Compounding as a Pharmacy Specialty Susan Finstrom May

Compounding as a Pharmacy Specialty Susan Finstrom May 2020

Learning Objectives ➧After this presentation you should be able to answer these questions: § Why is compounding an essential part of pharmacy practice? § How does compounding help to handle drug shortages? § How does a pharmacist assess a patient and help to manage the patient’s medication ingredient allergies or intolerances?

What is Compounding? ➧In everyday terms, compounding is preparing a medication by mixing or altering the ingredients to make the medication specific to a certain person’s unique need. § A patient may need liquid medications, for example, if they are tube-fed. § Video–patient needing liquid medication - https: //youtu. be/2 m. Yqfh-f. PJk Polling Question: Could the patient in the video successfully take manufactured medications?

How does compounding differ from manufacturing? ➧ Compounding • Prepared with a specific patient in mind § Only a limited quantity is prepared § May be prepared quickly ➧ Manufacturing • Produced for distribution to the entire nation • A large quantity is produced with limited variety • Takes time to adjust to increased demand Breakout rooms: Why is compounding essential?

Reasons why compounding is essential to healthcare When the manufactured dosage form may be inappropriate for the patient For example: a patient is unable to swallow a tablet and needs a liquid form instead A Non-Sterile Compounding Pharmacist

Reasons why compounding is essential to healthcare When an animal patient needs a human medication, but in a different dose or dosage form—think of the variety of animals For example: a dog needs medication for an ear infection and that medication is not in a manufactured medication. A Veterinary Compounding Pharmacist

Compounding for Veterinary Patients ➧An example–Canine Chronic Ear Infections • Dogs have long and angled ear canals, making medication delivery deep in the ear canal challenging. • A compounder can make otic (ear) gel. • The medications are mixed in a special gel which is water-based, has bio-adhesive properties, and is biodegradable. It will remain in the ear for several days and eliminates multiple daily dosing. It goes in as a liquid, but body heat turns into a semisolid gel.

Reasons why compounding is essential to healthcare When a preparation is not stable long enough to make it from manufacturer to patient A Nuclear Pharmacist preparing a radioactive medication

Reasons why compounding is essential to healthcare When a preparation is not available due to manufacturing shortages For example: Sterile injections are needed for ventilator patients A Sterile Compounding Pharmacist

Compounding--Meeting the Need When Shortages Happen ➧ MEDICATION SHORTAGE FOR VENTILATORS? ➧ THERE IS NOW A COMPOUNDERS' SHORTAGE DRUG SOURCE FOR HOSPITALS § The Compounders' Shortage Drug Source for Hospitals lists what formulations are available from what pharmacies and outsourcing facilities. It’s a mean to connect supplier with buyer.

Compounding--Meeting the Need When Shortages Happen Shortage! A Solution to the Shortage Compounded Hydroxychloroquine

Compounding Meets Special Medication Needs ➧Reasons why medication shortages happen: § A manufacturer’s production is stopped temporarily § A manufacturer decides to completely stop producing a medication (usually for financial reasons) § More medication is being used than expected by analysts (demand exceeds current supply)

Reasons why compounding is essential to healthcare When a patient is allergic to an ingredient in the dosage form For example: preparing capsules without using lactose A Non-Sterile Compounding Pharmacist

Allergy/Intolerance to a Medication ➧ If a patient is allergic or intolerant to a medication, prescribers and pharmacists must ask: § Can the medication be stopped? § Can the patient take a different medication used for the same condition? ➧ Allergy or intolerance may be due to the active ingredient or it may be due to the inactive ingredients (excipients). § Most often it is due to the active ingredient; § But it could be due to inactive ingredients.

Synthroid and Allergy Symptoms ➧ Synthroid (active ingredient: levothyroxine) prescribing information states: § Hypersensitivity (allergy) to levothyroxine itself is not known to occur. § Hypersensitivity reactions to inactive ingredients have occurred in patients treated with thyroid hormone products. • These include urticaria, pruritus, skin rash, flushing, angioedema, various gastrointestinal symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness, and wheezing. § Discussion question—Is it the active ingredient or the inactive ingredients that could cause allergy issues?

An Example of a Manufactured Medication and Its Ingredients Synthroid contains the inactive ingredients acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc. Synthroid tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Strength Color Additive 25 mcg FD&C Yellow No. 6 Aluminum Lake 50 mcg None (More strengths available, but not listed here) Let’s look at a polling question.

The Compounding Option ➧In the case of Synthroid, there may be other manufacturers’ products which eliminate the inactive ingredients that are causing the allergies/intolerances. ➧If those products won’t help or aren’t available, there is a pure levothyroxine powder that a compounding pharmacist can use.

Focus on Lactose Intolerance: What happens in the gut? ➧ Lactose is a type of sugar found in milk. ➧ Lactase, an enzyme, is needed in the intestines to break apart lactose into absorbable parts. ➧ When there is a lactase deficiency, lactose remains in the small intestine. ➧ The abundance of lactose creates an osmotic effect, resulting in excessive water being retained, which can result in diarrhea. ➧ The undigested lactose begins to ferment, and the resulting byproducts can result in nausea, diarrhea, abdominal distention, cramps, gas, and more. .

How Can a Compounding Pharmacist Help Patients with Lactose Intolerance? ➧Eliminate lactose as much as possible from pharmaceutical preparations! X

A Case of Medically-Significant Lactose Intolerance ➧ 45 year-old man with lactose intolerance who has to be on the anticoagulant, warfarin sodium. ➧ When he is exposed to lactose, he has ventricular arrhythmias, (this is an unusual reaction to lactose), but for him it could be life-threatening. ➧ Manufactured warfarin sodium contains lactose as a filler. ➧ The doctor said the patient must stay on the warfarin sodium. ECG examples of arrhythmias

A Compound of Warfarin Sodium ➧How did a compounding pharmacist solve this patient’s problem? § The pharmacist was able to obtain the pure warfarin sodium powder. § He used that powder plus a different filler than lactose, in this case, calcium carbonate, to make lactose-free warfarin sodium capsules for the patient. The patient did well, and he has continued on the compounded prescription. • Reference: Glasnapp, Andrew. Alternatives for the Lactose-Intolerant Patient. Intl J Pharm Comp 2(6); Nov-Dec 1998: 412 -3.

Ingredients that May Cause Allergy or Intolerance Issues ➧ Lactose/Milk ➧ Gluten ➧ Corn-sourced products ➧ Soy ➧ Peanuts ➧ Tree nuts ➧ Eggs ➧ Sugar ➧ Food Coloring ➧ Animal-sourced products like Gelatin ➧ Shellfish ➧ Sesame oil

A Compounding Pharmacist Serves as a Medication Problem -Solver When Traditionally-Available Medications Do Not Meet Patients’ Needs Questions?