Putting Nursing Into the Pharmaceutical Usage Equation

Smart pharma marketers know that, for many types of medications, a physician is not the be-all and end-all when it comes to prescribing decisions: nursing staff play an advisory or outright decisionmaking role of their own. Among marketing and medical affairs departments, there are discussions and organized efforts to assist nursing staff in prescribing and administering medications; among nursing organizations, there is a constant call for better training, support and education for working nurses.

The usual mechanism for meeting these needs is continuing medical education (CME), but just as the topic has been controversial among physicians, so is there a debate, which seems to get vociferous at times, in the nursing community. And all this is happening in a context where shortages of nursing staff are occurring, and where even the ability of the education system to ramp up production of graduates is experiencing difficulty (see box, p. 24).

Paradigm shift

The nursing community has been quietly reshaping itself in recent years, and today, a variety of market forces are promising to create the momentum needed to push these changes more quickly. Specifically, individual nurses and the nursing associations that support them have been working to advance the level of practice and professionalism among their members, in order to help nurses shake off their historic reputation as the ‘handmaidens of the medical staff,’ and change the way in which both patients and their professional colleagues view them.

The idea that nurses can and should play a bigger, more vital and visible role within the care teams on which they serve is growing in popularity and necessity — whether it is in a primary care office setting, hospital setting, long-term care facility or nursing home, or in the increasingly popular walk-in clinics that are today located in many pharmacies — due to a variety of market forces that are at work today.

These include existing and projected workforce shortages among both nurses and doctors (primary care physicians and specialists in some fields), the aging of the population (which not only increases patient loads but is driving record retirement rates among aging nurses), and anticipated healthcare reform efforts, which are expected to open the floodgates in the years to come, bringing millions of new patients into a healthcare system that is already operating at capacity.

In the face of these changing workplace conditions, today’s nurses, nurse practitioners (NPs) and physicians assistants (PAs) are often expected to take on additional responsibilities. Increasingly, these front-line care providers are expected to play a more integral role not just in a guiding a patient’s overall preventive healthcare efforts (by supporting patient education to improve preventive care and drug adherence), but by direct efforts to help shape the successful evaluation, administration and ongoing fine-tuning of the multi-drug regimens their patients are on to treat both acute and chronic illnesses. With this added responsibility comes the need to remain as well-schooled as possible about not only complex disease states, but about complicated and ever-changing pharma and biologic treatment options, acceptable versus unacceptable off-label use scenarios, potential drug-drug and drug-allergy interactions, evolving safety profiles, potential side effects and adverse events, changes in labeling, and the emergence of black box warnings.

Today, there are about 2.9 million RNs practicing in the US, and according to industry estimates the number of NPs will soon reach 125,000 (roughly the same number as primary care physicians). “We know we’re in a crisis here in terms of staffing shortages and we don’t have enough healthcare providers overall. Industry needs to support policies that allow nurses and nurse practitioners — who are already very well-trained to manage many chronic diseases in a way that helps to avoid more costly acute interventions — to have more of a leadership role where it’s appropriate,” says Sharon Brigner, RN, deputy VP in the Alliance Development Division of the Pharmaceutical Research and Manufacturers of America (PhRMA; Washington, DC).

“The services of currently underutilized advanced practice nurses — such as nurse practitioners, clinical nurse specialists and certified nurse-midwives — can relieve burdens on the healthcare system, given a funding source,” wrote Rebecca M Patton, RN, president of the American Nurses Assn. (ANA; Silver Spring, Md.), in a letter to the Washington Post, published April 20. “Nurse practitioners, the fastest-growing group of primary care professionals in the country…They are licensed to diagnose, order and interpret tests, and prescribe medication — in short, to provide services on part with those offered by primary care physicians….The key is to integrate them into our health care system more effectively.”

Defining appropriate outreach

Today, pharma outreach directed at nurses, NPs and PAs can run the gamut from direct-to-consumer and direct-to-physician advertising (which, while intended to raise awareness of specific branded products among consumers and physicians, certainly catches the attention of mid-level practitioners, as well), and one-to-one and group-oriented detailing visits from pharma sales reps, to publication of evidence-based scientific articles in nursing journals, sponsorship of CME coursework, and unrestricted grants that enable the nursing community to fund various pilot projects. Not surprisingly, different forms of pharma outreach are met with different types of responses from advocates and critics alike.

“The more information nurses have, the more credibility they have in advising and recommending drugs to the attending physicians during the overall medication-management process,” says Valerie Metil, a clinical psychiatric nurse by training, and senior director of operations for Innovex, a subsidiary of Quintiles Transnational Corp. (Research Triangle Park, NC), which helps its pharma clients to develop and deploy clinical nurse-educator teams to support various drug franchises.

Whether or not they are actually able to write the prescription, all nurses play some role in the overall medication-management process. “RNs routinely make valuable assessments and recommendations related to medications that advise and influence attending physicians,” says Metil.

This phenomenon is often more pronounced in hospital, nursing home or long-term-care facility settings. In these settings, nurses provide discerning eyes and ears at the bedside and are thus uniquely positioned to observe changes in the patient’s condition or mood, to gauge day-by-day reactions and clinical responses to the overall medication load. Similarly, nurses in these settings are also uniquely positioned to field the relevant observations of concerned family members — observations about changes in mood, sleeplessness, anxiety, or the onset of transient delusions on the heels of introducing a new antidepressant, for example (Pharmaceutical Commerce, September, p. 1.)

When nurses and NPs share these critical observations and assessments with the primary care physician or specialists on the case — who may literally only spend minutes per day or less with the patient — and make specific recommendations related to adding or removing a particular medication, or adjusting the dosage to improve the tolerability and clinical outcomes for the patient, they are helping to influence prescribing decisions in healthcare situations that often evolve in ways that are utterly fluid and unpredictable.

Similarly, Metil of Innovex notes: “Patients in hospitals or long-term care setting may be seeing a pulmonologist, cardiologist and gastroenterologist with each issuing their own prescriptions without full knowledge of what else the patient is already taking,” she says. “It’s often the nurses, NPs and PAs who provide a single point of continuity in these settings and monitors the entire drug list. Thus, they must be well-versed enough to look for possible contraindications.”

“Nurses have always filled in that gap where patients are underserviced, and today, family nurse-practitioners (FNPs) and other mid-level clinicians have a lot of authority and autonomy and this will continue to grow,” says Anne Herlick, an FNP with the Barnard University Student Health Service (New York), who has been in practice for ten years. But she notes that the ability to fully exploit the capabilities of NPs to fill such gaps will require that prevailing barriers related to billing be removed, saying: “Most insurance plans do not reimburse as much when an NP administers the same procedures as a doctor, and this limits their ability to use these team members to the fullest extent.”

Grooming nurse-educators

One outreach option that seems to be growing in importance is pharma industry’s development and deployment of so-called nurse-educators, who receive specialty training that is paid for by pharma companies and carried out by third-party contractors.

In some cases, these nurse-educators work directly with patients — either one-on-one, by conducting group classes in doctors’ offices, hospital settings, or by phone. In other cases, these nurse-educators are employed in a “train-the-trainer” mode, where they conduct classes with other nurses in private practice or hospital settings.

In all cases, these nurse-educators help both patients and other nurses to understand particular disease states more completely and complex drug regimens, to use medical devices or self-administered injectible drugs appropriately, and to recognize and deal with side effects in order to maximize adherence to medications.

Many pharmaceutical companies (including EMD Serono, Pfizer, Eli Lilly, Sanofi-Aventis Pharmaceuticals, Hoffman-LaRoche and others) have deployed nurse-educators in recent years to help other nurses and patients better understand and manage such chronic diseases as asthma, diabetes, heart disease, multiple sclerosis, chronic obstructive pulmonary disease (COPD), HIV/AIDS and cancer.

“Nurses are hungry for knowledge about the mechanisms of action of today’s medications, and they need to know what side effects and drug-drug interactions to be aware of, and how to manage adverse events,” says Metil of Innovex, which routinely screens and assembles nurse-educator teams for its pharma industry clients. “Everyone who touches the drug — nurses and patients alike — must understand both the need for it and how to take it properly. Nurses who are specially trained to educate either patients or other nurses are very effective, because they have great credibility among their peers and patients.”

And compared to pharma-outreach efforts that seek to educate individual nurses or patients one by one, investments in “train-the-trainer’ sessions give pharma companies the ability to impact more patients, because such programs have a tremendous ripple effect. “We’re able to reach so many more patients by training nurses who are then able to train the many other nurses in group settings,” says Metil. “It’s exponential.”

“When nurses and patients truly understand the issues associated with their medical conditions and medications, patients are more likely to stay on their chronic medications (and thus help to improve clinical outcomes), even when they may be experiencing unpleasant side effects or may be symptom-free,” she adds.

Nurse-educator programs can be unbranded (related to specific diseases) but they can be drug-specific, too. Consider the example of a new diabetes medication that has particularly complex administration requirements. “The pharma reps can share their drug information to raise awareness among physicians and other prescribers, but educating nurses is still a critical piece of the equation, to make sure there is adequate training among the entire staff that will actually be interfacing with the patients on a go-forward basis,” says Metil.

Critics worry that conflicts of interest may arise, whereby the educational messaging may be skewed (intentionally or unintentionally) as a result of the the nurse-educators’ direct link to the pharma companies underwriting the training program and supplying the information.

Advocates say that it’s a win-win for everyone when pharma foots the bill for train and deploy specially trained nurse-educators — patients benefit by increasing their knowledge about their medical conditions, their medications and the importance of consistent adherence, and improved adherence helps to reduce more costly acute interventions and improve clinical outcomes, while helping to maintain medication sales, as well.

“Transparency is key to maintaining integrity and trust when developing nurse-educator programs,” says Metil. “If we are training nurses on how to use inhalers properly as part of an unbranded nurse-educator program around asthma, we’ll demonstrate every inhaler on the market. But when we are developing branded nurse-educator programs around a specific product, there is no hidden agenda — it’s obvious we are training nurses about the specifics of a given drug or medical device.”

The role of sales reps

Critics of pharma outreach to nurses, NPs and PAs are most vocal in their opposition to pharma detailing sales reps, who they claim can have a coercive impact on their unsuspecting targets.

“When I was in private practice, it seemed like the pharma reps were coming in every day, bringing in lunch, and we were all obliged to sit through their presentations,” says Barnard FNP Herlick. “A lot of nurses feel underpaid and underappreciated, so they appreciate the ‘free lunch’ but at a certain point, you realize you will be under their influence, and you always have to keep your guard up and keep the company’s marketing motives in the back of your mind. Studies show that these types of activities definitely influence nurses’ attitudes about specific medications.”

In a study published in March 2009 (J Adv Nurs. 2009 Mar; 65(3):525-33), Nancy Crigger, PhD, MA, ARNP, BC, Associate Professor in the Dept. of Nursing at William Jewell College (Liberty, MO), reports that FNPs viewed pharma marketing uncritically as educational and beneficial, and they perceived other providers — but not themselves — as influenced by pharma marketing practices. According to Crigger and her co-authors, “lack of education and participation in marketing, and psychological and social responses may impede family nurse practitioners’ abilities to respond critically and appropriately to marketing strategies and the conflicts of interest that they create.”

“The influence of marketing on physician prescribing has been widely researched,” says Crigger. “Our study suggests that pharma marketing is already widespread among FNPs (who are also being given greater responsibility for prescribing some types of medicine) and that these individuals fail to recognize how they are being influenced by this practice.”

However, Brigner from PhRMA counters those claims, saying: “The federal government has been very aggressive when it comes to pharma sales reps. Their messaging (whether it’s directed at doctors or nurses) must adhere to the FDA-approved labeling and they cannot talk about off-label use. Our focus groups confirm that most nurses and nurse practitioners don’t have the time to seek information on their own, so they appreciate getting credible educational materials, and they find their interactions with competent, well-trained pharma reps — who really know the evidenced-based story behind the drug franchises they represent — to be a very important source of such information.”

“It makes sense that — given the thousands of pages of data they have developed around them — well-trained reps from the companies are most knowledgeable source of information about these drugs and should be allowed to present this information to the healthcare professionals who most need it most,” she adds.

However, not everyone agrees. Critics suggest that any continuing education programs related to disease awareness and medication management should be taught by impartial educators and not by the pharma industry.

“Numerous studies have found that doctors, regardless of seniority, tend to have poor understanding of marketing and of their own vulnerability, decisionmaking processes and conflicts of interest,” says Annemarie Jutel, RN, PhD, Associate Professor at Otago Polytechnic (Dunedin, NZ). “Nurses are even less well-studied in this regard, but are likely to have similar difficulties, exacerbated by their relatively meager training in pharmacology, statistical inference and critical appraisal.”

“Nurses and NPs can be pretty naïve and they need to be schooled to recognize when the information they are being presented may be coercive or persuasive and not truly educational or objective,” adds Crigger.

In a 2008 publication (Jutel A, Menkes DB, Soft targets: Nurses and the Pharmaceutical industry, PLoS Medicine, February 2008, Vol. 5, Issue 2, e5), Jutel and her co-author call for a three-pronged strategy to reduce drug company promotion to nurses: Nurses and nursing students must be trained to understand and manage the impact of commercial drug industry outreach directed at them; institutional guidelines, policy and quality assurance protocols should be developed to complement such education and prevent the intrusion of external interests in clinical decisionmaking at the bedside; and ongoing research must be conducted to gain a better understanding of nurses’ role in, and influence on prescribing, so that nurses don’t become “soft targets for pharmaceutical promotion,” she says.

“Educational outreach must be independent of any influence from those who stand to benefit from the sales of those medications,” says Jutel. “We must divorce the commercial interest from the clinical interest — we’ve got to break that chain.”

“As nurses, we can’t just vilify the drug industry, and I do believe there is a place for pharma involvement in the education process, but we need to get it to a place where the information that is presented is uniformly and consistently balanced, evidence-based and peer-reviewed,” adds Crigger. “Dinners and lunches — all that stuff needs to stop. Anything that comes with gifts is not appropriate. We need to develop creative ways that really extricate pharma companies from anything that can create potential conflicts of interest when it comes to influencing nurses’ decisions around medications.”

Even sampling programs are under fire. While many think they are useful for patients, others view the practice as inherently wasteful, as the samples often end up getting thrown away. “A far more effective approach would be to give out vouchers that the patient could take to the pharmacy to get a free sample or rebate,” says Crigger (see story on p. 1 of this issue).

Nonetheless, PhRMA recognizes that appropriate interactions between drug makers and all players in the medical community require adherence to prevailing legal requirements and voluntary ethical standards. Toward that end, last January the group updated and enhanced its voluntary “Code on Interactions with Healthcare Professionals,” which was last revised in 2002. The update reaffirms that interactions between company representatives and healthcare professionals “should be focused on informing the healthcare professionals about products, providing scientific and educational information, and supporting medical research and education.” It spells out a variety of restrictions on the ways in which drug makers can interact with healthcare providers, and prohibits the distribution of branded reminder object.

Healthcare providers such as nurses are included in the legislation passed earlier this year restricting interactions between them and the pharma industry. These include Massachusetts’ “Pharmaceutical and Medical Device Manufacturer Conduct” code, and Vermont’s expanded Pharmaceutical Marketing Disclosure Law. Several other states, including California, Maine, Minnesota, Nevada, West Virginia and the District of Columbia have similar (although less onerous) disclosure laws in place, and in 2008, nine states proposed legislation similar to the Massachusetts, according to a client advisory alert by The Mintz Levin Healthcare Group (Washington, D.C.).

The potential for a patchwork of onerous state rules has motivated the drug and device industries to lend their support for the Physician Payment Sunshine Act of 2009, sponsored by Senators Charles Grassley (R-IA) and Herb Kohl (D-WI), which would create federal mandates for manufacturers and group purchasing organizations to disclose all payments or transfers of value to physicians worth $100 or more. PC

Who Can Prescribe, Who Cannot?

While there are numerous types of nurses and particular licensing and certification requirements varies state by state, all nurses can be categorized by one critical distinction — those who (in addition to administering prescription medications to patients), are allowed to write prescriptions themselves, and those who are not.

Once nurses have completed their primary education (via a four-year BSN degree, a two- or three-year associates’s degree at a junior or community college, or a hospital diploma via a two- or three-year, hospital-based nursing program), they can become licensed as a registered nurse (RN), an advanced practice nurse such as a nurse practitioner (NP), or a licensed practical nurse (LPN).

Among these three, LPNs have the least autonomy, and must carry out their nursing functions under the direct supervision of a physician or RN. RNs enjoy greater autonomy in the overall provision of care and administration of medications, but they cannot write prescriptions themselves.

Only advanced practice nurses such as nurse practitioners (NPs) have the certification required to allow them to write prescriptions themselves. NPs have master’s degrees or advanced clinical training beyond that required for an RN, and may further specialize in adult or family practice, pediatrics, or anesthesia.

The nurses who aren’t there

A 2008 online poll conducted by the American Nurses Association (ANA; Silver Spring, Md.), which drew more than 15,000 responses, indicated that more than 7 in 10 nurses said that staffing on their unit or shift is insufficient, and more than half (about 7,900) said they are currently considering leaving their position.

One particular problem is a persistent shortage in the number of qualified nursing instructors, which has become a critical bottleneck that is already hampering future growth of the nursing workforce. For instance, while industry-wide outreach efforts in recent years have been successful in enticing more students to pursue nursing degrees, US nursing schools are currently operating at capacity due to a shortage in qualified nursing instructors. As a result, roughly 50,000 qualified applicants will be turned away from baccalaureate and graduate nursing programs this year, according to industry estimates.

This trend, coupled with the pending retirement of today’s older nurses will lead to a projected shortfall of 260,000—500,000 RNs by 2025.

Meanwhile, the oncology field is one area where pending doctor shortages are expected to result in greater responsibility for NPs and PAs. For instance, a 2007 study of the oncologist workforce by the American Society of Clinical Oncology (ASCO; Alexandria, Va.) and the Association of American Medical Colleges (Washington, D.C.) projects that the demand for oncology-related doctor visits will grow by 48% by 2020, yet the number of oncologists during that same period will grow by just 14%. This disparity will create in a shortage of 2,500 to 4,000 oncologists.

That study found that 56% of oncologists currently use NPs and PAs in their practice, and that those who do have higher visit rates from patients compared to those who do not. Having identified the increased use of such “non-physician practitioners” as a possible way to manage the pending shortage of oncologists, ASCO recently announced a follow-up study — the Study of Collaborative Practice Arrangements, to be published in 2011. PC