Sunday, February 15, 2015

Editorial oct- dec 2014



Editorial--
In 2014, our dreams were simple, Health promotion and supporting the downtrodden were our main objectives. Indeed it was a memorable year and the year started with one month filariasis mass drug administration program by 5th year pharm.D students followed by street drama and massive rally on TB day organized by students of 4th year Pharm. D 
 The department of pharmacy practice, since its inception has been actively involved in conducting continuing education programs for the students and health care professionals with the help of external resource person. The department of Pharmacy Practice has arranged  5 continuing education programs and two hands on training program on various aspects of clinical pharmacy.
Pharm.D module advance learning series 8th have  been organized by Alshifa college of Pharmacy and highlights of the event is covered in the current issue. Also included is the special message from formidable leader Dr. B Suresh, PCI president. Puppet show was organized by 4th year Pharm. D students during the last quarter and the purpose of this puppet show was to brief teenagers on the dangers of poisonous substance there by educating them on the dangers of street drugs and their abuse. Additional talks were conducted at local high schools to educate the students on drug abuse.
The department of Pharmacy Practice maintained the academic excellence this year, as the overall pass rate of the students stand above 95 % including Rank at University level, there by maintaining the First position for the 5th consecutive year.  Bon voyage of Mr Linu Mohan to USA to be part of a month long Pharmabridge Internship, 1 Month Training at Aramaco, Saudi Arabia of 5th Pharm.D student, Mary Mathew are some of the notable achievements of 2014.
Achieving our goals were not that easy, there were struggles and challenges through out ! M.Pharm Pharmacy practice and Pharm D students  were equally part of this movement throughout 2014, as we worked together with the spirit of welfare for every body. Service to humanity has been the driving force. Community involvement is important for pharmacist and  the overall goal of the community based health promotion program was to provide service learning opportunity for pharmacy students to improve the quality of life and health education in the surrounding community. Also such programs build relationships,trust and encourage continuity of care.The importance of a pharmacist as an integral member of the community and a reliable guide for maintaining the health status of the community is conveyed through these programs.

Mr. Ng Yen Ping (Board Certified Pharmacotherapy Specialist (BCPS), Ambulatory Care Pharmacy Specialist (BCACP) and Certified Clinical Cardiology Pharmacist, Malaysia) has shared Malaysian experience of pharmacy practice with our readers in this issue  and I am sure it will be an interesting read.

New year comes with all the  promise, hope and great anticipations. I wish to take this opportunity to thank each and every one of the faculty members , students, Doctors of Alshifa Hospital, and especially to Dr G.P,Mohanta, Professor Annamalai University for their valuable contribution in making 2014 successful.
I am especially grateful to Dr. TNK Suriaprakash, Principal, Alshifa College of Pharmacy for giving constant support and guidance to me. Special thanks is deserved by Mr P. Unneen, Managing Trustee of Alshifa Hospital for his continues support towards our department.
My dear readers, I can’t express enough how thankful I am for all your support.Thank you for all your comments, feedback and encouragement. I wish you all a very Happy  and wonderful New year!
Stay Positive and Be Happy!
Dr Dilip Chandrasekhar
Editor In Chief
Shifaclinpharm newsletter,
BLOG:Clinpharmindia.blog,
www.dicalshifa.org

Saturday, February 14, 2015

Enhancing electronic health records –how can incorporating a Clinical Decision Support System (CDSS) inthe EHR help?



Enhancing electronic health records –how can incorporating a Clinical Decision Support System (CDSS) inthe EHR help?
 Mary Raju Mathew, Chinnu P.B, Pharm. D 5th Year. Alshifa college of Pharmacy

Hospitals have increasingly started to switch from paper charts and medical health files to electronic medical records. This quick shift is clearly because of the easier and highly manageable benefits these electronic patient records provide compared to paper records. They provide instant access to patient details like a patient's medical and medication history, track lab results, help in prescribing medications, and even store and retrieve discharge summaries. Well, the EMR, indeed saves a lot of time, makes it easy to manage a big amount of data, keeps old records easily retrievable within just a click on the mouse and can also track information regarding medicines including prescribing and dispensing.
Now, what if these electronic medical records can be used to flag potentially dangerous drug interactions (to help prescribing doctors explore alternative saferdrug options), verify medications and dosages (to ensure that pharmacists dispense the right drug), and share information with other healthcare providers, even with patients and their family caregivers. Such technological solutions can help healthcare providers embrace tangible improvements in their ability to make better clinical decisions, these IT solutions are called electronic health records (EHR). EHR’s have been developed and used in healthcare around the world since the last decade. According to a national survey[1] of US doctors whose hospitals use an EHR:
~        94% of providers report that their EHR makes records readily available at point of care.
~        88% report that their EHR produces clinical benefits for the practice.
~        75% of providers report that their EHR allows them to deliver better patient care.
Over the years, electronic health records and databases help physicians manage the rising tide of information, the benefits of using an EHR led to developing and incorporating a more interactive and intelligent clinical decision supporting health IT system within the EHR called the Clinical Decision Support Systemor CDSS. In India, e-clinicians CDSS [2]was launched with an intend to obtain patient-specific recommendations and solutions which can further improve decision making and help ensure patient safety. Such e-computer technology, assist by generating case-specific advice for clinical decision making and as to know how this is programmed and its various gains, read on.
As use of CDSS requires familiarity with EHR’S, lets first see what EHR’S are;
An EMR contains standard medical and clinical data gathered about a patient- which is in fact just a digital version of a patient’s case record. Electronic Health Records (EHRs) go beyond such data collected and include  more comprehensive details like patient history& diagnosis,lab data, drug choices, drug allergy alert, drug dose range alert, drug interaction alerts, drug duplication alert, quick drug information reference database links, built-in safeguards against potential adverse events, more reliable e-prescribing which is electronically sent to the  pharmacy, administration details like time of administration, details of the administering nurse, availability in the pharmacy, details of the dispenser, dispensing details like next scheduled date of drug for the patient, automatic drug stop orders for antibiotics etc..,  drug review by pharmacist, patient education links etc.

EHRs are designed to contain and share information from all providers involved in a patient’s care. EHR data can be created, managed, and consulted by authorized providers and staff from across more than one health care organization. Each authorised person will have a personal ID and password to access the EHR just like using an EMR, sometimes the access to certain data is restricted to specific health care providers. It also allows a patient’s health record to move with them—to other health care providers, specialists and hospitals. In an emergency condition, EHRs can also provide instant access to information about a patient's medical history, allergies, and medications. This can enable providers to make decisions sooner, thus quickly provide care in life threatening conditions.
EHR isa single record that includes all of a patient's health information: a record that is up to date, complete, and accurate. This puts providers in a better position to work with their patients to make good decisions. If EHRs are connected to a network of healthcare institutions[3],then in rural areas where distances between clinics are great and specialists are often few, EHRs can instantly provide accurate, up-to-date, and complete information about patients, so rural health care organizations can make timely decisions and save lives and also enable rural health care providers toaccess remote clinicians, pharmacists, and staff members, improving and extending access for patients
EHRs can also alert potentially dangerous drug interactions, drug allergies and verify medications and correct drug dose ranges. EHR can automatically check for drug-drug and drug-allergy interactions whenever a new medication is prescribed and alert the clinician.A quick drug information database linked to an EHR like Lexicomp™ can help provide live, accurate and helpful information to many healthcare professionals.Paper prescriptions can get lost or misread. With e-prescribing doctors communicate directly with the pharmacy. An e-prescribing system can help save lives by reducing medication errors and checking for drug interactions, lower costs, and improve care. It is more convenient for doctors and pharmacies, and safer for patients.
It’s a quick and easy means to share information with patients and their family caregivers, which would help patients and their families to improve their part in making decisions about their health care.With EHRs, providers can manage appointment schedules electronically and exchange e-mail with their patients on next scheduled dose etc. thus creating an avenue for communication with their patients. Providers and patients who share access to electronic health information can collaborate in informed decision making.Also, patient portals with online interactionwith providers and electronic referrals, allows easier access to follow-up care with specialist.
Administrative tasks, such as filling out forms and processing billing requests, represent a significant percentage of health care costs. EHRs can increase practice efficiencies by streamlining these tasks, significantly decreasing costs.
EHR can be the foundation for quality improvements: Medication error reporting, drug use pattern statistics can be generated, change of brand/generic name of a drug in the hospital formulary can also be notified by email to all the health care providers.
Over the last decade, using EHRs in hospitals and health care facilities proved to be successful in reaping benefits such as reduction in errors, availability of records and data, drug reminders and alerts, and e-prescribing/refill automation and thereby the healthcare costs were cut down significantly. The financial expenditure for installing an EHR proved to reap profits, because of the reduction in cost aided by preventing various errors. Well trained care providers, informatics pharmacist, health IT consultants worked together to test and improve EHRs during the initial years of use in various hospitals across the world.
When health care professionals reported that EHR’S assisted in enhancing their clinical decisions and practices, enhanced decision support systems called as Clinical decision support systems (CDSS) were developed. The notableCDSSs being presently usedare MYCIN™, EPIC™, and QMR™etc. CDSS can support the delivery of high-quality health care by providing intelligently-filteredpatient-specific knowledge at the point of careto enhance better health care. CDSS encompasses a variety of tools to enhance decision-making in the clinical workflow[4]. Clinical decision support softwares (CDSS) are interactive computer programs, which are designed to assist physicians and other health professionals with decision making tasks.
A clinical decision support system uses two or more items of patient data to generate case-specific advice. The clinician interacts with a CDSS to help determine diagnosis, analysis, etc. of a patient. 95% of the clinicians around the world have agreed that CDSS has helped improve the patient care outcome to various extents in evidence based clinical practice[2].
Clinicians nowadays, interact with the CDSS by utilizing both the clinician’s knowledge and the CDSS software to make a better analysis of the patients’ data than either human or CDSS could make on their own[5].
Typically the CDSS would make suggestions of outputs or a set of outputs for the clinician to look through and the clinician officially picks useful information and removes erroneous CDSS suggestions. The doctor then takes the output of the CDSS and figures out which diagnoses are relevant and which are not. EHRs can support provider decision making; EHRs can help providers make effective, efficient decisions about patient care.
According to Agency for Healthcare Research and Quality's (AHRQ) CDSS encompasses a variety of tools andinterventions such as computerized alerts and reminders, clinical guidelines, patient data reports, a, documentation templates, diagnostic support, and clinical workflow tools. CDSS applications range from “electronically available clinical data (e.g. information from a clinical laboratory system or information from a disease registry), electronic full-text journal and textbook access, evidence-based clinical guidelines, and systems that provide patient and situation-specific advice (e.g., EKG interpretation).The doctor uses these systems at point-of-care to help them as they are dealing with a patient, with the timing of use as either pre-diagnosis, during diagnosis, or post diagnosis.
Pre-diagnoses CDSS systems are used to help the physician prepare the diagnosis. CDSS used during diagnosis are to help review and filter the physician’s preliminary diagnostic choices to improve their final results. Post-diagnosis CDSS systems are used to mine data to derive connections between patients and their past medical history and clinical research to predict future events.[2]
Now, Howdoes a CDSS work?CDSS not only keeps a record of a patient's medication or allergies, it also automatically checks for problems whenever a new medication is prescribed and alerts the clinician to potential conflicts. Automated formulary checks and alerts are generated when a drug or data is entered. The CDSS rely on well-defined mathematical techniques like the Boolean logic to do the reasoning. International Classification of Diseases (ICD 10) codes are incorporated to help in data mining and to monitor standards across health care delivery sites[4]. Each data like drug names; etc, are coded in the programming language and fed to the system.
For pharmacy health professionals, pharmacoinformatics has become an increasingly valued disciple of study where informaticspharmacists are trained to manage pharmacy information management systems like the drug module in a CDSS. They focus on medication-related data information, CDSS troubleshooting and statistical data mining, by working in concert with IT consultants and health informatics specialists.
In India, City-based Coresys InfoTech launched eClinician, a CDSS and its mobile version on Android software, which will help medical professionals diagnose disease easily.eClinician CDSS  is the outcome of an ambitious project conceived over 9 years ago. It was developed over the years by physicians and software developers who have successfully integrated information from standard medical text books and literature systematically. The working medical team consisted of 24 medical specialists, many of whom are academic faculty members throughout the world. In addition to these experts, the team had general physicians who ensured that the software is user friendly for general physicians.This software has been refined over several years now and is seen as an innovative tool that can improve the quality of care and decision during a patient’s course of treatment[2].

















Percentage of physicians whose electronic health records provided selected benefits: United States,
2011SOURCE: CDC/NCHS, Physician Workflow study, 2011
In a survey conducted in 2011, to identify the percentage of physicians in US whose electronic health records provided selected benefit shows thata majority of adopters reported having accessed a patient's chart remotely (74%) and having been alerted to critical lab values (52%) by using their EHR system within the past 30 days. A majority also reported that using their EHR system had resulted in enhanced overall patient care (74%)[6].
Conclusion
A large part of any physician’s work, involves acquiring information and then, aided by evidence and experience, making decisions for the best possible outcome. With the burgeoning amount of data now available for each patient and the increasing body of medical evidence, we need tools to help us make rational decisions based on all this information.The final diagnosis by doctors in a study conducted by using eClinician CDSS in India showed up the list of differential diagnosis generated by eClinician CDSS, in all the cases under study. In 35 cases, the final diagnoses made by the doctors were first among the list of differential diagnosis. For three cases the final diagnosis matched with the second among the list and for the remaining two it matched with third among the list of differential diagnosis generated by eClinician.
Computer technology can thus assist by generating case-specific advice for clinical decision making. The systems used are usually referred to as clinical decision support systems or CDSS.In the coming years,many healthcare ventures will invest in new health information systems. Computer decision support systems integrated with EHR can help make this investment worthwhile by leading to safer, more efficient, and more effective health care.
CDSS software is fairly accurate, user friendly and has high potential to not only improve efficiency in providing clinical care but also to improve the overall quality of health care.
 REFERENCES
1.       Jamoom, E., Patel, V., King, J., & Furukawa, M. National perceptions of EHR adoption: Barriers, impacts, and federal policies. National conference on health statistics.2012, August. 
2.       Importance of CDSS in Clinical Practice : Dr. Vijayabhaskar Reddy Kandula Physician, St Mark’s Hospital Salt Lake City, Utah. USA & Dr. Sanjay Deodhar Consultant, National Rural Health Mission, Ministry of Health, Govt. of India. Dec 2009. Available from: www.ehealth.com
3.       Benefits of Electronic Health Record[Internet]. US government: Health IT in association with NLC. 2014 August [cited December 2014]. Available from: http://www.healthit.gov/providers-proffesionals.
4.       Eta S. Berne. Clinical Decision Support Systems: Theory and Practice. 2nd Edition. New York. Springer Science & Business Media; 2007. p. 34-36.
5.       Van der Lei J. Clinical decision support systems. In: van Bemmel J, Musen M (eds). Handbook of Medical Informatics. Heidelberg: Springer-Verlag, 1997:261-276
6.       Jamoom E, Beatty P, Bercovitz A, et al. Physician adoption of electronic health record systems: United States, 2011. NCHS data brief, no 98. Hyattsville, MD: National Center for Health Statistics.2012.




Tides in India pharma, by Levin Thomas



Tides in India pharma, by Levin Thomas

1. India bans polyethylene terephthalate (PET) bottles as primary packaging material in pharma industry.

According to the recent notification by the health ministry, no manufacturer shall use the polyethylene terephthalate (PET) or plastic containers in liquid oral formulations for primary packaging of drug formulations for paediatric use, geriatric use and for use in pregnant and women of reproductive age.
The pharma companies have been given a transition period of six months until May 2015, to switch to glass bottles which, though are more expensive but ensures higher stability and efficacy of liquid formulations. Earlier the packaging industries had expressed objections on this ban. The ban was introduced on the recommendation of India’s Drug Technical Advisory Board (DTAB) in October, on the basis that plastic packaging has an adverse effect on humans due to the presence of endocrine disruptors – chemicals that can interfere with the hormone system. With the ban, the pharmaceutical industry will now have to switch to glass bottles-which accordingly will be a costlier affair. As the alternative for PET is glass container, an estimated increase of 25-30% per bottle is expected.


2. Toll free number to report ADR’s

Now, consumers can call to directly report adverse reactions or their bad experiences from any medicine. The health ministry has launched a toll-free number where people can call and report the side-effects and problems faced by them along with details of the medicine, suspected to have caused the adverse reaction. The information received would be then screened and assessed by the Adverse Drug Reaction Monitoring Centres by using international parameters set by the World Health Organisation (WHO). Thereafter, the analyzed information would be forwarded to the national coordinating centre, which maintains a database for adverse drug reactions (ADRs). The government would also share this database with international agencies including WHO, which manages the Global Pharmacovigilance Database. The ministry also plans to make it mandatory for pharmacists, hospitals and other independent clinics to display the toll free number - 18001803024 - in public interest. The idea is to empower consumers to report adverse reactions on their own
.




Expiry of drug patents in the US is great news for the Indian pharmaceutical companies that have an opportunity to capitalise on the patent cliff and gain a greater share of the growing generics market. At present, India accounts for nearly 40 per cent of generic drugs, over-the-counter products and 10 per cent of finished dosages used in the US. During 2014-2016, about $92 billion worth of patented drugs are expected to go off-patent in the USA as compared to $65 billion during 2010-12.  Indian companies' share in the US generics market has grown rapidly on the back of aggressive Abbreviated New Drug Application (ANDA) filings, successful pursuit of Para-IV and capitalisation on patent expiries of blockbuster drugs. Under US laws, ANDA filed with a Para-IV certification states that the generic company which is the first-to-file a Para IV, gets "exclusive rights" to sell the generic version of a branded drug for 180 days, with only the patent holder as the other player in the market. Ranbaxy, Dr Reddy's and Lupin have been the most prolific filers for Para-IVs. Indian players with a robust product portfolio, filings and necessary manufacturing infrastructure are well placed to capitalise on this forthcoming opportunity. Indian companies have built a strong pipeline of products to be sold in the US. During 2013, Indian companies secured 39 per cent of total 400 ANDA approvals from the United States Food and Drug Administration. Gleevec, Provigil, Combivent, Prezista, Benicar, Crestor, Avodart, Copaxone etc. are some of the top pharmaceutical brands undergoing patent expiry in US in 2015 and 2016.
 


4. New drugs approved in India (October-November)


Sl. No

Drugs

Indications

1.

Rivastigmine transdermal patch. Each Transdermal patch contains 27mg Rivastigmine.                              

For the treatment of patients with severe dementia of the Alzheimer's type.

2.

Dabigatran Etexilate Mesilate hard gelatin capsule- 75/110/150mg.


1. Treatment of acute deep vein thrombosis (DVT) and /or pulmonary embolism (PE) and prevention of related death. 2.Prevention of recurrent deep vein thrombosis (DVT) and /or pulmonary embolism (PE) and  related death.

3.

Olanzapine Pamoate-Prolonged release powder for suspension for I.M injection.


For the treatment of schizophrenia.

4.

Canagliflozin Tablet 100/300mg.




Indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type-2 Diabetic Mellitus.