Boots Pharmacy, part of the largest pharmacy chain in Europe and the United States, has once again found itself in the spotlight for yet another dispensing error. On the 14th of December, the incorrect medication was dispensed to a customer at a Basingstoke, Hampshire branch (United Kingdom). The pharmacist on duty filled the patient’s prescription for Amitriptyline, a drug used to treat insomnia, with a drug of similar name – Amlodipine – used to combat high blood pressure. The patient suffered symptoms for three days, including difficulty breathing, difficulty sleeping, nausea, loss of appetite, and pain in the right calf. This incident comes only four years following a string of dispensing errors from May 2012 to November 2013, which resulted in the loss of three lives.
Due to the nature of the business, the pharmaceutical industry is subject to an additional precautionary step in the process of product flow/sale that is not common in other industries. This step is the prescription process in which, in order for the consumer to purchase the product, they must first be evaluated by a physician who decides on the most suitable medication for that patient, and writes a prescription giving the individual clearance to make the purchase at a pharmacy. At the pharmacy, the prescription is verified, filled, and sold to the patient in the exact dosage, form, and quantity specified by the physician. This extra procedure is vital to ensure patient safety (i.e., that the correct medication is issued to the correct patient). It also presents a strong sense of trust between the patient and healthcare providers as the common consumer has limited knowledge of the medications they consume and therefore rely heavily on doctors and pharmacists to provide them with the correct product. So accuracy is absolutely crucial.
Medication errors can potentially be traced to each step of the prescription process; errors are made in the prescribing, dispensing, preparing, administering, or monitoring of a drug. Much of these errors can be chalked up to the simple fact that pharmacists and other professionals in this field are merely human. Humans are imperfect beings, therefore human error is inevitable and expected. However, mistakes in the medical field are unacceptable as they come with great repercussions and may lead to adverse effects that threaten the health, or life, of a patient. Thus, medical mistakes such as dispensing errors must not be taken lightly and must be addressed rapidly with the utmost importance.
Of the approximated 220 million prescriptions filled by Boots in the year beginning April 2016, 901 medication errors resulting in patient harm were reported to the NHS. Investigations into Boots Pharmacy concluded that these rare dispensing errors were mostly the result of human error – clerical errors, mistaking drugs of similar names and packaging, mislabelling, and more – all of which have procedural policies in place to prevent their occurrences, such as the double-checking procedure by a colleague. However, these incidents have involved numerous pharmacists and technicians at multiple Boots locations. Therefore, these can no longer be considered random errors, but of systemic nature. It emerges the necessity to investigate the causes that lie behind these potentially fatal errors.
Upon employee interviews conducted throughout multiple locations, a common theme became apparent. Pharmacists and technicians were generally unhappy with their working conditions. Many felt overworked and highly stressed, the result of insufficient staffing levels. Many said this has lead to shortcuts in the process and an increase in errors. Additionally, employees felt pressure to meet sales quotas following the company takeover in 2007 by private firm KKR and billionaire Stefano Pessina.
Earning the title of largest pharmacy chain in Europe and the United States, it is clear that the Walgreens Boots Alliance is financially secure enough to equip its branches with an adequate amount of staffing. However, that has not been the case. The reason appears to lie in the tendency of pursuing minimum staffing policies to generate greater profits. Taking into consideration that pharmaceutical chains operate in what can be defined as a sensitive industry, where patient safety should always be first priority, this conduct amounts to a highly irresponsible corporate behavior. Consequently, when frugal company operations motivated by corporate greed take place, thus compromising patient safety, the company must be held fully accountable for its irresponsible actions.
Specifically, in cases resulting in death due to inadequate staffing levels, although difficult to establish a causal link between the business operations and the fatalities under the causation requirement of Corporate Manslaughter, the organization should be considered morally responsible for its unethical business operations and its reputation negatively affected.
It is possible to identify at least four corporate social responsibility issues that must be addressed as a matter of utmost importance.
Absence of adequate regulatory standards
The first issue the pharmaceutical industry is currently facing is the absence of adequate regulatory standards of safety. At the present time, there are no staffing level requirements such as a threshold of pharmacists per number of prescriptions imposed by regulations.
To solve this issue, a mandatory corporate social responsibility measure could be implemented, allowing an independent governing body, such as the General Pharmaceutical Council (GPhC), to set and enforce minimum staffing levels to ensure safe operation in each individual pharmacy. This can be achieved by enforcing a minimum staffing threshold dependent on the average amount of prescriptions filled daily at each individual pharmacy location. The Pharmacy Board of Australia, for example, has a threshold they recommend to pharmacies nationwide, yet do not appear to strictly implement these guidelines. This method is utilized in Boots and other UK pharmacies already, where a workload calculation, like any other business, would determine the appropriate number of employees according to the amount of business they conduct. However, there are no set guidelines in the UK that determine the appropriate level of staffing, so individual companies set their own requirements, making this a conflict of interest when considering profitability. Due to the nature of the industry, there must be a strict, widely accepted level of staffing applied to all pharmacies in the nation to minimize the risk to patient safety. But in the absence of these regulations, pharmacy chains must develop corporate social responsibility measures to hold themselves accountable in regards to adequate staffing when lines become blurred between the business of medicine versus the practice of medicine.
Lack of corporate transparency
Although Boots conducted its own investigation into recent dispensing errors, when asked to release documentation of their own findings, management refused. Additionally, as it emerged from a BBC documentary, when asked about the workload calculation employed in the company’s staffing model, management confirmed staffing levels were within acceptable range but refused to share any more details or the staffing formula used, claiming it is a “company trade secret”. If all internal investigations supported that staffing levels were adequate, making the documentation available should not be an issue. Even if it is the company’s legal right to withhold this information, it is the moral responsibility of the company to be completely transparent with the public by revealing these numbers as customer safety is at stake and is directly affected by staffing levels.
Introduction of mandatory reporting regimes
In the year beginning April 2016, over 17,000 cases were reported to the NHS, but there are no laws requiring that pharmacies report medication errors. This is strictly voluntary, so that number may be much higher. Without proper policies in line, it is difficult to hold these corporations accountable for their actions. Not only must reporting errors to an independent governing body such as the GPhC be mandatory by law, with sanctions applied if the company is not compliant, but the GPhC should also thoroughly investigate any concerns brought to them.
Implementation of incentives and proper protective measures for whistleblowers
Greg Lawton, a former clinical governance pharmacist and manager at Boots, worked on behalf of Boots Pharmacy conducting an investigation into the store’s staffing levels and training protocol. After raising concern to the GPhC to later have his findings dismissed because “there was not sufficient evidence to suggest a risk to patient safety,” Mr. Lawton made the decision to leave the company. But his work was not over, as he acted responsibly and did his part in making the issue known, becoming a “whistleblower” in the matter. It is of utmost importance for our legal systems to provide protection, as well as incentives, to individuals acting on their moral duty to report any corporate malpractice within their organization. The implementation of vital changes within corporations across all sectors, for instance, the recent Cambridge Analytica and Facebook data breach, are often the result of the voice and investigative work of leakers and whistleblowers. In the pharmaceutical industry, however, where these changes will improve patient safety and potentially save thousands of lives, it is critical that programs are in place to foster the ease and comfort in which individuals are able to report serious concerns. An idea could be to introduce a system to reward corporate whistleblowers in the pharmaceutical sector similar to the one that has been recently introduced in the U.S. through the Motor Vehicle Safety Whistleblower Act of 2015, which aims at giving industry insiders a financial incentive to bring to light safety-related problems. Such systems have proved to be very effective as it has been demonstrated by the circumstance that, in March 2018, three former Takata Corp employees were awarded with $1.7 million after they alerted authorities to the risks of deadly airbag inflators that led to the largest recall in automotive history. A system such as this would naturally nourish safer practices in the pharmaceutical sector.