A study was done that looked at how clinician training and public funding affected the use of long-acting reversible contraceptives (LARCs). LARCs include IUDs and implants. The study was done at 40 Planned Parenthood centers and 20 of the clinics received a four hour long training session. 1500 women aged 18 to 25 were enrolled and followed for 1 year. The training included a didactic session, an insertion practicum, and counseling role play. Patient-centered counseling was emphasized. The results showed that the clinics with training had higher initiation of LARC use (22% vs 18% of the women enrolled in the study). Also, participants who were at sites with Medicaid family planning expansion programs that could cover the costs of the contraception had higher initiation rates than sites without the program (25% vs 13% of the women). The role of the pharmacist in this situation could be emphasized. Pharmacists are trained in all types of birth control, including IUDs and implants, and this could be utilized to improve use and results as the article is aiming for. Unintended pregnancy is a continual public health concern, and effective IUD use with the help of the training of pharmacists could be used as a tool.
Am J Public Health. 2016;106(3):541-546
A study was done at the clinics of the University of Puerto Rico Center for IBD (inflammatory bowel disease). It assessed the knowledge about human papilloma virus (HPV) infection and the HPV vaccine in women with IBD. This demographic of females with IBD was targeted because they may be at increased risk for HPV infection because many are immunocompromised due to the use of immunosuppressant agents. The study included 147 patients who were administered a questionnaire including demographic information and HPV knowledge. The mean age of participants was 36.6 years. It was determined that there was poor knowledge about HPV in the group studied. 77% of the women had awareness that HPV existed. Of those 77%, only 57.5% knew that the virus is sexually transmitted, 79.6% knew that HPV can cause cervical cancer. 58% of the women questioned knew that there is a HPV vaccine. 2% of women within the recommended ages had previously been given the HPV vaccine, however 50% of the women stated they would be inclined to get the vaccine in the future.
With the demographic information obtained, there were trends within education levels observed. The more highly educated women were more likely to have heard of HPV. Also, women were more likely to have heard of the vaccine if they had graduated high school/had some college education than the women who did not have a high school degree. Despite poor knowledge about HPV infection and the vaccine, there is hope for the future because women are showing receptiveness and acceptance towards vaccination and learning about HPV. The HPV vaccine could be rather beneficial especially in a population with increased risk such as the IBD population.
J Racial Ethn Health Disparities. 2016;3(1):55-62
There is a new guideline released by The American Pain Society that addresses practices to improve pain management postoperative. They complied this guideline from reviews of more than 6500 scientific abstracts and clinical studies and is based on that there is often inadequate pain relief leading to larger, prolonged negative outcomes. The panel that wrote the guideline includes 23 members and incorporate anesthesia, pain management, nursing, and surgery specialties. There are 32 recommendations that are rated based on the quality of evidence as strong, moderate, or weak. There are four recommendations graded as strong. The first recommendation is that there should be wider use of a variety of analgesic medications and techniques. Multimodal anesthesia that specifically target different mechanisms of actions in the nervous systems have shown better pain relief than single medications using one technique. The second recommendation is to use acetaminophen and/or NSAIDs as part of the multimodal management post-surgery. The third recommendation is for clinicians to consider peripheral, regional anesthetic techniques at the surgical site. The fourth recommendation is for patients at risk for cardiac and pulmonary complications or prolonged intestinal distress that spinal analgesia is appropriate in major thoracic and abdominal procedures. They authors of the guideline state that the intended audience of their guideline is all clinicians who manage pain after surgery. How does the pharmacist fit into the target audience, and how could they use these guidelines within their field of practice?
J Pain. 2016;17(2):131-157
A meta-analysis was done to look at RAS blockers use in patients with Type 2 diabetes. RAS blockers are renin angiotensin system blockers. The main medications in this group are ACEs and ARBs. RAS blockers are antihypertensive agents and in the study were compared to other antihypertensive agents in people with diabetes. The study looked if they lowered the risk of certain outcomes; death, end-stage renal disease, cardiovascular death, heart attack, angina, stroke, and heart failure. 19 trials were looked at, and included 25,414 participants. They compared the RAS blockers with thiazides, calcium channel blockers, and beta blockers. The conclusion is that RAS blockers do not prevent these adverse effects to a better degree than the other antihypertensive medications. Treating hypertension in patients with diabetes is shown to be important and preventative, but a specific class of drug (such as RAS blockers) is not better than the others. The finding of this meta-analysis support the recommendations of the Joint National Committee (JNC 8) on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, and of the European Society of Cardiology/European Society of Hypertension guidelines. However, this contradicts the recommendation of the 2015 American Diabetes Association guidelines and the 2013 American Society of Hypertension guidelines which favor RAS blockers as first line treatment for people with diabetes and hypertension. What are the implications of having conflicting guidelines in situations such as this?
For the treatment of hepatitis C virus (HCV), the FDA has approved Zepatier. Zepatier is a combination of elbasvir and grazoprevir and is a product of Merck & Co. This treatment is approved specifically for genotypes 1 and 4 of HCV. Genotype 1 is the most common type of hepatitis C and it is the most difficult to treat with genotype 4 being more readily curable. Zepatier was also approved with or without ribavirin. In the clinical trials for this treatment, 1,373 participants with chronic HCV were given the combination drug once daily for 12 weeks or 16 weeks. The measurable outcome was if HCV was still detected in the blood 12 weeks after the end of treatment. If there was no detection, the participants’ infection can be considered cured. The success rates for the participants with genotype 1 were 94-97% and the success rates for genotype 4 were 97-100%. They still suggest tailoring the length of treatment to the individual patient and the characteristics of their virus. What are the future implications if hepatitis C is now curable?
APhA DrugInfoLine. 2016; 2
A pilot study was done to look at medication therapy management intervention and fall risk-increasing drugs (FRIDs) in older adults. FRIDs can include both prescription and OTC medications and are often used by older adults despite being a factor associated with falling along with living environment and physical status. Falls for older adults are common and costly, but modifying medications that could increase risk of falling can help prevent this issue. Older adults use an average of 2.34 FRIDs, but MTM intervention by a pharmacist is an idea of how to curb this problem.
The study was a randomized, controlled trial with 80 older adults (average age 74.9 and 76.3 years) split into a control group or an MTM intervention group. The outcomes of the study that were used to measure were the discontinuation of FRIDs, and the number of falls, as well as the acceptance of recommendations of the pharmacist by the patients and the prescribers. 77% of the intervention group had their FRID use discontinued while only 28% of the control group had their FRID use discontinued (outside of pharmacist intervention). 28% of the intervention group fell post intervention while 24% of the control group fell. There was a 75% acceptance rate of the pharmacist recommendations by patients and prescribers. Overall, pharmacists providing MTM intervention focusing on FRID use in older adults was effective in modifying the use and supports that pharmacists can play a role in modifying FRID use in older adults. In the future, it could be useful to study the relationship between reducing FRID use by pharmacists and the rate of falls more closely.
J Am Pharm Assoc. 2016; 56(1): 22-28
The USPSTF has updated its recommendation from 2009 on screening adults for depression. The USPSTF is the US Preventive Services Task Force. The recommendation applies to the population over the age of 18 and is for the general population. The update in the recommendation is that there is specific mention of screening of pregnant and postpartum women unlike the 2009 recommendation in which that sub group was not mentioned. The 2009 recommendation also suggested selective screening based on professional judgment and patient preference or when staff-assisted depression care supports are in place. This is omitted in the new recommendation, claiming that the screening no longer needs to be selective, but all inclusive.
Besides suggesting that the general adult population and postpartum women be screened, the recommendation suggests that “screening should be implemented with adequate systems in place to ensure accurate diagnosis, effective treatment, and appropriate follow-up.” This a category B recommendation, meaning that it is recommended to offer or provide service and that there is high certainty that the net benefit is moderate.
Depression is the lead cause in disability in those over the age of 15, and with postpartum women, depression can be harmful not only to the woman, but also to the child. Creating effective screening and treatment for depression can have large impacts on health.
The USPSTF acknowledges that they do not consider the cost when making recommendations. How would the cost of screening and treatment of depression that is suggested affect the implementation of this recommendation? In addition, would these costs actually be lower than the costs of untreated depression?
Siu, AL. Screening for Depression in Adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2016;315(4):380-387. doi:10.1001/jama.2015.18392.
The FDA has just approved a combined regimen of Opdivo + Yervoy for the treatment of unresectable or metastatic melanoma. Opdivo is nivolumab and Yervoy is ipilimumab. The indication is now for patients with the BRAF V600 wild type mutation and the BRAF V600 positive mutation. Previously the indication was only for the wild-type mutation in unresectable or metastatic melanoma. When it says melanoma, it means skin cancer, unresectable meaning that the cancer cannot be removed with surgery, and metastatic meaning that it has spread from the initial cancerous site. The FDA also approved the use of Opdivo to treat BRAF V600 mutation positive melanoma as a single agent, without the Yervoy.
The approval came because of a Phase 3 trial, Checkmate -067. Treatment with Opdivo + Yervoy was compared with treatment of only Opdivo, and also with treatment of only Yervoy. The study was double-blind and randomized with only previously untreated patients with both the wild-type and positive mutation of BRAF V600. The endpoint of progression-free survival in the patients was median of 11.5 months for the Opdivo + Yervoy, 6.9 months for Opdivo monotherapy, and 2.9 months for the Yervoy monotherapy. The combined therapy showed a 58% reduction in disease progression risk and the Opdivo single agent therapy showed a 43% reduction in risk compared to the Yervoy single agent therapy.
Both Opdivo and Yervoy target the cancer through the immune system via immune checkpoint inhibition. The cancer cells abuse these checkpoint pathways in the body so they are being targeted in these checkpoints. With the combined therapy, they are targeting two different checkpoint pathways in order to be more effective and comprehensive. Yervoy augments T-cell activation, but Opdivo restores the response of the active T-cells towards the cancer. With the Opdivo monotherapy, only that one pathway is targeted. Opdivo was the first immune checkpoint inhibitor to be used with melanoma, and this is the first combined dual immune checkpoint inhibition treatment for unresectable or metastatic melanoma.
Because this is a new way of treating melanoma, there seems to be hope that it could be a more effective therapy in treating the disease. This is a particularly difficult disease, but is also a more common disease so a new way to combat it could be very beneficial. However, the continued FDA approval for these indications may be contingent upon further trials that confirm it. What are the implications of the FDA’s accelerating of the initial approval, now and in the future as further tests are conducted?
Styles, JW. Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status. Business Wire. January 23, 2016.