European Regulatory Roundup: Sweden Limits Availability of Paracetamol (5 November 2015)

Regulatory NewsRegulatory News | 05 November 2015 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Swedish Regulators Limit Availability of Paracetamol

Sweden has prohibited the sale of paracetamol tablets outside of pharmacies. The action follows a decision by the Swedish Medical Products Agency (MPA), which ruled in April to limit where the drug is sold in an attempt to curb the rise in paracetamol poisonings. 

MPA’s ruling overturned a decision from 2009, at which time the Swedish government cleared gas stations and grocery stores to sell paracetamol tablets alongside 600 other over-the-counter drugs. Convenience stores quickly captured a slice of the market but the period also coincided with a sharp rise in the number of people being poisoned by the drug. In 2009, 621 paracetamol poisonings were reported in Sweden. By 2013, the number had jumped more than 85% to 1,161.

Faced with a correlation between the availability of paracetamol and the number of poisonings, MPA decided to once again restrict sales of the tablets to pharmacies. The new policy, which came into force on 1 November, means consumers who want to buy paracetamol tablets can only do so from one of the 1,350 pharmacies in Sweden. Convenience stores will continue to sell paracetamol in other dosage forms, such as liquid formulations and effervescent tablets. 

“The aim is to reduce the number of poisoning without substantially restricting normal use of medicines treating pain and fever,” MPA wrote in a statement to explain the decision.

MPA Statement

MHRA Teams with Industry to Create Patient-Friendly Alzheimer’s Packaging

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has started working with the industry to create drug packaging tailored to the needs of people with Alzheimer’s disease. MHRA is aiming to introduce the packaging in June 2016.

Officials at MHRA initiated the collaboration in response to feedback from people with Alzheimer’s about the difficulties they face when handling standard packaging. The revised packaging is designed to address these concerns, notably by displaying the days of the week clearly on blister packs. MHRA foresees the change helping patients to continue independently taking their medicines as the disease progresses. The new labeling could also aid compliance and therefore improve outcomes.  

A desire to make life easier for people living with Alzheimer’s is at the root of all of these potential benefits. “Medication packaging can be confusing for people with dementia,” George McNamara, head of policy at Alzheimer’s Society, said. “Simple modifications, such as indicating the days of the week or making the font clearer to read, can have huge implications for both the independence and the safety of people living with dementia.”

For now, the initiative is focused on the packaging of Alzheimer’s drugs, but given the prevalence of long-term comorbidities among the dementia population there is interest in expanding the scheme to cover medications targeting other indications. Such an expansion of the program is a long-term goal for McNamara. In the near term, the focus is on getting the design of the packaging of dementia drugs ready for its introduction to the market in seven months’ time.

Press Release

AstraZeneca Posts Warning About Three Years of Local Anesthetic Supplies

AstraZeneca has posted a warning about every batch of Marcain Polyamp Steripack 0.5% released in the United Kingdom since December 2012. The alert was released after AstraZeneca learned every batch produced over that period featured an error in the text on the packaging.

Labels on each carton and ampule of the local anesthetic Marcain Polyamp Steripack 0.5% released over an almost three-year period stated the product was suitable for intra-articular administration. This is not true. The summary of product characteristics for Marcain Polyamp Steripack 0.5% has the correct information, though, and the error is not thought to pose a threat to patient safety. As such, MHRA released a class 4 drug alert advising caution but stopped short of initiating a recall.

Batches of Marcain Polyamp Steripack 0.5% with incorrect labeling will therefore stay on the market and will in fact continue to be released. MHRA is allowing AstraZeneca to continue shipping affected stock while it works to fix the situation to avoid a shortage of bupivacaine hydrochloride, the local anesthetic that is sold by AstraZeneca under the brand name. The plan is to start shipping batches with the correct labels in January. 

While MHRA sees the error posing no threat to patients, intra-articular infusions of local anesthetics have been linked to adverse events. The United States Food and Drug Administration (FDA) label for Marcaine, the brand name under which bupivacaine hydrochloride is sold in the US, warns post-marketing reports have linked the infusion of local anesthetics following arthroscopic and other surgical procedures to the destruction of cartilage cells, a process known as chondrolysis.  

MHRA Notice

MHRA Starts Medical Assessor Recruitment Drive

MHRA has started a campaign to recruit medical assessors. The initiative is intended to present the role as an attractive option to people with medical backgrounds who are thinking about making a career change.

Medical assessors contribute to medicine licensing and post-marketing surveillance activities at the regulator, tasks that entail the review of safety issues and preparation of reports on adverse events. MHRA is hoping the work will prove attractive to people who have trained as doctors but are unsure whether they want to follow the traditional career path. Given the ongoing dispute between the government and junior doctors, a substantial pool of people fall into this category.

MHRA thinks it can provide an attractive alternative to healthcare professionals. “The timelines we work to are very short in the clinical trials unit, but this means no two days are the same: one day it’s a trial for a new cancer agent, the next it’s the latest gene therapy product,” Kirsty Wydenbach, a MHRA medical assessor, said. The regulator is also talking up the training it offers and the route it can provide into organizations such as the Faculty of Pharmaceutical Medicine.

Press Release

Other News:

The European Medicines Agency (EMA) has finalized its inventory of pediatric therapeutic needs in gastroenterology following a public consultation. EMA received comments from three sources but dismissed almost all of the suggestions. Some of the drug additions proposed by the public will be included in an upcoming neonatology document. Gastroenterology Pediatric Needs, Comments

The manufacturer of a substance used in eye operations has denied it is the cause of 13 cases of blindness. Spain recalled the product, Ala Octa, after 13 of its citizens lost sight in one eye and a further 28 people suffered injuries. France has also recalled the product amid safety concerns but its manufacturer, Alamedics, has found no evidence that the batches are contaminated. AFP

The European Commission has proposed enacting an export waiver for supplementary protection certificates (SPCs). The generic industry supports the plan. “Europe needs to rapidly introduce a targeted SPC waiver to capitalize on this tremendous opportunity for pharmaceutical manufacturing in the EU,” Adrian van den Hoven, EGA Director General, said.

Mainstay Medical has applied for a CE Mark for its implantable neurostimulation system. The device is designed to treat chronic lower back pain by stimulating the nerves that cause the contraction of muscles. In a 46-person trial, around two-thirds of people experienced a reduction in lower back pain symptoms after living with the implant for three months. FierceMedicalDevices



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