Drug shortage prescription versus shortage with side effects

Drug shortage: prescription versus shortage with side effects?

Common questions

Status: 12/21/2022 1:48 pm

The Minister of Health, Lauterbach, wants to put an end to the “discount policy” of medicines and has presented concrete measures against supply bottlenecks. What do they look like – and how quickly do they work?

the initial situation

Drug shortages in the rich industrial country of Germany? Families in particular are concerned that some medicines for their children are not available from pharmacies. The reasons for supply bottlenecks are varied, and some are also homemade. “We also exaggerate the economics of supplying off-patent drugs,” said Federal Health Minister Karl Lauterbach. He spoke of “discount policy”. To counteract this, pillars of a law include new pricing rules. The production of medicines should come back.

What is missing?

The Federal Office of Medicines and Medical Devices (Bfarm) classifies 51 drugs with 17 active ingredients as critical in about 300 reported delivery bottlenecks. The focus here is on off-patent drugs. There are particular difficulties in the therapy of oncological diseases (tamoxifen, folinate) and fever juices for children (paracetamol and ibuprofen).

How are medications reimbursed?

The lump sums are maximum values ​​for medication reimbursement by health plan operators. If the price is higher, the patient has to pay the difference – in addition to the normal contribution of five to ten euros. If the price is 30% lower, there is no co-payment for the drug at the pharmacy. at the discount agreements health insurance companies enter into special contracts with the cheapest generic supplier. Pharmacists are only authorized to dispense this medication to the insured person. Currently, a Corona exception regulation applies to pharmacies: if the drugs are not available, pharmacies can switch the drug.

What is the current issue?

Price competition in the generics market is forcing some drug manufacturers to withdraw, mainly from active principles that require higher production costs (infusions, juices, suppositories, drugs against cancer). This fuels the process of concentration on just a few manufacturers and suppliers in third countries. This means that there is a risk of strategic dependencies on third countries to supply pharmaceuticals for important groups of active ingredients such as antibiotics. Lack of diversity leads to delivery bottlenecks if a manufacturer or supplier fails.

What is Minister Lauterbach planning?

For pediatric drugs pricing rules are relaxed: fixed prices and discount contracts are abolished. For certain drugs, up to 1.5 times the fixed amount must be paid by legal health insurers – that is, the maximum amount that you previously paid the manufacturer for a preparation. Lauterbach said at ARD that cash registers would be instructed immediately to pay that extra 50 percent. This means that there are more alternatives for patients with legal health insurance. According to the ministry’s key points, specialists from the Federal Institute of Medicines and Medical Devices should create a list of necessary preparations for child care. In order to reduce the cost pressure, there should no longer be discount agreements for them.

for gaps in supply networks To avoid this in the future, supply must be better secured, also against problems with deliveries from Asia and dependencies on individual suppliers. Health insurers should initially be given a location to consider when bidding on cancer drugs and antibiotics. In an additional part, in addition to the award based on price, they had to contract based on the criterion “part of active ingredient production in the EU”. This should ensure that more reliable European manufacturers are preferred, Lauterbach explained. Mandatory storage of drugs at a discount for several months is stipulated for health insurance contracts with manufacturers.

also in sight pharmacies, who take care of alternatives for customers when products are not currently available. “If a medicine is not in stock, they will be able to sell a medicine with the same active principle in the future or make juices from pills”, explained Lauterbach. “If you have to see the doctor for that, you’ll be rewarded for it.” As per the key points, a flat fee of 50 cents is provided. The Federal Union of German Pharmacists’ Associations called the amount “an impertinence”. That doesn’t even begin to subsidize working hours.

What Health Minister Lauterbach is planning against drug shortages

Nicole Kohnert/Eckhardt Wolf, ARD Berlin, daily topics 22:10, December 20, 2022

Will the defect be fixed quickly?

This is questionable. The minister spreads optimism. He expects the measures he has initiated to improve drug supplies to children “to take effect very quickly,” Lauterbach said on Tuesday. General practitioners and pharmacies, on the other hand, only see a first aid sticker on plans. “The measures now discussed will only help to a limited extent in short-term general practitioner care,” Nicola Buhlinger-Göpfarth, deputy head of the German Association of General Practitioners, told the “Rheinische Post”. The bottlenecks of childbirth can be felt very clearly in the practices of the family doctor.

The North Rhine Pharmacists’ Association also expects long-lasting problems in drug delivery. “We assume that delivery problems will continue into 2023 and that other drugs will be affected,” said association leader Thomas Preis. Lauterbach’s plans are just “a drop in the ocean” because they don’t solve the structural problem. “As with the corona vaccine, the state must give manufacturers guarantees for the purchase of basic medicines,” he demanded.

Statutory health insurers spokesman Florian Lanz reiterated his doubts about the effectiveness of Lauterbach’s measures. “I think it’s extremely unlikely that we’ll get even a cough syrup from the pharmacy faster,” Lanz told Bavarian radio.

Health insurers reacted particularly critically – why?

Because they themselves would have to bear the additional costs of higher drug prices. GKV CEO Doris Pfeiffer spoke of an “impressive Christmas present for pharmaceutical companies”. She blamed the pharmaceutical industry for the situation. “Fulfillment of supply contracts and reliable delivery of promised products must be a matter of routine, especially in such a sensitive area as the supply of pharmaceuticals,” explained Pfeifer. “Unfortunately, the pharmaceutical industry has not acted that way in many cases.” Delivery failures and supply problems were the result.

However, Lauterbach’s plans will not initially lead to higher health insurance contributions. Although policyholders of statutory health insurance insurers will have to pay higher additional contributions in 2023, they are likely to be lower than expected. So far, it can be assumed that the additional contribution will increase by 0.2 percentage points to a total of 1.5, Pfeiffer told newspapers of the Funke media group. Health operators were below the 0.3 percentage point increase announced by the Ministry of Health. A record shortfall of €17 billion is expected for statutory health insurance next year.

What does the pharmaceutical industry say?

From the point of view of the pharmaceutical industry, the ministry has finally recognized that the “main principle of cheapness” is destabilizing supply. This goes to the root of the problem, explained the association Pro Generika.

What is the next?

Legislative plans must be implemented in the new year. Until then, there will still be a need for speeches, and there could also be a “medicines summit” with everyone interested at one table. However, Lauterbach receives basic political support for his plans.

The minister’s plans are not going to change the tense situation of many families with sick children, in overcrowded offices and clinics – especially now before Christmas and the turn of the year. The German Association of Cities therefore appealed to resident doctors to keep their offices open longer. “Please consider keeping your practices open after 6 pm on Saturdays, Sundays and public holidays,” general manager Helmut Dedy told newspapers from the Funke media group.

In the case of simple illnesses, patients should call the resident doctors’ outpatient emergency number, 116 117, and not the local emergency service’s 112 number. This is for real emergencies only. In addition to Corona, other respiratory illnesses such as the RS virus in children are causing many serious infections and overwhelmed clinics. Many clinic staff are also sick.