The Risks of Generic Drugs

Marc

Hunkered Down for the Duration
Staff member
Admin
#1
I wasn't sure where to put this. It isn't really news, and doesn't really belong in the pharmaceutical forums. So...

I posted this because I have been hearing and reading about the dangers of Generic Drugs. More and more people are fighting their insurance company over insurance company requirements for generic drugs. I know in the past there were a few drugs that I took that it was obvious that the generic drug "equivalent" simply did not have the same effects as the brand name. I also noticed that several states have enacted laws for certain drugs, such as drugs to treat epilepsy and other seizure conditions, which do not allow generic drugs. If you are prescribed a generic drug, it may actually be harmful. I do know a few people who have challenged their insurance company over not paying for "brand name" drugs.

It's your life - Are you willing to take a chance?

The Risks of Generic Drugs

Just because it is a "generic" drug doesn't mean it is an *equivalent* drug. It doesn't even mean it's safe to take.

Just my :2cents: - Something to think about.
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#2
Disclosure: I work for a generics company; My specialism is meddevices so an indepth discussion on bioequivalence, pharmacokinetics etc is beyond me.

The bias in this article is quite apparent in my opinion. All pharmaceuticals are reviewed by the authorities, including generics...FDA/european competent authorities. They have all been deemed suitable for the issue of a license. If they are not up to the necessary standards they are not issued with a license

Fundamentally, all medications carry risks and side effects, including the brand; the statement that "just because it carries a brand does not mean it's safe to take" can also be said to be true.

It is acknowledged and well known that certain medications, such as those used to treat epilepsy cannot be easily changed to a generic form, but it goes both ways - a patient who starts on generics equally cannot easily be switched the branded variant.

I think on balance, the doctor, using their expertise and training needs to make a balanced on the best method to treat their patient, weighing up risk, outcomes and cost. As patients we need to be able to trust them in their ability to do this as do the insurance companies or health service (whoever pays the bill)

Edit:
1. just read that most of the generic actives come from overseas...where do they think the brand actives come from?!
2. glass in lipitor...of course no branded drug has ever had a quality issue! :sarcasm:

...I'm just angry now.
 
Last edited:

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
The article is biased to some degree, as are most. The reason I posted is that I have experienced the problem of the drug not working like the "brand name" drug, as have some other people I know. The most recent was someone I know who was prescribed Restoril. The first few prescriptions the insurance company paid for. It then "made a judgement" that a generic would be OK and refused to pay for the brand name. Since the brand name was about 10x more expensive she simply could not afford it. She stopped taking the generic because it simply didn't work. So, she has a prescription for a drug but doesn't even bother to fill it.

This is as much about insurance companies as it is about generic drugs.

As to doctors, being from a medical family, I know the games (e.g.: How would you like a nice 5 day cruise?) and I know that many doctors these days do not necessarily weigh (or know) the risks of many generic vs. brand drugs.

I'll also speak as someone who majored in biology in college (with a minor in chemistry), admittedly many years ago, but I did take organic chemistry and biochemistry so I do have a decent understanding of pharmaceuticals and how they work. "Reverse engineering" a process is often a gamble. While the formula is important, the *process* (in this case drug synthesis) often is just as important.

Add to that:
From the Article said:
Since the original drug has already been tested for safety, the FDA only requires that the generic produce the same level of medicine in the bloodstream (within the 80-125% range), i.e. bio-equivalence, as the brand name. The testing for this is done not on actual patients, but on a small number of healthy volunteers (between 24 and 36 people). Many critics point out the need to test the generics on actual patients in order to determine efficacy.
That's the point that gets me. Efficacy. Without clinical testing its not known whether the drug actually works as intended or not.
 

Miner

Forum Moderator
Staff member
Admin
#4
Another issue that I see, that is arguably worse, is where the insurance companies drive the use of a different generic medication, not just a generic version of what the doctor prescribed. This different medication may not be as effective as the generic version of the prescribed medication.
 
P

PaulJSmith

#5
Under any type of "managed" health care system, this will likely always be a problem. So long as the focus is on cost, suitability will always be of secondary importance. This is the primary reason why allowing bureaucrats and bean counters (or anyone other than doctors, for that matter) the power to make medical decisions is a bad idea.
 
W

Walnut

#6
I agree with Pauls concerns except I have little trust in the Doctors making good decisions also. Think who is paying their invoices. Their customers are the government and insurance companies not us. Now being good Quality professionals who is the stakeholder that gets first priority?
 

Mike S.

Happy to be Alive
Trusted Information Resource
#7
Someone has to pay when a more expensive drug is taken vs. a cheaper one. There is no free lunch.

For the record, every drug I take right now is generic and the lab tests and/or my response suggest they are working, FWIW. I once needed a more expensive brand-name drug (no generic available) and had to first try a cheaper brand name drug before my insurance would allow the more expensive one, but I would have done the same experiment myself if it was money from my pocket.

If the money is coming out of your own pocket and you have a choice of a $300 brand-name and a $45 generic which one would you pick to try first?

And there is nothing stopping you from paying for the more expensive drug if you truly need it.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#8
<snip> And there is nothing stopping you from paying for the more expensive drug if you truly need it.
People who can afford it. Not everyone can pay for a prescription that costs US$300+ a month (or more) as many drugs do, not to mention often there are multiple prescriptions/different drugs.

Since about 1998 I have just ordered drugs from Canada, the UK, or Switzerland. Brand name drugs are usually only about 15 to 25% of what I would pay in the US. Prices of generics in the US have gone up so much recently that buying brand name from outside the US these days is about as cheap, or as cheap as, as generics in the US. Then again, if it's something simple like aspirin (one of the drugs I remember synthesizing in an early chemistry class in college) - The local store.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#9
How do you know you are getting the same brand name drug as in the US when you buy from a foreign country?

Surely you have read those horror stories?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#10
The only difference is the price as those governments control drug costs. I trust brand drugs from Canada, the UK and Switzerland as much as "US" drugs. There was a short period not too long ago when the US tried to stop people from importing drugs, or in places like the northern border of the US people just driving over and picking them up. That didn't last too long.

The only horror stories I have read about are about drugs from "no prescription necessary" pharmacies. They rarely have any brand drugs to begin with, or at least didn't in the past. I haven't checked any of those in a long time.
 
Thread starter Similar threads Forum Replies Date
S Are risks in supply chain and development activities within scope of MDD? EU Medical Device Regulations 3
Robert Stanley I'm @ RISK of not showing my RISKS! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
Richard Regalado Top 10 operational risks of 2019 for business continuity planning Business Continuity & Resiliency Planning (BCRP) 6
A Managing overseas travel risks to food handlers Food Safety - ISO 22000, HACCP (21 CFR 120) 3
T ISO 14971-2019 doubt - Evaluate if estimated risks are acceptable ISO 14971 - Medical Device Risk Management 9
M Informational US FDA – URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Dev Medical Device and FDA Regulations and Standards News 0
Jacquie Collins 6 Risks and Opportunities ISO 14001:2015 ISO 14001:2015 Specific Discussions 6
D How to Identify the Risks and Opportunities required for QMS Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Are Risks and Opportunities Required as Part of the Process Definition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
H Addressing of Undesirable side-effects, harms, risks and side-effects in clinical evaluation report (CER) EU Medical Device Regulations 12
M Informational How To Avoid Compliance & Timeline Risks When Selecting A Medical Device Supplier Medical Device and FDA Regulations and Standards News 0
M Informational Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House Medical Device and FDA Regulations and Standards News 0
M FDA News Safety Alert – USFDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation Medical Device and FDA Regulations and Standards News 0
B ISO 17025 8.5 Actions to address risks and opportunities ISO 17025 related Discussions 7
A Risks and Opportunities associated to Legal Compliance - 6.1.3 ISO 14001:2015 Specific Discussions 4
O Examples of the external and internal issues and their risks and opportunities IATF 16949 - Automotive Quality Systems Standard 2
A Risks related to Method Validation and Stability Studies Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
qualprod ISO 9001 Risk control method - What could be the better way to control risks? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Redundancy between Process risks and Process Performance indicators ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Risks and opportunities that could be associated with the purchasing department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q ISO 14001:2015 Clause 6.1: Actions to address Risks & Opportunities ISO 14001:2015 Specific Discussions 2
Sidney Vianna Guidance on Management of Psychosocial Risks in the Workplace Occupational Health & Safety Management Standards 5
H Depth in the organization for Interested Parties and Risks & Opportunities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Compliance Obligations - Implementing 6.1.1 and 6.1.3 NOTE - Determine risks and... ISO 14001:2015 Specific Discussions 1
I Is risk acceptability really needed if all risks must be reduced as far as possible? ISO 14971 - Medical Device Risk Management 6
Q ISO 9001:2015 - Clarification in 6.1.2 Note 1 (Options to Address Risks) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Practical guide to scan for Risks in all QMS systems without missing any ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Q Risks Examples in Top Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
oldqamanager How will you handle Clause 6.1 - Risks and Opportunities for AS9100 Rev. D Auditors? Risk Management Principles and Generic Guidelines 22
Q SWOT Outputs - Risks, Opportunities and Improvements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Source of practice to Evaluate Risks? (ISO 9001:2015) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Opportunities only derived from Risks? Detecting Risk & Opportunities in ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Does KPI for Processes need to be correlated with the specific Risks for Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Actions To Address Risks and Opportunities IATF 16949 - Automotive Quality Systems Standard 1
W Chinese Authorized Representative - What are the regulatory risks? China Medical Device Regulations 3
M Informational Is Identification of Risks and Opportunities required for QMS Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 96
V Deleting Risks if a particular Risk has been Eliminated ISO 14971 - Medical Device Risk Management 3
A Informational Confusion about Risks for Processes in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 44
R OHSAS 18001:2007 Section 3 - Controlling Work Place Risks Occupational Health & Safety Management Standards 3
D Biological and Chemical Risks to the user in the Hazard Analysis ISO 14971 - Medical Device Risk Management 1
C Risks involved in requesting Cert to ISO9001:2015 right when released ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Risks to Health - Patient and Clinician ISO 14971 - Medical Device Risk Management 4
Ajit Basrur FDA issues Guidance Document - Benefits-Risks Factors to consider for 510(K) US Food and Drug Administration (FDA) 1
x-files [QMS] Identification and Evaluation of Aspects, Impacts and Risks... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S How are risks managed according to AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
L Residual risks which the PMCF study is based on ISO 14971 - Medical Device Risk Management 7
J Risks Analysis of an Active Implantable Muscle Stimulator ISO 14971 - Medical Device Risk Management 8
Q Risk Factors Checklist identifying the Risks for meeting the Customer Indent AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
V Utility (power production) Company - Mitigating risks in Verification and Validation. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
O Requirements under OHSAS 18001 for the Control of Risks Occupational Health & Safety Management Standards 8

Similar threads

Top Bottom