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Discuss the incidence and pathophysiology of venous disorders Identify patients at risk for the development of venous disorders Describe the effects and medical efficacy of medical compression stockings for venous disorders Evaluate the alternative revenue that graduated compression garments can generate Assess the role of the pharmacist in maximizing patient compliance and slowing disease progression Identify strategies to increase routine use of graduated compression garments for venous disease
What percentage of Americans areaffected by venous disease?A.20%B.30%C.40%D.50%E.60%
60% of American suffer from venous disease and its sequelae More than 80 million Americans suffer from vein problems, most common are › Varicose veins › Spider veins Incidence increases with age and is more common in women More people lose work time from venous disease than from arterial diseaseNational Heart Lung and Blood Institute (NHLBI). Available at: http://www.nhlbi.nih.gov/ Accessed 01/27/11.American College of Phlebology (ACP). Available at: http://www.phlebology.org/patientinfo/index.html Accessed01/27/11.Vascular Disease Foundation Newsletter. Spring 2005; Volume 5, N2
Family history Females › Pregnancy › Medications Travel (periods ≥8 hours) DVT Lifestyle Injury to vein walls and › Sedentary venous valves › Obese (women) Immobilization post- › Smoking (men) surgery › Prolonged standing or sitting occupation Increasing age (changes elasticity of veins) Bergan JJ. The Vein Book. 2007; p. 42 Geerts WH, et al. CHEST. 2008; 133: 381S-453S.
Prospective case-control study of 134 families (402 total subjects) › 67 controls and their parents › 67 patients and their parents Varicose veins in legs 30-40 years old No history of DVT Risk for development of varicose veins in › Both parents affected: 90% males and females › One parent affected: males 25%, females 62% › Neither parent affected: 20% males and females
Study DataMark PE, et al. Approx. 1.1-1.5 per 100,000 US and EU deliveries result in death from pulmonary embolismsThaler E, et al. 33% of primaparas and approx. 50% of multiparas have evidence of varicose veins after pregnancy Emergent varicose veins occur in approximately 25% if pregnanciesRodger M. Pregnant women have a 7- to 10-fold increased risk of VTE compared to nonpregnant women VTE kills 1 in every 20,000 pregnant women annually VTE occurs in up to 12 per 10,000 women from conception to delivery and up to 7 per 10,000 women after deliveryDresang LT, et al VTE is the leading cause of maternal death in the US 78-90% of DVTs during pregnancy occur in left legMarik PE, et al. NEJM. 2008; 359(19):2025-2033Thaler E, et al. Swiss Med Wkly. 2001; 351:659-662Rodger M. Hematology. 2010: 173-180Dresang M. Hematology. 2010: 173-180
30% first time pregnancy; 55% two or more result in varicose veins › Increased blood volume (40-50%) › Hormonal changes › Pressure of the fetal head Compression Stockings are beneficial during pregnancy and post partum periodSwiss Medical Weekly 2001; 659-662Physiology 1998; Issue 9: 1-3Br J. Obstec Gynecol. 1999; Jun; 106: 106(6): 563-9
Deep Vein System › High Pressure System › Handles up to 90% of venous blood volume › Include: Anterior and posterior tibial veins, peroneal veins, popliteal vein, superficial femoral vein, common femoral vein Superficial Vein System › Low Pressure System › Handles remaining 10% of venous blood volume › Include: Greater and lesser saphenous vein Perforating/Communicator Veins › Communicator veins connect “like” veins › Perforating veins connect deep to/from superficial veins
Think of a Roadmap! Deep Superficial Perforating/ Communicator
Primary function of venous system is blood return to the heart Three mechanisms to achieve venous blood return to heart Multiple muscle pumps Competent valves A pressure gradientLohr, J, et al. Curriculum Recommendations from American Venous Forum. 2006. Available at:http://veinforum.org/index.php?page=venous-curriculum Accessed 1/27/11
Which muscle pump(s) is/arereferred to as the“peripheral heart” and is primarilyresponsible for venous return?A.Foot/ankle pumpB.Arterial pressureC.Calf pumpD.A and C onlyE.All of the above
The major peripheral pump consists of calf muscle Calf Muscle Contraction (Systole) Increase in venous blood pressure forces valves open Blood shunts towards heart to empty veins Calf Muscle Relaxation (Diastole) Decrease in venous blood pressure allows valves to close Prevents blood reflux
Dynamic Pressure › Energy imparted by pumping action of the heart Hydrostatic Pressure › Pressure generated by the effects of gravity on the lower extremity › Venous blood is pumped out of the dependent limb against the force of gravity › Pressure determined by the distance (height) to the right atriumLohr, J, et al. Curriculum Recommendations from American Venous Forum. 2006. Available at:http://veinforum.org/index.php?page=venous-curriculum Accessed 1/27/11
Pressure at the Ankle in Pressure at the Ankle inDefective Venous System Normal Venous SystemLying Down 10 mmHgStanding ≥100 mmHg 90 mmHg PressureWalking ≤70 mmHg 25-35 mmHg Difference 30-40mmHg 40-50mmHg The effect of the calf, ankle and foot pumps takes place after only 7 steps!
Disturbances within the veins which alter venous blood return to the heart Due to local pathological changes: Venous thrombosis Valvular function Changes in venous wall Endothelial damageEklof B, et al. Controversies in the Management of Venous Disorders. London: Butterworths, 1989.
DVT affects approx. 2 million Americans annually Pulmonary embolisms kill up to 300,000 Americans annually The Awareness… 74% of adults have little or no awareness of DVT 57% are unable to name any common risk factors or pre-existing conditions that could lead to the development of DVT 95% report that their physician had never discussed this medical condition with them September 15, 2008 “Call to Action” by acting Surgeon General – Steven Galson, Virchow’s Triad MD, MPHAPHA Deep-Vein Thrombosis Omnibus Survey. Conducted by Wirthlin Worldwide 2002.The Coalition to Prevent Deep-vein Thrombosis Web site. 2010. http://www.preventdvt.org/about/what-is-dvt.aspx. Accessed: 10/27/2010.
Arch Intern Med. 2007; 167(14): 1471-1475 Observational study of 7222 subjects residing in Worchester, MA to evaluate VTE diagnosis (determined from ICD-9 codes) post- hospitalization from 1999, 2000, and 2003 1897 subjects experienced DVT (n=1348), PE (n=285), or both (n=264) within the 3-year period. Of the 1897 validated VTE cases, 73.7% (n=1399) presented in the outpatient setting with signs and symptoms or confirmed VTE diagnosis within 1 day of hospital admission.
True or False. Venousinsufficiency is synonymous witharterial insufficiency.A.TrueB.False
Peripheral Arterial Insufficiency (Disease) Peripheral Vein Insufficiency (Disease) Narrowing of the arteries, commonly the Inadequate return of venous blood from pelvis & legs the legs to the heart Clinical Symptoms: cramping, pain, tired Clinical Symptoms: tired/heavy, achy legs or hip muscles cramping in the legs Clinical Indication: pain worsens when Clinical Indication: pain that worsens standing and improves with leg during walking/activity and subsides with elevation and leg activity rest PAD=peripheral arterial disease; PVD=peripheral venous disease
Reduces symptomatic and asymptomatic VTE by 50-65% Oral vitamin K antagonist Coumadin (warfarin) Direct thrombin inhibitor Pradaxa (dabigatran) Anti-factor Xa inhibitor Heparin Lovenox (enoxaparin) Fragmin (dalteparin) Arixtra (fondaparinux) Xarelto (rivaroxaban) Oral investigational drugs* Apixaban*Awaiting market approval.Vascular Disease Foundation Newsletter. Spring 2005; Volume 5, N2
Main Constituen ts: Blueberry Sweet Clover Resveretro l Quericiten Red Wine Pycnogenol ElderberryGrape Seed Extract Butcher’s Broom Horse Chestnut Seed Extract
Sclerotherapy Radiofrequency Ablation (RFA) Endovenous Laser Treatments (EVLT) Phlebectomy Stripping & Ligation Before After In practice, it is recommended that graduated compression therapy be worn pre- and post- vein procedures
Improve blood flow velocity To restore blood flow velocity to normal To reduce or prevent edema Prevent/treat venous diseases 44
Graduated Compression Therapeutic Compression Ranges: 15-20mmHg6 (class I) up 20 - 40% to 50-60mmHg (class IV) Utilized in the community setting, including assisted living facilities, 50 - 80% long-term care facilities, and nursing homes 100% Commonly available as: Socks and stockings Graduated Compression Calf-length, thigh-high, andIndicated for prevention and pantyhose stylesmanagement of venous Cotton and/or nylon fabrics anddisorders in ambulating patients yarnsand wheel-chair bound patientsPicture obtained from http://www.newlook.com.sg/tedantiembolismstockings.asp. Accessed 09/02/10.
Anti-embolism Stockings “TEDS are for BEDS” Therapeutic Compression Ranges: 18-8mmHg, 20- 10mmHg Utilized in the hospital or nursing home setting Anti-embolism Stockings Indicated for prevention of For bed-ridden patients thromboembolisms in recumbent patientsClass A (8-15mmHg) compression reflects the standard in some countries but there is insufficient clinical evidence tosupport it’s use in practice. (European Prestandard, 2001)TEDS=Thromboembolic Deterrent Stockings
“OTC” Medical Therapy (Prescription Recommended) 15-20mmHg 18-25mmHg 20-30mmHg 30-40mmHg 40+mmHg• Tired, achy legs • Lower extremity • Heavy, fatigued, • Moderate • Severe• Occupational or edema in diabetic aching legs varicosities w/ varicosities evening edema patients without • Mild edema in mild-moderate • Severe edema• Leg discomfort from prolonged A simple change varicosities edema ± contraindications and ABI >0.6 lower extremities • Mild of socks!!! pregnancy • CEAP C4, C5, C6 standing/sitting w/ minimal • Post-procedure • Recurrent• Preventing edema of larger veins venous pregnancy • Mild varicosities • CEAP C3, C4, ulceration varicosities & pregnancy C5, C6 • Severe post &swelling edema • Recurrent or traumatic,• Predisposed risk • Post-procedure active venous fracture edema• Reduce travel of small veins ulceration • Severe PTS swelling • DVT prevention • DVT prevention• Prevention of or management or management traveler’s • DVT or PTS thrombosis treatmentThere is insufficient clinical evidence to support the clinical efficacy of compression pressures <15mmHg tosupport ambulatory patients. (European Prestandard, 2001)
“OTC” Medical Therapy (Prescription Recommended) 15-20mmHg 18-25mmHg 20-30mmHg 30-40mmHg 40+mmHg• Tired, achy legs • Lower extremity • Heavy, fatigued, • Moderate • Severe• Occupational or edema in diabetic aching legs varicosities w/ varicosities evening edema patients without • Mild edema in mild-moderate • Severe edema• Leg discomfort simple change of socks!!! A contraindications lower extremities edema ± • CEAP C4, C5, from prolonged and ABI >0.6 • Mild varicosities pregnancy C6 standing/sitting w/ minimal • Post-procedure • Recurrent• Preventing edema of larger veins venous pregnancy • Mild varicosities • CEAP C3, C4, ulceration varicosities & pregnancy C5, C6 • Severe post &swelling edema • Recurrent or traumatic,• Predisposed risk • Post-procedure active venous fracture edema• Reduce travel of small veins ulceration • Severe PTS swelling • DVT prevention • DVT prevention• Prevention of or management or management traveler’s • DVT or PTS thrombosis treatment
Signs of infection Extensive venous ulceration Skin sensitivities or allergies Neuropathy History of diabetes Confinement to bed or non-ambulatory use unless otherwise prescribed by the physician Progressive arterial insufficiency Uncontrolled congestive heart failure Acute dermatitis, weeping dermatosis, cutaneous sepsis
True or False. Diabetic patientsshould not wear graduatedcompression socks.A.TrueB.False
Lower extremity edema is a common clinical finding in diabetic patients Lack of reliable measures to objectively quantify edema makes it difficult to assess it’s prevalence in diabetic patients Edema in diabetics is difficult to isolate and may have multiple etiologiesBrodovicz KG, et al. Clin Med Res. 2009;7(1-2):21-31.Fries R. MMW Fortschr Med. 2004;146(16):39-41.Powell AA, et al. Am Fam Physician. 1997;55(5):1721-6.
What features should a diabeticcompression sock include?A.At least 18-25mmHgB.Is graduated in pressureabove the calfC.Flat-toe seamD.Cushioned soleE.Only C and EF.All of the above
4-week pilot study N=18 Diabetes Lower extremity edema of the leg, foot, and ankle Ankle-brachial index (ABI) >0.6 Assess whether diabetic compression socks* can reduce LE edema in diabetic patients without compromising vascularity Fitted for 4-7 pair of diabetic compression socks which were white, padded foot, and flat toe seamLE=lower extremityDiabetic compression socks provided 18-25mmHg
Mean Foot Circumference 27.98 27.42 27.58 27.41 27.60
Mean Ankle Circumference 25.28 24.42 24.32 24.36 24.14Statistically significant
Mean Calf Circumference 41.59 40.32 41.12 41.10 41.08Statistically significant
Safety and Efficacy of Mild Compression (18-25mmHg) Therapy in Patients with Diabetes and Lower Extremity EdemaWu SC, Crews RT, Najafi B, et al. J Diabetes Sci Technol 2012 Vol 6 Issue 3 ABI 1.26 1.18 1.16 1.10 1.05
Mild graduated compression socks decreasedswelling in diabetic patients with LE edemawithout compromising vascularity
Promotes circulation Fiber blend of cotton, acrylic, nylon, and elastic Regular 100% wool or cotton socks are too tight on the foot, reduce circulation, and are not cool and do not keep the foot dry Cushioned Regular socks do not provide comfort and protection Flat seams Coarse seams on regular socks rub the foot and . cause blisters and calluses to emergeFeldman CB, et al. Diabetes Spectrum.14(2), 59-613Herring KM, et al. J Amer Pod Med Assn. 80, 63-70.
Pre-diabetic Newly diagnosed Edema Gestational diabetes No neuropathy ABI >0.6 without claudicationDiabetic patients a more likely toexercise when their legs feel good!
Key Benefits:• Designed for oversized legs•Made with Nano Bamboo Charcoal Fiber which is anatural deodorizer that absorbs odor causing agents andreduces microbial growth• Helps regulate skin temperature•Releases Infrared Rays that may promote bloodcirculation.• Padded heel and forefoot for extra comfort.• Ventilated airflow mesh on top of forefoot and instep.Compression Level: 10-15mmHg up to 20-30mmHgStyle(s): Ankle, Crew, Merry Jane, Over the CalfColor(s): Black, Navy, Sand, White (Not all styles in allcolors) Sizing based on shoe size, availability varies byproductPrice: $9.95-$12.95
Key Benefits:•Clinically proven to reduce swelling and improvecirculation•American Podiatric Medical Association (APMA)Seal of Approval•Non-binding calf band•Flat toe seam•Extra padding on foot•DriRelease fiber blend for moisture wicking, odorcontrol, and softness•Latex free•True graduated compressionCompression Level: 18-25mmHgStyle(s): Over the CalfColor(s): WhiteSizing ankle & calf measurementsPrice: $30-40
SilverSoleKey Benefits:• Unisex. Sized by shoe size.• Silver knitted for antimicrobial benefits• Pillowed sole adds cushion to reduce blisteringand callous buildup• Mid-foot compression to prevent sockbunchingCompression Level: 12-16mmHgSize(s): S, M, L, XLStyle(s): Anklet, Low Cut, Crew Length, Knee-HighColor(s): Black, White, PinkPrice: $16-$17
Key Benefits:•Non-irritating, smooth toe seam•Extra padding in the foot, heel and toe•Moisture-wicking acrylic multi-fiber yarns•Antibacterial, antifungal finishCompression Level: 8-15mmHgStyle(s): Knee Length, Crew Length, Mini-Crew LengthColor(s): White, Black, Navy, Brown/ Mini-Crew white onlyPrice: $9-$12.99 or 3/$34.50
“Your labs show you have diabetes. I know your legs hurt but you need to exercise to improve your circulation, and start these medications!”
Average Prescription Margins in 2009for an Independent Pharmacy were 6-12% (margins vary based upon brand vs. generic medication and cash vs. insurance reimbursement) How is the average independent pharmacy combating tight margins when 93% of their revenue is from Prescription Drugs? In addition to offering retail items on the front-end… SOME dramatically increase # of prescriptions filled/day! MINIMAL PROFIT INCREASE…PHARMACY CLOSES OTHERS find a Niche Service with wide margins! HUGE PROFIT INCREASE…PHARMACY SURVIVALGude S. Drug Topics. 2007 Oct 22. 70
School Supplies Pens Pencils Paper Book Bags Toys Greeting Cards Magazines Candy Hairbows Household Items Paper Towels Toilet Tissue Laundry Detergent All Purpose Cleaner Trash Bags 71
How Many Pregnant Women Per Month? 10 120 Per Year 6 # pairs per year 720 pairs per year purchased $30 Retail Per Pair $21,600 in Sales (Avg) $10,800 in GP $$$ Margin 50%
How many pregnant patients enter your pharmacy monthly? 20 If, half purchased two pair every six months 480 pairs sold per year 50% margin $7,200 in GROSS PROFIT $14,400 in SALES
How many pregnant patients enter your pharmacy monthly? 40 If, half purchased two pair every six months 960 pairs sold per year 50% margin $19,200 in GROSS PROFIT $38,400 in SALES
What type of products and serviceswould you want from a graduatedcompression manufacturer?A.Business supportB.Quality productC.AffordabilityD.Precise sizing to fit patientsE.All of the above
Business partnership with company and sales representative Doctor detailing Marketing support and literature Health and wellness fairs Education and training Clinically studied products, medically efficacious Product quality Safe and properly fit garments
Parent company to many subsidiaries supplying durable medical equipment items Manufacturer of orthopedic soft goods & bracing products including: casting, bracing, wound care, and Premium Line compression stockings Premium Line Economy Line Economy Line
Manufacture products ranging from medical hosiery to bandages. #1 physician recommended brand in the United States Specialize in custom made garments
World’s largest, physician founded, Ready to Wear graduated compression stocking company Global leader & “Compression Specialists” Precise fit sizing system (PFS2) accommodates patients with an average or full sized calf with a short or long leg
All medical hosiery is Covered Spandex/Lycra manufacturered with double- covered yarns NOT bare spandex 2nd covering Only company with an in- (S-twist) house pharmacist to manage the Pharmacy Relations 1st covering (Z-twist) Department to address pharmacy business support needs.
A subsidiary of 3M Widely recognized manufacturer of economical braces, supports, and compression stockings Available in most national & regional chain/franchise locations
How can pharmacists help theirpatients to prevent and/or managechronic venous disease?A.Offer clinically-basedrecommendations to patientsregarding graduated compressiontherapyB.Measure patients and fit them into agraduated compression garment thatprecisely fitsC.Monitor patients compliance andcomfortability in wearing graduatedcompression therapyD.All of the above
Webb JA. Drug Topics. June 2010; Vol 154(6): 25-28
Ask your patients about their medical history Ask your patients about their compression history Recommend compression therapy to your patients Counsel patients and physicians about the medical benefits of compression therapy Educate your patient Discuss and emphasize the need for compliance
126.96.36.199: Recommend that mechanical methods of thromboprophylaxis be used primarily in patients at high risk for bleeding, or possibly as an adjunct to anticoagulant-based thromboprophylaxis 2.1.4: For general surgery patients with multiple risk factors for VTE, a pharmacological method should be combined with a mechanical method 2.1.5: For general surgery patients with a high risk of bleeding, we recommend the optimal use of mechanical thromboprophylaxis with properly fitted GCS or IPC. When the high bleeding risk decreases, we recommend that pharmacologic thromboprophylaxis be substituted for or added to the mechanical thromboprophylaxis.Geerts WH CHEST 2008;133: 381S-453SKearon C, et al. CHEST 2008; 133;454S-545S
3.1.1: Patient with symptomaticproximal DVT, we recommend use of an elastic compression stocking with an ankle pressure gradient of 30-40 mmHg. Compression therapy, should be started after starting anticoagulant therapy and should be continued for a minimum of 2 years, and longer if patients have symptoms of PTS. 7.2.8: For all pregnant women with previous DVT, we suggest the use of GCS both antepartum and postpartum.Geerts WH CHEST 2008;133: 381S-453SKearon C, et al. CHEST 2008; 133;454S-545S
9.1: If there is a perceived high risk of VTE in long distance travelers (> 8 hours), we suggest the use of a properly fitted, below knee GCS, providing 15-30 mm Hg of pressure at the ankle, or a single dose of LMWH injected prior to departureGeerts WH CHEST 2008;133: 381S-453S
Krijen R, et al. J Occu Environ Med. 1997;39(9):889-894 93 male workers with CVI from 14 meat factories randomized to the intervention (n=43; 20-30mmHg compression stockings or floor mats) or control (n=50) to assess the effect of compression stockings vs. floor mats on leg edema and pain Leg pain was measured via subjects subjective complaints of tired legs and leg pain Leg edema (volume) by Doppler ultrasound (standing) and light reflection rheography (sitting) Control Group Compression Rubber Mat Tired Legs No Difference P<0.005 P<0.01 Leg Pain No Difference P<0.05 No Difference Volume Change No Difference P<0.05 No Difference
Mr. Little John is a 34 y.o. male and regular patient at yourpharmacy. Today he presents with a new prescription forCoumadin 3mg daily. During his ‘pick up’ consultation youlearn that he recently had a DVT and spent the past twoweeks in the local hospital and wore TEDS during hishospital stay. You notice that he is still wearing his TEDhose and he tells you that he has never had to wearcompression therapy but his doctor told him that he willneed to wear them daily while on Coumadin therapy. He isambulating, intends to resume his normal daily routine anddaily exercise schedule. Per CHEST guidelines andcompression indications, do you agree with the Mr. LittleJohn’s physician’s recommendations?
Per CHEST guidelines andcompression indications, whatcompression level would yourecommend for Mr. Little John?A.8-15mmHgB.15-20mmHgC.20-30mmHgD.30-40mmHgE.Nothing, consult physician first
Following an in-depth dialogue with Mr. LittleJohn, you both decide to switch his compressiontherapy from TEDs to graduated compressiontherapy. You now measure Mr. Little John anddetermine his measurements to be:Shoe Size: 9.5Ankle Circumference: 9 inchesCalf Circumference: 16 inchesCalf Length: 16.5 inches
How old is the patient? What co-morbid conditions does the patient have? How compliant will this patient be with the recommended level of compression? What type of lifestyle does the patient live? What type of work does the patient perform on a daily basis? What type of shoe is commonly worn? What type of venous disorder(s) does the patient have? What area of the leg requires compression? Do the toes need to be monitored during treatment?
For sure your patient will say – or be thinking…” I HATE U”!STOCKINGS ARE: Too Hot Too hard to Apply and remove Too Tight Too Expensive Too UglyHOW WILL YOU RESPOND? 101
Too Hot Recommend cool and comfortable cotton or other breathable fabrics (i.e., microfibers)Too Hard to Apply Show patient how to use donning tools such as gloves, foot sleeves,& Remove and extensorsToo Tight Explain how compression works and that their legs will adjust Double compression garmentsToo Expensive Prove the value On average they cost <$0.60 per day “Medicine you Wear” No drug interactions Last 6-months or longer Non compliance ± medications can cost thousands per year! Some raw materials provide easier donning, more durability, less shininess, and stay on better!Too Ugly Show the patient “NEW” fashion forward products Suggest camouflaging the sock or stocking under their everyday socks and stockings
Cost is dependent on the severity of venous disease, with indirect cost rising sharply as disease severity increases Estimated venous ulcer cost per-episode can exceed $40,000 Estimated 2 million workdays per calendar year are lost due to chronic venous ulcers Rudolph DM, et al. J Wound Ostomy Continence Nurs 1998; 25: 248-55.
Medication Intervention Medications Class OpportunityAnticoagulants DVT, PE, or Coumadin (warfarin), Lovenox PTS (enoxaparin), Arixtra (fondaparinux)Antiemetics Travelers- Bonine or Antivert (meclizine), related Phenergan (promethazine), Zofran thrombosis (ondansetron), Transderm Scop (scopalamine), Dramamine (dimenhydrinate)Prenatal Pregnancy- Prenatal DHA, Prenate Advance,Vitamins related leg NataChew, Prenate Elite, Nestabs FA edema Pregnancy- ANY PRENATAL VITAMIN related varicose veins
Identify candidates for prophylactic graduated compression socks and stockings Consult patients on graduated compression socks and stockings Encourage appropriate use and compliance of graduated compression socks and stockings Implement safe and effective monitoring of venous disease patients