COVID-19 Prompts OTC Sales Restrictions Across Europe
Executive Summary
Countries across Europe are restricting sales of OTC drugs in response to COVID-19 to maintain supply and counteract stockpiling. The approach varies widely across the region: countries such as Germany and France have introduced strict limits, while others, such as the UK and Ireland, have not ordered official restrictions. HBW Insight presents an analysis of the actions taken by 14 European countries to the upsurge in demand for OTCs.
COVID-19 is spreading rapidly across Europe leading to an unprecedented upsurge in demand for popular OTC drugs which can be used to treat some of the virus’ symptoms.
While some countries in the region have been hit harder than others by the pandemic, stockpiling of non-prescription products appears to be an almost universal problem, according to reports from regulators, retailers and the pharmaceutical industry.
Seeking to prevent shortages of OTCs, a number of national drug regulators have introduced strict limits to the number of non-prescription products which consumers can purchase at any one time, while others have urged retailers to be mindful of depleting stocks too low.
HBW Insight has investigated the response of 14 European countries to OTC drug stockpiling and outlined the measures regulators are taking to ensure continued supply.
The actions taken vary widely across the region, with countries like France and Germany introducing strict limits on OTC purchases, while others, such as the UK and Ireland have refrained from imposing official restrictions.
Austria
Austria’s Federal Office for Safety in Health Care has urged consumers not to stockpile OTC drugs in response to the coronavirus outbreak.
The regulator said that based upon the latest information it had from pharmaceutical manufacturers and wholesalers, the supply of drugs was currently secure.
While it was closely monitoring the situation, the Federal Office said at this time there was no need for Austrian consumer to “hamster away drugs”. It has reminded pharmacies to only dispense drugs in the “necessary quantities.”
Belgium
Belgium’s Federal Agency for Medicines and Health Products (FAMHP) has introduced limits on OTC sales of paracetamol and warned consumers not to panic buy drugs.
The agency said it had asked pharmacies – both bricks-and-mortar stores and online outlets – not to supply more than one pack of paracetamol per customer. Anyone looking to purchase paracetamol in a larger quantity will now require a doctor’s prescription.
Alongside the paracetamol restriction, FAMHP has asked consumers “not to pointlessly stock up on medicinal products” with stocks of certain OTC drugs “selling out rapidly” in Belgian pharmacies.
Consumers should only buy the quantities of medicinal products that they need right now, according to the agency, as depleting stocks could put other patients in danger.
Despite the new restrictions, FAMHP reassured consumers that there were still sufficient wholesale stocks of medicinal products in Belgium, with no shortages currently anticipated.
Denmark
Denmark has introduced restrictions on the sale of all OTC drugs to prevent hoarding.
National drug agency Laegemiddelstyrelsen has ruled that Danish consumers can purchase only one pack of OTCs per active ingredient each day. The rule applies to both pharmacy and grocery.
Due to supply problems for OTC pediatric paracetamol, the agency has banned all sales of such presentations outside pharmacy, specifically for the liquid suspension and suppositories. It said it was acting to ensure children in need could access the drug.
“There is a great deal of pressure on demand from the companies that manufacture [paediatric paracetamol], and the COVID19 pandemic is a contributing factor to that,” noted Laegemiddelstyrelsen director Thomas Senderovitz.
France
France’s drug agency, ANSM, has taken measures to limit sales of non-prescription analgesics.
“In order to guarantee their availability, from March 18 pharmacists will be able to dispense without prescription only one single pack of paracetamol (500mg or 1g) per patient with no symptoms, or two packs (500mg or 1g) in the event of symptoms of pain and/or fever,” ANSM stated on its website.
Additionally, online sales of medicines containing paracetamol, ibuprofen and/or aspirin were also suspended, the agency declared. (Also see "France Limits Sale Of OTC Analgesics In Response To Covid-19" - HBW Insight, 19 Mar, 2020.)
Germany
Due to a significant increase in demand for paracetamol in Germany, minister of health Jens Spahn has told pharmacies – both bricks-and-mortar and mail-order – to only supply the drug without prescription if there are no suitable therapeutic alternatives. If paracetamol is required, pharmacies must only supply a limited amount for a short duration of treatment.
Pointing to “bottlenecks” in drug supply chains, Spahn also told manufacturers and wholesalers not to rush to over-supply pharmacies with paracetamol, a move which would only deplete stocks further.
The minister said he wanted to “continue to ensure a needs-based supply of medicines containing paracetamol.”
Spahn’s move comes after Germany’s Federal Institute for Drugs and Medical Devices, BfArM, asked manufacturers and wholesalers not to supply drugs “beyond normal needs.” Supplies to pharmacies should be based on average monthly sales volumes for 2019.
“According to the information available to BfArM, there is currently an excessive stockpiling of individual market participants with medicinal products, which leads directly to an unequal distribution,” the agency noted.
Ireland
Ireland’s Healthcare Products Regulatory Authority has not implemented sales restrictions on OTC drugs, but has asked consumers “not to seek supplies of medicines over and above their normal requirements.”
“Doing so,” HPRA noted, “will disrupt existing stock levels and hamper the supply of medicines for others.”
The regulator said it additional stocks of drugs were built into the Irish supply chain therefore it was unlikely to face supply issues “now or in the near future as a result of any COVID-19 related issues.”
“There is no need for hospitals or healthcare professionals to order extra quantities of medicines,” the regulator added, “or for doctors to issue additional prescriptions.”
Italy
Italy’s drug agency AIFA has teamed up with industry trade groups to monitor and counteract shortages in the countries pharmaceutical supply chain.
Enrique Häusermann, president of Italy’s generic drug manufacturers association Assogenerici, noted that while production and distribution of pharmaceuticals had gone into overdrive in the country, the sector was “reacting well.”
In particular, the demand for all drugs belonging to the classes of muscle relaxants, anesthetics, opioids and sedatives had notably increased, Häusermann reported.
"Companies in this our hour of need are showing a sense of responsibility and unprecedented collaboration,” he noted. “Production has been increased, production lines have been transformed, imports made in record time from other countries, a frenetic activity that has seen a great collaboration between companies, with the immediate support of AIFA.”
While AIFA is working closely with the pharmaceutical industry to prevent drug shortages, it is yet to introduce any official limits on purchasing for consumers.
Netherlands
The Netherlands is yet to place any formal restriction on the supply of OTC drugs, however, local drugstore association Centraal Bureau Drogisterijbedrijven (CBD) has introduced its own measures to combat shortages.
Following consultation with Netherlands’ Ministry of Health, Welfare and Sport, the CBD has urged all drugstores to move paracetamol behind the counter and to limit supply to two packs per customer.
While there were “sufficient” stocks of paracetamol in Dutch drugstores, CBD it was taking action after seeing a notable rise in demand from consumers. “If we take each other into account, there is enough for everyone,” the group stated.
Meanwhile, the health ministry said it continued to monitor drug availability in the Netherlands, and internationally. “There are currently no drug shortages due to the outbreak of the virus. However, it cannot be ruled out that supply problems may arise if trade with China and India is hindered for a longer period of time.”
Norway
Norway’s drug agency Statens Legemiddelverk has ordered pharmacies to limit supply of all non-prescription products “to ensure everyone gets the medicines they need.”
Pharmacies can now only supply one adult formulation and one child formulation of an OTC product per customer. The agency said the limit applied to all drugs classified in Norway as OTC.
Informing consumers of the new purchase limitations, Statens Legemiddelverk called on the public to “show solidarity,” adding “don’t buy more than you need!”
Portugal
Portugal’s drug agency Infarmed has urged pharmacies and other retail outlets to limit sales of all non-prescription products to one pack per active ingredient per customer.
“Particular attention should be paid to observing this guidance for all presentations of paracetamol,” Infarmed noted.
The regulator said it was taking action to prevent hoarding of OTC drugs and to ensure all consumers had access to the treatments they needed.
Currently, there were no issues in OTC drug supply in Portugal, Infarmed noted.
Spain
Spain’s General Council of Pharmacists has urged consumers not to stock up on popular OTCs, such as paracetamol, to avoid future shortages.
The Council noted that the move by France to limit sales of paracetamol had led to an upsurge in demand for the drug in Spain as consumers feared its own country would follow suit.
While OTC stocks remained high, Spanish pharmacists would now assess the appropriateness of all paracetamol purchases, the association noted, while the Council would centrally monitor availability of all in-demand OTCs on a daily basis to help control supply.
“We must insist that citizens do not stock up on certain drugs if we want to make them available to those who need them most,” commented Council president Jesús Aguilar.
Separately, Spain’s ministry of health has published a list of “essential” drugs that manufacturers must continue to supply during the COVID-19 epidemic. Many OTC drugs are on the list, including paracetamol. (More to follow on this story.)
Media reports in Spain note that Spain’s military have begun producing paracetamol – along with disinfectants – to meet demand. The Centro Militar de Farmacia de Defensa, located in Colmenar Viejo, is acting on the orders of the Ministry of Health.
Sweden
Sweden’s medical products agency, Lakemedelsverket, has called on pharmacies and other retail outlets to limit the amount of OTC drugs they sell to individual consumers to prevent stockpiling.
While it had not received reports of disruptions in drug deliveries due to the outbreak of COVID-19, the agency said it had seen signs of increased demand for certain drugs at individual pharmacies and retail outlets. This has led to the temporary suspension of certain drugs in product ranges.
"We want to encourage all concerned to do what they can to counteract excessive purchases of medicines," said Catarina Andersson Forsman, Lakemedelsverket’s director general.
Switzerland
Switzerland’s Federal Council has introduced sales restrictions for a number of non-prescription products to ensure continued supply for the duration of the coronavirus outbreak.
Analgesics such as paracetamol, acetylsalicylic acid and ibuprofen are limited to one pack per customer in pharmacies and drugstores. Carbasalate calcium, diclofenac, codeine and mefenamic acid are among the other drugs limited to one pack per sale.
Valid for an initial period of six months, the restrictions are based on Switzerland’s state supply act, which enables the Federal Council to take measures to ensure supply of essential goods in the event of existing or imminent shortages.
UK
In the UK there have been reports of shortages of paracetamol as a result of consumers stockpiling the drug.
HBW Insight’s sister publication Chemist + Druggist says that while pharmacists are having difficulty getting hold of the drug, the UK’s Department of Health and Social Care insists there is no shortage.
Responding to reports of depleted stocks, John Smith, chief executive of the Proprietary Association of Great Britain, said there had been in recent weeks an “unprecedented increase in demand for paracetamol.”
“PAGB member companies are working incredibly hard to increase supplies and will do all they can to ensure paracetamol products are available in pharmacies and supermarkets across the UK,” Smith noted.
While the Medicines and Healthcare products Regulatory Agency is yet to introduce official restrictions on paracetamol sales, PAGB said it understood some stores were limiting purchases of the drug.
“We welcome the measures that retailers are putting in place to manage demand,” Smith said. “We urge people to only buy what they currently need.”