Quantitative Analyses of Sennosides A and B in Over-the-Counter Drugs Containing Rhubarb or Rhubarb and Senna Leaf / 医薬品情報学

Objective: Sennosides A and B, which are dianthrone glycosides contained in Rhubarb and Senna Leaf, exhibit laxative effect. Although a number of over-the-counter (OTC) drugs used as laxatives contain Rhubarb or Rhubarb and Senna Leaf, the total amounts of sennosides A and B are not mentioned in the package insert. To determine the total amounts of sennosides A and B in OTC drugs containing Rhubarb or Rhubarb and Senna Leaf, quantitative analyses of sennosides A and B were performed for 24 OTC drugs.Methods: Sennosides A and B were extracted from 24 OTC drugs and quantitatively analyzed by high-performance liquid chromatography. Statistical analyses were carried out by a one-way analysis of variance followed by Dunnett's test or Tukey's test.Results: The OTC drugs contained sennosides A and B in the range of 1.5-10 mg in the minimum daily dosage and in the range of 2.7-17 mg in the maximum daily dosage. In 11 of the OTC drugs (Products Nos. 1-5, 11, 12, and 15-18), the maximum daily dosage contained almost equal or higher amounts of sennosides A and B compared to that in a tablet of the prescription medicine Pursennid® 12 mg. Furthermore, the amounts of sennosides A and B in the maximum daily dosage were significantly higher in products Nos. 1 and 11 and lower in products Nos. 8-10, 14, and 20-24 compared to those of a tablet of Pursennid® 12 mg.Conclusion: Although some OTC drugs have the same Rhubarb content, the total amounts of sennosides A and B can vary. Thus,there is no correlation between the Rhubarb content and total amounts of sennosides A and B. This is because of the inconsistent quality of Rhubarb and/or the differences in the manufacturing methods of the OTC drugs containing Rhubarb. Because the total amounts of sennosides A and B cannot be estimated based on the Rhubarb content, a constipated patient should start taking an OTC drug containing Rhubarb at the minimum daily dosage. It is also recommended that the total amounts of sennosides A and B are mentioned in the package insert of OTC drugs containing Rhubarb or Rhubarb and Senna Leaf.

Empirical Study on Promotion of Appropriate Pharmacotherapy in Patients with Seasonal Allergic Rhinitis / 社会薬学

The prevalence of seasonal allergic rhinitis (hereinafter “hay fever”) is increasing annually. While self-medication with over-the-counter (OTC) drugs is growing, some hay fever patients also use OTC drugs alongside medical visits. Issues arising from co-administration, such as excessive dosing and reduced quality of life (QOL) due to drowsiness, have been highlighted. However, no research has investigated the factors contributing to the concomitant use of prescribed and OTC drugs. Therefore, this study examined the following three patient groups: those using only prescribed drugs, those using only OTC drugs, and those using a combination of both. Initial analyses compared adherence, overuse extent, QOL (as measured by the Japanese Rhino-conjunctivitis Quality of Life Questionnaire [JRQLQ]), treatment satisfaction, lifestyle habits, and health literacy (as measured by the Communicative and Critical Health Literacy Scale [CCHL]) among the groups. Subsequently, a multinomial logistic regression analysis focusing on combination users identified factors associated with co-administration. The results revealed that combination users exhibited lifestyle issues and lower QOL compared to those using prescribed or OTC drugs only, although differences in CCHL were not significant. Furthermore, co-administration was linked to social life-related JRQLQ and excessive usage during symptom onset. In conclusion, patients with hay fever should avoid the concurrent use of prescribed and OTC drugs. Co-administration may not necessarily improve symptoms and might even lead to overuse risks. Thus, patients should be guided to consult medical professionals before purchasing OTC drugs, and lifestyle improvements should be emphasized as well.

Introduction of OTC Monograph System in USA and Its Enlightenment to China / 中国药房

OBJECTIVE：To put forward some suggestions for the implementation of OTC monograph in China. METHODS ： Literature research was used to comprehensively review the concept ，emergence and development ，function of OTC monograph in USA；referring to experience in USA ，the necessity and feasibility of monograph system for OTC registration and evaluation in China were explored ，and some suggestions were put forward to the implementation of OTC monograph in China. RESULTS & CONCLUSIONS：OTC monograph in USA refers to the regulatory standards that should be followed when selling OTC products not included in new drug applications. The monograph originates from the re-evaluation project of the effectiveness of OTC drugs ， which plays a special role in accelerating the drug marketing and promoting product innovation. The OTC monograph system is necessary to help to optimize the OTC registration and evaluation ，but at present ，the conditions to establish and implement OTC monograph are not yet ripe in China. Based on the optimization of resource allocation and infrastructure construction ，national OTC drug management experience ，OTC monograph can play a full part in OTC registration and evaluation ，in terms of carrying out in-depth research ，taking pilot test ，improving risk management system and enhancing drug review resource allocation ability.

Status of Responses to Foreign Language Inquiries When Selling OTC Drug / 医薬品情報学

Objective: Along with the increase in the number of foreign visitors to Japan, the number of inquiries in foreign languages at the time of OTC drug sales has increased.　To clarify the current status of responses to foreign language inquiries when selling OTC drug, we surveyed the frequency of foreign language response, languages used, trouble experienced, and preparation useful in responding to foreign language inquiries when selling OTC drug.Methods: Our survey was conducted with 694 registered salesclerks of drugs at an external training seminar in Tokyo, Japan.Results: Of the 649 respondents, 337 (51.9%) had experience in responding to inquiries in a foreign language when selling OTC drug.　The languages used were as follows: ”English,” 86.4%; ”Chinese,” 70.0%; ”Korean,” 25.8%.　Of the respondents who had experience in responding to inquiries in a foreign language when selling OTC drug, 107 (31.8%) responded ”I experienced trouble because I could not understand what was being said,” and 228 (67.7%) responded ”I could not respond and experienced trouble.”　When asked about preparation/tools useful for selling OTC drug, 434 (66.9%) responded ”multilingual written correspondence table,” 359 (55.3%) responded ”smartphone or tablet‐based correspondence multilingual table,” 299 (46.1%) responded ”marks and illustrations,” and 253 (39.0%) responded ”I would like to be taught how to respond in a foreign language (simple conversation).”Conclusions: Our results revealed that when selling OTC drug, response to inquiries in a foreign language occurred frequently and trouble was experienced in listening comprehension and speaking a foreign language.　Therefore, urgent countermeasures such as preparing a multilingual correspondence table of symptoms, usage, and dosage, and lectures on methods of responding through simple foreign language conversations are necessary.　In addition, efforts such as creation of multilingual drug package inserts by pharmaceutical companies were considered to be an effective measure.

Analysis of 45 Cases of OTC Drug Induced ADR / 中国药房

OBJECTIVE:To investigate the occurrence of ADR induced by over-the-counter(OTC)drug in order to guide the rational use of drugs. METHODS:45 cases of ADR induced by OTC drug were analyzed retrospectively in terms of patient's gen-eral information,allergic history,allergenic drugs,reason for drug use,route of administration,incubation period,days of hospi-talization,clinical manifestation,treatment,outcome,etc. RESULTS:Among 45 patients,there were 14 male and 31 female. The patients were mainly 20-30 year-old(31.1%). Three patients had previous history of allergy(6.7%). Most ADR were induced by oral drugs(82.2%). Reasons for drug use were mainly disease of respiratory system(23 cases,51.1%). The results of causality as-sessment were positive in 3 patients(6.7%),probable in 35(n=77.8%),and possible in 7 patients(15.6%). ADR were mainly induced by non-steroidal anti-inflammatory drugs (NSAIDs,57.8%),Chinese patent medicine (20.0%),drugs for external use (17.8%). The clinical manifestations mainly included exanthematous drug eruption (33.3%),erythama multiforme drug eruption (24.4%),urticarial drug eruption(13.3%). CONCLUSIONS:NSAIDs are the main allergenic drugs,and ADR induced by OTC traditional Chinese medicine can not be ignored. To improve medical knowledge and skills of the public and the scientific use of OTC drug are beneficial to improve the clinical treatment level.

Investigation of Residents’Perceptions for Pharmaceutical Care When Purchasing OTC Drugs in Yinchuan / 中国药房

OBJECTIVE:To explore consumers’perceptions for pharmaceutical care by community pharmacist when purchas-ing OTC drugs. METHODS:Semi-structured interview was conducted for 100 consumers who were recruited in Xingqing District, Jinfeng District and Xixia District of Yinchuan,Ningxia Hui Autonomous Region,their expection for pharmaceutical care by com-munity pharmacists was summarized. RESULTS:Totally 100 residents were interriewed,and 97 completed a full interview with ef-fective interview rate of 97%. Consumers still did not clearly on distinguishing the OTC drugs. The majority of consumers chosen OTC drugs were based on experience and brand,a handful of consumers were under the guidance of community pharmacists. Con-sumers were most concerned about the efficacy,adverse reactions and drug quality in using OTC drugs. Most consumers were not satisfied with the pharmaceutical care in purchasing OTC drugs. Nevertheless,due to a lack of medicine knowledge,consumer had a great demand for pharmaceutical care and willingness to accept it. Low professional level of community pharmacist and staff in current community pharmacy and lack of effective communication between pharmacist and consumer were the obstacles of develop-ing pharmaceutical care. CONCLUSIONS:Because of their distrust on competence of community pharmacist,consumers seek less pharmaceutical care of OTC drugs at community pharmacy though they had expectations on pharmaceutical care of OTC drugs by community pharmacist. Consumers’rely on self-choice of drugs make them exposed to more drug risks.

Analysis of the Prescription Drugs and Over the Counter Drugs in 51 Hospitals of 4 Provinces in Southwest China During the Period 1999-2000 / 中国药房

OBJECTIVE: To survey and objectively evaluate the present situation and trend of the usages of the prescription drugs and over the counter( OTC) drugs. METHODS: To make a survey of the usage for above - mentioned drugs in 51 hospitals of 4 provinces in southwest China during the period 1999- 2000 concerning the sum of money for drugs, main kinds of drugs etc. . RESULTS: The sum of money for the prescription drugs and OTC drugs increased 55% and 33% in 2000 compared with those in 1999, respectively.The sums of money for OTC drugs accounted for 2.18% and 2.56% of those of the prescription drugs in 2000 and in 1999,respectively.CONCLUSION:The sums of money for the prescription drugs and OTC drugs increased rapidly ,but total sale of OTC drugs was very low compared with that of the prescription drugs.

A New Concept of Over-the-Counter(OTC)Drugs Marketing——Emotional Marketing / 中国药房

OBJECTIVE:To search a new concept of marketing for the dog-eat-dog OTC drug market.METHODS:The concept of emotional marketing was explained and the application of which in each link of the OTC drug marketing was ana-lyzed.RESULTS&CONCLUSION:The consumption of OTC drugs has come into to an emotional marketing stage.Adopting emotional marketing strategy,seizing consumer's psychology and moving customers by real affection can consolidate status of OTC drugs in the trade war.