SD9 - Study of the Need to Regulate Pharmacy Technicians


Executive Summary:
Senate Joint Resolution 61, patroned by Senator Yvonne Miller and passed by the 1998 Session of the General Assembly, requested the Virginia Board of Pharmacy to examine the need to regulate pharmacy technicians. The resolution refers to the integral role of the pharmacist in providing health care along with the additional responsibility to provide patient counseling on prescriptions. Demands on pharmacists’ time are requiring them to employ persons who are not regulated health professionals to “perform important and responsible activities, such as counting pills and distributing the prepared prescriptions”. (See Appendix I)

In the words of the resolution, “given the complexity of prescriptions and their lack of formal training, pharmacy technicians are placed in a situation where serious mistakes could occur”. The resolution further expresses the concern that “many citizens are unaware that untrained or only moderately trained personnel are handling their prescriptions”. To address the “concerns about the lack of regulatory purview over the activities and training of these technicians,” the Board of Pharmacy was requested to examine the need to regulate pharmacy technicians and present its findings to the Governor and the 1999 General Assembly.

To achieve broad representation of pharmacy practices, the Board utilized the Regulation Committee of the Board and invited several additional persons to serve on a Task Force for consideration of findings and development of recommendations to the Board. Those persons represented the Virginia Pharmacists Association, hospital practices, retail chain pharmacies, independent pharmacies, and pharmacy technicians.

In conducting the study and making its report to the 1998 General Assembly, the Board of Pharmacy has examined the need to regulate pharmacy technicians according to the criteria for regulation established in 1992 by the Board of Health Professions and reaffirmed by that board in 1997. The criteria and comment as to their applicability are as follows:

Criterion 1: Risk for harm to the consumer.

The unregulated practice of the health occupation will harm or endanger the public health, safety or welfare. The harm is recognizable and not remote or dependent on tenuous argument. The harm results from (1) practices inherent in the occupation, (2) characteristics of the clients served, (3) the setting or supervisory arrangements for the delivery of the health services, or (4) from any combination of these factors.

If current Virginia pharmacy laws and regulations are strictly followed, the risk of harm to the consumer if pharmacy technicians are not regulated is minimal. Current law and regulations requires that all work performed by a pharmacy technician be checked and verified by a registered pharmacist. Hence, the risk of harm to the consumer resulting directly from a pharmacy technician is small. The problem arises, however, when the pharmacist is unable to adequately supervise pharmacy technicians. This failure to adequately supervise may be due to time constraints imposed by federal OBRA'90 requirements or state law requirements (i.e., prospective DUR, patient profiling and counseling), demands by upper management to increase sales without adequately increasing pharmacy personnel, or low compensation by third party payers or other financial issues where pharmacists cannot afford to hire additional pharmacists to meet increasing demands. Changes within the pharmacy profession itself may also encourage pharmacists to assume more clinical responsibilities. These added responsibilities may cause a pharmacist to spend time on other activities rather than on the close supervision of the technician.

Several other potential situations regarding pharmacy technicians may pose a risk of harm to the consumer. Currently, there is no way to track pharmacy technicians as they change jobs. A pharmacy technician may continue to work in the pharmacy field even if they have diverted or abused drugs, have been convicted of a felony or have willfully acted negligent while working in a pharmacy in the past. The risk of harm to the public results when a pharmacist is unaware of past or current problems. Although the law requires that a pharmacy technician must be directly supervised by a pharmacist, many times the pharmacist does not actually watch the technician perform the task. Therefore, a mistake may be made by the pharmacy technician and, if the mistake is not reported to the pharmacist, the pharmacist may not know about the error. The risk of harm to the consumer in these potential situations is very real.

Criterion 2: Specialized skills and training.

The practice of the health occupation requires specialized education and training, and the public needs to have benefit by assurance of initial and continuing occupational competence.

While there is specialized education and training needed to perform the tasks of a pharmacy technician, there is currently no training mandated for technicians in Virginia. Most pharmacy technicians receive their training on-the-job. The type of specialized skills a technician possesses depends on the practice setting, their job function and their employer's needs. In some pharmacies in Virginia, technicians may only be allowed to remove drug from shelves, count out the appropriate number of tablets, type labels and perform clerical duties involving inventory and third party payers. Whereas in other pharmacies around the state, pharmacy technicians under supervision may be allowed to enter prescriptions into the computer, enter information into the patient file, reconstitute oral liquids, compound medications for dispensing, do pharmacy calculations, prepare IV and parenteral nutrition solutions as well as chemotherapy, and work in a controlled substance vault.

Technicians should have a working knowledge of pharmacy laws, how to read prescriptions and enter information into the computer, how to label prescriptions with appropriate auxiliary labels, how to compound preparations, how to prepare intravenous solutions using aseptic technique and what precautions to exercise when handling medications (e.g., chemotherapy). Most of the above skills are hospital oriented and taught on-the-job, but even community technicians must know about pharmacy law, how to read prescriptions and how to compound. Also, with the increase the home health companies, many must also learn the skill of aseptic technique.

Criterion 3: Autonomous practice.

The functions and responsibilities of the practitioner require independent judgment and the members of the occupational group practice autonomously.

The independent judgment required for a technician depends on the practice setting and what tasks technicians are allowed by their employers to perform. If only counting tablets, placing into the appropriate container and labeling the container, which is then checked by the pharmacist, not much independent judgment is involved. However, when doing calculations and compounding or selecting the drug for filling the prescription, however, there is a higher degree of judgment and accuracy required. While pharmacists are supposed to be supervising a technician and checking all of their work, there are many times when the pharmacist is not constantly watching the pharmacy technician perform the task. The pharmacist depends on the technician to be honest and responsible and must trust the technician to let them know if they made a mistake.

According to Virginia law, the pharmacist must directly supervise all unlicensed personnel, must initial and verify all work a technician performs and assumes all responsibility for the final product, therefore independent judgment of pharmacy technicians is minimal. All semi-judgmental tasks given to them must always be checked by the pharmacist by law. Hence, what autonomy technicians are given is minimized. Unless legislative or regulatory changes are made so technicians' responsibilities are increased, independent judgment will continue to be minimal. Currently in Virginia, pharmacy technicians do not make choices regarding doses or product selection, they perform no patient counseling or advising, they do not make final checks before dispensing, and they are not allowed to accept call prescriptions or refill authorizations.

Criterion 4: Scope of practice.

The scope of practice is distinguishable from other licensed, certified and registered occupations, in spite of possible overlapping of professional duties, methods of examination, instrumentation or therapeutic modalities.

The 1996 study of the need to regulate pharmacy technicians by the Board of Health Professions compared their practice to that of dental assistants who are not regulated by the Board of Dentistry. However, it might be more appropriate to compare the practice of pharmacy technicians to veterinary technicians, radiologic technologists-limited, or nursing assistants – all of whom are licensed or certified by boards within the Department of Health Professions. Comparisons with other regulated professions may not be informative for this study. Comparisons with the regulation of pharmacy technicians by other jurisdictions in the United States may provide more information about the current practice of technicians and the need to regulate. (See Appendix III)

The scope of practice of pharmacy technicians is distinguishable from that of pharmacists. Pharmacy technicians are not accountable for their mistakes, they are not allowed to practice pharmacy, and they cannot counsel patients or advise other health care professionals. Technicians are supposed to perform non-judgmental duties while being directly supervised by a registered pharmacist. While these duties are not currently listed in Virginia pharmacy regulations, a list of duties that only a pharmacist can perform is outlined.

Criterion 5: Economic impact.

The economic costs to the public of regulating the occupational group are justified. These costs result from restriction of the supply of practitioners, and the cost of operation of regulatory boards and agencies.

The economic impact of regulating pharmacy technicians is difficult to predict. If they are allowed to assume greater responsibility because of education and certification, pharmacists may be able to spend more time on pharmaceutical care, which should improve patient outcomes and decrease overall health care costs. Amendments to current regulations regarding the pharmacist to technician ratio may also occur with increased technician responsibility. If the pharmacist to technician ratio is increased from 1:1 to 1:3 if all technicians in the pharmacy are certified by PTCB, as is proposed by the Board of Pharmacy, the cost of health care may be affected. Care must be exercised to ensure that technicians are supervised by a pharmacist at all times and cannot make decisions of independent judgment. Failure to do so could result in potential medication errors that would greatly outweigh any potential benefit of technician regulation.

Because the concept of pharmacy technician regulation is relatively new, the available economic data regarding their regulation is minimal. Limited information is available about the average pharmacy technician salaries in the United States, and even less information is available about salary differences between regulated and unregulated technicians. While the Virginia Association of Chain Drug Stores opposes regulation of technicians based in part on a contention that it would increase cost, their comments state that “no study has been undertaken attempting to quantify this increase in cost”. Consequently, a cost-analysis can not be provided with any accuracy.

Criterion 6: Alternatives to regulation.

There are no alternatives to State regulation of the occupation which adequately protect the public. Inspections and injunctions, disclosure requirements, and the strengthening of consumer protection laws and regulations are examples of methods of addressing the risk for public harm that do not require regulation of the occupation or profession.

While pharmacists continue to assume responsibility for the actions and training of pharmacy technicians on an individual basis, changes in the pharmacy profession and in the delivery of health care may have increased the risk of harm to the consumer.

There are several alternatives to regulation which may include:

A requirement for pharmacy technicians to be formally trained by a pharmacist, using a training program approved by the Board. The training may be completed either on-the-job or prior to employment to ensure that pharmacy technicians have the knowledge required to perform designated tasks in the pharmacy.

A definition of pharmacy technicians in Virginia regulations/statutes according to pre-requisites for employment and the duties that technicians are allowed to perform. Further defining of pharmacy technicians may decrease the potential harm to the consumer by limiting their duties. If definitions are too narrow, however, they may hinder the pharmacists’ ability to provide pharmaceutical care to his patients and fulfill OBRA'90 and state counseling requirements.

Criterion 7: Least restrictive regulation.

When it is determined that the State regulation of the occupation or profession is necessary, the least restrictive level of occupational regulation consistent with public protection will be recommended to the Governor, the General Assembly and the Director of the Department of Health Professions.

If the regulation of pharmacy technicians is necessary, the least restrictive level would be registration, which is favored in the “White Paper on Pharmacy Technicians”, as endorsed by the American Pharmaceutical Association and the American Society of Health-System Pharmacists. Certification by the state would constitute title protection and would be confused with the private certification offered through examination by the PTCB. Licensure would imply a level of independent practice inappropriate for the technician, who should continue to work under supervision of the licensed pharmacist who remains accountable for the quality and safety of services provided.

Findings of the Board of Pharmacy:

Information gained from the survey of pharmacies indicates that 90% employ fewer than 6 technicians with a mean number of 3.8 per pharmacy; the mean drops to 2.8 per pharmacy if only community/retail pharmacies are examined. Hospital pharmacies reported that 84% of their technicians had worked 3 years or longer; only 2% had worked less than one year. On the other hand, 15% of technicians in community pharmacies had worked less than one year, and 52% had worked 3 years or longer. Technicians in hospitals are more likely to work a full 40-hour week, while more of those in community/retail settings work less than 40 hours a week.

Almost all pharmacies report that their technicians are trained on-the-job. In addition, approximately 25% report that there was formal in-house training and self-study coursework. Most had their competency checked by observation of the pharmacist; only 15% reported their technicians had national certification.

In evaluating the risk of harm to the patient, any of the mistakes/errors - if they were to go undetected – could have catastrophic results for a patient. The risk of harm is recognizable and not based on tenuous arguments. What is debatable is the risk of an error going undetected by a professional pharmacist who has the responsibility for supervising the work of the technician. By regulation, that supervision is required to be direct and that drug is not supposed to be delivered to the patient without checking by the pharmacist. In practice, that may not always be the case, judging from letters the Board has received from pharmacists and technicians.

Pharmacists estimated that the typical technician makes about 3 mistakes per week. The mean (or average) number is 6.5 mistakes/errors per week, meaning that a number of those surveyed reported relatively large numbers of mistakes/errors by their technicians. The number of mistakes/errors does not seem to be related to the type of training, but instead has more to do with the experience of the technician and to whether the technician works part-time or full-time.

The mistakes that appeared on the survey as being made either often or occasionally included: wrong drug selected from stock (31.4%); wrong drug selected from computer (23.2%); wrong direction for use (22.2%); miscalculation of dose/quantity (16.2%). Persons who commented on the survey mentioned counting errors and incorrect information being given to a patient most frequently. While the press has reported egregious cases of prescription error, a scientific study on prescription error has not been conducted to indicate either the extent of the increase in errors or the involvement of technicians in those errors.

All indicators reveal that the practice of pharmacy is evolving as a result of the changes in health care delivery systems, financial pressures of managed care, workload issues, legal requirements for drug reviews and counseling, the extension of pharmacy education from five to six years with an emphasis on training the pharmacists to provide patient care in addition to dispensing prescriptions. It is logical to assume that the use of technology (robotics, automated dispensing machines, etc.) and technicians will become an increasingly important aspects of pharmacy practice.

Loss and theft reports indicate a significant number of units of prescription drugs being diverted by employees of pharmacies. If a pharmacist is involved in that diversion, a disciplinary case is opened by this Department. If a technician is involved, there would be no report made and no disciplinary action taken. The technician may be able to be re-employed by another pharmacy unaware of a prior history of abuse or diversion.

The issue of the public’s lack of knowledge about who is filling their prescriptions and what is the training and experience of such persons was not specifically addressed by this study. Requests for public comment did not product comment from consumers, and the Board did not attempt to specifically survey consumers of pharmacy services.

Based on the criteria established by the Board of Health Professions, the practice of pharmacy technicians does not warrant licensure. It is not an autonomous practice with highly specialized, formal education and training. Though the risk of harm to the consumer is significant, there are adequate safeguards currently in place to minimize that risk.

Likewise, state certification of pharmacy technicians would provide title protection but would not provide any additional assurance of competency or safeguards from the risk of prescription error or drug diversion.

Registration of technicians would provide a means of tracking technicians who have diverted or abused drugs and would offer the possibility of establishing minimal requirements for a technician to register.
Final Recommendation of the Board of Pharmacy:

The Board recommends that no changes in law or regulation for the regulation of pharmacy technicians are necessary. It would consider a requirement that pharmacists, pharmacy interns, pharmacy technicians or technician-trainee be clearly identified as such to the public.