A Complaint Involving the Dispensing of the High Tech Medicine Revlimid®

The Professional Conduct Committee (PCC) heard a complaint in which a patient had been supplied with the high tech medicine Revlimid® without a valid prescription and not in compliance with mandatory procedures required by the marketing authorisation.

  • The PSI received a complaint from a consultant haematologist stating that the correct procedure to dispense Revlimid® (lenalidomide) had not been followed by the community pharmacy. These procedures are a requirement of the product’s marketing authorisation to reduce the serious risks associated with this drug. The consultant expressed her concern about patient safety because she was aware of a separate recent incident in which a community pharmacy had dispensed Revlimid® to one of her patients, without any of the appropriate documentation being completed.
  • This came to the consultant’s attention when the patient failed to collect the high tech prescription and the prescription authorisation form from the hospital. A prescription authorisation form is required alongside a valid prescription to order Revlimid® from the wholesaler, as per the requirements set out in the ‘Healthcare Professional’s Information Pack produced by the Marketing Authorisation Holder, Celgene.
  • Two pharmacists were the subject of this inquiry. The supervising pharmacist at the time the incidents took place accepted that he supplied Revlimid® on five occasions without a valid prescription. The second pharmacist involved in this complaint accepted that she supplied Revlimid® on one occasion without a valid prescription. 
  • Both pharmacists accepted that over the period of one year they failed to comply with Celgene’s requirements set out in the ‘Healthcare Professional’s Information Pack for Ireland’, including failing to keep the prescription authorisation forms. 
  • The supervising pharmacist stated in his evidence that he was not aware of Celgene’s requirements regarding supply of this product. 
  • He gave evidence that the patient, who was a man in his 60s, had been prescribed this medicine previously and would have been familiar with the medicine, the dosage cycles and the strength he was on. 
  • The second pharmacist had previously acted as the supervising pharmacist for the pharmacy and as such she had completed the training and documentation required by Celgene. In her evidence she stated that on the occasions when the patient presented without a prescription and/or the prescription authorisation form she dispensed the medication as she did not want the patient to break the cycle of chemotherapy, and took the patient at his word that his treatment and course of therapy had not changed.

Important Learnings

Learnings from this complaint should be shared with all staff members. You should review your pharmacy’s policies and procedures which relate to the high tech scheme, and in particular Revlimid® if you have a patient receiving this medicine. You should also review your own knowledge and practice, to help ensure a similar incident does not happen in your pharmacy.

We would like to highlight the following important learnings from this inquiry:

  • Revlimid® is authorised by the European Medicines Authority for the treatment of patients with multiple myeloma. It is structurally related to thalidomide, a known human teratogenic substance that causes severe and life-threatening birth defects. If Revlimid® is taken during pregnancy, a teratogenic effect of Revlimid® in humans is expected.
  • Given the potential serious risks associated with Revlimid®, its marketing authorisation requires additional safety controls to be in place for its supply, including a pregnancy prevention programme. The requirements of this programme must be followed in addition to the normal legal requirements for supply of a high tech medicine.
  • These controls include a requirement that:
  1. all pharmacies must register with Celgene in order to obtain a supply of Revlimid®,
  2. pharmacists must ensure that they have read and understood the ‘Healthcare Professional’s Information Pack for Ireland’ before dispensing Revlimid® to any patient, 
  3. every prescription for Revlimid® must be accompanied by a prescription authorisation form, which has been completed by the prescriber to confirm that the patient has been counselled about the teratogenic risk of treatment with Revlimid®,
  4. the pharmacist should not order or dispense Revlimid® until he/she has received both the prescription authorisation form and a valid prescription for Revlimid®
  5. the pharmacist signs the prescription authorisation form to show that he/she is satisfied that the authorisation form has been completed in full by the prescriber, dispensing is taking place within 7 days of the date of the prescription and that he/she has read and understood the contents of the ‘Healthcare Professional’s Information Pack’, and 
  6. every prescription authorisation form is kept in the pharmacy for a minimum of two years.
  • Both women and men must be counselled before initiation of therapy and throughout, to ensure that the appropriate precautions are taken to prevent pregnancy.
  • As gatekeepers to medicines it is of vital importance that all pharmacists follow the legislation and procedures in place, to ensure the safe supply of this medicine and reduce the risk of harm.
  • The need to provide the pharmacy with a valid prescription and the prescription authorisation form, before Revlimid® can be ordered, should be emphasised to the patient to ensure their understanding of the controls in place and that they receive their medicine in time to start their next cycle. 
  • If the prescribing doctor has not completed the prescription authorisation form the medicine should not be ordered by or supplied from the pharmacy.
  • It is important to reinforce the potential toxicities of this medicine to the patient at each dispensing, and that care must be taken in safeguarding this medication when it is in their own possession. 
  • As a pharmacist it is your responsibility to ensure that you are knowledgeable on the medicines that you are supplying to patients, and this is particularly important for high tech medicines. The marketing authorisation holder will often provide training materials for healthcare professionals or you can review the product’s Summary of Product Characteristics (SmPC), available on the Health Products Regulatory Authority’s (HPRA) or European Medicine Agency’s website. This is necessary to carry out your legal and professional responsibilities to therapeutically review the prescription and provide counselling to the patient. You should not assume that a colleague or another healthcare professional has provided adequate counselling to the patient and you should always confirm the patients understanding of what you have told them. 
  • Patients on Revlimid® are generally reviewed on a monthly basis to assess clinical response and side effects or toxicities, which can lead to changes to the medicines dosage. Therefore, you must review the current, in date prescription to confirm the correct strength and dosage instructions for the period of supply. 
  • When these incidents occurred there was a standard operating procedure (SOP) in place within the pharmacy specific to the ordering, storage and dispensing of drugs under the high tech scheme. This SOP highlighted that pharmacists must ensure that the prescription authorising supply is valid for each and every dispensing and each prescription must be stamped at the time of dispensing and endorsed by the pharmacist who performed the final check. However, from the actions of the pharmacists it is clear that this was not being followed, as if it had been this poor practice would not have occurred. SOPs should be followed at all times to ensure that a process is carried out to a consistently high standard by all staff members involved, in line with legislation and good practice and to minimise the risk of errors.
  • If you have a patient who has been prescribed Revlimid® there should be a SOP in place in your pharmacy that specifically addresses the requirements for supply of this medicine. All relevant staff members should be trained on this SOP to ensure that they are following it and understand the patient safety reasons for the controls that are in place. Training records should be maintained to document this. 
  • An error log must be completed for all errors made in the pharmacy, the staff members involved informed of the error, and appropriate follow-up regarding the patients care provided. Recording errors should not be used as a way to blame individuals, but rather to encourage an environment of openness and learning, so that procedures can be reviewed and amended, and practices changed to guard against a similar error occurring again.

Further reading to help you review your practice: