Risk of Cardiovascular Events With Oral Contraceptives, Part 2 - Regulating Off-Guideline Prescription

Inmaculada (Inma) Hernandez, PharmD, PhD, is an assistant professor at the University of Pittsburgh School of Pharmacy. Her research program is built at the intersection of pharmaceutical health services and outcomes research, pharmacoepidemiology, pharmacoeconomics, and pharmaceutical policy. Specifically, she is interested in the real-world use and outcomes of oral anticoagulation therapy in stroke prevention in atrial fibrillation; the use of large data sets, advanced data mining techniques, and comparative effectiveness research to predict and compare outcomes of medications; and value-based health insurance and health services delivery.
Using the case of oral contraceptives as an example, I explain the differences between off-label and off-guideline prescription, and explain how the inappropriate use of oral contraceptives could be reduced by the regulation of off-guideline prescription.
A few weeks ago, I wrote the first part of a post on the cardiovascular side effects of oral contraceptives (OC), where I discussed the incidence of these events among OC users, as well as the subgroups at elevated risk of experiencing them. In this post, I will discuss the goals of public policy with OC users, and a strategy to regulate the off-guideline prescription of OCs, which has the potential be applied to other pharmacological agents as well.

Health Policy Goals

The goals of public health policy in relation to the cardiovascular risks associated with the inappropriate use of OC are:
  1. To decrease the incidence of all adverse events related to the use of OC
  2. To improve awareness of the risks associated with OC among women and especially, among OC users
  3. To promote prudent prescribing
  4. To promote appropriate allocation of the available contraception methods so that a woman can choose the one with a more favorable benefit/risk ratio 
  5. To maintain or reduce the rate of unwanted pregnancy
  6. To respect individual patient preferences and prescription rights of doctors
  7. To implement an efficient and politicaly feasible program to achieve these objectives
Undoubtedly, there are certain trade-offs among these goals. For instance, promotion of prudent prescribing conflicts with the respect for liberty of prescription. Similarly, strict compliance with clinical guidelines also restricts the individual preferences of users. For example, some women may have a greater concern with cardiovascular events and may be willing to accept a lower efficiency in the prevention of pregnancy is they are assured of a lower incidence of side effects. Other women, however, may prefer to accept an increased risk for cardiovascular events for a lower risk of unwanted pregnancy. In addition, reducing the risk of cardiovascular events associated with OCs may conflict with maintaining a constant rate of unwanted pregnancies, since OCs are the most effective contraceptive method.

Policy Alternatives

I propose 2 different policy approaches to reduce the inappropriate use of OCs (use of OCs among women at elevated risk of experiencing OC-related cardiovascular events). In this post, I will discuss a potential policy intervention to regulate the off-guideline prescription of these agents, and in the last part of this series of posts (part 3), which will be available online in a few weeks, I will discuss the implementation of pharmaceutical counseling services. Both policy alternatives could also be applied to other pharmacological agents.

Off-Guideline Prescription Regulation

What is off-label and what is off-guideline prescription?

As described in my previous post, off-label use is the prescription and use of a drug for a condition for which it has not been approved. Off-guideline use is the prescription and use of a drug for an individual for whom the therapeutic guidelines consider that another therapeutic alternative is preferred, even if they have the condition for which the treatment is indicated. For instance, the prescription of an OC for a woman with Factor V Leiden for contraceptive purposes is off-guideline, even though it is not off-label, since she would be using it for contraceptive purposes. An example of off-label use of hormonal contraceptives is cross-sex administration for transgender patients, since such indication has not been approved by the FDA. This type of off-label use of contraceptives is beyond the scope of this paper. However, the use of OC among women with conditions that place high-risk for OC use, and hence, for whom another contraceptive method is preferred, is certainly concerning, as I previously discussed in part 1 of this post.

How would off-guideline prescription regulation work?

Given the rich evidence about conditions that imply a high risk for OC use, compliance with WHO recommendations and other clinical guidelines should be promoted among prescribers. The regulation of off-guideline prescription of OC is a strategy that could potentially achieve this goal. Under such regulation, the prescriber would be required to provide an off-guideline form with any prescription for OCs that does not comply with the clinical guidelines. In such a form, the prescriber would acknowledge the off-guideline character of the prescription, and attest that alternative OC methods have been discussed with the patient. The patient would also have to sign the off-guideline form, acknowledging that the prescriber has informed her of the off-guideline character of the prescription and of the cardiovascular side-effects associated with the use of OCs in high-risk populations. Prior to dispensing an off-guideline prescription, pharmacists would be required to double-check the availability of an off-guideline form signed by both prescriber and patient.

Is off-guideline prescription regulation a feasible policy alternative in the United States?

It seems logical that the regulation of off-guideline prescription should come after the regulation of off-label prescription. Therefore, the feasibility of this policy intervention in the US is certainly limited, since off-label prescription of medicines is not regulated in the United States. However, this policy alternative could be piloted, and eventually implemented, in other countries such as the United Kingdom, where off-label prescription is already regulated, and therefore, the regulation of off-guideline prescription would likely face less backlash from practitioners than in the United States.


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