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How should FDA regulate prescription drug promotion on the Internet?

The current scheme for regulating prescription drug labeling and advertising developed in a world in which information was centralized, static, and one-dimensional. Advertising was merely incidental to other activities such as reading magazines or watching programs. The Internet-wired world is different. Information is now instantly, globally accessible. Consumers can search through varied levels of detail on almost any topic. Anyone can join the fray by publishing their own materials on the Internet. This article addresses the unique problems raised by any proposed regulation of prescription drug labeling and advertising on the Internet. In particular, the article reviews the history, culture, technology, and popular uses of the Internet, and examines some of the models for regulation presented at an October 1996 Food and Drug Administration (FDA) conference on regulation of Internet content. Finally, the article suggests a new direction for regulation prescription drug promotion on the Internet.

Advertising↗

[Prescription of antibiotics for periodontitis patients by dental practitioners in the Netherlands].

In 1993 a representative sample of dentists in the Netherlands was questioned on the use of antibiotics in the treatment of periodontitis. It was found dat 50% of the general practitioners had a positive attitude, 15% a negative one and 35% had an indifferent attitude towards the use of antibiotics in periodontal treatment. Almost 40% of them indicated the prescription of antibiotics for periodontal reasons in the previous year. Most of the dentists (71%) prescribed a combination of metronidazole and amoxicillin. The average prescription frequency in 1992 was 18 times. The prescription frequency and the choice of a combination of metronidazole and a broad spectrum penicillin in the treatment of periodontitis is discussed, emphasizing the importance of the traditional mechanical therapy, the disturbance of the colonization resistance by means of antibiotics and the worldwide concern about the usage of antibiotics.

Amoxicillin↗

[Motives for the prescription of antibiotics in the emergency department of the University Hospital Center in Nice. A prospective study].

OBJECTIVES: Since April 1999, we have set-up an infectious disease consultation in the emergency unit of the University Hospital in Nice. Unjustified antiobiotherapy is often initiated. We therefore conducted a survey to study the motives and validity of antibiotic prescriptions. METHOD: This prospective study was conducted in two phases. The first consisted in asking the emergency physicians prescribing antibiotics to fill-in a questionnaire giving information on the diagnosis established and the antiobiotherapy proposed. In the second phase, the diagnoses and corresponding treatments were submitted to 4 experts who assessed the acceptability of the diagnoses and the antibiotics prescribed. The experts only had access to the clinical and para-clinical data available. Moreover, their therapeutic judgement was based on previously published consensuses. RESULTS: The 6-month survey collected 117 questionnaires that could be analysed. The rate of error in diagnosis was of 33% (39/117). Thoracic x-rays could not be interpreted in 11% of cases. In single variant analysis, factors of erroneous diagnosis were due to its interpretation by an internist, the diagnostic category of "broncho-pulmonary infections" and the lack of documentation. In multi variant analysis, only the lack of documentation was related to erroneous diagnosis (OR = 5.5; IC 95% (2.03; 15.30), p < 0.0002). The rate of antibiotherapy not adapted to the diagnosis made by the physician was of 32% (37/117). In 24 cases the modalities of the prescription were incorrect and in 13 cases the prescription was unjustified. Only the status of the prescriber (internist) was statistically associated with an antibiotherapy not adapted to the diagnosis (OR = 2.2; IC 95% (0.93; 5.26), p < 0.05). CONCLUSION: Unjustified antibiotherapy in an emergency unit is generally due to erroneous diagnosis of infection. The lack of documentation and inexperience of the prescribers appear to be the two elements contributing to unjustified antibiotherapy.

Anti-Bacterial Agents↗

[New evidences for adapting Qian jin yao fang (Thousand golden essential prescriptions) by Office of Revising Medical Books of the Song dynasty].

Qian jin yao fang (Thousand Golden Essential Prescriptions) written by Sun Simiao in the Tang dynasty has two kinds of extant editions in circulation: one is the revised edition, Bei ji qian jin yao fang (Essential Prescriptions Worth a Thousand Gold for Emergencies) revised by the Office of Revising Medical Books of the Song dynasty, the other is the Song edition, Sun zhenren qian jin fang (Master Sun's Thousand Golden Prescription) (20 volumes extant) not revised by Song people. There are great discrepancies between these two editions not only in the order of chapter contents, including the order of items in the same chapter, but also in its texts. Concerning the causes of this difference, we already made preliminary analysis in our former paper. However, there are new evidences to further explain it with our recent research.

China↗

[Reduced use of restricted-prescription preparations in general practice].

BACKGROUND: General practitioners in our community found that the use of drugs with restrictions on prescription was twice that of a neighbouring community, and made an effort at cutting down on the prescription of such drugs. MATERIAL AND METHODS: A retrospective analysis of this reduction is presented. RESULTS: The reduction observed was 33% over one year. The number of prescriptions in the neighbouring community remained unchanged. INTERPRETATION: The comparison with the neighbouring community was a good starting point for change. The most important contributing factor was probably the consistent approach of the doctors involved.

Drug Prescriptions↗

[Pharmaco-epidemiological study on antipsychotic drug prescription in French Psychiatry: Patient characteristics, antipsychotic treatment, and care management for schizophrenia].

UNLABELLED: In 2000, a one week national survey was conducted among 202 psychiatrists (129 participants) in France, from hospitals and clinics, private or public. The first 20 inpatients and 10 outpatients prescribed at least one antipsychotic drug (age range 18-65), were included. The diagnostic procedure was standardized with a structured interview: the Mini International Neuropsychiatric Interview (MINI). A total 2 068 patients were included, among whom 892 (43.1%) reached the criteria of schizophrenia according ICD-10. We present here data on these latter patients. Mean age was 38.8 years; with 38.8% females. Median duration of current antipsychotic treatment was 0.5 year in inpatients and 2 years in outpatients. Median duration of any antipsychotic treatment was 10 years, without difference between groups. Comorbid situations (anxiety disorder, depression and suicidal risk) were found in 33.1% of schizophrenic patients, with higher frequency among inpatients in private hospitals (54.8%) than in other groups. 46.8% patients were prescribed at least 2 neuroleptics, and 73.6% at least one non-neuroleptic drugs. Cyamemazine accounted for 16.6% of all neuroleptics drugs, and 56% of patients were prescribed an atypical antipsychotic (risperidone, olanzapine, amisulpride or clozapine). Atypical drugs accounted for 59.4% of patients who were prescribed only one neuroleptic drug. Inpatients had more neuroleptics coprescription than outpatients (mean 1.8 vs 1.4 drugs), with higher daily dose. In addition, inpatients had more other psychotropics prescribed (mean 1.5 vs 1.1 drugs). Overall, more other psychotropic drugs were prescribed among patients with -, than those without - comorbid situations (1.7 vs 1.2 drugs). Median time since admission, at the time of the study, were similar in private and public hospitals (107 vs 99 days) but maximal time since admission was respectively 2.8 and 48.9 years. Visit frequency for outpatients was more than one every two weeks for 43.1% in private and 24.7% in public clinics. Among inpatients only we found a difference between private and public hospitals for polypharmacy of non neuroleptics psychotropics, (mean 1.9 vs 1.5). In outpatients, long acting depot accounted for 26.6% of neuroleptics treatments in public clinics and 15.4% in private clinics. Finally, we found that polypharmacy among outpatients increased with duration of antipsychotic treatment. CONCLUSION: in France, important differences are reported in antipsychotic prescription for schizophrenia between in- and outpatients. Current antipsychotic prescription is more recent in inpatients than in outpatients, with similar duration of overall antipsychotic treatment. Inpatients have more drug prescription, antipsychotics and other psychotropics, than outpatients. Differences are less important between private and public providers. Inpatients in private hospitals receive more non neuroleptic drugs than in public hospitals, and depot antipsychotics are more used among patients of public clinics. Long term inpatients are found in public hospitals only. Outpatients follow up is more intensive in private than in public clinics.

Adolescent↗

Recognizing nursing's independent license: prescriptive authority for APNs.

A landmark study, published in the Yale Journal on Regulation by Yale Law School Dean Barbara J. Safriet, addresses the cost effectiveness and quality of advanced practice nurses: "Since the productivity of [APNs] has been demonstrated by the fact that they can provide equal care for a full range of health services traditionally provided by physicians, and since their training costs and employment costs are substantially less than those of physicians, it appears indisputable that they are truly cost-effective health care providers. This cost effectiveness, combined with their proven ability to provide quality care to a large number of people, suggests that they should play a central role in the solutions currently being developed for our health care crisis. Despite their proven and potential contributions, however, several unnecessary barriers stand in the way of their full utilization.... Chief among these are conflicting and restrictive state provisions governing the scope of practice and prescriptive authority of [APNs].... As a result of these provisions, [APNs] are severely hampered--or disabled altogether--in their efforts to fulfill their fully proven potential to enhance our nation's health.... Prescriptive authority is central to APNs' effective practice.... States that limit APNs to a physician-dependent scope of practice, including prescriptive authority, actively impede the public's access to safe and effective health care."

Cost Control↗

Pharmacists' attitudes toward advanced practice nurses' prescriptive authority.

In an era of managed care, the new healthcare paradigm emphasizes a team approach to primary care health services. A team approach requires collaboration among healthcare providers. One model that has not been adequately explored is that of the advanced practice nurse (APN) and the pharmacist. This study examines the attitudes of pharmacists in Colorado toward the prescriptive authority of APNs and explores some of the issues that may discourage a collaborative relationship between APNs and pharmacists. Although the response rate was limited (18%), a preliminary impression of pharmacists' attitudes was gathered. In general, the pharmacists were supportive of APNs' prescriptive authority, although they qualified their responses with the fact that the workload increased. Other concerns were lack of information about the legal ramifications of APNs' prescriptive authority and difficulty with third-party insurors who did not recognize APNs as primary care providers. Suggestions for developing a more cohesively collaborative relationship between APNs and pharmacists were discussed.

Adult↗

Recognizing nursing's independent license: prescriptive authority for APNs.

A landmark study, published in the Yale Journal on Regulation by Yale Law School Dean Barbara J. Safriet, addresses the cost effectiveness and quality of advanced practice nurses: "Since the productivity of [APNs] has been demonstrated by the fact that they can provide equal care for a full range of health services traditionally provided by physicians, and since their training costs and employment costs are substantially less than those of physicians, it appears indisputable that they are truly cost-effective health care providers. This cost effectiveness, combined with their proven ability to provide quality care to a large number of people, suggests that they should play a central role in the solutions currently being developed for our health care crisis. Despite their proven and potential contributions, however, several unnecessary barriers stand in the way of their full utilization.... Chief among these are conflicting and restrictive state provisions governing the scope of practice and prescriptive authority of [APNs].... As a result of these provisions, [APNs] are severely hampered--or disabled altogether--in their efforts to fulfill their fully proven potential to enhance our nation's health.... Prescriptive authority is central to APNs' effective practice.... States that limit APNs to a physician-dependent scope of practice, including prescriptive authority, actively impede the public's access to safe and effective health care."

Drug Prescriptions↗

[Authors of "Classified Collection of Medical Prescriptions"].

In this study, the career and official ranks of the authors of the Sejong text (1443-1445), Sejo text (1451-1464), and Seongjong text (1475-1477) of "Classified Collection of Medical Prescriptions" were investigated. In the completion of Sejong text, Kim Rye-mong (1406-1469), Ryu Seong-won (?-1456), and Min Bohua (?) collected and arranged all medical books inside and outside of Choseon; Kim Moon (?-1448), Shin Seok-jo (1407-1459), Lee Ye (1419-1480), Kim Soo-on (1410-1481), Jeon soon-eui (?), Choi Yun (?), and Kim Yu-ji (?-1469) took part in the edition; Lee Yong (1418-1453), Lee Sa-cheol (1405-1456), Lee Sa-soon (?-1455), and Rho Joon-g-rye (?-1452) participated in the editorial supervision. Ryang Seong-ji (1415-1482), Son So (1433-1484), Ryu Yo (?), Han Chi-ryang (?), An Geuk-sang (?), Han Kye-mi (1421-1471), and Choi Young-rin (?) took part in the completion of Sejo text. Han Kye-heiu (1423-1482), Rym Won-joon (1423-1500), Kueon Chan (1430-1487), Ryu Seo (?), and Baek Soo-heui(?) participated in the completion of Seongjong text. All 96 persons participated in the completion of draft text, revision text, and first-publication text of "Classified Collection of Medical Prescriptions". 14 persons (14.58%) participated in the completion of draft text. 77 persons (80.21%) participated in revision text, and 5 persons (5.21%) participated in first-publication text. Even though "Classified Collection of Medical Prescriptions" is a medical book, civil officials participated in its completion together with medical officials. The scholars of Jiphyeonjeon (The Jade Hall of Scholars) who led the academy at those days and famous medical officials were ordered to complete it by Sejong (1419-1450), Sejo (1455-1468), and Seongjong (1470-1494) who showed special interest in their own health and the health of common people.

Books↗

[Impact of algorithms on abusive prescriptions of parental drugs at the health post level in the Tambacounda health district, Senegal].

In order to increase the effectiveness and the efficiency of diagnosis and treatment procedures of the most common diseases, algorithmic pathways have been developed and applied within the implementation of the "Bamako Initiative Strategy" at the health post level in Senegal. Among the many expected advantages of these pathways, was a reduction of abusive prescriptions of parental drugs. A study comparing the trend of the prescriptions 2 years before (1991) and 2 years after (1996) the implementation of the Bamako Initiative strategy, was conducted using 810 randomly selected patients in 7 out of the 19 health posts of the Tambacounda Health district, one of the 45 health districts of Senegal. In 1991, all the oral drugs prescribed (sirup, pills, powder) represented 54.5% against 45.5% for parental drugs (intramuscular and intravenous drugs). These proportions had risen to respectively 78.1% and 21.9% in 1996. The difference thus observed is statistically significant with a khi2 test of 47.76 and p<10(-7). This result then suggests that the use of pathways had highly reduced the prescription of parental drugs among patients treated in the health posts of the Tambacounda health district in Senegal.

Adult↗

Prescription monitoring in an Irish hospital.

The prescribing of medicines is an integral part of the provision of healthcare and represents a relatively safe, effective and inexpensive mode of treatment. Hospital prescribing is of importance not alone for patients but also for the impact that it has on the prescribing of drugs in the community. We conducted a 'snap-shot' study of 1,488 hospital prescriptions and assessed such areas as legibility, generic prescribing and drug dosage. The average number of active prescriptions per patient was 5.47 for medical in-patients and 5.05 for surgical in-patients. 5% of prescriptions were deemed illegible and the rate of generic prescribing was relatively low. However the rate of compliance with the hospital formulary was good. The spectrum of drugs prescribed changed significantly from a previous study performed in 1987. Continuous review of doctors' prescribing habits will ensure the safe and economic use of medications.

Drug Prescriptions↗

General prescribing principles. The prescription.

Remember ... Prescribe within your qualifications. Write clear, legible and complete prescription. You are responsible for your prescription. Good record keeping is essential. Keep prescription pads secure.

Drug Prescriptions↗

Prescription drugs: elderly enrollee reports of financial access, receipt of free samples, and discussion of generic equivalents related to type of coverage.

OBJECTIVE: To compare elderly health plan enrollee's survey responses regarding access to prescription drugs, receipt of samples, and discussion of generic equivalents across healthcare delivery systems and to examine the extent to which member characteristics are related to responses. STUDY DESIGN: Cross-sectional, observational study. PATIENTS AND METHODS: Elderly enrollees (aged 65 and over) in the Preferred Provider Organization (PPO in = 10,2201) and Medicare cost contract (n = 14,635) of a single health insurer responded to a 2001 member satisfaction survey. Multivariable logistic regression was used to estimate the relationship between outcomes (eg, not filling prescriptions) and patient characteristics. RESULTS: Elderly enrollees in a PPO had more comprehensive drug coverage and better access to pharmaceuticals than Medicare enrollees, with 14% of Medicare enrollees reporting that they "occasionally" or "always" skipped filling prescriptions due to cost, compared with 6% of PPO members (P < .001). Similarly, 14% of Medicare enrollees reported taking less medication than prescribed to save money, compared with 7% of PPO members. Ethnicity was one of the strongest predictors of financial access to pharmaceuticals among elderly enrollees, with the predicted probability of "occasionally" or "never" filling medications ranging from 0.06 for Japanese to 0.16 for Filipinos. A majority of members in both health plans reported receiving free samples of pharmaceuticals from their physicians. CONCLUSIONS: Further research is needed to determine which medications are not being filled, the impact of sampling on subsequent drug utilization, and specific chronic conditions for which more extensive coverage is cost effective.

Aged↗

[Drug prescription after acute coronary syndrome].

Each year in France, 150,000 to 180,000 new patients are the subject of prescriptions following acute coronary syndrome with or without ST segment elevation. There are two targets of the treatment, 1) atherosclerosis, a diffuse, evolving trouble which, in this situation, is coming out of an unstable phase, and 2) the myocardium, which has often been revascularized and has suffered deterioration of its contractile and electrophysiological characteristics to a greater or lesser extent. Prescriptions, based on proven factors and always centred around hygiene and dietary advice and the use of a combination of statins and aspirin, are adapted to suit the atherosclerotic and myocardial risk assessed for the individual patient. The prescription starts off the secondary preventive phase. It marks the first stage of the follow up, which is inevitable though of variable duration, for a disease which may evolve. It is the first step in the accompaniment of an attentive, informed patient whose confidence has been restored and whom must now avoid falling into the double trap of not taking the treatment sufficiently seriously or of obsessively overreacting.

Acute Disease↗

[Prescriptions for individually prepared dermatologic agents. I].

The present paper reports the results of a survey of contemporary medical prescriptions of solutions, suspensions and emulsions used in dermatological practice. The obtained results were compared with the district prescription lists from Slovakia. The analysis of contemporary prescription was carried out in 27 districts in the years 1987 and 1989. The results show that 112 drugs are prescribed in the preparation of solutions. Most solutions are composite and 90% of solutions are hydrophilic. An analysis of suspensions revealed that in hydrophilic suspensions the liquid media water-glycerol or spirit-water prevail, and in hydrophobic suspensions nearly always plant oils are used. Emulsions are represented in topical extemporaneous preparations in a smaller amount than solutions and suspensions; it is 0.7% in the set under study.

Czechoslovakia↗

Writing the prescription and informing the patient.

BACKGROUND: Having decided on the generic drug to prescribe the prescription needs to be written and the patient informed regarding the treatment. OBJECTIVE: This article discusses some regulatory requirements for writing a legal prescription, but predominantly discusses important aspects of informing patients regarding drug therapy. DISCUSSION: The actual writing of a prescription is a small part of the prescribing process and needs to comply with local regulations. Including patients in the decision to embark on a treatment and informing them of drug treatment is a very important part of the prescribing process. There is no simple formula, but patients need to be informed on what they want to know, when they want to know it, and in the way that is most acceptable to them. It is important to use both verbal and written forms of communication and to allow patients to reflect over the information, ask questions, and be further informed over subsequent consultations. Consumer medicine information leaflets can be a useful aid, but require that the clinician understand and be prepared to answer questions raised by them.

Aged↗

Importing prescription drugs: risky business.

As prescription drug costs continue to soar, some employee benefit plans are looking beyond U.S. borders. This article outlines the regulatory framework governing importation of prescription drugs from foreign countries, additional concerns raised by the fiduciary requirements of ERISA, and significant legislative proposals in Congress that seek to address the issue of the high cost of prescription drugs in the United States.

Commerce↗