Prescription Refill Rules, Exceptions, Emergencies, and Limits

Posted October 26, 2020 by Michael Chamberlain - See Editorial Guidelines

Here’s what you need to know when it comes to prescription refill rules. But let’s start with a quick response to this question, then we’ll discuss the main points in more detail.

Prescription Refill Rules – Prescription refill rules are in place for patient safety and to control healthcare costs. Different health insurance plans are available in different states, but all are bound to the same prescription refill rules. Exceptions for emergencies are possible but require additional applications. 

When it comes to prescription refill laws, every insurance plan or program will review the clinical and FDA drug approval literature regarding setting, altering, or even changing prescription refill rules. If prescription refill rules are reviewed or changed by the FDA, all insurance plans will have to adapt such changes within a specified period.

So, below are some of these significant prescription refill rules that decide how a prescription refill process works. 

Prescription Refill Rules on Quantity Limits 

Prescription Refill Rules

The FDA solely decides how much (quantity) of a specific drug can be refilled in a specific period.

Different medications have different quantity limits when it comes to refills. In cases where the quantity limits on the refill of medicines have recently been implemented, the rules for those will then differ for those new to the medications versus those who have been taking the medication for quite some time. 

Prescription refill rules can have a daily quantity limit, up to a monthly or even a weekly quantity limit. For example, if your insurance plan covers only one tablet of a drug per day, for a 30 day supply, you’ll only get a refill of 30 tablets.

Some plans can have a monthly timeframe, where 4 tablets are given for 28-30 days and you’ll get a refill of another 4 tablets only after 28-30 days.

For riskier drugs like opioids, the prescription refill quantity may be limited to a week only. This means you may have to refill the specified quantity weekly.

However, there are times where your prescription refill quantity limit will need to be revised to suit your medical condition. For this, there is a different set of rules and procedures that should be followed. 

Exceptions for Prescription Refill Rules on Quantity Limit

If your prescription refill quantity isn’t enough for your medical condition, you can apply for a quantity limit exception for your prescription refills. Of course, the procedure for this varies according to different insurance plans, but the concept is the same per the FDA prescription refill rules.

According to prescription refill rules, if you need an exception on the quantity limit, you will need to follow these steps:

  • Ask your doctor for help in submitting a quantity limit exception form.
  • Your doctor will be required to explain your health condition and provide some background to it. This will invariably include an explanation as to why the quantity limit exception is needed for your refills. 
  • Your doctor will also be required to explain why the current quantity limit would be harmful to you. i.e. the impact of not having the quantity change.
  • Evidence, such as medical reports, may need to be submitted to explain how and why lower doses of the specified medications or any other alternative medication haven’t worked.
  • Your insurance plan will take 3 days to review your prescription refill quantity exception request. Your plan will match your conditions set against the FDA prescription refill rules and find if you’re eligible for the exception based on how compelling the exception form is.
  • If your prescription refill quantity limit exception is denied you can opt for an appeal. Your plan will give you a set period after the denial where you can submit an appeal. This appeal should be sent with a written request before the specified period expires.
  • You will get a response to the appeal in 30 days. If you’re in a health emergency, you can also apply for an expedited appeal. This expedited appeal will shorten the review time of 4 weeks (30 days) to just a few days. 

Prescription Refill Rules for Early Refills

By law, you cannot have an early refill. If you ask for a refill before the refill period is over, the pharmacist will inform you that it’s “too soon” to refill.

This rule is enforced to make sure you’re taking medications as directed. Limiting the ability to fill prescriptions early prevents potential drug abuse (in case of controlled medications).

Emergency Refills

Prescription Refill Rules

If you need an emergency refill for situations such as lost or stolen medication, or when you need a refill at another pharmacy, then there are ways to get an early refill, or more specifically, an emergency refill.

For this, your pharmacist can use their clinical judgment following state laws to dispense emergency refills of up to a 30-day supply of medications. However, this emergency refill does not apply to controlled substances.

This emergency refill law or rule is also known as Kevin’s law. This also allows pharmacists to allow an early refill for chronic medications if your doctor cannot be reached to authorize a prescription.

However, this early refill or emergency refill law can vary from one state to another depending on the specific medications allowed, how much of the medication can be dispensed, how often you can get an emergency refill, and if the medication will be covered by insurance.

Sometimes this rule can have different processes depending on the health insurance plan, which may or may not make this emergency refill readily available.

Prescription Refill Rules for Controlled Substances

This is for controlled substances listed In Schedules III, IV, and V

While these prescription refill rules are common for many medications, these refill rules are stricter when it comes to controlled medication refills. 

Below is a thorough breakdown of prescription refill rules exclusively for controlled medications:

Prescription Refill Rules
  1. No prescription for a controlled substance listed in Schedule III or IV can be filled or refilled for more than six months, after the date on which such controlled prescription was issued. Along with that, no prescription for controlled medication that is listed in Schedule III or IV can be authorized to be refilled more than five times.
  2. Every refill must be recorded behind the original prescription or any other appropriate document. If the details of a refill are entered on any other document other than the original prescription, such a document should be uniformly maintained and readily retrievable. The retrievable information should include the following:
  • The name and dosage form of the controlled medication. 
  • The date the medication is filled or refilled.
  • The quantity of medication dispensed.
  • The initials of the dispensing pharmacist for each refill.
  • The total number of refills for the specific controlled prescription.
  1. If your pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record, it should be taken to mean the full amount of the refill (that is five times for controlled medications) has been dispensed and no more refills will be dispensed.
  2. Your prescribing practitioner can authorize or direct additional refills of Schedule III or IV controlled substances on the original prescription to your pharmacists. This can be done through an oral refill authorization transmitted to the pharmacist. However, when doing so, the following conditions should be met:
  • The total quantity authorized by the practitioner does not exceed five refills or extend beyond six months from the date of issue of the original prescription.
  • The pharmacist who obtains the authorization should do two things. The first is to record on the reverse of the original paper prescription or annotate the electronic prescription record with details such as the date, quantity of refill, and the number of additional refills authorized.

Secondly, the pharmacists should initial the paper prescription or annotate the electronic prescription record showing who received the authorization from the prescribing practitioner who issued the original prescription for the refill.

  • The quantity of each additional refill authorized should be equal or lesser than the quantity prescribed for the first fill of the original prescription. 
  • If a prescribing practitioner wants to authorize additional refills beyond the five within a six-month limitation, then a new separate prescription should be issued.

Finally

We hope this sets out some basics for you to follow when asking about prescription refill rules. As always, if you’re in any doubt, then consult your doctor or pharmacist for an explanation regarding your specific medical prescriptions.

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