Regs, robbery responses among top “pharmacy gamechangers” for 2016

Geoffrey C. Wall, PharmDFederal track-and-trace regulations and growing robbery risks in the wake of crackdowns on opioid prescribing are among the top 10 “pharmacy gamechangers” this year, Geoffrey C. Wall, PharmD, FCCP, BCPS, CGP, told McKesson’s ideaShare 2016 in Chicago.

The annual list also includes major new drugs, clinical studies and guidelines, newly reported adverse drug events, and legal, economic, and social developments that will affect pharmacy practice in the coming year. Here, in no particular order, are the 2016 gamechangers mentioned by Wall, a professor of Clinical Sciences, Drake University, College of Pharmacy and Health Sciences, Des Moines, Iowa.

1. Neprilysin inhibitors for heart failure

In the PARADIGM-HF study, a combination of neprilysin inhibitor sacubitril with angiotensin receptor blocker (ARB) valsartan reduced cardiovascular death and heart failure hospitalization by about 20% compared with the angiotensin-converting enzyme (ACE) inhibitor enalapril, which is currently recommended under ACC/AHA heart failure treatment guidelines. ( See McMurray JJV, Packer M, Desai AS, et al. Angiotensin-neprilysin inhibition vs. enalapril in heart failure. N Engl J Med. 2014;371:993-1004.) As a result, this first-in-class drug has the potential to change the landscape of heart failure treatment, said Wall.

However, sacubitril/valsartan is associated with adverse reactions, including hypotension, hyperkalemia, cough, and dizziness. Angioedema risk is also higher compared with ARBs, and these risks can increase in combination with other drugs. Moreover, these safety issues may have been underrepresented in the PARADIGM-HF study, because its design excluded patients who did not tolerate sacubitril/valsartan during a run-in period.

In light of the fact that safety and efficacy concerns kept a previous neprilysin inhibitor from market, sacubitril/valsartan’s place in heart failure therapy may remain uncertain until new guidelines emerge, Wall said.

2. “Track and Trace”

As of July 2015, Title II of the Drug Quality and Security Act requires pharmacists to maintain for six years transaction information, including product lot numbers, the history of everyone who has handled the product, and a statement of compliance for most drugs. The goal is to safeguard the U.S. drug supply chain against pharmaceutical drug diversion and counterfeiting.

HHS will offer alternatives to help small independent pharmacies comply with these complex and expensive requirements, Wall said, “but I wouldn’t hold my breath about alternative compliance processes being much easier or cheaper.”

For implementation guidance, Wall recommends organizations such as the National Community Pharmacists Association (NCPA), the American Society of Health-System Pharmacists (ASHP), and the Independent Pharmacy Alliance (IPA).

3. Antimicrobial stewardship in LTC

Up to 75% of antibiotics in long-term care (LTC) are used inappropriately, endangering patients and promoting drug-resistant bacteria. Antimicrobial stewardship programs that educate staff, incorporate evidence-based guidelines, and target a few common issues, such as diagnosis for a urinary tract infection, can reduce the problem substantially. (See Trivedi KK, Kuper K. Hospital antimicrobial stewardship in the nonuniversity setting. Infect Dis Clin North Am. 2014;28:281-289.)

Implementing minimum symptom criteria for antibiotics also can reduce inappropriate use and overuse of newer, broad-spectrum drugs, Wall said. (See Loeb M, Brazil K, Lohfeld, et al. Effect of a multifaceted intervention on number of antimicrobial prescriptions for suspected urinary tract infections in residents of nursing homes: cluster randomized controlled trial. BMJ. 2005;331:669.)

4. Deprescribing in the elderly

The benefit of many long-term drug therapies drops as patients age. Therefore, reducing or discontinuing medications can cut the risk of adverse responses and drug interactions as patients develop multiple diseases. Wall tells patients, “Congratulations, you’re 95, you win, and you can stop the statins.”

Deprescribing may be particularly useful for palliative care as the goal shifts from prolonging life to improving the quality of life.

Pharmacists can aid in deprescribing, although getting paid for not dispensing may be difficult.

5. Robberies and burglaries

According to the Drug Enforcement Administration, pharmacy robberies jumped 16% to 829 in 2014, although with six or fewer reported in 31 states, the actual total is almost certainly much higher, Wall said. The trend follows crackdowns on opioid prescribing that make drugs like hydrocodone and tramadol harder to get and more expensive on the street.

Responses to robberies include time locks on pharmacy safes, bullet-proof glass, and buzzing patients into secure pharmacies. Training staff to comply with robbers’ demands and to limit the threat to themselves and customers also makes sense.

“Pharmacists need to walk a fine line between protecting themselves and limiting access,” Wall said. “We don’t have all the answers. I have nothing but respect for those who continue to care for patients under the specter of violence.”

6. Steroids for community-acquired pneumonia

Despite antibiotic and vaccination advances, community-acquired pneumonia (CAP) is still the leading cause of infectious-disease-related death, with mortality in the range of 10% to 20% and annual hospital costs exceeding $13 billion, Wall said. (See Yu H, Rubin J, Dunning S, Li S, Sato R. Clinical and economic burden of community-acquired pneumonia in the Medicare fee-for-service population. J Am Geriatr Soc. 2012;60:2137-2143.)

A Spanish study suggests that steroids may be helpful for the treatment of a proinflammatory state that leads to late treatment failure. However, the study is relatively underpowered for other differences, adverse events are not well understood, and the Spanish population may have included more resistant organisms than those in the U.S. (See Torres A, Silba O, Ferrer M, et al. Effect of corticosteroids on treatment failure among hospitalized patients with severe community-acquired pneumonia and high inflammatory response: a randomized clinical trial. JAMA. 2015;313:677-686) Nonetheless, steroids may be beneficial for hospitalized patients with CAP.

7. New insulin formulations and difficulties

Insulin glargine injection, 300 U/mL (Toujeo) provides more gradual and prolonged release from a smaller subcutaneous depot, and better 24-hour glycemic control than insulin glargine injection, 100 U/mL (Lantus), currently the most prescribed basal insulin. However, the two are not interchangeable.

It usually takes more units of Toujeo to maintain glycemic control, even though it may require just one daily injection instead of two, and conversion errors can cause dosing problems, Wall said.

Products in the pipeline include those that last 36 hours and one that lasts more than 48 hours, which may further complicate the picture. For insulin pumps, billing rules mean that pharmacists can lose money on each prescription, a practice that needs to change in order for pharmacists to help patients.

8. EMR in community pharmacies

An Iowa pilot program connecting pharmacies, physicians, health systems, labs, and long-term care with an electronic data exchange promotes electronic prescribing, and gives pharmacists critical lab and clinical information needed to manage medication therapy.

Shared electronic medical records (EMRs) also create a platform for paid adherence programs, all leading to better patient outcomes. But cost has prevented shared EMRs from realizing their full potential, Wall said. The Iowa program currently waives user-connection fees, which may foster better care integration.

9. 2015 ACCP COPD exacerbation guidelines

Acute exacerbations of chronic obstructive pulmonary disease (COPD) are the main drivers behind 8 million office visits, 1.5 million emergency department visits, and 715,000 hospitalizations costing $50 billion - and 134,000 deaths annually, Wall said.

Pharmacists have a big role to play in ensuring implementation of the new guidelines issued by the American College of Chest Physicians (ACCP). These include pneumococcal and influenza vaccinations, smoking cessation, assistance with appropriate use of inhalers, and recommendations for appropriate oral therapies. (See Criner GJ, Bourbeau J, Diekemper RL, et al. Executive summary: Prevention of acute exacerbation of COPD: American College of Chest Physicians and Canadian Thoracic Society Guideline. Chest. 2015;147:883-893.)

10. Perioperative anticoagulation in patients on warfarin

The recent BRIDGE study found that for patients with atrial fibrillation and moderate stroke risk who stop warfarin for elective surgery, the use of heparin as a bridge anticoagulant is usually not necessary and may increase bleeding risk. However, high-risk patients, such as those with recent stroke or embolism, probably should be bridged, Wall said. (See Douketis JD, Spyropoulos AC, Kaatz S, et al. Perioperative bridging anticoagulation in patients with atrial fibrillation. N Engl J Med. 2015;373:823-833.)

Making the list

Gamechangers are selected annually by a panel that represents hospital, community, and LTC practice, overseen by a pharmacist with regulatory affairs expertise. The panel members compile a list and winnow it down to 10.

“Your biggest gamechanger may not have been included, and this presentation does not have all the answers in controversial areas,” Wall said. However, the process ensures that changes affecting all areas of pharmacy practice are included. He encouraged pharmacists everywhere to contact him with ideas for next year’s list.