FIP Calls for Members with Interest in Two Working Groups
Hello, HPS Members
FIP has created a Working Group on ethics, as a continuation of the work done recently by Betty Chaar from Australia and William Zellmer from the United States. Betty and Bill will also co-chair this new group. Interested hospital pharmacists should let Lee Vermeulen, or I know if you would like to participate in this working group (our contact details are at the end of this newsletter). The deadline for submission of names is July 1, 2015, so please let us know at your earliest convenience if you are interested.
Another potential working group has been stimulated by discussion at the World Health Assembly held in May in Geneva on the topic of medical devices. The WHO would welcome an HPS working group to address global needs for harmonized standards for medical devices. Hospital pharmacists in particular have a lot of experience in applying regulatory standards and conducting risk assessment and effectiveness evaluations based on published literature of medications which could translate nicely to a similar process for medical devices. If you are interested in joining a working group to create a regulatory framework for medical devices please let Lee or me know. We are working with FIP headquarters staff to identify group members and a charge/purpose of the group’s work. Your early indication of interest or suggestion of other hospital pharmacists is appreciated.
I hope that you plan to attend the 2015 FIP Congress in Dusseldorf from Sept 28 thru October 3. There are many details on the www.FIP.org website including a Master Class on the logistics and protecting the integrity of medicines within the supply chain. The class will be held on Sept 28th and Sept 29th. You will need to plan ahead to register for this session.
I noted that the WHO sponsored the World Health Assembly in May in Geneva, Switzerland. Several FIP pharmacists promoted the pharmacists role including Giovanni Pauletti, Henri Manasse, Ema Paulino and FIP staff Luc Besançon and Zuzana Kusynová. Antibiotic resistance, the Ebola outbreak, global vaccine plan and mental health were all discussed during the assembly. Angela Merkel, German Chancellor, attended the meeting as well as many other dignitaries and health care authorities. Sylvia Matthews Burwell, U. S. Secretary of Health and Human Services, indicated that “Patience is the key to collaborating.”
We have learned the value of patience in the HPS and have had great collaboration on activities that will lead to improved practice. Our work in health care has very great interest on the international stage. Thank you-you are an important part of this collaboration.
Marianne Ivey President; Hospital Pharmacy Section 3
Project to promote the inclusion of laboratory test values in external prescriptions – a strategy expected to increase the safety of health care
Yasuo Takeda, Ph.D.
Professor and Director, Kagoshima University Hospital, JAPAN.
Vice President of JAPAN, Hospital Pharmacy Section of FIP
In Japan, a project is currently underway involving all outpatients who receive external prescriptions: 131 to 16 laboratory values, indicators of the renal function and adverse effects, are included in external prescriptions. The project aims to inform community pharmacists, health care professionals in charge of the prescription, the results of laboratory tests conducted to examine the renal, hepatic, and cardiac function of patients, or patient information required by pharmacists to determine appropriate doses according to the conditions of individual patients and identify adverse effects in the early stages, and increase the safety of outpatient services.
1 Thirteen principal test items written on external prescriptions: WBC (white blood cells), Hb (hemoglobin), PLT (platelets), PT-INR (international normalized ratio of prothrombin time), AST (aspartate aminotransferase), ALT (alanine aminotransferase), T-Bil (total bilirubin), sCr (serum creatinine), eGFR (estimated glomerular filtration rate [mL/min/1.73 m2]), CK (creatinine phosphokinase), CRP (C-reactive protein), K (potassium), and HbA1c (hemoglobin A1c)
Most hospitals and clinics in Japan provide both in- and outpatient services, and implement drug treatment. Under the slogan of “the promotion of separating dispensing from medical practice” initiated by the Ministry of Health, Labour, and Welfare, most hospitals and clinics have provided 4
drug treatment for outpatients based on external prescription: community (family) pharmacists selected freely by patients’ dispensed drugs. However, since prescriptions do not include basic information such as the names of disorders and blood test results, community pharmacists in charge of prescriptions have to: assume the names and conditions of diseases, conduct prescription checking and dispensing, and provide drug administration guidance. However, some patients refuse to disclose their conditions, and pharmacists often have to conduct dispensing and provide drug administration guidance even when they are unable to conduct prescription checking or confirm the appropriateness of doses.
In 1993, a sorivudine-related incident occurred in Japan. In this incident, patients who had been administered a combination of sorivudine, a drug for the treatment of herpes zoster, and fluorouracil (5-FU), an anticancer drug, developed severe blood-related problems, including significant decreases in the numbers of leucocytes and platelets. This may be the most serious drug interaction to have occurred in Japan, resulting in fatalities. Fifteen patients died due to this during the one-year period following the launch of sorivudine.
Patients who have been administered anticancer drugs may develop secondary viral infectious diseases as complications due to impairment of the immune system occur as adverse effects of the drugs. The risk of severe adverse effects posed by the combined use of sorivudine and 5-FU is stated in written documentation. However, most cancer patients were not informed of the disease at that time, and it was difficult to determine whether or not patients with herpes zoster had been administered 5-FU by other health care institutions. In other words, the accident was attributed to the following multiple causes: inadequate information-sharing and collaboration between hospitals and pharmacies, prescribing physicians’ lack of knowledge/recognition of drugs, and an inadequate system for checking by pharmacists. In recent years, there have also been reports of the inappropriate administration of drugs to patients with an impaired renal function and their adverse effects. 5
Dr. Masada, Professor and Director of the Department of Pharmacy of Fukui University Hospital, suggested that it is necessary to prevent such incidents by conveying necessary information on laboratory test results to community pharmacists, and providing follow-up care for patients. In March 2011, he initiated a project to add modifications to external prescriptions so that new prescriptions would include the results of 34 laboratory tests required to assess the efficacy and safety of drugs, including the eGFR, an indicator of the renal function, and the glycated hemoglobin (HbA1c) level, an indicator of blood sugar control; he selected laboratory test values required to evaluate specific drugs. In general, laboratory test values are data unavailable to community pharmacists. Laboratory test values written on prescriptions help community pharmacists control the doses of drugs and check for adverse effects in patients with impaired hepatic and renal functions, which could not be easily examined at pharmacies in the past, and confirm the hepatic and renal functions, the numbers of leukocytes and neutrophils, and adverse effects in patients undergoing outpatient chemotherapy. This suggests that laboratory test values written on prescriptions will help pharmacists identify adverse effects in the early stages and ask physicians questions.
Efforts are currently underway in many hospitals and areas to require prescriptions to include laboratory test values, including the results of tests of hepatic and renal functions, blood coagulation ability, and blood sugar, lipid, and electrolyte levels. In 2012, Chikamori Hospital started to issue prescriptions including laboratory test values for all outpatients, followed by Hokkaido University Hospital and Kyoto University Hospital in 2013. In particular, Dr. Matsubara, Professor and Director of the Department of Pharmacy of Kyoto University Hospital, developed a prescription form with a field for physicians to write comments to community pharmacists, as well as a field for laboratory test values. He also established systems for patient information-sharing and management by adopting a tool designed to promote interactive communication (tracing paper): from hospitals to community pharmacies or vice versa. He commented: “Community pharmacists positively assessed these efforts. 6
They welcome and are pleased with the newly adopted system”. Since then, there has been an increase in the number of hospitals that require prescriptions to include laboratory test values. According to the results of a survey involving 8,536 hospitals in Japan conducted by the Pharmaceutical and Medical Devices Agency between January and February this year (response rate: 53.4%), there are 34 hospitals that provide prescriptions to include laboratory test values at present. Since January this year, Kagoshima University Medical and Dental Hospital has provided community pharmacists in charge of prescription with laboratory test values on 16 items (in the past seven examinations) for outpatients undergoing chemotherapy. The hospital plans to initiate a system requiring prescriptions to include laboratory test values for all outpatients in the near future.
Hospitals in Japan have held discussions with regional pharmaceutical associations in charge, and adopted different and unique forms of prescription including laboratory test values. It is advisable for the Japanese Society of Hospital Pharmacists and the Japan Pharmaceutical Association to establish a standard format in the future.
As demand for home health care increases, it will become important for community pharmacists to collaborate with hospital pharmacists to conduct pharmaceutical management as members of inter-professional home health care teams. Laboratory test values written on external prescriptions help hospital and community pharmacists closely collaborate with each other, and this collaboration is expected to ensure that patients receive seamless health care in secure manners. Such information written on prescriptions also serves as a useful tool used when asking questions to prescribing physicians, and is expected to help community pharmacists significantly contribute to the improvement of drug treatment for outpatients and patients cared at home. I expect its further development.