Medicine shortages in Romania: how to find out, and legal alternatives

In recent years Romania has faced repeated shortages of essential medicines — some chronic (insulins, antiepileptics), others acute (pediatric antibiotics, paracetamol syrup). Here is what the Essential Medicines List with Risk of Discontinuity (MED-ESS) is, how to find out in real time what is unavailable and what legal alternatives you have.

Why shortages occur in Romania

The causes are multiple, but three dominate:

1. Parallel export — distributors buy in RO at a low price and resell in EU countries with higher prices. For Romania, the mechanism of referencing the price to the lowest in the EU (see the CANAMED reference price, CANAMED being the national catalogue of maximum approved medicine prices) is attractive for export. Manufacturers deliver limited quantities to discourage this practice.
2. Global production problems — the COVID-19 pandemic exposed the fragility of supply chains. Active substances (API) come 70-80% from China and India. Disruptions there (factory fires, customs blockages) immediately affect the EU market.
3. Strategic discontinuities — manufacturers sometimes decide to withdraw a product from RO if the market is not profitable (low volume, low regulated price). For old (off-patent) medicines, this is frequent.

The MED-ESS list — the national framework

ANMDMR (the Romanian National Agency for Medicines and Medical Devices) + the Ministry of Health manage the Essential Medicines List with Risk of Discontinuity (MED-ESS), introduced by Order MS 269/2017 (Ministry of Health Order) and updated through successive government ordinances (OG). The list comprises ~300-400 medicines considered vital (oncology, cardiology, essential antibiotics, insulins, vaccines).

Listed manufacturers are obliged to notify ANMDMR at least 60 days before any interruption of deliveries in RO. The notifications are public on anm.ro → 'Medicine discontinuities'. There you can see in real time what is unavailable and what alternatives have been identified.

How to find out a medicine is unavailable

Official sources

• anm.ro → 'Discontinuity notifications' — official list with all active notifications. You search by INN (International Nonproprietary Name — the active-substance name) or commercial name.
• The ANMDMR informative bulletin — a newsletter for professionals, but publicly accessible.
• cnas.ro (CNAS — the National Health Insurance House) — announcements about discontinuities for reimbursed medicines.

Practical sources

• Your pharmacist — knows in real time what is out of stock and since when. Call 2-3 pharmacies before heading out.
• Large online chains — the websites dona.ro, catena.ro, farmaciatei.ro, helpnet.ro, drmax.ro show the 'In stock / Unavailable' status in real time.
• HartaFarmacii — on the product page you see in how many pharmacies it is listed at public prices — a good proxy for national availability.

Legal alternatives — what you can do

1. INN substitution — different manufacturer, same medicine

The easiest alternative. If the originator is unavailable, a generic may be present (or vice versa). The pharmacist proposes; you accept or not. The active substance, dose and form are identical. See the article on generic vs brand.

2. A different INN from the same therapeutic class

Decided by the doctor, not the pharmacist. For example, if lisinopril is missing, the doctor can switch to enalapril or ramipril (all ACE inhibitors — angiotensin- converting enzyme inhibitors). Requires a new prescription.

3. Authorized parallel import

ANMDMR can authorize the parallel import of a medicine from an EU country when the Romanian version is missing. A bureaucratic procedure, it takes weeks. For serious cases (oncology, rare diseases).

4. Special procurement through the hospital

For hospitalized patients or those with rare diseases, the hospital can carry out special procurement directly from the manufacturer or through an approved distributor — procedures through the ANMDMR Commission.

5. Personal purchase from another EU state

Legal — within the EU you can buy Rx medicines for personal use from other states, with the original prescription. You need a cross-border recognized prescription (standardized form) and to comply with the customs rules of the source country. Impractical for chronic conditions, but sometimes the last resort.

Notable RO cases 2023-2026

• Lantus and Toujeo insulin (2023-2024) — repeated discontinuities; solution: temporary switch to Levemir or Tresiba (other long-acting analogues), coordinated by the diabetologist.
• Pediatric paracetamol syrup (winter 2022-2023) — massive European shortage. Solutions: alternative manufacturers (Terapia, Antibiotice Iași), suppositories, dissolvable paracetamol tablets.
• Pediatric amoxicillin syrup (2023) — shortage for a few months. Alternatives: amoxicillin tablets (over 6 years, under medical supervision), or alternative antibiotics (clarithromycin, cephalexin) at the doctor's decision.
• Salbutamol inhaler (Ventolin) — episodic discontinuities. Alternatives: other salbutamol inhalers (generics), or other short-acting β2-agonists (terbutaline).

The role of large chains and distributors

Chains with extensive networks (Catena, Dona, Tei, Help Net, Dr.Max) have advantages in managing shortages:

• Large volumes — they can maintain centralized safety stocks in their own warehouses. When a local pharmacy doesn't have it, it is restocked within 24-48h from another point in the network.
• Direct contracts with manufacturers — partial bypass of distributors, priority for delivery in case of limited stocks.
• Integrated IT systems — you see in real time on the chain's website in which pharmacies the product is 'In stock' and you reserve it for pickup.
• Specialized chains — Mattca and Springfarma have a more specialized profile in certain categories (dermocosmetics, supplements, pediatric products). For OTCs and supplements, prices may be better. For essential Rx, supply is similar to the large chains.
• Independents — often supply exclusively through a distributor, without large own reserves. More vulnerable to short shortages. They do, however, have personal relationships with patients and can call when the product is available.

For you, as a patient with a critical medicine, the practical recommendation is: build yourself a 'network' of 2-3 pharmacies — one in a large chain with volume, one personalized independent, possibly one online with fast delivery. That way, if one doesn't have it, you have alternatives.

The EU-level reporting mechanism

At the European level, the EMA (European Medicines Agency) coordinates monitoring of the availability of critical medicines through the SPOC (Single Point of Contact) group. Each member state reports shortages to the EMA, and the EMA publishes the Critical Medicines Shortages Catalogue — accessible on ema.europa.eu.

Also, starting in 2024, the EMA manages a buffer of strategic stocks for several vulnerable categories (essential antibiotics, vaccines, critical oncology). The stocks are distributed to states with severe shortages through a European solidarity mechanism. If Romania reports a critical shortage, ANMDMR can request access through this mechanism.

The impact of shortages on patients

European studies show that medicine shortages produce three types of harm:

• Treatment interruptions — especially in psychiatry (antidepressants, antipsychotics) where abrupt discontinuation produces withdrawal or relapse. In epilepsy, missing antiepileptics can lead to seizures.
• Switching to less optimal alternatives — the patient stabilized on X is forced to switch to Y, with different side effects, possibly less well tolerated. Adjustment takes weeks.
• Additional costs — expensive alternatives (when generics are missing, the originator remains available but with an additional payment by the patient over the reference price).

Patient associations (FAR-Rare, Coalition for Cancer Patients, the Diabetes Federation) monitor these impacts and can mediate reports to ANMDMR + the press. For individual patients, the first step is your pharmacist; the second, the family doctor or specialist.

What to do as a patient with a chronic medicine

1. Reserve stock. Always at least 7-14 days beyond the current treatment. For insulin-dependent patients, at least 2 active pens.
2. Check ANMDMR Notifications at every treatment change. If you start a new medicine, check on anm.ro whether it is listed among possible discontinuities.
3. Know the class alternatives. Ask your doctor: 'If X is not available, what alternative from the same class exists?' — that way you have a plan B ready.
4. For 90-day chronic prescriptions — pick up the entire stock at the first visit, not monthly. If a shortage appears, you have the reserve.
5. For rare diseases — keep in contact with the patient association (FAR-Rare, the Cancer Patients Association, etc.). They monitor stocks at accredited centers.

How to report a shortage

If you find an essential medicine unavailable in several pharmacies, you can report it on the ANMDMR form (anm.ro → shortage reports) or on the CNAS green line (0800.800.350). Reports feed the monitoring lists and can accelerate parallel import or special procurement procedures.