Thai Pharmacists Fear OTC sales following FDA decision

Most pharmacists will be able to tell you meaningful stories behind what motivated them to join the industry. When we asked Rungthip, a veteran pharmacist in Bangkok about her motivations, she told us the story of the time she moved her grandmother into a nursing home. While moving her belongings she discovered a shoebox hidden away full of medications her grandmother had not taken. She said at that point in time, she knew immediately that she wanted to help other patients by knowing everything she could about those medications. It became her mission to provide direct patient care by helping to improve medication adherence and misuse. There are many such stories in the industry. 

With this in mind, you can imagine the outcry in 2018 when Thailand’s Food and Drug Administration (FDA) delisted a drug which Thai pharmacists consider dangerous. Fear arose not only for the side effects of the drug in question but the fear of setting a dangerous precedent. Being the first line of defense in the healthcare system, it’s common for pharmacists to see the devastating effects of misuse when it comes to medication – for most pharmacists like Paithoon, this is the very reason why they joined the profession. It’s also a very real concern. According to the World Health Organisation, almost half of patients don’t take their medication as prescribed, so it’s reasonable for pharmacists whom are entrusted with the health of their patients to fear what happens when a drug with common side effects no longer needs a prescription. 

What drug was delisted by the FDA?

The drug that sparked this outcry was Loratadine – an antihistamine used to treat symptoms of runny noses and eye and skin irritations caused by nasal allergies or hives. It is more commonly sold under the brand names Claritin and Claritin-D (which contains additional pseudoephedrine). With the delisting by Thailand’s FDA it means that loratadine is now available for over the counter (OTC) purchase without subscription. 


Why do pharmacists think loratadine is dangerous?

According to The Bangkok Post, a pharmacists against the decision cited that FDA’s Health Product Vigilance Centre had recorded 501 cases in 2018 of patients experiencing uncomfortable side effects from taking loratadine. The common side effects of loratadine include: 

  1. Sleepiness and tiredness
  2. Stomach pains
  3. Headaches
  4. Dry eyes, mouth, and throat
  5. Diarrhea
  6. Paradoxical CNS stimulation which causes excited, jittery, or nervous feelings

More severe side effects of loratadine include:

  1. Liver damage or inflammation
  2. Difficulty breathing and tightness in the chest or breathing tube
  3. Unconsciousness
  4. Seizures
  5. Low platelet count (thrombocytopenia)

The drug is also particularly harmful to pregnant women in their first trimester, older patients and those with hepatitis or kidney problems need to take adjusted doses. It is also a powerful drug that should not be given to children under the age of 6. The most overlooked precaution however is that adults should not take more than 10 milligram (mg), equivalent to one tablet per day. Those who take more than the recommended dosage are at greater risk of severe sleepiness, racing heartbeat, and headaches, while children who overdose may start to move and behave similarly to people who have Parkinson’s disease.

Findings consistent with mClinica’s, SwipeRx platform  

A recent survey conducted on SwipeRx among pharmacy professionals in Thailand supports these media findings. The results showed that over 87% of pharmacists from urban areas and 92% of pharmacists from rural areas were against the delisting. The biggest concerns stemmed from their experience with the misuse of loratadine and their belief that it’s not 100% safe. They believe the potential for misuse outweighs the benefits of making it more readily available.

The insight from Thai pharmacists on SwipeRx highlights a key risk when delisting a prescription product and allowing it to become an over-the-counter product that has not been addressed – a lack of public information and education on the many possible side effects. 

According to the pharmacists we surveyed 95% of them agreed that additional efforts need to be put in place to ensure that more people are aware of the strong side effects of loratadine. The most commonly suggested way to solve this problem was for manufacturers and the regulator to highlight the side effects and dangers of overusing the drug more prominently on the label. The pharmacists we surveyed felt this would help raise awareness when the drug is being dispensed and improve patient safety. 

What can mClinica do?

The outcry shown by urban and rural pharmacists in Thailand on the FDA’s decision is a testament to the strong community spirit shared by our pharmacist on SwipeRx. At the heart of mClinica’s business is the pharmacies but it’s clear the effects snowball across all stakeholders in the healthcare industry and our biggest beneficiary will always be the patient who stands to gain the most. 

mClinica designed SwipeRx to provide a first of its kind pharmacy network that can bring pharmaceutical companies, healthcare providers and policy makers direct first-hand knowledge on patient needs and facilitate rapid product education and awareness programmes. mClinica is the only major professional company in Southeast Asia that brings together fragmented pharmacies to better support the healthcare industry’s first line of defense. 

If you are looking to gather business intelligence from our pharmacy network or increase your brand recognition or product understanding among pharmacists and patients contact [email protected] to find out what opportunities are available. 

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