Difficult-to-Understand Wording, Confusing Dosage for Children, and Unclear Adverse Reactions
Pharmaceutical Instructions Read Like an Exam
Earlier this month, the National Medical Products Administration (NMPA) released the third batch of pilot programs for the reform of drug labeling aimed at the elderly and those with disabilities, which includes over 300 medications. The initiative seeks to introduce “large-print” labels. However, a recent investigation revealed that aside from being “small as an ant,” many drug labels are overcrowded with complex information and often present vague details regarding pediatric dosages and adverse reactions. Experts suggest adding QR codes to drug labels so patients can scan them to access audio or video explanations for a quicker understanding of the medication’s details.
Overwhelmed by Information
Mr. Sui, a patient with chronic bronchitis, had purchased a box of Moxifloxacin Hydrochloride tablets that he intended to continue using. Upon reviewing the instruction manual, he found himself bewildered.
“The front and back of the label are packed with text. I spent an hour trying to decipher the dosage instructions, and it felt like doing a reading comprehension test,” he remarked. He measured the instruction sheet, which was over 60 centimeters long. The “Dosage and Administration” section alone had nearly 20 lines detailing various conditions, such as acute bacterial sinusitis and chronic bronchitis, along with a complex 7-line chart explaining the treatment regimen. For someone without a medical background, it can be quite overwhelming.
Other patients have expressed similar frustrations, joking that “reading the drug label makes you want to cry.”
“As a patient, my main concerns are the applicable conditions, dosage, and contraindications. Can’t the instruction manual highlight these key points better?” asked Mr. Huang, who bought Atorvastatin tablets. He noted that sections on drug interactions and pharmacokinetics took up roughly four-fifths of the information, making it necessary to display patience to fully understand the dosage.
Responding to these patient concerns, Liu Lihong, Director of the Pharmacy Department at the China-Japan Friendship Hospital, stated, “The drug label is a statutory document conveying important information about the medication.” These labels serve as a legal guide for doctors in selecting medications and provide critical data on safety and efficacy for patients.
In May 2022, the NMPA published a guideline outlining the general format and writing standards for chemical and biological product labels, mandating that these should contain over 20 pieces of information, including indications, dosage, clinical trials, and standards of use.
Wang Yue, a professor of medical ethics and law at Peking University, noted that the significance of prescription and over-the-counter drug labels differs for patients. For prescription medications, doctors already specify the dosage, leaving the patient only needing to follow the prescription without needing to peruse the label.
For over-the-counter drugs, patients should focus on essential information, such as indications, dosing, contraindications, and storage, without getting lost in technical jargon. If unsure, they should consult with a physician instead of taking medications indiscriminately.
Ambiguous Pediatric Dosing
Determining the appropriate dosage for children can feel like an experiment. Ms. Ge’s 7-year-old daughter was recently diagnosed with acute tonsillitis, and the doctor prescribed a box of Ampicillin granules.
After reviewing the instructions at home, Ms. Ge found that the “Children’s Dosage” section stated: administer 25 to 50 mg for every kilogram of body weight per day, with one packet containing 0.125 grams. “I had to grab paper and pencil, treating it like a chemistry problem,” she complained.
Moreover, some instructions specify reducing adult dosages to calculate pediatric dosages. For capsule or tablet forms, one must break or grind the medication before measuring.
“According to the instructions, my child would need to take 2.25 bags of medicine, which is nearly impossible to measure accurately,” said Ms. Han. One bag of Azithromycin suspension is only 0.1 grams, and her kitchen scale can’t measure that precisely; she ends up estimating, “I feel like I’m conducting a chemistry experiment.”
Liu Lihong noted that the children’s medication market in China often lacks variety in formulations and dosages, leading to a reliance on adult medications that are adjusted for pediatrics.
“The clinical trials for pediatric drugs are more complex and have stricter requirements,” Wang Yue explained. Recruiting children for study trials faces ethical hurdles, resulting in significant costs that deter pharmaceutical companies from developing children’s drugs.
“To address the shortage of specialized pediatric medications, China has been actively working to encourage research and expedite the approval process for innovative pediatric drugs,” Liu added. From 2016 to 2024, the National Health Commission has consistently released a list encouraging research into children’s medications.
Untested Adverse Reactions Raise Concerns
“Unclear adverse reactions—should we feel safe taking this?” Recently, Ms. Qian experienced diarrhea and night sweats, and a pharmacy staff member recommended she try a traditional Chinese medicine product, Yipingfeng granules. However, upon opening the box at home, she found that the sections on “Adverse Reactions,” “Contraindications,” and “Drug Interactions” were all marked “not clear,” which raised her concerns about the safety of the product.
The pharmacy staff reassured her, saying, “Many adverse reactions for traditional Chinese medicines are labeled ‘not clear.’ Rest assured, any drug approved for sale is certainly safe.”
Similarly, Ms. Zhao was troubled after being diagnosed with mumps and prescribed two boxes of Cold-Heat Dispelling capsules by a community health center. Unlike western medications, which often come with multi-page instructions, this capsule’s label was tiny and just a few hundred words long, with adverse reactions and contraindications simply labeled “not clear.”
After researching online, she learned that one of the main ingredients, golden Aster, has associated liver toxicity and teratogenic effects, with long-term use potentially linked to cancer. Although her doctor advised her to return for a follow-up if she experienced discomfort, Ms. Zhao ultimately decided against using the medication. “Going forward, I won’t take any medications that don’t specify their adverse reactions and risk groups,” she declared.
In visits to ten pharmacies around the city, eight pharmacies reported receiving inquiries from patients regarding adverse reactions to traditional Chinese medicines. One pharmacy staff member pointed out, “Patients have polarizing views on traditional Chinese medicine. Some feel the side effects are minimal and safe, so they don’t require adverse reactions to be documented; others see ‘not clear’ as a red flag for safety concerns.”
Liu Lihong shared that while China has a long history of using traditional Chinese medicine, clinical trials for these drugs didn’t begin until the late 1980s, lacking standards and data for research, which explains the absence of clear adverse reactions for some products. In 2006, the guideline for managing clinical laboratories began to streamline and standardize clinical research for traditional Chinese medicines.
“Labeling adverse reactions as ‘not clear’ doesn’t mean there are no adverse effects,” Liu emphasized. Due to the lengthy and expensive nature of clinical trials, some pharmaceutical companies hesitate to perform new standardized trials, leading to gaps in information about adverse reactions in traditional Chinese drugs. For these medicines used clinically, it is crucial to provide clear information about adverse reactions, contraindications, and precautions as they directly relate to patient safety. She urged manufacturers to enhance the details in their labeling promptly.
In response to these challenges, the NMPA has frequently reminded traditional Chinese pharmaceutical companies to revise their labels, adding warning statements and specifying adverse reactions and precautions. In February 2023, the NMPA released specialized regulations requiring that any traditional Chinese medicines seeking re-registration after three years must clarify any item still labeled as “not clear.”
Expert Recommendations
“Provide both a patient-friendly version and a professional version,” Liu Lihong suggested, stating that the challenge of difficult reading stems from not distinguishing between target audiences. Future drug labels could offer patient versions that minimize technical jargon, highlighting crucial information like dosing and adverse reactions. For more complex medications, Liu recommended including a QR code within the label for audio or video explanations.
“Support for establishing pharmaceutical clinics in medical institutions is essential,” Wang Yue proposed. He believes that in the future, pharmaceutical companies could collaborate with search engines and social media platforms to provide professional, authoritative drug instructions online to aid patient education. However, simply re-designing labels won’t fully resolve the confusion surrounding medication use; key policies must be enacted to support the establishment of pharmaceutical clinics that can provide specialized guidance for patients.
