Pharmacist Challenges- EU5
The pharmaceutical market is a strongly regulated market with many restrictions. Challenges include price cuts by the government, the inability to expand services, medication non-adherence, and medication shortages.
- In the EU, the main regulatory agencies for specialty pharmaceuticals are the European Medicines Agency (EMA) and the European Commission. Additionally, each country has its own agencies that enact and enforce strict laws for managing drugs and pharmaceutical stakeholders.
A Strongly Regulated Market
- The European Commission challenged ownership rules in the European Court a few years ago. They wanted to expand the market, but the courts stated that the restrictions placed on the number of pharmacies allowed and what they are able to exclusively sell are justified based on public health grounds. Pharmacists in Germany, Italy, and France celebrated this victory. With more and more countries favoring on lifting the restricting bans, no one knows how much longer the monopolies will remain in place. In France, pharmacists are engaged in a fierce battle with their own competition authorities to preserve the OTC monopoly. Even German pharmacists are pessimistic about the chances of excluding chains in the future.
- Critics of the market state that tradition limits customer choice and inflates prices. The EU has pushed to deregulate services for years, which account for 70% of the bloc’s gross domestic product and 90% of its jobs, arguing that doing so could expand the bloc’s economy by almost 2%. The EU in 2010 fined France’s order of pharmacists $5.7 million for cartel activities in the clinical laboratory market.
- With the economic issues facing the EU, many governments have slashed pharmacy budgets. They are not directly cutting payments to pharmacists, but they are driving down the prices of medicines, especially generics. Price cuts are a big problem if the pharmacy relies partly on discounts.
Inability to Expand Services
- The UK is very similar to the US market, with pharmacists providing community services like blood pressure checks, but in the rest of the EU that is not the case. There are legal restrictions that prevent them from doing anything other than dispensing medication. As curious as that sounds, it comes from a strong opposition of physicians. They are paid on a per visit basis usually and do not want pharmacies cutting into any of their billings.
- The Pharmaceutical Group of the European Union (PGEU) is the association representing Europe’s community pharmacists. With the aging population and increased need for medical services, coupled with a physician shortage, they are advocating for a change in the pharmacist's role. This role would be more patient centered and place the pharmacist on the care team fort he patient.
- Community pharmacy could provide the entry-point into the health service, with the community pharmacists acting as a preventive care provider (e.g. screening for chronic diseases) and reliable, rapid diagnostic testing (e.g. for the presence or otherwise of bacterial infections). There are also opportunities; community pharmacists could increase their support for managing minor and self limiting ailments, act as health educators, collaborate more closely with care and / or nursing homes and managing the medication of polypharmacy patients.
- According to the PGEU, medication non-adherence costs the EU $1.35 billion per year in direct and indirect costs. There are 194,500 deaths yearly from not taking medication correctly.
- 69% of medication-related hospital admissions are due to poor adherence.
- 50% of new statin patients will stop taking their medication after 6 months.
- A continuing challenge is meeting patient needs for medication when there are shortages. The European Association of Hospital Pharmacists (EAHP) has called for action on medication shortages since 2012 and it published the first Europe-wide survey on the topic in 2014. Many of the actions called for at that time are currently underway, with increased research on the topic in an EU-funded initiative, the COST Action on medication shortages1 and actions at national level supported by the European Medicines Agency (EMA) and the Heads of Medicines Agencies.
- "EAHP believes that there is an increased risk of medication shortages in 2019 and 2020 because of the manufacturing changes required by the Falsified Medicines Directive and because of Brexit. Many marketing authorizations need amendments because of medications authorized for use in Europe through the UK medicines agency (MHRA). As it is believed that this agency will not be part of the European network post-Brexit, pharmaceutical companies need to examine their marketing authorizations to ensure these are valid for Europe post-Brexit."
Oxford Community Pharmacist Study- France
- Oxford University carried out a community study of challenges that pharmacists faced when dispensing drugs. Out of 165 difficulties in 145 total prescriptions, the most common difficulties encountered were:
- Quality of prescribing form- 60.6%
- Name of physician unspecified- 62%
- Failure in supply chain/logistics- 32.7%
- Drug or medical device out of stock at the community pharmacy- 77.8%
- Date of the prescription missing- 10%
- Drug or medical device out of stock at the manufacturer- 5.6%
- Drug or medical device not reimbursed under French public plans- 3.7%
- Drug or medical device ceased to be marketed- 3.7%
- Insufficient quantity prescribed- 3.7%
- Drug prescribed twice- 1.9%
- Drug marketed in a foreign country, but not France- 1.9%