Annual Report Archives - European Industrial Pharmacists Group (EIPG)

The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

Environmental sustainability: the EIPG perspective


Piero Iamartino Although the impact of medicines on the environment has been highlighted since the 70s of the last century with the emergence of the first reports of pollution in surface waters, it is only since the beginning of the Read more

PGEU annual medicine shortages report

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by Giuliana Miglierini

The situation of medicine shortages is getting worse, with many countries which in 2023 experienced more issues than the previous years, according to the PGEU annual report on medicine shortages. Community pharmacists are on the front line to find suitable solutions to provide patients with the products they need to treat their diseases.

“Despite pharmacists continued best efforts to find solutions, shortages still leave many patients without their prescribed treatment – said PGEU President Aris Prins. – This situation causes frustration and inconvenience for patients and erodes their trust in pharmacists and in the healthcare system. They also cause stress for pharmacy staff and impose an additional administrative burden on pharmacies daily work”.

The main outcomes of the yearly survey
As every year, PGEU (the association representing community pharmacists at the European level) run a survey among its members to assess the current situation of medicine shortages. The survey was run between 4 December 2023 and 17 January 2024; 26 PGEU’s members provided their contribution to the 15 questions (1 answer per country).

All respondent countries experienced medicines shortages in 2023. Only three respondents reported positive improvements over the previous year (Cyprus, Greece and North Macedonia, representing 12% of the total), some other a stable situation (23%). In the great majority of cases (65%), shortages increased with respect to 2022, confirming the already known trend. Among the more significant data, the Netherlands reported 2.292 medicine shortages in 2023 (in comparison the 1.514 registered in 2022), a negative trend that impacted on 5 out of 13 million medicine users. A similar situation was reported by Sweden, where 2.457 packages were reported to be in shortage in September 2023, compared to the 1.615 in 2022. Spain also reported an increase in 36% of medicine shortages compared to the previous year.

The time spent by community pharmacies to deal with shortages almost tripled over the last 10 years, reaching an average of 10 hours per week in 2023.

The lack of anti-infective for systemic use (i.e. antibiotics) is particularly worrying, as it was experienced in 100% of the respondent countries. Slightly lower are data on shortages of medicines for the respiratory system (96% of countries impacted) and cardiovascular systems (92%). Other therapeutic classes often impacted at a European level are medicines for alimentary tract and metabolism, the nervous system, and antineoplastic and immunomodulating agents (77% of countries impacted, respectively). It is significant to note that, according to the report, there are no categories of medicinal products exempt from shortage issues.

The worsening of this trend is also acknowledged by the fact that in many responding countries (27%) the list of medicines facing shortages exceeded 600 references at the time of the survey, and was between 500-600 references in another 15% of countries.

The problem is not only referred to medicines: medical devices are also concerned, with shortages in community pharmacies reported by 69% (+3% vs 2022) of the countries participating to the survey. In this case too, all classes of medical devices are touched by the problem, with higher percentages for Class I (low risk devices – e.g. bandages, thermometers, surgical face masks) (27%) and Class IIa (medium risk devices – e.g. lancets, needles, short-term contact lenses) (23%). In the case of medical devices, only two countries reported the existence of a specific system to monitor shortages.

The impact for patients and community pharmacies
Patients are hardly impacted by medicine shortages. According to the PGEU report, distress (100% of respondent countries) and interruption of therapeutic treatments (88%) are the more frequent inconvenience. In many cases, patients have no other alternative than to buy other more expensive or non-reimbursable medicines (73%), thus increasing the rate of private expenditure for co-payments. The survey also highlights the occurrence of suboptimal treatment with reduced efficacy (73%), a practice that might negatively impact on patients’ health.

These issues can also lead to patients losing trust in the pharmacy, a negative effect reported by 77% of participating countries; employee satisfaction may be also impacted (73%). A very high percentage of countries (92%) indicated that community pharmacies may experience financial losses linked to medicine shortages, due to the dedicated amount of time needed and increased administrative responsibilities.

According to the report, disruption/suspension of the manufacturing process (65%), national pricing and procurement strategies (62%), and unexpected/high increase in demand of medicines (50%) are the main causes identified by pharmacists leading to medicine shortages. In the majority of countries (69%) there are already reporting systems in place for community pharmacists to report shortages.

Different solutions for different countries
It is worthwhile to note that only 46% of countries participating to PGEU’s survey have a commonly accepted definition of medicine shortages at the national level. This definition is incorporated in the national legislation in 19% of cases. Significantly, 35% of respondent countries still do not apply a standardised definition for shortages.

The PGEU annual report also assessed the solutions available to community pharmacists in different countries. Generic substitution is a very diffuse practice across Europe (92% of respondent countries), while far less often encountered are the preparation of compounding formulations (50%), or the adjustment of therapy and posology with a different strength of the same medicine (50%). Both these practices may require the issuing of a new prescription by the doctor in charge of the patient. Some countries are experiencing new approaches to simplify the process. In Germany, for example, a new legal basis was created to allow pharmacists to deviate from the medical prescription without consulting the prescribing doctor upon certain conditions in case of a shortage.

PGEU also calls the European and national institutions to adopt urgent and ambitious measures to better address medicine shortages. The availability of a timely and adequate supply of medicines to patients should be the first priority, to be included in the ongoing revision of the pharmaceutical legislation. This last one should put patients’ interests over commercial ones. An improved compliance to public service obligations of supply chain actors would be also required, as well as the impact of pricing policies on medicines availability and on the security of the supply chain.

Shared electronic communication tools between pharmacists and prescribers (i.e. electronic health records) may prove important to possibly expand the role of pharmacists to handle shortages, by allowing them to substitute the missing product with the most appropriate alternative. Reporting, monitoring, and communication on medicine shortages should be also improved according to PGEU, with action to be taken both at the central (EMA) and national level, e.g. working at increasing the efficiency and effectiveness of joint notification and assessment practices. A greater transparency on shortages data would be also appreciated by community pharmacists, to be achieved in each country through the connection of all medicine supply chain actors and national competent authorities in consistent reporting systems. Last, but not least, PGEU asks for a better recognition and valorisation of investments made by pharmacists and pharmacies to manage shortages.


PIC/S Annual Report 2021

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by Giuliana Miglierini

The Annual Report of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) resumes the many activities and results achieved in 2021, despite the ongoing pandemic that required remote coordination and on-line virtual meetings. To this regard, a written procedure has been used to manage important decisions. PIC/S also supported the harmonisation of the distant assessment procedures used by the various regulatory authorities to run GMP inspections during the pandemic period.

The non-binding co-operative arrangement between international regulatory authorities aims to implement harmonised GMP standards and quality systems in support to harmonised inspection procedures. PIC/S’ new strategic plan for 2023-2027 will be presented at the PIC/S 50th anniversary in 2022. The PIC/S Committee has elected Paul Gustafson (Canada/ROEB) as the new Chairperson for the period 2022-2023; he takes the place of Anne Hayes (Ireland/HPRA).

New memberships and re-assessments

Last year saw the entry into the PIC/S scheme of the Brasilian Agência Nacional de Vigilância Sanitária (ANVISA), one of the main regulators of South America, representing the largest market for medicinal products for this geographic area. ANVISA is the 54th member of PIC/S.

Five other membership applications continued the process of assessment. These include the application of Armenia’s Scientific Center of Drug and Medical Technologies Expertise (SCDMTE), that was requested to update its documentation; the preliminary report should be issued soon.

The Bulgarian Drug Agency (BDA) will benefit of a partial assessment of its application, due to the fact the agency already went through an audit under the EMA Joint Audit Programme (JAP) whose report was shared with PIC/S. Health Canada will also collaborate to this assessment under a MRA procedure.

The Jordan Food and Drug Administration (JFDA) also filed a membership application, as well as another regulator from Africa, the Saudi Food & Drug Authority (SFDA), whose preliminary report is soon expected.

Particularly complex is the case of the application by several Competent Authorities of the Russian Federation that jointly submitted a complete membership application in December2020. A larger team, consisting of a Rapporteur and several Co-Rapporteurs, shall be nominated to better manage the procedure. The involved Russian authorities are the Ministry of Industry and Trade of the Russian Federation (Minpromtorg Russia), the Federal Service for Surveillance in Healthcare (Roszdravnadzor), including the “Information and Methodological Center for Expertise, Accounting and Analysis of Circulation of Medical Products” (FGBU “IMCEUAOSMP” of Roszdravnadzor),the Federal “State Institute of Drugs and Good Practices” (FSI “SID & GP”), and the Federal “Scientific Center for Examination of Medical Devices” of the Ministry of Health of the Russian Federation (FSBI ”SCEMD”).

Among authorities undergoing the pre-accession procedure is the Chinese regulatory agency National Medical Products Administration (NMPA), whose application will be assessed by Jacques Morenas (France/ANSM) as Rapporteur and Raphael Yeung (Hong Kong SAR, China/PPBHK) as Co-Rapporteur.

Reviewing of the pre-accession application is also ongoing for the Analytical Expertise Center (AEC) of the Ministry of Health of Azerbaijan, the Bangladesh’s Directorate General of Drug Administration (DGDA, this 2-year timeframe for the pre-accession expired in February 2021, and a new application was required) and the Drug Regulatory Authority of Pakistan (DRAP), that was invited to apply for membership subject to the implementation of the PIC/S GMP Guide.

PIC/S also run a Joint Reassessment Programme (JRP) in parallel with the EU’s JAP to re-evaluate its members for equivalence on a regular basis. In 2021 the JRP included the reassessment of regulatory authorities from Indonesia (NADFC), New Zealand (Medsafe), and South Africa (SAHPRA).

PIC/S also established new contacts in 2021 with other non-member authorities, including Cameroon’s Laboratoire National de Contrôle de Qualité des Médicaments et d’ Expertise, China’s Institute of Veterinary Drug Control, Cuba’s Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED), and Montenegro’s Institute for Medicines and Medical Devices.

New guidances and revisions of existing ones

Among the new guidances adopted in 2021 are the Annex 2A for the Manufacture of ATMP for Human Use and Annex 2B for the Manufacture of Biological Medicinal Substances and Products for Human Use, that entered into force on 1 May 2021 (PE 009-15). The documents were finalised by the PIC/S Working Group on the revision of Annex 2 of the PIC/S GMP Guide.

The Working Group on Data Integrity issued two other guidance documents that entered into force on 1 July 2021, the Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) and a restricted Aide Memoire on inspection of data management and integrity (PI 049).

PIC/S also issued the Good Practice Guidelines for Blood Establishments and Hospital Blood Banks (PE 005) and the related Aide Memoire to Inspections of Blood Establishments and Plasma Warehouses (PI 008), that entered into force on 1 June 2021. The dedicated Working Group will now address the revision of PI 019 (PIC/S Site Master File for Source Plasma Establishments) and PI 020 (PIC/S Site Master File for Plasma Warehouses).

PIC/S and EMA’s joint Working Group on Annex 1 reviewed the comments received to the second public consultation and drafted the final version of the Annex.

The Working Group on Harmonisation of the Classification of Deficiencies is finalising the revision of the PIC/S SOP on Inspection Report Format (PI 013-3) in order to align it with the abovementioned PI 040-1. The Working Group on Controlling Cross-Contamination in Shared Facilities is as well finalising the revision of its Guidance on Cross-Contamination in Shared Facilities (PI 043-1).

PIC/S is also working to harmonise its GMP Guide and Annexes to the rules established by the European Union, in collaboration with EMA through the PIC/S-EMA Joint Consultation Procedure. Many chapters and annexes of the PIC/S-EU GMP Guide were considered during 2021, including Chapter 1 (Pharmaceutical Quality System), Chapter 4 (Documentation) and Annex 11 (Computerised Systems), Annexes 4 and 5 (Veterinary Medicinal Products), Annex 13 (Investigational Medicinal Products), Annex 16 (Certification by an Authorised Person & Batch Release), and Annex21 (GMP Obligations for Importation to the EU).

Virtual training in the pandemic period

Four virtual training events were organised in 2021, among which a PIC/S webinar for inspectors on ICH Q12 (Pharmaceutical Product Lifecycle Management) that was attended by around350 participants from 50 agencies and 44 different jurisdictions.

The webinar on Distant assessment/Remote Virtual Inspection co-organised with the EU Commission Expert Sub-Group on Inspections in the Blood, Tissues and Cells Sectors (IES) was attended by around 325 participants.

The 2021 PIC/S annual seminar was hosted by the Ministry Food and Drug Safety (MFDS) of the Republic of Korea, and saw the participation of 315 inspectors from 54 authorities.

The 2nd meeting of the PIC/S Expert Circle on Controlling Cross-Contamination in Shared Facilities (CCCISF) was virtually hosted and was attended by 375 participants.

Last year saw also the provision of new harmonised and standardised GMP training activities for inspectors under the PIC/S Inspectorates’ Academy (PIA) initiative, a web-based educational centre also involved in setting up a standardised qualification process of inspectors.