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Intranasal Drug Delivery

By 8 months ago 95 Views No comments

Intranasal Transmucosal Drug Delivery

LMA MAD Nasal Intranasal Mucosal Atomization Device

Intranasal medication is a procedure for administering medications through the nasal passages. Also known as transmucosal administration or nasal drug delivery, intranasal medicating employs an atomization device that fragments the medication into fine particles as it is being sprayed into the nose. This method of administration offers several advantages. This article will examine these advantages as well as what medications are commonly dispensed using this method.

Transmucosal Administration

The use of nasal administrated medications offers 6 key advantages. Nasal administration provides a direct route for medications, avoiding gastrointestinal destruction and hepatic first pass metabolism. Transmucosal medicating effectively increases bioavailability while decreasing time of onset. The process is easy to use and safe. We will explore these six advantages in more detail below.

Direct Route

Nasal administration is a nose-brain pathway for a much more rapid dispersal. The olfactory mucosa is in direct contact with the brain and cerebrospinal fluid (CSF). When medications are absorbed through the olfactory mucosa, they are directly transported to the CSF. This nose-to-brain pathway offers a rapid and direct route for medication deliver to the brain.

Gastrointestinal Destruction

Drugs administered orally are absorbed through the gastrointestinal tract. While enroute, the drug can be significantly degraded by gastric acidity, intestinal membrane enzymes, complexion with food constituents or bacterial enzymes. Oral medications sit in the stomach for 30 to 45 minutes before being sent to the intestines for absorption. After absorption into the blood, the medication is delivered to the liver for detoxification. This time consuming digestive process destroys much of the medication before it reaches the blood stream for dispersal throughout the body. While oral administration remains the most convenient delivery method, it provides very little absorption and transfer of the drug to the blood stream.

Becton Dickinson Accuspray

Hepatic First Pass Metabolism

Nasal medication bypasses first pass metabolism while oral medications do not. As mentioned above, all blood from the intestines is routed to the liver for detoxification. The liver metabolizes around 90% of oral medications before the medication reaches the heart. This leaves very little of the drug remaining after liver detoxification for patient use. A nasal administered drug; however, absorbs directly into the veins through the nasal mucosa; therefore, by-passing first pass metabolism. The heart then pumps the drug to the entire body without delay.

Bioavailablity

Bioavailability refers to the amount of drug transmitted into the bloodstream. For instance, IV administered medications have 100% bioavailability while most oral medications have only around 5 to 10% bioavailability. The bioavailability of nasal medications is dependent upon molecule size and pH of the medication. For instance, Nalozon, a poplular intranasal medication, has 90+% bioavailability while midazolam has 75+% Nalozone and Fentanyl has 80+%. Transmucosal administration is generally more effective than subcutaneous or intramuscular injections.

Time of Onset

Intranasal administration is rapidly effective with an onset time between only 2 to 10 minutes.

Ease of Use

Nasally administered drugs are convenient and easy. The administration is painless and does not expose the patient or caregiver to accidental needle sticks. Waste is reduced without the need for sharps containers and hazardous disposal. Intranasal administration is safe for the patient with no high peak serum levels. Nasal administered drugs are safer to use for violent individuals or for seizure victims. Various medications may be delivered to the patient in any position, whether sitting, lying down, prone, on side or upside-down. Since nasal administration takes only a second to administer the patient may not need to be restrained.

Types of Nasal Mucosa Administrations

Nasal administrations may take the form of spray bottles, nose droppers, pressurized aerosol or atomized unit dose sprays. The latter is the most effective method. Spray bottles fail to provide a consistent dosage and often results in excessive amounts of the drug draining into the throat. Large particles of the medication can also form deposits on the nasal mucosa. Nose droppers often produce the same unwanted results as spray bottles with much of the medication not being absorbed and draining into the throat. Pressurized aerosol devices tend to break the medication into smaller particles that flow down to the lungs which offer less effectiveness with absorption and may result in respiratory complications.

Carpuject

Atomization of the medication reduces the particles into 2 to 10 micrometers that provide for optimal absorption through the nasal mucosa. The mucosa offers a large surface area of more than 180 square centimeters of highly vascularized tissue. This area has more blood vessels per gram of tissue than in muscle tissue, the brain, or even the liver. Absorption through the nasal mucosa offers the best results for rapidity and efficacy. Atomization best reduces the medication particles to the optimal size for absorption. Additionally, because the medication is atomized into a mist form, it less is likely to be expelled from the nose into the external environment.

Nasal Medication Delivery Devices

There are several manufacturers that make nasal medication devices. Below is a list of the bestselling devices listed alphabetically.

  • Accuspray by Becton Dickenson - offers patients a less invasive drug administration. Designed for use by both doctors and patients, Accuspray is easy-to-use with no pre-activation or loading required. The drug to be administered is clearly visible, allowing visual inspection of the medication before administration. Accuspray provides for the administration to be easily divided, allowing the drug to be delivered to each nostril to access more mucosa membrane for better dispersal.
  • Carpuject by Pfizer - Carpuject has a compact design that is needleless and prevents injuries. The Carpuject syringe system can dispense a wide variety of medications with easy-loading cartridges. Caregivers enjoy the easy one-handed operation and disposal.
  • Liquid OptiNose
  • OptiNose - The OptiNose nasal device is designed to treat chroinic nasal inflammatory diseases, migraines, and Autism Spectrum disorder. OptiNose provides two separate delivery devices designed to administer either powder and liquid medications. The devices minimize local irritation and allows patients to self-medicate.
  • MAD Intranasal Mucosal Atomization Device by Teleflex – This nasal atomization device is designed to be used with drugs approved for intranasal delivery. It requires no sterile procedures, is painless, and is quick and easy to administer. The atomized medication is rapidly absorbed across the mucosal membranes directly into the blood stream for greater bioavailablity.
  • CPD by Kurve Technology - This nasal atomization device is non-invasive and provides controlled particle dispersion to deliver medications directly to the brain. The CPD nasal drug delivery system can control the size of the liquid droplets down to 1 micron regarless of the viscosity of the formulation.
  • DirectHaler by Acerus Pharma - The DirectHaler is also known as the Direct-Haler and is a nasal drug delivery device designed to use the patients breath to disperse dry powered medications to the patient. Recently, the Acerus Pharmaceutical Corporation has acquired this award-winning intranasal drug delivery device from a company in Denmark.
  • VeriDoser by Mystic Pharmaceuticals - The VeriDoser offers nasal drug delivery with precise, calibrated dosing. Mystic's VeriDoser requires no priming and has a dose counter. The spray plume is configurable into steam, spray or aerosolized spray. The design accommodates proteins, peptides and stem cells formulations to treat CNS, neurodegenerative disorders, brain tumors, HIV encephalopathy, epilepsy, Huntington, Alzheimer's and Parkinson.

Powder OptiNose

Common Medications Dispensed Using Nasal Atomization

Nasal atomization delivery is being developed for many applications, including Alzheimer's, Parkinson's, brain tumors, diabetes, multiple sclerosis, schizophrenia, pain control, and migranies. Below is a list of the most popular drugs currently dispensed by intranasal administration grouped by treatment type.

Pain Control - Opiates
Fentanyl
Sufentanyl
Ketamine

Sedation - ά-2 Agonists
Midazolam
Dexmedetomidine

Seizure Therapy – Benzodiazepines
Larazepam
Midazolam

Opiate Overdose
Naloxone (Narcan)

Motion Sickness
Scopolamine

Reversal of Conscious Sedation
Romazicon

Urination Suppression
DDAVP (Desmopressin)

Angina (Chest Pain)
Nitroglycerin

Migraines
Sumatriptan

Kurve CPD

Specific Nasal Drug Delivery Administrations

Fentanyl

Fentanyl is an opiate used for pain control and is an ideal drugs for use with intranasal administration. A prescription is required for this drugs. Fentanyl has a rapid onset and short duration and is one of the strongest opiate drugs sold on the market. Intranasal fentanyl is rapidly absorbed, reaching maximum concentration in just 4 to 11 minutes. Bioavailability is around 71% but appears to be pH dependent with increased bioavailability associated with higher pH. 1

Ketamine

Ketamine is a dissociative anesthetic opiate that is often used for treatment-resistant depression. Beside IV administration, intranasal is the second most common method of dispensing Ketamine. Intranasal administration requires less skill to use and offers less risk to the patient. However, many patients report that infusion offers more relief and lasts longer while intranasal is less expensive and more convenient. 2

Midazolam

Midazolam produces sleepiness or drowsiness and helps relieve anxiety. It also produces amnesia so that the patient will forget any discomfort or pain that may occur following surgery. In intensive care hospital situations, Midazolam is used to induce unconsciousness. This drug is also used to treat epilepsy and seizures. Midazolam requires a prescription and close doctor supervision. Intranasal midazolam was found in a study to have the same efficacy as IV administrations but that the short administration time for nasal as opposed to IV set up favored the use of nasal delivery. 3

Narcan

Narcan is an FDA-approved drug known as naloxone hydrochloride. This drug is an opioid antagonist used for the emergency treatment of individuals with respiratory or central nervous system failure due to opioid overdose. Administration of naloxone by nasal spray atomization is easy and convenient and offers increased efficacy. Narcan nasal spray is designed to provide a singe 4 mg dose. Administration of the drug using a Narcan MAD Syringe allows the medication to be atomized for quick metabolism. 4 The LMA MAD Nasal Intranasal Mucosal Atomization Device from Teleflex is specifically designed for administering this lifesaving drug.

VeriDoser

First Responders Use of Intranasal Naloxone

Emergency Medical Technicians (EMT) and ambulance crews have found the use of narcan nasal spray to restore spontaneous respiration for drug overdose patients in just a matter of seconds. Ease of use without the risk of needlestick injury are cited as primary benefits. The requirement for minimal training has also been cited as a benefit. Some have advocated extending the use of Narcan nasal sprays to community workers that often come into contact with drug abusers. 5Some police departments are now equipping officers with opioid-overdose antidote because the police are often the first on the scene.6 The U.S. Attorney General Eric Holder advocates that the police and fire departments should equip their first responders with naloxone to save drug overdose victims.7

Parental Use of Nasal Nacan

Some states are allowing Naloxone to be sold at drug stores without a prescription in an effort to curb teenage overdose deaths. 8

Nasal Narcan Studies

Citations

1Foster, David, et al. "Pharmacokinetics and pharmacodynamics of intranasal versus intravenous fentanyl in patients with pain after oral surgery." Annals of Pharmacotherapy 42.10 (2008): 1380-1387.
2"Route of Administration: Critical to Achieving Relief." Ketamine Advocacy Network. N.p., 2015. Web. 30 Aug. 2016.
3"Therapeutic Intranasal Drug Delivery." Treating Seizures with Intranasal Medications. N.p., n.d. Web. 30 Aug. 2016.
4Narcan.com
5Strang, John, et al. "Clinical provision of improvised nasal naloxone without experimental testing and without regulatory approval: imaginative shortcut or dangerous bypass of essential safety procedures?." Addiction (2016).
6Fuller, Steve. “City police make first Narcan save." The Ellsworth American. August 24, 2016.
7Sledge, Matt. “Eric Holder Calls On First Responders To Carry Naloxone, Anti-Overdose Drug." The Huffington Post. April 16, 2014.
8Fiangan, Katlin. “Narcan to Be Sold at Pharmacies Without Prescription in Vermont." NECN.com. August 25, 2016.

Other Applicable Studies of Using Intranasal Administration







Burt Cancaster, Author

Medical Expense Reimbursements

By 9 months ago 104 Views 1 comment

Health Care Cost Reimbursement

How does insurance reimbursement work for medical supplies?

The Affordable Care Act became law in March 23, 2010. The purpose of this law was to make health care more accessible, affordable and of higher quality for families, seniors, and businesses. This new law still accommodates many different types of reimbursement plans for medical expenses. This article examines some of the key medical expense reimbursement plans available for Americans.

Reimbursable Medical Expenses

Eligible medical expenses for reimbursement include the costs of curing, diagnosis, mitigation, prevention of disease, and treatment affecting any part or function of the body. These expenses must be associated with legal medical services provided by licensed dentists, physicians, surgeons, and other medical practitioners. Reimbursable medical expenses may include the costs of diagnostic devices, medical equipment, and medical supplies. Some examples include bandages, arm slings, braces, BPAP device, compression socks, flu shots, weight loss drugs, hand sanitizers, heart monitors, and oxygen equipment. Qualified medical expenses must be primarily to alleviate or prevent a physical or mental defect or illness.

Cosmetic or “general health" expenses are not qualified for reimbursement. These items include teeth whitening, tooth brushes, laser hair removal, marriage counseling, maternity clothes, and air duct cleaning. Below is a link to a brief list of medical items that are and are not reimbursable.

Brief List of Medical Reimbursable Expenses

Prescriptions

Health Insurance Claims

Over the counter (OTC) items such as equipment, medical devices and medical supplies are reimbursable without a prescription (Rx). Examples of items that do not require a prescription include crutches, walkers, bandages, dressings, blood sugar test kits, and diabetic supplies.

Letter of Medical Necessity

Although OTC items do not require a Rx for reimbursement, a Letter of Medical Necessity must be provided in a written order from a Medical Doctor (MD) or a Doctor of Osteopathic Medicine (DO) licensed in the state they are legally practicing The Letter of Medical Necessity must include all required information, including the name and quantity of the medical item required by the patient and the duration of the treatment that must not exceed one year. Below is a link to a sample form of a Letter of Medical Necessity.

Letter of Medical Necessity

Reimbursement for medical expenses is usually accomplished in one of the following ways—Medicare Part B, Health Savings Accounts, Flex Spending Accounts, Section 105 Plans and standard medical care plans. Medical care plans are governed by regulations and by the company that provides the plan. The other medical expenses reimbursement plans are briefly described below.

Medicare Part B

Medical Treatments

Medicare Part B covers durable medical equipment (DME) expenses. These expenses are for medical necessity items that your doctor prescribes for you to use in your home. These items must be used for a medical purpose, must be durable with an expected product lifetime of at least 3 years, must be used in your home, and is not useful to someone who is not sick or injured. Examples of medical equipment covered by Medicare Part B include walking canes, crutches, hospital beds, nebulizers, oxygen concentrators, patient lifts, suction pumps, and walkers.

Medicare Part B works through medical suppliers that accept assignment. That means that your DME supplier and your doctor must be enrolled in Medicare. If they are not enrolled, Medicare will not reimburse your expenses.

If you meet the requirements for Medicare Part B, Medicare will reimburse you up to 80% of the Medicare-approved amount minus the part B deductible. Additionally, Medicare Part B may require one of three options—that you purchase the equipment, that you rent the equipment or that you choose to purchase or rent.

Health Savings Accounts (HSA)

Health Savings Accounts allow you to contribute to a HSA through enrolling in a Qualified High Deductible Health Plan. Sometimes referred to Section 125 Plans or Cafeteria Plans, an HAS allows your employer to deduct from your salary up to a specified amount that is tax free for use in paying medical expenses. To use an HAS, you cannot have any other health coverage for the first $1,300 of your eligible medical expenses or $2,600 if family coverage is provided. Any amounts contributed to an HSA and any earnings are tax free as long as they are used for proper medical expenses. There is no requirement to use the money you contribute by a specific date; however, there is a cap on how much you can contribute for each calendar year.

Health Checkup

Essentially, a Health Savings account is a modified bank account. HSA withdrawals can be made for any qualified medical expense specified in IRS Publication 502 and include both medical and dental expenses. Over-the-counter medications are not qualified without a medical doctor's prescription. Health Savings Accounts may be used for your own medical expenses, for your spouse, or any tax dependents up to the age of 26.

Flex Spending Accounts (FSA)

Flex Spending Accounts allow money to be set aside into a Medical Reimbursement Account that is deducted from your paycheck completely pre-tax. No Federal, State or FICA taxes are ever paid on that money. When you get your W-2 at the end of the year, your gross wages, Social Security wages, and Medicare wages will be reduced by any amount you put into your FSA during the calendar year. A signed salary redirect agreement is required each year and you must elect an amount to contribute to your account during the plan year to participate. The salary redirect agreement and election amount must be submitted before the plan year begins. Your election amounts cannot be rolled over from year to year. Your entire election amount is available for reimbursement to you the first day of the plan year; therefore, you will not be allowed to make changes to that election amount during the plan year unless you have a Change of Family Status. Some Flex Spending Account plans allow for an additional time period after the end of the plan year to use the money from the previous plan year.

Health Reimbursement Arrangement (HRA)

Health Reimbursement Accounts are employer-funded health benefit plans that offer certain tax advantages to employers on behalf of their employees. Approved by the IRS, this plan is not considered health insurance but allows employees to be reimbursed for out-of-pocket medical expenses and individual health insurance premiums. An HRA plan supplements health insurance benefits while allowing employees to pay for a wide range of medical expenses not commonly covered by health insurance. Health Reimbursement Arrangements, employers reimburse employees directly only after the employees incur approved medical expenses. There is no limit to the amount of money an employer can contribute to an employee's Health Reimbursement Arrangement. Reimbursable expenses are defined under IRS Section 213d; however, employers may limit reimbursable expenses in any way they choose. HRA's also allow annual rollovers of unused balances to the next year.

Approved Medical Claims

Medical Expense Reimbursement Plans (MERP)

Medical Expense Reimbursement Plans are also known as Section 105 Plans, Accident and Health Plans or Self-Insured Reimbursement Plans. An MERP allows a small business owner to provide tax-free reimbursement of personal health insurance expenses to their employees. MERP's are group health plans that must be administered to comply with the Affordable Care Act (ACA) and associated regulations such as PHS 2711 (prohibition on annual limits) and PHS 2713 (preventive care) -- as well as numerous new administrative requirements. Because traditional employer-provided health insurance is too expensive, many small businesses opt for a Section 105 Plan. The average amount of savings spent by participants is 50%, yielding a 50% savings for the employer.

Below is a chart summarizing the differences in four of the most popular medical expense reimbursement accounts.

FSA

HSA

HRA

MERP

Eligibility

All employees except self-employed

Self-employed or an employee of a small business (50 or fewer employees)

All employees

All employees

Qualified medical expenses

Unreimbursed medical care expenses as defined by Internal Revenue Code section 213, excluding premiums for health insurance coverage and long-term care expenses

Unreimbursed medical care expenses as defined by Internal Revenue Code section 213 Health insurance premiums under a continuation of coverage arrangement (such as COBRA) Health insurance premiums when receiving unemployment compensation Qualified long-term care insurance premiums

Unreimbursed medical care expenses as defined by Internal Revenue Code section 213 and as defined by employer

Unreimbursed medical care expenses as defined by Internal Revenue Code section 213

Nonqualified medical expenses

Expenses not under Internal Revenue Code section 213 Health insurance premiums under a continuation of coverage arrangement (such as COBRA) Health insurance premiums when receiving unemployment compensation Qualified long-term care insurance premiums

Expenses not under Internal Revenue Code section 213 Employer may set additional restrictions

Expenses not under Internal Revenue Code section 213

Expenses not under Internal Revenue Code section 213

Must be covered by a health insurance plan

No

Yes

No

No

Contributor

Employee, employer, or both

Employee or employer, but not both

Employer

Employer

Contribution limits

n limits No statutory limit; limits may be set by employer

Single coverage--65 percent of deductible
Family coverage--75 percent of deductible

No statutory limit; limits may be set by employer

No statutory limit; limits may be set by employer

Funds carried over to next year

No

Yes

Yes

Yes

Portability

Account cannot be maintained if the employee is no longer working for the employer

Continued access to unused account balance if the employee is no longer working for the employer Withdrawals for non-medical purposes are subject to income tax and a 15 percent penalty tax Once the account holder reaches age 65 (the Medicare eligibility age), becomes disabled, or dies, withdrawals for nonmedical purposes are subject to income tax only, with no penalty

At employer discretion

At employer discretion

Cash out of unused amounts.

Not permitted.

Permitted, but results in taxable income.
Subject to 10% excise tax.
Excise tax waived for participants over age 65,
following death or in a divorce situation.

Not permitted.

Permitted, but results in taxable income.







Lung Bacteria and COPD by Peter Henry

By 10 months ago 122 Views No comments

New Research on Lung Bacteria could mean new treatment for Some Types of COPD

Everyone's lungs have hundreds of types of bacteria living in them all the time. These colonies are both potentially good and bad depending on their effects on the body. The colonies of bacteria living in our lungs is called a microbiome and researchers are working towards better understanding it to help create new treatments for COPD and ultimately to unveil the causes of COPD.1

Is COPD Treatment Hurting or Helping Your Microbiome?

Each day your lungs are exposed to pathogens and chemicals and sometimes even drugs for COPD treatments or other conditions. Every time we are exposed to these environmental factors one side in the war ends up winning.

How do Breathing Treatments for COPD Affect it?

DeVilbiss Pulmo-Aide

For many individuals with chronic obstructive pulmonary disorder a treatment plan involves using a handheld inhaler. While the benefits of bronchodilators and inhaled corticosteroids are convenience, portability and sometimes life-saving, the downsides are the many people don't use them correctly and that the treatments deal with symptoms rather than the cause. Many doctors who prescribe inhalers can't explain to patients how to properly use inhalers.2 Individuals who use inhalers have different bacteria in their lungs but researchers don't yet know why or what this means for individuals with COPD.3 Some researchers seem to think taking a corticosteroid alone could have serious effects by increasing bacterial populations.4

Nebulizer treatments for COPD are used for antibiotics, bronchodilators, corticosteroids, and several other types of medications. Some nebulizer treatments like TOBI tobramycin solution for inhalation need a special nebulizer like the DeVilbiss Pulmo Aide to even administer the medication.

Researchers have found that if they treat their patients with antibiotics alone the population of lung bacteria becomes much less diverse, eliminating many bad bacteria. The growth of these bacteria is then delayed for a time. If treatment for COPD includes a steroid the bacteria populations increase faster once again.4

What Does this Mean for Your COPD?

MABIS CompXP Deluxe Compressor Nebulizer

The treatments for COPD available at this time are mostly used to combat symptoms during exacerbation. The final effect on the cause of COPD is still unknown. Finding the best way to deal with these symptoms is the greatest concern. Nebulizer therapy can be a much better option for many individuals especially because they are usually easier to use than inhalers. Ease of use and portability don't need to be sacrificed to use a nebulizer. For instance, using nebulizer like the MABIS CompXP Deluxe Compressor Nebulizer can greatly reduce the limitations of using a standard nebulizer. Adherence to a COPD treatment program can be critical to recovery and prevention of future exacerbations.5

What Can You do Now?

Oxygen Concentator Comparison Chart

Learning as much as you can about treatments is the best option for COPD exacerbation prevention. Knowing how to select the right oxygen concentrator and using it properly can help you to get the correct amount of oxygen your body needs. Getting a complete run-down on how to properly complete your nebulizer treatment can make a huge difference on your overall quality of life. Knowledge and committment are most beneficial to prevent future exacerbations.

Citations

1R., Dy; S., Sethi. The lung microbiome and exacerbations of COPD. Current Opinion in Pulmonary Medicine. May 2016, Volume 22, Issue 3 p. 196-202. Web. 6 July, 2016. .

2Alismail, A. et al. Diverse Inhaler Devices: A Big Challenge for Health-Care Professionals Respiratory Care. May 1, 2016 vol. 61 No. 5 pp.593-599. Web. 8 July, 2016.

3Pragman, A. A. et al. The Lung Microbiome in Moderate and Severe Chronic Obstructive Pulmonary Disease. PLOS one Open Access PLoS ONE 7(10): e47305. doi:10.1371/journal.pone.0047305. Web. 7 July, 2016.

4Huang, Y. J. Et al. Airway Microbiome Dynamics in Exacerbations of Chronic Obstructive Pulmonary Disease. Journal of Clinical Microbiology. 2014 Aug; 52(8): 2813-2823. Web. 7 July., 2016.

5Santos-Longhurst, A. Nebulizers for Sever COPD. Web. 8 July, 2016.