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Background: Asthma management has been fraught with several challenges especially for partly or uncontrolled cases. Incremental dosage strategy with salmeterol, fluticasone propionate combination offers stable yet effective control of symptoms preventing further exacerbations. However, there is limited evidence available on the need and safety profile of this incremental dosage strategy with the combination especially in Indian settings. To examine the safety and adverse clinical outcomes of Airtec SF when prescribed in patients with well- or poorly controlled persistent asthma. Methods: Based on the principle of prescription event monitoring (PEM) for safety reporting, this study was conducted at 20 centers across India. PEM study booklets with study questionnaire were provided to capture information related to adverse “events” during the observation period of 30 days. Results: Data of 384 patients were analyzed, with a mean age 44.5 years. 39% (n=150) were newly diagnosed and 61% (n=234) being in poorly controlled asthma status (i.e., partly or uncontrolled asthma). Of them, 42% (161), 44% (n=169) and 14% (54) patients were diagnosed with mild, moderate or severe persistent asthma, respectively. These were prescribed with metered-dose inhaler (n=187) or dry powder inhaler (n=197) formulations. 56% (n=216) patients suffered from concomitant allergic rhinitis. Among newly diagnosed patients with moderate to severe asthma dosage were tapered in 5.5% (n=3) cases. Dosage consistency was well-maintained in 98.2% (n=155) among partial or uncontrolled asthmatics with moderate to severe asthma with exacerbation rate of 1.9% (n=3). Adverse events including infective pneumonitis and upper respiratory tract infection were transient with none requiring treatment withdrawal. Conclusion: Use of Airtec SF was safe and well-tolerated with a negligible rate of exacerbations in Indian population especially amongst poorly controlled asthma patients.
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<b>Objective</b> : To find methods to minimize ‘lost to follow-up’ in the long-term follow-up in a pilot study of Prescription-Event Monitoring in Japan (J-PEM) where hypertensive subjects who took losartan or a control drug and gave informed consent to the study were directly followed by researcher for years.<br><b>Design</b> : Cohort Study<br><b>Methods</b> : We conducted the follow-up survey twice, in which questionnaires were sent to hypertensive patients who had consented to being involved in the survey and returned it by mail. In the questionnaire, we asked about the use of the monitoring drug, change of medical institutions for the treatment of hypertension, significant health-related events. In the second survey, we reminded the non-responders by a letter of reminder and by telephone. When no information was obtained from the subject, we sent a letter, together with a copy of the informed consent given by the subject, to the municipal office where the subject's home was registered to inquire about the subject's current address and related information including the vital status. We calculated Standardized Mortality Ratio (SMR) using the information on death obtained from the mailed questionnaires, telephone and information in the municipal office.<br><b>Results</b> : In a pilot study of J-PEM on losartan, 4344 and 3517 questionnaires were sent to pharmacists and doctors, respectively. The doctors handed the informed consent form to the patients and 422 patients agreed to participate the study and sent back the signed form to the study office. In the first and second surveys, a questionnaire was mailed to the subject approximately 1 and 5 years after the first prescription of losartan or a control drug, respectively. The response rate was 73 and 60% in the 1 st and 2 nd survey, respectively. In the manuscript, the results of the 2 nd survey were mainly presented. The reminders by mail and telephone increased the response rate from 60 to 81% and provided the information on the vital status for 86% of the subjects. The response rate was further increased to 84% and the vital status was known for 99% when the information in the municipal office was used. SMR was estimated to be 0.59 (95% CI : 0.34-1.01) before reminding subjects, 0.78 (0.52-1.17) after reminding subjects by a letter and telephone and 0.92 (0.65-1.31) after further addition of the information from the municipal office. During the 5 years of the observation, 21% of 343 subjects who sent back a filled questionnaire did and 70% did not change the clinic/hospital where they received the care for hypertension, while 9% did not answer the relevant question.<br><b>Conclusion</b> : The method of the systematic survey may be useful in minimizing the ‘lost to follow-up’ subjects in the long-term pharmacoepidemiology studies in Japan where a patient can change the clinic/hospital for his/her own health care without any letter of reference. In the systematic survey, the researchers may try to follow the subjects by using several methods including reminders like a letter or telephone as well as the use of the information in the municipal office. To facilitate better follow-up, a careful design of the study including the proper design of the informed consent form is essential to maximize the amount and quality of the available information, particularly when the subject has a serious event or dies in a hospital or institution apart from that where the patient has been registered.
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OBJECTIVE:To facilitate the evolvement of Chinese ADR monitoring.METHODS:Approaches concerning prescription-event monitoring in England and its progresses were investigated.RESULTS:Early warning signals that of precaution effect were available through prescription-event monitoring on primary safeguarded newly marketed drugs.CON?CLUSION:Voluntary ADR reporting system is now prevalent in China,the prescription-event monitoring system assumed by England set a good example for us to follow.
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Objective : To evaluate the necessity to complement the information obtained from pharmacists in the community pharmacy by that from the hospital pharmacy in Prescription-Event Monitoring in Japan (J-PEM) by using data in a J-PEM pilot study.<BR>Methods : For each patient, two questionnaires were sent to the prescribing doctor and the pharmacist who registered the patient ID code in the pilot study. If the patient ID code was registered by the pharmacist in the community pharmacy and if a pharmacist inside the hospital where the prescription was issued was willing to co-operate, a third questionnaire for the same patient was sent to the pharmacist in the hospital pharmacy. The information given by pharmacists was analyzed for 150 pairs of questionnaires (on 150 patients) sent back from pharmacists in both community and hospital pharmacies. The questions in the questionnaire were categorized into [1] those on drugs used by patients (concurrent drugs, daily dose of the drug monitored, and compliance), [2] those on events which the patient had experienced after the prescription of the drug monitored, [3] those on patients (the first date of prescription, reason of prescribing the drug monitored, initial date when the disease developed, underlying diseases or complications and whether and when the patient was lost to follow-up). The questionnaires were examined to determine whether the answer was given to each question. When the answer was given, its quality and quantity were then assessed. The answer to each question given by the pharmacist in the community pharmacy (C) and that by the pharmacist in the hospital pharmacy (H) were compared by the McNemar test after the pairs of answers were classified into the following categories : [1] C is better than H, [2] H is better than C, [3] C and H are similar to each other, and [4] impossible to classify. The difference was considered to be significant where p<0.05.<BR>Results and conclusion : For the initial date when the disease developed and 'underlying diseases or complications', H was significantly better than C. However, for concurrent drugs, compliance and events, C was significantly better than H. Otherwise, the difference was not statistically significant. Being compatible with the superiority of C over H in regard to concurrent drugs and events, the fraction of patients lost to follow-up during the observation period was small not only in H but also in C. This observation may be associated with the fact that almost all prescriptions were issued by a single hospital in more than 60% of community pharmacies in the pilot study, and most patients identified in the study were probably a regular visitor to one of such community pharmacies. The most important information to be provided by the pharmacists in J-PEM is that on events and drugs used by patients. It is thought to be not necessary to complement the information obtained from the community pharmacy by that from the hospital pharmacy.
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Background : With a support from Ministry of Health and Welfare (MHW) Japan, we embarked on a pilot study for Prescription-Event Monitoring (PEM) adapted to Japanese environment. <BR>Methods : A pilot study was conducted according to the report on this subject to MHW in 1996. <BR>Results and Conclusion : PEM using monthly claims called as “Rezept” issued by individual hospitals and clinics is judged to be difficult unless the use of the claims for epidemiological studies is legally separated from the examination process of the medical cost claimed. PEM using the prescriptions dispensed by individual pharmacies is easier to conduct. Some progress has been attained by employing the latter scheme in the pilot study where approximately 1300 patients with a new antidiabetic agent, troglitazone, are compared with 1300 patients who have recently started one of “old” antidiabetics.
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Background : Health insurance claims contain invaluable data for epidemiological survey. However their use for research purposes has been hampered by both bureaucratic red-tape and technical limitations. These include the lack of legal rationale for disclosure and the lack of electronic data transfer. In response to the recent advancement in these field, such as the governmental policy change to allow disclosure of the claims to patients and a rapid computerization of the claims, researchers interested in health insurance claims held liaison meetings to exchange views and know-hows to facilitate the epidemiological research using health insurance claims.<BR>Reports on the Meeting : The liason meetings have so far been held twice as part of Japan Public Health Association annual assembly, at Yamagata in 1995 and at Yokohama in 1997, both sponsored by the author. Fourteen researchers presented their research activities using health insurance claims and discussed with the attendants on their experience to overcome the bureaucratic red-tape and technical limitations. Two of the presenters beside the author were pharmacoepidemiologists : Dr. Hayashi addressed the value and possibilities of the claims as data source for pharmacoepidemiology and Dr. Kubota proposed PEM (Prescription Event Monitoring) using health insurance claims as triggers to complement the present voluntary ADR reporting.<BR>Implications : Since the bureaucratic and technical obstacles may be better handled through a coordinated and liaisoned action of the researchers, it is necessary to form a consortium of researchers and professionals who have any interest in health insurance claims regardless of their purposes and make guidelines and recommendations to assure legitimate and appropriate utilization of the potentially sensitive but useful individual information.
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Background : With a suppport from Ministry of Health and Welfare (MHW) Japan, we studied the feasibility of conducting event monitoring in Japan similar to Prescription-Event Monitoring in England. The manuscript presented is a report to MHW in 1996.<BR>Methods : Means available in Japan to identify drug, patient and doctor are examined. In addition, any modification needed to make on a questionnaire sent to doctors in PEM conducted in Japan is examined.<BR>Results and Conclusion : Monthly claims called as “Rezept” issued by individual hospitals and clinics and sent to insurers and outpatient prescriptions issued by hospitals to be dispensed by the pharmacies outside the hospitals are considered to be two available means to identify drug, patient and doctor. To have a sample representative of all drug users, the use of “Rezept” is needed as only a fraction of outpatient prescriptions are dispensed by independent pharmacies. However, the use of prescriptions dispensed by the independent pharmacies together with the cooperation of individual pharmacies is capable of finding a contemporary control which is a group of patients who have recently started “old” drugs comparable to the new “test drug”. In Japan no doctor may have a complete list of the hospitals and clinics a patient has visited and it is mandatory to ask doctors the last date when the patient visited the doctor. To clarify what problems arise when a PEM-like study is introduced to Japan, a pilot study is going to be done during 1997 and the feasibility will be examined further based on the results.