OTC Case Studies (February 2020)

CASE 1: PREMENSTRUAL SYNDROMEQ: GG is a 23-year-old woman who says that every month, about 5 days before her period starts, she feels abdominal bloating, breast tenderness, and cramping. She says that her symptoms cause her distress but are mild. Upon questioning, GG says that these symptoms affect her quality of life because she usually does not want to go out during this time. She is looking for something to take monthly prior to her period to prevent these symptoms. Some of GG’s friends take OTC medications to prevent these symptoms, but she does not know what to take. She does not take any other medications and is relatively healthy. What recommendations do you have?

A: GG appears to be suffering from premenstrual syndrome (PMS). The goals of therapy for this condition are to allow patients to maintain their usual activities and decrease distress. Nonpharmacologic approaches include cutting back on alcohol, caffeine, chocolate, and salt; exercise; and stress management. If GG is looking for something over the counter, she can try taking 1200 mg of elemental calcium divided into 2 doses and 600 IU of vitamin D daily. Results from one large clinical study showed a 48% reduction in total symptom scores from baseline compared with a 30% reduction in the placebo by 3 months. The authors concluded that calcium supplementation is an effective symptom treatment for PMS.¹ If calcium and vitamin D do not help GG’s symptoms, she can try other OTC medications, such as magnesium pyrrolidone or pyridoxine.

CASE 2: CHASTEBERRY FOR PMSQ: RM is a 29-year-old woman who says she feels bloated and has mood changes every month a few days before her period. Her cycle is regular, with periods lasting 4 or 5 days, and is typically 28 to 30 days long. RM’s mother recommended that she try chasteberry, but RM is concerned about trying herbal products, because she has heard that they can be harmful. RM does not take any other medications and is relatively healthy. What recommendations do you have?

A: Chasteberry may inhibit prolactin and interact with estrogen receptors so should be avoided in patients on estrogen therapy or those who should avoid estrogen therapy, such as individuals with certain types of cancer.² A few trials show that chasteberry can be beneficial for reducing breast tenderness, fluid retention, mood swings, and pain. All 4 symptoms significantly improved after 3 months in 1 study. The authors concluded that chasteberry was “effective in treating moderate to severe PMS in Chinese women, especially in symptoms of negative affect and water retention.”³ Another study demonstrated that symptoms were also significantly lower than the baseline in both groups (P <.0001) after 3 months. In addition, no serious adverse events were reported. Although there are no large clinical trials with chasteberry, it appears that short-term use may be safe. But RM should be advised to try other methods, such as calcium and vitamin D, first.

CASE 3: STEVIA IN DIABETESQ: BD is a 58-year-old man who wants to refill his prescription for metformin 1000 mg twice daily. He has had type 2 diabetes for 15 years and also has hypertension. BD’s friend told him that he recently read that stevia can reduce postprandial glucose levels. BD is thinking about adding stevia into his diet while continuing to take metformin. He exercises most days of the week, has a relatively healthy diet, and is constantly looking for new foods to try to help control his diabetes. What recommendations do you have?

A: Stevia has grown more popular over time. In 2008, the FDA granted stevia generally recognized as safe status as a food additive sweetener.⁴ One study evaluated the acute effects of stevia in patients with type 2 diabetes. Although it was a small study with 12 patients, the authors found that 1 g of stevia leaf extract reduced postprandial blood glucose levels.⁵ Results of another study showed that stevia decreased the desire to eat, thus lowering appetite sensation. Therefore, the authors concluded that stevia does not further increase food intake and postprandial glucose levels.⁶ Based on the safety evidence, BD could add stevia to his diet without harm. He should be educated to increase his blood glucose monitoring because he is modifying his normal diet. In addition, BD should be advised not to stop taking metformin and should consult with a physician before making any medication changes.

CASE 4: OTC TAMIFLUQ: HJ is a 39-year-old single woman who wants to get the human papillomavirus (HPV) vaccine. Over the past year, she has had several partners, though she has never been told she has been exposed to HPV. HJ’s doctor recently suggested that she get the HPV vaccine. However, HJ has heard that the vaccine is effective only in individuals up to age 26 years. She is healthy and has no medical conditions. What recommendations do you have?

A: The CDC issued an update in August for recommendations on the HPV vaccine for adults. The recommendations changed to increase vaccination to males through age 26 years. Therefore, the vaccine should be routinely recommended at age 11 or 12 years but can start early as 9 years of age. Vaccination is recommended both in females and males through age 26. For patients such as HJ, shared clinical decision making is now recommended. For adults aged 27 to 45 years who have not been vaccinated, it is important to determine whether the patient would benefit from receiving the HPV vaccine. The new recommendations have guidance for patients in this age group. Patients are at an increased risk if they have new sex partners. The guidance document also states that most sexually active adults have been exposed to some HPV types, though it is difficult to determine if they are the same as the ones in the vaccine. At this time, no clinical antibody test can detect if the patient already has HPV. Vaccine effectiveness might be low among patients who have risk factors for HPV, such as multiple sex partners or previous infections. With shared clinical decision making, it is important to determine if the vaccine will be beneficial for the patient. Most patients who are in monogamous relationships are at lower risk of having a new HPV infection. For HJ, because she is sexually active with multiple partners, it may be beneficial to receive the vaccination. It is important to advise HP that the vaccination will not protect her from HPV infections to which she may have already been exposed.⁷

Rupal Patel Mansukhani, PharmD, CTTS, FAPhA, is a clinical associate professor at the Ernest Mario School of Pharmacy at Rutgers, the State University of New Jersey, and a transitions-of-care clinical pharmacist at Morristown Medical Center in New Jersey.

Ammie J. Patel, PharmD, BCACP, is a clinical assistant professor of pharmacy practice at the Ernest Mario School of Pharmacy and an ambulatory care specialist at RWJBarnabas Health, part of the Barnabas Health Medical Group.

REFERENCES

• Thys-Jacobs S, Starkey P, Bernstein D, Tian J. Calcium carbonate and the premenstrual syndrome: effect on premenstrual and menstrual symptoms. Am J Obstet Gynecol. 1998;179(2):444-452. doi: 10.1016/s0002-9378(98)70377-1.
• Ma L, Lin S, Chen R, Wang X. Treatment of moderate to severe premenstrual syndrome with Vitex agnus castus (BNO 1095) in Chinese women. Gynecol Endocrinol. 2010;26(8):612-616. doi: 10.3109/09513591003632126.
• He Z, Chen R, Zhou Y, et al. Treatment for premenstrual syndrome with Vitex agnus castus: a prospective, randomized, multi-center placebo controlled study in China. Maturitas. 2009;63(1):99-103. doi: 10.1016/j.maturitas.2009.01.006.
• GRAS Notice (GRN) No. 768. FDA website. fda.gov/media/119340/download. Published March 14, 2018. Accessed January 15, 2020.
• Gregersen S, Jeppesen PB, Holst JJ, Hermansen K. Antihyperglycemic effects of stevioside in type 2 diabetic subjects. Metabolism. 2004;53:73-76. doi:10.1016/j.metabol.2003.07.013.
• Farhat G, Berset V, Moore L. Effects of stevia extract on postprandial glucose response, satiety and energy intake: a three-arm crossover trial. Nutrients. 2019;11(12):pii: E3036. doi: 10.3390/nu11123036.
• Meites E, Szilagyi PG, Chesson HW, Unger ER, Romero JR, Markowitz LE. Human papillomavirus vaccination for adults: updated recommendations of the Advisory Committee on Immunization Practices. Morb Mortal Wkly Rep. 2019;68(32):698-702. doi: 10.15585/mmwr.mm6832a3.