National Drug Formulary Research Articles

Providing safe medicines for children in Nigeria: The impediments and remedies

Promoting safety of medicines for children is a global concern which has prompted the World Health Organization (WHO) to launch a campaign of "Making Medicines Child Size". Children in Nigeria were once victims of unethical clinical medicine trials and repeated victims of use of fake and adulterated medicines. Considering the magnitude of harms children had suffered in Nigeria from the use of medicines, there is a need for literature review to identify the factors preventing children from accessing safe medicines and to suggest remedies to the problems. Lack of access to up- to- date medicine information, lack of training and research in pediatric clinical pharmacology, deficiencies in undergraduate and postgraduate teaching of medicine risk management and clinical pharmacology and therapeutics, irrational medicine use due to lack of pediatric focus on essential medicine list and inappropriate home storage of medicines by parents, lack of evidence- based medicine (EBM) practice, lack of national adverse drug reaction surveillance among children, and weak national drug policies were the major problems identified. It is to be hoped that development and provision of a pediatric national drug formulary for health professionals in Nigeria, creating a comprehensive national pediatric drug research network in collaborations with developed countries, reviewing the undergraduate and postgraduate curriculum in pediatrics to include teaching of basic elements of rational prescribing, drug dose calculations, adverse drug reactions and pharmacovigilance, increasing access to essential medicines for children, postgraduate teaching of EBM, and strengthening of the national drug policies would improve children's access to safe medicines in Nigeria.

Biologically active components of a Papua New Guinea analgesic and anti-inflammatory lichen preparation

A traditional preparation of Parmotrema saccatilobum (Taylor) Hale (Family: Parmeliaceae) is being considered for inclusion into the PNG national drug formulary by the Ministry of Health Taskforce on Traditional Medicines. The lichen preparation is traditionally used in the Milne Bay province of Papua New Guinea for analgesic and anti-inflammatory activities. A hexane extract of P. saccatilobum yielded the principle components atranorin and chloroatranorin. Atranorin and chloroatranorin were tested in a COX-1 and -2 enzyme inhibition assay, which showed that atranorin inhibited COX-1 in a dose dependent manner and suggests partial inhibition by atranorin and chloroatranorin of COX-2 and COX-1, respectively.

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.

Inappropriate prescribing in the elderly

Drug therapy is necessary to treat acute illness, maintain current health and prevent further decline. However, optimizing drug therapy for older patients is challenging and sometimes, drug therapy can do more harm than good. Drug utilization review tools can highlight instances of potentially inappropriate prescribing to those involved in elderly pharmacotherapy, i.e. doctors, nurses and pharmacists. We aim to provide a review of the literature on potentially inappropriate prescribing in the elderly and also to review the explicit criteria that have been designed to detect potentially inappropriate prescribing in the elderly. We performed an electronic search of the PUBMED database for articles published between 1991 and 2006 and a manual search through major journals for articles referenced in those located through PUBMED. Search terms were elderly, inappropriate prescribing, prescriptions, prevalence, Beers criteria, health outcomes and Europe. Prescription of potentially inappropriate medications to older people is highly prevalent in the United States and Europe, ranging from 12% in community-dwelling elderly to 40% in nursing home residents. Inappropriate prescribing is associated with adverse drug events. Limited data exists on health outcomes from use of inappropriate medications. There are no prospective randomized controlled studies that test the tangible clinical benefit to patients of using drug utilization review tools. Existing drug utilization review tools have been designed on the basis of North American and Canadian drug formularies and may not be appropriate for use in European countries because of the differences in national drug formularies and prescribing attitudes. Given the high prevalence of inappropriate prescribing despite the widespread use of drug-utilization review tools, prospective randomized controlled trials are necessary to identify useful interventions. Drug utilization review tools should be designed on the basis of a country's national drug formulary and should be evidence based.

The Economic Impact of Introducing Serotonin-Noradrenaline Reuptake Inhibitors into the Brazilian National Drug Formulary

To determine the cost effectiveness, from the Brazilian Ministry of Health viewpoint, of three antidepressant classes for major depressive disorder (MDD), and the budget impact of introducing serotonin-noradrenaline (norepinephrine) reuptake inhibitors (SNRIs) into the current Brazilian national drug formulary, assuming a 6-month treatment duration. An existing decision-tree model was adapted to Brazil, based on local guidelines. Clinical data were obtained from published meta-analyses. Patients included adults aged > or =18 years with MDD, diagnosed using the Diagnostic and Statistical Manual of Mental Disorders, third and fourth editions (DSM-III/IV), with moderate-to-severe disease (Hamilton Depression Rating Scale [HAMD] > or =15 or Montgomery-Asberg Depression Rating Scale [MADRS] > or =18), without co-morbidities or co-medications, receiving > or =6 weeks of treatment with SNRIs, selective serotonin reuptake inhibitors (SSRIs) and/or tricyclic antidepressants (TCAs). Clinical outcome was remission (HAMD < or =7 or MADRS < or =12). Direct costs (drugs, physician visits, hospitalisations) were included. Drug costs were obtained from the 2006 Brazilian National Drug Price List, and hospitalisation and physician costs from the 2006 Healthcare System database. Costs were valued in Brazilian Reais ($Brz), year 2006 values ($Brz1 = $US0.47). Univariate and Monte Carlo sensitivity analyses tested model robustness. Expected costs per patient treated were SNRIs $Brz4848; SSRIs $Brz5466; and TCAs $Brz5046, and overall success rates (primary plus secondary treatment across all decision tree branches) were SNRIs 78.1%; SSRIs 74.0%; and TCAs 76.4%. Average costs/success were SNRIs $Brz6209; SSRIs $Brz7385; and TCAs $Brz6602. SNRIs dominated in incremental cost-effectiveness analyses. Monte Carlo analysis confirmed drug classes' relative positions; however, there was considerable uncertainty. Introducing SNRIs into the formulary could generate average savings of 1% of the total budget, with a 52% probability of savings. SNRIs appear to be cost effective against SSRIs and TCAs when prescribed to patients with MDD in Brazil. However, their inclusion into the national drug list would generate minor savings compared with the current formulary of SSRIs and TCAs. Thus, we considered such inclusion as 'cost-neutral', since no major probability of savings or increased expenditures were observed.

Global Pharmacogenetics: Giving the Genome to the Masses

With pharmacogenetics comes the promise of individualized therapy selection for many common diseases where multiple treatment options are available. Recent advances including the Human Genome Project, the International HapMap project, advances in throughput and reduction in cost of genetic testing, and the inclusion of genotype-related dosing recommendations into package inserts all point to the integration of pharmacogenetics into clinical practice. However, many countries will not have access to pharmacogenetics resources in the near future. Generation of global genotype profiles will provide a useful, but not perfect resource for incorporating pharmacogenetics into national drug formularies in the form of prioritization or surveillance where individual genotype data would not be attainable. The PharmacoGenetics for Every Nation Initiative is a first step to making pharmacogenetics applicable on a global level.

The Evolving Use of Cost-Effectiveness Analysis in Formulary Management Within the Department of Veterans Affairs

The Veterans Health Administration (VHA) runs the largest integrated healthcare system in the nation. Formulary management within VHA primarily involves 3 national groups: the Medical Advisory Panel, the Veterans Integrated Service Network Formulary Leaders, and the Pharmacy Benefits Management Strategic Healthcare Group. Together, these groups manage the VHA national drug formulary with a goal of providing a comprehensive, safe, and cost-effective pharmacy benefit for veterans. Traditionally, VHA has relied on cost-minimization analyses in formulary decisions. More recently, VHA has emphasized the use of cost-effectiveness data, especially for newer, costly drugs. In addition to including this data in drug monographs, the VHA has begun requiring formal cost-effectiveness analysis from manufacturers of selected pharmaceuticals. VHA has also requested that clinically relevant information such as quality of life plus mortality benefit be made available from industry so that internal cost analyses can be performed. It is hoped that by setting the expectation that cost-effectiveness will be formally considered in all VHA formulary decisions, the pharmaceutical industry and others will be stimulated to collect and report data that enables these analyses. We believe that if other organizations also place an emphasis on economic evaluations, industry and the public will be more accepting of decisions that incorporate cost considerations.

Use of pharmacoeconomics in prescribing research. Part 5: modelling--beyond clinical trials.

This paper provides an overview of modelling in the economic evaluation of pharmaceuticals, reflecting the increasing use of models in analyses prepared for reimbursement applications to national and local drug formularies. The paper seeks to demystify the most commonly encountered modelling techniques (extrapolation, decision analysis, Markov modelling and Monte Carlo simulation), and to provide guidance in assessing the quality of submitted or published modelled economic evaluations.

Doctorline: a private toll-free telephone medical information service. Five years of activity: old problems and new perspectives.

Introduction; Healthcare professionals need to continually update their knowledge to provide care based on scientific evidence. In some cases it can be difficult to gain access to the different sources of medical information. In an attempt to overcome these problems, a toll-free telephone medical information service (Doctorline) was established. To describe the development, aims, organization, and activities of this private service. Doctorline is an independent, unbiased, toll-free medical information service that provides information on clinical, pharmacologic, and toxicologic issues; bibliographic searches; full-text articles; public and private clinics; details of forthcoming congresses; and legislative documentation. The service is available Monday through Friday, 1000 to 2000. Staff members are physicians trained in communication techniques, literature evaluation methodologies, and computerized database use. The main on-line facilities are MEDLINE, Micromedex-CCIS, and the Italian Formulary on CD-ROM. Books, bulletins, national and international drug formularies, and property files (i.e., directory of Italian public and private clinics) are also available. In 5 years, Doctorline has received 65 258 calls. Nearly 34% of the calls were made by general practitioners, followed by cardiologists (22%), orthopedists (15%), pharmacists (14%), gastroenterologists (13%), and urologists (10%). From 1991 to 1996, nearly 20% of the calls concerned pharmacologic issues, 43% nonpharmacologic issues, while the rest of the calls were for nonclinical requests. Approximately 21% of all questions received an answer during the same phone call (on-line answers); for the other answers (off-line answers) the mean +/- SD waiting time was 7.8 +/- 10.4 days. Although the nature of the questions has been recorded since 1991, data about the exact number of physicians who used the service are available only from 1994. Data from 1994 indicate that of the 52,181 physicians who could access the service, only 8817 (16.9%) called at least once, with a mean number of calls per physician of 3.9 (range 3.0-5.6). The future of Doctorline will depend on the quality and validity of the information provided (i.e., based exclusively on scientific evidence, independent of the source of funds), the promotion of the aims, organization, and clinical utility of the service (especially among physicians who made little or no use of the service), and differentiation of the service activities in relation to the physician's specific needs.

Pharmaceutical cost containment and innovation in the United States

In the United States, government has played a limited role in containing the costs of pharmaceuticals. There are no price controls, no national drug formularies, no universal cost-sharing policies, and perhaps most important, no national coverage of prescription drugs. Rather, pharmaceutical cost containment was historically left to private insurers and managed care companies, while consumers paid out of pocket for close to 62% of all drug expenditures. US utilization has historically been relatively low and prices by far the highest of the four industrialized countries. The major change in pharmaceutical cost containment in the 1990s has been the consolidation of purchaser power at the level of the insurer and managed care companies. These ‘whole sale’ purchasers now represent 70% of direct manufacturer sales, and they are demanding and receiving deeper price discounts. Meanwhile these same players are implementing formulary policies, utilization controls, and disease management programs, the outcomes of which have not yet been systematically evaluated. Failure to pass on savings to consumers, cost shifting by manufacturers to vulnerable consumer groups, and potential under-utilization of cost-effective drugs remain of concern.

Italian national drug formulary ‘undoubtedly useful’

Italian national drug formulary ‘undoubtedly useful’

The Need for a National Drug Formulary System in Saudi Arabia

The Need for a National Drug Formulary System in Saudi Arabia

National drug formularies: lessons from Latin America.

Although pharmaceuticals comprise up to 40% of the health care budget in developing countries, the majority of the population does not have access to many of the essential drugs needed to treat prevalent diseases. This situation demands the development of a national formulary of essential drugs for the public sector. The approach used in developing countries is to select drugs of choice for the treatment of prevalent morbidities and avoid therapeutic duplication, unacceptably dangerous drugs, or drugs of unproven efficacy. Drugs are selected based on a review of the prevalent morbidities, health care worker training, patient characteristics, and efficacy/risk information resulting from scientifically sound studies. An added component to the formulary is the inclusion of concise, unbiased prescribing information for each drug selected. A number of product selection guidelines were proven to be effective in establishing and maintaining an essential drug formulary for developing countries. These guidelines include: 1. Selection of drugs with proven efficacy and acceptable risk; 2. Selection of minimum number of drugs needed to treat the prevalent diseases; 3. Inclusion of new products only if they are found to have distinct advantages over products currently in use; 4. Inclusion of combination products only when they provide true benefit over single ingredients; 5. Selection of drugs with clear "drug of choice" indications for prevalent diseases; 6. Evaluation of the administrative and cost impact of products; and 7. Selection of drugs with established high quality.