Comments

1

Diagnosis Requirement on Prescription

TKH

1.      We’ve not mentioned this before ... but: remember to read the definition sections in RCW/WAC or USC/CFR. You’ve cited regulations in a section that pertains only to parenteral products:

WAC 246-871-001 Scope and purpose. The purpose of this chapter is to provide standards for the preparation, labeling, and distribution of parenteral products by licensed pharmacies, pursuant to an order or prescription. These standards are intended to apply to all parenteral products not administered in a hospital.

There are other sections of RCW/WAC that define the information required on a prescription. Suggestion: use the “search” function in www.leg.wa.gov.

2.      You’ve referenced the IOM report titled “To Err is Human”. Turns out that this – and much of the published literature – refers to medication errors in the inpatient setting. While it is tempting to extrapolate from the inpatient setting (where you typically DO have access to “intended use”) to community practice, reviewers would be critical of this approach.

3.      Section 4 – goals/objectives/measurable change: this section needs some spiffing up. Please come see me or Josh.

2

Establishing a C-II Prescription Expiration Date in Washington

TKH

Introduction section. Thorough! Recall the requirement in both DEA and WA law that

Sec. 1306.04 Purpose of issue of prescription.

(a) A prescription for a controlled substance to be effective must

be issued for a legitimate medical purpose by an individual practitioner

acting in the usual course of his professional practice.

So, consider the prescription that’s nearly a year old. “Legitimate”?

Be careful about the history of the missing section; don’t think you’ve got it quite right.

In footnote #8, you use as an authority a pharmacist in practice in Seattle. It would be better to provide the citation to federal or state law. I’m unaware of this “requirement”, even though it may be excellent business or clinical practice.

You’ve cited

WAC 246-869-100(2)(d) Prescription refill limitations -- No prescription may be refilled for a period longer than one year from the date of the original prescription. "PRN" prescriptions shall expire at the end of one year. Expired prescriptions require authorization before filling. If granted a new prescription shall be written and placed in the files.

... which refers to refills, not original prescriptions. This section has been used to cover the C-II expiration date problem (so I’m told) because there isn’t anything better in WA.

I don’t find the rest of the assignment.

3

Introduction of CPR Certification for Pharmacy Licensure in Washington State

Do you mean “pharmacist” or “pharmacy”?

[Note: your footnotes sort of went missing; couldn’t find #2. In Word, do footnotes by

In print layout view, click where you want to insert the note reference mark.

On the Insert menu, click Footnote.

Click Footnote or Endnote.

Under Numbering, click the option you want.

Click OK.

Word inserts the note number and places the insertion point next to the note number.

Type or paste the footnote text.

Scroll to your place in the document and continue typing. ]

I glanced through the Stiell et al. article. I believe that the Ontario intervention was an upgrading of training for EMT’s to parallel advanced cardiac life support (ACLS), which is a good deal more intensive than CPR training. In the Discussion section, the reference made to “bystander” CPR appears to be anecdotal; see citation 6.

So, two questions that you will probably want to address: (1) what is the demonstrable need? Legislators want to know about smoking bodies. What is the evidence that there is a problem? As a side issue, are you familiar with the employment practices of institutions where pharmacists are employed? My circumstances may be unique, but I had to be CPR certified when I worked at UCLA, and was ACLS certified while working at a community hospital where pharmacists were required to respond to all “code blues”. So maybe some employers agree with you. They are a potential source of information to support your case. (2) what, specifically, could you measure to show that your program has had the desired effect – fewer smoking bodies, or whatever.

4

Recommendation for Minimum Patient Counseling Guidelines

Please clarify terminology. Typically, “guideline” refers to an agency’s “thinking” on a particular topic, and is not enforceable. For instance, FDA typically uses the following language on all of its guidelines:

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

It is OK to develop a “guideline” it that is what you really want.

Somehow your footnotes went missing. Please see the comment above for Group 3.

I suggest strengthening the “boundaries” section. It isn’t clear what the specific problem is, other than wanting to be more prescriptive. This links to the “fact base” & “what you can measure” sections which, though nicely laid out, may present some problems in implementation. For instance, the IOM To Err is Human publication has very little information about outpatient medication errors. Please see me, Josh or Don for some suggestions.

Outcome measure(s): the metric (number of reported errors per year) is good, except for a detail. There are not that many reported errors, and I suspect that there is a big problem with under-reporting. Your “satisfaction” survey suffers from the reverse problem: processing of survey data (let along, developing and validating the “instrument” in the first place) is very expensive. Just had a brain cramp ... maybe the requirement could be to include an information brochure explaining the importance of obtaining adequate counseling, and include the BOP’s number with an encouragement to contact them if the patient perceives that insufficient counseling was provided. Or some such.

The insufficient staffing issue: this is my bottom line. With the pharmacist shortage, there is absolutely no justification for staying with a crumby job! You are professionals. If you elect to continue to work at a crumby job ....

5

Intern Preceptor Relations

Pretty brief.

I suggest that you download and read the manuals and forms for preceptors (and interns!)

https://fortress.wa.gov/doh/hpqa1/HPS4/Pharmacy/forms.htm#preceptor

... and schedule a visit to Tumwater to get the Board employee’s views. Let’s chat!

This topic keeps coming up so I hope you make some progress!

6

Rescheduling Pseudoephedrine to C-V

Interesting background information on methamphetamine. Didn’t find much addressing this week’s assignment. For your project to proceed, you need to think through these elements, especially the part about how you will measure the consequences of your change.

7

Verbal Communication (who can call in prescriptions)

Very good background material.

In §4, eventually provide details on measurement of change from program implementation.

8

Identifying Pas Authorized to Prescribe C-II Medications

In §1, check specific requirements in CRF/RCW/WAC regarding “corresponding liability” [i.e., 21CFR1306.05(a)] versus “reasonable” or “good faith effort” [i.e., 21CFR1305.11(d)(3)].

In §3, be sure that the VA and WA regulations for PAs are similar.

In §§4 & 5, more specifics will be needed for the final report.

Overall, final report will need to be substantially referenced. See comments above re footnotes.

9

C-II Expiration Date

Coordinate with Group 2 so that project substance differs.

Provide more information for what constitutes abuse/misuse, and how you will measure the impact of your intervention.

Differentiate short-term from chronic use in a manner that will not require revision of WAC or RCW when disease definition or drug therapies involving CS change.

Don’t forget current provisions for hospice care.

Interesting fact base!

In §4, provide more specifics about what you will measure.

In §5, what impacts might you anticipate (positive vs. “unintended consequences”), whether you measure them or not?

10

Alternative & Complementary Medicines Curriculum Change (Accreditation Standards?)

In §1, arguably, if a dietary supplement is unsafe under conditions of intended use, the product violates DSHEA. See http://www.cfsan.fda.gov/~dms/ds-oview.html#regulate.

Also, see Seth Hettena. Seattle Times. Seattle, Wash.: Oct 17, 2004. pg. A.3 

Companies: Metabolife International Inc (NAICS: 325411 ) , Food & Drug Administration (NAICS: 922190, Sic:9400, Duns:13-818-2175 ) Author(s):       Seth Hetten

In §2, note the very long political history for dietary supplements industry. See legislation carried by Proxmire, Hatch, shifting FDA’s regulatory authority.

Measurement section is weak. What will change? School’s curricula, pharmacist knowledge ... all measure how?

11

MTMS: Comment on NOPR

Suggestion: schedule time with Cass Hartnett about format of comments you are planning to submit.

Measurement section: You may not want to include this in the submitted comment, however it is required for the project.

12

Clarification of the Role of the Pharmacist in Offering Patient Counseling

See comments for parallel project for Group 4. Work with them so that your projects differ.

Nicely stated!