May 25, 2010

Electronic Prescriptions for Controlled Substances

Proposed Rule
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Additional details
Agency
Department of Justice
Regulatory Identification Number
1117-AA61
Agency Name
Department of Justice
Rule Publication Date
06/27/2008

RULE SUMMARY

DEA is proposing to revise its regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. These regulations would also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These proposed regulations would be an addition to, not a replacement of, the existing rules.

METHODOLOGY

There are twelve criteria within our evaluation within three broad categories: Openness, Analysis and Use. For each criterion, the evaluators assign a score ranging from 0 (no useful content) to 5 (comprehensive analysis with potential best practices). Thus, each analysis has the opportunity to earn between 0 and 60 points.

Criterion Score

Openness

1. How easily were the RIA , the proposed rule, and any supplementary materials found online?
There are no obvious intuitive links from home page, but the search function returns the proposed rule and RIA at the top of the list. The proposed rule also has a web link to the RIA. The RIA does not appear to be in regulations.gov, but a search using the RIN turns up the proposed rule.
4/5
2. How verifiable are the data used in the analysis?
Data on affected providers and wages are sourced, but time estimates are not. Many of the time estimates seem improbably low.
2/5
3. How verifiable are the models and assumptions used in the analysis?
The analysis has a decent list of references and information justifying assumptions is often footnoted, but not always. Some references are peer reviewed.
4/5
4. Was the analysis comprehensible to an informed layperson?
The analysis is quite readable; most technical terms and background are explained. Calculations are clear. Some of the security technology discussion was a rough read.
4/5

Analysis

5. How well does the analysis identify the desired outcomes and demonstrate that the regulation will achieve them?
3/5
Does the analysis clearly identify ultimate outcomes that affect citizens’ quality of life?
Yes; reduced callbacks from pharmacies to prescribers, reduced customer wait time for prescriptions, and reduced drug diversion.
5/5
Does the analysis identify how these outcomes are to be measured?
The analysis measures the first two but not the third. Measures include dollars, reduced wait time, and reduced number of callbacks.
3/5
Does the analysis provide a coherent and testable theory showing how the regulation will produce the desired outcomes?
The first two benefits are benefits of e-prescribing generally, not benefits associated with the security precautions in the rule. For the third, the analysis offers a plausible theory suggesting that the security measures will either reduce drug diversion below current levels or prevent increases in diversion that might be possible with e-prescriptions.
3/5
Does the analysis present credible empirical support for the theory?
There is a fair amount of data and support for the first two outcomes. The analysis explicitly declines to calculate the rule's effect on drug diversion due to lack of data.
3/5
Does the analysis adequately assess uncertainty about the outcomes?
The analysis notes sources of uncertainty about benefits but does not calculate ranges of estimates.
1/5
6. How well does the analysis identify and demonstrate the existence of a market failure or other systemic problem the regulation is supposed to solve?
3/5
Does the analysis identify a market failure or other systemic problem?
The impetus for the proposed rule is that electronic prescriptions are currently not permitted for controlled substances. The security restrictions in the rule are meant to enforce U.S. drug laws by preventing drug diversion.
4/5
Does the analysis outline a coherent and testable theory that explains why the problem (associated with the outcome above) is systemic rather than anecdotal?
The analysis explains how the proposed rule, by permitting e-prescriptions, could prevent some drug diversion associated with paper prescriptions. The systemic problem is clearer due to a fairly thorough explanation of types of prescriptions, risks, parties involved, etc
4/5
Does the analysis present credible empirical support for the theory?
The analysis presents evidence that misuse of prescription controlled substances is a significant and costly problem. But there is no assessment of the extent to which the problem is caused by paper prescriptions.
3/5
Does the analysis adequately assess uncertainty about the existence or size of the problem?
The analysis acknowledges the rate of adoption of e-prescribing as a key uncertainty but does not incorporate this into any estimates.
2/5
7. How well does the analysis assess the effectiveness of alternative approaches?
3/5
Does the analysis enumerate other alternatives to address the problem?
Several, including in-person, identify proofing by the prescription service provider, identify proofing by a DEA-registered hospital, use of a digital signature, or a requirement that the pharmacist phone the prescriber to verify every electronic prescription.
5/5
Is the range of alternatives considered narrow (e.g., some exemptions to a regulation) or broad (e.g., performance-based regulation vs. command and control, market mechanisms, nonbinding guidance, information disclosure, addressing any government failures that caused the original problem)?
Alternatives are all different ways of verifying that electronic prescriptions are written by individuals who have authority to do so and are authentic. In that sense, the alternatives are narrow. However, a relatively wide variety of methods are considered, including one that requires no advance checks because pharmacies would simply phone the prescriber for confirmation.
4/5
Does the analysis evaluate how alternative approaches would affect the amount of the outcome achieved?
Quantified benefits are assumed to be the same for all versions considered. There's no discussion of how the non-quantified benefits (effect on drug diversion) might vary under alternative versions of the rule.
1/5
Does the analysis adequately address the baseline? That is, what the state of the world is likely to be in the absence of federal intervention not just now but in the future?
The baseline is no e-prescriptions for controlled substances, since DEA will not allow these prescriptions in the absence of the regulation. The analysis mentions that e-prescriptions with no increase in security measures would probably increase drug diversion, but does not measure this.
3/5
8. How well does the analysis assess costs and benefits?
3/5
Does the analysis identify and quantify incremental costs of all alternatives considered?
Not all incremental costs are considered (see below). Costs are calculated for all options considered.
4/5
Does the analysis identify all expenditures likely to arise as a result of the regulation?
The analysis considers additional costs associated with the security measures, but does not calculate marginal physician time costs associated with filling out e-prescriptions, even though it counts the benefits of these e-prescriptions as benefits. The analysis notes that e-prescriptions take physicians longer and may require additional staff time for training, but does not include these in the calculations.
3/5
Does the analysis identify how the regulation would likely affect the prices of goods and services?
Not directly, but the RIA makes a plausible case that the costs which were calculated are not high per provider or transaction.
1/5
Does the analysis examine costs that stem from changes in human behavior as consumers and producers respond to the regulation?
The analysis makes a plausible case that few behavioral changes are likely because costs per provider or transaction are small. It also examines possible sources and prevention of fraud, unintentional errors; how adoption of electronic prescriptions will change over time.
3/5
If costs are uncertain, does the analysis present a range of estimates and/or perform a sensitivity analysis?
The analysis acknowledges uncertainties but does not calculate a range of estimates.
2/5
Does the analysis identify the alternative that maximizes net benefits?
The analysis does not perform this calculation, but it is possible to do so from the cost and benefit information represented. However, some key costs and benefits are missing. Section 5.3 mentions why other options were not chosen, but doesn't actually say that it chose option 1.
1/5
Does the analysis identify the cost-effectiveness of each alternative considered?
See above.
1/5
Does the analysis identify all parties who would bear costs and assess the incidence of costs?
The analysis very clearly specifies this in sec 4.3—practitioners, providers, pharmacies; it also conducted small entity analysis. The only thing missing is consumers.
4/5
Does the analysis identify all parties who would receive benefits and assess the incidence of benefits?
The analysis shows who receives the quantified benefits, but not the unquantified benefits. Callbacks are avoided (pharmacies, practitioner) and public wait time reduced (patients). It would be important to know whether the unquantified benefits (costs of drug diversion avoided) are primarily borne by the people making the decision to abuse drugs or by society as a whole.
4/5

Use

9. Does the proposed rule or the RIA present evidence that the agency used the analysis?
The agency rejected the option whose monetized costs outweighed the monetized benefits.
4/5
10. Did the agency maximize net benefits or explain why it chose another alternative?
The option chosen costs twice as much as the lowest-cost option. Minimal justification is provided for the single provision that accounts for most of these costs—a requirement that prescribers review logs of their prescriptions monthly. DOJ does explain why it declined to choose the option with the highest net benefits.
3/5
11. Does the proposed rule establish measures and goals that can be used to track the regulation's results in the future?
Results calculated in the RIA suggest outcome measures the agency could use in the future, but it made no commitment to do so.
1/5
12. Did the agency indicate what data it will use to assess the regulation's performance in the future and establish provisions for doing so?
DEA appears to have access to data that would allow it to track the effects projected in the RIA, but it made no commitment to do so.
2/5
Total 36 / 60