Pharmacy Informatics

Healthcare software: Thoughts on usability

2011-09-14T13:41:00.001-07:00

Yesterday at the Build developer conference, Microsoft unveiled the next version of Windows to developers from around the world. Windows 8 has received a great deal of press over the past few months, with usability among the mantras. I am always interested in finding ways to improve the user interface for consumers. In the case of electronic health records (EHRs), organization and simplicity are thought to play a role in improving safety and productivity. Reviewing the general layout of some of the top certified EHRs in the country has left me desirous of a cleaner user experience.

We expect the systems to check for allergies, allow documentation of clinical impressions, or display critical lab values. However, we haven't really provided input to the vendor community on how these things should be shown. There are a number of lessons everyone in healthcare technology can learn from our counterparts in mainstream operating systems. This 90 minute developer video does a great job of showing just how much thought and resource IT companies are giving to the user interface. Some might argue the certification criteria should include usability measures, and we will most likely see healthcare software migrate to this thought process in the future. After all, it has taken the largest software company in the world over 25 years to gain the necessary experience.

Certainly we need to understand more about who needs to see it, where/when should it show, and what should it say. The information has to be meaningful and actionable, but it also needs to be clear. We try to show so much information to providers and clinical staff, sometimes we may be doing more harm than good. In Pharmacy Informatics, missing one piece of information in a sea of text can have dire consequences. it is our job to help vendor's understand just how important the user experience is to safe and effective patient care. I personally am looking forward to the journey with our vendor and clinical partners.

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When should we teach students about Pharmacy Informatics?

2011-07-22T09:50:00.001-07:00

The timing of student Informatics exposure came up in a recent discussion with Doina Dumitru, an Informatics colleague and editor of The Pharmacy Informatics Primer. We were approached by a well known college about the possibility of offering an elective Pharmacy Informatics course to students. You can imagine our excitement and enthusiasm for this request. We started charting out the curriculum and lecture topics, as well as appropriate class timelines. Initially we hoped to offer this during the summer of the student's second professional year, but quickly came to realize some challenges.

First, students lacked the pharmacy practice experience to understand much of what we taught. Informatics is an extension of the clinician, a way to take our experience and build it into computers. Students just don't possess the knowledge to absorb the implications or reasons for Informatics decisions. Informatics is about our practice experience, not about being an IT person. The IT skills are necessary, but secondary. Pharmacy workflows, regulations, and clinical practice play a big part in our decision making process. Paralleling the importance of these points to pharmacy curricula, we realized the students would not be ready for an entire Informatics course until a portion of their final clinical rotations were complete. While there may be an exemplary example with years of pharmacy technician or externship experience, it was not enough to justify a course.

Integrating a handful of lectures on Informatics topics into a required management course might be a better alternative, but what about the lecture content? The topics should focus on well known, high impact subjects such as Meaningful Use, the HITECH portion of ARRA 2009, and the overall impact of technology on pharmacy practice. How has technology shaped our profession over the past 30 years? What does Meaningful Use "mean" to the practicing pharmacist? How can pharmacists help their institutions and colleagues in healthcare with adoption of medication use methodologies in information systems? What is an electronic health record and how do medications flow through them? Topics such as automation technologies, downtime, data mining, and report writing came up in our discussions, but the group felt like they would be perceived as low impact lectures. In student speak "we will watch the lecture on video and sleep in a few hours."

The next topic was on how many hours of content the lectures would provide. The topics need to be targeted, high impact discussions that spark interest in the profession. They need to grab the student's attention and flip a few light bulbs to the "on" position. This is still an open discussion, but I would estimate 6 hours to cover the high impact topics.

Students are a precious resource, and represent our legacy. It is important for us to develop their exposure to Informatics in an interesting and paced manner. I welcome your comments and questions.

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Do we see only what we want to see in EHRs?

2011-06-21T17:31:00.001-07:00

I was recently informed of a situation in which a high alert medication was programmed incorrectly, causing a gross rounding error to occur. Certainly the system could have been checked more carefully before implementing the changes, but what about the physician, pharmacist, or nurse? In this case the physician missed the rounding calculation (although shown on the ordering screen below the ordered dose). The pharmacist, our medication expert in the hospital setting also checked the order in the EHR without question. Luckily the discrepancy was caught by a completely unrelated test order, or ADEs could have resulted. Have we become so trusting of what shows on a computer screen that we don't question the content?
The power of the suggestive mind is not new to humans. It helps us fill in the blanks on those fun crosswords and MadLibs, and with those difficult co-workers. However, when it comes to the power of suggestion in electronic health records, seeing what we want to see may potentiate errors. This lab order is always twice daily, why should I pay attention to it after ordering it 15 times? The TPN order has always defaulted to 2000ml, can't I just skip review of the field? On rotation, my students are informed of this critical vulnerability in the healthcare computing age. We must use our minds to be sure what we see in a computer, in a book, or on the news makes sense. In our profession, we cannot take the computer's word for it. After all, it was programmed by a human and we are all aware of our nature. As we continue to learn more about technology adoption in healthcare, we will become aware of these pitfalls. In the meantime, we must remain diligent and ever questioning.

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When does the journey begin?

2011-04-22T09:54:00.001-07:00

To Meaningful Use, of course :)

This piece on HCR Blog provides some wonderful insight into what it really means to use EHR technology. Think of a long hall with a doorway at the end. Although the implementation of EHRs might be that long journey down the hallway, and the door is golive.......... Once we step through we "see the light" and the real task at hand: Turning this technology into better patient care.

After golive your journey is just beginning, and organizations should put more emphasis on this than the implementation itself. How do we make things more efficient and safe for healthcare providers? How can we leverage technology to solve logistics issues and improve patient throughput? How can the pharmacist use CPOE to communicate formulary and safe medication choices to providers at the right time and place?

It was just an outstanding revelation for me to hear this again. It is so important to this transition. We must keep it in perspective.

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Should institutions wait to start Meaningful Use?

2011-03-24T15:02:00.001-07:00

A very interesting post at Thehealthcareblog on Meaningful Use, and why it might be wise to take a deep breath before a mad rush for implementation. Protima Advani has some very good points, may of which are relevant to pharmacists. A week or so ago we talked about what Stage 2 and 3 could mean for the pharmacist. Taking many key points from the article, it might be advisable to wait for more standardization and codification of data. In fact, some might recommend waiting as long as you can before implementation to ensure better adoption by HIT vendors. RxNorm is a current front runner for medication naming, and some data vendors are already supporting its translation database. However, we have a long way to go for codified Allergies, SIGs, and other components of medication order transmittal.

Most of meaningful use regarding medication use surrounds prescribing and actively maintaining pertinent information in patient specific lists. Without codification, it will be very difficult to achieve what many pharmacists consider true meaningful use of medication information. However, meeting the standard might be a few measures lighter.

One of the more critical points in the article surrounds adoption timeframes, and suggests that because the "first" year does not necessarily have to be 2011 it might be prudent to wait to implement. This is certainly a valuable agrument, but as a pharmacist I would challenge with advocacy for patient safety. Many hospitals and health systems are integrating EHRs this year, and meaningful use goes a long way in helping guide them to better patient safety. Providers and nurses are not accustomed to doing their work in computers, and this presents a risk to patient safety. As a pharmacist the more I can do to prepare my EHR, CPOE, eMAR, BCMA, and supporting systems for appropriate use, the better off patients will be. However, we should not sacrifice safety for speed of implementation. If you need the time, take advantage of it to improve the deliverable.

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ASHP Releases Statement on Barcode Verification

2011-03-21T09:54:00.001-07:00

ASHP recently released a statement on barcode verification of product in the pharmacy. As many of us are aware, barcoding at the point of medication administration (BCMA) is a common, albeit controversial technology that many hospitals and health systems are installing or evaluating. Barcode verification is considered by some to be a necessary precursor for successful BCMA implementation, as it adds a safety validation step to medications as they are put into pharmacy inventory, or removed to be used in auxiliary dispensing mechanisms. This initiative can also improve BCMA compliance by forcing the pharmacy to develop a workflow for ensuring 100% of products that leave the pharmacy are accurately barcoded. This type of barcoding process is an intensive undertaking for many pharmacy operations, requiring inpatient operations to re-distribute personnel to meet the demand of touching every product without a barcode. Some medications are already barcoded for us by manufacturers, others get a barcode from our Pharmacy Information System when patient specific labels are printed, and the rest require the manual addition of a readable, standardized barcode by a human or automated device. Pharmaceutical distributors many also offer barcoding/repackaging programs, allowing pharmacies to purchase repackaged and barcoded medications in ready to use containers for a fee.

The inventory verification step is an important and often overlooked technology by many organizations that are faced with EHR adoption or meeting Meaningful Use. Overall a very well designed position statement by my friends, colleagues, and ASHP. If you would like a copy of this statement, please contact me.

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How much longer can pharmacists distribute medications?

2011-03-17T07:39:00.001-07:00

Every once in awhile stories about healthcare automation reach the mainstream media. What better time to discuss the impact of automation on pharmacy practice!

From USAToday.com

Even administration of some medications is being done by robots in the US. The entire supply chain for pharmaceuticals is the perfect opportunity for automation companies to develop robotics. We have automation to prepare almost all meds that come from the pharmacy and package them in ready to use containers. We have robots that can deliver (on time) medications to patient’s and document they received the drug. There isn’t a great deal of the distributive process that can’t be done by automation. We continue to cling to an archaic practice that, although important is repetitive and mundane in many ways. These are the types of processes that automation and robotics are great at reproducing. We have seen it in other industries such as banking and automobile. With the push of Meaningful Use and Electronic Health Records, how long before a hospital administrator figures out using robotics and technicians can allow him to lay off 70% of the pharmacists in central distribution? How long before one of the large retail chains lobbies state legislatures to allow technicians to check prescriptions entered by a physician electronically? How long before retail pharmacy is run by robotics and technicians?

The longer we rely on pharmacists to run the entire supply chain, the higher our risk of obsolescence.

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What is Pharmacy Informatics: Student Perspectives

2011-03-14T14:57:00.001-07:00

Every once in awhile I am overwhelmed at the extent to which certain pharmacy students understand informatics. Recently I had the pleasure of working with Ben Philip, an outstanding student from Texas Southern University College of Pharmacy and Health Sciences. With minimal experience over a 4 week rotation, I asked Ben to put together a presentation to describe what he felt Informatics was about. Attached is his answer.

Personally I find the presentation to be well designed both aesthetically and didactically. Ben did a wonderful job laying out what many of use continue to deliberate in our small circles. Please join me in congratulating Ben for an excellent view of our profession.

What is Pharmacy Informatics? Let us know what you think.

What is pharmacy informatics 02-08-11.ppt Download this file

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AJHP Commentary on ePrescribing

2011-03-11T08:56:00.001-08:00

E-prescribing: One giant leap toward pharmacy practice integration

Mark offers a very well developed piece on how legislation attempts to help, what types of barriers we need to overcome, and the importance of interoperability.

In the past 10 years, one of my favorite words has become "interoperability". It explains so much of what we strive to create in the healthcare technology sector, yet remains one of our biggest challenges. One of the major design flaws with federal regulations regarding ePrescribing was the naivety of pharmacy practice. Appropriate workflows and order processing steps in the pharmacy setting were not reviewed in the pilot study, nor were they addressed in the rule with gusto until the comment periods opened to the pharmacy community. This leaves the pharmacy profession with questions and concerns about how to implement, utilize, and encourage our vendors to support ePrescribing. A great example of this is ePrescribing for controlled substances. We have a federal rule, but no vendors on the market can support the requirements to date. My experience in technology tells me you don't typically want to create policies without really knowing what developers are capable of building. Policy development is based on knowledge of practice and process. This of course includes how pharmacies are using electronic prescribing technology, what they are using it to do, and where they need improvement in workflow.

Please do not mis-interpret my widespread support for the electronic prescribing initiative. I understand and recognize its importance in creating a unified electronic health record. However, we have to be very careful not to segment information even further by allowing data to run rampant and un-checked by professionals. Often times humans are still accustomed to putting garbage into computer systems just to get to the next step. With drug formulary checks, cross checking drug duplicates, and reviewing medication profiles it can get out of hand quickly.

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Meaningful Use Stage 2 and 3 Comment Period Comes to a Close

2011-03-03T14:27:00.001-08:00

On 2/25/2011, the HIT Policy Committee closed the comment period on Meaningful Use stage 2 and 3 standards.

A few of the measures apply directly to what many Pharmacy Informatics professionals are dealing with today, including:

1. CPOE for med orders - This objective is still fairly easy to obtain if you have any manner of CPOE in place. It only requires 1 med order for 80% of patients to be electronically entered (not transmitted)

2. Drug-drug/drug- allergy interaction checks - lack of standards among data vendors, as well as practice differences makes this one very difficult. Luckily there are no real measurements, save stating they must be enabled on "appropriate evidence-based interactions". I am assuming the interpretation of "appropriate" is up to the individual institution.

3. ePrescribing - Stage 3 is proposed at 80% of outpatient and discharge prescriptions. Depending on current levels of adoption, this could be difficult.

4. Maintain active medication list - This is somewhat ironic, requiring 80% of medication lists to be up to date. The irony entails the fact that most often the longer institutions have been live with physicians managing medication lists, the more inaccurate they become. Therefore those adopting closer to the stage 3 requirements will actually have cleaner lists, unless major cleanup efforts are undertaken. A great deal of work is ahead of institutions that have been live for years. Of course we can interpret the "up to date" requirement to mean someone has looked at it, but personally I would take it one step further and state it must be both accurate and up to date.

5. Maintain active med allergy list - Similar to #4, this objective gets worse the longer you are live, unless corrective measures are in place. Not to mention the lack of standardized allergy nomenclature in information systems. I apply the same comments regarding "up to date" as in #4.

6. Implement drug formulary checks - ePrescribing is becoming more common at facilities, but as we have seen in recent commentary, it still presents a standards challenge. If you would like a copy of Mark Siska's wonderful comments on ePrescribing in general, please email me.

7. [NEW] Inpatient med orders are tracked via eMAR - The proposed stage 3 requirement includes 80% of medication orders. Take into consideration floor stock items, flushes, and those that even currently use eMAR may have to do some work to meet the requirement. For those that still print paper Medication Administration Records, start talking with your IT department now.

8. Patient centered electronic access to medical information - Although not directly related to medication, Personal Health Records currently allow for medication lists to be viewed. When you implement patient portals, be sure to work with your IT department to review the accuracy and usability of the medication information shown.

9. Medication Reconciliation - In Stage 3 the requirement rises to 80% for transitions of care. The interesting verbiage here places the burden on the receiving provider during a transition of care, not the sending provider. Some system re-engineering may have to take place if EHRs only support the latter.

10. Immunization data submitted to IIS - Immunization records can be difficult to tame, and transmission of data entails some data quality measures to keep things in order. Like # 3 and 4, the longer lists have been allowed to be populated without quality monitoring, the more cleanup required.

Overall, the progression of objectives is fully supported by this Informatics Pharmacist. However, the lack of standardization, challenges of EHR workflow in practice, and shear amount of work needed to meet the requirements is daunting. Best of luck to us all, but we can certainly agree we are headed in the right direction.

MU_Stage 2_RFC _2011-01-12_final.pdf View this on Posterous

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Wave goodbye

2010-08-04T20:18:00.001-07:00

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.

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Twenty-one criteria for a successful CPOE adoption

2010-06-23T18:44:00.001-07:00

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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Lexi-Comp not so Compromising

2010-05-26T17:09:00.001-07:00

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?

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iPad: One million and counting

2010-05-03T20:03:00.001-07:00

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.

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Drug manufacturer sued for making larger than necessary vials

2010-04-22T05:41:00.001-07:00

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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How effective is healthcare technology so far?

2010-04-19T20:09:00.001-07:00

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

Electronic Health Records' Limited Successes Suggest More Targeted Uses -- DesRoches et al. 29 (4): 639 -- 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?

Mixed Results In The Safety Performance Of Computerized Physician Order Entry -- Metzger et al. 29 (4): 655 -- Health Affairs

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.

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Navy to implement world's largest telepharmacy

2010-04-19T12:12:00.001-07:00

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.

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HisTalk EMR Predictions from 2007

2010-04-10T12:17:00.001-07:00

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.

Monday Morning Update 4/12/10 | HIStalk

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ePrescribing Controlled Substances 101

2010-04-08T18:32:00.001-07:00

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

2010-04-08T17:23:00.001-07:00

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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Eric Cropp weighs in on the error that sent him to prison

2009-12-15T07:17:00.001-08:00

via ismp.org

It is a shame how disillusioned the State of Ohio is regarding healthcare issues. This is akin to jailing anyone that runs into someone else in a car by accident. Ridiculous.

Posted via web from pillguy's posterous

The H1N1 Virus, ARRA and HIPAA Interact in a Web 2.0 World

2009-12-15T05:29:00.001-08:00

This feature in the Fall 2009 Hospital Buyer's Guide for Computer Talk Magazine highlights some of the challenges of information sharing in healthcare. One of my good friends, Dr. Brent Fox provides some intelligent, pharmacy-focused comments. It is an exciting read, but unfortunately I cannot find it at http://www.computertalk.com !

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NHIN Connect Project Freedom Award Acceptance Letter

2009-12-14T17:34:00.001-08:00

via linuxmednews.com

I am reading an increasing amount in the news and professional circles about NHIN. It is a wonderful idea, and my congrats to Vish Sankaran as this year's recipient.

Posted via web from pillguy's posterous