ADDRESSING THE PROBLEM OF IMMUNOGLOBULIN SHORTAGES FROM A MULTIDISCIPLINARY POINT OF VIEW THROUGH THE CREATION OF A CLINICAL ADVISORY COMMISSION
European Statement
Selection, Procurement and Distribution
Why was it done?
Immunoglobulins are currently used both for the indications included in the SmPC and for other indications with different degrees of evidence and priority. Nonspecific immunoglobulins are blood products obtained by fractionation of plasma. During the Covid 19 pandemic there has been a decrease in donations and therefore a decrease in reserves in blood banks, which has generated a general shortage of immunoglobulins.
What was done?
Creation of a multidisciplinary advisory commission for the evaluation and optimization of the use of immunoglobulins in the current situation of shortage.
How was it done?
A multidisciplinary commission was created made up of a pharmacist, a hematologist, and other specialists involved in the immunoglobulin prescription circuit. Chronic treatments with nonspecific immunoglobulins active between April and June 2021 were evaluated, an immunoglobulin use guide was developed prioritizing those indications with grade of evidence Ia, Ib and IIa and urgency of type A or B(solid evidence and absence of alternatives with equal efficacy)for both chronic and acute treatments. In addition, an emergency stock was established for acute pathology
What has been achieved?
After the intervention, the following were included in the guide for the use of immunoglobulins as priority indications: primary immunodeficiencies, Kawasaki disease (Ia, A), Guillain Barré (Ib, B), Multifocal Motor Neuropathy(Ib, A), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) )(Ia, A), Idiopathic Thrombocytopenic Purpura(ITP)(Ia, A),Secondary immunodeficiencies(Ib, A)with severe or recurrent infections, ineffective antimicrobial treatment, proven failure of specific antibodies and / or serum IgG level <4 gr / l. During the quarter prior to the creation of the commission, 31 patients were treated with immunoglobulins, 77.42% of whom were chronic; the most common indication was secondary immunodeficiency, 41.93%. Total immunoglobulin expenditure in this quarter (from April to June 2021) was 3,075g(mean: 99.2g / patient), with a cost of €15,925.98. While in the following trimester (post intervention)11 patients were treated, 72.73% being chronic, the most common indication was secondary immunodeficiency 36.36%. Total immunoglobulin expenditure in this quarter(from July to September 2021)was 660g (mean: 60g/patient), at a cost of €42,664.05
What next?
Carry out periodic control of active chronic treatments and assessment of the initiation of treatment according to the guidelines established by the Commission
DEVELOPMENT AND IMPLEMENTATION OF A PRE-EXPOSURE HIV PROPHYLAXIS DISPENSATION PROGRAM
European Statement
Clinical Pharmacy Services
Author(s)
Natalia Toledo Noda, Víctor Quesada Marqués, Laura Majuelos Aicart, Milagros Varela González, Maria Victoria Morales León
Why was it done?
Despite advances in the control of HIV infection, the number of people who become infected annually in the island (European ultra-periphery region) remains high. The implementation of a PrEP dispensing program would prevent many of these infections since it is known that there is a high number of undiagnosed infected people. In addition, the implementation would allow legally access to this therapy, being an effective, cheap and easily to use therapy.
What was done?
Development and implementation of a medication dispensing program for HIV pre-exposure prophylaxis (PrEP) in adults.
How was it done?
In 2016, the European Medicines Agency authorized the indication of tenofovir disoproxil fumarate 245mg + emtricitabine 200mg as a preventive treatment. In December 2019 the Ministry of Health incorporated it into the National Health System for people who met certain minimum criteria. The hospital was formed since then with the aim of establishing a prescription and dispensing circuit.
What has been achieved?
The following circuit was established:
1. The primary care physician will screen candidates who want to apply to the program and request an initial study. If the candidate meets the criteria, he will consult the infectious diseases unit.
2. The unit value the entry into the program and carry out clinical follow-up. The request for outpatient dispensing is generated for the Pharmacy Service.
3. The Pharmacy Service informs about how to take the medication and its adverse effects. It is dispensed for a maximum period of 3 months. If any problem related to the drug or lack of adherence is detected, it will be communicated to the doctor.
4. A clinical and analytical follow-up is carried out every 3 months to assess the correct use of the medication as well as the appearance of safety problems (renal function and bone involvement). The continuity in the program is evaluated annually.
Since then, the Pharmacy Service has dispensed medication to 20 users and only one discontinued due to lack of adherence.
What next?
Achieve a reduction in the incidence of HIV, which for years has remained stable. Contribute to generate data that support the efficacy and safety of these therapies in real life. Avoid the illegal sale of these drugs.