Pharmacy technicians face states' scrutiny, regulation

Overworked pharmacists rely increasingly on pharmacy technicians to help process a growing volume of prescriptions and perform administrative work, but the national debate over how technicians should be regulated and certified has yet to be resolved.

Data through March 2009 from the National Association of Boards of Pharmacy (NABP) reveal that of the 50 states and the District of Columbia, Guam, and Puerto Rico, 42 regulate pharmacy technicians. Eight states - Colorado, Delaware, Georgia, Hawaii, Michigan, New York, Pennsylvania, and Wisconsin - do not, while Florida, Guam, and Ohio only recently have adopted regulation.

A 2008 poll commissioned by the Washington, D.C.-based Pharmacy Technician Certification Board (PTCB), which has been working toward national credentialing since 1995, found that more than 85 percent of Americans mistakenly believe pharmacy technicians are uniformly trained and certified.

Ohio case spurs legislation

The events that led to the new Ohio regulations illustrate the sometimes opposed forces involved in the issue of certification.

In January 2009, Ohio Governor Ted Strickland signed a law that mandates qualification of the state’s pharmacy technicians by age, schooling, competency examinations, and background checks, and includes criminal penalties for employers who fail to comply. The law was in response to the tragic death in 2006 of Emily Jerry, a toddler who died from a lethal dose of sodium chloride in chemotherapy medication.

The hospital pharmacy technician had compounded her own normal saline base solution instead of using a commercially prepacked IV solution bag. She had prepared the intravenous treatment with more than 23 times the concentration of sodium chloride, poisoning the child, who slipped into a coma and died. The supervising pharmacist, who failed to catch the technician's mistake, lost his state license and pleaded no contest to involuntary manslaughter. He has been sentenced to six months' incarceration and six months of house arrest.

The pharmacy technician was never disciplined or charged with any crime because at the time Ohio had no laws regulating the training or testing of pharmacy technicians. She resigned from the hospital, but found work as a technician at another local pharmacy.

Ohio State Sen. Timothy J. Grendell, sponsor of “Emily’s Law,” worked with the Jerry family, the National Pharmacy Technician Association (NPTA), the Ohio Pharmacists Association (OPA), and the Ohio Society of Health-System Pharmacists to pass the bill that sets standards for the state's pharmacy technicians.

Under the new rules, technicians in Ohio must be at least 18 years of age, have a high school diploma or GED, pass a certifying competency examination approved by the Ohio State Board of Pharmacy, and clear state and federal criminal records checks. Technicians already employed on the law's effective date have 18 months to pass the exam. “It was the toughest fight I have ever had, to get that legislation passed,” Grendell said of Emily’s Law.

He hopes the new legislation will be a model for other states.

National vs employer-based examinations

Both the NPTA and the American Society of Health-System Pharmacists (ASHP) promote a national certification exam as critical for a qualified pharmacy technician workforce.

However, Ohio law allows either national certifying exams, such as those offered by the PTCB and the Institute for the Certification of Pharmacy Technicians, or employer-based exams that are more specific to individual employers’ requirements and have been approved by the Ohio State Board of Pharmacy. NPTA chairman and CEO Mike Johnston, CPhT, does not like employer-provided certification.

“NPTA believes that all pharmacy technicians should be required to be registered, complete a standardized formal training program, pass a nationally accredited certification exam, and complete ongoing continuing education accredited by the Accreditation Council for Pharmacy Education in order to be able to practice as a pharmacy technician,” he wrote in an e-mail.

The ASHP agreed. “By choosing a nationally accredited examination, rather than individual employer-based certification examinations, the public is better assured of a consistent and appropriate measure of skills and competencies,” said Geralyn Trujillo, MPP, the association director for state government affairs. National examinations assess the duties and responsibilities that should be required of all pharmacy technicians regardless of their practice settings, she said.

According to Johnston and Grendell, when the Ohio State Board of Pharmacy first met in committee to define board-approved examinations under Emily’s Law, it appeared to sidestep the legislation's intent by allowing chain-store pharmacies and large mail-order houses to influence what type of exam would best determine competency. The Board originally ruled that either national certification tests or individual employer-sponsored exams would be acceptable, but the ruling also allowed employers to determine the content of, and administer their own, examinations, and their tests would not be preapproved by the state pharmacy board unless it requested a review. In NPTA's opinion, said Johnston, this action rendered the law “useless.”

Grendell and William T. Winsley, MS, RPh, executive director of the Ohio State Board of Pharmacy, revised the language to specify that acceptable competency examinations would be provided either by a national pharmacy technician certification program accredited by the National Commission for Certifying Agencies or by an employer, after board approval and with specific requirements for content and administration. Such approved employer-provided examinations would be valid only for that employer's workplace.

The amended examination rule took effect this July. Board Executive Director Winsley said the new rules will ensure the competency of Ohio's pharmacy technicians.

“The responsibility for complying with the law now rests with the employers and there will be criminal penalties if employers get caught using an exam that is not approved by the Board of Pharmacy,” he said.

Grendell said he is “not totally committed” to requiring a national certification exam for pharmacy technicians in Ohio and that specific employer-provided exams testing for competencies expected from its own workforce might be better. “I will watch the situation for a year,” he said. “If the legislation is not meeting its goals, I will push for a national exam.”

Training pharmacy technicians in-house

Walgreen Co. and CVS Caremark use employer-based exams and in-house training to develop technicians.

“We approach requirements on a state-by-state basis and strictly follow those requirements,” said Al Carter, pharmacy affairs manager for Walgreens. “Currently, we use an employer-developed exam based on our American Society of Health-System Pharmacists-accredited training program," he said, noting that Walgreens would comply with Ohio’s new regulations. Walgreens encourages continuing education and offers incentives to its technicians for national certification, Carter said.

CVS operates its own training curriculum that “is designed to meet or exceed the standards of our state boards of pharmacy,” said Michael J. DeAngelis, director of public relations for pharmacy operations. “Our pharmacy technician exam for Ohio is being designed to comply with the new law.” Technician candidates must be at least 18 years old to be considered for employment at CVS and complete its internal pharmacy support staff training, DeAngelis said.

He described the training program as modules of increasing competency that include classroom instruction, self-paced learning, and on-the-job training. In addition, he said, CVS pays the registration fees for eligible employees who take the PTCB exam.

Federal or state standards?

As more states enact laws requiring certification of pharmacy technicians, the federal government has taken notice.

Last year, U.S. Rep. Steven LaTourette (R-Ohio) introduced the “Pharmacy Technician Training and Registration Act of 2008,” or “Emily’s Act,” which would require states to register technicians and certify them through the PTCB exam, and authorize federal grants to establish state registration programs.

The bill cited a 2006 Joint Commission study on hospital dispensing errors that found pharmacists had failed to detect more than 20 percent of filling errors made by technicians. A federal provision requiring states to formally certify technicians would unify “a hodgepodge of laws and standards across the country,” LaTourette said. “Emily’s Act” died in committee, but LaTourette might reintroduce it this year. “The pharmacy industry is opposed to a federal floor for training or certification of pharmacy technicians, so passage is not assured," he said. Some pharmacy associations, including the Ohio Pharmacists Association, do not see a federally mandated certification program as a viable solution.

“OPA believes this is an issue best handled at the state level,” said Kelly Vyzral, director of government affairs. ASHP also believes that state-based regulation allows each state to tailor its requirements to its unique needs. “We believe that the states are more than capable of setting these standards and implementing them,” said director Trujillo. “With over 300,000 pharmacy technicians currently certified by the PTCB examination to date, ASHP believes that the states can and should take the lead and mandate accredited certification on their own.”

ASHP is pushing for state laws that require completion of ASHP-accredited training and PTCB certification. Its Pharmacy Technician Initiative gives state bodies access to ASHP resources to advocate for laws and regulations. According to Trujillo, 19 states so far have partnered with ASHP's initiative - Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, South Carolina, and Wyoming.

This past May, PTCB announced a new recommendation issued by a NABP task force that all boards of pharmacy require their technicians to be certified by the year 2015, in accordance with the Joint Commission of Pharmacy Practitioners Future Vision of Pharmacy Practice.

According to Melissa Murer Corrigan, RPh, PTCB executive director and CEO, consistent requirements for technician certification in every state would be an important first step toward achieving the high standard of safety that patients expect and deserve.

The American Pharmacists Association also supports national standards for training as well as certification of new technicians by the PTCB, and likewise calls for meeting these standards by 2015. The association is encouraging individual state boards to phase in accreditation for current technicians.

Keeping patients safe

As the aging American population consumes a greater number of prescription drugs and the use of pharmaceuticals for primary care and wellness increases, harried pharmacists will need more technicians to help them meet demand.

Appropriate education, training, certification, and registration of the pharmacy technician workforce will ensure what ASHP calls “a culture of safety,” in which medications are dispensed appropriately and the public is protected against harmful medication errors, such as the pharmacy mistake that took the life of Ohio’s Emily Jerry.

“There is no way to eliminate human errors,” said OPA's Vyzral. “Everyone working in a pharmacy is human and you cannot legislate against mistakes. I think the steps Ohio has taken in passing [Emily’s Law] will go a long way to making sure pharmacy technicians are properly trained and in keeping patients in Ohio safe.”

Said ASHP’s Trujillo, “The spirit of Emily’s Law - to prevent such a tragedy from ever occurring again by emphasizing the need for appropriate training and certification of pharmacy staff - speaks to a shared belief and understanding that patient safety is the responsibility of all who are involved in the pharmacy profession.”