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. 2019 Oct 28;9(10):e032892. doi: 10.1136/bmjopen-2019-032892

Table 3.

Perceived medication safety risks and their management measures as identified in the interviews (n=32)*

Potential risk Descriptions of perceived risks with manifestation Methods to minimise risk as identified in the interviews (n=32)
The patient’s medication is interrupted or complicated temporarily or permanently The patient does not know how or is unable to use the administration device correctly (n=19)

  • The patient feels that the new administration device is difficult to use

  • Patient fails to administer medicine or he/she is not able to repeat administration

  • New administration device is not suitable for the patient (handicap, visual impairment)

  • Too wide a range of different devices is available

  • Pharmacy provides medication counselling including device counselling with optional injection training (n=23)

  • The interval† between substitutions should be longer for biological drugs than for generic medicines (n=15)

  • Further training of healthcare professionals on biosimilars (n=13)

  • Consistent, positive attitude towards substitution across healthcare and pharmacies (n=9)

  • A motivating conversation with the patient by a doctor and nurse (n=8)

  • Ensuring at every pharmacy and healthcare visit that the patient can use the device correctly (n=8)

  • Medication monitoring (n=8)

  • The patient knows where to contact in case of problems (n=7)

  • Prescriber can prohibit substitution if necessary (n=7)

  • Evaluation of the interchangeability of devices in a regulatory process (n=6)

  • Dispensing of biologics based on an appointment or pre-order (n=6)

  • Switches and substitution are avoided if medication has not been stabilised (n=6)

  • Evaluation of biological medicines suitable for substitution by the regulatory authority (n=6)

  • Postmarketing surveillance of medicines (n=5)

  • Regional co-ordination/co-operation between healthcare and pharmacies (n=4)

  • Substitution policy prevents shortages by supporting pharmaceutical companies to anticipate the market (n=3)

  • Mandatory reserve supplies of biological medicines (n=2)

  • Providing reliable drug information sources for the patient (n=2)
The medicine is not available at the right time (n=12)

  • The pharmacy does not have the product in stock

  • There is a medicine shortage

The patient does not trust the new medicine (n=11)

  • The patient has benefited significantly from the original product and does not want to change

  • The patient receives conflicting messages from different healthcare professionals

  • The substitution will surprise the patient at the pharmacy

  • Patient is suspicious due to different product appearance and trade names

The patient experiences adverse reactions after substitution (n=11)

  • Reactions to excipients

  • Nocebo-effect

  • Large-scale substitution may reveal problems that were not previously detected

Concern about losing the medicine’s effectiveness (n=8)

  • The development of drug antibodies is accelerated by repetitive switches

  • There is no large-scale experience on repetitive switches

The patient uses two products with the same active substance Based on the appearance or name of the product, it is not possible to determine whether the active substance is the same (n=11)

  • Different appearance of packages

  • Different trade names

  • Generic names can be confusing

  • Patient recognises only the established brand name

  • Demonstrating administration devices in drug counselling (visuality) (n=9)

  • Prescriber can prohibit substitution (n=7)

  • Printing drug lists and checking medication (n=1)

  • The new product is marked with a label that indicates the substitution (n=1)

  • The new product is not delivered too early, so the patient does not have two products at the same time at home (n=1)

  • Pharmacist invalidates the previous prescription when substituting (n=1)
The patient does not understand that substitution has taken place (n=8)

  • Patients with polypharmacy, the elderly, patients with impaired cognition

The patient has two prescriptions for the same active substance (n=3)

  • The patient has a prescription for the original product and another prescription for the biosimilar

The traceability of the product is compromised The biological drug can have long-term side effects (n=8)

  • The product that caused a side effect cannot be traced

  • The interval between substitutions should be longer for biologics than for generic medicines (n=15)

  • Promoting two-way information sharing between pharmacy and healthcare services (n=10)

  • Switches and substitution are avoided if medication has not stabilised (n=6)

  • Introduction of a drug certification system (automatic registration of the dispensed package and batch) (n=6)

  • Development of information systems so that the batch number of the delivered product is also registered in the electronical prescription centre (n=4)

  • Prescriber can check the brand name of the supplied medicine at the electronical prescription centre (n=3)
In case of a side effect, the product cannot be traced (n=5)

  • The physician is not aware of what brand and what batch the patient has used

  • Patient refers only to the originator’s brand name

The patient cannot get into healthcare in case of problems Healthcare is overloaded due to substitution (n=12)

  • Substitution increases patient contact with healthcare

  • Patients with substituted medicine would be in closer follow-up. The patient contacts the physician to obtain a substitution refusal

  • Further training of healthcare professionals on biosimilars (n=13)

  • Consistent, positive attitude towards substitution across healthcare and various pharmacies (n=9)

  • A motivating conversation with the patient by a doctor and nurse (n=8)
The patient does not receive substitution-related advice from a pharmacy ‘On behalf of the patient’ customers (n=5)

  • For example, a relative can apply for a medicine on behalf of a patient

  • Medication counselling with both visual and written material (n=7)

  • Prescriber can prohibit substitution (n=7)
New methods to dispense medicines (n=1)

  • The patient can apply for a medicine from the ‘smart box’ when convenient

The patient is distracted by the support material he receives There may be differences in written material received by the patient (n=2)

  • Material for various products is accumulated

  • Generic and harmonised risk minimisation materials (n=2)
The availability of additional materials may vary by product (n=2)

  • Pharmaceutical company supplies additional product-specific material such as web pages, storage and shipping boxes

*Please note, ‘patient perspective’ can be either patient representative’s view or other stakeholder representative’s assumption on patient’s view.

†In Finland, the substitution interval for generic small molecules (generic substitution interval), eg, how often patient’s medicine could be substituted at the pharmacy, is related to the reference price that establish the reimbursement level and is confirmed quarterly (reference price interval) (The Social Insurance Institution of Finland. Generic substitution and the reference price system. Available: https://www.kela.fi/web/en/medicine-expenses-generic-substitution-and-the-reference-price-system(accessed June 2019)).