The pharmaceutical file

• Abstract
• Purpose of health policy or idea
• Characteristics of this policy
• Political and economic background
• Purpose and process analysis
• Expected outcome
• References

Featured in half-yearly report: Health Policy Developments 11

Abstract

The national French pharmaceutical association proposed to create an electronic patient file which will allow pharmacists, subject to patients’ approval, to check for all medication consumed by a patient during the past four months, whether it is prescribed by a physician or not. The idea is to enable pharmacists to prevent the use of contraindicated drug combinations which can result in adverse reactions as well as to avoid unnecessary treatments.

Purpose of health policy or idea

The purpose of this policy is to promote coordination, quality and continuity of care by allowing pharmacists to check if a patient, when buying a medicine, runs an iatrogenic risk given his/her entire drug consumption during the past four months.

The pharmaceutical file was authorised by law in 2007; the law entrusted the pharmaceutical association with this task.

An individual electronic pharmaceutical file will thus be created for each insured person, subject to his or her consent. The patients can refuse access to that file at any time. The file contains the identification of the product, quantity and date of delivery. The prescribing physician and the delivering pharmacy cannot be identified from the file.  Patients are allowed to close their file at any time. They can also ask for a print-out of its content, for instance to inform health professionals in case of hospitalization. 

Beyond the necessity of patient's consent, the issue of individual freedoms is particularly addressed in the project. The creation of files required the authorisation of the French data protection agency. The individual files will not be kept by the pharmacists but will be hosted by a highly secured service provider. Each pharmacist would only keep information on the drugs purchased in his own pharmacy, for accounting and reimbursement purposes.

The pharmaceutical file can only be accessed by a pharmacist (or his pharmaceutical assistants) in the presence of the patient: the patient's electronic health insurance card is required as an access key, together with the pharmacist professional e-card. This procedure blocks access by any other health professional to the file. A patient can refuse to introduce some information in his/her own file; in that case a special mention is added to indicate that the file is incomplete.

Main points

Main objectives

The ultimate objective is to improve the coordination of health care and enhance  quality and safety of drug consumption. More specifically, the pharmaceutical file intends to :

• Control and avoid redundant treatments (medication) and adverse reactions due to contraindicated drug combinations;
• Facilitate therapeutic monitoring of patients.

 The computerized network created between pharmacists would also be used to rapidly circulate information on sanitary alerts concerning drugs. At the moment hospital pharmacies are not included in the project, but the idea is to include them gradually.

This project is currently tested in eight departments and, if all goes well, it will be implemented at the national level. In the long-term, the pharmaceutical file could be integrated in electronic personal medical records (see Chantal Cases, Philippe Le Fur. "Electronic medical records". Health Policy Monitor, October 2006, http://www.hpm.org/survey/fr/a8/3), the implementation of which has been delayed several times.

Type of incentives

In the present state of the project, there are no financial incentives/disincentives for the patients who refuse to open a pharmaceutical file. But penalties (in the form of reduced reimbursement) are envisaged for encouraging the use of  personal medical records (PMR). Therefore, in the long term, if the pharmaceutical file becomes a part of PMR, things could change.

The cost of the project is covered by the pharmaceutical association subsidised by the health insurance fund (quality of care subsidies). Hence the pharmacists themselves contribute partly to this project through their annual contributions to the national pharmaceutical association. The pharmacists are motivated to show that they can play a role to improve public health, given the pressures from hypermarkets for ending pharmacists' monopoly on selling over the counter drugs.

Groups affected

Patients, Community pharmacists, Health insurance and public heath authorities

Degree of Innovation	traditional		innovative
Degree of Controversy	consensual		highly controversial
Structural or Systemic Impact	marginal		fundamental
Public Visibility	very low		very high
Transferability	strongly system-dependent		system-neutral

Political and economic background

The French are among the highest drugs consumers in the world for many therapeutic classes. The simultaneous consumption of different drugs, possibly redundant and likely to generate adverse effects, is pointed out to be a serious problem. An estimated 130.000 hospital stays (more than a million inpatients' days a year) are due to adverse drug events. Inappropriate drug consumption is seen not only as a quality problem, but also an element contributing to increasing health expenditure.

The Health Insurance Reform Act in August 2004 had already declared that electronic health records would be created for each insured person (cf. Chantal Cases, Philippe Le Fur. "Electronic medical records". Health Policy Monitor, October 2006, http://www.hpm.org/survey/fr/a8/3 ). This project, initially announced to begin in 2007, has not been operationalised yet, and probably will not be implemented before several years, due to conceptual, technical and financal issues. The creation of a pharmaceutical file has been suggested by the French national pharmaceutical association as a first and simple step towards this objective. At the same time, the pharmacists are increasingly under pressure to justify their place and role in the system, since a proposition is made to free the OTC market. A law passed last month now obliges pharmacies  to dispose a list of non-prescription  products over the counter, which means on the shelves directly accessible by clients. This is  to allow patients to see and compare prices, which are not regulated for OTC drugs. Indeed the price of the same medication can vary significantly between pharmacies even within the same area. 

The pilot implementation started in May 2007 in six geographical areas (départements) to test technical aspects of the project, as well as the acceptability by pharmacists and patients. In February 2008, the data protection agency gave the authorisation for pursuing the experimentation for six more months in these areas and for extending to two more departments and other new places as a second step.

Purpose and process analysis

Current Process Stages

	Idea	Pilot	Policy Paper	Legislation	Implementation	Evaluation	Change
Implemented in this survey?

Initiators of idea/main actors

• Providers

Approach of idea

The approach of the idea is described as:
renewed:

Innovation or pilot project

Local level - yes, see above

Stakeholder positions

Pharmacists consider the file as a tool for strengthening their position in the system giving them a role in promoting quality of care. The pharmacists involved in the experimentation phase consider that the pharmaceutical file works well technically, in particular for transferring data between pharmacies. In the six departments included, 14% of pharmacies have been participating in the experiment. The technical adjustments were relatively simple as  pharmacists use already a specialised professional software to distribute products, to handle their stocks and electronically transmit data to sickness funds for prescribed drugs.

Patients are also largely supportive: the participation rate in the testing pharmacies is about 80%, according to the national pharmaceutical association.

Physicians are rather reserved. At present they feel excluded and the national physicians association declared that they are against the development of another patient file separate from the personal medical file. They asked for the right to have access to the pharmaceutical file for physicians, but until now they have not obtained cause.

Health insurance funds and public health authorities, for the moment, provide both financial and legal support to the project. 

Actors and positions

Providers
Pharmaceutical association	very supportive		strongly opposed
Physicians	very supportive		strongly opposed
Patients	very supportive		strongly opposed
Insurance funds	very supportive		strongly opposed

Actors and influence

Providers
Pharmaceutical association	very strong		none
Physicians	very strong		none
Patients	very strong		none
Insurance funds	very strong		none

Positions and Influences at a glance

Expected outcome

From patients' point of view there might be an improvement in pharmaceutical consumption if pharmacists have more information to play their role in preventing adverse events and contraindicated drug combinations. This prevention is still not guaranteed by the reforms of coordinated care pathways (cf Paul Dourgnon. "Preferred doctor reform". Health Policy Monitor, October 2006, http://www.hpm.org/survey/fr/a8/2) without a centralised medical file.

For pharmacists, the pharmaceutical file gives them an opportunity to enforce patients' trust in their advisory role in consuming medication.. This trust is particularly vital now with their monopoly for selling OTC products being under discussion.  However, the follow-up of auto-medication products in the file is challenging. In order to register these products, patient's electronic health insurance card is required, which is at present only used for prescribed medicine. Patients do not necessarily bring their card to buy an OTC drug. Moreover, women are likely to buy OTC medication for the whole family. In this case, it is not possible to follow up the consumption of individual members of the family.

The government and the Health insurance fund expect to improve quality of pharmaceutical consumption and reduce public pharmaceutical expenditure. Nevertheless, there is no reason for pharmacists not to encourage the consumption of OTC medication so the private drug expenditure might actually increase.

Impact of this policy

Quality of Health Care Services	marginal		fundamental
Level of Equity	system less equitable		system more equitable
Cost Efficiency	very low		very high

References

Sources of Information

www.ordre.pharmacien.fr

n. 2007-127 act, 30th January 2007, article 25, www.legifrance.gouv.fr

Author/s and/or contributors to this survey

Cases, Chantal and Philippe Le Fur

IRDES

Suggested citation for this online article

Cases, Chantal and Philippe Le Fur. "The pharmaceutical file". Health Policy Monitor, May 2008. Available at http://www.hpm.org/survey/fr/a11/2