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Qualitative Interview Summary with Doris Corda Penna, Regulatory

20.03.2020

Questions asked during the interview:

• Pouvez-vous vous présenter et raconter votre parcours ?

• Comment est-ce que l’industrie pharmaceutique est-t-elle régulé en Suisse et quelles sont les procédures à suivre ?

• Quel est l’antibiotique le plus utilisé ou le plus prescrit ?

• Que pensez-vous du gaspillage de médicament due aux emballages uniformes ? • Quels seraient, selon vous, les plus gros challengent de changer le système de

distribution ?

• Que pensez-vous du système de distribution actuel ?

• Comment est-ce que les hôpitaux reçoivent-t-il les antibiotiques ?

Translated summary of the interview conducted in French

SJ: Sophie Janett

DCP: Doris Corda Penna

SJ: Could you please introduce yourself, talk about your career so far and what is your role in the company?

DCP: Active since 2001 in pharma industry, PhD in bio chimie, clinical research, worked in many sectors also governance and quality, since 2006 responsible for regulatory affairs department, mainly works in oncology and injectable drugs.

SJ: how is the Swiss pharmaceutical industry regulated, what are the procedures to follow?

DCP: Switzerland is in a blister packaging distribution system, when registering with swissmedics, information about drug stability according to packaging used has to be transmitted, would be a very complex process for pharmaceutical companies if they have to submit stability reports of the drugs for new packaging, as the stability reports are for a period between 6 to 12 months. High admin implication. Every change has to be notified and approved. Studies have to be delivered to swissmedic showing that the drug remains stable in its packaging. This would be a huge process on the technical process to have the new packaging forms approved. Every change made has to be notified to authority Switzerland only works with blisters, after discussion with a pharmacist, most blisters are adapted to the prescribed treatment. It would be interesting to see how much is really wasted. Pharmaceutical companies really try to match their blisters to the most frequent prescribed treatment. Swissmedic asks why this kind of blister has been chosen and pharma has to explain why this number of pill is in the blister. BAG is responsible to supervise all prescription only medication, they will give the price and make sure the number of pills in the packaging is adequate for a certain treatment. During the manufacturing process are various counts done to ensure that nobody interfered during production. Quality norms are in place to make sure each pack is counted at specific

points during production. The number of pills in a blister are based on an average treatment posology.

SJ: what is the most used or prescribed antibiotic in Switzerland?

DCP: Most used antibiotic is co-amoxilin, given for sore throat and wounds SJ: What do you think about medication waste due to prepacked boxes?

DCP: Is not sure that with the law currently in force, a lot of medication is wasted. Waste might also be mostly about the patients not taking their medicine until the end. Patients are also responsible to take their treatment until the end because that is also a reason for waste.

SJ: What would be the biggest challenges in changing the antibiotic system?

DCP: The logistic aspect also has to be taken into consideration, especially for the pharmacist, what he will have to put in place in order to change the distribution system like in Canada. If the distribution system changes that would mean that the pharmacies would not only be a dispensing unit but would also turn into a production site as they have to prepare the exact number of pills, stick the label on it and inform the patient. The pharmacist is the only one allowed to do that, the logistical aspect is therefore immense. Therefore only a few pharmacies in Switzerland still produce some preparation onsite. All this has to be done under very strict regulations. Switzerland has stricter regulations compared to other countries. The producing pharmaceutical company tries to find right packaging, the authorities try to control the packaging needed are available and the OFSP will only refund packaging that make sense for prescription only. Canadian and US pharmacies probably have a certain infrastructure in place for this kind of distribution system that Switzerland has not, which would be a major change for the Swiss system. The major problem in Switzerland is that the leaflet is mandatory, this is not the case for Canada or the US. A leaflet has to be with every sold medication. Leaflet will give information for the patients; however, dosage and treatment lengths will not be available in the leaflet. The information for professionals will be at swissmedic where posology can be found. Dosage might depend on the age and weight of the patients or if the doctor estimates a longer treatment is making more sense. Prescribed treatment will also depend on the severity of the illness, the age and the weight of the patient

SJ: What do you think of the current distribution system?

DCP: Current system in Switzerland is time efficient at pharmacy level, control by pharmacist only takes a few seconds. Changing the distribution system in Switzerland would be a massive change Medication usually comes from factory and are stocked in their destination countries where the pharmaceutical companies have an important inventory, or they delegate the inventory management to third party. Never had the request to have medication in bulk. Happened a few times in the 90’s but very quickly changed to only blisters.

SJ: How are antibiotics dispensed in Hospitals?

DCP: Hospital also receive blisters, but they receive “uni-dose” blisters meaning that each blister will include the name, dosage and composition of the drug to ease the process. Blisters are pre-cut and each blister has a series number.

Appendix 5: Qualitative Interview Summary, Sebastien

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