 1 - CIHI 2021 abortion data

CIHI is out with their 2021 abortion numbers. They are now adjusting their numbers to use doctor's billing codes. That is good. But what is bad is that they are not including all of their previous stats.

"March 23, 2023 — Provision of abortion services in Canada has evolved in recent years. Since the medical abortion medication Mifegymiso became available in Canada in 2017, medical abortions have become increasingly accessible in non-hospital settings (e.g., nurse practitioner and physician offices, community and public health clinics). In addition, the ongoing COVID-19 pandemic may have further shifted abortion services to non-hospital settings. As a result, reporting from traditional hospital data sources has led to an underestimation of the true number of induced abortions in Canada."

There are a lot of caveats to the 2021 data:

"Reporting enhancements

As part of CIHI’s ongoing improvement efforts, we explored opportunities to address data gaps, resulting in a revised methodology for reporting induced abortions for some jurisdictions in Canada. The methodology now includes physician billing data as the source of total abortion volumes and method of abortion for some provinces. 

Because of the revised methodology, 2021 results are not comparable with historical data results. Restated 2020 abortion volumes using the revised methodology can be found in the notes to Table 1. The tables also contain information regarding data sources and coding methodology.

Frequently asked questions

Why is the total number of reported induced abortions larger than in previous years?

The number has increased due to changes in reporting methodology. More complete reporting for 5 provinces (Newfoundland and Labrador, Nova Scotia, Ontario, Manitoba and British Columbia) is now sourced from physician billing data. Restated 2020 abortion volumes using the revised methodology can be found in the notes to Table 1.

Why were the reporting changes made now?

We enhanced the methodology as part of our ongoing efforts to improve completeness of reporting. The revised methodology better captures induced abortions, which are increasingly occurring in non-hospital settings (e.g., nurse practitioner and physician offices, community and public health clinics).

Why is the revised methodology used for some provinces only?

Due to variations in physician billing data capture and completeness across the country, it was not feasible to use the revised methodology for all jurisdictions; this has resulted in some ongoing underestimation of total abortion volumes. More comprehensive reporting may be available in future CIHI releases.

Do the results include the number of induced abortions from RU-486/mifepristone/Mifegymiso? 

Reported volumes include abortions induced by Mifegymiso that occurred in a hospital, that were reported voluntarily by clinics or that were captured in the medical abortion physician billing codes. The data does not permit us to report these volumes separately because there is no unique code to identify Mifegymiso in the data sources. A high-level breakdown by method of abortion can be found in Table 3.

Why are there fewer data tables in the 2021 data release compared with previous years?

Breakdowns derived from hospitalization data only are no longer included since they are not representative of all abortions across all settings and represent only a small proportion of the total number of abortions."

So you can see that there is a lot of missing information from previous years:

  • By Gestational age
  • By number of previous deliveries
  • By Number of previous abortions
  • By complications

I had to do a fair amount of diddling with the report to get it to print properly, (formatting, etc) and haven't had time yet to review the actual data yet. 

Friday, January 27, 2023

Medical abortion is fatal for 19 year old woman

UPDATE: I could find nothing in the media about this tragedy. Two lives cut short. A family somewhere suffering from this young woman's death. And nothing in the pro-abortion media.

Since I last reported on the serious side effects of Mifegymiso (the medical abortion pill) a year ago, I checked again to see if there were any more adverse reactions (from the Canada Vigilance Adverse Reaction Online Database) to this deadly abortion pill.  

Unfortunately I discovered that a fatal report was submitted on 2022-07-04. This was a 19 year old young woman who died from septic shock by taking this horrific drug. 

This deadly drug is produced by Linepharma, who markets, distributes, sells and profits from abortion in over 25 countries, including Canada.









Don't let anyone tell you that this drug is safe. It is not. Not only does it kill children in the womb, it kills women.

Thursday, January 27, 2022

Linepharma, Mifegymiso, adverse reactions, and profit

This is my final post in this five part series on Linepharma, who markets, distributes, sells and profits from abortion in over 25 countries, including Canada. 

I've only documented a few of the adverse reaction cases from the 195 page ATIP package I received. You can view the other cases here from my Health Canada ATIP.

https://run-with-life.blogspot.com/2022/01/improving-womens-health-one-abortion-at.html

https://run-with-life.blogspot.com/2022/01/mifegymiso-case-17-year-old-serious-and.html

https://run-with-life.blogspot.com/2022/01/mifegymiso-case-37-year-old-life.html

https://run-with-life.blogspot.com/2022/01/mifegymiso-case-36-year-old.html

I cross referenced the 195 page report to the Canada Vigilance Summary of Reported Adverse  (43 records for MIFEGYMISO). Notice this from the first page of the summary report

"CAVEAT (from the report): This summary is based on information from adverse reaction reports submitted by health professionals and laypersons either directly to Health Canada or via market authorization holders. Each report represents the suspicion, opinion or observation of the individual reporter. The Canada Vigilance Program is a spontaneous reporting system that is suitable to detect signals of potential health product safety issues during the post-market period. The data has been collected primarily by a spontaneous surveillance system in which adverse reactions to health products are reported on a voluntary basis. Under reporting of adverse reactions is seen with both voluntary and mandatory spontaneous surveillance systems. Accumulated case reports should not be used as a basis for determining the incidence of a reaction or estimating risk for a particular product as neither the total number of reactions occurring, nor the number of patients exposed to the health product is known. Because of the multiple factors that influence reporting, quantitative comparisons of health product safety cannot be made from the data. Some of these factors include the length of time a drug is marketed, the market share, size and sophistication of the sales force, publicity about an adverse reaction and regulatory actions. In some cases, the reported clinical data is incomplete and there is not certainty that these health products caused the reported reactions. A given reaction may be due to an underlying disease process or to another coincidental factor. This information is provided with the understanding that the data will be appropriately referenced and used in conjunction with this caveat statement."

Lots of wiggle room there. Notice this statement: 

"Under reporting of adverse reactions is seen with both voluntary and mandatory spontaneous surveillance systems." (emphasis added)

Presumably there are many adverse reactions that are never reported to Health Canada. How many? We will probably never know. But women who take this deadly pill are really on their own. They go home, take the pills, and who knows what consequences these women will suffer? And will they be reported?

Medical abortions really just add another whole level of evil to the already abhorrent reality of abortion.

Wednesday, January 26, 2022

Mifegymiso case 36 year old, hospitilization, sepsis, missing information

This report for a 36 year old woman who suffered from sepsis after a Mifegymiso abortion, bears a strong similarity to some of the other reports.

It contains a lot of unknown information about her case.

A 36-year old female patient, unspecified weight and height, with unknown medical history, was administered Mifegymiso...unspecified dosage for induced abortion. Time frame was unknown. Time of gestation was not provided.

Concomitant treatment was not reported.

Corrective treatment, if any, was not reported.

The patient recovered from the event on unspecified date.

The health authority evaluated the case as serious (Hospitalization), coded sepsis as adverse reaction, suspected Mifegymiso and did not assess the causal relationship between Mifegymiso and the adverse reaction. (but I think we know the answer to this one)

Seriousness: -sepsis: yes (hospitalization) 

Causality assessment: Very poorly documented case, time frames and dosage of mifepristone administration were not provided. Chronology was unassessable.

Missing information: Confirmation of misoprostol administration.

More than one of these reports contain this lack of information. Why is that? Why isn't Health Canada following up with the person who reports the adverse reaction, to obtain this information? Isn't that a kind of crucial aspect of this reporting system?

Tuesday, January 25, 2022

Mifegymiso case 37 year old, life threatening and involved or prolonged inpatient hospitalization

In 2017 a 37 year old woman suffered "life threatening and involved or prolonged inpatient hospitalization".

From her Adverse Reaction Report:

"Report received [date]. 37 year old woman with unknown medical history. Received Mifegymiso. Patient was 45 days gestation.

Patient presented for follow-up appointment with heavy bleeding and vasovagal (See below). Ultrasound scan detected retained product of conception in and around cervix that physician attempted to remove. An assessment of stat hemoglobin was ordered, then patient called at home to [be] given results at 130. A date for dilation and curettage was booked by clinic. Patient reported passed large clot size of an orange on way home and felt much better. 

On [date], nurse called in the morning and patient said bleeding was only spotting and she felt better and cancelled dilation and curettage.

On [date], patient reported being admitted to hospital with hemorrhage and loss of consciousness on date with low hemoglobin and iron. She underwent emergency dilation and curettage and blood transfusion."

Reactions:

"Loss of consciousness, Low hemoglobin, Low iron, Hemorrhage, Transfusion, D&C, Syncope vasovagal, Retained product of conception, Heavy bleeding"

Notice the use of Retained product of conception. A human being by any other name.

"Vasovagal syncope (vay-zoh-VAY-gul SING-kuh-pee) occurs when you faint because your body overreacts to certain triggers, such as the sight of blood or extreme emotional distress. It may also be called neurocardiogenic syncope.

The vasovagal syncope trigger causes your heart rate and blood pressure to drop suddenly. That leads to reduced blood flow to your brain, causing you to briefly lose consciousness."

Monday, January 24, 2022

Mifegymiso case 17 year old, serious and life threatening

"Linepharma is a pharmaceutical company committed to improving sexual and reproductive health through expanding access to safe medication abortion."

Further to my last post about the company whose only product kills babies, I did an ATIP to Health Canada on the abortion drug Mifegymiso. My request:

"I would like to obtain the total number of medical abortions (mifepristone and misoprostol) dispensed in Canada since the drug became legal in 2017. I would also like to see any reports of adverse affects  attributed to these medical abortions in Canada since the drug became legal in 2017."

I am still waiting for the first part of my request, and received info back on the second part about adverse effects.

The first woman I will discuss who suffered from this dangerous drug was 17 years old. There are records for her from 2017, 2018, 2019 and 2020 in the system. I have no idea how long she suffered from her abortion, but there was a lot of paper work done on her.

Her case was classified as serious, life threatening.

This woman suffered the following horrible reactions to this drug.

Loss of consciousness, Hemoglobin low, Iron low, Hemorrage,Transfusion, Dilation and curettage, Retained products of conception, Heavy bleeding, Large clot, Toxic shock syndrome, Off label use, Escherichia sepsis (E. coli), Septic abortion, Abortion infected, Cardiovascular collapse, Circulatory collapse, Percutaneous cardiopulmonary support, Lung assist device therapy

Case Narrative: "Septic shock secondary to septic aabortion from incomplete medical abortion - was provided mifegymiso at 11-2 GA (well out of recommended gestational age); E.coli identified in blood cultures and from uterine contents; patient presented in cardiovascular collapse to local hospital, was transferred to other hospital level 2 center, urgent D&C carried out and ICU admission required with respiratory/cardiovascular support required, developed septic cardiomyopathy; recovered with extensive antibiotic coverage and intensive care; ultimately was discharged home with close followup."

This case was flagged as off-label use because:

"She had unknown relevant medical history. 11 Weeks 2 days gestation (79 days) patient received Mifegymiso beyond 63 days gestation." (emphasis added)

Interesting that 63 days number. Because from this Canadian Medical Abortion Dispensing Guide it says up to 70 days. So what is it Linepharma, 63 days or 70 days? And how do you make sure that women don't take it past this time like this girl did?

On one of the reports was the following comment.

"The case was reported by a physician to Health Canada on 22-Mar-2018 and retrieved by Linepharma on 16-Dec-2019."

Linepharma took a 21 full months to retrieve the information about this poor girl. You'd think that they would be a tad more interested in knowing about this horror story. And the other horror stories of women taking this dangerous drug. That they produce, market, make money from, and send around the world. 

How many people in countries not as advanced as Canada suffer from similar reactions? And what will happen if we start sending Mifegymiso to Africa? God only knows.

Sunday, January 23, 2022

Improving women's health one abortion at a time

"Linepharma is dedicated to improving women’s health and safe reproductive care."

Linepharma makes the medical abortion drug Mifegymiso. It is distributed in Canada by Celopharma.

Linepharma seems to be owned by a holding company AMRING HOLDING SA.

"There are currently 2 people with significant control at LINEPHARMA INTERNATIONAL LIMITED. One of of major shareholders of LINEPHARMA INTERNATIONAL LIMITED is AMRING HOLDING SA, which owns 1008 ORDINARY shares, with a total value of 1,008 GBP and AMRING HOLDING SA, which owns 404 ORDINARY B shares, with a total value of 404 GBP."

I couldn't find much about these companies, besides some basic information about their registrations etc, and their own very non informative websites. In fact Amring Holding SA doesn't seem to have a website of its own. Interesting.

Linepharma makes one product. The abortion pill Mifegymiso. Cellopharma distributes one product. The abortion pill Mifegymiso.

Linepharma distributes this product through the usual suspects, International Planned Parenthood, Marie Stopes, and United Nations Population Fund, and other stalwart organizations devoted to the killing of young fetuses.

Currently Linepharma sells their fatal fetal drug to women in Canada, Latin America, Asia, and Australia. And coming soon it will be in Japan, Chile, Bolivia, and South Korea.

We can only imagine how much money they make in their monopoly of medically killing children in the womb all over the world. If this isn't evil I have no idea what is.

Wednesday, January 27, 2021

The abortion bill: what a horrible way to die

The abortion pill is not a safe drug. Health Canada issued 40 adverse reaction reports on this drug. Of these, there were 26 individual women.

One woman died.

Two more experienced "life threatening" side effects.

23 women experienced "serious" side effects.

In 2017 there was one woman affected; in 2018 two women were affected; in 2019, it was six women. And in 2020 there were 16 women with serious side effects (Note that the report is only until July 31, 2020, so 2020 will undoubtedly have more serious problems reported).

Notice the trend here? As the abortion pill becomes more popular, even more women will suffer from its life threatening and possibly fatal side effects.

Not a safe drug at all.

Mifepristone (Search the database by active ingredient)

The woman who died was 27 years old. From the documented adverse reactions she experienced, it appears that her whole body, and all of her organs, went into extreme failure. Here were her symptoms:

Abdominal pain, Acidosis (a process causing increased acidity in the blood and other body tissues), Ascites (the abnormal buildup of fluid in the abdomen. Technically, it is more than 25 ml of fluid in the peritoneal cavity, although volumes greater than 1 liter may occur) Bacterial infection, Blood pressure decreased, Blood urea increased, Body temperature decreased, Cardiac arrest, Cardiovascular disorder, Chills, Dehydration, Dizziness, Endometritis, Gastritis haemorrhagic, Hyponatraemia (is a low sodium concentration in the blood), Hypoxia (is a condition in which the body or a region of the body is deprived of adequate oxygen supply at the tissue level), Leukocytosis (a condition in which the white cell is above the normal range in the blood. It is frequently a sign of an inflammatory response, most commonly the result of infection), Multiple organ dysfunction syndrome, Nausea, Oliguria (or hypouresis is the low output of urine specifically more than 80 ml/day but less than 400ml/day. The decreased output of urine may be a sign of dehydration, kidney failure, hypovolemic shock, hyperosmolar hyperglycemic nonketotic syndrome, multiple organ dysfunction syndrome, urinary obstruction/urinary retention, diabetic ketoacidosis, pre-eclampsia, and urinary tract infections, among other conditions), Palpitations, Pelvic pain, Pleural effusion (is excess fluid that accumulates in the pleural cavity, the fluid-filled space that surrounds the lungs), Pyrexia (Fever, is defined as having a temperature above the normal range due to an increase in the body's temperature set point), Sepsis, Septic shock, Uterine spasm, Vaginal discharge, Vaginal haemorrhage, Vomiting

From the data file produced

CAVEAT: This summary is based on information from adverse reaction reports submitted by health professionals and laypersons either directly to Health Canada or via market authorization holders. Each report represents the suspicion, opinion or observation of the individual reporter. The Canada Vigilance Program is a spontaneous reporting system that is suitable to detect signals of potential health product safety issues during the post-market period. The data has been collected primarily by a spontaneous surveillance system in which adverse reactions to health products are reported on a voluntary basis. Under reporting of adverse reactions is seen with both voluntary and mandatory spontaneous surveillance systems. Accumulated case reports should not be used as a basis for determining the incidence of a reaction or estimating risk for a particular product as neither the total number of reactions occurring, nor the number of patients exposed to the health product is known. Because of the multiple factors that influence reporting, quantitative comparisons of health product safety cannot be made from the data. Some of these factors include the length of time a drug is marketed, the market share, size and sophistication of the sales force, publicity about an adverse reaction and regulatory actions. In some cases, the reported clinical data is incomplete and there is not certainty that these health products caused the reported reactions. A given reaction may be due to an underlying disease process or to another coincidental factor. This information is provided with the understanding that the data will be appropriately referenced and used in conjunction with this caveat statement.

More information here on the abortion pill and its side effects. 

Thursday, December 3, 2020

Ontario abortion rates are going up

Ontario abortion rates as reported by the Ontario Ministry of Long-Term Care are going up. Yet CIHI shows a decrease in Ontario abortion rates. So I'm not sure why CIHI keeps reporting Ontario numbers. In any event, since the MOHLTC's numbers are based on doctor's billing records, they intuitively should be more accurate.

You can see from the chart that overall, MOHLTC's numbers went down for three years in a row (2014/2015 to 2017/2017), but then for the next three years (2017/2018 to 2019/2020), they went up.

This disturbing trend upwards is most likely due to the abortion pill which became legal in 2017. This is really bad news for Canadians, especially those still in the womb.

Previous recent posts on abortion statistics:

Ontario out of province abortions for 2017

Canadian abortion statistics: who does, and who does not, report medical abortions

Ontario abortion numbers 2017/2018 

UPDATE The facts about abortions statistics in Canada

Sunday, March 1, 2020

UPDATE: Alberta abortion statistics for 2015/2016 to 2018/2019

UPDATE March 4, 2020 Claim codes for Alberta.

UPDATE March 3, 2020
My question to AHS regarding their statistics, and their response: 
Q. Can you explain why your stats are consistently lower than those stats reported by CIHI?
A. There are two reasons
1.       Difference in Data source (We use Claims and CIHI uses inpatient/outpatient data).
2.       Difference in methodology (We restrict any claims with 60 days as one abortion) but am not sure about CIHI (You can confirm with them).

I received abortion statistics from Alberta Health Services (AHS) through a freedom of information request. I then compared these numbers to CIHI's numbers. As you can see, AHS's numbers are less than CIHI's. This was a surprise since both Quebec and Ontario's numbers are higher than CIHI's.

But notice the footnotes.

From CIHI data:
"patients with coverage under Quebec’s health insurance plan receiving care in Alberta are reported by Alberta. However, patients with coverage under Alberta’s health insurance plan receiving care in Quebec are not reported (by either Quebec or Alberta)."
So abortions covered by AHS, but done in Quebec, aren't reported anywhere.

From Alberta data:
"Mifegymiso prescriptions were introduced in July 2017 which affected abortions numbers for the last two fiscal years."
So abortions covered by AHS do not include medical abortions, but only surgical abortions. This means that 2017/2018 and 2018/2019 numbers would be higher than reported--if only we knew how many medical abortions were occurring in Alberta.

Once again we have confusion over abortion statistics.

Friday, January 24, 2020

2018 abortion numbers - are they going up or down?

CIHI has released 2018 abortion statistics. The numbers look like they're down from 2017, which is a good thing. But considering that CIHI doesn't report any abortions performed in doctor's offices; considering that not all clinic abortions are reported; together with the fact that an increasing number of abortions come from the easy availability of the abortion pill RU-486, we have no idea if abortions are really going down, or up.


NOTE: CIHI only reports the gestational ages of abortions for those done in hospitals, and not for those done in clinics, and not for those done in Quebec. This means that for the bulk of the abortions performed in Canada, we have no gestational ages.

Friday, August 12, 2016

CBC and its obvious bias on RU-486

Typical that the CBC keeps complaining about how RU-486 will be dispensed. They keep finding doctors who complain about the rules of the drug, which by the way, are there in the first place because this drug is so dangerous. And if you go to the CBC link above, you'll find more links to even more CBC articles, also complaining about RU-486.

Is it not at all possible for them to find even one doctor out there who thinks that RU-486 is not good for women? Because I'm pretty sure they're out there. Maybe they should do their job properly and find a few of those doctors who will tell the CBC of all the different risks this drug poses to women.

CBC, have you made any effort at all to do this? No? I thought so.

Thursday, January 14, 2016

Educating Sandeep Prasad of Action Canada for Sexual Health and Rights

Sandeep Prasad (Executive Director, Action Canada for Sexual Health and Rights) should know better. He thinks that RU-486 will:
"increase access to abortion in more remote and rural areas"
and that
"Limiting the ability to prescribe Mifegymiso to physicians especially restricts access to the service in communities where it is most needed, in rural and remote areas where physicians are lacking and abortion services are far and few between."
You'd think that the executive director of a major "pro-choice" organization would know of the dangers of RU-486 being used where "physicians are lacking and abortion services are far and few between".

Here you go Sandeep: Educate yourself on this dangerous drug. You don't want women in rural areas to take this drug. Not unless you don't care what happens to them if they have serious complications like:
"pelvic infections (endometritis, salpingitis [inflammation of the fallopian tubes]) and vaginal haemorrhages. Rare cases of fatalities were reported, therefore access to emergency care which can provide gynaecological surgical procedures, antibiotic intravenous therapy and blood transfusion in the rare cases where complications occur, is recommended in the labelling to ensure patient’s safety."
How will these women get the help they need in these rural and remote areas when things go wrong?

Friday, August 21, 2015

Joyce Arthur's logic isn't logical

This letter prompted Canada's number one pro-abortion Joyce Arthur to say this:
"It is irresponsible to allow dangerous medical misinformation like this to be published. The letter writer’s sources are apparently anti-abortion and therefore ideological."
Isn't that rich? Ms. Arthur dismisses the letter writer's sources because the writer is "anti-abortion and therefore ideological". Well since Arthur is "pro-abortion and therefore ideological", why would she think we wouldn't dismiss her as well?

I wonder if Ms. Arthur has read Renate Klein's book "RU486: Misconceptions, Myths and Morals."  Dr. Klein is extremely opposed to RU-486 and backs this up with extensive research into its harms. By Arthur's own logic, this book is worthy of paying attention to, since Dr. Klein is pro-choice.

Funny that Arthur doesn't mention the book in her letter.

Sunday, August 9, 2015

The pro-abortions and their heart of lead

"It’s deeply disturbing to look across the border and see how cavalierly the health and safety of American women are being tossed aside. The debate currently raging in the U.S. around reproductive health care just serves to reaffirm a sad truth: that for many people, the health and safety of women simply do not matter. To the Republican politicians who have made defunding Planned Parenthood a priority, it seems women’s lives and bodies are mere tools for inciting easy political and moral outrage."
The "health and safety of American women are being tossed aside"? What about the health and safety of the children they're carrying? What about the children being killed in their mother's womb for the sake of "reproductive choice"?

The pro-abortions are pathetic. As Carly Fiorina says: “Oh, please! Oh, please.”

And oh. It's also "excellent news" that we can now use the "gold standard" of killing pre-born children with pills. How awesome is that?
"In light of all this, it’s easy to look at the state of reproductive health in Canada and feel a comparative sense of pride. Just recently, it was announced that RU-486, or Mifegymiso, a drug widely considered the “gold standard” of medical abortions, will be available as early as January 2016. This is excellent news; the drug could play an enormous part in making abortion accessible and safe, especially for women who live in communities where access to clinics and abortion services is either difficult to obtain or (as is the case in Prince Edward Island) completely nonexistent."
Do these people ever listen to themselves? Do they have a heart at all or is it made of lead?

These people are so blinded by their "reproductive choice" pro-death agenda that they have no idea that other tiny defenseless human beings are being sacrificed at their altar of abortion. They're blinded, or more probably, they just don't care.

Wednesday, August 5, 2015

Health Canada and RU-486: fatalities, endometritis, salpingitis and haemorrhages

From Health Canada's website:
"Analysis of the pivotal trials revealed that the average bleeding time was 10.8 days including 2 days of heavy bleeding. The majority of adverse events reported were transient and mild to moderate in severity. The medication causes vaginal bleeding and commonly induced pain and cramping, which required pain medication in some women. The other adverse events more commonly reported were diarrhea, nausea, vomiting, fever/chills, headache, dizziness and weakness. Treatment failure (which was defined as viable pregnancy, non-viable persistent pregnancy, persistent bleeding and abdominal pain that required a surgical termination of pregnancy) was reported in 2% to 4.8% of women. 
A small number of patients who took Mifegymiso presented more serious complications, such as pelvic infections (endometritis, salpingitis [inflammation of the fallopian tubes]) and vaginal haemorrhages. Rare cases of fatalities were reported, therefore access to emergency care which can provide gynaecological surgical procedures, antibiotic intravenous therapy and blood transfusion in the rare cases where complications occur, is recommended in the labelling to ensure patient’s safety."