Pharmacists have been involved in clinical trials for many years. Typically, this is undertaken in either secondary or primary care and it involves pharmacists in either dispensing the medicines being trialled or in their administration to patients who have agreed to participate in the clinical trial.
Usually, in these trials, one of the groups of chemicals being given to patients is a placebo.
In these cases, the trial has been designed, planned and approved elsewhere by those who specialise in clinical trial design. The pharmacists involved in either the dispensing of, or the administration of the trials materials to patients are merely following the clinical trial protocols that have been established by someone else.
Involvement of pharmacists in either dispensing for, or administering clinical trials medicines to patients (subject to satisfactory protocols being in place) is fully covered for indemnity purposes by the principal indemnity cover provided by dint of PDA membership.
However, some pharmacists are now being asked to get involved in the initial design and planning stages of a clinical trial and this does involve them in a very significant increase in their exposure to liability. Many hundreds of clinical trials are successfully and routinely undertaken in the health service every year. However, highly publicised examples exist where clinical trials have gone badly wrong and numerous patients have been seriously harmed. In such instances it is the designers of the clinical trials process who would be likely pursued by claimants seeking compensation and it is for this reason that indemnity cover for involvement in the design and planning of clinical trials is excluded from the main PDA member’s scheme.
It is however, available upon direct application as a standalone insurance scheme provided by independent underwriters.
Conversely, the underwriters providing solely the planning and design of clinical trials cover will not provide the much wider indemnity cover and other benefits as provided by PDA membership.
To enjoy the wide range of indemnity and other benefits provided by dint of PDA membership pharmacists should complete their standard PDA membership application and then make contact with the specialist underwriters as a separate exercise.
Pharmacists are invited to call 0121 694 6897 or contact piacommercial.com for more details of the specialist independent underwriters.