MKO Melt

Imprimis Pharmaceuticals

The MKO Melt is a nonopioid, sublingual, compounded formulation for conscious sedation during ocular and other surgical procedures.

Berdhal Headshot Expert

John Berdahl, MD

Cataract, Cornea, and Glaucoma Surgeon, Vance Thompson Vision

Expert Reviewer

At-a-Glance
  • Patented noninvasive, nonopioid, sublingual, compounded formulation for conscious sedation during ocular and other surgical procedures

  • Available in bulk shipment from a 503B compounding pharmacy without patient-specific prescriptions

  • One to two melt dosage level is adequate for most cataract patients

  • May be used alone or as a precursor to IV placement in patients with a fear of needles

Description

The MKO Melt is an alternative option to intravenous (IV) anesthesia that is administered sublingually to sedate patients undergoing ocular and other surgical procedures. Its use in surgical procedures is often termed IV free. The combination of midazolam and ketamine HCl provides conscious sedation, also referred to as moderate sedation, to induce a state of relaxation and block pain while ondansetron helps prevent postoperative nausea. The melt typically dissolves under the tongue within 2-5 minutes and goes into peak effect in approximately 15 minutes. In ophthalmology, the MKO melt is most often used during cataract and LASIK procedures.

Midazolam (3mg) Sedative
Ketamine HCl (25mg) Anesthetic
Ondansetron (2mg) Antiemetic

The medication has a lemon flavor and comes in a one-tablet peel pack for $15. The anesthesiologist or nurse anesthetist must determine dosing based on age, weight, and history but one to two tablets is effective for most cataract patients. If the need for additional medication is expected intraoperatively, centers may proactively place a saline lock after the MKO Melt has been administered.

The Sticking Point

Elimination of IV equipment in addition to the time spent administering and monitoring the IV more than makes up for the cost of the MKO melt, especially in patients with “challenging” veins or a fear of needles that may increase anxiety and time required to insert the IV. Dispensing a melt offers a quick and easy alternative with consistent and predictable dosing.

Use of the MKO Melt does not obviate the need for an anesthesiologist or nurse anesthetist or render the services provided ineligible for reimbursement. Sedation with MKO Melt is billable under CPT codes 99151-99157 depending on the age of the patient and the care provider.

The compounds contained in the MKO Melt are familiar to anesthesiologists and CRNAs. The analgesic agents are non-opioid and therefore large dosing adjustments do not need to be made on account of patients’ chronic use of opioids. Additionally, they are not subject to recent opioid shortages caused by manufacturing problems and production quotas.

How to use the MKO Melt

Each case must be evaluated individually but this decision tree shows the basic guidelines for use of the MKO melt and intravenous supplementation.

Guide to Dosing

Maggie Jeffries, MD, and Chris Bender, CRNA, offer advice for incorporating the MKO Melt into the preoperative workflow and dosage considerations. These recommendations are based on their experience. Centers are encouraged to play around with the dosing and timing of the medication to suit the needs of their own practice.

In my practice we are using the MKO melt for short duration procedures. The sublingual MKO melt formulation is widely applicable across various health care specialties such as ophthalmology, dentistry, dermatology, plastics, and urology. When dosed properly, patients and practitioners prefer use of the MKO over traditional sedation. Sedation is so effective that we are able to go "IV free" in appropriately selected patients and when an IV is needed, we can use the MKO melt to ease anxiety and discomfort during placement.

Integration of the MKO melt into your practice has a steep learning curve. After the first 30 patients or so, physicians and nurses begin to feel more comfortable with the dosing and timing of the medication. The medication dissolves under the tongue in 3-5 minutes and the patient can feel the first effects around that time. Peak effect occurs at about 20 minutes and is steady for at least an hour.

We like to have the patient put the first melt under their tongue during the signing of consents, paperwork, vital signs, etc., so that surgery isn't delayed waiting for the sedative effects. If the patient isn't sufficiently sedated by the first melt, a second one is given when it is almost time for their cataract surgery. This seems to increase the sedation better than giving two at once. Patients on multiple psychiatric medications, pain medications, and young/robust typically get two melts as the first dose and sometimes a third if needing more sedation.

No adverse events have been witnessed in over 1,000 uses of the medication. Some patients will report a "high" feeling which is likely the ketamine but no negative outcomes related to those feelings. This medication works in all types of patients but is particularly well suited for the overly anxious, young persons, and patients with psychiatric or chronic pain histories.

Most patients require two melts for cataract surgery. Elderly patients over the age of 75 typically do well with only one melt.

Maggie Jeffries, MD

Texas Ambulatory Surgery Center Society, Austin, TX

At our center, we use the MKO Melt on nearly all surgical patients and start very few IVs. While other centers may still rely a lot on IVs or use the melts as more of a mixed/balanced approach for their sedation, we are confident with the MKO Melt.

If a patient has allergies, adverse reactions, or sensitivities to any of the medications in the melt, we will not use it. If a patient is highly anxious or very young, we will start an IV so we can supplement the sedation levels as needed in the operating room. Also these patients are given larger doses of the MKO melts. For example, if the dose required is 1 melt, I will increase to 1 1/2 melts. There are times when the IV is placed but the sedation was adequate and no additional medication was given. Other times, the IV is placed and we end up supplementing as expected. If a patient is very anxious and afraid of needles, or the prospect of having an IV started, we can give the melts to calm the patient for the IV start itself.

The ketamine contained in the melts is in an analgesic dose range and works on different pain receptors than opioids, hence patients with chronic use of opioids or other psychoactive medications can achieve pain relief and sedation without big dosage adjustments. This is particularly beneficial as most chronic pain patients take opioids to control their pain.

Chris Bender, CRNA

Vance Thompson Vision, Sioux Falls, South Dakota

Supplied by a 503B Pharmacy

As a 503B compounding pharmacy, Imprimis is able to make medications in bulk without patient-specific prescriptions and ship directly to surgical centers. To satisfy requirements of 503B, facilities are inspected by the FDA and manufacturing protocols must meet Current Good Manufacturing Processes (cGMP) guidelines to safeguard quality and safety. Each batch is tested for potency, sterility, and endotoxins, and continuous environmental testing is conducted to evaluate potential routes of microbial contamination that could arise from the air, surfaces, process, operation, or personnel practices.

Testimonials

The MKO melt has been a most welcome addition to our patient-friendly dropless cataract surgeries. Patients are referred to us for a premium experience and sublingual sedation with the MKO melt has only served to enhance their experience.

Patients have heralded the fact that they no longer have to fear the IV. Their fear and anxiety over the surgery is mitigated while in the preoperative area where they are most stressed. The sublingual route of the medication allows for a more gentle and more gradual sedation. So they come into the surgical suite with the perfect balance of amnesia, anesthesia and antiemesis.

From a staff standpoint, nursing time is optimized with improved efficiency over IV administration. No more hard sticks or struggles starting IV's. Our costs for the melts are less than the cost of IV kits with drugs and our anesthesiologists have developed a smooth routine for determining proper patient dosages so that our patients leave the facility unassisted and feeling good.

Overall the melt has offered our patients an enhanced, anxiety-free cataract surgery experience. From a marketing standpoint, the word-of-mouth referrals generated have patients seek us out specifically to avoid an IV. It's a win for everyone.

Sydney Tyson, MD

Eye Associates and SurgiCenter of Vineland, Vineland, NJ

The MKO Melt is an excellent, cost effective method to provide IV free conscious sedation. We have found many patients to be fearful of the needle stick required with a traditional, IV approach. From a marketing standpoint, we now have certain patients that have specifically sought us out since we can perform their cataract procedure without the need for an IV. The dosage for each patient can be easily titrated dependent upon his age and level of anxiety.

Shamik Bafna, MD

Cleveland Eye Clinic, Cleveland, Ohio

I went IV Free and have been using MKO Melts for all my patients undergoing cataracts, blepharoplasty, pterygium and glaucoma procedures for the last two years. It is an excellent combination of drugs for ocular surgery and I am very satisfied with the results. Previously, we were using Versed right before the start of the case. With the MKO Melts, the patients experience less anxiety preoperatively, and the level of anesthesia during the case is excellent. We had initial concerns that patients may take longer to recover sufficiently for discharge, but this has not been the case.

Paul Casey, MD, FACS

NVISION Eye Centers, Las Vegas, Nevada

We have completed more than 10,000 cataract surgeries using the MKO Melt and have had great success with it. We have found that it offers unique benefits to patients who may not be well suited for traditional IV sedation. I am pleased it is now protected by this newly issued patent, and potentially, other procedural sedation patent applications that remain pending.

John P. Berdahl, MD

Vance Thompson Vision, Sioux Falls, South Dakota

From Your Peers

If she chose to proceed, I would approach the case in a routine manner with topical and intracameral anesthesia and oral sedation with an MKO Melt (midazolam, ketamine HCl, ondansetron, lemon; Imprimis Pharmaceuticals)."

CRST, January 2018

Zaina Al-Mohtaseb, MD; Marjan Farid, MD; Russell Swan, MD; and Shachar Tauber, MD

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The MKO Melt improves upon a process that many surgeons perform without a thought. This is about more than just getting rid of the IV; it is about standardized dosage, comfortable patient sedation, and improved surgical flow."

CRST, June 2016

John Berdahl, MD

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Company Information

Contact the company for additional information, availability, or pricing:

Imprimis Pharmaceuticals, Inc.

www.imprimisrx.com/

info@imprimisrx.com

T: 844.446.6979

Financial disclosures: John Berdahl, MD, is a consultant to Imprimis Pharmaceuticals, Inc.