‘Medicine register is not accurate’
Patient questions South African Health Products Regulatory Authority after having adverse reaction to substitute medicine
The register for the South African Health Products Regulatory Authority (SAHPRA) is outdated and sub-standard, its chief executive has admitted to Mail & Guardian.
It has a 16 000-product backlog dating back to 1995, according to Dr Boitumelo Semete, who said the shortcomings were “being addressed” after the register’s website went live last week to enable interaction with the public and the healthcare industry while SAHPRA deals with the “last vestiges” of the backlog, which Semete asserts will be “cleared by the end of the year”.
This emerged after an alert Durbanite, Sharon Rina-rose de Villiers, who suffers from chronic rheumatoid arthritis, experienced a severe reaction after having to change to a different brand of a schedule six medicine she takes.
De Villiers proved to be a “patient outlier” in personally registering her complaint, but the chairperson and chief executive of SAHPRA admitted to “dealing with huge backlogs” and confirmed that doctors regularly rely on the register when patients suffer severe adverse reactions.
A shocked and outraged De Villiers, who contacted M&G after being frustrated by SAHPRA’S responses, says the registration number of the alternative brand appeared not to exist.
“It took me four days to find out from SAHPRA that the registration number did, in fact, exist and had done so for over two years, but that they had failed to update their registers.”
Concerned by this “extreme negligence”, she looked up the registration numbers of numerous other medicinal products sold by the same company that makes the methylphenidate to which she had the reaction.
“I searched for these registration numbers, many of them schedule four and above, on the SAHPRA website and found at least 23 other discrepancies.”
When she contacted SAHPRA “their excuse was that their registers were static (not up to date) but they would be publishing live registers soon”.
“It’s clear how completely useless these registers are in their current state — the public cannot use them, and in some cases, as it was with me, they are misinforming the public about extremely serious issues, like whether or not the medicine they’ve taken is counterfeit or legitimately registered.”
De Villiers said that considering the extreme rise in counterfeit medicine across the world and specifically in Africa in recent years, “I’m appalled at the state of this regulatory authority.”
Contacted in New York, SAHPRA chairperson Professor Helen Rees promised to get Semete to investigating the matter and report back to her and the M&G.
“There was a huge backlog that needed addressing in many different areas. It’s good to know if there’s an issue,” she said.
Semete responded: “We’re acutely aware of the problem — this is not the only complaint we’ve had. Typically, they don’t come from members of the public who hardly know that the register exists, but from healthcare practitioners wanting to check on products or checking on adverse drug reactions their patients have had.”
She said the biggest users of the register were stakeholders trying to procure a product or health sector players wanting to know whether a product was registered or wanting to bring in an alternative product that was unregistered. Another big user was the National Essential Medicines List Committee that doctors regularly use.
Semete said all serious adverse reaction reports led to eventual modifications in the personal information leaflet of the drugs concerned.
De Villiers said that her rheumatoid arthritis was so bad when she was a master’s student 12 years ago she was “practically bed-bound”.
Five years ago, a doctor suggested she try methylphenidate, more commonly known by the brand name
Ritalin, in an attempt to counteract the extreme sedative effects of the strong painkillers she was on.
Methylphenidate made a “significant difference” to her lifestyle and until recently she had not experienced any adverse effects with it, or any other drug.
“Two weeks ago, my father went to purchase methylphenidate on my behalf. The only brand the Alpha Pharm pharmacy had in stock was from Biotech Laboratories and this was what my father purchased. It was the first time I had ever tried medicine from this company and the reaction I had to it was extremely worrying,” she says.
“I stopped the medicine after two days, yet the side effects continued for an additional two days, and then over the following week began to gradually decrease in severity.”
She said that during these four days she lost coordination of her fingers so that typing on her phone or laptop was impossible. “It took 45 minutes to type two sentences as I kept making numerous mistakes despite concentrating as hard as I could.”
The loss of coordination was accompanied by nausea, blurry vision, stomach cramps and sporadic trembling of her hands.
“I’ll be the first to accept that we’ve had major challenges,” said Dr Semete. “As a regulator we should have an up-to-date database. The intention is to have all the latest information on products and their status. We’re also working with the industry to say, ‘This is what we have registered for you on our databases. Here’s the list, please verify with us.’”
She said the current dysfunction had to be viewed against the background of a severely understaffed and underfunded SAHPRA inheriting a backlog of 16 000 products from the former Medicines Control Council, whose functions it took over in 1995.
Added to this was the Covid-19 pandemic and “flood of incoming products that triggered — all of which we had to monitor and clear”.
“I’m happy to say we’ve cleared over 90% of the backlog and will have completed it by the end of the year, all the while dealing with thousands of new applications,” she said.
Semete said that the July 2021 riots in Kwazulu-natal included widescale looting of medicines, which resurfaced in spaza shops and popup backyard pharmacies countrywide. Teams had to be dispatched to retrieve and destroy these medicines.
Asked how bad the understaffing was, she said she had 300 highly skilled, mainly technical staff, while she required around 500 staff for full operational efficiency.
“We’re currently getting 40% of our budget from the treasury and raising the rest from our own fees. But we can’t rely on fees, so we’re negotiating with treasury to push their contribution up to 60%,” she said.
SAHPRA later said in a statement that it noted the register anomalies “with concern” and acknowledged the registers were “at times out of date”, in spite of being updated regularly.
The “real-time” register would reflect current information on registered products, including changes to the applicant, proprietary name or the registration status.
“Counterfeit medicines are a ubiquitous problem on a global scale and our compliance unit works tirelessly with law enforcement agencies to curb and eradicate this burgeoning illicit practice.
“Our registers only reflect registered and legitimate products. We regret the side-effects encountered by the patient and encourage all patients to download the Med Safety App (medsafety.sahpra.org.za),” the statement said.
De Villiers said she also researched Biotech Laboratories, the manufacturer of the drug to which she’d experienced the severe reaction.
“I found some very worrying things including a website dated 2019 and an out-of-date address featured on all their products, besides the very misleading brand name.”
Biotech Laboratories has never had a single laboratory and has nothing to do with research and development of medicinal products, which the word “Laboratories” implies. It simply imports all the medicine it sells from India and then sells it locally, De Villiers said.
“Most concerning of all was the conversation I had with one of their board members. He was very defensive regarding my queries and wasn’t in the least bit interested in my adverse reaction to their product — this was despite my telling him that the side-effects were extreme and that I was really worried.”
The chief executive of Biotech Laboratories, Stewart Barker, said it was the first adverse reaction reported on the schedule six medicine that his company imported and had registered with SAHPRA.
He stressed that Methylphenidate 10 Biotech was not indicated for rheumatoid arthritis, “so any offlabel use is not recommended and can be risky and irresponsible. This is why any patient needs to have a pre-treatment assessment by a medical doctor”.
Neither he nor his co-director had taken a call from De Villiers, whom he wished well in her recovery.
Barker said Biotech imported medicines from India, Switzerland, Cyprus and Spain, the last country being where the relevant medicine was made in accordance with European formulations when it was registered there.