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Quality made in Germany - And who is supervising the supervisors?
- Dr. Herbert H. Nehrlich (5 August 2004)
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Quality, efficiency and patient care.
- Dr.Naseem A. Qureshi MD, IMAPA, LMIPS (10 August 2004)
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International Quality control in academic research and clinical trials- an issue of quality
- Nilima A. Kshirsagar, Gogtay NJ and Dalvi SS (6 September 2004)
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Dr. Herbert H. Nehrlich, Private Practice Bribie Island, Australia 4507
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Der Gemeinsame Bundesausschuss. Roughly translated this means "working together", for the common good it is implied. I wasn't born a pessimist but predict here and now that in the Pharmaceutical Republic of Germany this will not work. In a very short time, the great friends of the people, Big Pharma, will have their sticky fingers in the Strudel. Notice how this Ausschuss is manned by doctors, insurance representatives and members of the public. Who chooses the members of the public? And will ALL the doctors present have close ties to the drug manufacturers? Will the scientific reports continue to be churned out by those who have something to sell for the management (not cure) of disease? And who will monitor the monitors? It stands to reason that prominent representatives from each group will make up the membership, which is tantamount to putting an entirely new meaning to the word "Quality Control". It is also very interesting to observe that the groundswell of complaints and dissatisfaction of the population with the many mistakes in the sickness industry has become very noticable. This in turn is good news for the tabloids and will keep the fires of political manoeuvring going. It's like so many things today, problems don't really need to be eliminated, the mere appearance of our concerned "leaders" being seen to do something is all that is required. More tax money will be wasted and even that needs only to be short term, because very soon, when Joseph and Hildegard Schmidt least expect it, some other fiasko will make the headlines taking their minds off things that need not concern them since the experts are taking care of everything. Nothing will change in the outcome, the treatment of sickness will remain a gigantic money-making business and , as a patient recently stated to me,"in the old days they bled people to treat diseases, today they bleed them too, but of their money." I know quite a few German physicians and especially like the country doctor type who has not been overtaken by excess sophistication.The ones who think in terms of doing an honest day's work and provide quality according to the old motto "Made in Germany" and the Oath of Hippocrates, not because an Ausschuss monitors them. There are at least a handful left. Competing interests: None declared |
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Dr.Naseem A. Qureshi MD, IMAPA, LMIPS, Medical Director(A), Director CME&R Buraidah Mental Health Hospital, Postcode:2292, Saudi Arabia
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Sir: It is nice to know that German doctors, health insurance companies, and patients, all important components of health delivery system, laid the foundation of the Institute for Quality and Economic Efficiency in Health Care, which is based on the working philosophy of England's NICE. Notably, Like NICE recently lauded by British intellectuals, this institute will perform several tasks; research the latest medical knowledge on diagnostics and therapy of selected diseases of immense public health concerns; provide expertise on quality and economic efficiency of new drugs, medical equipment and other health care paraphernalia; evaluate the evidence based guidelines of the most common diseases and prepare recommendations for setting up disease management programmes; evaluate the effectiveness of drug treatment and prepare information about the quality and efficiency of health care for the public. This new institute under the directorship of Dr. Peter Sawicki will hopefully work qualitatively and efficiently. Two main criticisms were raised by doctors and the pharmaceutical industry; "cookery book medicine" and "patronising state medicine,"; and bureaucratic obstacle to innovative drug treatment. It is wise to know that efficacy of drugs and overall quality of treatment intervention together with cost assessments should be based on two closely related concepts; individual patient evidenced-based data and evidenced-based data mainly derived from RCTs and meta-analyses. Reference: Annette Tuffs. Germany sets up quality control institute for health care. BMJ 2004; 329: 307-a. Competing interests: None declared |
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Nilima A. Kshirsagar, Dean (G & K), Prof. & Head, Dept. of Clinical Pharmacology Dept. of Clinical Pharmacology, Seth GSMC & KEMH, Parel, Mumbai-400 012.India., Gogtay NJ and Dalvi SS
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NA Kshirsagar, NJ Gogtay, SS Dalvi
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Dear Sir, We read with interest the formation of Germany’s institute for Quality and Economic efficiency in Health care (1). We present in this paper our own experience in quality control with two international laboratories , the findings and the implications therein for patient care. Modern medicine increasingly relies upon the provision of satisfactory analytical results from the laboratory and if these are to play their proper role, they must be trustworthy. Experience has shown that all analytical results are subject to errors arising from a variety of causes and it is obvious that these must be kept to a minimum. Quality control is defined as the study of these errors, which are the responsibility of the laboratory and the procedures used to recognize and minimize them. (2). We present in this paper our experience of quality control with two international laboratories, the findings and the implications therein for patient care. As part of an ongoing academic study, our department is presently phenotyping the activity of thiopurine methyltransferase (TPMT) in normal healthy volunteers and we eventually hope to apply it for patient care in patients of acute lymphoblastic leukemia. The activity of the TPMT enzyme is subject to genetic variability and 1 in 300 subjects is usually deficient. (3). Following the setting up of the method which involved addition of rbc lysate from subjects containing the enzyme to a solution containing 6-methylmercaptopurine (6MP), the method measures the amount of 6-methylmercaptopurine (6MMP) produced and thereby calculates the TPMT activity of a given subject. (4). The department linked up with a laboratory in the United Kingdom for quality control. Three quality control samples were provided by the QC laboratory- 2A, 2B and 2C for which we returned values of 25.07, 24.43, and 33.66 nmol/ml/hr rbc. These values were reported by the QC lab as being inordinately high and we were asked to check our method since the true values for the samples were low, intermediate and low TPMT activity respectively. On a dialogue with the QC lab, it was realized that in the blank samples, there is a small amount of production on non enzymatic 6-MMP which needs to be subtracted from the final result. When this was done, the values were categorized as being correct. (Table 1) In the second instance, in a sponsored clinical trial of a new anti malarial, 10 peripheral slides (thick and thin smears) were sent to us from a QC laboratory in South east Asia. These 10 slides were read by 3 technicians with over 8 years of smear reading experience. The results of the slides as read by the 3 technicians (between whom there was concurrence) versus that of the international QC lab are summarized in the table below. The initial report from the QC lab graded the results as being inaccurate based on 4 “incorrect” slides and refused to certify the technicians and at one point the QC issue threatened to jeopardize the conduct of the trial. Subsequently, all 10 slides and particularly those with scanty parasitemia were painstakingly photographed and the photos showing the ring forms of the parasites in the 4 slides labeled as incorrect by the South Asian lab sent to them. This was acknowledged by the QC lab and the technicians were then “certified” as being 100% accurate by the lab. It is likely that because the 4 slides had exceedingly low parasitemias, they were better picked up by locally experienced technicians working in a developing country in a malaria endemic area. (Table 2) In the first instance, the international QC laboratory helped us set the method right. In the second instance, we helped the international lab to redefine its QC parameters. Both examples highlight the fact the process of quality control should involve an ongoing dialogue between the provider and user and more so for tests like TPMT and parasite counts where patients’ lives are at stake. References: 1. Annette T. Germany sets up quality control institute for Health care. Br. Med. Jr. 2004; 329 : 307. 2.Quality control. In Varley’s practical Clinical Biochemistry. Ed Gowenlock AH. CBS Publishers, New Delhi, 6th edition, New Delhi, 285-289. Textbook of Clinical Biochemistry. Harper 3.Weinshilboum RM. Methylation Pharmacogenetics: thiopurine methyltransferase as a model system. Xenobiotica 1992; 22:1055-1071. 4.Jacqz-Aigrain E, Medard EY, Mircheva Y, Vilmer E. Thiopurine methyltransferase activity in a French population: h.p.l.c. assay conditions and effect of drugs and inhibitors. Br J Clin Pharmac 1994; 38: 1-8. Table 1 Sample no Our initial lab result nmol/hr/ml rbc International lab result of phenotyping International lab result actual value Units/ml rbc Our result after re-analysis nmol/hr/ml rbc 2A 25.07 Low 4.8 5.18 2B 24.43 Intermediate 10.8 16.38 2C 33.66 Low 4.9 3.89 Table 2 Sr. No. Slide number Species identification KEM Hospital, INDIA International QC Laboratory report 1 1 PVRTG (M) PVRTG 2 2 PVR (S) TG (VVS) PVR TG 3 3 PFR (S) PFR 4 4 PFR (VVS) Negative 5 5 PFR (VVS) Negative 6 6 PVRTG (H) PVRTG 7 7 PFR (VS) PFR 8 8 PFR (M) PFR 9 9 PFR (VVS) Negative 10 10 PFR (VVS) Negative Recheck of photographs sent at International QC Laboratory , confirmed the results of KEM, India QC results that were reported positive (as above), to be correct. Pv- Plasmodium vivax Pf- Plasmodium falciparum M-moderate, S-scanty, H-heavy VVS-very very scanty, R- rings T-Trophozoites, G-gametocytes Competing interests: None declared |
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