Pharmacologic Management of Anticoagulant Reversal · PDF file ·...

Mary M. Bridgeman, Pharm.D., BCPS,

CGP

Splitting Hairs: Pharmacist-Focused

Strategies for Individualizing Treatment

of Head Lice

1

Splitting Hairs: Pharmacist-Focused Strategies for

Individualizing Treatment of Head Lice

Mary M. Bridgeman, PharmD, BCPS, CGP

Clinical Assistant Professor

Ernest Mario School of Pharmacy

Rutgers, The State University of New Jersey

Piscataway, New Jersey

Faculty Information

Presenter:




Rutgers, The State University of New Jersey Piscataway, New Jersey

Moderator:

Steve Lin, PharmD

Director of Scientific Affairs

Pharmacy Times Office of CPE

Plainsboro, New Jersey

Faculty Disclosures and COI

Resolution

Mary Bridgeman, PharmD

– Is an employee of Rutgers, The State

University of New Jersey

– Does not have a vested interest in or

affiliation with any commercial entities (or their

competitors) whose products are mentioned

in this presentation

– Is not affiliated with an organization

that has a specific interest in the

therapeutic areas under discussion

Disclosures and COI Resolution (cont.)

Ernest Mario School of Pharmacy, Rutgers University

Planning Staff—Evelyn R. Hermes-DeSantis, PharmD, BCPS, Clinical

Professor; Chair, Continuing Education Committee—has no financial

relationships with commercial interests to disclose.

Pharmacy Times Office of Continuing Professional Education Planning Staff—Judy V. Lum, MPA, Steve Lin, PharmD, David Heckard, and Donna W. Fausak—have no financial relationships with commercial interests to disclose.

An anonymous peer reviewer has been used as part of content validation and conflict resolution. The peer reviewer has no relevant financial relationships with commercial interests to disclose.

The content of this webinar may include information regarding the use of products that may be inconsistent with or outside the approved labeling for these products in the United States. Pharmacists should note that the use of these products outside current approved labeling is considered experimental and are advised to consult prescribing information for these products.

Pharmacy Accreditation Ernest Mario School of Pharmacy is

accredited by the Accreditation Council for

Pharmacy Education (ACPE) as a provider

of continuing pharmacy education. This

activity is approved for 1.0 contact hour

(0.1 CEU) under the ACPE universal

activity 0038-9999-13-011-H01-P and

0038-9999-13-011-H01-T. The activity is

available for CE credit through August

23, 2013.

Type of Activity: Knowledge

This program is in co-sponsorship with Ernest Mario School of

Pharmacy, Rutgers University and Pharmacy Times Office of Continuing

Professional Education and is supported by an educational grant from

Sanofi Pasteur U.S.

Splitting Hairs: Pharmacist-Focused Strategies for

Individualizing Treatment of Head Lice




Rutgers, The State University of New Jersey

Piscataway, New Jersey


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of Head Lice

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Learning Objectives

Upon completion of this educational activity, participants

should be able to:

Examine the incidence and public health impact of

head lice infestation

Describe the differences between available lice

treatment options regarding safety, efficacy, application

and pediculicide resistance

Discuss the role of the pharmacist in individualizing

treatment of head lice, promoting the correct use of

products for self-care, and prevention re-infestation

through patient education

Head Lice: A Historical

Perspective

Ancient pest attributed to causing human

infestation for thousands of years

– Fossils of louse eggs found on human hair

dating to 10,000 BC

– Referenced in the Bible

– Found on mummified remains of ancient

Egyptians

Colloquial terms (eg, lousy, nit-wit) attributed

to outbreaks of infestation

Parasitol Today 2000;16:279.;

Paleomicrobiology: Past Human Infections. Berlin, Germany: Springer_verlag;2008:215-222.

Epidemiology of Infestations

Most common among:

– Preschool-aged children attending daycare

– Elementary school-aged children

– Household members of infested children

Exact annual prevalence difficult to estimate

– Estimates often derived from over-the-counter

(OTC) pediculicide sales data

– 6 to 12 million infestations likely to occur each

year in children aged 3-12 years

Int J Dermatol 2006;45(8):891-6.; Centers for Disease Control and Prevention. Available from:

http://www.cdc.gov/NCIDOD/dpd/parasites/lice.; World Health Organization Pesticide Evaluation Scheme; 1997.

Public Health Impact

“No-nit” school policies

– Estimated > 12-24 million missed school days annually due to head lice infestation

– Historically, children required to stay home for at least 24 hours after head lice discovery

Presence of nits not necessarily indicative of active infestation

– Can remain “glued” to hair follicles for several days after treatment

– May be empty egg casings, not live eggs

Int J Dermatol 2006;45(8):891-6.;

Centers for Disease Control and Prevention. Available from: http://www.cdc.gov/NCIDOD/dpd/parasites/lice.;

Gratz NG. World Health Organization, Division of Control of Tropical Disease, WHO Pesticide Evaluation Scheme; 1997.

Physiology and Biology of the

Louse

Ectoparasites

– Live on the skin and hair of body

– Feed exclusively on human blood

Species of louse known to affect humans

– Pediculus humanus capitis

– Pediculus humanus corporis

– Pthirus pubis

Transmission of Head Lice

Infestation

Wingless, sesame seed-sized parasites

– Move by crawling

– Spread by direct contact with hair of affected individual

Head-to-head contact poses greatest risk of transmission

– Fomites (eg, hats, scarves, combs, brushes) represent uncommon means of transmission

– Head lice survive for one day or less when removed from host

Curr Probl Dermatol 1999;11:73-120.; Pediatrics 2010;126:392-403.


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Lifecycle of the Head Louse

Three distinct stages:

– Egg

– Nymph

– Adult

Adult female head

louse has lifespan of

3-4 weeks

– May lay up to 10 eggs

per day

http://www.cdc.gov/parasites/lice/head/biology.html Pediatrics 2010;126:392-403.

Head Lice Images

Unhatched head louse nit Female head louse

Images from Centers for Disease Control and Prevention [CDC], Atlanta, GA. CDC Public Health Image Library, Image number

377 (louse) and 378 (nit). Available from: http://phil.cdc.gov/phil/home.asp.

Signs and Symptoms of

Infestation

Scalp symptoms

– “Tickling feeling”

– Sensation of movement

– Pruritus (sometimes severe)

– Allergic, macular rash where bitten

Pruritus and concerns

– May result in scalp excoriation

– Secondary bacterial skin infections

Diagnosis

Gold-standard technique

– Locate live louse on affected individual’s scalp

– Strategies to slow louse movement:

Dampen scalp

Coat head with conditioner

Visualizing nits

– May be easier to locate, especially behind

ears or at nape of neck

Pediatrics 2010;126:392-403.; Nurs Times 2002;98(46):57.

Prevention of Infestation

Teach children:

– Not to share personal care items (eg, combs, brushes, hair clips)

– Do not allow refusal to wear protective headgear due to fear of lice

Symptom awareness

– Teachers and child care providers should be aware of signs and symptoms of infestation

– Early detection and treatment to minimize transmission


Management of Head Lice

Initiate management strategies and

treatment only when diagnosis is clear

Two-fold treatment strategy:

– Prevention of infestation of others

Environmental sanitization practices

Elimination of human reservoirs

– Pharmacologic treatment of individuals with

active infestation



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Environmental Control

Strategies Recommend sanitization of all personal hair care items

Suggest washing in hot water or dry cleaning all household items utilized by infected individual – Clothing

– Pillow cases

– Bedding

– Towels

Advocate vacuuming furniture, car seats, carpeting

Pediatrics 2010;126:392-403.; Diaz JH. Lice (pediculosis). In: Mandell GL, Bennett JR, Dolin R, eds. Principles and Practice of

Infectious Diseases, 6th ed. New York, NY: Elsevier Churchill Livingstone; 2010:3629-3632.

Nit Combs

Can be difficult and

tedious!

Recommend using

fine-toothed,

specialized “nit

comb”

– Useful for removing:

Nits

Dead lice after

pharmacologic

treatment Image from: http://www.headlice.org/catalog/


Hot Air Therapy

LouseBuster™

– FDA-approved device

– Reported to eradicate

head lice with one 30-

minute hot air treatment

Mechanism of action

– Hot air treatment results

in louse desiccation

Should not be tried at

home!

Image from: http://www.lousebuster.com

Pediatrics 2010;126:392-403.; Pediatrics 2006;118(5):1962-1970.

Pharmacologic Treatment of

Head Lice

Permethrin (Elimite®; Nix®)

Pyrethrin combined with piperonyl

butoxide (Licide®; Pronto®; RID®)

Lindane (Kwell®)

Malathion (Ovide®)

Spinosad (Natroba®)

Benzyl alcohol (Ulesfia®)

Ivermectin (Sklice®)

Pediculicidal or Ovicial?

Pediculicidal agents:

– Benzyl alcohol

(Ulesfia®)

– Ivermectin (Sklice®)

– Permethrin (Elimite®;

Nix®)

– Pyrethrin combined

with piperonyl butoxide

(Licide®; Pronto®;

RID®)

Pediculicidal and

ovicidal agents:

– Lindane (Kwell®)

– Malathion (Ovide®)

– Spinosad (Natroba®)

Criteria for Self-Treatment

Infestation confined to scalp

No symptoms of secondary bacterial skin

infection

Not pregnant or breast-feeding

All products require topical application

– Recommend washing affected hair in sink

rather than bath or shower

– Minimize systemic exposure and toxicities

Pediatrics 2010;126:392-403.; Contemp Pediatr 1998;15(11):181-192.


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OTC vs. Prescription-Only

Products

OTC products:

– Permethrin (Elimite®;

Nix®)

– Pyrethrin combined

with piperonyl butoxide

(Licide®; Pronto®;

RID®)

Prescription-only

treatments:

– Lindane (Kwell®)


– Benzyl alcohol

(Ulesfia®)



OTC Products for Head Lice

Infestation

Active ingredients and brand names

– Permethrin (Elimite®; Nix®)

– Pyrethrin combined with piperonyl butoxide (Licide®; Pronto®; RID®)

Considered safe and effective in most cases

– Often first treatment sought by parents and caregivers due to availability

– Dosage based on patient’s age

Resistance documented due to overuse, improper use, or insufficient contact time

Pediatrics 2010;126:392-403.; Arch Dermatol 2002;138:220–4.; Arch Dermatol 2001;137:287–91.

Permethrin 1% (Elimite®; Nix®)

Agent of choice in treatment of head lice

infestation

– Most-studied pediculicide in U.S.

– Least toxic to humans

Mechanism of action

– Neurotoxin

– Disrupts sodium channels in central nervous

system (CNS) of louse

– Delays repolarization and causes paralysis

Clin Infect Dis 2003;36 (11): 1355-1361.; Pediatrics 2010;126:392-403.; Diaz JH. Lice (pediculosis). In: Mandell GL, Bennett JR,

Dolin R, eds. Principles and Practice of Infectious Diseases, 6th ed. New York, NY: Elsevier Churchill Livingstone; 2010:3629-3632.

Product-Specific Information Permethrin 1%

Contraindications

• Infants younger than 2 months of age

• Allergy to ragweed or chrysanthemums

Directions for Use

• Shampoo and towel-dry hair

• Wet hair and scalp with product

• Leave on for 10 minutes, rinse, and use nit comb

Need to Reapply?

• Not necessary

• Can retreat in 7-10 days if live lice observed

Adverse Effects

• Scalp irritation, pruritis, erythema, burning

• Stinging, tingling, numbness of scalp

Clin Infect Dis 2003;36 (11): 1355-1361.; Pediatrics 2010;126:392-403.; Nix® (permethrin) shampoo, 1%. Langhorne, PA: Insight

Pharmaceuticals; 2009.

Pyrethrins and Piperonyl Butoxide (Licide®; Pronto®; RID®)

Pyrethrins

– Resins from chrysanthemum flower

– Work by blocking nerve impulse transmission,

causing paralysis and death to louse

Piperonyl butoxide

– Petroleum derivative

– Helps augment effect of pyrethrins by

inhibiting activity of louse’s cytochrome P450

enzymes



Product-Specific Information Pyrethrins and Piperonyl Butoxide

Contraindications

• Infants younger than 2 years of age

• Allergy to ragweed or chrysanthemums

Directions for Use

• Apply product to dry hair or massage into wet hair

• Leave on for 10 minutes

• Rinse hair with regular shampoo, and use nit comb

Need to Reapply?

• No residual pediculicidal activity

• Second treatment recommended in 7-10 days to kill any remaining lice

Adverse Effects

• Irritation

• Erythema

• Itching

• Localized swelling

Clin Infect Dis 2003;36 (11): 1355-1361.; Pediatrics 2010;126:392-403.; Piperonyl butoxide and pyrethrum extract shampoo.

Allegan, MI: Major Pharmaceuticals; 2012.


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Prescription-Only Products

Active ingredients and brand names – Lindane (Kwell®)


– Benzyl alcohol (Ulesfia®)



Can be utilized: – In lieu of OTC products when resistance is

suspected

– In patients who have failed treatment with OTC products

Pediatrics 2010;126:392-403.

Lindane Shampoo 1% (Kwell®)

Mechanism of action

– Organochloride pesticide

– Inhibits gamma-amino butyric acid (GABA)

receptors in CNS of louse

Results in hyperexcitability and inability to feed

Place in therapy

– Second-line treatment due to potential for

causing neurotoxicity (black box warning)



Product-Specific Information Lindane Shampoo 1%

Contraindications

• Premature infants or neonates

• Children and individuals weighing less than 50 kg (110 lbs.)

• Immunocompromised patients

• Pregnant women

Directions for Use

• Apply product to clean, dry hair

• Leave on scalp for 4 minutes

• Dampen hair, lather, and wash off

• Use no more than 2 ounces per single application

Need to Reapply?

• Not recommended due to risk of serious side effects when applied too soon for retreatment

• No data available to indicate what is optimal time for reapplication

Adverse Effects

• CNS effects – seizures, convulsions, death

• Localized itching or burning

• Dry skin

• Skin rash

Clin Infect Dis 2003;36 (11): 1355-1361.; Pediatrics 2010;126:392-403.; US Food and Drug Administration. Available from:

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110848.htm#5.

Malathion Lotion 0.5% (Ovide®)

Mechanism of action

– Organophosphate pesticide

– Inhibits cholinesterase activity of louse

Place in therapy

– Indicated for treatment of head lice infestation in children 6 years of age and older

– Resistance common in European countries Formulation available in U.S. contains terpineol, dipentene, and pine needle oil

May improve efficacy and reduce resistance


Infectious Diseases, 6th ed. New York, NY: Elsevier Churchill Livingstone; 2010:3629-3632.; Malathione Lotion 5% [prescribing

information]. Woodcliff Lake, NJ: Karalex Pharma, LLC; 2008.

Product-Specific Information Malathion Lotion 0.5%

Contraindications

• Children younger than 24 months of age

Directions for Use

• Apply to dry hair

• Allow to air dry – NO heat

• Wash off 8-12 hours later

• Comb with nit comb

Need to Reapply?

• Can retreat in 7-9 days if live lice observed

Adverse Effects

• Chemical burns of scalp

• Skin and scalp irritation, stinging

• Conjunctivitis

Pediatrics 2010;126:392-403.; Malathione Lotion 5% [prescribing information]. Woodcliff Lake, NJ: Karalex Pharma, LLC; 2008.

Benzyl Alcohol Lotion (Ulesfia®)

Mechanism of action – Obstructs respiratory spiracles of louse

– Results in asphyxiation

Efficacy data – Established in two studies of more than 600 people

with active head lice infestation

– Intervention Two 10-minute treatments with either benzyl alcohol 5% lotion or placebo one week apart

– Outcomes Approximately 75% of patients who received benzyl alcohol 5% lotion were lice-free 14 days after treatment, compared to 26% who received placebo


Infectious Diseases, 6th ed. New York, NY: Elsevier Churchill Livingstone; 2010:3629-3632. ; Ulesfia® (benzyl alcohol) Lotion, 5%

[product information]. Florham Park, NJ: Shionogi Inc.; 2012.


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Product-Specific Information Benzyl Alcohol Lotion

Contraindications

• None

• Not indicated for use in children younger than 6 months of age

Directions for Use

• Apply product to dry hair


• Rinse hair with water

Need to Reapply?

• Repeat application recommended in 7 days

Adverse Effects

• Occular irritation

• Application site irritation

• Application site anesthesia and hypoesthesia

Pediatrics 2010;126:392-403.; Ulesfia® (benzyl alcohol) Lotion, 5% [product information]. Florham Park, NJ: Shionogi Inc.; 2012.

Spinosad (Natroba®)

Mechanism of action – Causes neuronal excitation in louse

– Results in paralysis and death

Efficacy data – Significantly more effective vs. permethrin 1% in

two phase III clinical trials

– Intervention 1038 patients given either spinosad (without comb) or permethrin (with comb)

– Outcomes 84.6% (study 1) and 86.7% (study 2) of spinosad-treated patients found to be lice-free at day 14

Natroba® (spinosad) topical suspension, 0.9% [product information]. Carmel, IN: ParaPRO LLC; 2011.

Product-Specific Information Spinosad

Contraindications

• None

• Not recommended for children younger than 4 years of age

Directions for Use

• Apply product to dry hair and scalp

• Leave on for 10 minutes and rinse with warm water

• No combing required

Need to Reapply?

• May need retreatment in 7 days if live lice seen

Adverse Effects

• Application-site redness

• Redness of eyes

• Application-site irritation

Natroba® (spinosad) topical suspension, 0.9% [product information]. Carmel, IN: ParaPRO LLC; 2011.

Ivermectin (Sklice®)

Mechanism of action – Antiparasitic agent

– Paralytic Binds to glutamate-gated chloride ion channels of nerve and muscle cells. Results in paralysis, rendering lice unable to feed

Also penetrates nits, affecting ability of emerging nymphs to feed, ultimately preventing them from thriving and maturing into adult lice

Efficacy data – In phase III trials, shown to resolve most infestations

with one 10-minute application without combing Two weeks after initial treatment, 71-76% of treated patients were lice-free

Sklice® (ivermectin) Lotion [prescribing information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2012.

Product-Specific Information Ivermectin

Contraindications

• None

• Not indicated for children younger than 6 months of age

Directions for Use

• Apply product to dry hair and scalp


• Rinse hair and scalp with water only

Need to Reapply?

• No reapplication required

Adverse Effects

• Conjunctivitis

• Ocular hyperemia

• Eye irritation

• Dandruff

• Dry skin and burning

Sklice® (ivermectin) Lotion [prescribing information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2012.

Comparison of Pharmacologic

Treatment Options

Active

Ingredients

Brand

Name Dosage Form

Need for

Reapplication?

Prescription

or Over-the-

Counter?

Pediculicidal/Ovicidal

Benzyl

alcohol Ulesfia® Topical lotion 5% Yes in 7 days

Prescription

Only

Pediculicidal against live

lice only Ivermectin Sklice® Topical lotion 0.5% No

Lindane Kwell® Topical shampoo

1% No

Pediculicidal and ovicidal

against live lice and nits Malathion Ovide® Topical lotion 0.5%

Yes in 7 days if live

lice observed

Spinosad Natroba® Topical suspension

0.9%


lice observed

Permethrin Elimite®

Nix®

Topical cream,

lotion, solution 1%


lice observed

Over-the-

Counter

Pediculicidal against live

lice only

Pyrethrin

combined

with piperonyl

butoxide

Licide®

Pronto®

RID®

Shampoo, topical

oil, solution of

pyrethrins 0.33%

and piperonyl

butoxide 4%

Yes in 7 days


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Alternative Medicines

Insufficient data to recommend in lieu of conventional therapies

– None considered curative or FDA-approved

Topical spray – coconut, anise, ylang ylang oils

– 92% effective for treatment of head lice in children

– Comparable to spray containing permethrin, malathion, piperonyl butoxide, and isododecane

– Further data needed

Recommend against agents that may be flammable or toxic

Pediatrics 2010;126:392-403.; Isr Med Assoc J 2002;4:790-3.

What About Young Children?

Pharmacologic products vary based on

age indications

If patient is too young:

– Consider recommending “wet-combing”

– Using occlusive therapy

Petroleum jelly

Cetaphil®

Pediatrics 2010;126:392-403.

The Pharmacist’s Role

Pharmacy counter is primary point of

contact for many patients

– Pharmacists need to be versed in proper

questions before recommending self-care

Older lice-killing products

– Contain neurotoxic pediculicides

Safety risks for children

Resistance a growing problem and concern

Head Lice. Mayo Clinic website. Available from: www.mayoclinic.com/health/headlice/DS00953/DSECTION=treatments-and-

drugs. Accessed April 19, 2013.; Lancet 2003;363:889-891.; J Am Acad Dermatol 2004;50:1-14.; Hosp Pharm 2003;38:241-246.

Pediculicide Resistance

Estimated to occur 1-2 times per week in

58.1% of pharmacists’ practices

May result in:

– More frequent treatment

– Use of higher doses of pesticides

Head Lice. Mayo Clinic website. Available from: www.mayoclinic.com/health/headlice/DS00953/DSECTION=treatments-and-

drugs. Accessed April 19, 2013.; Lancet 2003;363:889-891.; J Am Acad Dermatol 2004;50:1-14.; Hosp Pharm 2003;38:241-246.

Strategies to Minimize

Resistance

Counsel parents and caregivers on proper use of prescription and OTC products

– Particularly with regard to reapplication

– Many patients will fail to reapply in 7 to 10 days after initial treatment

Only recommend treatment for individuals with active infestation

Avoid product overuse

Recommend nonpharmacologic therapies (including combs) to improve efficacy

Pediatrics 2010;126:392-403.; Head Lice. Mayo Clinic website. Available from: www.mayoclinic.com/health/head-

lice/DS00953/DSECTION=treatments-and-drugs. Accessed April 19, 2013.; Lancet 2003;363:889-891.; J Am Acad Dermatol

2004;50:1-14.; Hosp Pharm 2003;38:241-246.

Prevention of Re-Infestation

Check all household members for presence of live head lice – Treat those:

Found to have live lice and nits

Who share bed with infested individual

– Clean all hair care products and implement environmental controls

Managing infestations in schools – Routine screening not recommended

– Notification to parents or caregivers No need for child to be sent home

Pediatrics 2010;126:392-403.


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Dispelling Common Myths About

Head Lice No need for prophylactic treatment – Gold-standard of diagnosis is live louse

– No need to treat members of household without signs of active infestation

“Natural” doesn’t equate with safe or more efficacious product

Educate parents and caregivers to avoid products and home remedies with little data to support safety of efficacy – Gasoline

– Kerosene

– Other dangerous treatments

Pediatrics 2010;126:392-403.

Conclusions

Head lice is extremely common type of parasitic infestation affecting school-aged children

Affected individuals may feel ostracized, humiliated and embarrassed

Pharmacists can provide empathy and encouragement when counseling to help affected individuals overcome these feelings

Thank You!

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