The abuse of drugs has become a serious social problem worldwide. Amphetamine-type stimulants such as methamphetamine are recreationally abused and can cause toxic effects in the body. Unfortunately, death from drug poisoning can occur due to careless intake. In postmortem examinations, the distribution of drugs in an entire organ gives valuable information for evaluating their toxicity. We developed methods to measure the distribution of drugs in organs using LC/MS and matrix-assisted laser desorption/ionization-imaging mass spectrometry (MALDI-IMS). The complementary use of the two methods provides more detailed information on the distribution and concentration of drugs in organs because the accurate quantification in LC/MS and small spatial resolution in MALDI-IMS are combined. On the other hand, it is important to elucidate the drug intake history of suspects and victims in drug-facilitated crimes (DFCs). Hair and nail samples are often used to confirm chronic drug intake because ingested drugs can stably remain in these specimens over several months. However, it is impossible to determine the day of drug ingestion in conventional segmental analysis of bulk samples. Therefore, we developed methods to cut hair strands at 0.4-mm intervals and nails at 0.2-mm intervals, which correspond to their respective growth rates over 1-2 d, to analyze the drugs in each segment efficiently using LC/MS. The microsegmental hair analysis method is applied to estimate the day of drug ingestion in DFC investigations. These methods could be applied to measure the distribution of compounds in various solid samples.
“Academic detailing” is used to clearly explain scientific issues. In the field of clinical practice, “academic detailing” is a form of interactive educational outreach to physicians in order to provide unbiased, non-commercial, evidence-based information about medications and other therapeutic modalities, with the goal of improving patient care. It is necessary to provide proper information about prescription drugs for their appropriate use in clinical practice. However, this requires of physicians significant time and labor to comprehensively collect and summarize all necessary information for the proper clinical application of pharmaceutical products, a task which may be both difficult and prohibitive to a busy physician. However, if clinical experience and other pharmaceutical or treatment information is derived solely from the commercial entities, this may lead to improper prescription practices. In western countries, public funds are used to support universities and other research institution programs. In Canada, clinical pharmacists act as “detailers”. Their mission and role is to listen to the needs of the physician or health care professional, to provide objective, evidence-based drug information on selected drug therapy topics, to educate physicians on the optimal use of medications, to provide practical alternatives, and to extend the physician's usable knowledge base. The importance of this “academic detailing” activity is also recognized in Japan, and pharmacists can be expected to act as detailers in the future. We hope that this will lead to improvement in the quality of medical care.
These days, the necessity of a multidisciplinary approach to cancer patients is well known. However, not all cancer patients are satisfied with their medical care. One reason for this is the difficulty integrating all the specialties required in order to provide individualized care that considers the needs of each patient. To achieve the best medical care, each specialist in any multidisciplinary teams needs to be a leader when it comes to his or her own specialty, to communicate with each other to share all the information available, and to apply evidence-based medicine considering each patient's physical, mental, psychosocial and spiritual status. Academic detailing, which draws on a chemical and pharmacological evidence-based database, is a good way for pharmacists to share their knowledge and experience with physicians in order to maximize the power of a patient's multidisciplinary team.
Better prescription assistance can be provided by applying basic pharmaceutical science concepts, and by considering evidence from clinical trials. For example, several drugs are currently used to treat ulcerative colitis (UC), a form of inflammatory bowel disease. In general, after a drug is administered, it is first absorbed into the upper part of the small intestine and then enters the bloodstream. However, 5-aminosalicylic acid (5-ASA), which is commonly used to treat UC, acts locally on the colonic mucosa; its absorption must be prevented in the upper gastrointestinal tract so that it can be delivered to the colorectal mucosa. Therefore, in this case, it is important to consider drug dissolution tests rather than pharmacokinetics. Currently, three types of 5-ASA formulations are available: a pH-dependent release formulation, a time-dependent release formulation, and a combination of the two at maximum dosages of 3600, 4000, and 4800 mg, respectively. Although it is often thought that selecting a high dose is better, the clinical effectiveness of 5-ASA is determined by the amount of drug actually delivered to the lesion. Therefore, rather than dosage, it is most important to understand differences in drug solubility. It is beneficial to provide prescription assistance for the treatment of UC by 5-ASA, because when 5-ASA fails, a steroid or expensive biological drug is administered. We will present a case study and discuss the future of prescription assistance using Academic Detailing.
Currently, the role of medical representative (MR) is responsible for providing information to medical doctors from pharmaceutical/medical equipment companies. In recent years, however, the newer role of medical science liaison (MSL) has been established to construct evidence and provide advanced medical and scientific information to health care professionals. This position, independent from the sales division of a pharmaceutical or medical equipment company, has already been established in Europe and the U.S. The MSL helps to combat concerns of conflicts of interest (COI) concerning the sophistication of expert information, and in support of clinical research. I will introduce the role of the MSL in Japan.
In the pharmaceutical industry, a Medical Affairs (“MA”) professional collects, organizes and transmits information about a health care product based on the judgment of science, medicine and ethical values, thereby optimizing the product's value, improving corporate value, and assuring quality medical care. The role of the MA is to construct a “medical strategy” through the process of collecting, analyzing and evaluating information. On the other hand, Academic Detailing is “a new approach to drug information that actively disseminates drug comparison information from a pharmacological viewpoint, linking the drug's foundation to clinical practice.” Cooperation between Academic Detailing and a pharmaceutical company's MA will be an essential relationship in realizing advanced prescribing proposals in the future, with the ultimate goal of optimal medication regimes for patients.
In order to implement academic detailing, it is extremely important to understand the pharmacological activity of drugs based on their chemical structures. To construct a database for academic detailing, a viewpoint for clinically utilizing the fundamental pharmacological features of a drug is required. These fundamental pharmacological features include chemical characteristics such as chemical structures, physical characteristics such as pharmaceutical formulations for efficient drug delivery to target organs, and a pharmacological viewpoint, which is a mechanism by which a drug is determined to be effective. In addition, in vivo kinetics are included in a drug's pharmacological features, i.e., a drug's excretion through urine and feces via the kidneys, its side effects due to differences in enzyme type when the drug is metabolized in the liver, as well as the capacity of the patient's current enzyme profile. This review describes academic detailing based on the chemical structure of drugs for breast cancer hormone therapy, as an example.
‘Academic Detailing’ is an approach to providing doctors with information about medicines based on the latest non-commercial evidence-based data for proper prescription. Overseas, pharmacists have been active as academic detailers. Academic Detailing in Japan, as a new approach to disseminating comparative drug information based on basic pharmaceutical sciences and clinical evidence, will influence clinical decision making by doctors, and contribute to better patient-centered medical care. Pharmacists have been participating in ensuring the proper use of drugs by their patients by entering their homes or wards. However, in the future, it is necessary to take steps to improving pharmaceutical decision making by doctors. Therefore, we are considering the following educational points in the Japanese version of training an academic detailer. “A: We shall compare medicines based on basic pharmaceutical sciences and the latest non-commercial evidence-based data. B: We shall understand the point of using medicines based on the patient's condition. C: We shall choose cost-effective drugs from the viewpoint of pharmacoeconomics. And D: We shall acquire communication skills for effective academic detailing.” In the future, this first class of Academic Detailers who facilitate academic detailing in the health care field will be pioneers. They will also participate in research to track and quantify the effects of academic detailing.
A new single nucleotide polymorphisms (SNP) genotyping method has been developed and validated using biological specimens directly as templates for TaqMan PCR without general DNA extraction and purification procedure from dried saliva samples attached on water-soluble papers. This new method can set up at ease and complete PCR analysis including data interpretation in under two hours with additional advantages of application for large-scale clinical research, diagnostics, and epidemiological studies at low cost. Specifically, SNP genotyping of alcohol metabolism-related genes ADH1B (rs1229984) and ALDH2 (rs671) were demonstrated by TaqMan PCR assay using dried saliva samples in the present investigation. In this protocol, by simplifying experimental operations and improving efficiency, omitting and simplifying the time and laborious DNA purification process, it is possible to shorten the experiment time and reduce the risk of human error such as contamination. Furthermore it became possible with great cost reduction. We succeeded in dramatically improving the judgment rate and accuracy of SNP genotyping by the master mix reagent for commercial available real-time TaqMan PCR. Moreover, it becomes possible to stably introduce template DNA into the reaction system, and it will be possible to apply it to copy number variation (CNV) by TaqMan probe method. The SNP analysis process using this optimized water-soluble paper will be applied to gene polymorphism analysis of drug metabolizing enzyme gene CYP, etc., to help efforts to realize personalized medicine.
We have developed a new SNP typing method, reducing the experiment time by simplifying the conventional DNA extraction and purification process. Furthermore, the risk of human error, such as sample contamination was reduced, and significant cost reduction was achieved. We aim to utilize genotyping of alcohol metabolism-related genes in health education, preventing drinking accidents for university freshmen, as well as promoting appropriate drinking habits in the community. By identifying genotypes for genes related to drug metabolisms, personalized medicine will be achieved.
Ophthalmic viscosurgical devices (OVDs), mainly containing sodium hyaluronate (HA), are used in cataract surgeries to protect the cornea endothelium. In this study, the rheological properties of 9 launched products (containing 1% HA) were evaluated. The molecular weights (MWs) of HA estimated based on intrinsic viscosity varied widely, between 1100-2500 kDa, and showed a particular value for each product. Of the 9 products, 6 are classified as cohesive OVDs and their product specifications show the same value for intrinsic viscosity (25-45 dL/g), with high MW HA (>2000 kDa); however, the MW of each HA showed a particular value (2200-2500 kDa) within the range of the product specification. As with the MW of HA, apparent viscosity and dynamic rheological parameters showed particular values for each OVD. The product Opegan-Hi exhibited the highest value of apparent viscosity at low shear rate, and a solid-like behavior among the OVDs. In a questionnaire survey among 198 cataract surgeons, 42% of surgeons had experienced a difference in ability to maintain the depth of anterior chamber during surgery among the different cohesive OVDs used. This suggested that surgeons select OVD properties based on surgical procedure and patient cases. In conclusion, we demonstrated that each OVD has particular rheological properties within the range of the product specification defined by the intrinsic viscosity. The results might provide useful information for surgeons in their selection of OVDs based on their experience.