Wednesday, August 4, 2010

Wave goodbye

http://mashable.com/2010/08/04/rip-google-wave/

To Google Wave. The concept was lots of fun, but we are a society of email. I fear only Apple will be able to beat enough sense into the masses to migrate from its grasp.

Thanks to Mashable for the story, and thanks to Google for trying something exciting.

Posted via email from pillguy's posterous

Wednesday, June 23, 2010

Twenty-one criteria for a successful CPOE adoption

A very nice list from a seasoned CPOE. No ornate study design or data to validate, just good old experience. While this does not always work in healthcare, the list parallels many of the experiences I have had as well. http://histalk2.com/2010/06/23/cio-unplugged-62310/

Thanks to Histalk for the great piece. In my experience, culture is one of the most challenging.

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Wednesday, May 26, 2010

Lexi-Comp not so Compromising

If you are planning on dropping a few hundred dollars on Lexi-Comp's suite of drug and medical information databases, read this first.  Some of you may not be aware, but there are two hidden "features" of the subscription.  I say hidden because they are in fact fine print, but not very intuitive.  FIrst I should mention Lexi-Comp has been my gold standard for medication information over the past 2 years.  They provide referenced, frequently updated information to subscribers.  I use the Lexi-Complete product, which offers over 14 databases.  

The two features I ran into were:

1.  Inability to access databases the DAY after the subscription is set to expire.  Unlike a nice book, once your subscription runs out the data is no longer yours.  No access at all.  I was hoping to just get access without any updates.  I guess in my mind the subscription covers updates to the information, and that is the main motivation for using a digital version over print.  Sorry Lexi-Comp, but I do not agree with your defin

2.  One subscription, one device.  So I was ok with #1, because in previous years I was able to pay one time (albeit hundreds of dollars) and put it on 2 devices.  After calling Lexi-Comp Support, they claim that was bug, and I violated the terms of use.  So this year after dropping just over $500 for a 2+ year subscription, they inform me that I will need to drop an additional $500 to get the same program on a device that is sitting right next to my iPhone on my desk in front of me.  No thank you.  

Sorry Lexi-Comp, but I do not agree with your definition of subscription, nor your idea of digital rights management.  You should review some of the more established online content distribution models, such as http://www.audible.com/ .  They charge per year, but you can put the digital content on multiple devices, and it always stays on your computer.  The agrument that you are a medical information vendor and Audible is a book vendor won't fly with me either.  Last time I checked both companies sell print and digital versions of their products.

As a result, I cancelled my subscription before the $500 expense had time to hit my wallet.  Money well saved.  

How do you feel about drug information software for mobile and desktop devices?  

Posted via email from pillguy's posterous

Monday, May 3, 2010

iPad: One million and counting

http://tech.fortune.cnn.com/2010/05/03/apple-28-days-1-million-ipads/

Apple has sold over 1 million iPads in less than a month.  I have not seen any statistics, but I would bet my 3G iPad that no other tablet type computer has even come close.  

Source:  Company Reports via forbes.com

It is absolutely astounding.  I received my iPad 3G from our reliable friends at Fedex on Friday.  It really has been a magical device to use.  I find myself grabbing it to show the kids and wife things at home (math problems, netflix queues, pdf articles, etc)  and as a quick lookup tool in meetings at work.  Magic aside, I am very interested to see how this device makes my life more productive and fun.  

Posted via email from pillguy's posterous

Thursday, April 22, 2010

Drug manufacturer sued for making larger than necessary vials

As reported on ASHP NewsLink (http://www.ashp.org/newslinks):

http://www.lvrj.com/news/doctor-in-endoscopy-trial-testifies-vials-of-sedative-were-too-large-91684569.html

Teva pharmaceuticals is being sued because they make a 50ml vial of propofol, and a physician's poor practice lead to Hepatitis C contamination.  Amazing.  The physician chooses to reuse part of a 50ml vial of propofol and it ends up giving the next patient Hep C. 

Next we will have lawyers suing car manufacturers because a person decided drive under the influence, claiming the car manufacturer makes it too easy for people to grab their keys after drinking excessively (recommending they should add a security device to the car that checks blood alcohol before entry). 

Without a doubt the physician that allowed reuse of the vial should be reprimanded.  I just don't see the manufacturer as being liable.  What are your thoughts?

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Monday, April 19, 2010

How effective is healthcare technology so far?

Two very exciting articles were published this month in the Journal of Health Affairs:

This study uses data mining to gain a sample size of 2.952 hospitals.  The hospitals either had a Comprehensive EHR, a Basic EHR, or no EHR.  The key measures were risk adjusted length of stay (ALOS), risk adjusted 30 day readmission rates, and risk adjusted inpatient costs.  The staggering and sobering results show there was no difference between EHR and non EHR facilities on quality measures such as AMI, CHF, and pneumonia.  In addition, there were no differences with ALOS for the most part (pneumonia showed a minor decrease with EHR - 0.5 days), no difference with 30 day readmission rates, and no difference with risk adjusted total costs.  What are we spending billions on again?  

This study looked at the 62 hospitals participating in The Leapfrog Group for Patient Safety  CPOE analysis tool.  It found that systems caught drug-allergies in most cases, but did poorly at drug-diagnosis contraindications such as pregnancy.  The interesting measurement was in the prevention of fatal drug doses, where they were only caught in 47% of cases.  In addition, drug-lab and drug-age alerts only flagged appropriately in 21% of cases.  The investigators noted the vendor chosen by the hospital played a statistically significant part in the outcome of testing, suggesting some vendors may build to the leapfrog test or standards.  Systems also seem to do a better job detecting adverse drug events that occur infrequently, as opposed to those that occur frequently.  

These studies parallel some of the results we have seen with Barcoded Medication Administration.  However, in contrast we should consider the stages of adoption in most hospitals.  In the US, we are still trying to learn how to use technology in our daily routines.  Healthcare has been a late player in the game, and the impact on productivity and safety has been minimal.  This is what we should expect.  We need to give healthcare workers time to learn to use the technology to do their daily tasks.  They are still struggling to find where menus are or buttons.  They don't easily find things they used to flip to in a paper chart.  Once integrated into their workflows, we can start to look at obtaining some real benefits from clinical decision support and interoperability.  Interoperability has a long way to go, so we certainly have time to refine our EHRs for the better.  My final impressions are we need to train more, take ownership of our EHRs and work to improve patient care through their use.  

Posted via email from pillguy's posterous

Navy to implement world's largest telepharmacy

http://www.fiercehealthit.com/press-releases/u-s-navy-pharmacies-improve-pati...

Thanks to FierceHealthIT for catching this announcement. It has huge implications on the retail pharmacy business in the US. The Navy will demonstrate that they can take pharmacists in a central location and have them check prescriptions at remote pharmacies around the world. My guess is businesses like Walgreen's or Wal-Mart are waiting for approvals to do something similar. Operating pharmacies without having to staff a pharmacist in the physical location could be a huge cost savings, especially in low volume pharmacies. It will be very interesting to see where Class A pharmacies are able to take this.

Posted via email from pillguy's posterous

Saturday, April 10, 2010

HisTalk EMR Predictions from 2007

A great laugh, both for the comedy and brutal truth. Thanks to HisTalk for posting these again.  

Mr. HIStalk’s Universal Rules for Big EMR Rollouts (From 2007)

1. Your hospital will pledge to make major process changes, vowing to “do it right” unlike all those rube hospitals that preceded you, but the executive-driven urgency to recoup the massive costs means the noble goals will change to just bringing the damn thing up fast, hopefully without killing patients in the process.

2. The project and/or system must be anointed with an incredibly dopey and user-embarrassing name, preferably chosen from user submissions and with the offer of crappy vendor paraphernalia or lame IT junk as a prize, and also preferably made up of a far-fetched phrase whose contrived acronym spells out a medically related word or female name. Instead of inspiring the expected collegial chumminess among users, it will serve as a bitter reminder of the innocent, naive days between RFP and go-live before it got ugly.

3. Doctors won’t use it like you think, if at all, because hospitals are one of few organizations left that doctors can say ‘no’ to.

4. You’ll spend a fortune on mobile devices and carts that will sit parked in a corral due to the short life of their $100 battery and a dysfunctional but not yet fully depreciated wireless network, the keystone arches to the entire project.

5. All the executives who promised undying support to firmly hold the tiller through the inevitable choppy waters and who overrode all the clinician preferences in a frenzy of inflated self esteem will vanish without a trace at the first sign of trouble, like when scarce nurses or pharmacists threaten to leave or when the extent of the vendor’s exaggeration first sees the harsh light of day in some analyst’s cubicle.

6. It will take three times as long and twice the cost of your worst-case estimate.

7. You’ll pay a vendor millions for a software package consisting of standardized business rules, then argue bitterly that all of them need to be rewritten because your hospital is extra-special and has figured out the secrets that have eluded the vendor’s 100 similar customers. The end result, if the vendor capitulates, will be a system that looks exactly like the one you kicked out to buy theirs.

8. You’ll loudly demand that the vendor ship regular software upgrades to fix all the bug issues you submit, but then you’ll refused to apply them because you’re scared of screwing something up with the skeleton maintenance staff you can afford, given that millions were spent on systems with nothing left for additional IT support staff or training.

9. All those metrics you planned to collect to show how quickly the EMR would pay for itself instead show the situation unchanged or getting worse, so factors beyond your control will be blamed (like a ridiculously long implementation time that changed all the assumptions and external conditions) and ROI will not be brought up again in polite company.

10. No matter how unimpressive the final result toward patient care or cost, the EMR will be lauded far and wide as wonderful since the vitality of the HIT industry (vendors, CIOs, consultants, magazines, HIMSS, bloggers) requires an unwavering belief that IT spending alone will directly influence quality, even when nothing else changes.

Posted via email from pillguy's posterous

Thursday, April 8, 2010

ePrescribing Controlled Substances 101

Last month the ePrescribing for Controlled Substances Interim Final rule was published in the Federal Register.  Here is a general overview.  Feel free to comment.

Background

General provisions of the Controlled Substances Act provide that a controlled
substance in Schedule II may only be dispensed by a pharmacy pursuant to a ‘‘written prescription,’’ except in emergency situations.  In contrast, for  controlled substances in Schedules III and IV, the CSA provides that a pharmacy may dispense pursuant to a ‘‘written or oral prescription.’’ Where an oral prescription is permitted by the CSA,
the DEA regulations further provide that a practitioner may transmit to the
pharmacy a facsimile of a written, manually signed prescription in lieu of an oral prescription.

Traits of a Controlled Substance Prescription

A CS prescription is much more than the mere method of transmitting dispensing information from a practitioner to a pharmacy. The prescription serves both as a record of the practitioner’s determination of the legitimate medical need for the drug to be dispensed, and as a record of the dispensing, providing the pharmacy with the legal justification and authority to dispense the medication prescribed by the practitioner. The prescription also provides a record of the actual dispensing of the controlled substance to the ultimate user (the patient) and, therefore, is critical to documenting that controlled substances held by a pharmacy have been dispensed legally.

Limitations of current interface standards technology

Currently the NCPDP SCRIPT standard is used in most HL7 transmissions for electronic prescriptions.  Unfortunately this standard does not address other aspects of prescription or pharmacy applications (e.g., what information is displayed and stored at a practice or
pharmacy, logical access controls, audit trails). SCRIPT provides for, but does not mandate the use of, some fields (e.g., practitioner first name and patient address) that DEA requires. In addition, although the standard mandates that applications include certain fields, it does not require that those fields be completed before transmission is
allowed.

Rule 

Private Sector transmission flow

The private sector approach included identity proofing of individual practitioners authorized to sign controlled substances prescriptions prior to granting access to sign such prescriptions, two-factor authentication including a hard token separate from the
computer for accessing the signing functions, requirements for the content and review of prescriptions, limited transmission provisions, requirements of pharmacy applications processing controlled substances prescriptions for dispensing, third party audits of the application providers, and internal audit functions for electronic prescription application providers and pharmacy applications.  Most importantly the prescription must not be altered during transmission by any intermediaries.  These will be described in more detail below.  

Registration and Certification
Only DEA registrants may be granted the authority to sign controlled substance electronic prescriptions. The approach must, to the greatest extent possible, protect against the theft of registrants’ identities. No single individual will have the ability to grant access to an electronic prescription application or pharmacy application. For individual practitioners in private practice (as opposed to practitioners associated with an institutional practitioner registrant), identity proofing will be done by an authorized third party that will, after verifying the identity, issue the authentication credential to a registrant. As some commenter’s suggested, DEA is requiring registrants to apply to certain Federally approved credential service providers (CSPs) or certification authorities (CAs) to obtain their authentication credentials or digital certificates. These CSPs or CAs will be required to conduct identity proofing at National Institute of Standards and Technology (NIST) SP 800–63–1 Assurance Level 3, which allows either in-person or remote identity proofing. Once a Federally approved CSP or CA has verified the identity of the practitioner, it will issue the necessary authentication credential individuals who set the logical access controls will verify that the practitioner’s DEA registration is valid and set the application’s logical access controls to grant the registrant access tofunctions that indicate a prescription is ready to be signed and sign controlled substance prescriptions. One person will enter the data; a registrant must approve the entry, using the two-factor authentication protocol, before access becomes operational.  DEA is allowing but not requiring, institutional practitioners to conduct identity proofing in-house as part of their credentialing process. At least two people within the credentialing office must sign any list of individuals to be granted access control.

Authentication
The method used to authenticate a practitioner to the electronic prescribing system must ensure to the greatest extent possible that the practitioner cannot repudiate the prescription. Authentication methods that can be compromised without the practitioner being aware of the compromise are not acceptable. As proposed, DEA is requiring in this interim final rule that the authentication credential be two-factor. Two-factor authentication (two of the following— something you know, something you have, something you are).  
Prescription Review
In addition to authentication, the DEA is requiring that the application display a list of controlled substance prescriptions for the practitioner’s review before the practitioner may authorize the prescriptions. A separate list must be displayed for each patient. All information that the DEA regulations require to be included in a prescription for a controlled substance, except the patient’s address, must appear on the review screen along with a notice that completing the two-fact of authentication protocol is legally signing the prescription. A separate key stroke will not be required for this statement. Registrants must indicate that each controlled substance prescription shown is ready to be signed. When the registrant indicates that one or more prescriptions are to be signed, the application must prompt him to begin the two-factor authentication protocol. Completion of the two-factor authentication protocol legally signs the prescriptions. When the two-factor authentication protocol is successfully completed, the application must digitally sign and archive at least the DEA-required information.

Downtime/Transmission Failure Protocols
DEA has clarified that the application may print copies of an electronically transmitted prescription if they are clearly labeled as copies, not valid for dispensing. If a practitioner is notified by an intermediary or pharmacy that a transmission failed, he may print a copy of the transmitted prescription and manually sign it. The prescription must indicate that it was originally transmitted to a specific pharmacy and that the transmission failed. The pharmacy is responsible for checking to ensure that the prescription was not received electronically and no controlled substances were dispensed pursuant to the electronic prescription prior to filling the paper prescription.

Security
The security systems used by any electronic prescription application must, to the greatest extent possible, prevent the possibility of insider creation or alteration of controlled
substance prescriptions.

Alteration by Licensed Pharmacies
DEA has also clarified that the requirement that the DEA-required contents of the prescription not be altered during transmission applies only to changes to the content (not format) by intermediaries, not to changes that may lawfully be made at a pharmacy after receipt. Pharmacy changes to electronic prescriptions for controlled substances are governed by the same statutory and regulatory limitations that apply to paper prescriptions.

Audit Trails and Data Integrity
Audit trail in eRX and pharmacy apps the pharmacy must archive the digitally signed prescription. Both the electronic prescription application and the pharmacy application must maintain an internal audit trail that records any modifications, annotations, or deletions of an electronic controlled substance prescription or when a functionality required by the rule is interfered with.  In addition, the application provider and the registrants must develop a list of auditable events; auditable events should be occurrences that indicate a potential security problem. For example, an unauthorized person attempting to sign or alter a prescription would be an auditable event; a pharmacist annotating a record to indicate a change to a generic version of a drug would not be. The applications must run the internal audit function daily to identify any auditable events. When one occurs, the application must generate a readable report for the practitioner or pharmacist. If a practitioner or pharmacy determines that there is a potential security problem, they must report it to DEA within one business day.

Reliability and Record Keeping
The prescription records must be reliable enough to be used in legal actions (enforcing laws relating to controlled substances) without diminishing the ability to establish the relevant facts and without requiring the calling of excessive numbers of witnesses to verify records.  In addition, All records must be maintained for two years from the date on which they were created or received. Pharmacy records must be backed up daily; DEA is not specifying where back-up files must be stored.

Enforcement 
DEA wishes to emphasize that the electronic prescribing of controlled substances is in addition to, not a replacement of, existing requirements for written and oral prescriptions for controlled substances. This rule provides a new option to prescribing practitioners and pharmacies. It does not change existing regulatory requirements for written and oral prescriptions for controlled substances. Prescribing practitioners will still be able to write, and manually sign, prescriptions for Schedule II, III, IV, and V controlled substances, and pharmacies will still be able to dispense.

Posted via email from pillguy's posterous

Apple releases iPhone OS 4.0 SDK

http://www.apple.com/iphone/preview-iphone-os/

For those iPhone users, Apple has added some very nice new features to the soon to be released 4.0 version of software for iPhone, iPod Touch, and iPad. If you are like me and have a hundred or so apps on your phone, the Folders feature might be the best of the lost. Multitasking is nice, and it appears Apple spent a great deal of time engineering it to save resources on the devices. A unified inbox is also new, allowing easier management of multiple email accounts on 1 screen. I am a big threaded conversation user in Outlook, and was happy to see Apple adding this feature to Mail. The iPhone and iPod Touch versions will release this summer, with the iPad sometime in the fall.

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