In February, the pharmacy manager at one of the country’s largest hospital pharmacies sounded the alarm about his own workplace. The hospital pharmacy in Bergen (SiB) has over 130 employees and supplies important medicines to the whole country. Pharmacy manager Pål Espen Johannessen sent a report of concern to the Norwegian Health Authority and the Norwegian Medicines Agency about the conditions at his own pharmacy, and thought it was a danger to life and health. The reason was that his boss, Jon Bolstad, did not spend money on giving the pharmacy its own operations engineer. For a long time, the pharmacy has struggled with machines that make medicine working poorly. At the same time, it emerged that termination proceedings had been initiated against Johannessen. Bolstad, who is managing director of Hospital Pharmacy Vest (SAV), said Johannessen did not follow orders and instructions from management. It resulted in large protests from the employees of the hospital pharmacy, who collected signatures to prevent Johannessen from becoming the eleventh hospital pharmacist to quit his job since 2010. Then the notices against the top management in the healthcare company began to rain. Had not corrected a five-year-old discrepancy Now the inspection report from the Norwegian Medicines Agency’s visit to Haukeland is ready. It states that Johannessen is largely right in his concern, and believes that Hospital Pharmacy Vest should have sorted things out a long time ago. In total, the Norwegian Medicines Agency has uncovered a total of twelve non-conformities. One critical, four major and seven other deviations which they ask SAV and SiB to correct. The most serious deviation is a five-year-old deviation that has not yet been satisfactorily corrected. – The Norwegian Medicines Agency sees it as serious that the same deviation is pointed out again, the report states. This was revealed by the inspection at the Hospital Pharmacy in Bergen. The Norwegian Medicines Agency inspected the Hospital Pharmacy in Bergen after hospital pharmacist Pål Espen Johannessen sent a report of concern on 13 February 2023. He believes that the pharmacy, which supplies hospitals throughout the country with medicine, is not capable of supplying a number of sterile medicines. The Norwegian Medicines Agency carried out inspections on 20 and 21 February, where one critical, seven major and four other non-conformities were discovered. The Hospital Pharmacy in Vest (SAV) and the Hospital Pharmacy in Bergen (SiB) have received notice of an order to correct the following deviations: Critical deviation: Deviations from supervision of the pharmacy’s manufacturing in 2018 have not been satisfactorily followed up. The discrepancy has been upgraded from “major” to “critical” because the same discrepancy was pointed out and classified as major during the inspection of the Hospital Pharmacy in Bergen in October 2018. This discrepancy is still not corrected. Major deviations: The pharmacy licensee (in this case Sjukehusapoteka i Vest, by managing director Jon Bolstad) has not sufficiently ensured that the pharmacy has access to essential resources with the right expertise to solve technical tasks related to deficiencies, errors and maintenance of production rooms and equipment. “This can result, and has resulted, in periods where the pharmacy is not able to fulfill the conditions regarding delivery obligations in the pharmacy’s manufacturer’s license and professional requirements for pharmacy operations that follow from law, regulations and good manufacturing practice. The pharmacy licensee has not ensured that there is an agreement between Helse Bergen HF and SAV to deliver engineering services to the pharmacy when the engineer who was employed at the pharmacy was transferred to the technical department of Helse Bergen HF in 2019. There is therefore no binding agreement at the date of inspection which ensures the pharmacy access to the necessary technical expertise for the operation and maintenance of rooms and equipment at the pharmacy, even though the pharmacy has in periods received assistance from an engineer employed by Helse Bergen HF”. The pharmacy concessionaire has not established routines and/or an authorization matrix that ensures that recommendations from pharmacies must always be taken before the pharmacy concessionaire decides on appointments, dismissals, suspensions, dismissals and transfers of the pharmacy’s staff. There are a great many employees who report to the same manager in the departments for hospital dispatch and additions. Considering the number of employees, SiB also has fewer managers than the other pharmacies in SAV. Through interviews, it became clear that the department heads also participated in daily operations, and that there was a large turnover of personnel, especially when it came to department heads and pharmacists. This increases the risk that the pharmacy cannot ensure professionally sound operations. Maintenance and repairs of equipment used in the manufacture of medicinal products have not been carried out within the set deadlines. The manufacturing premises do not have a satisfactory clean room standard. A number of deviations linked to environmental controls in several locks to manufacturing rooms class B and C have not been followed up with satisfactory measures. The pharmacy’s routines for qualifying equipment that has been substantially changed and qualifying new loading patterns in autoclaves are deficient. The pharmacy has changed the production pressure for some stock-produced products. The medicine was previously autoclaved in a sprinkler autoclave, but since the autoclave was no longer available, the medicine was instead produced aseptically with subsequent heat treatment in a steam autoclave. Furthermore, the pharmacy has not carried out sufficient control of the aseptic part of the process. Other deviations: The routines for change control have not been used for changes that affect operations and routines in the pharmacy. The deputy role for hospital pharmacists is not described in the quality system and the content of this is therefore not sufficiently accessible to the staff in the pharmacy. The pharmacy’s documentation practices are occasionally deficient. Items that are not essential in the production process are stored in the clean room. The inspectors point out that there is a radio inside the room. – Not positive in any way. Among other things, the Norwegian Medicines Agency states that Sjukehusaapoteka i Vest, as a pharmacy concessionaire, should ensure that there were agreements in place to ensure that operating technicians with the right skills maintained machines and equipment. The Norwegian Medicines Agency believes that SAV, through its managing director, has contributed little to getting such an agreement in place. – This has led to the pharmacy ending up in a situation where they have at times been unable to deliver some of the medicines they manufacture, writes the Norwegian Medicines Agency in the report. Managing director Jon Bolstad says he takes the findings in the report “very seriously”. – This is not positive in any way. We are already in the process of dealing with a part that comes up. We agree that upgrades are needed, but it has a complexity that means it takes some time. – Do you take self-criticism after this report? – There is always reason to be self-critical. I wish that some matters in the report had been clarified earlier. Things have taken too long, and I think that’s very unfortunate, says Bolstad. Leiinga has been given until 24 March to come up with its response to the report. Bolstad says they will use the time in the future to go through the report. HAUKELAND: The hospital pharmacy in Haukeland produces medicine for several of the country’s hospitals. Photo: Gerd Johanne Braadland Eleven pharmacy managers in thirteen years The inspectors also state that there are challenges linked to the workload for managers in the pharmacy. Since 2010, there have been eleven changes of pharmacy managers. At the same time, there has been a relatively frequent change of department heads. The inspectors state that there are far fewer managers per employee at the Hospital Pharmacy in Bergen than at the other hospital pharmacies in SAV. In a five-year period, a total of fifteen people have had leadership responsibilities in the four departments: three department heads in the Department of Pharmaceutical Services six different department heads in Hospital Expedition four department heads in Additive Production three department heads in the Public Department – The frequent replacement of both pharmacists and department heads may be related to a demanding work situation with high workload and a wide range of tasks, write the inspectors in the report. After the inspection has been completed, the head of the department for additive manufacturing has also resigned from his job. The reason was high work pressure, according to the report. In this department, over a hundred chemotherapy treatments are often prepared every day. The Norwegian Medicines Agency is particularly concerned about high work pressure in a department where the consequences of errors are particularly large. – The inspectors believe that it is particularly worrying if the workload becomes too high in such a department, which could mean that the risk of producing a product that is harmful to the patient increases. In 2020, one person died of a chemotherapy overdose in Haukeland. A doctor had made a mistake on an order, so that the ordered dose was ten times too high. The error was not caught in the production department at the Hospital Pharmacy. Both Helse Bergen and the Hospital Pharmacy in Bergen were fined millions in corporate penalties. STANDING BEHIND: Head of department Gunvor Johnsen is among the initiators behind the petition which has been sent to the board of SAV. They ask the board to intervene to stop the dismissal process they believe has been started against pharmacy manager Johannessen. Photo: Sissel Rikheim / news Notice about a culture of fear and work pressure In the last few weeks, a total of three notices have been sent to, among others, the board of Hospital Pharmacy Vest about working conditions at the hospital pharmacy in Bergen. Hospital pharmacist Pål Espen Johannessen believes the company experiences an unsafe working environment, and a significant culture of fear. He believes that the employees are on the verge of unreasonable work pressure, which increases the risk of mistakes. Place trustee for the pharmacists at Sjukehuspoteka, Oddgeir Selaas, has notified. He does not want to go into the details of the notification, but says he has notified via the formal channels. Johannessen’s predecessor, who was in the job until 2020, Roy Rangjord, has also submitted a notice to the board. – Based on what emerges in the media, I can support Johannessen’s portrayal of a poor cooperative climate with management. Something that is also a strong contributory reason why I myself chose to resign from the position, says Rangjord to news. news has also spoken to another former pharmacy manager at Haukeland. This also gives his full support to Johannessen’s experience of the collaboration with the top management. The board of SAV held an extraordinary board meeting at the end of February. The consulting company Deloitte is already in the process of carrying out investigations based on the notification. Trustee Oddgeir Selaas tells about a tough time in the workplace. – It is a difficult situation for us who work here. I have a clear expectation that the notification will be taken with the seriousness it deserves in view of all those involved, Selaas previously told news. – Will not comment on whether he is in danger of losing his job Managing director Jon Bolstad confirms that the pharmacy manager in Bergen, Pål Espen Johannessen, has an ongoing personnel case against him. Bolstad will not comment on whether he feels that it is Johannessen’s version that is now supported in the Norwegian Medicines Agency’s report. – We must distinguish between personnel matters and supervision according to the regulations. I do not want to comment on whether he is in danger of losing his job, says Bolstad. The employees at SiB have also written an appeal in support of Johannessen in connection with the personnel case against him. There are steep fronts between the parties. Bolstad will not comment on whether he experiences a lack of trust among the employees at the Hospital Pharmacy in Bergen. – That is another matter. The notification system must be handled properly. PHARMACY MANAGER: Pål Espen Johannessen. Photo: Gerd Johanne Braadland
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The Norwegian Medicines Agency uncovered twelve discrepancies at the hospital pharmacy – news Vestland
