10
F-329 UNNECESSARY MEDICATIONS: REGULATIONS VERSUS GUIDANCE Wes Nunn, PharmD Candidate Wingate University School of Pharmacy; Natasha Michaels, PharmD, BCACP; David Phillips, PharmD, BCPS The State Operations Manual (SOM) serves as a guide to surveyors for keeping a long term care (LTC) facility "up to code." The manual provides regulations and guidance written by the Cen- ter for Medicare and Medicaid Services (CMS). In order to participate in Medicare and Medicaid programs, LTC facilities must abide by the CMS regulations. Surveyors use guidance to enforce these regulations during inspections. This is because the regulations can be broad and non-specific, whereas the guidance goes into much greater detail to assist surveyors in interpreting whether reg- ulations are being properly followed. Items listed in the guidance document do not impose any ad- ditional requirement that is not already listed in the regulation. One way that consultant pharma- cists assist healthcare teams in managing the care of their residents is by recommending gradual dose reductions (GDRs) for psychotropic medications to determine the lowest effective dose as well as to helping lower the national average of patients on antipsychotic medications by 25% by the end of 2015. This helps to avoid unwanted side effects and reduce medication costs. Below is the specific regulation and guidance around F-329 and psychotropic medications. As shown above, the regulations state the necessity of GDRs for antipsychotic drugs in order for facilities to be eligible for licensure and partake in Medicare and Medicaid programs; how- ever, the guidance goes on to suggest GDR measures for sedatives, hypnotics, and psychopharma- cological drugs. Technically a surveyor should not cite F-329 for failure to attempt a GDR on any medication that is not an antipsychotic since the other medications are just listed in the guidance; however, a surveyor could cite F-329 for excessive duration or F-309 as part of the quality of care for the resident. It is important for the healthcare team to thoroughly document patient behaviors, medications histories, diagnoses, and other aspects of the resident's health for surveyor visits but also for the healthcare team to determine if a GDR is clinically appropriate, regardless of medica- tion class. Reference: State Operations Manual, Appendix PP (Rev, 133, 02-06-15) PILL-ANTHROPY POST SUMMER 2015 F-Tag Regulation Guidance F-329 - Unneces- sary Medi- cations Antipsychotic drugs: Based on a comprehensive assess- ment of a resident, the facility must ensure that residents who use antipsychotic drugs receive GDRs and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs. Antipsychotic drugs: "Within the first year in which a resident is admitted on an antipsychotic medication or after the facility has initiated an antipsychotic medication, the facility must attempt a GDR in two separate quarters (with at least one month between the attempts). After the first year, a GDR must be attempted annu- ally." Sedatives/Hypnotics: "For as long as a resident remains on a seda- tive/hypnotic that is used routinely and beyond the manufacturer’s recommendations for duration of use, the facility should attempt to taper the medication quarterly unless clinically contraindicated." Psychopharmacological drugs: "During the first year in which a resident is admitted on a psychopharmacological medication (other than an antipsychotic or a sedative/hypnotic), or after the facility has initiated such medication, the facility should attempt to taper the medication during at least two separate quarters. After the first year, a tapering should be attempted annually."

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Page 1: SUMMER 2015 F-329 UNNECESSARY EDICATIONS EGULATIONS … · SUMMER 2015 F-Tag Regulation Guidance F-329 - Unneces-sary Medi-cations Antipsychotic drugs: Based on a comprehensive assess-ment

F-329 UNNECESSARY MEDICATIONS: REGULATIONS VERSUS GUIDANCE

Wes Nunn, PharmD Candidate Wingate University School of Pharmacy; Natasha Michaels, PharmD, BCACP; David Phillips, PharmD, BCPS

The State Operations Manual (SOM) serves as a guide to surveyors for keeping a long term care (LTC) facility "up to code." The manual provides regulations and guidance written by the Cen-ter for Medicare and Medicaid Services (CMS). In order to participate in Medicare and Medicaid programs, LTC facilities must abide by the CMS regulations. Surveyors use guidance to enforce these regulations during inspections. This is because the regulations can be broad and non-specific, whereas the guidance goes into much greater detail to assist surveyors in interpreting whether reg-ulations are being properly followed. Items listed in the guidance document do not impose any ad-ditional requirement that is not already listed in the regulation. One way that consultant pharma-cists assist healthcare teams in managing the care of their residents is by recommending gradual dose reductions (GDRs) for psychotropic medications to determine the lowest effective dose as well as to helping lower the national average of patients on antipsychotic medications by 25% by the end of 2015. This helps to avoid unwanted side effects and reduce medication costs. Below is the specific regulation and guidance around F-329 and psychotropic medications.

As shown above, the regulations state the necessity of GDRs for antipsychotic drugs in order for facilities to be eligible for licensure and partake in Medicare and Medicaid programs; how-ever, the guidance goes on to suggest GDR measures for sedatives, hypnotics, and psychopharma-cological drugs. Technically a surveyor should not cite F-329 for failure to attempt a GDR on any medication that is not an antipsychotic since the other medications are just listed in the guidance; however, a surveyor could cite F-329 for excessive duration or F-309 as part of the quality of care for the resident. It is important for the healthcare team to thoroughly document patient behaviors, medications histories, diagnoses, and other aspects of the resident's health for surveyor visits but also for the healthcare team to determine if a GDR is clinically appropriate, regardless of medica-tion class. Reference: State Operations Manual, Appendix PP (Rev, 133, 02-06-15)

PILL-ANTHROPY POST S U M M E R 2 0 1 5

F-Tag Regulation Guidance

F-329 - Unneces-sary Medi-cations

Antipsychotic drugs: Based on a comprehensive assess-ment of a resident, the facility must ensure that residents who use antipsychotic drugs receive GDRs and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.

Antipsychotic drugs: "Within the first year in which a resident is admitted on an antipsychotic medication or after the facility has initiated an antipsychotic medication, the facility must attempt a GDR in two separate quarters (with at least one month between the attempts). After the first year, a GDR must be attempted annu-ally."

Sedatives/Hypnotics: "For as long as a resident remains on a seda-

tive/hypnotic that is used routinely and beyond the manufacturer’s recommendations for duration of use, the facility should attempt to taper the medication quarterly unless clinically contraindicated."

Psychopharmacological drugs: "During the first year in which a

resident is admitted on a psychopharmacological medication (other than an antipsychotic or a sedative/hypnotic), or after the facility has initiated such medication, the facility should attempt to taper the medication during at least two separate quarters. After the first year, a tapering should be attempted annually."

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P A G E 2

ACETAMINOPHEN DOSING AND LIVER DAMAGE Ariana DeBussey, PharmD Candidate; David Phillips, PharmD, BCPS; Andrea Leone, PharmD

In January 2011, the FDA issued a safety alert asking manufacturers to limit the amount of acetaminophen in prescription combination drug products to no more than 325 mg per tablet or capsule by January 2014. This recommendation, which is now fully implemented, was requested by the FDA to protect consumers from the risk of severe liver damage that can occur from taking too much acetaminophen. In response to these changes, the maker of Tylenol®, McNeil, announced new instructions to lower the maximum daily dose from 4000 mg to 3000 mg in July 2011, which has been incorporated into the product labeling.

Acetaminophen overdose can result in liver failure, transplant, or death. The risk is in-creased when acetaminophen use exceeds 4000 mg in 24 hours and in certain patient populations. According to the 2013 Annual Report of the American Association of Poison Control Centers’ National Poison Data System, acetaminophen combination products and acetaminophen alone accounted for 298 fatalities reported in the National Poison Data System in 2013. Many healthcare professionals are now recommending a 3000 mg total daily dose of acetaminophen to decrease the risk for acci-dental overdose and liver injury; however, it is still safe to use up to 4000 mg in most patients when appropriately managed. Lower dose limits are preferred with the concurrent use of isoniazid, consumption of three or more alcoholic beverages daily, and in patients with a history of malnour-ishment or stage IV chronic kidney disease. The use of acetaminophen should be avoided in patients with a history of alcoholism or hepatic cirrhosis. It is important for prescribers and pharmacists to instruct patients and caregivers on how appropriately administer acetaminophen either through direct patient counseling or by adding dose limits to prescriptions (i.e. do not exceed 3000 mg/day). Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Norco, Vicodin), oxycodone with acetaminophen (Percocet), tramadol with aceta-minophen (Ultracet), and codeine with acetaminophen (Tylenol with Codeine, Capital/Codeine). Be aware that abbreviations such as APAP, AC, Acetaminophen, Acetaminoph, Acetaminop, Aceta-min, or Acetam may be written on the label in place of the word acetaminophen. Acetaminophen is also found in many over-the-counter (OTC) pain and fever medications, cough and cold products. References:

1. U.S. Food and Drug Administration. Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing. www.fda.gov. January 14, 2014. Accessed June 16, 2015.

2. U.S. Food and Drug Administration. Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communica-tion. www.fda.gov. January 13, 2011. Accessed June 16, 2015.

3. UpToDate. Acetaminophen (paracetamol): Drug information. www.uptodate.com. Accessed June 17, 2015. 4. Tylenol Dosing. www.tylenol.com. Accessed June 17, 2015. 5. Drugwatch. FDA Sets Acetaminophen Dose Limit, Warns of Liver Damage. www.drugwatch.com. January 28, 2014. Accessed June 15,

2015. 6. Mowry JB, Spyker DA, Cantilena LR, et al. 2013 Annual Report of the American Association of Poison Control Centers’ National Poison

Data System (NPDS): 31st Annual Report. Clinical Toxicology 2014;52:1032-1283.

P I L L - A N T H R O P Y P O S T

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P A G E 3 S U M M E R 2 0 1 5

PHARMACY  FACTS! MEDICATION  RETURNS  AND  CREDITS A. Returned medications must be documented on and accompanied by the Blue Ridge Pharmacy

“Drugs Returned to Pharmacy or Released to the Patient” form. Narcotics must be docu-mented on a separate form.

B. Please hold meds for residents who are discharged to the hospital for 30 days, if your facility policy permits. Many third party payers will only pay for meds one time in a month. Other-wise, medications should be returned promptly after discontinuation.

C. Medications returned to the pharmacy will be processed for eligible credit.

D. Medications and accompanying paperwork are to be placed in totes for return to pharmacy.

E. Medication that is returned, but deemed non-creditable will be destroyed per pharmacy policy.

***Medications that may be returned, but are not eligible for credit include, but are not limited to the following:

Flu season is right around the corner!

Call today to reserve a supply of vaccines

for your facility!

(828) 298-7600

Ask for Kelly Bradish

Not Eligible for Credit Controlled substances Medications in altered condition (i.e. partial creams, half tablets, compounds) Topicals, otics, ophthalmics, & inhalants Refrigerated or freezer items Bulk and multi-dose items Medications submitted for reimbursement to a third party payer Syringes or other supplies

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P A G E 4 S U M M E R 2 0 1 5

WHAT’S NEW WITH INHALATION DEVICES? Wes Nunn, PharmD Candidate Wingate University School of Pharmacy;

Natasha Michaels, PharmD, BCACP

Inhaler devices are used to deliver a variety of inhaled medications, which include short acting beta agonists (SABA), long acting beta agonists (LABA), short acting anticholinergics (SAAC), long acting anticholin-ergics (LAAC), and inhaled corticosteroids (ICS) for asthma and COPD treatment. The three types of deliv-ery devices are metered dose inhalers (MDI), dry powder inhalers (DPI), and soft mist inhalers (SMI). MDI’s require good hand strength/dexterity for actuation, hand-breath coordination, and fine motor control. While DPI’s technique requires exhalation before inhalation and a good deep and rapid inhalation to receive the medication. Along with the ability to hold their breath after inhalation and not blocking the mouthpiece, which can be difficult for cognitively impaired patients. 1 SMI’s provide a more concentrated aerosol cloud that is re-leased slower allowing patients with hand-breath coordination issues to get an effective dose of the medica-tion. Patients who are cognitively impaired, frail, or have mobility/strength issues frequently have trouble using these inhalers, which can result in decreased drug delivery and potentially reduced efficacy.1

Newer inhalation devices (Table 1) have been developed to reduce the chances of delivery error, in-cluding Ellipta DPI and Respimat SMI, which have less complex steps allowing for easier use by patients. The Pressair inhaler has the advantage of having a color coded strip that tells the patient when the dose is ready to administer. The ProAir® RespiClick is a DPI and does not require proper hand-breath technique compared to the Proair HFA inhaler, allowing for easier administration during an exacerbation. The Neohaler device requires a capsule to be inserted into the device similar to the Handihaler device, which ensures a dose of medication is not accidentally wasted. Most of the new devices allow for once daily administration, which can help with adherence compared to other products on the market. Below is a comparison of some of the new-er devices and the medications they deliver.

Table 1 Active Ingredient Class Indication Dose Role in Treatment

Ellipta Incruse® umeclidinium 62.5mcg/inh LAAC COPD 1 inhalation daily Maintenance Anoro® umeclidinium 62.5mcg and

vlianterol 25mcg/inh LAAC/LABA COPD 1 inhalation daily Maintenance

Breo® fluticasone 100mcg and vilanterol 25mcg/inh

ICS/LABA Asthma/COPD 1 inhalation daily Maintenance

Arnuity® fluticasone 100mcg or 200mcg/inh

ICS Asthma 100-200mcg daily Maintenance

Respimat Combivent® ipratropium 20mcg and

albuterol 100mcg/inh SABA/SAAC COPD 1 inhalation 4

times daily (max of 6 inh/24 hours)

Step up therapy after failure of SA-BA or SAAC

Spiriva® tiotropium 2.5mcg/inh LAAC COPD 2 inhalations daily Maintenance Striverdi® olodaterol 2.5mcg/inh LABA COPD 2 inhalations daily Maintenance

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P A G E 5

P I L L - A N T H R O P Y P O S T

References 1. Dolovich, M et al. Device selection and outcomes of aerosol therapy: evidence-based guidelines. American College of Chest Physicians. January 2005, Vol 127, No. 1. Available online at: ttp://journal.publications.chestnet.org/article.aspx?articleid=1083082#t1

Table 1 cont.

RespiClick

ProAir® albuterol 108 mcg/inh SABA Asthma/COPD 2 inhalations eve-ry 4-6 hours PRN

Rescue inhaler

Pressair Tudorza® aclidinium 400mcg/inh LAAC COPD 1 inhalation daily Maintenance Neohaler Arcapta® indacaterol 75mcg/cap LABA COPD inhale contents of

1 capsule daily Maintenance

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P A G E 6

Cardiovascular disease (CVD) is the leading cause of death in the U.S. and most developed countries.1 Aspirin produces statistically significant and clinically important reductions in the risk of my-ocardial infarction (MI), stroke, and vascular death among patients who have survived a CVD event. However, current literature, including treatment guidelines, differs in recommendations regarding the use of aspirin for primary prevention. In May 2014, the FDA released a statement to consumers concluding that current evidence does not support the use of aspirin as a preventative medication in patients with no history of heart dis-ease or stroke (primary prevention). They stated that the use of aspirin in these patients places them at risk for serious bleeding events.2 In November 2014, a study published in the Journal of the American Medical Association found that once daily, low-dose aspirin did not significantly reduce the risk of the composite outcome of cardiovascular death, nonfatal stroke, and nonfatal myocardial infarction among Japanese patients 60 years or older with atherosclerotic risk factors.3 Although these results can not be generalized to Americans, it will be interesting to see the results of several trials currently underway (ARRIVE, ASCEND, ASPREE and ACCEPT-D), which are assessing primary prevention in predominantly Western populations. Currently available literature published by other organizations in the U.S. such as the American Heart Association (AHA) and the U.S. Preventative Services Task Force (USPSTF) recom-mend aspirin for primary prevention only in patients at sufficient risk for CVD (i.e. 10-year CV risk > 10%). The USPSTF also states that there is insufficient evidence to assess the use of aspirin in patients >80 years of age.4 In a recently published article from the American College of Cardiology more than 1 in 10 patients in a national registry were receiving inappropriate aspirin therapy for primary prevention.5

In secondary prevention, the evidence has more stroke and CVD death end points and shows conclusive benefits on MI, stroke, and CVD death. When aspirin is used for secondary prevention, the benefit of therapy almost always exceeds the risk of major bleeding.1 Although data better supports the use of aspirin in this population, the optimal dose is often debated. The most widely tested regimen in the secondary prevention trials was aspirin at a dose of 75 to 325 mg/day. Studies have found daily dos-es of 50 to 160 mg of aspirin to be effective for primary and secondary prevention of cardiovascular events. This included the prevention of stroke and stent restenosis. It is also important to note that studies have shown that gastrointestinal side effects and major bleeding are directly related to aspirin dose.6 Higher doses can double the risk of GI bleed.7 Based on this information, it is recommended to use the lowest dose of aspirin that has been found to be effective for secondary prevention.

So, when is aspirin too much of a good thing? In the end, it depends on the patient, weighing the risks vs. the benefits of daily aspirin therapy, and selecting the appropriate dose of aspirin when it is indicated. Anyone who is considering aspirin therapy for any condition or disease state should talk to a health care professional first to get an informed opinion. References:

1. Benefits and risks of aspirin in secondary and primary prevention of cardiovascular disease. Up to date. Accessed April 2015. 2. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm390539.htm 3. Ikeda Y, Shimada K, Teramoto T, et al. Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Japanese Patients 60 Years

or Older With Atherosclerotic Risk Factors: A Randomized Clinical Trial. JAMA 2014;312:2510-2520. 4. US Preventive Services Task Force. Aspirin for the Prevention of Cardiovascular Disease: Preventive Medication. USPSTF website http://

www.uspreventiveservicestaskforce.org/. Accessed April 2015. 5. Hira R, Kennedy K, Nambi V, et al. Frequency and practice-level variation in inappropriate aspirin use for the primary prevention of cardi-

ovascular disease: insights from the National Cardiovascular Disease Registry's Practice Innovation and Clinical Excellence registry. J Am Coll Cardiol 2015; 65: 111–121.

6. Eikelboom JW, Hirsh J, Spencer FA, et al. Antiplatelet drugs: antithrombotic therapy and prevention of thrombosis, 9th ed: American Col-lege of Chest Physicians evidence-based clinical practice guidelines. Chest 2012;141(Suppl 2):e89S-119S.

7. Serebruany VL, Steinhubl SR, Berger PB, et al. Analysis of risk of bleeding complications after different doses of aspirin in 192,036 patients enrolled in 31 randomized controlled trials. Am J Cardiol 2005;95:1218-22.

ASPIRIN: TOO MUCH OF A GOOD THING? Sarah Creasman, PharmD Candidate; David Phillips, PharmD, BCPS

P I L L - A N T H R O P Y P O S T

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P A G E 7 S U M M E R 2 0 1 5

Brian  Holt Driver,  2009

THANK YOU FOR YOUR DEDICATED SERVICE! HONORING BLUE RIDGE PHARMACY EMPLOYEES WITH 5 OR MORE YEARS OF SERVICE

Not  pictured:   Tom  Whitaker,  Driver,  2005 Jerry  Boone,  Driver,  2007

Kelly  Bradish Billing  Supvr,  2007

Courtney    Mabe Pharmacist,  2010

Wes  McCall Dir.  Of  Pharmacy  Services,  2007

Ben  Wax Dir.  Of  Marketing,  2009

Beth  Redden Access  Care  

Coordinator,  2009

Susan  Breedlove Medical  Records,  2005  

Jenny  Robinson Order  Entry,  2007

Marissa  Ledbetter Order  Entry  Supvr,  2008

Mark  Carlson Office  Manager,  2007

Laura  Louis Access  Technician,  2010

Johnny  Dalton Technician,  2006

Page 8: SUMMER 2015 F-329 UNNECESSARY EDICATIONS EGULATIONS … · SUMMER 2015 F-Tag Regulation Guidance F-329 - Unneces-sary Medi-cations Antipsychotic drugs: Based on a comprehensive assess-ment

Address: 1070 Tunnel Road | Asheville, NC 28805

175 Towerview Court | Cary, NC 27513

Phone: 828-298-7600 (Asheville)

919-377-0189 (Cary)

Fax: 828-298-0155 Hours: 9am- 6pm Mon-Fri, 9am-1pm Saturday, Closed Sunday Online: www.blueridgerx.com

Address: 948 Tunnel Road | Asheville, NC 28805

Phone: 828-298-3636

Fax: 828-298-8190 Hours: 9am- 6pm Mon-Fri, 9am-1pm Saturday, Closed Sunday Online: www.blueridgerx.com

LIKE US ON

Address: 948 Tunnel Road | Asheville, NC 28805

Phone: 828-348-3000

Fax: 828-298-8190 Hours: 9am- 6pm Mon-Fri, 9am-1pm Saturday, Closed Sunday Online: www.blueridgerx.com

Contact Us!

FOLLOW US ON

Page 9: SUMMER 2015 F-329 UNNECESSARY EDICATIONS EGULATIONS … · SUMMER 2015 F-Tag Regulation Guidance F-329 - Unneces-sary Medi-cations Antipsychotic drugs: Based on a comprehensive assess-ment

First Line Treatment: - Cool compress: to cool the skin and relieve pain - Oatmeal baths (Aveeno), calamine lotion, aloe vera: to

soothe the skin and help with pain and irritation - Tylenol (acetaminophen) or Advil (ibuprofen): to help

with pain and/or inflammation o Ask your Blue Ridge pharmacist which

medication would be best for you!

If you have a severe sunburn (blisters over a large area or severe pain), contact your doctor as it may require more intensive treatment For Next Time…

- Seek shade or reduce exposure to the skin during the hours of 10am-4pm when the sun is most intense

- Wear protective clothing and don’t forget a hat and sunglasses!

- Apply a golfball size amount (1-2 ounces) of broad spectrum SPF 30+ sunscreen every 1-2 hours while out in the sun

----- Have any questions? Ask your Blue Ridge Pharmacist! -----

Protect Your Skin

This Summer!

Sunburns

Page 10: SUMMER 2015 F-329 UNNECESSARY EDICATIONS EGULATIONS … · SUMMER 2015 F-Tag Regulation Guidance F-329 - Unneces-sary Medi-cations Antipsychotic drugs: Based on a comprehensive assess-ment

Lorem Ipsum Dolor [Issue] :: [Date]

2

Insect Bites and Poison

Ivy

Poison Ivy First Line Treatment:

- Oatmeal baths (Aveeno), calamine lotion: to soothe the skin and help with itching and irritation - Topical astringents (Burow’s solution, aluminum acetate): to help dry weeping lesions - Oral antihistamines like Benadryl (diphenhydramine): to help with itching - Hydrocortisone 1%: to help relieve itching and discomfort - Tylenol (acetaminophen) or Advil (ibuprofen): to help with pain and/or inflammation

o Ask your Blue Ridge pharmacist which medication would be best for you!

Avoid scratching as it may cause the skin to break and allow an infection to occur

Poison ivy rashes will usually clear up without treatment in 1-3 weeks

If the rash is severe or is covering a large or sensitive area, contact your doctor For Next Time…

- Wear protective clothing including gloves when working out in the yard - If you come in contact with poison ivy, gently wash the area with mild soap and water

o You can also use products like Zanfel or Ivy Block that may bind with the poison ivy oils to help remove them

Insect Bites First Line Treatment:

- Cool compress: to reduce swelling - Oral antihistamines like Benadryl (diphenhydramine): to help with itching - Oatmeal baths (Aveeno), calamine lotion: to soothe the skin and help with itching and irritation - Hydrocortisone 1%: to help relieve itching and discomfort

Avoid scratching as it may cause the skin to break and allow an infection to occur For Next Time…

- Avoid dusk and standing water where mosquitos and other insects are commonly found - Wear protective clothing like long-sleeved pants and shirt when needed - Use an insect repellant with DEET when going into the woods

----- Have any questions? Ask your Blue Ridge pharmacist! -----