Rheumatoid Arthritis patient had medication switched without consultation twice

A Rheumatoid Arthritis patient has had her medication switched around twice without having been consulted about the situation beforehand, The Malta Independent is informed, effectively being left with no option but to accept the change or face paying high prices privately.

During the month of September, representatives of Arthritis patients raise awareness about this hidden yet fatal autoimmune disease, and while the month is coming to an end, the challenges that these patients face on a daily basis persist.

One of the more recent and detrimental challenges such patients face involves a switch in their medication, in some cases, twice in a row without the patient having been consulted.

This applies to Bernadette* who lives with Rheumatoid Arthritis (RA), which is defined as a hereditary autoimmune disease that causes the immune system to attack one’s body and organs rather than intruders, shortening the person’s life span. RA is incurable, but it can be managed through heavy medication – including biological medication which is the most effective of them all.

Biological medication is branded medication that uses a substance that comes from a living organism or its products.

“I remember one day, in my twenties, where I went to bed and I could not get up the next morning. My whole body was swollen, my veins turned bluish-purple and I was in so much pain, feeling tired like I had been hit by a truck,” Bernadette told this newsroom.

Following these symptoms, she was prescribed heavy doses of corticosteroids and biological medicine by a rheumatologist.

She expressed her gratitude for being treated rapidly, which she explained saved her from developing disabilities at an early stage. However, the downside is that she is completely dependent on this medication for life.

“I was not surprised when I got it,” Bernadette said, “but I was still in shock because it is hard for people to understand; even for some GPs and doctors. They look at you and assume that you are healthy, but this is not true since I manage my disease through medication.”

Apart from the pain and discomfort she feels on a daily basis, RA has also forced Bernadette to make some heart wrenching decisions, including her decision not to have any children of her own.

“Since RA is hereditary, there is a high probability that I could pass it on to my children and I did not want them to suffer with an incurable illness like mine. My doctor told me that I would pass on this disease at a high level, seeing that all the women in my family had some kind of autoimmune condition,” she recounted emotionally.

Taking her medication while pregnant was also an issue – “I have to take care of myself so I could not see myself taking care of a child if I am sick myself and risk spreading that sickness onto them.”

Bernadette explained that she still has to work, even though the pain in her arms and hands cause difficulty. “I was planning to progress in my studies, but I had to ask myself ‘is it really worth it?’ Since this disease has a chance of shortening my life I always question what I am doing. I have to try and enjoy each day, which is also why the switch in my medication really aggravated me.”

‘The original was a miracle drug for everyone’

Bernadette explained that she had been on biological, branded medication for over a decade and was doing well with her blood tests and inflammation levels. After she switched to biosimilar medication, her inflammation levels remained quite low, but she started feeling pains she had never experienced before.

Biosimilar medication is made from living organisms but produced in different ways, such as in laboratories and used as an alternative to the original.

She noted that the biosimilar has the same active ingredient as the biological medication, however, the former can result in a ‘loss of effect’. With the biological medication, Bernadette could hold up to between seven or nine days with no medication she said, but with the biosimilar she started noticing unfamiliar pains by the fifth day.

Another issue she faced with the biosimilar is the needle through which the medication is administered, which she said hurt when compared to the biological one. This is something that other patients and medical professionals reported worldwide and after speaking with her rheumatologist she discovered that patients were being switched, yet again, to another medicine because of this issue.

The third medication is a generic type of the biological which is supposed to be more effective than biosimilars. Bernadette has been on this medication for the past couple of weeks and it seems to be working well, though she is feeling more tired than usual.

Generic medication is a copy of an existing biological medication, but is generally cheaper in price.

Having to make the switch twice has left her feeling helpless as she had no guarantee that this medication will have the same effect as the biological she used to take, and it takes weeks to evaluate progress.

She explained that the generic medication comes at a significantly cheaper price, which made her speculate whether this is a case of pharmaceutical greed. “While I do understand why they need to cut costs, since biologicals are expensive due to their effectivity, I do not think this should have been done across the board; a case by case approach is needed.”

“It is always good to look for better alternatives, but it has to be based on medical feedback not financial or economic factors. Doctors have to go along with the decision, but they are the experts, this is not a business decision, this is about someone’s life.

While speaking to this newsroom, Mary Vella, President of the Arthritis and Rheumatism Association Malta (ARAM), said that in making these unprecedented changes to medications, Malta is going against all recommendations from international bodies about switching.

She explained that the European League Against Rheumatism (EULAR) recommendations state that no switch should take place before a thorough consultation between the patient and the prescribing consultant.

“In Malta, stocks of a biological medications can dry up, and then the patients are offered a biosimilar substitute, with no option. Furthermore, when the patient refuses the switch, he or she is directed to his consultant in hospital. This is not a feasible option at the present time – to go to Mater Dei for counselling and training on the new injecting device,” she said.

Notably, this newsroom has already reported a similar case of switches in medication from someone with Chron’s Disease. The Malta Independent asked the Health Ministry why this switch was not communicated with the patients and if it was done for economic gain.

The Ministry did not give a direct answer to these questions, however, it did say that Public Procurement Regulations and competition laws stipulate that the procurement of medicines should be led by non-branded specifications (as is the case for biosimilars).