NORLAND AVENUE PHARMACY PRESCRIPTION COMPOUNDING FOR GENERAL PRACTICE

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1 AUGUST 2011 PRESCRIPTION COMPOUNDING N ORLANDA VENUEP HARMACY. COM We customize individual prescriptions for the specific needs of our patients. INSIDE THIS ISSUE: Hemorrhoids 2 Celiac Disease 3 PRESCRIPTION COMPOUNDING FOR GENERAL PRACTICE Pruritus Norland Avenue, Suite 105 Chambersburg, PA Phone: (717) Fax: (717) Web:

2 Page 2 HEMORRHOIDS The following clinical paper discusses the effectiveness of a product that contains hydrocortisone and pramoxine, which is not available in the USA, for the treatment of hemorrhoids for women who are pregnant - The effectiveness of Proctofoam-HC for treatment of hemorrhoids in late pregnancy (J Obstet Gynaecol Can Jul;31(7):654-9). OBJECTIVE: Currently no topical anti-hemorrhoidal agents have been studied for effectiveness in pregnancy. This study evaluated the effectiveness of Proctofoam-HC used during the last trimester of pregnancy. METHODS: In this prospective, open-label, observational study, pregnant women prescribed Proctofoam-HC were asked to complete two telephone interview questionnaires. RESULTS: A total of 88 women completed the study. All hemorrhoidal symptoms, including pain, pruritus, swelling, itching, decreased significantly (P < 0.001) and overall well-being improved. The improvement was clinically very significant after correction for potential placebo effect. We have the ability to compound hydrocortisone and pramoxine into special suppository that may speed the healing process. The rectal rocket is a special suppository that is only available to compounding pharmacies. This unique design rivals traditional suppositories in three ways: It does not get lost in the rectum, but remains at the point of insertion It treats internal and external hemorrhoids simultaneously The paitent can expel gas without losing the suppository CONCLULSIONS: Proctofoam-HC appears to provide effective treatment of hemorrhoids in late pregnancy. PMID: With our state of the art compounding laboratory and pharmaceutical knowledge and experience, we have the ability to compound hydrocortisone and pramoxine together into one suppository for any of your patients suffering from hemorrhoids. Hydrocortisone 2%/Pramoxine 1% Rectal Rocket Suppository #6 Insert 1 suppository ⅔ into rectum HS

3 Page 3 CELIAC DISEASE The following study finds that pharmacists can play an important role by identifying patients who may have celiac disease, providing information for gluten-free foods and pharmaceutical products, and encouraging adherence to the gluten-free diet - Caring for patients with celiac disease: the role of the pharmacist (J Am Pharm Assoc 2008 Sep-Oct;48(5). OBJECTIVE: To review the epidemiology, pathophysiology, diagnosis, treatment, and complications of celiac disease, in order to provide guidance to pharmacists. DATA SOURCES: Published articles identified through Medline using search terms such as celiac disease, gluten sensitivity, and gluten enteropathy. Additional resources were identified from personal bibliographies collected by the authors and bibliographies from gathered articles. DATA SYNTHESIS: Celiac disease is an autoimmune disorder that is characterized by intolerance to gluten and affects approximately 3 million Americans. Although the most common manifestations of the disease are gastrointestinal, including diarrhea, steatorrhea, and weight loss, the disease is a multisystem disorder. Malabsorption is common, often leading to vitamin and mineral deficiencies and resulting in anemia and osteoporosis. Diagnosis is initiated through serology testing and confirmed by intestinal biopsy. The only treatment for celiac disease is strict, lifelong adherence to a gluten-free diet, which includes avoidance of foods, prescription and nonprescription pharmaceutical products, and cosmetics containing wheat, barley, and rye. Adherence to the gluten-free diet will promote intestinal healing and symptom relief and usually prevent complications of celiac disease. CONCLUSION: Pharmacists can play an important role by identifying patients who may have celiac disease, providing information for gluten-free foods and pharmaceutical products, and encouraging adherence to the gluten-free diet. PMID: Children with autism may benefit from a gluten-free and caseinfree diet. Many commonly used medications, bulk chemicals, and even flavors may contain gluten and some probiotics contain casein. Compounded preparations that are free of gluten, and casein can solve problems for sensitive individuals. Methylcellulose is a suspending agent that does not contain gluten or casein, and does not feed yeast. We have the ability to compound methylcellulose as a suspending vehicle for patients suffering from celiac disease. (Active Drug) mg/ml in Methylcellulose 1% Flavored Suspension (Quantity of Active Drug) ml Directions

4 Page 4 PRURITUS In this study more than 70% of patients using topical naltrexone experienced a significant reduction of pruritus - Treatment of pruritus with topically applied opiate receptor antagonist (J Am Acad Dermatol Jun;56(6):979-88). BACKGROUND: Pruritus is the most common and distressing skin symptom, and treatment of itch is a problem for thousands of people. The currently available therapies are not very effective. Therefore there is an urgent need to find new effective topical drugs against itching. OBJECTIVE: We conducted two separate studies to evaluate the efficacy of topically applied naltrexone, an opioid receptor antagonist, in the treatment of severe pruritus. The objective of the first open study was to correlate the clinical efficacy of topically applied naltrexone in different pruritic skin disorders to a change of epidermal mu-opiate receptor (MOR) expression. The second study was a double-blind, placebo-controlled, crossover study on pruritus in atopic dermatitis. METHODS: Initially we performed an open pilot study on 18 patients with different chronic pruritic disorders using a topical formulation of 1% naltrexone for 2 weeks. A punch biopsy was performed in 11 patients before and after the application of the naltrexone cream and the staining of epidermal MOR was measured. Subsequently, a randomized, placebo-controlled, crossover trial was performed with the same formulation. We included in this trial 40 patients with localized and generalized atopic dermatitis with severe pruritus. RESULTS: In the open study more than 70% of the patients using the 1% naltrexone cream experienced a significant reduction of pruritus. More interestingly, the topical treatment with naltrexone caused an increase of epidermal MOR staining. The regulation of the epidermal opioid receptor correlated with the clinical assessment. The placebo-controlled, crossover trial demonstrated clearly that the cream containing naltrexone had an overall 29.4% better effect compared with placebo. The formulation containing naltrexone required a median of 46 minutes to reduce the itch symptoms to 50%; the placebo, 74 minutes. LIMITATIONS: We could only take biopsy specimens in 11 patients, which means that a satisfactory statistical analysis of the changes of epidermal MOR staining was not possible. In addition, there was an insufficient number of patients with nephrogenic pruritus and pruritic psoriasis to draw definitive conclusions. CONCLUSIONS: The placebo-controlled study showed a significant advantage of topically applied naltrexone over the placebo formulation. This finding is supported by the biopsy results from the open studies, showing a regulation of MOR expression in epidermis after treatment with topical naltrexone, especially in atopic dermatitis. These results clearly show potential for topically applied opioid receptor antagonist in the treatment of pruritus. The placebo formulation also had some antipruritic effects. This underlines the importance of rehydration therapy for dry skin in the treatment of pruritus. PMID: With our state of the art compounding lab and pharmaceutical knowledge and experience, we can compound naltrexone as a topical cream. Naltrexone 1% Topical Cream 60gm Apply sparingly to affected area(s) up to twice daily

5 Prescriber Name Prescriber Address City State Zip Phone Fax Date Patient Name DOB Address City/State/Zip Phone Patient will pick up at pharmacy Please ship to patient Bill Insurance Plan: ID# Hemorrhoids All topical compound %s are per 1 ml or 1 gm unless otherwise noted [ ] Hydrocortisone 2%/ Pramoxine 1% Rectal Rocket Suppository Quantity #6 Directions: Insert 1 suppository ⅔ into rectum HS Celiac Disease [ ] (Active Drug) mg/ml in Methylcellulose 1% Flavored Suspension (Quantity of Active Drug) ml Directions: Pruritus [ ] Naltrexone 1% Topical Cream Quantity 60gm Directions: Apply sparingly to affected area(s) up to twice daily Directions Prescriber s Signature Refills: NR 757 Norland Avenue, Suite 105 Chambersburg, PA Phone: (717) Fax: (717)