OBJECTIVE: To further improve the regulation of medical device Introduction for Use (IFU) and improve the quality of medical device Introduction for Use (IFU). METHODS: Summarize domestic regulatory experience and deficiencies through literature research, and introduce the international experience gathered from the IMDRF coordination document Principles of Labelling for Medical Devices and IVD Medical Devices. RESULTS: The IMDRF international coordination document categorizes ten chapters to define and summarize the basic principles that medical device instructions and labels should contain. CONCLUSIONS According to the current status of medical device specification supervision and drawing on international supervision experience, improvement suggestions are proposed in terms of refining the IFU requires to improve the quality of the instructions, e.g. dynamic adjustment of IFU management requirements, strengthen the management of IFU for home used medical devices, and improving the standardization and rationality of medical device IFU content. We should continue to maintain effective management of medical device IFU.
Product Labeling

OBJECTIVES: To reassess the safety and efficacy of once-weekly teriparatide 56.5 mg in osteoporosis patients with a high fracture risk. METHODS: This postmarketing observational study was conducted at 72 weeks according to the package insert. Of the 3573 Japanese osteoporosis patients in the safety analysis set, 91.80% were women, the mean age was 78.1 years, and 69.89% had a history of prevalent fragility fractures, indicating that a high proportion of patients at high risk of fracture were enrolled. RESULTS: Persistence with weekly teriparatide treatment was 59.36%, and 38.95% at 24 and 72 weeks, respectively. Adverse drug reactions (ADRs) were reported in 898 patients (25.13%), and serious ADRs were reported in 26 patients (0.73%). The most frequent ADRs were nausea, vomiting, and headache. The cumulative incidence of new vertebral fractures 72 weeks after the start of treatment was 3.31%. Increases in the bone mineral density were observed in the lumbar spine, femoral neck, and proximal femur. The serum levels of the bone formation markers, procollagen type I N-terminal propeptide and bone-type alkaline phosphatase, increased slightly at 24 weeks and then decreased to baseline levels. At 24 and 72 weeks, the bone resorption markers, serum cross-linked N-terminal telopeptide of type I collagen and urinary cross-linked N-terminal telopeptide of type I collagen, were the same as or slightly lower than at baseline. Visual analogue scale scores for low back pain also decreased. CONCLUSIONS: The present results showed that once-weekly teriparatide may also be useful for osteoporosis patients with a high risk of fracture.
Alkaline Phosphatase ; Asian Continental Ancestry Group ; Biomarkers ; Bone Density ; Bone Resorption ; Collagen Type I ; Drug-Related Side Effects and Adverse Reactions ; Female ; Femur ; Femur Neck ; Headache ; Humans ; Incidence ; Low Back Pain ; Nausea ; Observational Study ; Osteogenesis ; Osteoporosis ; Product Labeling ; Spine ; Teriparatide ; Vomiting

Dietary supplements are popular worldwide and their use has been increasing. The purpose of this study was to evaluate the mineral contents of multi-vitamins and minerals (MVMs) in most commonly sold among dietary supplements. Ninety popular MVM supplements sold in South Korea were surveyed regarding their characteristics and ingredients including minerals listed on the labels through off-line and on-line search. Daily mineral contents of the MVM supplements were compared with Korean Dietary Reference Intakes (DRIs) by target populations. The average price of 90 MVM supplements was $41.3 per bottle, with a price of $0.9 per day and the average number of minerals contained per supplement was 4.7. A total 14 minerals were found in the MVM supplements including calcium, phosphorus, sodium, potassium, and magnesium. Nine minerals (e.g. calcium, magnesium, and iron) were included in more than 30% of the MVM supplements examined. When daily mineral dose of MVMs was compared to DRIs, calcium was the lowest (34.0% of recommended intake [RI]) and chromium was the highest (218.7% of adequate intake [AI]), and zinc, copper, selenium, and chromium were also higher than their RI or AI levels. The daily mineral contents of the 90 MVM supplements were below the tolerable upper-intake level, but some minerals were higher than RI or AI with high variance among products. Therefore, there is a great need to educate the public for the adequate selection and use of MVM supplements based on the contents of MVM supplements and individual's mineral intake derived from the diet.
Calcium ; Chromium ; Copper ; Diet ; Dietary Supplements ; Health Services Needs and Demand ; Korea* ; Magnesium ; Minerals* ; Miners* ; Phosphorus ; Potassium ; Product Labeling ; Recommended Dietary Allowances ; Selenium ; Sodium ; Zinc

OBJECTIVE: To compare the analgesic effects and adverse drug reactions (ADRs) of fentanyl intravenous patient-controlled analgesia (ivPCA) with nefopam, a centrally acting analgesic agent with demonstrated opioid sparing activity, as compared to ketorolac in a tertiary teaching hospital. METHODS: A retrospective evaluation of electronic medical records was conducted on patient records including either nefopam or ketorolac with opioid ivPCA for post-operative pain management in general surgery department from January to December 2014. The status of pain control and ADRs were collected. RESULTS: Out of 6,330 general surgery cases, nefopam was given in 153 prescriptions (6.9%) and ketorolac in 81 prescriptions (3.6%). The level of pain control was not different between two groups (70.9% vs. 75.3%; p = 0.51), but ADRs were more frequently reported in nefopam group (9.8% vs. 2.5%; p < 0.05). New ADRs of hot flushes (n = 1) and paresthesia in hands (n = 1) were reported in nefopam group and they were unlisted in the approved package insert. No serious ADRs were reported in both groups. CONCLUSION: Our findings presented that nefopam showed a similar analgesic effect and higher ADR rates compared to ketorolac as an adjuvant to fentanyl iv PCA for postoperative pain management in general surgery patients in South Korea.
Analgesia, Patient-Controlled ; Analgesics, Opioid ; Drug-Related Side Effects and Adverse Reactions ; Electronic Health Records ; Fentanyl ; Hand ; Hospitals, Teaching ; Humans ; Ketorolac* ; Korea ; Nefopam* ; Pain Management* ; Pain, Postoperative ; Paresthesia ; Passive Cutaneous Anaphylaxis ; Prescriptions ; Product Labeling ; Retrospective Studies

Filler injection is an extremely popular cosmetic procedure in Korea, but surprisingly few dermatologists are aware of the package inserts in filler products. In the era of legal dispute, it is important that we fully understand the indications, contraindications, and side effects of the individual filler products. The purpose of this paper is to provide a general overview of the contents of package inserts of filler products that are commercially available in Korea, especially in terms of the contraindications of filler injection. The authors emphasize that greater improvement in the Korean package inserts of filler products can be expected. Currently, practicing physicians are usually blamed for filler complications. We also found many significant translational errors. We hope that dermatologists take more interest in filler package inserts by reading this overview.
Dissent and Disputes ; Hope ; Korea* ; Product Labeling*

This study examined the awareness, understanding, attitudes, and purchase intention regarding food labeling on bakery products in the context of health consciousness. The purpose of the study was to provide basic data for bakery product labeling, which has been insufficient to date, and to develop measures to expand the labeling system. The results of the study showed that higher subjective understanding and better attitude towards bakery food labeling can positively increase the purchase intention. We believe that the bakery industry needs to promote food labeling proactively, while also developing products addressing health concerns. This study is also valuable to academia because it provides insights into the relationship between the consumer's understanding of and attitudes towards nutritional information and purchase intention. In addition, it is beneficial to the bakery industry because it establishes marketing strategies that increase the purchase intent among both consumers with high health consciousness and those who infrequently purchase baked goods.
Consciousness* ; Food Labeling* ; Intention* ; Marketing ; Product Labeling

BACKGROUND: Ischemic heart disease is the most common type of heart disease and an important cause of death in Korea. Among marketed anti-anginal medications, molsidomine, nicorandil, and trimetazidine are approved in Korea with unique mechanism of actions. As these drugs are not approved by the US Food and Drug Administration, the access to the up-to-dated and comprehensive safety-related information has been less than optimal from drug information resources used by Korean pharmacists. METHODS: A systematic review was conducted using Embase and Korean manuscripts to compile safety updates for these medications. Out of 418 articles from keyword searches, 52 studies were reviewed in full to compare adverse effects (AEs) with the approved package inserts (PI). RESULTS: Molsidomine related adverse effects were mostly mild or moderate, but anxiety, palpitation, epigastric pain, and sexual potency reduction were additional AEs found from the review not listed in PI. Although PI has included ulceration in oral cavity and gastrointestinal tracts including anus by nicorandil, the Korea FDA recently recommended adding corneal, genital, and skin ulcers to the approved PI. Trimetazidine induced Parkinsonism, worsening of the symptoms for patients diagnosed with Parkinson's disease, gastrointestinal burning, and muscle cramps were additionally identified AEs not listed in PI for trimetazidine. CONCLUSION: Continuous evaluations of the safety profile of these agents are needed to balance the risks and benefits to provide evidence-based safety counseling to the patients. In addition, more focused efforts on spontaneous reporting are warranted by healthcare professionals to safeguard patients against AEs.
Anal Canal ; Anxiety ; Burns ; Cause of Death ; Counseling ; Delivery of Health Care ; Gastrointestinal Tract ; Heart Diseases ; Humans ; Korea ; Molsidomine* ; Mouth ; Muscle Cramp ; Myocardial Ischemia ; Nicorandil* ; Parkinson Disease ; Parkinsonian Disorders ; Pharmacists ; Product Labeling ; Risk Assessment ; Skin Ulcer ; Trimetazidine* ; Ulcer ; United States Food and Drug Administration

BACKGROUND: Since November 2012, some of over-the-counter (OTC) medications have been sold in convenience store without pharmacist' s supervision. We purposed to examine if the product labels of OTCs provide sufficient information that is appropriate for consumers who may have low health literacy. METHODS: We compared the difficulty of words that are utilized in pharmaceutical product labels of interest (intervention) with those in the 6th grade textbook (control). Pharmaceutical products of interest were comprised of 13 OTCs which have been sold currently in convenience stores. We grouped words into the 4 levels of difficulty based on the Korean Vocabulary Classification for Education, and statistically tested words frequency in each level between OTCs and control. RESULTS: The 13 OTC labels included lay language (easier or equal to language used in primary school) about 10% less; professional language about 10% more (p < 0.001 in all). Labels for analgesics had the longest and most difficult information, followed by common cold preparations, muscle pain relievers as plaster or cataplasma and digestives. CONCLUSION: The 13 OTC labels might fail to provide appropriate information for safety use by consumers in terms of the difficulty level of words. The improvement of labels of OTC medications and consumer education strategies are called for safety use of OTC medications sold in convenience stores.
Analgesics ; Classification ; Common Cold ; Comprehension* ; Education ; Health Literacy ; Myalgia ; Organization and Administration ; Pharmaceutical Preparations ; Product Labeling* ; Vocabulary

Unique Device Identification (UDI) is a hot spot research area in the medical device administration. It comes a breakthrough from International Medical Device Regulators Forum (IMDRF) and government implementation recently. The article reviewed the advancement of IMDRF UDI program, discussed the framework for UDI system, analyzed the implementation of UDI in other countries, put forward some suggestions on the development of medical device coding system in our country.
Equipment and Supplies ; standards ; Product Labeling ; standards

The use of psychotropic medications in lactating women is controversial. Despite widely accepted advantages of human milk, patients and professionals hesitate to use medications during breastfeeding. Package inserts written by manufacturers routinely discourage breastfeeding to prevent law suits. Here we conducted a review to help professionals to decide medication for lactating women on an evidence-based risk-benefit analysis. First, we reviewed lactational pharmacology. The relative infant dose (RID) was defined to give an objective measure for infant exposure to medication, and drugs with RID lesser than 10% were considered quite safe. Subsequently, we reviewed each category of psychotropic medications which were commonly used in mental illness. We provided information for each drug such as Dr. Hale's lactation risk category, RID, half-life, and time to peak plasma level as references for the risk analysis. There was no contraindicated psychotropic medication during breastfeeding, but for lithium, close monitoring of infant serum levels is warranted. In conclusion, most of medications used to treat mental illness in lactating women were usually safe. Nevertheless, medication use in lactating women should always be considered on an individualized risk-benefit analysis, and untoward adverse effects on the infant should be monitored.
Breast Feeding ; Drug Combinations ; Female ; Half-Life ; Humans ; Infant ; Jurisprudence ; Lactation ; Lithium ; Milk, Human ; Piperonyl Butoxide ; Plasma ; Product Labeling ; Pyrethrins