To
All Chinese
Brothers and Sisters
wishing you a
HAPPY and PROSPEROUS
CHINESE NEW YEAR
"Charity begins at home"
Warmest Regards and Best Wishes
Malaysian KidneySPA
Monday, January 31, 2011
Friday, January 28, 2011
Should HD Centre be allow to mix their own dialysate?
Malaysian KidneySPA comments...
of pharmaceutical products is required by the local governing body - The Ministry of Health Malaysia (KKM) to conform with stringent requirements laid down for the industry. As hemodialysis concentrates (HDC) are also produced by these manufacturers, therefore production of HDC also needs to conform with these strict and stringent requirements.
Lets start from the beginning, in order to set up a pharmaceutical manufacturing facility, a prospective company need to obtain numerous licenses from many government agencies. To fulfill all the requirements takes months if not years and numerous visits and inspection by the relevant authorities. A comprehensive manufacturing facility may cost tens of millions of Ringgit and over time, investment may exceed hundreds of millions of Ringgit.
To register a new pharmaceutical product too requires a heap of paperwork, time and expense. To register a new pharmaceutical product not in the local market may need clinical study and this will incur cost.
The company then has to decide which international pharmacopeia standard it wishes to follow, British Pharmacopeia (BPC), United States of America Pharmacopoeia (USPC) or the European Pharmacopeia (EUPC). Having decided on one, then all products manufacture must conform the pharmacopoeia standard requirements.
Raw material too are only source from reputable suppliers. These suppliers are audited from time to time by the company to ensure they comply with international standards. Only materials that are pharmaceutical grades and conform to the pharmaceutical standards are used. They are kept in a secured area in the manufacturing plant in order to ensure its safety link is maintained.
The production process is a tedious process of of make analysis after analysis to ensure that the electrolyte composition is within the range stipulated in the pharmaceutical standards. After the quality control officer is satisfied, then only will the HDC be bottled. Although it is a non sterile solution but steps are taken to minimised contamination. Manufacturers never reuse canisters but HD centre do.
The bottled HDC solutions is then quarantined for 10-14 days. Tests are done to ensure that the HDC solutions conform to the pharmceutical standards employed. After being satisfied, the quality assurance officer will sign off the batch for release.
The in-house laboratory used for testing of products produced is also accredited and accorded the latest ISO certification.
Most importantly, the production facility is audited by the National Bureau of Pharmaceutical Control of the KKM. Failing to pass their audit will result the shutting down of the whole production facility until the fault is resolved to their satisfaction.
As manufacturers have to comply with these stringent requirements to operate, do you think it is advisable to allow HD Centres to product their own HDC? Suppliers of Bicarbonate powders can only vouch the powder supplier IF mixed with the correct amount of water would give the stipulated concentration of electrolyte but would and could they vouch for what actually takes place during the mixing procedure?
HD centres do not have the laboratory facilities to monitor the HD concentrate solution while being mixed. Do they quarantine each a every batch before final testing and before being allow to be used. Do they have qualified personnel with the right qualification and equipement to carry out the task?
Lastly, I wish to revisit an open letter by the President of the Medico Legal Society of Malaysia which was posted on this blog on 29/10/2010.Read letter here Why have double standards!!! We should strived for the highest standard for the best outcome and well-being of the patients. Never compromised!!!
of pharmaceutical products is required by the local governing body - The Ministry of Health Malaysia (KKM) to conform with stringent requirements laid down for the industry. As hemodialysis concentrates (HDC) are also produced by these manufacturers, therefore production of HDC also needs to conform with these strict and stringent requirements.
Lets start from the beginning, in order to set up a pharmaceutical manufacturing facility, a prospective company need to obtain numerous licenses from many government agencies. To fulfill all the requirements takes months if not years and numerous visits and inspection by the relevant authorities. A comprehensive manufacturing facility may cost tens of millions of Ringgit and over time, investment may exceed hundreds of millions of Ringgit.
To register a new pharmaceutical product too requires a heap of paperwork, time and expense. To register a new pharmaceutical product not in the local market may need clinical study and this will incur cost.
The company then has to decide which international pharmacopeia standard it wishes to follow, British Pharmacopeia (BPC), United States of America Pharmacopoeia (USPC) or the European Pharmacopeia (EUPC). Having decided on one, then all products manufacture must conform the pharmacopoeia standard requirements.
Raw material too are only source from reputable suppliers. These suppliers are audited from time to time by the company to ensure they comply with international standards. Only materials that are pharmaceutical grades and conform to the pharmaceutical standards are used. They are kept in a secured area in the manufacturing plant in order to ensure its safety link is maintained.
The production process is a tedious process of of make analysis after analysis to ensure that the electrolyte composition is within the range stipulated in the pharmaceutical standards. After the quality control officer is satisfied, then only will the HDC be bottled. Although it is a non sterile solution but steps are taken to minimised contamination. Manufacturers never reuse canisters but HD centre do.
The bottled HDC solutions is then quarantined for 10-14 days. Tests are done to ensure that the HDC solutions conform to the pharmceutical standards employed. After being satisfied, the quality assurance officer will sign off the batch for release.
The in-house laboratory used for testing of products produced is also accredited and accorded the latest ISO certification.
Most importantly, the production facility is audited by the National Bureau of Pharmaceutical Control of the KKM. Failing to pass their audit will result the shutting down of the whole production facility until the fault is resolved to their satisfaction.
As manufacturers have to comply with these stringent requirements to operate, do you think it is advisable to allow HD Centres to product their own HDC? Suppliers of Bicarbonate powders can only vouch the powder supplier IF mixed with the correct amount of water would give the stipulated concentration of electrolyte but would and could they vouch for what actually takes place during the mixing procedure?
HD centres do not have the laboratory facilities to monitor the HD concentrate solution while being mixed. Do they quarantine each a every batch before final testing and before being allow to be used. Do they have qualified personnel with the right qualification and equipement to carry out the task?
Lastly, I wish to revisit an open letter by the President of the Medico Legal Society of Malaysia which was posted on this blog on 29/10/2010.Read letter here Why have double standards!!! We should strived for the highest standard for the best outcome and well-being of the patients. Never compromised!!!
Thursday, January 27, 2011
Reader's question answered....
Our reader, Yudi has posed a question which is very interesting as it involved with the preparation of dialysate in a clinical setting:
Yudi:
"I was involved with the Mutu and Piawaian document creation. One of the questions raised in the Mutu and Piawaian discussion was on the need for industry to give it's input regarding procedure, preparation of dialysate, safety measures that need to be in place to ensure treatment is safe."
Malaysian KidneySPA has forwarded the question to Ain Medicare, the leading supplier of Hemodialysis Concentrate for their view and here is their reply:
Ain Medicare:
"There are many steps and procedures in the production process which must comply with stringent requirements of international and local regulatory bodies needed to be adhered to while ensuring quality of the hemodialysis solutions are in constant control. Below are some of the major considerations in the production of hemodialysis solutions:
1.WATER: water used in preparation of our hemodialysis solution is of Water For Injection (WFI) quality. Regular monitoring of the WFI to ensure its chemical & microbiological requirements are constantly met are conducted by our ISO 17025 accredited in-house Chemical & Microbiological laboratories.
2.MATERIALS: materials (Active Pharmaceutical Ingredients-API & Packaging ) used in our hemodialysis products are from Approved vendors, whereby their quality system & quality of the materials have been verified.
3.MANUFACTURING PROCESS: During the manufacturing process, all necessary steps are taken to ensure that the end product quality complies with the latest British Pharmacopoeia (BP) requirements. Critical control points are established for process monitoring and sampling. Although the hemodialysis solutions are not claimed as 'sterile'; strict precautions are taken to ensure control of microbiological aspects.
As an example: manufacturing of the hemodialysis solutions are done in a cleanroom environment whereby the level of airborne particulate and microbes are controlled, all surface (eg. pipes) which are in contact with the hemodialysis solutions are cleaned with WFI using Clean-In-Place (CIP) concept and followed with sterilization with PURE STEAM using Sterilization-In-Place (SIP) concept. Correct aseptic technique is emphasised during manufacturing.
4. PERSONNEL: All personnel working in the manufacturing of the hemodialysis solutions are trained & qualified on the correct procedures involved in manufacturing steps. This is to ensure the quality of our hemodialysis solutions are consistent at all times.
5. DOCUMENTATION: All manufacturing activities and training / qualification of staff are properly documented to ensure full traceability."
Patient's safety and wellness is of upmost importance to us in Ain Medicare.
Malaysian KidneySPA will post its comments on this subject soonest....
Malaysian KidneySPA will post its comments on this subject soonest....
Wednesday, January 26, 2011
Easy Reading....
Health is wealth
By Dr C.S. FOO
The Star Online 26/1/2011
The key to health and longevity is finding the trigger to demolish the barrier to a healthier and better life.
IN sitcoms, there is often an episode that plays flashbacks to consolidate the storyline. For those who had joined our tour from the beginning, we have discussed the four pillars of true health. Knowing the benefits of exercise, appropriate lifestyle habits, healthy dietary choices, and a science-based approach to supplementation is still not good enough. It is the keying in of the right digits that opens the combination lock of the door to optimal health that makes the difference.
Call Mr Raymond Tan @ +60126392833 today to find out how he can help you.
Tuesday, January 25, 2011
Depression and Suicide Risk in Hemodialysis Patients With Chronic Renal Failure
Received June 17, 2010; revised July 15, 2010; accepted July 16, 2010. From the Dept. of Psychiatry and Nephrology, Chang Gung Memorial Hospital at Keelung, Taiwan; Chang Gung University School of Medicine, Taiwan; Division of Mental Health and Drug Abuse Research, National Health Research Institute, Miaoli, Taiwan; and the Master of Public Health Degree Program, College of Public Health, National Taiwan University, Taipei, Taiwan. Send correspondence and reprint requests to Liang-Jen Wang, M.D., Dept. of Psychiatry, Chang Gung Memorial Hospital at Keelung. No. 200 Ave 208 Chi-Chin-Yi Rd., Keelung, Taiwan. e-mail: WangLiangJen@gmail.com
sychosomatics 51:528-5286, November-December 2010
doi: 10.1176/appi.psy.51.6.528
© 2010 Academy of Psychosomatic Medicine© 2010 The Academy of Psychosomatic Medicine
Abstract
BACKGROUND: Depression and suicide are well established as prevalent mental health problems for patients on hemodialysis.
OBJECTIVE: The authors examined the demographic and psychological factors associated with depression among hemodialysis patients and elucidated the relationships between depression, anxiety, fatigue, poor health-related quality of life, and increased suicide risk.
METHOD: This cross-sectional study enrolled 200 end-stage renal disease patients age
18 years on hemodialysis. Psychological characteristics were assessed with the Mini-International Neuropsychiatric Interview, the Hospital Anxiety and Depression Scale, the short-form Health-Related Quality of Life Scale, and Chalder Fatigue Scale, and structural equation modeling was used to analyze the models and the strength of relationships between variables and suicidal ideation.
RESULTS: Of the 200 patients, 70 (35.0%) had depression symptoms, and 43 (21.5%) had had suicidal ideation in the previous month. Depression was significantly correlated with a low body mass index (BMI) and the number of comorbid physical illnesses. Depressed patients had greater levels of fatigue and anxiety, more common suicidal ideation, and poorer quality of life than nondepressed patients. Results revealed a significant direct effect for depression and anxiety on suicidal ideation.
CONCLUSION: Among hemodialysis patients, depression was associated with a low BMI and an increased number of comorbid physical illnesses. Depression and anxiety were robust indicators of suicidal ideation. A prospective study would prove helpful in determining whether early detection and early intervention of comorbid depressionand anxiety among hemodialysis patients would reduce suicide risk.
Read full article here
sychosomatics 51:528-5286, November-December 2010
doi: 10.1176/appi.psy.51.6.528
© 2010 Academy of Psychosomatic Medicine© 2010 The Academy of Psychosomatic Medicine
Abstract
BACKGROUND: Depression and suicide are well established as prevalent mental health problems for patients on hemodialysis.
OBJECTIVE: The authors examined the demographic and psychological factors associated with depression among hemodialysis patients and elucidated the relationships between depression, anxiety, fatigue, poor health-related quality of life, and increased suicide risk.
METHOD: This cross-sectional study enrolled 200 end-stage renal disease patients age
18 years on hemodialysis. Psychological characteristics were assessed with the Mini-International Neuropsychiatric Interview, the Hospital Anxiety and Depression Scale, the short-form Health-Related Quality of Life Scale, and Chalder Fatigue Scale, and structural equation modeling was used to analyze the models and the strength of relationships between variables and suicidal ideation. RESULTS: Of the 200 patients, 70 (35.0%) had depression symptoms, and 43 (21.5%) had had suicidal ideation in the previous month. Depression was significantly correlated with a low body mass index (BMI) and the number of comorbid physical illnesses. Depressed patients had greater levels of fatigue and anxiety, more common suicidal ideation, and poorer quality of life than nondepressed patients. Results revealed a significant direct effect for depression and anxiety on suicidal ideation.
CONCLUSION: Among hemodialysis patients, depression was associated with a low BMI and an increased number of comorbid physical illnesses. Depression and anxiety were robust indicators of suicidal ideation. A prospective study would prove helpful in determining whether early detection and early intervention of comorbid depressionand anxiety among hemodialysis patients would reduce suicide risk.
Read full article here
Tuesday, January 18, 2011
Workload & Staffing....
Workload & Staffing Requirement Study
We have uploaded a simple "workload and requirement" study for those whom might be interested in initiating a similar study for their own centre in order to justify request for additional staffing.
Please note that this sample is only but a sample.
Read more here
We have uploaded a simple "workload and requirement" study for those whom might be interested in initiating a similar study for their own centre in order to justify request for additional staffing.
Please note that this sample is only but a sample.
Read more here
Monday, January 17, 2011
1Division of Nephrology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN USA.
Nephrol Dial Transplant. 2010 Apr 16;: 20400448 (http://lib.bioinfo.pl/pmid:20400448)
BACKGROUND: Intradialytic blood pressure (BP) profiles have been associated with all-cause mortality, but its pathophysiology remains unknown. We tested the hypothesis that intradialytic changes in BP reflect excess volume.
METHODS: The dry weight reduction in hypertensive haemodialysis patients (DRIP) trial probed dry weight in 100 prevalent haemodialysis patients; 50 patients who did not have their dry weight probed served as time controls. In this post hoc analysis, intradialytic BP was recorded at each of the 30 dialysis treatments during the trial. The slope of intradialytic BP over dialysis was calculated by the log of BP regressed over time. Using a linear mixed model, we compared these slopes between control and ultrafiltration groups at baseline and over time, tested the effect of dry weight reduction on these slopes and finally tested the ability of change in intradialytic slopes to predict change in interdialytic systolic BP.
RESULTS: At baseline, intradialytic systolic and diastolic BP dropped at a rate of approximately 3%/h (P < 0.0001). Over the course of the trial, compared to the control group, the slopes steepened in the ultrafiltration group for systolic but not diastolic BP. Those who lost the most post-dialysis weight from baseline to 4 weeks and baseline to 8 weeks also experienced the greatest steepening of slopes. Each percent per hour steepening of the intradialytic systolic BP slope was associated with 0.71 mmHg [95% confidence interval (CI) 0.01-1.42, P = 0. 048] reduction in interdialytic ambulatory systolic pressure.
CONCLUSIONS: Intradialytic BP changes appear to be associated with change in dry weight among haemodialysis patients. Among long-term haemodialysis patients, intradialytic hypertension may, thus, be a sign of volume overload.
Thursday, January 13, 2011
SKF management upset with Health Ministry
The Borneo Post : 8th Jan 2011 by Philip Wong
Sibu: The management of Sibu Kidney Foundation (SKF) is losing patience with the Health Ministry for what it regards as “unnecessary” inspections that are hindering the smooth development of the centre.
Its manger Ivy Lau said Health Ministry officials from Kuala Lumpur arrived on separate occasions over the years, demanding them to improve or upgrade the little things that were irrelevant to kidney dialysis treatment.
She claimed that each time after they complied with the ministry’s requirement and followed the guidelines, a different team of officials would come again and bring a new set of plans and requirements.
“This goes on and on and it’s a never ending story. Our patience is running thin with the Health Ministry and we believe these officials must have their own agenda to be so uncompromising” she added.
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