Fostering a drug-free workplace

Drug abuse costs American industry and the public an estimated $100 billion a year. As a result, workplace drug testing programs have become a serious option for many companies. Federal guidelines regarding testing and laboratories are in place. An overview of the current components necessary in designing a corporate drug testing program that complies with these guidelines is presented. Essential features of a corporate workplace drug testing program, that is, the policy, the testing process, and the laboratory contracted to test employees, are detailed from designs suggested in the current literature and in compliance with federal guidelines. Developing a cost-effective corporate program that meets federal guidelines, stands up to court scrutiny, and is universally accepted by employees is the objective of a drug testing program. The challenge can be met by building consensus, spelling out policy, maintaining high testing standards, and above all making rehabilitation of employees who test positive the ultimate goal of a drug-free workforce/workplace.     

The relation between methods and recommendations in clinical practice guidelines for hypertension and hyperlipidemia

OBJECTIVE: To assess the association between methods used to develop clinical practice guidelines and the recommendations that are made. STUDY DESIGN: Systematic review of clinical practice guidelines for hypertension or hyperlipidemia. OUTCOMES MEASURED: Two people independently appraised guideline methods by using 8 criteria and the aggressiveness of recommendations for treatment thresholds, initial drug selection, and screening. RESULTS: We identified 33 guidelines. Only 6 fulfilled 5 or more of the 8 criteria. For 5 of the criteria, fewer than 50% of the guidelines fulfilled those criteria. There was wide variation in recommendations for treatment thresholds, drug selection, and cholesterol screening. Guidelines that did not fulfill the criteria tended to suggest more aggressive recommendations than did guidelines that met the criteria. For 6 of the 8 criteria, guidelines published by specialty societies were less likely to fulfill them compared with guidelines not published by specialty societies. CONCLUSIONS: Guideline developers who did not use rigorous methods tended to promote intervening more aggressively for hypertension and hyperlipidemia.     

Industry perspectives on ICH guidelines

In 1990 the International Conference on Harmonization (ICH) effort was begun with the intent of standardizing the drug registration and approval process. The need to rationalize and harmonize regulation was driven by concerns over rising costs of health care, escalation of the cost of research and development and the need to meet the public expectation that there should be a minimum delay in making safe and efficacious new treatments available to patients in need. Since most regulatory agencies have limited resources to interact with sponsor companies, standardized guidelines would help expedite communications with companies at the programme design stage. The ICH is a joint initiative involving both regulators and industry as partners in scientific and technical discussions of the testing procedures which are required to ensure the safety and efficacy of medicines. While all regions of the world have some input to the process, the primary development of the guidelines is derived from industry and regulatory representatives from Europe, Japan and the United States. Much progress has been made in the ten years since the initiation of the ICH, but the implementation and maintenance of the guidelines are in the early stages for most if not all of the published guidelines. If the guidelines do not gain a solid foothold early on, then drift between the regions in use of the guidelines will defeat the goals of the ICH. While the ICH covers the entire drug development process, this paper will review the guidelines that pertain most closely to clinical trials and their use in the drug registration process. Some of the guidelines have been approved and some are still in the development stage.     

Evidence-based and value-based formulary guidelines

Health plans and hospitals have long used drug formularies, but the processes by which formulary committees made decisions have typically lacked transparency and scientific rigor. A growing number of organizations have begun implementing formulary guidelines issued by the Academy of Managed Care Pharmacy (AMCP). These guidelines call for health plans to request formally that drug companies present a standardized "dossier" that contains detailed information not only on the drug's effectiveness and safety but also on its economic value relative to alternative therapies. This paper describes the guidelines, reviews progress to date, and analyzes several critical issues for the future.     

Improvement in the pre-hospital care of recreational drug users through the development of club specific ambulance referral guidelines

Background

Previously developed 'club guidelines' developed for club owners and promoters have tended to focus more on the legislative aspects of clubs, rather than the medical management of unwell clubbers within club environments. Despite this lack of guidance on the management of unwell clubbers, a significant proportion of clubs have 'club medic' rooms for managing these individuals. However, due to the lack of specific guidance on the training of staff working in these rooms and guidelines on when an ambulance should be called for an unwell clubber, there have been instances previously where clubbers have been inappropriately managed within the club environment, and often referred to hospital only after significant physiological derangement has occurred, thereby leading to an increased risk of morbidity and mortality.

Methods

We identified owners and promoters of local club venues within the catchment area of our Emergency Department and working jointly with them and other key stakeholders, in particular the London Ambulance Service and Metropolitan Police, identified strategies to improve pre-hospital care for clubbers who become unwell as a result of recreational drug use. These included developing guidelines detailing indications for ambulance transfer to hospital for clubbers with recreational drug toxicity and the training of club medic staff to use the guidelines

Results

Following the initial development of a pilot set of guidelines, an audit of their use identified training needed relating to the assessment of unwell clubbers with recreational drug toxicity and revisions required to the pilot version of the guidelines. After training related to the revised guidelines, all the club medic staff were confident in their ability to assess unwell clubbers with recreational drug toxicity, the use of the guidelines and also when to call an ambulance.

Conclusion

Working with key stakeholders in the local community, we have developed guidelines that can be used to improve the pre-hospital care of clubber unwell with recreational drug toxicity, and demonstrated that individuals with a variety of medical knowledge can be trained to use these guidelines. Wider dissemination of these guidelines, both regionally, nationally and potentially internationally, may help to reduce the pre-hospital morbidity and mortality associated with recreational drug toxicity encountered in club environments.     

A practical guide to monitoring for adverse drug reactions during antihypertensive drug therapy

Monitoring of patients taking antihypertensive treatment can identify potential adverse drug reactions (ADRs). However, published guidelines give divergent or incomplete recommendations on monitoring for ADRs. Using a predetermined strategy, we undertook a systematic review to identify hypertension guidelines published from January 2001 to October 2011 with recommendations for monitoring for ADRs. We screened 88 abstracts and 187 web-based guidelines, and identified 19 published guidelines on monitoring the biochemical effects of antihypertensive drug therapy. We then produced a set of practical clinical guidelines, synthesized from those recommendations. Our recommendations are designed to provide efficient monitoring. They reduce the number of tests to a minimum consistent with safe practice and align monitoring schedules, so that creatinine, potassium and sodium concentrations are measured at the same times in all cases. The instructions for biochemical monitoring in current guidelines differ greatly, both in the extent of advice and in the detail provided. The current lack of consistent and workable instructions poses serious difficulties for practitioners. The recommendations distilled from this systematic review should help practitioners when they monitor therapy with antihypertensive drugs.     

'Codes' and practice: information in drug advertisements--an example from Sri Lanka

The amount of scientific information that should appear in an advertisement for a drug has been discussed for over 20 years. The information should promote the rational use of the drug. There is a lack of data from developing countries. We analysed all drug advertisements in the Ceylon Medical Journal (CMJ) 1985-1986. Conformity with the existing WHO guidelines and IFPMA code was also assessed. The 111 advertisements constituted 42% of the pages in the CMJ. Thirty-one of 34 companies were from the industrialized nations. Twenty-one per cent of the advertisements did not have the generic name; 94% had information on indications, whereas only 23 and 22% had information on adverse effects and contraindications. Only 16% provided information on generic name, indications, dosage, adverse effects and contraindications. Despite this 68% satisfied the criteria of the WHO guidelines and IFPMA code mainly under an ill defined 'reminder advertisement' clause. The existing guidelines are insufficient to ensure the minimum scientific information in drug advertisements.     

Comparison of antineoplastic drug handling policies of hospitals with OSHA guidelines: a pilot study.

Hospital antineoplastic drug handling policies of 24 hospitals in eight Southwestern Ohio counties were compared with recommendations of the 1986 Occupational Safety and Health Administration (OSHA) guidelines. Although most study facilities where antineoplastics are handled have policies, content varies and is generally less complete than OSHA guidelines, particularly regarding storing, transporting, and disposing of drugs; managing equipment; informing personnel of risk; and surveillance. Recommendations for personal protection concur more closely with OSHA guidelines than do other content areas.     

Do Cost-Effectiveness Analyses Account for Drug Genericization? A Literature Review and Assessment of Implications

ObjectivesWe investigated how health technology assessment (HTA) organizations around the world have handled drug genericization (an allowance for future generic drug entry and subsequent drug price declines) in their guidelines for cost-effectiveness analyses (CEAs). We also analyzed a large sample of published CEAs to examine prevailing practices in the field.MethodsWe reviewed 43 HTA guidelines to determine whether and how they addressed drug genericization in their CEAs. We also selected a sample of 270 US-based CEAs from the Tufts Medical Center’s CEA Registry, restricting the sample to studies on pharmaceuticals published from 1991 to 2019 and to analyses taking a lifetime time horizon. We determined whether each CEA examined genericization (and if so, whether in base case or sensitivity analyses), and how inclusion of genericization influenced the estimated incremental cost-effectiveness ratios.ResultsFourteen (33%) of the 43 HTA guidelines mention genericization for CEAs and 4 (9%) recommend that base case analyses include assumptions about future drug price changes due to genericization. Most published CEAs (95%) do not include assumptions about future generic prices for intervention drugs. Only 2% include such assumptions about comparator drugs. Most studies (72%) conduct sensitivity analyses on drug prices unrelated to genericization.ConclusionsThe omission of assumptions about genericization means that CEAs may misrepresent the long run opportunity costs for drugs. The field needs clearer guidance for when CEAs should account for genericization, and for the inclusion of other price dynamics that might influence a drug’s cost-effectiveness.     

Current guidelines poorly address multimorbidity: pilot of the interaction matrix method

ObjectivesTo develop a framework to identify and classify interactions within and among treatments and conditions and to test this framework with guidelines on chronic heart failure (CHF) and its frequent comorbidity.Study Design and SettingText analysis of evidence-based clinical practice guidelines on CHF and 18 conditions co-occurring in ≥5% of CHF patients (2–4 guidelines per disease). We extracted data on interactions between CHF and comorbidity and key recommendations on diagnostic and therapeutic management. From a subset of data, we derived 13 subcategories within disease–disease (Di-Di-I), disease–drug (Di-D-I), drug–drug interactions (DDI) and synergistic treatments. We classified the interactions and tested the interrater reliability, refined the framework, and agreed on the matrix of interactions.ResultsWe included 48 guidelines; two-thirds provided information about comorbidity. In total, we identified N = 247 interactions (on average, 14 per comorbidity): 68 were Di-Di-I, 115 were Di-D-I, 12 were DDI, and 52 were synergisms. All 18 comorbidities contributed at least one interaction.ConclusionThe interaction matrix provides a structure to present different types of interactions between an index disease and comorbidity. Guideline developers may consider the matrix to support clinical decision making in multimorbidity. Further research is needed to show its relevance to improve guidelines and health outcomes.     

1993 guidelines for the management of mild hypertension: memorandum from a WHO/ISH meeting.

The present guidelines were prepared by the Guidelines Sub-Committee of the WHO/ISH (International Society of Hypertension) Mild Hypertension Liaison Committee. They represent the third revision of the WHO/ISH guidelines and were finalized after discussions at the Sixth WHO/ISH Meeting on Mild Hypertension in Chantilly, France, on 28-31 March 1993. The new guidelines discuss the cardiovascular risk in patients with hypertension, the definition and classification of mild hypertension, drug treatment (including the elderly) and non-drug measures, cost-effectiveness, and further research.     

2008年安徽省原发HIV-1感染者耐药毒株变异情况研究

目的分析安徽省艾滋病病毒1型(human immunodeficiency virus 1,HIV-1)在原发感染人群中耐药毒株变异情况,为全省艾滋病抗病毒及耐药性监测方案的制定提供科学依据。方法参照世界卫生组织提出的HIV耐药警戒线调查方法(HIV drug resistance threshold survey,HIVDR-TS)指导方案,采用横断面调查,收集安徽省2008年度检测的58名小于25岁的HIV-1感染者血浆样本,进行HIV-1 POL区亚型及耐药基因型分析。结果获得49份样本,POL区29个有效序列中,B/C重组亚型比例最大,达44.8%,其次为B亚型,占37.9%。没有针对PR区的主要耐药性基因突变,PR区耐药株流行率为0。29个序列中针对核苷酸反转录酶区(NRTI)的耐药突变有2例,非核苷酸反转录酶区(NNRTI)有4例,仅V179D突变对依非韦仑(EFV)和奈韦拉平(NVP)出现潜在耐药,RT区耐药株流行率为3.4%,均属于低度流行(<5%)。结论安徽省未经抗病毒治疗新发HIV-1感染者中已经出现POL区耐药突变株,但传播水平尚处于低流行状态,治疗前尚不需要进行大规模耐药性监测。     

Guidelines for economic evaluation of pharmaceuticals in Korea]

An economic evaluation is required in order to apply to the Health Insurance Review and Assessment Service (HIRA) for a listing in the national drug formulary. To assist companies in preparing the necessary documents, HIRA published guidelines for the economic evaluation of pharmaceuticals in 2006. The guidelines are composed of two parts: guidance an explanatory notes. Each guideline reflects the best practice which meets both the theoretical consensus within the academic community and local situations, like data availability. To enhance the transparency of evaluation, guidelines emphasize the reproducibility of data and analysis result. That is, all evaluation processes are required to be described in enough detail to be replicated by reviewers. With growing experience and theoretical development in this area, HIRA guidelines will be revised periodically.     

Update: Fatal and severe liver injuries associated with rifampin and pyrazinamide treatment for latent tuberculosis infection

Reports of fatal and severe liver injury associated with treatment of latent tuberculosis infection (LTBI) with the drug combination rifampin and pyrazinamide (RZ) prompted CDC to issue revised guidelines for the use of this regimen on August 31, 2001. To determine if these revised guidelines were effective in reducing morbidity and mortality, CDC has continued to collect reports on adverse effects associated with this regimen. This update summarizes the results of this ongoing investigation.